{"id":"F2017L01264","name":"National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8) (PB 71 of 2017)","slug":"national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97182,"registerId":"commonwealth-F2017L01264-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8) (PB 71 of 2017)","content":"![](image.001.png)\n\nPB 71 of 2017\n\nNational Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017  \n(No. 8)\n\nNational Health Act 1953\n\nI, JULIANNE QUAINE, First Assistant Secretary (Acting), Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Instrument under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953.\n\nDated 19 September 2017\n\nJULIANNE QUAINE\n\nFirst Assistant Secretary (Acting)\n\nTechnology Assessment and Access Division\n\nDepartment of Health\n\n  \n1 Name of Instrument\n\n(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8).\n\n(2) This Instrument may also be cited as PB 71 of 2017.\n\n2 Commencement\n\nThis Instrument commences on 1 October 2017.\n\n3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)\n\nSchedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).\n\nSchedule 1 Amendments\n\n\\[1\\] Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg\n\n    (a) insert in the column headed “Schedule Equivalent” for all brands: a\n    (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | ZETIN | RW  | MP  | C5727 C5789 |     | 100 | 2   | 100 |     |     |\n| --- | --- | --- | --- | ----- | --- | --- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[2\\] Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) \\[Maximum  \nQuantity: 1; Number of Repeats: 2\\]\n\n    (a) omit from the column headed “Circumstances”: C6518 C6567 C6574 C6594  \n    insert in numerical order: C7078 C7100 C7101 C7132\n    (b) omit from the column headed “Purposes”: P6567 P6574 P6594  \n    insert in numerical order: P7100 P7101 P7132\n\n\\[3\\] Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) \\[Maximum  \nQuantity: 1; Number of Repeats: 5\\]\n\n    (a) omit from the column headed “Circumstances”: C6518 C6567 C6574 C6594  \n    insert in numerical order: C7078 C7100 C7101 C7132\n    (b) omit from the column headed “Purposes”: P6518  \n    insert in numerical order: P7078\n\n\\[4\\] Schedule 1, entry for Alprazolam in the form Tablet 500 micrograms\n\nomit:\n\n|     |     |     | a   | Alprax 0.5 | QA  | MP NP | C6773 |     | 10  | 0   | 50  |     |     |\n| --- | --- | --- | --- | ---------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\nsubstitute:\n\n|     |     |     | a   | Alprax 0.5 | QA  | MP NP | C6773 |     | 10  | 0   | 10  |     |     |\n| --- | --- | --- | --- | ---------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n|     |     |     |     |            |     | MP NP | C6773 |     | 10  | 0   | 50  |     |     |\n\n  \n\n\\[5\\] Schedule 1, entry for Alprazolam in the form Tablet 1 mg\n\nomit:\n\n|     |     |     | a   | Alprax 1 | QA  | MP NP | C6773 |     | 10  | 0   | 50  |     |     |\n| --- | --- | --- | --- | -------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\nsubstitute:\n\n|     |     |     | a   | Alprax 1 | QA  | MP NP | C6773 |     | 10  | 0   | 10  |     |     |\n| --- | --- | --- | --- | -------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n|     |     |     |     |          |     | MP NP | C6773 |     | 10  | 0   | 50  |     |     |\n\n\\[6\\] Schedule 1, after entry for Amino acid formula without valine, leucine and isoleucine\n\ninsert:\n\n| Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid | Sachets containing oral powder 12.5 g, 30 (PKU Anamix First Spoon) | Oral |     | PKU Anamix First Spoon | SB  | MP NP | C4295 |     | 8   | 5   | 1   |     |     |\n| -------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------ | ---- | --- | ---------------------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[7\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 5/10 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 5/10 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n  \n\n\\[8\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 5/20 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 5/20 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n\\[9\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 5/40 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 5/40 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n\\[10\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 5 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 5/80 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 5/80 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n  \n\n\\[11\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 10 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 10/10 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | ---------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 10/10 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n\\[12\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 20 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 10/20 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | ---------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 10/20 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n\\[13\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 40 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 10/40 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | ---------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 10/40 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n  \n\n\\[14\\] Schedule 1, entry for Amlodipine with Atorvastatin in the form Tablet 10 mg amlodipine (as besylate) with 80 mg atorvastatin (as calcium)\n\n    (a) omit:\n\n|     |     |     |     | Chem mart Amlodipine/ Atorvastatin 10/80 | CH  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | ---------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Terry White Chemists Amlodipine/ Atorvastatin 10/80 | TW  | MP NP | C5619 C5694 C5750 C5751 C5787 C5788 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------------------------------------------------- | --- | ----- | ----------------------------------- | --- | --- | --- | --- | --- | --- |\n\n\\[15\\] Schedule 1, entry for Auranofin\n\ninsert as first item in the columns in the order indicated:\n\n|     | Capsule 3 mg | Oral |     | Ridaura | BZ  | MP NP |     |     | 60  | 5   | 60  |     |     |\n| --- | ------------ | ---- | --- | ------- | --- | ----- | --- | --- | --- | --- | --- | --- | --- |\n\n\\[16\\] Schedule 1, entry for Azacitidine\n\ninsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | AZACITIDINE DR.REDDY'S | RI  | MP  | See Note 3 | See Note 3 | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | ---------------------- | --- | --- | ---------- | ---------- | ---------- | --------- | --- | --- | ------ |\n\n\\[17\\] Schedule 1, entry for Bimatoprost in the form Eye drops 300 micrograms per mL, 3 mL\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Bimatoprost Sandoz | SZ  | MP AO |     |     | 1   | 5   | 1   |     |     |\n| --- | --- | --- | --- | ------------------ | --- | ----- | --- | --- | --- | --- | --- | --- | --- |\n\n    (b) insert in the column headed “Schedule Equivalent” for the brand “Lumigan”: a\n\n\\[18\\] Schedule 1, after entry for Brentuximab vedotin\n\ninsert:\n\n| Brexpiprazole | Tablet 1 mg | Oral |     | Rexulti | LU  | MP NP | C4246 |     | 30  | 0   | 30  |     |     |\n| ------------- | ----------- | ---- | --- | ------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n|               | Tablet 2 mg | Oral |     | Rexulti | LU  | MP NP | C4246 |     | 30  | 5   | 30  |     |     |\n|               | Tablet 3 mg | Oral |     | Rexulti | LU  | MP NP | C4246 |     | 30  | 5   | 30  |     |     |\n|               | Tablet 4 mg | Oral |     | Rexulti | LU  | MP NP | C4246 |     | 30  | 5   | 30  |     |     |\n\n  \n\n\\[20\\] Schedule 1, entry for Capecitabine in the form Tablet 150 mg\n\nomit:\n\n|     |     |     | a   | Capecitabine Sandoz | SZ  | MP  |     |     | 60  | 2   | 60  |     |     |\n| --- | --- | --- | --- | ------------------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n\\[21\\] Schedule 1, entry for Cefepime in each of the forms: Powder for injection 1 g (as hydrochloride); and Powder for injection 2 g  \n(as hydrochloride)\n\nomit:\n\n|     |     |     | a   | Cefepime Sandoz | SZ  | MP NP | C5842 |     | 10  | 0   | 1   |     |     |\n| --- | --- | --- | --- | --------------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[22\\] Schedule 1, entry for Cefotaxime in the form Powder for injection 1 g (as sodium)\n\n    (a) omit:\n\n|     |     |     |     | Cefotaxime Sandoz | SZ  | MP NP | C5827 C5828 C5829 |     | 10  | 0   | 1   |     |     |\n| --- | --- | --- | --- | ----------------- | --- | ----- | ----------------- | --- | --- | --- | --- | --- | --- |\n|     |     |     |     |                   |     | PDP   | C5892             |     | 10  | 0   | 1   |     |     |\n\n    (b) omit from the column headed “Circumstances” for Authorised Prescriber MP NP: C5827 C5828 C5829 substitute: C5826 C5881 C5890\n    (c) omit from the column headed “Circumstances” for Authorised Prescriber PDP: C5892 substitute: C5905\n\n\\[23\\] Schedule 1, entry for Chorionic gonadotrophin\n\nomit:\n\n|     | Injection set containing 3 ampoules powder for injection 1,500 units and 3 ampoules solvent 1 mL | Injection |     | Pregnyl | MK  | MP  | C6991                         |     | 1   | 0   | 1   |     | C(100) |\n| --- | ------------------------------------------------------------------------------------------------ | --------- | --- | ------- | --- | --- | ----------------------------- | --- | --- | --- | --- | --- | ------ |\n|     |                                                                                                  |           |     |         |     | MP  | C6979 C6987 C6989 C6990 C6995 |     | 1   | 5   | 1   |     |        |\n\n\\[24\\] Schedule 1, entry for Cisplatin in the form I.V. injection 100 mg in 100 mL\n\nomit:\n\n|     |     |     |     | Cisplatin Ebewe | SZ  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | --------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n  \n\n\\[25\\] Schedule 1, entry for Dexamethasone in the form Intravitreal injection 700 micrograms\n\nomit from the column headed “Circumstances”: C6542 C6560 substitute: C7083 C7133\n\n\\[26\\] Schedule 1, entry for Doxorubicin\n\nomit:\n\n|     | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 10 mg in 5 mL single dose vial | Injection/ intravesical |     | Doxorubicin SZ      | HX  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | ------------------------------------------------------------------------------------------------------------------------------ | ----------------------- | --- | ------------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n|     |                                                                                                                                |                         |     | Hospira Pty Limited | PF  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n\n\\[27\\] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 50 mg in 25 mL single dose vial\n\n    (a) insert in the columns in the order indicated:\n\n|     |     |     |     | Adriamycin | PF  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | ---------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n    (b) omit:\n\n|     |     |     |     | Hospira Pty Limited | PF  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | ------------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n\\[28\\] Schedule 1, entry for Doxorubicin\n\nomit:\n\n|     | Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 100 mg in 50 mL single dose vial | Injection/ intravesical |     | Doxorubicin Ebewe | SZ  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | -------------------------------------------------------------------------------------------------------------------------------- | ----------------------- | --- | ----------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n  \n\n\\[29\\] Schedule 1, entry for Doxorubicin in the form Solution for I.V. injection or intravesical administration containing doxorubicin hydrochloride 200 mg in 100 mL single dose vial\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     |     | Adriamycin | PF  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | ---------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n    (b) omit:\n\n|     |     |     |     | Doxorubicin SZ | HX  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | -------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n\\[30\\] Schedule 1, entry for Ibuprofen\n\nsubstitute:\n\n| Ibuprofen | Tablet 400 mg | Oral | a   | APO-Ibuprofen 400 | TX  | MP NP MW PDP |     |                   | 30  | 0   | 30  |     |     |\n| --------- | ------------- | ---- | --- | ----------------- | --- | ------------ | --- | ----------------- | --- | --- | --- | --- | --- |\n|           |               |      | a   | Brufen            | GO  | MP NP MW PDP |     |                   | 30  | 0   | 30  |     |     |\n|           |               |      | a   | APO-Ibuprofen 400 | TX  | PDP          |     | P6256 P6282       | 90  | 0   | 30  |     |     |\n|           |               |      | a   | Brufen            | GO  | PDP          |     | P6256 P6282       | 90  | 0   | 30  |     |     |\n|           |               |      | a   | APO-Ibuprofen 400 | TX  | MP NP        |     | P6149 P6214 P6283 | 90  | 3   | 30  |     |     |\n|           |               |      | a   | Brufen            | GO  | MP NP        |     | P6149 P6214 P6283 | 90  | 3   | 30  |     |     |\n\n\\[31\\] Schedule 1, entry for Irbesartan with Hydrochlorothiazide in the form Tablet 300 mg-12.5 mg\n\nomit:\n\n|     |     |     | a   | Irbesartan/HCTZ RBX 300/12.5 | RA  | MP NP | C4374 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | ---------------------------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[32\\] Schedule 1, entry for Irinotecan in the form I.V. injection containing irinotecan hydrochloride trihydrate 40 mg in 2 mL\n\n    (a) insert in the column headed “Manner of Administration”: Injection\n    (b) omit:\n\n|     |     |     |     | Irinotecan Ebewe | SZ  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | ---------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n  \n\n\\[34\\] Schedule 1, entry for Irinotecan in each of the forms: I.V. injection containing irinotecan hydrochloride trihydrate 100 mg in 5 mL; and  \nI.V. injection containing irinotecan hydrochloride trihydrate 500 mg in 25 mL\n\nomit:\n\n|     |     |     |     | Irinotecan Ebewe | SZ  | MP  |     |     | See Note 3 | SeeNote 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | ---------------- | --- | --- | --- | --- | ---------- | --------- | --- | --- | ------ |\n\n\\[35\\] Schedule 1, entry for Iron Polymaltose Complex\n\nomit:\n\n|     |     |     |     | Ferrum H | AS  | MP NP |     |       | 5       | 0       | 5   |     |     |\n| --- | --- | --- | --- | -------- | --- | ----- | --- | ----- | ------- | ------- | --- | --- | --- |\n|     |     |     |     |          |     | MP NP |     | P4302 | 5CN4302 | 5CN4302 | 5   |     |     |\n\n\\[36\\] Schedule 1, entry for Leflunomide in the form Tablet 10 mg\n\ninsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Ataris 10 | AF  | MP  | C5681 C5766 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[37\\] Schedule 1, entry for Leflunomide in the form Tablet 20 mg\n\ninsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Ataris 20 | AF  | MP  | C5681 C5766 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[38\\] Schedule 1, entry for Methylphenidate in the form Tablet containing methylphenidate hydrochloride 10 mg\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Artige | NM  | MP NP | C6226 |     | 100 | 5   | 100 |     |     |\n| --- | --- | --- | --- | ------ | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n    (b) insert in the column headed “Schedule Equivalent” for the brand “Ritalin 10”: a\n\n\\[39\\] Schedule 1, entry for Mirtazapine in the form Tablet 15 mg\n\n    (a) insert in the column headed “Schedule Equivalent” for all brands: a\n    (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | MIRTANZA | RF  | MP NP | C5650 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n  \n\n\\[40\\] Schedule 1, entry for Mirtazapine in the form Tablet 30 mg\n\n    (a) insert in the column headed “Schedule Equivalent” for all brands: a\n    (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | MIRTANZA | RF  | MP NP | C5650 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[41\\] Schedule 1, entry for Mirtazapine in the form Tablet 45 mg\n\n    (a) insert in the column headed “Schedule Equivalent” for all brands: a\n    (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | MIRTANZA | RF  | MP NP | C5650 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[42\\] Schedule 1, entry for Modafinil\n\n    (a) insert in the column headed “Schedule Equivalent” for the brand “Modafin”: a\n    (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Modafinil Mylan | AF  | MP  | C6537 C6556 |     | 120 | 5   | 60  |     |     |\n| --- | --- | --- | --- | --------------- | --- | --- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[43\\] Schedule 1, entry for Morphine in the form Tablet containing morphine sulfate 10 mg (controlled release)\n\ninsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Morphine MR Mylan | AF  | MP NP | C4556 |     | 28  | 0   | 28  |     |     |\n| --- | --- | --- | --- | ----------------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[44\\] Schedule 1, entry for Morphine in each of the forms: Tablet containing morphine sulfate 30 mg (controlled release); Tablet containing morphine sulfate 60 mg (controlled release); and Tablet containing morphine sulfate 100 mg (controlled release)\n\ninsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Morphine MR Mylan | AF  | MP NP | C4556 |     | 28  | 0   | 28  |     |     |\n| --- | --- | --- | --- | ----------------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[45\\] Schedule 1, entry for Norfloxacin\n\nomit:\n\n|     |     |     |     | Norfloxacin Sandoz | SZ  | MP NP | C5744 C5806 |     | 14  | 1   | 14  |     |     |\n| --- | --- | --- | --- | ------------------ | --- | ----- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[46\\] Schedule 1, entry for Oxycodone in the form Oral solution containing oxycodone hydrochloride 5 mg per 5 mL, 250 mL\n\n    (a) omit from the column headed “Form”: 5 mg per 5 mL substitute: 1 mg per mL\n    (b) omit from the column headed “Brand”: OxyNorm Liquid 5mg/5mL substitute: OxyNorm Liquid 1mg/mL\n\n\\[47\\] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 10 mg (controlled release)\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Novacodone | HX  | MP NP | C4583 |     | 28  | 0   | 28  |     |     |\n| --- | --- | --- | --- | ---------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n    (b) insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”: a\n\n\\[48\\] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 20 mg (controlled release)\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Novacodone | HX  | MP NP | C4583 |     | 28  | 0   | 28  |     |     |\n| --- | --- | --- | --- | ---------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n    (b) insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”: a\n\n\\[49\\] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 40 mg (controlled release)\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Novacodone | HX  | MP NP | C4583 |     | 28  | 0   | 28  |     |     |\n| --- | --- | --- | --- | ---------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n    (b) insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”: a\n\n\\[50\\] Schedule 1, entry for Oxycodone in the form Tablet containing oxycodone hydrochloride 80 mg (controlled release)\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Novacodone | HX  | MP NP | C4583 |     | 28  | 0   | 28  |     |     |\n| --- | --- | --- | --- | ---------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n    (b) insert in the column headed “Schedule Equivalent” for the brands “Oxycodone Sandoz” and “OxyContin”: a\n\n\\[51\\] Schedule 1, entry for Paracetamol\n\nomit:\n\n|     | Tablet 665 mg (modified release) | Oral |     | Osteomol 665 Paracetamol | CR  | MP NP | C6225 C6280 | P6225 | 192 | 3   | 96  |     |     |\n| --- | -------------------------------- | ---- | --- | ------------------------ | --- | ----- | ----------- | ----- | --- | --- | --- | --- | --- |\n|     |                                  |      |     |                          |     | MP NP | C6225 C6280 | P6225 | 192 | 3   | 192 |     |     |\n|     |                                  |      |     |                          |     | MP NP | C6225 C6280 | P6280 | 192 | 5   | 96  |     |     |\n|     |                                  |      |     |                          |     | MP NP | C6225 C6280 | P6280 | 192 | 5   | 192 |     |     |\n\n  \n\nsubstitute:\n\n|     | Tablet 665 mg (modified release) | Oral | a   | APOHEALTH Osteo Relief Paracetamol 665 mg | TX  | MP NP | C6225 C6280 | P6225 | 192 | 3   | 96  |     |     |\n| --- | -------------------------------- | ---- | --- | ----------------------------------------- | --- | ----- | ----------- | ----- | --- | --- | --- | --- | --- |\n|     |                                  |      | a   | Osteomol 665 Paracetamol                  | CR  | MP NP | C6225 C6280 | P6225 | 192 | 3   | 96  |     |     |\n|     |                                  |      |     |                                           |     | MP NP | C6225 C6280 | P6225 | 192 | 3   | 192 |     |     |\n|     |                                  |      | a   | APOHEALTH Osteo Relief Paracetamol 665 mg | TX  | MP NP | C6225 C6280 | P6280 | 192 | 5   | 96  |     |     |\n|     |                                  |      | a   | Osteomol 665 Paracetamol                  | CR  | MP NP | C6225 C6280 | P6280 | 192 | 5   | 96  |     |     |\n|     |                                  |      |     |                                           |     | MP NP | C6225 C6280 | P6280 | 192 | 5   | 192 |     |     |\n\n\\[52\\] Schedule 1, entry for Paroxetine\n\n    (a) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | APO-Paroxetine | TX  | MP NP | C4755 C6277 C6636 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | -------------- | --- | ----- | ----------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     |     | Paroxetine Actavis | ED  | MP NP | C4755 C6277 C6636 |     | 30  | 5   | 30  |     |     |\n| --- | --- | --- | --- | ------------------ | --- | ----- | ----------------- | --- | --- | --- | --- | --- | --- |\n\n    (c) insert in the column headed “Schedule Equivalent” for all brands: a\n\n\\[53\\] Schedule 1, entry for Raloxifene\n\n    (a) insert in the column headed “Schedule Equivalent” for all brands: a\n    (b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     | a   | Raloxifene AMNEAL | ED  | MP NP | C6314 |     | 28  | 5   | 28  |     |     |\n| --- | --- | --- | --- | ----------------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n\\[54\\] Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe \\[Maximum  \nQuantity: 1; Number of Repeats: 2\\]\n\n    (a) omit from the column headed “Circumstances”: C6500 C6553 C6570 C6581 substitute: C7081 C7102 C7106 C7115\n    (b) omit from the column headed “Purposes”: P6553 P6570 P6581 substitute: P7081 P7102 P7106\n\n\\[55\\] Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 1.65 mg in 0.165 mL pre-filled syringe \\[Maximum  \nQuantity: 1; Number of Repeats: 5\\]\n\n    (a) omit from the column headed “Circumstances”: C6500 C6553 C6570 C6581 substitute: C7081 C7102 C7106 C7115\n    (b) omit from the column headed “Purposes”: P6500 substitute: P7115\n\n\\[56\\] Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL \\[Maximum Quantity: 1; Number of Repeats: 2\\]\n\n    (a) omit from the column headed “Circumstances”: C6500 C6553 C6570 C6581 substitute: C7079 C7115 C7118 C7127\n    (b) omit from the column headed “Purposes”: P6553 P6570 P6581 substitute: P7079 P7118 P7127\n\n\\[57\\] Schedule 1, entry for Ranibizumab in the form Solution for intravitreal injection 2.3 mg in 0.23 mL \\[Maximum Quantity: 1; Number of Repeats: 5\\]\n\n    (a) omit from the column headed “Circumstances”: C6500 C6553 C6570 C6581 substitute: C7079 C7115 C7118 C7127\n    (b) omit from the column headed “Purposes”: P6500 substitute: P7115\n\n\\[58\\] Schedule 1, entry for Riluzole\n\nomit:\n\n|     |     |     |     | Riluzole Winthrop | WA  | MP NP | C5341 C5365 |     | 56  | 5   | 56  |     |     |\n| --- | --- | --- | --- | ----------------- | --- | ----- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[59\\] Schedule 1, entry for Risedronic Acid in the form Tablet containing risedronate sodium 150 mg\n\n    (a) omit:\n\n|     |     |     | a   | Chem mart Risedronate | CH  | MP NP | C6310 C6323 C6327 |     | 1   | 5   | 1   |     |     |\n| --- | --- | --- | --- | --------------------- | --- | ----- | ----------------- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     | a   | Terry White Chemists Risedronate | TW  | MP NP | C6310 C6323 C6327 |     | 1   | 5   | 1   |     |     |\n| --- | --- | --- | --- | -------------------------------- | --- | ----- | ----------------- | --- | --- | --- | --- | --- | --- |\n\n\\[60\\] Schedule 1, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate)\n\ninsert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:\n\n|     |     |     |     | MAXATAN | RW  | MP NP | C5708 |     | 4   | 5   | 2   |     |     |\n| --- | --- | --- | --- | ------- | --- | ----- | ----- | --- | --- | --- | --- | --- | --- |\n\n  \n\n\\[61\\] Schedule 1, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30\n\nomit:\n\n|     |     |     |     | Ventolin Nebules | GK  | MP NP | C6815 C6825 |     | 2   | 5   | 1   |     |     |\n| --- | --- | --- | --- | ---------------- | --- | ----- | ----------- | --- | --- | --- | --- | --- | --- |\n\n\\[62\\] Schedule 1, entry for Somatropin in the form Solution for injection 5 mg (15 i.u.) in 1.5 mL cartridge (with preservative)\n\nomit:\n\n|     |     |     |     | Omnitrope | SZ  | MP  | C5150 C5151 C5152 C5153 C5156 C5157 C5158 C5165 C5166 C5167 C5198 C5199 C5201 C5202 C5211 C5235 C5236 C5237 C5242 C5247 C5285 C5286 C5287 C5305 C5306 C5310 C5318 C5319 C5320 C5346 C5348 C5352 C5353 C5354 C5355 C5378 C5379 C5380 C5419 C5420 C5432 C5433 |     | See Note 3 | See Note 3 | 1   |     | D(100) |\n| --- | --- | --- | --- | --------- | --- | --- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --- | ---------- | ---------- | --- | --- | ------ |\n\n\\[63\\] Schedule 1, entry for Temozolomide in the form Capsule 5 mg\n\n    (a) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     |     | 5   | 5   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     | P4897 | 15  | 2   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | ----- | --- | --- | --- | --- | --- |\n\n  \n\n\\[64\\] Schedule 1, entry for Temozolomide in the form Capsule 20 mg\n\n    (a) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     |     | 5   | 5   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     | P4897 | 15  | 2   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | ----- | --- | --- | --- | --- | --- |\n\n\\[65\\] Schedule 1, entry for Temozolomide in the form Capsule 100 mg\n\n    (a) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     |     | 5   | 5   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     | P4897 | 15  | 2   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | ----- | --- | --- | --- | --- | --- |\n\n\\[66\\] Schedule 1, entry for Temozolomide in the form Capsule 140 mg\n\n    (a) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     |     | 5   | 5   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     | P4897 | 15  | 2   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | ----- | --- | --- | --- | --- | --- |\n\n\\[67\\] Schedule 1, entry for Temozolomide in the form Capsule 180 mg\n\n    (a) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     |     | 5   | 5   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n    (b) omit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     | P4897 | 15  | 2   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | ----- | --- | --- | --- | --- | --- |\n\n\\[68\\] Schedule 1, entry for Temozolomide in the form Capsule 250 mg\n\nomit:\n\n|     |     |     | a   | Astromide | FR  | MP  |     |     | 5   | 5   | 5   |     |     |\n| --- | --- | --- | --- | --------- | --- | --- | --- | --- | --- | --- | --- | --- | --- |\n\n  \n\n\\[70\\] Schedule 1, entry for Timolol in the form Eye drops 5 mg (as maleate) per mL, 5 mL\n\nomit:\n\n|     |     |     |     | Tenopt | QA  | MP AO |     |     | 1   | 5   | 1   |     |     |\n| --- | --- | --- | --- | ------ | --- | ----- | --- | --- | --- | --- | --- | --- | --- |\n\n\\[71\\] Schedule 1, entry for Ustekinumab in the form Injection 45 mg in 0.5 mL \\[Maximum quantity: 2; Number of Repeats: 0\\]\n\nomit from the column headed “Purposes”: C7061 substitute: P7061\n\n\\[72\\] Schedule 1, entry for Verteporfin\n\nomit from the column headed “Circumstances”: C6099 C6100  \ninsert in numerical order: C7109 C7130\n\n\\[73\\] Schedule 1, entry for Vismodegib\n\nomit from the column headed “Circumstances”: C6802  \nomit from the column headed “Circumstances”: C6820  \ninsert in numerical order: C7098 C7129\n\n\\[74\\] Schedule 4, Part 1\n\nomit from the column headed “Authority Requirements (part of Circumstances; or Conditions)” (multiple occurrences and in all instances), the phrase:  \nWritten or Telephone\n\n\\[75\\] Schedule 4, Part 1, entry for Aflibercept\n\n    (a) omit:\n\n|     | C6518 | P6518 |     | Diabetic macular oedema (DMO)Initial treatmentPatient must have visual impairment due to diabetic macular oedema; ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised. | Compliance with Authority Required procedures |\n| --- | ----- | ----- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- |\n|     | C6567 | P6567 |     | Branch retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.     | Compliance with Authority Required procedures |\n|     | C6574 | P6574 |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.                                                                                                                                                                                                                                                                                                                                                                                      | Compliance with Authority Required procedures |\n|     | C6594 | P6594 |     | Central retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.     | Compliance with Authority Required procedures |\n\n    (b) insert in numerical order after existing text:\n\n|     | C7078 | P7078 |     | Diabetic macular oedema (DMO)Initial treatmentPatient must have visual impairment due to diabetic macular oedema; ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. | Compliance with Written Authority Required procedures |\n| --- | ----- | ----- | --- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |\n|     | C7100 | P7100 |     | Branch retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.     | Compliance with Written Authority Required procedures |\n|     | C7101 | P7101 |     | Central retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.     | Compliance with Written Authority Required procedures |\n|     | C7132 | P7132 |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.                                                                                                                                                                                                                                                                                                                                                                                      | Compliance with Written Authority Required procedures |\n\n\\[76\\] Schedule 4, Part 1, after entry for Amino acid formula without valine, leucine and isoleucine\n\ninsert:\n\n| Amino acid formula with vitamins and minerals, low phenylalanine and supplemented with docosahexaenoic acid and arachidonic acid | C4295 |     |     | Phenylketonuria |     |\n| -------------------------------------------------------------------------------------------------------------------------------- | ----- | --- | --- | --------------- | --- |\n\n\\[77\\] Schedule 4, Part 1, after entry for Brentuximab vedotin\n\ninsert:\n\n| Brexpiprazole | C4246 |     |     | Schizophrenia | Compliance with Authority Required procedures - Streamlined Authority Code 4246 |\n| ------------- | ----- | --- | --- | ------------- | ------------------------------------------------------------------------------- |\n\n\\[78\\] Schedule 4, Part 1, entry for Cefotaxime\n\n    (a) omit:\n\n|     | C5827 |     |     | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |     |\n| --- | ----- | --- | --- | ------------------------------------------------------------------------------------------------------------------- | --- |\n|     | C5828 |     |     | Septicaemia, suspected                                                                                              |     |\n|     | C5829 |     |     | Septicaemia, proven                                                                                                 |     |\n\n    (b) omit:\n\n|     | C5892 |     |     | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |     |\n| --- | ----- | --- | --- | ------------------------------------------------------------------------------------------------------------------- | --- |\n\n    (c) insert in numerical order after existing text:\n\n|     | C5905 |     |     | Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent |     |\n| --- | ----- | --- | --- | ------------------------------------------------------------------------------------------------------------------- | --- |\n\n\\[79\\] Schedule 4, Part 1, entry for Dexamethasone\n\n    (a) omit:\n\n|     | C6542 |     |     | Diabetic macular oedema (DMO)Initial treatmentPatient must have visual impairment due to diabetic macular oedema; ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; ORPatient must be unsuitable for treatment with VEGF inhibitors; ORPatient must have failed prior treatment with VEGF inhibitors; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Patient must have had a cataract removed in the treated eye; ORPatient must be scheduled for cataract surgery in the treated eye.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised. | Compliance with Authority Required procedures |\n| --- | ----- | --- | --- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------- |\n|     | C6560 |     |     | Diabetic macular oedema (DMO)Grandfathering treatmentPatient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2016; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Patient must have had a cataract removed in the treated eye; ORPatient must be scheduled for cataract surgery in the treated eye.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Compliance with Authority Required procedures |\n\n    (b) insert in numerical order after existing text:\n\n|     | C7083 |     |     | Diabetic macular oedema (DMO)Initial treatmentMust be treated by an ophthalmologist.Patient must have visual impairment due to diabetic macular oedema; ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDPatient must have a contraindication to vascular endothelial growth factor (VEGF) inhibitors; ORPatient must be unsuitable for treatment with VEGF inhibitors; ORPatient must have failed prior treatment with VEGF inhibitors; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Patient must have had a cataract removed in the treated eye; ORPatient must be scheduled for cataract surgery in the treated eye.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. | Compliance with Written Authority Required procedures |\n| --- | ----- | --- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | ----------------------------------------------------- |\n|     | C7133 |     |     | Diabetic macular oedema (DMO)Grandfathering treatmentMust be treated by an ophthalmologist.Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 November 2016; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Patient must have had a cataract removed in the treated eye; ORPatient must be scheduled for cataract surgery in the treated eye.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        | Compliance with Written Authority Required procedures |\n\n\\[80\\] Schedule 4, Part 1, entry for Ranibizumab\n\n    (a) omit:\n\n|     | C6500 | P6500 |     | Diabetic macular oedema (DMO)Initial treatmentPatient must have visual impairment due to diabetic macular oedema; ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised. | Compliance with Authority Required procedures |\n| --- | ----- | ----- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------- |\n|     | C6553 | P6553 |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.                                                                                                                                                                                                                                                                                                                                                                                      | Compliance with Authority Required procedures |\n|     | C6570 | P6570 |     | Central retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.     | Compliance with Authority Required procedures |\n|     | C6581 | P6581 |     | Branch retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.     | Compliance with Authority Required procedures |\n\n    (b) insert in numerical order after existing text:\n\n|     | C7079 | P7079 |     | Central retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.     | Compliance with Written Authority Required procedures |\n| --- | ----- | ----- | --- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |\n|     | C7081 | P7081 |     | Central retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to central retinal vein occlusion (CRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 24 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/320), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.     | Compliance with Written Authority Required procedures |\n|     | C7102 | P7102 |     | Branch retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.     | Compliance with Written Authority Required procedures |\n|     | C7106 | P7106 |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.                                                                                                                                                                                                                                                                                                                                                                                      | Compliance with Written Authority Required procedures |\n|     | C7115 | P7115 |     | Diabetic macular oedema (DMO)Initial treatmentPatient must have visual impairment due to diabetic macular oedema; ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 78 and 39 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/32 to 20/160), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be as monotherapy; ORThe treatment must be in combination with laser photocoagulation; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Diabetic Macular Oedema (DMO) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report. | Compliance with Written Authority Required procedures |\n|     | C7118 | P7118 |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the optical coherence tomography or fluorescein angiogram report.                                                                                                                                                                                                                                                                                                                                                                                      | Compliance with Written Authority Required procedures |\n|     | C7127 | P7127 |     | Branch retinal vein occlusion with macular oedemaInitial treatmentPatient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion (BRVO); ANDPatient must have documented visual impairment defined as a best corrected visual acuity score between 73 and 20 letters based on the early treatment diabetic retinopathy study chart administered at a distance of 4 metres (approximate Snellen equivalent 20/40 to 20/400), in the eye proposed for treatment; ANDThe condition must be diagnosed by optical coherence tomography; ORThe condition must be diagnosed by fluorescein angiography; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by an ophthalmologist.Authority approval for initial treatment of each eye must be sought.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form; andc) a copy of the optical coherence tomography or fluorescein angiogram report.A telephone application must be made following submission by facsimile of a copy of a completed Retinal Vein Occlusion Initial PBS authority application Supporting information form and a copy of the optical coherence tomography or fluorescein angiogram report.     | Compliance with Written Authority Required procedures |\n\n\\[81\\] Schedule 4, Part 1, entry for Verteporfin\n\n    (a) omit:\n\n|     | C6099 |     |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be predominantly classic (greater than or equal to 50%); ANDThe treatment must be the sole PBS-subsidised therapy for this condition; ANDThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by fluorescein angiography; ANDPatient must have a baseline visual acuity equal to or better than 6/60 (20/200).Must be treated by an ophthalmologist.The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised.                                                                                                                                                                               | Compliance with Written or Telephone Authority Required procedures |\n| --- | ----- | --- | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------ |\n|     | C6100 |     |     | Subfoveal choroidal neovascularisation (CNV)Initial PBS-subsidised treatmentThe condition must be predominantly classic (greater than or equal to 50%); ANDThe condition must be due to macular degeneration; ANDPatient must have been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the MBS Visudyne Therapy Program; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a ophthalmologist.The first authority application for each eye must be made in writing or by telephone.A written application must include:(a) a completed authority prescription form; and(b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form, which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and(c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. The original documentation must be submitted to the Chief Executive Medicare by post after the application has been authorised. | Compliance with Written or Telephone Authority Required procedures |\n\n    (b) insert in numerical order after existing text:\n\n|     | C7109 |     |     | Subfoveal choroidal neovascularisation (CNV)Initial treatmentThe condition must be predominantly classic (greater than or equal to 50%).Must be treated by an ophthalmologist.The treatment must be the sole PBS-subsidised therapy for this condition; ANDThe condition must be due to age-related macular degeneration (AMD); ANDThe condition must be diagnosed by fluorescein angiography; ANDPatient must have a baseline visual acuity equal to or better than 6/60 (20/200).The first authority application for each eye must be made in writing or by telephone.A written application must include:a) a completed authority prescription form;b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form; andc) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram.                                                                                                                                                                                   | Compliance with Written Authority Required procedures |\n| --- | ----- | --- | --- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |\n|     | C7130 |     |     | Subfoveal choroidal neovascularisation (CNV)Initial PBS-subsidised treatmentThe condition must be predominantly classic (greater than or equal to 50%); ANDThe condition must be due to macular degeneration; ANDPatient must have been authorised by the Angiogram Review Panel to receive treatment with verteporfin in the same eye under the MBS Visudyne Therapy Program; ANDThe treatment must be the sole PBS-subsidised therapy for this condition.Must be treated by a ophthalmologist.The first authority application for each eye must be made in writing or by telephone.A written application must include:(a) a completed authority prescription form; and(b) a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form, which includes the date of review by the Angiogram Review Panel and the number of treatments administered in that eye under the MBS Visudyne Therapy Program; and(c) a copy of the fluorescein angiogram demonstrating that the CNV is predominantly classic (greater than or equal to 50%).A telephone application must be made following submission by facsimile of a copy of a completed Subfoveal Choroidal Neovascularisation (CNV) - PBS Supporting Information Form and a copy of the fluorescein angiogram. | Compliance with Written Authority Required procedures |\n\n  \n\n\\[83\\] Schedule 4, Part 1, entry for Vismodegib\n\n    (a) omit:\n\n|     | C6802 |     |     | Metastatic or locally advanced basal cell carcinomaContinuing treatmentPatient must have previously received an authority prescription for this condition with this drug; ANDThe condition must not have progressed; ANDThe condition must remain inappropriate for surgery; ANDThe condition must remain inappropriate for curative radiotherapy; ANDPatient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.The authority application must be made in writing and must include:a) A completed authority prescription form; andb) a completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; andc) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery; andd) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy; ande) A confirmation statement from the treating doctor that the disease has not progressedThe assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.Inappropriate for surgery is defined as:i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; orii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); oriii/ Medical contraindication to surgeryInappropriate for curative radiotherapy is defined as:i/ Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; orii/ Limitations due to location of tumour; oriii/ Limitations due to cumulative prior radiotherapy dose; oriv/ Progressive disease despite prior irradiation of locally advanced BCC | Compliance with Written Authority Required procedures |\n| --- | ----- | --- | --- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |\n\n    (b) omit:\n\n|     | C6820 |     |     | Metastatic or locally advanced basal cell carcinomaInitial treatmentThe condition must be inappropriate for surgery; ANDThe condition must be inappropriate for curative radiotherapy; ANDPatient must not receive more than 16 weeks of treatment under this restriction.The authority application must be made in writing and must include:a) A completed authority prescription form; andb) a completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; andc) A histological confirmation of BCC; andd) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery; ande) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy; andf) A signed patient acknowledgement.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.Inappropriate for surgery is defined as:i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; orii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); oriii/ Medical contraindication to surgeryInappropriate for curative radiotherapy is defined as:i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; orii/ Limitations due to location of tumour; oriii/ Limitations due to cumulative prior radiotherapy dose; oriv/ Progressive disease despite prior irradiation of locally advanced BCC. | Compliance with Written Authority Required procedures |\n| --- | ----- | --- | --- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |\n\n    (c) insert in numerical order after existing text:\n\n|     | C7098 |     |     | Metastatic or locally advanced basal cell carcinomaContinuing treatmentPatient must have previously received an authority prescription for this condition with this drug; ANDThe condition must not have progressed; ANDThe condition must remain inappropriate for surgery; ANDThe condition must remain inappropriate for curative radiotherapy; ANDPatient must not receive more than 16 weeks of treatment per continuing treatment under this restriction.The authority application must be made in writing and must include:a) A completed authority prescription form; andb) A completed Basal Cell Carcinoma Continuing PBS Authority Application Form - Supporting Information Form; andc) A confirmation statement from the treating doctor that the disease has not progressed; andd) In patients with locally advanced BCC, a letter from a surgically qualified clinician demonstrating that the condition remains inappropriate for surgery; or a letter from a radiation oncologist demonstrating that the condition remains inappropriate for curative radiotherapy.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.Inappropriate for surgery is defined as:i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; orii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); oriii/ Medical contraindication to surgeryInappropriate for curative radiotherapy is defined as:i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; orii/ Limitations due to location of tumour; oriii/ Limitations due to cumulative prior radiotherapy dose; oriv/ Progressive disease despite prior irradiation of locally advanced BCC. | Compliance with Written Authority Required procedures |\n| --- | ----- | --- | --- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------- |\n|     | C7129 |     |     | Metastatic or locally advanced basal cell carcinomaInitial treatmentThe condition must be inappropriate for surgery; ANDThe condition must be inappropriate for curative radiotherapy; ANDPatient must not receive more than 16 weeks of treatment under this restriction.The authority application must be made in writing and must include:a) A completed authority prescription form; andb) a completed Basal Cell Carcinoma Initial PBS Authority Application Form - Supporting Information Form; andc) A histological confirmation of BCC and whether the condition is metastatic or locally advanced; andd) A letter from a surgically qualified clinician demonstrating inappropriateness for surgery for patients with locally advanced BCC; ande) A letter from a radiation oncologist demonstrating inappropriateness for curative radiotherapy for patients with locally advanced BCC; andf) A signed patient acknowledgement.The assessment of the patient's response to this PBS-subsidised course of therapy must be made within the 4 weeks prior to completion of the course of treatment. It is recommended that an application is submitted to the Department of Human Services no less than 2 weeks prior to the date the next dose is due in order to ensure continuity of treatment for those patients who meet the continuation criteria.Inappropriate for surgery is defined as:i/ Curative resection is unlikely, such as where BCC has recurred in the same location after two or more surgical procedures; orii/ Anticipated substantial morbidity or deformity from surgery or requiring complicated reconstructive surgery (e.g. removal of all or part of a facial structure, such as nose, ear, eyelid, eye; or requirement for limb amputation or free tissue transfer); oriii/ Medical contraindication to surgeryInappropriate for curative radiotherapy is defined as:i/Hypersensitivity to radiation due to genetic syndrome such as Gorlin Syndrome; orii/ Limitations due to location of tumour; oriii/ Limitations due to cumulative prior radiotherapy dose; oriv/ Progressive disease despite prior irradiation of locally advanced BCC.                                                                                                                                            | Compliance with Written Authority Required procedures |\n\n\\[84\\] Schedule 5, omit entry for Chorionic gonadotrophin\n\n\\[85\\] Schedule 5, entry for Rizatriptan in the form Tablet (orally disintegrating) 10 mg (as benzoate) \\[GRP-17623\\]\n\ninsert in numerical order in the column headed “Brand”: MAXATAN\n\n\\[86\\] Schedule 5, entry for Salbutamol in the form Nebuliser solution 2.5 mg (as sulfate) in 2.5 mL single dose units, 30 \\[GRP-21535\\]\n\nomit from the column headed “Brand”: Ventolin Nebules","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":8,"scope_assessment":{"changed":false,"description":"This instrument is a targeted amendment to the existing PBS listings and authority procedures rather than a change to the statutory scope of the PBS. It updates which brands, strengths and forms are listed, revises maximum quantities/repeats, and modifies authority codes and application wording (notably removal of 'Written or Telephone' in Schedule 4 [74] and replacement text in several entries [75], [79]–[83]). It does not create new subsidy categories or expand the PBS's legal remit."},"complexity_factors":["Large number of line-item amendments across Schedule 1 (brands, forms, strengths, max quantities, repeats) (see Schedule 1 amendments [1]–[66], [68], [70]–[73]).","Multiple changes to authority-coding (C###) and purpose-coding (P###) for ophthalmic and oncology drugs requiring precise cross-referencing (see amendments for Aflibercept [2]–[3], Ranibizumab [54]–[57], Dexamethasone [25], Verteporfin [72], [81]).","Alteration of Authority Requirements wording and procedures in Schedule 4 (removal of the phrase 'Written or Telephone' and replacement with written-authority formulations) with ripple effects for many entries (see [74], [75], [79]–[83]).","Mix of insertions, omissions and substitutions increases drafting complexity and risk of transcription or indexing errors (numerous brand inserts/omits such as Alprazolam [4]–[5], Oxycodone [46]–[50], Paracetamol [51]).","Interplay with Notes and cross-references (e.g. 'See Note 3', D(100) listings) that impose special dispensing or pricing rules (see entries for several oncology injectables [16], [24], [26]–[29]).","Administrative impact on stakeholders: different approval routes, new streamlined authority codes (e.g. Brexpiprazole C4246 at [77]), and changes to complying documentation increase operational and compliance burden.","Technical legal drafting required to preserve statutory effect while ensuring machine-readable and human-readable PBS schedules are consistent (amendment to multiple schedules and parts [74]–[86])."],"plain_english_summary":"This instrument updates the Pharmaceutical Benefits Scheme (PBS) listings: it adds and removes specific brands and formulations, adjusts dosing, maximum quantities and repeats, and changes schedule-equivalent entries. It also revises authority codes and the required application procedures for certain medicines. These changes affect prescribers, pharmacists, product sponsors and patients by changing which products are subsidised and by altering the approval paperwork and administrative burden for PBS-subsidised prescriptions."},"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-realtime","completionTokens":1740},"content_quality":"ok","complexity_score":6,"scope_assessment":{"changed":false,"description":"This amendment instrument performs exactly the expected function of updating the PBS listing. While it contains numerous changes (86 items), they fall within the standard administrative scope of adding/removing brands, updating authority restrictions, and adjusting subsidy rules. There is no mission creep beyond the original purpose of maintaining the pharmaceutical benefits list."},"complexity_factors":["86 separate amendment items with cross-references to the principal 2012 instrument","Extensive use of cryptic authority codes (C6518, P7100, etc.) referring to clinical restrictions","Technical pharmaceutical terminology (intravitreal injections, chemical compounds, dosage forms)","Tabular amendment format with multiple column operations (omit/insert/substitute)","Complex brand name variations and manufacturer codes (e.g., SZ, QA, MP NP)","Nested authority requirements involving multiple clinical criteria and diagnostic tests"],"plain_english_summary":"This instrument updates Australia’s Pharmaceutical Benefits Scheme, making technical changes to listings, prices and prescribing rules that affect patients, prescribers and pharmacies. It adds new subsidised medicines (including brexpiprazole and a PKU infant formula), introduces generics, removes some branded entries, tightens controls on alprazolam, alters approvals for expensive eye and cancer treatments, and shifts many items to “Written Authority Required,” increasing paperwork and oversight."}},"importantCases":[],"_links":{"self":"/api/acts/national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017","history":"/api/acts/national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017/history","analysis":"/api/acts/national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017/analysis","conflicts":"/api/acts/national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017/conflicts","importantCases":"/api/acts/national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017/important-cases","documents":"/api/acts/national-health-listing-of-pharmaceutical-benefits-amendment-instrument-2017-no-8-pb-71-of-2017/documents"}}