Section 1 - National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8) (PB 71 of 2017) - National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8) (PB 71 of 2017)

1National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8) (PB 71 of 2017)

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PB 71 of 2017

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017
(No. 8)

National Health Act 1953

I, 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.

Dated 19 September 2017

JULIANNE QUAINE

First Assistant Secretary (Acting)

Technology Assessment and Access Division

Department of Health

1 Name of Instrument

(1) This Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2017 (No. 8).

(2) This Instrument may also be cited as PB 71 of 2017.

2 Commencement

This Instrument commences on 1 October 2017.

3 Amendment of National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012)

Schedule 1 amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012).

Schedule 1 Amendments

[1] Schedule 1, entry for Acitretin in each of the forms: Capsule 10 mg; and Capsule 25 mg

(a) insert in the column headed “Schedule Equivalent” for all brands: a
(b) insert in the columns in the order indicated, and in alphabetical order for the column headed “Brand”:

			a	ZETIN	RW	MP	C5727 C5789		100	2	100

[2] Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum
Quantity: 1; Number of Repeats: 2]

(a) omit from the column headed “Circumstances”: C6518 C6567 C6574 C6594  
insert in numerical order: C7078 C7100 C7101 C7132
(b) omit from the column headed “Purposes”: P6567 P6574 P6594  
insert in numerical order: P7100 P7101 P7132

[3] Schedule 1, entry for Aflibercept in the form Solution for intravitreal injection 4 mg in 100 microlitres (40 mg per mL) [Maximum
Quantity: 1; Number of Repeats: 5]

(a) omit from the column headed “Circumstances”: C6518 C6567 C6574 C6594  
insert in numerical order: C7078 C7100 C7101 C7132
(b) omit from the column headed “Purposes”: P6518  
insert in numerical order: P7078

Tablet 1 mg	Oral	Rexulti	LU	MP NP	C4246	30	0	30
Tablet 2 mg	Oral	Rexulti	LU	MP NP	C4246	30	5	30
Tablet 3 mg	Oral	Rexulti	LU	MP NP	C4246	30	5	30
Tablet 4 mg	Oral	Rexulti	LU	MP NP	C4246	30	5	30

	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)
				Hospira Pty Limited	PF	MP			See Note 3	SeeNote 3	1		D(100)

a	APO-Ibuprofen 400	TX	MP NP MW PDP		30	0	30
a	Brufen	GO	MP NP MW PDP		30	0	30
a	APO-Ibuprofen 400	TX	PDP	P6256 P6282	90	0	30
a	Brufen	GO	PDP	P6256 P6282	90	0	30
a	APO-Ibuprofen 400	TX	MP NP	P6149 P6214 P6283	90	3	30
a	Brufen	GO	MP NP	P6149 P6214 P6283	90	3	30

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

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

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

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

C7078

P7078

Compliance with Written Authority Required procedures

C7100

P7100

Compliance with Written Authority Required procedures

C7101

P7101

Compliance with Written Authority Required procedures

C7132

P7132

Compliance with Written Authority Required procedures

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

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

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

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

C6500

P6500

Compliance with Authority Required procedures

C6553

P6553

Compliance with Authority Required procedures

C6570

P6570

Compliance with Authority Required procedures

C6581

P6581

Compliance with Authority Required procedures

C7079

P7079

Compliance with Written Authority Required procedures

C7081

P7081

Compliance with Written Authority Required procedures

C7102

P7102

Compliance with Written Authority Required procedures

C7106

P7106

Compliance with Written Authority Required procedures

C7115

P7115

Compliance with Written Authority Required procedures

C7118

P7118

Compliance with Written Authority Required procedures

C7127

P7127

Compliance with Written Authority Required procedures

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

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

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

C7130

Compliance with Written Authority Required procedures

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

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

MP NP	C6225 C6280	P6225	192	3	96
MP NP	C6225 C6280	P6225	192	3	192
MP NP	C6225 C6280	P6280	192	5	96
MP NP	C6225 C6280	P6280	192	5	192

a	APOHEALTH Osteo Relief Paracetamol 665 mg	TX	MP NP	C6225 C6280	P6225	192	3	96
a	Osteomol 665 Paracetamol	CR	MP NP	C6225 C6280	P6225	192	3	96
			MP NP	C6225 C6280	P6225	192	3	192
a	APOHEALTH Osteo Relief Paracetamol 665 mg	TX	MP NP	C6225 C6280	P6280	192	5	96
a	Osteomol 665 Paracetamol	CR	MP NP	C6225 C6280	P6280	192	5	96
			MP NP	C6225 C6280	P6280	192	5	192

	C5827			Infection where positive bacteriological evidence confirms that this antibiotic is an appropriate therapeutic agent
	C5828			Septicaemia, suspected
	C5829			Septicaemia, proven