Note 1: A number of expressions used in this instrument are defined in the Act, including the following:
(a) Chief Executive Medicare;
(b) hospital;
(c) public hospital.
Note 2: Under subsection 4(1A) of the Act, a word or phrase defined for the purposes of the Health Insurance Act 1973 has the meaning that it would have if used in that Act. Expressions used in this instrument that are defined in that Act include the following:
accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis B in accordance with this instrument.
accredited prescriber of medication for the treatment of hepatitis C means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of hepatitis C in accordance with this instrument.
accredited prescriber of medication for the treatment of HIV or AIDS means a medical practitioner, or an authorised nurse practitioner, approved by a State or Territory to prescribe medication for the treatment of HIV or AIDS in accordance with this instrument.
accredited prescriber of medication for the treatment of schizophrenia means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of schizophrenia in accordance with this instrument.
Act means the National Health Act 1953.
affiliated: a specialist is affiliated with a hospital if the specialist is:
(a) a staff specialist of the hospital; or
(b) a visiting or consulting specialist of the hospital.
approved ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.
approved hospital authority has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.
approved medical practitioner has the same meaning as in Part VII of the Act.
approved pharmacist has the same meaning as in Part VII of the Act.
Approved Pharmacists Commonwealth Price Determination means the Commonwealth price (Pharmaceutical benefits supplied by approved pharmacists) Determination 2020.
Approved Pharmacists Conditions Determination means the National Health (Pharmaceutical Benefits) (Conditions for approved pharmacists) Determination 2017.
approved supplier has the same meaning as in Part VII of the Act, as affected by section 11 of this instrument.
authorised nurse practitioner has the same meaning as in Part VII of the Act.
authorised prescriber has the meaning given by section 7.
CAR drug (short for Complex Authority Required drug) means any of the following highly specialised drugs:
(a) abatacept;
(b) adalimumab;
(c) ambrisentan;
(d) anifrolumab;
(e) avatrombopag;
(f) azacitidine;
(g) benralizumab;
(h) bosentan;
(i) burosumab;
(j) difelikefalin;
(k) dupilumab;
(l) eculizumab;
(m) eflornithine;
(n) elexacaftor with tezacaftor and with ivacaftor, and ivacaftor;
(o) eltrombopag;
(p) epoprostenol;
(q) etanercept;
(r) iloprost;
(s) infliximab;
(t) ivacaftor;
(u) lenalidomide;
(v) lumacaftor with ivacaftor;
(w) macitentan;
(x) macitentan with tadalafil;
(y) mepolizumab;
(z) midostaurin;
(aa) nusinersen;
(ab) omalizumab;
(ac) onasemnogene abeparvovec;
(ad) pasireotide;
(ae) patisiran;
(af) pegcetacoplan;
(ag) pegvisomant;
(ah) pomalidomide;
(ai) ravulizumab;
(aj) riociguat;
(ak) risdiplam;
(al) romiplostim;
(am) selexipag;
(an) sildenafil;
(ao) tadalafil;
(ap) teduglutide;
(aq) tezacaftor with ivacaftor and ivacaftor;
(ar) tocilizumab;
(as) ustekinumab;
(at) vanzacaftor with tezacaftor and with deutivacaftor;
(au) vedolizumab;
(av) vutrisiran.
circumstances code means the letter “C” followed by a number.
community access medication means any of the following:
(a) medication for the treatment of hepatitis B;
(b) medication for the treatment of HIV or AIDS, other than a pharmaceutical benefit that has the drug:
(i) azithromycin; or
(ii) doxorubicin ‑ pegylated liposomal; or
(iii) rifabutin;
(c) medication for the treatment of opioid dependence;
(d) medication for continuing treatment of schizophrenia;
(e) edaravone, if it is for continuing treatment;
(f) lanreotide;
(g) octreotide, if:
(i) the description of its form includes “Injection (modified release)”; and
(ii) it is for continuing treatment.
CTG registered patient means a patient registered under subsection 10(2) of the CTG Special Arrangement.
CTG Special Arrangement means the National Health (Closing the Gap – PBS Co‑payment Program) Special Arrangement 2016.
CTG supplier has the same meaning as in the CTG Special Arrangement.
dangerous drug has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.
dangerous drug fee has the same meaning as in the Approved Pharmacists Commonwealth Price Determination.
day admitted patient: a person is a day admitted patient of a hospital on a day if, on that day, the person:
(a) is admitted to the hospital (other than through the hospital’s emergency department); and
(b) receives treatment; and
(c) is discharged from the hospital;
in accordance with a pre‑existing plan for the person’s treatment.
dispensed price:
(a) for a special arrangement supply of an HSD pharmaceutical benefit by an approved hospital authority for a public hospital—has the meaning given by section 29; and
(b) for a special arrangement supply of an HSD pharmaceutical benefit by an approved supplier other than an approved hospital authority for a public hospital—has the meaning given by section 32.
EFC patient has the meaning given by subsection 8(7).
eligible patient has the meaning given by section 8.
General statement for drugs for the treatment of hepatitis C has the same meaning as in the Listing Instrument.
highly specialised drug means a listed drug mentioned in Schedule 1.
hospital authority has the same meaning as in Part VII of the Act.
HSD hospital authority means a hospital authority for which:
(a) an approval under section 94 of the Act, as modified by section 10 of this instrument, is in force; or
(b) an approval mentioned in section 38 of this instrument is in force.
HSD pharmaceutical benefit means a pharmaceutical benefit mentioned in Schedule 1.
listed drug has the same meaning as in Part VII of the Act.
Listing Instrument means the National Health (Listing of Pharmaceutical Benefits) Instrument 2024 (PB 26 of 2024).
medication chart prescription has the same meaning as in the Regulations.
medication for the treatment of hepatitis B means any of the following:
(a) entecavir;
(b) lamivudine;
(c) tenofovir.
medication for the treatment of hepatitis C means medication mentioned in the table in clause 3 of the General statement for drugs for the treatment of hepatitis C.
medication for the treatment of HIV or AIDS means any of the following:
(a) abacavir;
(b) abacavir with lamivudine;
(c) atazanavir;
(d) atazanavir with cobicistat;
(e) azithromycin;
(f) bictegravir with emtricitabine with tenofovir alafenamide;
(g) cabotegravir;
(h) cabotegravir and rilpivirine;
(i) darunavir;
(j) darunavir with cobicistat;
(k) darunavir with cobicistat, emtricitabine and tenofovir alafenamide;
(l) dolutegravir;
(m) dolutegravir with abacavir and lamivudine;
(n) dolutegravir with lamivudine;
(o) dolutegravir with rilpivirine;
(p) doxorubicin ‑ pegylated liposomal;
(q) emtricitabine with rilpivirine with tenofovir alafenamide;
(r) emtricitabine with tenofovir alafenamide;
(s) etravirine;
(t) ganciclovir;
(u) lamivudine;
(v) lamivudine with zidovudine;
(w) lopinavir with ritonavir;
(x) maraviroc;
(y) nevirapine;
(z) raltegravir;
(aa) rifabutin;
(bb) rilpivirine;
(cc) ritonavir;
(dd) tenofovir;
(ee) tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat;
(ff) tenofovir with emtricitabine;
(gg) tenofovir with emtricitabine and efavirenz;
(hh) valganciclovir;
(ii) zidovudine.
medication for the treatment of opioid dependence means any of the following:
(a) buprenorphine;
(b) buprenorphine with naloxone;
(c) methadone.
medication for the treatment of schizophrenia means clozapine.
ODT pharmaceutical benefit means an HSD pharmaceutical benefit that has a drug that is a medication for the treatment of opioid dependence.
pack quantity has the same meaning as in Part VII of the Act.
pharmaceutical benefit has the same meaning as in Part VII of the Act.
pharmaceutical item has the same meaning as in Part VII of the Act.
proportional ex‑manufacturer price of a listed brand of a pharmaceutical item has the same meaning as in Part VII of the Act.
purposes code means the letter “P” followed by a number.
Regulations means the National Health (Pharmaceutical Benefit) Regulations 2017.
residential care service has the same meaning as in the Regulations.
special arrangement supply has the meaning given by sections 13 and 41.
UNAR drug (short for Unrestricted—No Authority Required drug) means any of the following highly specialised drugs: