National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 7) (PB 58 of 2015) (Cth)

PB 58 of 2015

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No. 7)

National Health Act 1953
___________________________________________________________________________

I, JULIANNE QUAINE, Assistant Secretary, Pharmaceutical Access Branch, Pharmaceutical Benefits Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsections 100(1) and 100(2) of the National Health Act 1953.

29 June 2015

JULIANNE QUAINE
Assistant Secretary
Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

1 Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2015 (No.7).

(2)This Instrument may also be cited as PB 58 of 2015.

2 Commencement

This Instrument commences on 1 July 2015.
3 Amendment
Schedule 1 amends the National Health (Highly specialised drugs program for hospitals) Special Arrangement 2010 (PB 116 of 2010).

Subsection 1(1)
Substitute:
This Special Arrangement is the National Health (Highly specialised drugs program) Special Arrangement 2010.
Section 4
Insert after the definition of ABN:
accredited prescriber of medication for the treatment of hepatitis B means a medical practitioner approved by a State or Territory to prescribe medication for the treatment of hepatitis B for this Special Arrangement.
Section 4
Insert after the definition of accredited prescriber of medication for the treatment of HIV or AIDS:
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 for this Special Arrangement.
Section 4 (definition of eligible medical practitioner)
Insert into the definition after subsection (b):
(ba) who is, for the prescription of medication for the treatment of hepatitis B - an accredited prescriber of medication for the treatment of hepatitis B; or
(bb) who is, for the prescription of medication for the treatment of schizophrenia - an accredited prescriber of medication for the treatment of schizophrenia; or
Section 4
Insert after the definition of medication chart prescription:
medication for the treatment of hepatitis B means any of the following:
(a)    adefovir dipivoxil
(b)    entecavir monohydrate
(c)    interferon alfa - 2a
(d)    interferon alfa - 2b
(e)    lamivudine
(f)     peginterferon alfa - 2a
(g)    telbivudine
(h)    tenofovir
Section 4 (definition of medication for the treatment of HIV or AIDS)
Substitute:
medication for the treatment of HIV or AIDS means any of the following:
(a) abacavir
(b) abacavir with lamivudine
(c) abacavir with lamivudine and zidovudine
(d) atazanavir
(e) azithromycin
(f) darunavir
(g) didanosine
(h) dolutegravir
(i) dolutegravir with abacavir and lamivudine
(j) doxorubicin, pegylated liposomal
(k) efavirenz
(l) emtricitabine
(m) enfuvirtide
(n) etravirine
(o) fosamprenavir
(p) foscarnet
(q) ganciclovir
(r) indinavir
(s) lamivudine
(t) lamivudine with zidovudine
(u) lopinavir with ritonavir
(v) maraviroc
(w) nevirapine
(x) raltegravir
(y) rifabutin
(z) rilpivirine
(za) ritonavir
(zb) saquinavir
(zc) stavudine
(zd) tenofovir
(ze) tenofovir with emtricitabine
(zf) tenofovir with emtricitabine and efavirenz
(zg) tenofovir with emtricitabine, elvitegravir and cobicistat
(zh) tenofovir with emtricitabine and rilpivirine
(zi) valganciclovir
(zj) tipranavir
(zk) zidovudine
Section 4
Insert after the definition of medication for the treatment of HIV or AIDS:
medication for the treatment of schizophrenia means clozapine.
Section 4 (definition of under co-payment data)
Omit “approved pharmacist” and substitute “approved pharmacist, approved medical practitioner”.
Section 4 Note
Insert into the note, in alphabetical order, the following:
· approved medical practitioner
Subsection 18(1)
Omit “This Special Arrangement” and substitute “Subject to section 18A, this Special Arrangement”.
After Section 18
Insert:
18A     Supply of certain HSD pharmaceutical benefits under this Special Arrangement via community access
(1)    This section applies to the following HSD pharmaceutical benefits
(a)       medication for the treatment of hepatitis B;
(b)medication for the treatment of HIV or AIDS, other than the pharmaceutical benefits known as azithromycin, doxorubicin - pegylated liposomal and rifabutin; and
(c)       medication for the treatment of schizophrenia when used in continuing therapy.
(2)    HSD pharmaceutical benefits to which this section applies, can be supplied under this Special Arrangement using section 18 or can be supplied to an eligible patient:
(a)      by an approved pharmacist; or
(b)     by an approved medical practitioner; or
(c)      by an approved hospital authority.
(3) To avoid doubt, this section modifies section 94 of the Act in that an approved hospital authority may supply pharmaceutical benefits for an eligible patient receiving treatment in or at the approved hospital or outside of the approved hospital.
Section 19
Substitute:
Regulation 25 of the Regulations does not apply to the supply of HSD pharmaceutical benefits.
Part 4, Division 3 heading
Omit “pharmacists” and substitute “pharmacists or approved medical practitioners”.
Subsection 36(2)
Substitute:
(2) An approved pharmacist or an approved medical practitioner is entitled to be paid by the Commonwealth the amount, if any, by which the dispensed price for the supply of an HSD pharmaceutical benefit is greater than the amount that the approved pharmacist or approved medical practitioner was entitled to charge under subsection 47(2).
Subsection 36(3)
Omit “approved pharmacist” and substitute “approved pharmacist or by an approved medical practitioner”.
Part 5, Division 2 heading
Omit “pharmacist” and substitute “pharmacist or approved medical practitioner”.
Section 39 heading
Omit “pharmacist” and substitute “pharmacist or by an approved medical practitioner”.
Subsection 39(1)
Omit “approved pharmacist,” and substitute “approved pharmacist, or by an approved medical practitioner”.
Section 47 heading
Omit “pharmacists” and substitute “pharmacists or approved medical practitioners”.
Subsection 47(1)
Omit “approved pharmacist” and substitute “approved pharmacist or an approved medical practitioner”.
Subsection 47(2)
Omit “approved pharmacist” and substitute “approved pharmacist or the approved medical practitioner”.
Section 49
Substitute:
49 Compliance and audit arrangements
(1)If an approved supplier supplies HSD pharmaceutical benefits under this Special Arrangement, the approved supplier that supplies the HSD pharmaceutical benefits must keep adequate, secure and auditable records of all supplied HSD pharmaceutical benefits for which a claim is made.
(2)The records must be kept in systems that are able to be audited by the Chief Executive Medicare on reasonable notice being given to the approved supplier.
Subsection 50(3)
Omit “approved pharmacist” and substitute “approved pharmacist or approved medical practitioner”.
Paragraph 51(f)
Omit “approved pharmacist” and substitute “approved pharmacist, approved medical practitioner”.
After section 55
Insert:
56 Transitional arrangements for repeat prescriptions
(1)Where an authorised prescriber has issued a repeat prescription prior to 1 July 2015, the new arrangements apply to the supply of the repeat pharmaceutical benefits.
(2)In this section new arrangements mean the National Health (Highly specialised drugs program) Special Arrangement 2010 as in force on 1 July 2015.
Schedule 1, entry for Eltrombopag in each of the forms Tablet 25 mg and 50 mg
omit from the column headed “Responsible Person”:GK substitute: NV
Schedule 1, entry for Abacavir in each of the forms Tablet 300 mg (as sulfate) and Oral solution 20 mg (as sulfate) per mL, 240 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Abacavir with lamivudine in the form Tablet containing abacavir 600 mg (as sulfate) with lamivudine 300 mg
omit from the column headed “Circumstances”: C4505 C4538
Schedule 1, entry for Abacavir with lamivudine and zidovudine in the form Tablet containing abacavir 300 mg (as sulfate) with lamivudine 150 mg and zidovudine 300 mg
omit from the column headed “Circumstances”: C4472 C4523
Schedule 1, entry for Adefovir dipivoxil in the form Tablet containing adefovir dipivoxil 10 mg
omit from the column headed “Circumstances”: C3971 C3972 C3973 C3974 substitute: C4490 C4510
Schedule 1, entry for Atazanavir in each of the forms Capsule 150 mg (as sulfate); Tablet 200mg (as sulfate); and Tablet 300 mg (as sulfate)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Clozapine in each of the forms Tablet 25 mg, Tablet 50 mg, Tablet 100 mg and Tablet 200 mg and Oral liquid 50 mg/mL, 100 mL
omit from the column headed “Circumstances”: C4371 C4411 substitute C4998 C5001 C5015
Schedule 1, entry for Darunavir in each of the forms Tablet 150 mg (as ethanolate) and 600 mg (as ethanolate)
omit from the column headed “Circumstances”: C3594 C3595 substitute C4313
Schedule 1, entry for Darunavir in the form Tablet 800 mg (as ethanolate)
omit from the column headed “Circumstances”: C4346
Schedule 1, entry for Didanosine in each of the forms: Capsule 125 mg (containing enteric coated beadlets), Capsule 200 mg (containing enteric coated beadlets); Tablet 250 mg (containing enteric coated beadlets); and Tablet 400 mg (containing enteric coated beadlets)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Dolutegravir in the form Tablet 50 mg (as sodium)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Dolutegravir with abacavir and lamivudine in the form Tablet containing dolutegravir 50 mg with abacavir 600 mg and lamivudine 300 mg
omit from the column headed “Circumstances”: C4472 C4523
Schedule 1, entry for Efavirenz in each of the forms: Tablet 200 mg; Tablet 600 mg; and Oral solution 30 mg per mL, 180 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Emtricitabine in the form Capsule 200 mg
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Enfuvirtide in the form Pack containing 60 vials powder for injection 90 mg with 60 vials water for injections 1.1 mL (with syringes and swabs)
omit from the column headed “Circumstances”: C3596 C3597 substitute: C5014
Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 0.5 mg
omit from the column headed “Circumstances”: C3959 C3960 C3961 C3962 substitute: C4993 C5036
Schedule 1, entry for Entecavir in the form Tablet containing entecavir monohydrate 1 mg
omit from the column headed “Circumstances”: C3963 C3964 C3965 C3966 substitute: C5037 C5044
Schedule 1, entry for Etravirine in the form Tablet 200 mg
omit from the column headed “Circumstances”: C3596 C3597 substitute: C5014
Schedule 1, entry for Fosamprenavir in each of the forms: Tablet 700 mg (as calcium); and Oral liquid 50 mg (as calcium) per mL, 225 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Foscarnet in the form I.V infusion containing foscarnet sodium 24 mg per mL, 250 mL
omit from the column headed “Circumstances”: C1413 C1610 C3322 C3378 substitute: C4973 C4980
Schedule 1, entry for Ganciclovir in the form Powder for I.V. infusion 500 mg (as sodium)
omit from the column headed “Circumstances”: C1612 C1830 C1831 C3379 C3380 C3381 substitute: C4972 C4990 C4999 C5000 C5025
Schedule 1, entry for Indinavir in the form Capsule 400 mg (as sulfate)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Interferon alfa-2a in each of the forms Injection 3,000,000 I.U. in 0.5 mL single dose pre-filled syringe; injection 4,500,000 I.U. in 0.5 mL single dose pre-filled syringe; 6,000,000 I.U. in 0.5 mL single dose pre-filled syringe; and 9,000,000 I.U. in 0.5 mL single dose pre-filled syringe
omit from the column headed “Circumstances”: C1463 C3382 C3959 C3960 C3961 C3962 substitute: C4993 C5003 C5036 C5042
Schedule 1, entry for Interferon alfa-2b in each of the forms Solution for injection 10,000,000 I.U. in 1 mL single dose vial, 18,000,000 I.U. in 1.2 mL multi-dose injection pen, 18,000,000 I.U. in 3 mL single dose vial, 25,000,000 I.U. in 2.5 mL single dose vial, 30,000,000 I.U. in 1.2 mL multi-dose injection pen and 60,000,000 I.U. in 1.2 mL multi-dose injection pen
omit from the column headed “Circumstances”: C1009 C1463 C3382 C3384 C3959 C3960 C3961 C3962
substitute: C4974 C4993 C5003 C5033 C5036 C5042
Schedule 1, entry for Lamivudine in each of the forms Tablet 100 mg and Oral solution 5 mg per 100mL, 240 mL
omit from the column headed “Circumstances”: C3959 C3960 C3961 C3962 substitute: C4993 C5036
Schedule 1, entry for Lamivudine in each of the forms Tablet 150 mg, 300 mg and Oral solution 10 mg per 100mL, 240 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Lamivudine with zidovudine in the form Tablet 150 mg - 300 mg
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Lopinavir with ritonavir in each of the forms Tablet 100 mg - 25 mg, 200 mg - 50 mg and Oral liquid 400 mg-100 mg per 5 mL, 60 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Maraviroc in each of the forms Tablet 150 mg and 300 mg
omit from the column headed “Circumstances”: C3598 C3599 substitute: C5008
Schedule 1, entry for Nevirapine in each of the forms Tablet 200 mg and Oral suspension 50 mg (as hemihydrate) per 5 mL, 240 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Nevirapine in the form Tablet 400 mg (extended release)
omit from the column headed “Circumstances”: C4460 C4469
Schedule 1, entry for Peginterferon alfa-2a in each of the forms Injection 135 micrograms in 0.5 mL single use pre-filled syringe and 180 micrograms in 0.5 mL single use pre-filled syringe
omit from the column headed “Circumstances”: C2334 C3412 C3975 C3976 C3977 C3978 substitute: C5004 C5010 C5016 C5020
Schedule 1, entry for Raltegravir in each of the forms Tablet 25 mg (as potassium) and 100 mg (as potassium)
omit from the column headed “Circumstances”: C4273 C4276
Schedule 1, entry for Raltegravir in the form Tablet 400 mg (as potassium)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Rilpivirine in the form Tablet 25 mg (as hydrochloride)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Ritonavir in each of the forms Tablet 100 mg and Oral solution 600 mg per 7.5 mL (80 mg per mL), 90 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Saquinavir in the form Tablet 500 mg (as mesylate)
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Stavudine in each of the forms Capsule 20 mg, 30 mg and 40 mg
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Telbivudine in the form Tablet 600 mg
omit from the column headed “Circumstances”: C3967 C3968 C3969 C3970 substitute: C4994 C4995
Schedule 1, entry for Tenofovir in the form Tablet containing tenofovir disoproxil fumarate 300 mg
omit from the column headed “Circumstances”: C4455 C4469 C4499 C4509 C4544 C4545
Schedule 1, entry for Tenofovir with emtricitabine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg
omit from the column headed “Circumstances”: C4455 C4469
Schedule 1, entry for Tenofovir with emtricitabine and efavirenz in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and efavirenz 600 mg
omit from the column headed “Circumstances”: C4494 C4533
Schedule 1, entry for Tenofovir with emtricitabine, elvitegravir and cobicistat in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg
omit from the column headed “Circumstances”: C4494 C4533
Schedule 1, entry for Tenofovir with emtricitabine and rilpivirine in the form Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg and rilpivirine 25 mg (as hydrochloride)
omit from the column headed “Circumstances”: C4494 C4533
Schedule 1, entry for Tipranavir in the form Capsule 250 mg
omit from the column headed “Circumstances”: C3600 C3601 substitute: C4981
Schedule 1, entry for Valganciclovir in each of the forms Tablet 450 mg (as hydrochloride) and Powder for oral solution 50 mg (as hydrochloride) per mL, 100 mL
omit from the column headed “Circumstances”: C1620 C1964 C3420 C3421 substitute: C4980 C4989 C5031
Schedule 1, entry for Zidovudine in each of the forms Capsule 100 mg and 250 mg and Syrup 10 mg per mL, 200 mL
omit from the column headed “Circumstances”: C4455 C4469
Schedule 3, entry for Abacavir
substitute

Abacavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Abacavir with lamivudine
substitute

Abacavir with Lamivudine

C4527

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4527

C4528

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4528

Schedule 3, entry for Abacavir with lamivudine and zidovudine
substitute

Abacavir with Lamivudine and Zidovudine

C4480

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4480

C4495

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve;
Patient must be aged 12 years or older; AND
Patient must weigh 40 kg or more

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4495

Schedule 3, entry for Adefovir
substitute

Adefovir

C4490

Chronic hepatitis B

Patient must not have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR
Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4490

C4510

Chronic hepatitis B

Patient must have cirrhosis; AND
Patient must have failed antihepadnaviral therapy; AND
Patient must have detectable HBV DNA

Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy

Compliance with Written and Telephone Authority Required procedures ‑ Streamlined Authority Code 4510

Schedule 3, entry for Atazanavir
substitute

Atazanavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment

Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Clozapine
substitute

Clozapine

C4998

Schizophrenia
Continuing treatment
Patient must have previously received PBS-subsidised therapy with this drug for this condition, AND
Patient must have completed at least 18 weeks therapy, AND
Patient must be on a clozapine dosage considered stable by a treating psychiatrist, AND
The treatment must be under the supervision and direction of a psychiatrist reviewing the patient at regular intervals.
Must be treated by a psychiatrist; OR
Must be treated by an authorised medical practitioner, with the agreement of the treating psychiatrist.
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4998

C5001

Where the patient is receiving treatment at/from a private hospital

Schizophrenia
Initial treatment
Patient must be non-responsive to other neuroleptic agents; OR
Patient must be intolerant of other neuroleptic agents.
Must be treated by a psychiatrist or in consultation with the psychiatrist affiliated with the hospital or specialised unit managing the patient.
Patients must complete at least 18 weeks of initial treatment under this restriction before being able to qualify for treatment under the continuing restriction.
The name of the consulting psychiatrist should be included in the patient's medical records.
A medical practitioner should request a quantity sufficient for up to one month's supply. Up to 5 repeats will be authorised.

Compliance with Written or Telephone Authority Required procedures

C5015

Where the patient is receiving treatment at/from a public hospital

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5015

Schedule 3, entry for Darunavir
substitute

Darunavir

C4313

Human immunodeficiency virus (HIV) infection
The treatment must be in addition to optimised background therapy
The treatment must be in combination with other antiretroviral agents
The treatment must be co‑administered with 100 mg ritonavir
Patient must have experienced virological failure or clinical failure or genotypic resistance after at least one antiretroviral regimen
Patient must not have demonstrated darunavir resistance associated mutations detected on resistance testing.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment‑limiting toxicity

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4313

Schedule 3, entry for Didanosine
substitute

Didanosine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Dolutegravir
substitute

Didanosine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Dolutegravir with abacavir and lamivudine
substitute

Dolutegravir with abacavir and lamivudine	C4480	P4480	HIV infection – Continuing treatment Patient must have previously received PBS-subsidised therapy for HIV infection. Patient must be aged 12 years or older, and must weigh 40 kg or more.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4480
C4495	P4495	HIV infection – Initial treatment Patient must be antiretroviral treatment naive. Patient must be aged 12 years or older, and Patient must weigh 40 kg or more.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4495

Schedule 3, entry for Efavirenz
substitute

Efavirenz

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Emtricitabine
substitute

Emtricitabine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Enfuvirtide
substitute

Enfuvirtide

C5014

HIV infection
The treatment must be in addition to optimised background therapy, AND
The treatment must be in combination with other antiretroviral agents, AND
Patient must be antiretroviral experienced, AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5014

Schedule 3, entry for Entecavir
substitute

Entecavir	C4993	Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4993
C5036	Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must have detectable HBV DNA. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5036
C5037	Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must have failed lamivudine, AND Patient must have detectable HBV DNA. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5037
C5044	Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must have failed lamivudine, AND Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5044

Schedule 3, entry for Etravirine
substitute

Etravirine

C5014

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5014

Schedule 3, entry for Fosamprenavir
substitute

Fosamprenavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Foscarnet
substitute

Foscarnet	C4973	Herpes simplex virus infection The condition must be aciclovir resistant, AND Patient must have HIV infection.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4973
C4980	Cytomegalovirus retinitis Clinical criteria: Patient must have HIV infection.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4980

Schedule 3, entry for Ganciclovir
substitute

Ganciclovir	C4972	Where the patient is receiving treatment at/from a public hospital Cytomegalovirus disease Prophylaxis Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4972
C4990	Where the patient is receiving treatment at/from a private hospital Cytomegalovirus disease Prophylaxis Patient must be a bone marrow transplant recipient at risk of cytomegalovirus disease.	Compliance with Written and Telephone Authority Required procedures
C4999	Where the patient is receiving treatment at/from a public hospital Cytomegalovirus disease Prophylaxis Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4999
C5000	Cytomegalovirus retinitis Patient must be severely immunocompromised, including due to HIV infection.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5000
C5025	Where the patient is receiving treatment at/from a private hospital Cytomegalovirus disease Prophylaxis Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.	Compliance with Written and Telephone Authority Required procedures

Schedule 3, entry for Indinavir
substitute

Indinavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Interferon alfa-2a
substitute

Interferon alfa-2a	C4993	Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4993
C5003	Where the patient is receiving treatment at/from a private hospital Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic Myeloid Leukaemia (CML) The condition must be Philadelphia chromosome positive.	Compliance with Written and Telephone Authority Required procedures
C5036	Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must have detectable HBV DNA. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5036
C5042	Where the patient is receiving treatment at/from a public hospital Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic Myeloid Leukaemia (CML) The condition must be Philadelphia chromosome positive.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5042

Schedule 3, entry for Interferon alfa-2b
substitute

Interferon alfa-2b	C4974	Where the patient is receiving treatment at/from a public hospital Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Malignant melanoma The treatment must be as adjunctive therapy to current standard care, AND Patient must have undergone surgery, AND The condition must include nodal involvement.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4974
C4993	Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4993
C5003	Where the patient is receiving treatment at/from a private hospital Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic Myeloid Leukaemia (CML) The condition must be Philadelphia chromosome positive.	Compliance with Written and Telephone Authority Required procedures
C5033	Where the patient is receiving treatment at/from a private hospital Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Malignant melanoma The treatment must be as adjunctive therapy to current standard care, AND Patient must have undergone surgery, AND The condition must include nodal involvement.	Compliance with Written and Telephone Authority Required procedures
C5036	Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must have detectable HBV DNA. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5036
C5042	Where the patient is receiving treatment at/from a public hospital Treatment with interferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic Myeloid Leukaemia (CML) The condition must be Philadelphia chromosome positive.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5042

Schedule 3, entry for Lamivudine
substitute

Lamivudine	C4454	HIV infection Continuing treatment Patient must have previously received PBS‑subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454
C4512	HIV infection Initial treatment Patient must be antiretroviral treatment naïve; AND The treatment must be in combination with other antiretroviral agents	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512
C4993	Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4993
C5036	Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must have detectable HBV DNA. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5036

Schedule 3, entry for Lamivudine with zidovudine
substitute

Lamivudine with zidovudine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Lopinavir with ritonavir
substitute

Lopinavir with ritonavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Maraviroc
substitute

Maraviroc

C5008

HIV infection
Patient must be infected with CCR5-tropic HIV-1, AND
The treatment must be in addition to optimised background therapy, AND
The treatment must be in combination with other antiretroviral agents, AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.
A tropism assay to determine CCR5 only strain status must be performed prior to initiation. Individuals with CXCR4 tropism demonstrated at any time point are not eligible.

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5008

Schedule 3, entry for Nevirapine
substitute

Nevirapine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

C4526

HIV infection
Initial treatment
Patient must have been stabilised on nevirapine immediate release; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4526

Schedule 3, entry for Peginterferon alfa-2a
substitute

Peginterferon alfa-2a	C5004	Where the patient is receiving treatment at/from a public hospital Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic hepatitis C infection Patient must have compensated liver disease, AND Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C, AND Patient must have a contraindication to ribavirin, AND The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop, AND The treatment must be limited to a maximum duration of 48 weeks. Population criteria: Patient must be aged 18 years or older, AND Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age. Must be treated in an accredited treatment centre. Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5004
C5010	Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must not have previously received peginterferon alfa therapy for the treatment of hepatitis B, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by confirmed elevated serum ALT or liver biopsy, AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5010
C5016	Where the patient is receiving treatment at/from a private hospital Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic hepatitis C infection Patient must have compensated liver disease, AND Patient must not have received prior interferon alfa or peginterferon alfa treatment for hepatitis C, AND Patient must have a contraindication to ribavirin, AND The treatment must cease unless the results of an HCV RNA quantitative assay at week 12 (performed at the same laboratory using the same test) show that plasma HCV RNA has become undetectable or the viral load has decreased by at least a 2 log drop, AND The treatment must be limited to a maximum duration of 48 weeks. Patient must be aged 18 years or older, AND Patient must not be pregnant or breastfeeding, and must be using an effective form of contraception if female and of child-bearing age. Must be treated in an accredited treatment centre. Evidence of chronic hepatitis C infection (repeatedly anti-HCV positive and HCV RNA positive) must be documented in the patient's medical records.	Compliance with Written and Telephone Authority Required procedures
C5020	Treatment with peginterferon alfa has been associated with depression and suicide in some patients. Patients with a history of suicidal ideation or depressive illness should be warned of the risks. Psychiatric status during therapy should be monitored. Chronic hepatitis B infection The treatment must be limited to a maximum duration of 48 weeks, AND Patient must have cirrhosis, AND Patient must have detectable HBV DNA, AND The treatment must be the sole PBS-subsidised therapy for this condition. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 5020

Schedule 3, entry for Raltegravir
substitute

Raltegravir	C4274	HIV infection Continuing treatment The treatment must be in combination with other antiretroviral agents, Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti‑retroviral therapy, Patient must have previously received PBS‑subsidised therapy for HIV infection, Patient must be aged 2 years or older	Compliance with Written and Telephone Authority Required procedures ‑ Streamlined Authority Code 4274
C4275	HIV infection Initial treatment The treatment must be in combination with other antiretroviral agents, Patient must be antiretroviral experienced with at least 6 months therapy with 2 alternate classes of anti‑retroviral therapy, Patient must have a CD4 count of less than 500 per cubic millimetre; OR Patient must have symptomatic HIV disease, Patient must be aged 2 years or older	Compliance with Written and Telephone Authority Required procedures ‑ Streamlined Authority Code 4275
C4454	HIV infection Continuing treatment Patient must have previously received PBS‑subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454
C4512	HIV infection Initial treatment Patient must be antiretroviral treatment naïve; AND The treatment must be in combination with other antiretroviral agents	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Rilpivirine
substitute

Rilpivirine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Ritonavir
substitute

Ritonavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Saquinavir
substitute

Saquinavir

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Stavudine
substitute

Stavudine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Telbivudine
substitute

Telbivudine	C4994	Chronic hepatitis B infection Patient must have cirrhosis, AND Patient must be nucleoside analogue naive, AND Patient must have detectable HBV DNA, AND The treatment must be the sole PBS-subsidised therapy for this condition. Patients with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4994
C4995	Chronic hepatitis B infection Patient must not have cirrhosis, AND Patient must be nucleoside analogue naive, AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection, AND Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy, AND The treatment must be the sole PBS-subsidised therapy for this condition.	Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4995

Schedule 3, entry for Tenofovir
substitute

Tenofovir	C4454	HIV infection Continuing treatment Patient must have previously received PBS‑subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454
C4476	Chronic hepatitis B Patient must have cirrhosis; AND Patient must be nucleoside analogue naïve; AND Patient must have detectable HBV DNA; AND The treatment must be the sole PBS‑subsidised therapy for this condition Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4476
C4489	Chronic hepatitis B Patient must not have cirrhosis; AND Patient must be nucleoside analogue naïve; AND Patient must have elevated HBV DNA levels greater than 20,000 IU/mL (100,000 copies/mL) if HBeAg positive, in conjunction with documented hepatitis B infection; OR Patient must have elevated HBV DNA levels greater than 2,000 IU/mL (10,000 copies/mL) if HBeAg negative, in conjunction with documented hepatitis B infection; AND Patient must have evidence of chronic liver injury determined by: (i) confirmed elevated serum ALT; or (ii) liver biopsy; AND The treatment must be the sole PBS‑subsidised therapy for this condition	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4489
C4490	Chronic hepatitis B Patient must not have cirrhosis; AND Patient must have failed antihepadnaviral therapy; AND Patient must have repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration, in conjunction with documented chronic hepatitis B infection; OR Patient must have repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a 1 log reduction in HBV DNA within 3 months whilst on previous antihepadnaviral therapy, except in patients with evidence of poor compliance	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4490
C4510	Chronic hepatitis B Patient must have cirrhosis; AND Patient must have failed antihepadnaviral therapy; AND Patient must have detectable HBV DNA Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy	Compliance with Written and Telephone Authority Required procedures ‑ Streamlined Authority Code 4510
C4512	HIV infection Initial treatment Patient must be antiretroviral treatment naïve; AND The treatment must be in combination with other antiretroviral agents	Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Tenofovir with emtricitabine
substitute

Tenofovir with emtricitabine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512

Schedule 3, entry for Tenofovir with emtricitabine and efavirenz
substitute

Tenofovir with emtricitabine and efavirenz

C4470

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4470

C4522

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4522

Schedule 3, entry for Tenofovir with emtricitabine, elvitegravir and cobicistat
substitute

Tenofovir with emtricitabine, elvitegravir and cobicistat

C4470

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4470

C4522

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4522

Schedule 3, entry for Tenofovir with emtricitabine and rilpivirine
substitute

Tenofovir with emtricitabine and rilpivirine

C4470

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4470

C4522

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4522

Schedule 3, entry for Tipranavir
substitute

Tipranavir

C4981

HIV infection
The treatment must be in addition to optimised background therapy, AND
The treatment must be in combination with other antiretroviral agents, AND
Patient must be antiretroviral experienced, AND
The treatment must be co-administered with 200 mg ritonavir twice daily, AND
Patient must have experienced virological failure or clinical failure or genotypic resistance after each of at least 3 different antiretroviral regimens that have included one drug from at least 3 different antiretroviral classes.
Virological failure is defined as a viral load greater than 400 copies per mL on two consecutive occasions, while clinical failure is linked to emerging signs and symptoms of progressing HIV infection or treatment-limiting toxicity.

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4981

Schedule 3, entry for Valganciclovir
substitute

Valganciclovir

C4980

Cytomegalovirus retinitis
Patient must have HIV infection.

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4980

C4989

Where the patient is receiving treatment at/from a public hospital

Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Written and Telephone Authority Required procedures - Streamlined Authority Code 4989

C5031

Where the patient is receiving treatment at/from a private hospital

Cytomegalovirus infection and disease
Prophylaxis
Patient must be a solid organ transplant recipient at risk of cytomegalovirus disease.

Compliance with Written and Telephone Authority Required procedures

Schedule 3, entry for Zidovudine
substitute

Zidovudine

C4454

HIV infection
Continuing treatment

Patient must have previously received PBS‑subsidised therapy for HIV infection; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4454

C4512

HIV infection
Initial treatment
Patient must be antiretroviral treatment naïve; AND
The treatment must be in combination with other antiretroviral agents

Compliance with Written or Telephone Authority Required procedures ‑ Streamlined Authority Code 4512