National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 3) (PB 30 of 2017) (Cth)

PB 30 of 2017

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 3)

National Health Act 1953

___________________________________________________________________________

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

Dated    27    April 2017

Julianne Quaine

Assistant Secretary

Pharmaceutical Access Branch

Pharmaceutical Benefits Division

Department of Health

___________________________________________________________________________

Part 1        Preliminary

1                  Name of Instrument

(1)This instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2017 (No. 3).

(2)This instrument may also be cited as PB 30 of 2017.

2              Commencement

This instrument commences on 1 May 2017.

3              Amendment

The Schedule amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule – Amendments

Schedule

National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010)

1. Division 1, Section 4, definition for 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)  darunavir with cobicistat

(h)  didanosine

(i)  dolutegravir

(j)  dolutegravir with abacavir and lamivudine

(k)  doxorubicin, pegylated liposomal

(l)  efavirenz

   (m)  emtricitabine

(n)   emtricitabine with rilpivirine with tenofovir alafenamide

(o)   emtricitabine with tenofovir alafenamide

(p)  enfuvirtide

(q)  etravirine

(r)  fosamprenavir

(s)  foscarnet

(t)  ganciclovir

(u)  indinavir

(v)  lamivudine

(w)  lamivudine with zidovudine

(x)  lopinavir with ritonavir

(y)  maraviroc

(z)  nevirapine

(za)  raltegravir

(zb)  rifabutin

(zc)  rilpivirine

(zd)  ritonavir

(ze)  saquinavir

(zf)  stavudine

(zg)  tenofovir

(zh)  tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat

(zi)  tenofovir with emtricitabine

(zj)  enofovir with emtricitabine efavirenz

(zk)  tenofovir with emtricitabine, elvitegravir and cobicistat

(zl) tenofovir with emtricitabine and rilpivirine

(zm)  valganciclovir

(zn)  tipranavir

(zo)  zidovudine

1. Schedule 1, entry for Alemtuzumab

Substitute:

Alemtuzumab	Solution concentrate for I.V. infusion 12 mg in 1.2 mL	Injection	Lemtrada	GZ	EMP	C6847 C6877 C6878 C6884	P6847 P6878	3	0	D
Lemtrada	GZ	EMP	C6847 C6877 C6878 C6884	P6877 P6884	5	0	D

1. Schedule 1, repeal entry for Boceprevir

1. Schedule 1, after entry for Emtricitabine                          Insert:

Emtricitabine with rilpivirine with tenofovir alafenamide Tablet containing emtricitabine 200 mg with rilpivirine 25 mg with tenofovir alafenamide 25 mg Oral Odefsey GI EMP C4470 C4522 60 5 D

1. Schedule 1, after entry for Emtricitabine with rilpivirine with tenofovir alafenamide             

   Insert:

Emtricitabine with tenofovir alafenamide	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 10 mg	Oral	Descovy	GI	EMP	C4454 C4512	60	5	D
	Tablet containing emtricitabine 200 mg with tenofovir alafenamide 25 mg	Oral	Descovy	GI	EMP	C4454 C4512	60	5	D

1. Schedule 1, entry for Interferon Alfa-2a                         Omit:

Injection 6,000,000 I.U. in 0.5 mL single dose pre‑filled syringe Injection Roferon‑A RO EMP C4993 C5003 C5036 C5042 30 5 C

1. Schedule 1, entry for Ivacaftor

Substitute:

Ivacaftor	Sachet containing granules 50 mg	Oral	Kalydeco	VR	EMP	C6857 C6861 C6862	56	5	D
	Sachet containing granules 75 mg	Oral	Kalydeco	VR	EMP	C6857 C6861 C6862	56	5	D
	Tablet 150 mg	Oral	Kalydeco	VR	EMP	C6861 C6862	56	5	D

1. Schedule 1, entry for Levodopa with Carbidopa

Omit from the column headed ‘Circumstances’: C6154 C6179   Insert: C6863 C6880

1. Schedule 1, entry for Natalizumab

Omit from the column headed ‘Circumstances’: C5987 C6012 C6043   Insert: C6845 C6850 C6875

1. Schedule 1, after entry for Nevirapine, in the form ‘Tablet 400 mg (extended release)’ and brand ‘Viramune XR’

Insert:

Nevirapine XR APOTEX TX EMP C4454 C4526 60 5 D

1. Schedule 1, after entry for Tenofovir

Insert:

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg Oral Genvoya GI EMP C4470 C4522 60 5 D

1. Schedule 1, entry for Tenofovir with Emtricitabine

Omit:

Tablet containing tenofovir alafenamide 10 mg with emtricitabine 200 mg	Oral	Descovy 10/200	GI	EMP	C4454 C4512	60	5	D
Tablet containing tenofovir alafenamide 25 mg with emtricitabine 200 mg	Oral	Descovy 25/200	GI	EMP	C4454 C4512	60	5	D

1. Schedule 1, entry for Tenofovir with emtricitabine, elvitegravir and cobicistat

Substitute:

Tenofovir with emtricitabine, elvitegravir and cobicistat Tablet containing tenofovir disoproxil fumarate 300 mg with emtricitabine 200 mg, elvitegravir 150 mg and cobicistat 150 mg Oral Stribild GI EMP C4470 C4522 60 5 D

1. Schedule 3, entry for Alemtuzumab

Substitute:

Alemtuzumab	C6847	P6847	Where the patient is receiving treatment at/from a public hospital Multiple sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must not receive more than one PBS-subsidised treatment per year; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a neurologist.	Compliance with Authority Required procedures - Streamlined Authority Code 6847
	C6877	P6877	Where the patient is receiving treatment at/from a private hospital Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND Patient must be ambulatory (without assistance or support). Must be treated by a neurologist. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures
	C6878	P6878	Where the patient is receiving treatment at/from a private hospital Multiple sclerosis Continuing treatment Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must not receive more than one PBS-subsidised treatment per year; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have demonstrated compliance with, and an ability to tolerate this therapy. Must be treated by a neurologist.	Compliance with Authority Required procedures
	C6884	P6884	Where the patient is receiving treatment at/from a public hospital Multiple sclerosis Initial treatment The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by accompanying written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to the multiple sclerosis, in the preceding 2 years; AND Patient must be ambulatory (without assistance or support). Must be treated by a neurologist. Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.	Compliance with Authority Required procedures - Streamlined Authority Code 6884

1. Schedule 3, repeal entry for Boceprevir

1. Schedule 3, after entry for Emtricitabine

Insert:

Emtricitabine with rilpivirine with tenofovir alafenamide	C4470	HIV infection Continuing Patient must have previously received PBS-subsidised therapy for HIV infection.	Compliance with Authority Required procedures - Streamlined Authority Code 4470
	C4522	HIV infection Initial Patient must be antiretroviral treatment naive.	Compliance with Authority Required procedures - Streamlined Authority Code 4522

1. Schedule 3, after entry for Emtricitabine with rilpivirine with tenofovir alafenamide               

Insert:

Emtricitabine with tenofovir alafenamide	C4454	HIV infection Continuing Patient must have previously received PBS-subsidised therapy for HIV infection; AND The treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 4454
	C4512	HIV infection Initial Patient must be antiretroviral treatment naive; AND The treatment must be in combination with other antiretroviral agents.	Compliance with Authority Required procedures - Streamlined Authority Code 4512

1. Schedule 3, entry for Ivacaftor

Substitute:

Ivacaftor	C6857	Where the patient is receiving treatment at/from a private or public hospital Cystic fibrosis Initial treatment - Grandfather patients Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND Patient must have received treatment with ivacaftor for this condition prior to 1 May 2017; AND Patient must have received treatment with ivacaftor within the last 6 months at the time of application; AND Patient must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be 2 to 5 years of age. Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry. Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug. Dosage of ivacaftor must not exceed the dose of one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. A patient may qualify for PBS-subsidised treatment under this restriction once only. For continuing PBS-subsidised treatment, a Grandfathered patient must qualify under the Continuing treatment criteria. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Ivacaftor Application Supporting Information Form; and (3) an acknowledgement signed by a parent, or authorised guardian if applicable; and (4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene performed prior to commencing treatment with ivacaftor; and (5) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and (6) a copy of sweat chloride result performed prior to commencing treatment with ivacaftor for this condition; and (7) height and weight measurements at the time of application; and (8) height and weight measurements performed immediately prior to commencement of ivacaftor; and (9) a baseline measurement of number of days of CF-related hospitalisation (including hospital-in-the home) in the 12 months prior to commencement of ivacaftor; and (10) a measurement of the number of days of CF-related hospitalisation (including hospital-in the home) in the 6 months prior to the date of application; and (11) dates of prior ivacaftor therapy.	Compliance with Written Authority Required procedures
	C6861	Where the patient is receiving treatment at/from a private or public hospital Cystic fibrosis Initial treatment - New patients Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have G551D mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene on at least 1 allele; OR Patient must have other gating (class III) mutation in the CFTR gene on at least 1 allele; AND Patient must have a sweat chloride value of at least 60 mmol/L by quantitative pilocarpine iontophoresis; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged 2 years or older. Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry. Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Ivacaftor Authority Application Supporting Information Form; and (3) a signed patient acknowledgement; or an acknowledgement signed by a parent or authorised guardian, if applicable; and (4) a copy of the pathology report detailing the molecular testing for G551D mutation or other gating (class III) mutation on the CFTR gene; and (5) the result of a FEV1 measurement performed within a month prior to the date of application, if aged from 6 years or older. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and (6) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and (7) a copy of a sweat chloride result; and (8) height and weight measurements at the time of application; and (9) a baseline measurement of the number of days of CF-related hospitalisation (including hospital-in-the home) in the previous 12 months.	Compliance with Written Authority Required procedures
	C6862	Where the patient is receiving treatment at/from a private or public hospital Cystic fibrosis Continuing treatment Patient must be assessed through a cystic fibrosis clinic/centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at such a unit is not possible because of geographical isolation, management (including prescribing) may be in consultation with such a unit; AND Patient must have received PBS-subsidised initial therapy with ivacaftor, given concomitantly with standard therapy, for this condition; AND Patient must not receive more than 24 weeks of treatment under this restriction; AND The treatment must be given concomitantly with standard therapy for this condition. Patient must be aged 2 years or older. Patients receiving PBS-subsidised ivacaftor must be registered in the Australian Cystic Fibrosis Database Registry. Treatment must not be given to a patient who has an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease in the last 4 weeks prior to commencing this drug. Patients who have an acute infective exacerbation at the time of assessment for continuing therapy may receive an additional one month's supply in order to enable the assessment to be repeated following resolution of the exacerbation. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet twice a week, if the patient is concomitantly receiving one of the following strong CYP3A4 drugs inhibitors: boceprevir, clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Where a patient is concomitantly receiving a strong CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 28 weeks. Dosage of ivacaftor must not exceed the dose of one tablet (150 mg) or one sachet once daily, if the patient is concomitantly receiving one of the following moderate CYP3A4 inhibitors: amprenavir, aprepitant, atazanavir, darunavir/ritonavir, diltiazem, erythromycin, fluconazole, fosamprenavir, imatinib, verapamil. Where a patient is concomitantly receiving a moderate CYP3A4 inhibitor, a single supply of 56 tablets or sachets of ivacaftor will last for 8 weeks. Ivacaftor is not PBS-subsidised for this condition as a sole therapy. Ivacaftor is not PBS-subsidised for this condition in a patient who is currently receiving one of the following CYP3A4 inducers: Strong CYP3A4 inducers: avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, St. John's wort Moderate CYP3A4 inducers: bosentan, efavirenz, etravirine, modafinil, nafcillin Weak CYP3A4 inducers: armodafinil, echinacea, pioglitazone, rufinamide. The authority application must be in writing and must include: (1) a completed authority prescription form; and (2) a completed Cystic Fibrosis Ivacaftor Authority Continuing Application Supporting Information Form; and (3) the result of a FEV1 measurement performed within one month prior to the date of application, if aged 6 years or older. Note: FEV1, must be measured in an accredited pulmonary function laboratory, with documented no acute infective exacerbation at the time FEV1 is measured; and (4) a copy of a current medication history, including any CYP3A4 inhibitors and/or CYP3A4 inducers; and (5) height and weight measurements at the time of application; and (6) a measurement of number of days of CF-related hospitalisation (including hospital in the home) in the previous 6 months.	Compliance with Written Authority Required procedures

1. Schedule 3, entry for Levodopa with Carbidopa

Substitute:

Levodopa with carbidopa	C6863	Where the patient is receiving treatment at/from a public hospital Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic.	Compliance with Authority Required procedures - Streamlined Authority Code 6863
	C6880	Where the patient is receiving treatment at/from a private hospital Advanced Parkinson disease Patient must have severe disabling motor fluctuations not adequately controlled by oral therapy; AND The treatment must be commenced in a hospital-based movement disorder clinic.	Compliance with Authority Required procedures

1. Schedule 3, entry for Natalizumab

Substitute:

Natalizumab	C6845	Where the patient is receiving treatment at/from a private hospital Clinically definite relapsing-remitting multiple sclerosis Continuing treatment The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND Patient must not show continuing progression of disability while on treatment with this drug; AND Patient must have demonstrated compliance with, and an ability to tolerate, this therapy. Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.	Compliance with Authority Required procedures
	C6850	Where the patient is receiving treatment at/from a private hospital Clinically definite relapsing-remitting multiple sclerosis Initial treatment The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. Patient must be aged 18 years or older. Must be treated by a neurologist. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.	Compliance with Authority Required procedures
	C6875	Where the patient is receiving treatment at/from a public hospital Clinically definite relapsing-remitting multiple sclerosis The treatment must be a sole PBS-subsidised disease modifying therapy for this condition; AND Patient must be ambulatory (without assistance or support); AND Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years; AND The condition must be confirmed by magnetic resonance imaging of the brain and/or spinal cord; OR Patient must be deemed unsuitable for magnetic resonance imaging due to the risk of physical (not psychological) injury to the patient. Patient must be aged 18 years or older. Must be treated by a neurologist. The date of the magnetic resonance imaging scan must be included in the patient's medical notes, unless written certification is provided, in the patient's medical notes, by a radiologist that an MRI scan is contraindicated because of the risk of physical (not psychological) injury to the patient. Treatment with this drug must cease if there is continuing progression of disability whilst the patient is being treated with this drug. For continued treatment the patient must demonstrate compliance with, and an ability to tolerate, this drug. Neurologists prescribing natalizumab under the PBS listing must be registered with the Tysabri Australian Prescribing Program.	Compliance with Authority Required procedures - Streamlined Authority Code 6875

1. Schedule 3, after entry for Tenofovir

Insert:

Tenofovir alafenamide with emtricitabine, elvitegravir and cobicistat	C4470	HIV infection Continuing Patient must have previously received PBS-subsidised therapy for HIV infection.	Compliance with Authority Required procedures - Streamlined Authority Code 4470
	C4522	HIV infection Initial Patient must be antiretroviral treatment naive.	Compliance with Authority Required procedures - Streamlined Authority Code 4522