National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9) (PB 106 of 2020) (Cth)

Case

PB 106 of 2020

National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9)

National Health Act 1953

___________________________________________________________________________

I, BEN SLADIC, Assistant Secretary, Pharmacy Branch, Technology Assessment and Access Division, Department of Health, delegate of the Minister for Health, make this Amendment Instrument under subsection 100(2) of the National Health Act 1953.

Dated         29 October 2020

BEN SLADIC

Assistant Secretary

Pharmacy Branch

Technology Assessment and Access Division

Department of Health

___________________________________________________________________________

  1. Name of Instrument

(1)This Instrument is the National Health (Highly specialised drugs program) Special Arrangement Amendment Instrument 2020 (No. 9).

(2)This Instrument may also be cited as PB 106 of 2020.

  1. Commencement

This Instrument commences on 1 November 2020.

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

Schedule 1 amends the National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010).

Schedule 1     Amendments

  1. Part 1, Division 1, Subsection 4A(2)

omit:

(d)   sofosbuvir

  1. Schedule 1, entry for Bosentan in each of the forms: Tablet 62.5 mg (as monohydrate); and Tablet 125 mg (as monohydrate)

(a)omit from the column headed “Circumstances” (all instances): C10286 C10305

(b)insert in numerical order in the column headed “Circumstances” (all instances): C10924 C10945

  1. Schedule 1, entry for Darunavir

omit:

Tablet 150 mg (as ethanolate) Oral Prezista JC C5094 240 5 D

  1. Schedule 1, omit entry for Lenograstim

  1. Schedule 1, entry for Macitentan

substitute:

Macitentan Tablet 10 mg Oral Opsumit JC C10228 C10236 C10285 C10728 C10845 C10846 C10850 C10869 30 5 D

  1. Schedule 1, after entry for Mepolizumab in the form Powder for injection 100 mg

insert:

Methoxsalen Solution for blood fraction 20 microgram per mL, 10 mL Extracorporeal Circulation Uvadex TQ C10971 C10985 C10988 C10989 P10988 P10989 1 5 D
C10971 C10985 C10988 C10989 P10971 P10985 2 6 D

  1. Schedule 1, omit entry for Sofosbuvir

  1. Schedule 2, after details relevant to Responsible Person code TK

insert:

TQ Terumo BCT Australia Pty Limited 87 130 046 865

  1. Schedule 3, entry for Alemtuzumab

substitute:

Alemtuzumab C6847 P6847 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 the 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
C7714 P7714 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 the 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 multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; 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 7714
C9589 P9589 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 the 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 9589
C9636 P9636 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 the 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 multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; 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 9636

  1. Schedule 3, entry for Bosentan

(a)omit:

C10286 Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term ‘PAH agents’ refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Applications for authorisation must be in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Where it is not possible to perform all 3 tests on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
The test results provided must not be more than 2 months old at the time of application.
Prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information. No repeats will be authorised for this prescription.
Prescribers should request the second authority prescription of therapy with either the 62.5 mg tablet or the 125 mg tablet strengths, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats. 		Compliance with Written Authority Required procedures
C10305 Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term ‘PAH agents’ refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent’s restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
Prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information. No repeats will be authorised for this prescription.
Prescribers should request the second authority prescription of therapy with either the 62.5 mg tablet or the 125 mg tablet strengths, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats. 		Compliance with Authority Required procedures

(b)insert in numerical order after existing text:

C10924 Pulmonary arterial hypertension (PAH)
Initial 2 (change)
Patient must have documented WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
Patient must have had their most recent course of PBS-subsidised treatment for this condition with a PAH agent other than this agent; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
Swapping between PAH agents: Patients can access PAH agents through the PBS according to the relevant restrictions. Once these patients are approved initial treatment (monotherapy) with 1 of these 8 drugs, they may swap between PAH agents at any time without having to re-qualify for treatment with the alternate agent. This means that patients may commence treatment with the alternate agent, subject to that agent's restriction, irrespective of the severity of their disease at the time the application to swap therapy is submitted.
Applications to swap between the 8 PAH agents must be made under the relevant initial treatment (monotherapy) restriction.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. 		Compliance with Authority Required procedures
C10945 Pulmonary arterial hypertension (PAH)
Initial 1 (new patients)
Patient must not have received prior PBS-subsidised treatment with a pulmonary arterial hypertension (PAH) agent; AND
Patient must have been assessed by a physician with expertise in the management of PAH; AND
Patient must have WHO Functional Class II PAH, or WHO Functional Class III PAH, or WHO Functional Class IV PAH; AND
The treatment must be the sole PBS-subsidised PAH agent for this condition.
The term 'PAH agents' refers to bosentan monohydrate, iloprost trometamol, epoprostenol sodium, sildenafil citrate, ambrisentan, tadalafil, macitentan, and riociguat.
PAH agents are not PBS-subsidised for patients with pulmonary hypertension secondary to interstitial lung disease associated with connective tissue disease, where the total lung capacity is less than 70% of predicted.
PAH (WHO Group 1 pulmonary hypertension) is defined as follows:
(i) mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg at rest and pulmonary artery wedge pressure (PAWP) less than or equal to 15 mmHg; or
(ii) where a right heart catheter (RHC) cannot be performed on clinical grounds, right ventricular systolic pressure (RVSP), assessed by echocardiography (ECHO), greater than 40 mmHg, with normal left ventricular function.
Applications for authorisation must be in writing and must include:
(1) two completed authority prescription forms; and
(2) a completed Pulmonary Arterial Hypertension PBS Authority Application - Supporting Information form which includes results from the three tests below, where available:
(i) RHC composite assessment; and
(ii) ECHO composite assessment; and
(iii) 6 Minute Walk Test (6MWT).
Where it is not possible to perform all 3 tests on clinical grounds, the following list outlines the preferred test combination, in descending order, for the purposes of initiation of PBS-subsidised treatment:
(1) RHC plus ECHO composite assessments;
(2) RHC composite assessment plus 6MWT;
(3) RHC composite assessment only.
In circumstances where a RHC cannot be performed on clinical grounds, applications may be submitted for consideration based on the results of the following test combinations, which are listed in descending order of preference:
(1) ECHO composite assessment plus 6MWT;
(2) ECHO composite assessment only.
Where fewer than 3 tests are able to be performed on clinical grounds, a patient specific reason outlining why the particular test(s) could not be conducted must be provided with the authority application.
Where a RHC cannot be performed on clinical grounds, confirmation of the reason(s) must be provided with the authority application by a second PAH physician or cardiologist with expertise in the management of PAH.
The test results provided must not be more than 2 months old at the time of application.
If patients will be taking 62.5mg for the first month then 125 mg, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information and no repeats.
Prescribers should request the second authority prescription of therapy with the 125 mg tablet strengths, with a quantity for one month of treatment, based on the dosage recommendations in the TGA-approved Product Information, and a maximum of 4 repeats.
If patients will be taking 62.5mg for longer than 1 month, prescribers should request the first authority prescription of therapy with the 62.5 mg tablet strength, with the quantity for one month of treatment and a maximum of 5 repeats based on the dosage recommendations in the TGA-approved Product Information. 		Compliance with Written Authority Required procedures

  1. Schedule 3, omit entry for Lenograstim

  1. Schedule 3, after entry for Mepolizumab

insert:

Methoxsalen C10971 P10971 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Initial treatment
Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Patient must be aged 18 years or over. 		Compliance with Authority Required procedures - Streamlined Authority Code 10971
C10985 P10985 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Initial treatment
Patient must have experienced disease progression while on at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; OR
Patient must have experienced an intolerance necessitating permanent treatment withdrawal to at least one systemic treatment for this PBS indication prior to initiating treatment with this drug; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14247 of the Medicare Benefits Schedule; AND
Patient must not have previously received PBS-subsidised treatment with this drug for this PBS indication.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
Patient must be aged 18 years or over. 		Compliance with Authority Required procedures - Streamlined Authority Code 10985
C10988 P10988 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND
Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment 		Compliance with Authority Required procedures - Streamlined Authority Code 10988
C10989 P10989 Erythrodermic stage III-IVa T4 M0 Cutaneous T-cell lymphoma
Continuing treatment
Patient must have received PBS-subsidised treatment with this drug for this PBS indication; AND
Patient must have demonstrated a response to treatment with this drug if treatment is continuing beyond 6 months of treatment for the first time; AND
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; OR
The treatment must be in combination with peginterferon alfa-2a only if used in combination with another drug; AND
Patient must be receiving the medical service as described in item 14249 of the Medicare Benefits Schedule.
Must be treated by a haematologist; OR
Must be treated by a medical physician working under the supervision of a haematologist.
A response, for the purposes of administering this continuing restriction, is defined as attaining a reduction of at least 50% in the overall skin lesion score from baseline, for at least 4 consecutive weeks. Refer to the Product Information for directions on calculating an overall skin lesion score. The definition of a clinically significant reduction in the Product Information differs to the 50% requirement for PBS-subsidy. Response only needs to be demonstrated after the first six months of treatment 		Compliance with Authority Required procedures - Streamlined Authority Code 10989

  1. Schedule 3, entry for Natalizumab

substitute:

Natalizumab C9744 Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be the 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 of commencing a PBS-subsidised disease modifying therapy for this condition; 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.
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 9744
C9818 Clinically definite relapsing-remitting multiple sclerosis
Must be treated by a neurologist.
The treatment must be the 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 of commencing a PBS-subsidised disease modifying therapy for this condition; 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.
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 9818

  1. Schedule 3, entry for Ocrelizumab

substitute:

Ocrelizumab C7386 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
The treatment must be the 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 7386
C7699 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 the 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 multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; 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 7699
C9523 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 the 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 multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; 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 9523
C9635 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
The treatment must be the 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 9635

  1. Schedule 3, omit entry for Sofosbuvir

  1. Schedule 3, Part 1 - General statement for drugs for the treatment of hepatitis C

substitute:

Schedule 3 Part 1—General statement for drugs for the treatment of hepatitis C

1        Criteria for eligibility for drugs for the treatment of chronic hepatitis C

The criteria for patient eligibility for drugs for the treatment of chronic hepatitis C are that:

(1)     the patient has been assessed in accordance with paragraph 2 of this Part; and

(2)     the patient is:

(a)       treated by a medical practitioner or an authorised nurse practitioner who is experienced in the treatment of patients with chronic hepatitis C infection; or

(b)       treated by a medical practitioner or an authorised nurse practitioner in consultation with:

(i)         a gastroenterologist; or

(ii)        a hepatologist; or

(iii)       an infectious diseases physician.

2        Assessment of patient

For the purpose of subparagraph 1(2) of this Part, the patient has been assessed if the treating medical practitioner has:

(1)     documented the following information in the patient’s medical records:

(a)       evidence of chronic hepatitis C infection; and

(b)       where possible, evidence of the patient’s hepatitis C virus genotype; and

(2)     chosen a regimen in accordance with paragraph 3 of this Part; and

(3)     collected the following information for the purposes of the authority application:

(a)       whether the patient is:

(i)         cirrhotic; or

(ii)        non-cirrhotic

(b)       details of the previous treatment regimen (only for requests for sofosbuvir with velpatasvir and voxilaprevir or glecaprevir with pibrentasvir for 16 weeks’ treatment in patients who have previously failed a treatment with a regimen containing an NS5A inhibitor).

(4)     In this paragraph, evidence of chronic hepatitis C infection is documentation of:

(a)       repeat test results showing antibody to hepatitis C virus (anti-HCV) positive; and

(b)       test result showing hepatitis C virus ribonucleic acid (RNA) positive.

3        Treatment regimen

For the purpose of subparagraph 2(2) of this Part, the treating medical practitioner has chosen a regimen in accordance with this paragraph if the patient:

(1)     is a kind of patient mentioned for an Item in column 2 of the following table; and

(2)     is to receive one of the regimens mentioned in column 3 of the same Item of the following table.

Item Kind of patient Regimen
1

Patient:

(a)   all genotypes (pan-genotypic); and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic.

Either:

(a)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)   GLECAPREVIR with PIBRENTASVIR for 8 weeks.
2

Patient:

(a)   all genotypes (pan-genotypic); and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic.

Either:

(a)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 8 weeks; or

(d)   GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(e)   GLECAPREVIR with PIBRENTASVIR 16 weeks.
3

Patient:

(a)   with Genotype 1; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic.

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 8 weeks; or

(b)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(c)   GRAZOPREVIR with ELBASVIR for 12 weeks.
4

Patient:

(a)   with Genotype 1; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic.

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
5

Patient:

(a)   with Genotype 2; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
6

Patient:

(a)   with Genotype 2; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
7

Patient:

(a)   with Genotype 3; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
8

Patient:

(a)   with Genotype 3; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
9

Patient:

(a)   with Genotype 4; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic.

 GRAZOPREVIR with ELBASVIR for 12 weeks.
10

Patient:

(a)   with Genotype 4; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic.

Either:

(a)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(b)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
11

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment naïve; and

(c)   who is non-cirrhotic.

 Refer to item 1 above (pan-genotypic, treatment naïve and non-cirrhotic regimens).
12

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment experienced; and

(c)   who is non-cirrhotic.

 Refer to item 2 above (pan-genotypic, treatment experienced and non-cirrhotic regimens).
13

Patient:

(a)   all genotypes (pan-genotypic); and

(b)   who is treatment naïve; and

(c)   who is cirrhotic.

Either:

(a)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)   GLECAPREVIR with PIBRENTASVIR for 12 weeks.
14

Patient:

(a)   all genotypes (pan-genotypic); and

(b)   who is treatment experienced; and

(c)   who is cirrhotic.

Either:

(a)   SOFOSBUVIR with VELPATASVIR for 12 weeks; or

(b)   SOFOSBUVIR with VELPATASVIR and VOXILAPREVIR for 12 weeks; or

(c)   GLECAPREVIR with PIBRENTASVIR for 12 weeks; or

(d)   GLECAPREVIR with PIBRENTASVIR 16 weeks.
15

Patient:

(a)   with Genotype 1; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic.

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 12 weeks; or

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks.
16

Patient:

(a)   with Genotype 1; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic.

Either:

(a)   LEDIPASVIR with SOFOSBUVIR for 24 weeks; or

(b)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(c)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
17

Patient:

(a)   with Genotype 2; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
18

Patient:

(a)   with Genotype 2; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
19

Patient:

(a)   with Genotype 3; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
20

Patient:

(a)   with Genotype 3; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
21

Patient:

(a)   with Genotype 4; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic.

 GRAZOPREVIR with ELBASVIR for 12 weeks.
22

Patient:

(a)   with Genotype 4; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic.

Either:

(a)   GRAZOPREVIR with ELBASVIR for 12 weeks; or

(b)   GRAZOPREVIR with ELBASVIR and RIBAVIRIN for 16 weeks.
23

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment naïve; and

(c)   who is cirrhotic.

 Refer to item 13 above (pan-genotypic, treatment naïve and cirrhotic regimens).
24

Patient:

(a)   with:

(i)    Genotype 5; or

(ii)   Genotype 6; and

(b)   who is treatment experienced; and

(c)   who is cirrhotic.

 Refer to item 14 above (pan-genotypic, treatment experienced and cirrhotic regimens).
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