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PB 87 of 2021 Lists as made
This instrument amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme and related matters.
Administered by: Health
Registered 31 Aug 2021
Tabling HistoryDate
Tabled HR01-Sep-2021
Tabled Senate02-Sep-2021
To be repealed 11 Feb 2022
Repealed by Division 1 of Part 3 of Chapter 3 of the Legislation Act 2003

EXPLANATORY STATEMENT

NATIONAL HEALTH ACT 1953

NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 8)

PB 87 of 2021

Purpose

The purpose of this legislative instrument, made under sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 (the Act), is to amend the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012) to make changes to the pharmaceutical benefits listed on the Pharmaceutical Benefits Scheme (PBS) and related matters.

PB 71 of 2012 determines the pharmaceutical benefits that are on the PBS through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (equivalent brands, responsible persons, prescribing circumstances, maximum quantities, number of repeats, determined quantity and pack quantity, section 100 only status and prescriber bag only status).

Authority

This Instrument exercises various powers in Part VII of the Act, as set out below:

Pharmaceutical benefits listed on the PBS

Subsection 85(2) provides that the Minister may declare drugs and medicinal preparations to which Part VII applies.  A drug or medicinal preparation for which there is a declaration in force under subsection 85(2) is a ‘listed drug’ (subsection 84(1)).  Subsections 85(3) and 85(5) respectively provide that the Minister may determine the form or forms of a listed drug and the manner of administration of a form of a listed drug.  A listed drug in a determined form with a determined manner of administration for that form is a pharmaceutical item (section 84AB).  Subsection 85(6) provides that the Minister may determine a brand of a pharmaceutical item.

The Minister may also determine the responsible person for a brand of a pharmaceutical item (subsection 84AF(1)).  Under the provisions of section 84AK the Minister may determine the determined quantity and pack quantity for a brand of a pharmaceutical item.

Prescribing pharmaceutical benefits

Paragraph 85A(2)(a) allows the Minister to determine the maximum quantity or number of units of the pharmaceutical item in a pharmaceutical benefit (or of the pharmaceutical benefit where there is no pharmaceutical item) that may, in one prescription, be directed to be supplied on one occasion.  Paragraph 85A(2)(b) also allows the Minister to determine the maximum number of occasions on which the supply of the pharmaceutical benefit may, in one prescription, be directed to be repeated.  The maximum quantities and repeats may be determined for all purposes or for particular purposes.

Subsection 85(7) provides that the Minister may determine the circumstances in which a prescription may be written for the supply of a pharmaceutical benefit.

Section 88 provides that the Minister may determine the pharmaceutical benefits that may be prescribed by different classes of prescribers, including medical practitioners (subsection 88(1)), participating dental practitioners (subsection 88(1A)), authorised optometrists (subsection 88(1C)), authorised midwives (subsection 88(1D)) and authorised nurse practitioners (subsection 88(1E)).

Paragraph 88(1EB) provides that the Minister can list pharmaceutical benefits without determining any authorised prescribers for the benefit allowing the benefit to be supplied only.

This legislative instrument is made pursuant to section 88 and subsection 100(2) of the National Health Act 1953 (the Act).

Supplying pharmaceutical benefits

Subsection 85(2A) provides that the Minister must declare that a particular listed drug can only be provided under a special arrangement under section 100 if the Pharmaceutical Benefits Advisory Committee (PBAC) has recommended under subsection 101(4AAD) that the drug be made available only under special arrangements under section 100.

Subsection 85(2AA) provides that the Minister must declare that a particular listed drug can only be provided under one or more of the prescriber bag provisions if the PBAC has recommended under subsection 101(4AACA) that the drug be made available only under one or more of the prescriber bag provisions.

Subsection 85(6A) provides that the Minister may also determine for the purposes of paragraph 103(2A)(b) that a brand of a pharmaceutical item determined under subsection 85(6) is to be treated as equivalent to one or more other brands of pharmaceutical items.

Paragraph 85(7A) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under one or more of the prescriber bag provisions.

Paragraph 85(8)(a) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100.

Paragraph 85(8)(b) provides that the Minister may determine that a particular pharmaceutical benefit may only be supplied under special arrangements under section 100 for one or more of the circumstances determined for that pharmaceutical benefit under subsection 85(7).

Variation and revocation

Unless there is an express power to revoke or vary PB 71 of 2012 cited in this Instrument and explanatory statement, subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary PB 71 of 2012.

Subsection 101(4AAA) allows the Minister to, by legislative instrument, revoke or vary a subsection 85(2) declaration in relation to a drug or medicinal preparation.  Advice from the PBAC is required if the effect of the legislative instrument would be that a drug or medicinal preparation would cease to be a listed drug (subsection 101(4AAB)).

Changes to PB 71 of 2012 made by this Instrument

Schedule 1 to this Instrument provides for the addition of the listed drugs cariprazine, obeticholic acid, and prednisolone acetate, and the addition of forms of the listed drugs adrenaline (epinephrine), amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides, deferasirox, diazepam, high fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate, and vedolizumab to the Schedule of Pharmaceutical Benefits. It also provides for the deletion of the listed drug interferon alfa-2a, and the deletion of forms of the listed drugs diazepam, fluoxetine, metformin, and trihexyphenidyl. Additionally, it provides for the alteration of circumstances in which a prescription may be written for the supply of the listed drugs abiraterone, adalimumab, brentuximab vedotin, enzalutamide, etanercept, lacosamide, semaglutide, and tocilizumab.

Schedule 1 to this Instrument also provides for the following changes:

·                the addition of 9 brands of existing pharmaceutical items;

·                the alteration of the maximum quantity that can be prescribed for 4 existing pharmaceutical items;

·                the addition of 1 maximum quantity and number of repeats for an existing pharmaceutical item;

·                the alteration of responsible person name for 4 existing responsible persons; and

·                the addition of 3 brands of existing pharmaceutical items to supply only.

These changes are summarised, by subject matter, in the Attachment.

Consultation

The involvement of interested parties through the membership of the PBAC constitutes a formal and ongoing process of consultation.  The PBAC is an independent expert body established by section 100A of the Act which makes recommendations to the Minister about which drugs and medicinal preparations should be available to Australians as pharmaceutical benefits.  The PBAC members are appointed following nomination by prescribed organisations and associations from consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and specialists, with at least one member selected from each of those interests or professions.  Remaining members are persons whom the Minister is satisfied have qualifications and experience in a field relevant to the functions of the PBAC, and that would enable them to contribute meaningfully to the deliberations of the PBAC.  In addition, an industry nominee has been appointed to the PBAC membership under the PBS Access and Sustainability Package of reforms announced in May 2015.  When recommending the listing of a medicine on the PBS, PBAC takes into account the medical conditions for which the medicine has been approved for use in Australia, its clinical effectiveness, safety and cost-effectiveness compared with other treatments.

Pharmaceutical companies are consulted throughout the process of the listing of their medicines on the PBS and in relation to changes to those listings.  This includes the company submission to the PBAC and involvement throughout the PBAC process, negotiations or consultation on price, guarantee of supply and agreement to final listing details.

It was considered that further consultation for this Instrument was unnecessary due to the nature of the consultation that had already taken place.

General

A provision-by-provision description of this Instrument is contained in the Attachment.

This Instrument commences on 1 September 2021.

This Instrument is a legislative instrument for the purposes of the Legislation Act 2003.


ATTACHMENT

PROVISION-BY-PROVISION DESCRIPTION OF NATIONAL HEALTH (LISTING OF PHARMACEUTICAL BENEFITS) AMENDMENT INSTRUMENT 2021 (No. 8)

Section 1         Name of Instrument

This section provides that the Instrument is the National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 8) and may also be cited as PB 87 of 2021.

Section 2         Commencement

Subsection 2(1) provides for commencement dates of each of the provisions specified in Column 1 of the table, in accordance with Column 2 of the table. In accordance with Column 2 of the table, Schedule 1 to the Instrument commence on 1 September 2021.

Section 3         Authority

This section specifies that sections 84AF, 84AK, 85, 85A, 88 and 101 of the National Health Act 1953 provide the authority for the making of this Instrument.

Section 4         Schedules

Section 4 provides that each instrument that is specified in a Schedule to the Instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to the Instrument has effect according to its terms.

Schedule 1       Amendments

The amendments in Schedule 1 involve the addition and deletion of listed drugs, the addition and deletion of forms of listed drugs, the addition of brands, the alteration of maximum quantities, the addition of a maximum quantity and number of repeats, the alteration of responsible person names for brands of pharmaceutical benefits, the addition of 3 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme. These changes are summarised below.

 

SUMMARY OF CHANGES TO THE PHARMACEUTICAL BENEFITS SCHEME
MADE BY SCHEDULE 1 OF THIS INSTRUMENT

Listed Drugs Added

Listed Drug

Cariprazine

Obeticholic acid

Prednisolone acetate

Listed Drugs Deleted

Listed Drug

Interferon alfa-2a

Forms Added

Listed Drug

Form

Adrenaline (epinephrine)

I.M. injection 500 micrograms in 0.3 mL single dose syringe auto-injector

Amino acid formula with fat, carbohydrate, vitamins, minerals, trace elements and medium chain triglycerides

Oral powder 800 g (Essential Care Jr)

Deferasirox

Tablet, dispersible, 125 mg

Tablet, dispersible, 250 mg

Tablet, dispersible, 500 mg

Diazepam

Oral liquid 10 mg per 10 mL, 100 mL

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral semi-solid 100 g, 36 (K.Yo)

Vedolizumab

Injection 108 mg in 0.68 mL single use pre-filled pen

Forms Deleted

Listed Drug

Form

Diazepam

Oral liquid 1 mg in 1 mL, 100 mL

Fluoxetine

Capsule 20 mg (as hydrochloride) (USP)

Metformin

Tablet (prolonged release) containing metformin hydrochloride 500 mg

Trihexyphenidyl

Tablet containing trihexyphenidyl hydrochloride 2 mg (USP)

Brands Added

Listed Drug

Form and Brand

Adrenaline (epinephrine)

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector (Anapen Junior 150)

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector (Anapen 300)

Diazepam

Tablet 2 mg (APX-Diazepam)

Tablet 5 mg (APX-Diazepam)

Fluticasone propionate with salmeterol

Pressurised inhalation containing fluticasone propionate 125 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) (Evocair MDI)

Pressurised inhalation containing fluticasone propionate 250 micrograms with salmeterol 25 micrograms (as xinafoate) per dose, 120 doses (CFC-free formulation) (Evocair MDI)

Mirtazapine

Tablet 15 mg (APX-Mirtazapine)

Tablet 30 mg (APX-Mirtazapine)

Tablet 45 mg (APX-Mirtazapine)

 


 

Alteration of Maximum Quantity

Listed Drug

Form

Brand Name

Maximum  Quantity

Adrenaline (epinephrine)

I.M. injection 150 micrograms in 0.3 mL single dose syringe auto-injector

Adrenaline Jr Mylan

From: 1

To: 2

EpiPen Jr.

From: 1

To: 2

I.M. injection 300 micrograms in 0.3 mL single dose syringe auto-injector

Adrenaline Mylan

From: 1

To: 2

EpiPen

From: 1

To: 2

Addition of Maximum Quantity and Number of Repeats

Listed Drug

Form

Brand Name

Maximum Quantity

Number of Repeats

Lacosamide

Oral solution 10 mg per mL, 200 mL

Vimpat

2

5

Alteration of Responsible Person Name

From:

To:

Norgine Pty Limited (NE)

Norgine Pty. Ltd. (NE)

Novo Nordisk Pharmaceuticals Pty Limited (NF, NI, NO)

Novo Nordisk Pharmaceuticals Pty. Limited (NF, NI, NO)

Alteration of Circumstances in Which a Prescription May be Written

Listed Drug

Listed Drug

Abiraterone

Etanercept

Adalimumab

Lacosamide

Brentuximab vedotin

Semaglutide

Enzalutamide

Tocilizumab

Supply Only Status

Note: From 1 November 2020 Supply Only benefits are available on the Schedule for dispensing but not for prescribing, usually for a period of up to 12 months from when it is deleted.

Listed Drug

Form and Brand

High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate

Oral semi-solid 100 g, 48 (Keyo) (Keyo)

Olaparib

Capsule 50 mg (Lynparza)

Zoledronic acid

Injection concentrate for I.V. infusion 4 mg (as monohydrate) in 5 mL (DBL Zoledronic Acid)

 


 

Documents Incorporated by Reference

Listed Drug

Document incorporated

Document access

Adalimumab

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI).  The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The BASDAI is a widely used tool that enables measurement and evaluation of the level of disease activity in Ankylosing Spondylitis.

The BASDAI is available for download for free from the Services Australia website www.servicesaustralia.gov.au

Vedolizumab

Crohn Disease Activity Index (CDAI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)b of the Legislation Act 2003.

The Crohn’s Disease Activity Index (CDAI) is a research tool used to quantify the symptoms of patients with Crohn’s disease.

Crohn Disease Activity Index (CDAI) is available for download for free from the PubMed website:

https://pubmed.ncbi.nlm.nih.gov/12786607/

A CDAI score calculation form is included in the Services Australia application form

Vedolizumab

Mayo clinic score and partial Mayo clinic score. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The Mayo clinic score and the partial Mayo clinic score (an abbreviated form of the Mayo clinic score) are medical diagnostic tools used to measure disease activity, in a standardised way, in Ulcerative Colitis through the evaluation of symptoms.

The Mayo clinic score and the partial Mayo clinic score are available to download for free from the Inflammatory Bowel Diseases Journal via the Oxford University Press website: https://academic.oup.com/ibdjournal/article/14/12/1660/4654949?login=true

Adalimumab

Psoriasis Area Severity Index (PASI). The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The PASI is a widely used tool that enables measurement of the severity and extent of baseline and response of therapy in psoriasis.

The PASI calculation form is available for download for free from the Services Australia website: https://www.servicesaustralia.gov.au/ and forms part of the SA authority application process.

Adalimumab

Etanercept

Tocilizumab

Vedolizumab

Therapeutic Goods Administration (TGA)-approved Product Information. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

This document provides health professionals with a summary of the scientific information relevant to the safe and effective use of a prescription medicine.

TGA-approved Product Information is available for download for free from the TGA website: https://www.tga.gov.au/product-information-0

Abiraterone

Enzalutamide

World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status. The document is incorporated as in force on the day this Instrument takes effect, pursuant to paragraph 14(1)(b) of the Legislation Act 2003.

The WHO/ECOG performance status is a standard medical diagnostic tool used to measure how cancer impacts a patient’s daily living abilities, by evaluating a patient’s level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.).

The WHO/ECOG Performance Status is available for download for free from the ECOG-ACRIN Cancer Research Group website: https://ecog-acrin.org/resources/ecog-performance-status

Diagnostic tools referenced in the Instrument

The following standard medical diagnostic tools are referenced in the Instrument but are not intended to incorporate a document by reference.

Listed Drug

Diagnostic tool

Purpose and use in the Instrument

Reason this reference does not serve to incorporate a document

Brentuximab vedotin

Lugano Classification

The Lugano Classification provides guidance to clinicians on how to objectively assess a patient’s response to treatment for Non-Hodgkin Lymphoma.

 

Patient response must be reported on as part of the authority application for this PBS listed drug.

The Lugano Classification provides guidance to assess a patient’s response to treatment for Non-Hodgkin Lymphoma and does not constitute a written record of information that must be referred to in order to determine whether statutory conditions have been met.

The response criteria has been reproduced within the restriction text for Brentuximab vedotin. This restriction text is included in the current month amendments to the National Health (Listing of Pharmaceutical Benefits) Instrument 2012.

 

 


 

Statement of Compatibility with Human Rights

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 8)

(PB 87 of 2021)

This Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.

Overview of the Instrument

The National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2021 (No. 8) amends the National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (the Principal Instrument) which determines the pharmaceutical benefits that are on the Pharmaceutical Benefits Scheme (PBS) through declarations of drugs and medicinal preparations, and determinations of forms, manners of administration and brands.  It also provides for related matters (responsible persons, prescribing circumstances, schedule equivalence, maximum quantities, number of repeats, determined quantities, pack quantities, section 100 only status and prescriber bag only status).

The amendments in Schedule 1 involve the addition and deletion of listed drugs, the addition and deletion of forms of listed drugs, the addition of brands, the alteration of maximum quantities, the addition of a maximum quantity and number of repeats, the alteration of responsible person names for brands of pharmaceutical benefits, the addition of 3 brands of pharmaceutical items to supply only status, and the alteration of circumstances for prescribing various pharmaceutical benefits available on the Pharmaceutical Benefits Scheme.

Human rights implications

This Instrument engages Articles 2 and 12 of the International Covenant on Economic, Social and Cultural Rights by assisting with the progressive realisation by all appropriate means of the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

The PBS is a benefit scheme which assists with advancement of this human right by providing for subsidised access by patients to medicines.  The recommendatory role of the Pharmaceutical Benefits Advisory Committee (PBAC) ensures that decisions about subsidised access to medicines on the PBS are evidence-based.  The pharmaceutical industry now has a nominee on the PBAC membership.

Conclusion

This Instrument is compatible with human rights because it advances the protection of human rights.

 

 

 

Nikolai Tsyganov

Assistant Secretary (Acting)

Pricing and PBS Policy Branch

Technology Assessment and Access Division

Department of Health