National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 6) (PB 59 of 2015)

EXPLANATORY STATEMENT

National Health Act 1953

National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 6)

PB 59 of 2015

Authority

Subsection 100(1) of the National Health Act 1953 (the Act) enables the Minister to make special arrangements for the supply of pharmaceutical benefits.  

Subsection 100(2) of the Act provides that the Minister may vary or revoke a special arrangement made under subsection 100(1).

Purpose

The purpose of this legislative instrument, made under subsections 100(1) and 100(2) of the Act, is to amend the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011) (the Special Arrangement).

The instrument covers both routine updates that occur each month and changes relating to the chemotherapy initiate from the Sixth Community Pharmacy Agreement (6CPA).

The amendments in this instrument:

• introduce a new fee, the compound fee, to be paid to chemotherapy compounders;
• differentiate the fee for Therapeutic Goods Administration (TGA) licenced and non-TGA licenced compounders;
• specify a process for applying for payment of the compounding fee;
• reduce the amount of the preparation fee;
• change the amount paid for the mark-up for pharmaceutical benefits that do not have trastuzumab, to an amount in line with the 6CPA;
• amend the definitions for ‘diluent fee’, ‘dispensing fee’, ‘distribution fee’ and ‘preparation fee’ to reflect the indexation of these fees for 1 July 2015. These fees are indexed annually (WCI9) in conformity with the indexation of other fees provided for in the relevant Community Pharmacy Agreement;
• add two pharmaceutical benefit ‘Pertuzumab’ and ‘Trastuzumab emtansine’; and the associated circumstances and purposes;
• add new circumstance codes,  purpose codes and the associated circumstances for the listed drug ‘Trastuzumab’;
• update the responsible person for listed brands of multiple listed drugs from GlaxoSmithKline Australia Pty Ltd (GK) to Novartis Pharmaceuticals Australia Pty Limited (NV); and
• remove the responsible person GlaxoSmithKline Australia Pty Ltd (GK) and adds the responsible person Novartis Pharmaceuticals Australia Pty Limited (NV).

Consultation

An ongoing and formal process of consultation in relation to matters relevant to the Special Arrangement includes the involvement of interested parties through the membership of the Pharmaceutical Benefits Advisory Committee (PBAC). 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 as pharmaceutical benefits. 

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 PBAC, and that would enable them to contribute meaningfully to the deliberations of PBAC.  When recommending the listing of a medicine on the Pharmaceutical Benefits Scheme (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.

Stakeholder consultation on the Chemotherapy initiative was undertaken by the 6CPA negotiation team.  Stakeholders consulted included: The Pharmacy Guild of Australia, representing community pharmacy, Therapeutic Goods Administration (TGA) licenced compounders, Society of Hospital Pharmacists of Australia (SHPA), Australian Private Hospitals Association (APHA) and Consumer health Forum (CHF).

Details of the instrument are set out in the Attachment.

This instrument commences on 1 July 2015.

This instrument is a legislative instrument for the purposes of the Legislative Instruments Act 2003.

ATTACHMENT

Details of the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 6)

Section 1 Name of Instrument

This section provides that the name of this instrument is the National Health (Efficient Funding of Chemotherapy) Special Arrangement Amendment Instrument 2015 (No. 6).  It can also be cited as PB 59 of 2015.

Section 2 Commencement

This section provides that this instrument commences on 1 July 2015.

Section 3 Amendment

This section provides that Schedule 1 amends the National Health (Efficient Funding of Chemotherapy) Special Arrangement 2011 (PB 79 of 2011).

Schedule 1 Amendments

Items 1 to 8 Section 3

Items 1 to 8 amend section 3 of the Special Arrangement, the definitions section, by adding or redefining definitions..

Item 1 inserts the compounder definition.

Item 2 inserts the compound fee definition.

Item 3 revises the diluent fee to reflect that due to indexation the fee is $5.07 on and from 1 July 2015.

Item 4 revises the dispensing fee to reflect that due to indexation the fee is $6.93 on and from 1 July 2015.

Item 5 revises the distribution fee to reflect that due to indexation the fee is $25.59 on and from 1 July 2015.

Item 6 revises the definition of the preparation fee to reflect $82.67 from 1 July 2015 to the start date and $42.67 on and from the start date.

Item 7 inserts the definition of the start date.

Item 8 inserts the definition of TGA licenced compounder.

Item 9  Division 2A – payment of claim to compounder

Item 9 introduces a new division 2A into the Special Arrangement.  This division introduces a new fee, the compound fee, to be paid to a new group of persons, compounders.

Under new section 46A a compound fee is able to be paid to a compounder.  The amount of this fee differs depending on whether the compounder is TGA licensed or not.  The definitions of compounder and compound fee can be found in section 3.

New section 46B sets out how claims are to be made to the Commonwealth by a compounder.  The form used must be an approved form, and the form must be accompanied by a certification from the compounder:

• that each infusion to which the claim relates was prepared in accordance with a compounding order; and
• that the information in the claim form is correct.

Item 10  Section 48

Item 10 amends section 48.  The mark-up for maximum multiple was defined by the now repealed table set out in old subsection 48(2).  The amendment now defines the mark-up for maximum multiple by reference to a new administration, handling and infrastructure fee.  The administration, handling and infrastructure fee is determined under paragraph 98B(1)(a) of the Act and is tiered to three levels to recognise the different costs of dispensing PBS subsidised medicines.  This fee was agreed under the 6th Community Pharmacy Agreement.

Item 11  Section 61

Item 11 inserts new section 61, a transitional provision, in relation to payment of compounders.  Subsection 61(1) does not allow an effective double-payment for the preparation/compounding of the pharmaceutical benefit.  In the situation where a compounder has already been paid for the compounding of a pharmaceutical benefit specified in this Special Arrangement, (by an approved pharmacist, approved medical practitioner, or hospital authority) the compounder will not also be able to claim payment of the compound fee from the Commonwealth.

Where this situation occurs subsection 61(2) makes it clear that the preparation fee to be paid to the approved pharmacist is that paid prior to the amendments taking effect under this instrument – an amount of $82.67. 

The transitional provisions cease to have effect on and from 1 November 2015. 

Item 12 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Ofatumumab’ in each of the forms ‘Solution concentrate for I.V. 100 mg in 5 mL’; and ‘Solution concentrate for I.V. 1000 mg in 50 mL’ and brand ‘Arzerra’ by changing the responsible person code from ‘GK’ to ‘NV’.

Item 13 inserts a new listed drug ‘Pertuzumab’ into Schedule 1 Part 1 of the Special Arrangement by adding new pharmaceutical benefit, which is the listed drug ‘Pertuzumab’ in the form ‘Solution for I.V. infusion 420 mg in 14 mL’ with the manner of administration ‘Injection’ and brand ‘Perjeta’.

Item 14 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Topotecan’ in the form ‘Powder for I.V. infusion 4 mg (as hydrochloride)’ and ‘brand Hycamtin’ by changing the responsible person code from ‘GK’ to ‘NV’.

Item 15 amends the entry in Schedule 1 Part 1 of the Special Arrangement for ‘Trastuzumab’ each of the forms ‘Powder for I.V. infusion 60 mg’ and ‘Powder for I.V. infusion 150 mg’ with manner of administration ‘Injection’ adding the new circumstance codes ‘C5024’, ‘C5032’, C5041’.

Item 16 inserts a new listed drug ‘Trastuzumab emtansine’ into Schedule 1 Part 1 of the Special Arrangement by adding new pharmaceutical benefits, which is the listed drug ‘Trastuzumab emtansine’ in the forms ‘Powder for I.V. infusion 100 mg’ and ‘Powder for I.V. infusion 160 mg’ with the manner of administration ‘Injection’ and brand ‘Kadcyla’.

Item 17 amends Schedule 1 Part 2 of the Special Arrangement by adding the maximum amount and number of repeats for the listed drug ‘Pertuzumab’.

Item 18 amends Schedule 1 Part 2 of the Special Arrangement for ‘Trastuzumab’ by and adding the new purpose codes ‘P5024’, ‘P5032’, P5041’, and the associated maximum amounts and number of repeats.

Item 19 amends Schedule 1 Part 2 of the Special Arrangement by adding the maximum amount and number of repeats for the listed drug ‘‘Trastuzumab emtansine’.

Item 20 amends the entry in Schedule 3 of the Special Arrangement by removing the responsible person code ‘GK’ and the associated responsible person, ‘GlaxoSmithKline Australia Pty Ltd’.

Item 21 amends Schedule 3 of the Special Arrangement by adding a new responsible person code ‘NV’ and associated responsible person, ‘Novartis Pharmaceuticals Australia Pty Limited’.

Item 22 amends Schedule 4 of the Special Arrangement by adding circumstance codes, purpose codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Pertuzumab’.

Item 23 amends Schedule 4 of the Special Arrangement by adding circumstance codes ‘C5024’, ‘C5032’, C5041’, purpose codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Trastuzumab’.

Item 24 amends Schedule 4 of the Special Arrangement by adding circumstance codes, purpose codes and the associated circumstances for pharmaceutical benefits with the listed drug ‘Trastuzumab emtansine’.