National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 11) (No. PB 95 of 2014)

Overview

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 11) was enacted to address the allocation of certain drugs to the F1 and F2 formularies of the Pharmaceutical Benefits Scheme (PBS) as outlined under the National Health Act 1953. This amendment was introduced by the Australian Government to refine the categorisation of listed drugs, ensuring they are appropriately assigned to either the F1 formulary, which is designated for single brand drugs, or the F2 formulary, which accommodates drugs with multiple brands or those within a therapeutic group with other multi-brand drugs. The policy objective behind this amendment was to ensure that the PBS effectively manages pharmaceutical costs and ensures equitable access to medications for Australians. This legislative instrument was created under the authority of the Minister for Health, acting in accordance with the legislative powers conferred by the National Health Act 1953.

Scope and Application

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 applies to pharmaceutical companies with drugs listed on the Pharmaceutical Benefits Scheme (PBS) and involves the allocation of these drugs to the F1 and F2 formularies. The F1 formulary is designated for drugs with a single brand, while the F2 formulary is for drugs with multiple brands or those in therapeutic groups with other multi-brand drugs. This Act operates under the National Health Act 1953 at the Commonwealth level, and its jurisdiction covers the entire nation. The Minister for Health has the authority to determine which drugs are assigned to F1 or F2, based on specific criteria outlined in the Act. The Amending Determination introduces eight new drugs to F1 and reassigns four existing drugs from F1 to F2, as well as moving three combination drugs from the administrative combination drug list to F2. The changes take effect from 1 December 2014 and are subject to consultation with pharmaceutical companies and recommendations from the Pharmaceutical Benefits Advisory Committee, ensuring a balanced consideration of various stakeholder interests.

Key Provisions

The National Health (Listed drugs on F1 or F2) Amendment Determination 2014 (No. 11) amends the National Health (Listed drugs on F1 or F2) Determination 2010. This Amendment Determination allocates eight newly listed drugs to the F1 formulary of the Pharmaceutical Benefits Scheme (PBS) and moves four already PBS listed drugs from F1 to F2. It also shifts three combination drugs from the combination drug list to F2 (subsection 85AB(5)). Specifically, brentuximab vedotin, eculizumab, enzalutamide, glycine with carbohydrate, ivacaftor, midazolam, simeprevir and umeclidinium are added to F1. Adefovir, celecoxib, oxycodone and raloxifene are moved from F1 to F2. Dipyridamole with aspirin, dorzolamide with timolol and valsartan with hydrochlorothiazide are moved from the combination drug list to F2. This Amendment Determination is made under subsection 85AB(1) of the National Health Act 1953 (the Act). The Act requires that listed drugs must satisfy certain criteria to be placed on F1 or F2. A drug may only be placed on F1 if there are no listed brands of pharmaceutical items that have the drug that are bioequivalent or biosimilar, and no listed brands of pharmaceutical items that have another drug in the same therapeutic group as the first drug that are bioequivalent or biosimilar. The drug must also not have been on F2 the day before the determination comes into effect. A drug may only be placed on F2 if it does not satisfy one or more of the criteria for F1. If a listed drug has a single brand combination item on the PBS, it is not placed on F1 or F2, but on the administrative combination drug list (subsection 85AB(5)). This Amendment Determination allocates drugs to the F1 and F2 formularies in accordance with these criteria. The Amending Determination imposes obligations on pharmaceutical companies with medicines listed on the PBS. Before drugs are listed and allocated to formularies, there are detailed consultations about the drug with the intended responsible person, and a recommendation is received from the Pharmaceutical Benefits Advisory Committee (PBAC). Any PBAC recommendation is made following receipt of submissions by affected pharmaceutical companies. Two-thirds of the PBAC membership is from the following interests or professions: consumers, health economists, practising community pharmacists, general practitioners, clinical pharmacologists and medical specialists. The Amending Determination affects these pharmaceutical companies by allocating their drugs to the F1 or F2 formularies. There are no offences, penalties, or civil/criminal consequences for breach stated in the Act or the Amending Determination. Subsection 33(3) of the Acts Interpretation Act 1901 is relied upon to revoke or vary the Principal Determination. The Amending Determination commences on 1 December 2014 and constitutes a legislative instrument for the purpose of the Legislative Instruments Act 2003.