Decision Maker Response

Catherine King’s response

May 8, 2019 — Dear Raphaella (and petition signers),

Thank you for your petition regarding the listing of medications, in particular Aimovig for the treatment of miagraines, on the Pharmaceutical Benefits Scheme (PBS).

Labor created the PBS, and we want all Australians to have affordable access to recommended medicines.

That’s why Bill Shorten recently announced Labor’s Affordable Medicines Guarantee – a commitment to list all drugs that are recommended by the independent experts on the PBS.

A Shorten Labor Government will also deliver faster access to cheaper medicines by endorsing changes to the Pharmaceutical Benefits Scheme.

As you may be aware, listing drugs on the PBS is a three-step process.

First, medicines must be judged to be safe and effective by the Therapeutic Goods Administration (TGA). The TGA is tasked with safeguarding the health of Australians through effective and timely regulation of therapeutic goods.

Every medicine that is registered for use in Australia by the TGA must be used in accordance with the conditions and criteria under which it is registered. For each medicine this information is outlined in a Product Information Statement, which can be accessed here: http://tga-search.clients.funnelback.com/s/search.html?query=&collection=tga-artg.

Second, drugs must be considered by the independent Pharmaceutical Benefits Advisory Committee (PBAC).

Drugs can only be considered by the PBAC following nomination by their sponsor, usually the drug manufacturer. The PBAC will consider the drug in terms of its effectiveness and cost, including in comparison to other available treatments.

An application for the listing of ERENUMAB, Injection 70 mg in 1 mL single dose pre-filled pen, Aimovig for the treatment of migraine was considered by the PBAC at the July 2018 meeting.

The review of the application and the PBAC’s decision not to recommend Aimovig can be seen on the PBS website here (scroll to section seven): http://www.pbs.gov.au/industry/listing/elements/pbac-meetings/psd/2018-07/files/erenumab-psd-july-2018.pdf

For an application drug that has previously been considered and rejected by the PBAC, the sponsor is able to address the concerns raised in the PBAC’s report and resubmit for further consideration.

Norvartis made a second application to the PBAC for the listing of Aimovig at the March 2019 meeting of the PBAC. The PBAC did not recommend this listing of Aimovig on the PBS at this meeting.

Norvatis is able to make another application to the PBAC for the listing of Aimovig. Norvatis has indicated they are working towards this task but have not specified a timeframe. Contact details for Norvatis can be found here: https://www.novartis.com.au/about-us/contact-us

Finally, if PBAC recommends a listing, the government of the day must negotiate with the sponsor to list the drug on the PBS.

Unfortunately, the Liberals have admitted there are at least 18 drugs recommended by PBAC that they will never list. And at last count, there were dozens more drugs that had been recommended by the PBAC but not yet listed on the PBS.

In contrast, a Shorten Labor Government will list all drugs recommended by the PBAC, ensuring that all Australians can access the medicines that they need.

Please be assured, should the PBAC in the future recommend the listing of Aimovig, a Shorten Labor Government would act to make this happen as quickly as possible.

I hope this information is of assistance to you.

Yours sincerely,

Catherine King
Shadow Minister for Health and Medicare