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PBAC says "No" to PrEP

By Andrew Burry, CEO, WA AIDS Council    

On Friday 19th August, the Pharmaceutical Benefits Advisory Committee (PBAC) made public its decision on an application by Gilead Sciences to have Truvada™ listed on the Pharmaceutical Benefits Scheme (PBS) for use as Pre-Exposure Prophylaxis (PrEP). Their decision was that it should not be listed.

The impact of this decision is that PrEP will not be subsidised meaning that those who are prescribed it, will have to meet the full cost of it. The cost will amount to more than $1,000 per month if purchased from an Australian pharmacy. The alternative is to privately import a generic version, which is still costly and complex.

It is important to note that there is NO suggestion by PBAC that Truvada™ is ineffective. Indeed, PBAC acknowledge the growing and solid scientific evidence of its ability to substantially remove the risk of acquiring HIV by those who take the medication in accordance with the recommendations.

In short, the grounds for PBAC’s decision was around economics. PBAC suggests that Gilead’s asking price of $1,200 per month was excessive and that their calculation of the extent of its prescription was not credible and thus a necessary requirement for costs and benefits was not established.

We have not seen the actual submission made by Gilead and can only rely on the published minutes of the PBAC meeting and surmise. It is hard not to question Gilead’s strategy for a drug that moves out of patent in mid 2018. They could re-submit in November (and we hope they do) in time for the next PBAC meeting in March 2017, but even if then successful, they would be left with at best 12 months of PrEP prescribing in advance of the local availability of generic equivalents.

The impact of this decision is not evenly spread across the country however. The Eastern States (QLD, NSW, Victoria and the ACT) have the advantage of their local governments making substantial investments in making PrEP available in significant numbers through the establishment of access projects or trials. Participation in these is restricted to those who live in the respective jurisdictions.

Other states, including WA, cannot participate and thus access to PrEP is more complex and costly. Nonetheless, PrEP is available in Perth and the WA AIDS Council is working to promote awareness and to help facilitate personal importation for those who decide it is the appropriate means of personal protection against HIV risk. This isn’t ideal. Already bottlenecks are appearing in obtaining a prescription, and in some cases, patients are subject to high co-payments above the Medicare rebates. M Clinic is currently supporting more than 50 patients already on PrEP and helping them to maintain knowledge of their sexual health including the presence of other STIs. The WA AIDS Council has made considerable effort to secure the services (for a fee) of doctors able to prescribe PrEP at M Clinic itself so that the journey for PrEP users involves a single location and that a high level of peer support and education is maintained. So far these efforts have been unsuccessful.

Given this latest setback in a comprehensive establishment of PrEP as an essential tool in achieving our collective target of substantially eliminating the sexual transmission of HIV in WA by 2020, new strategies must be contemplated. The ACT Government successfully negotiated with the NSW Department of Health for the inclusion of ACT residents at high risk of HIV acquisition to be able to participate in the NSW EPIC program. An opportunity exists for the WA Government to attempt the same.

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To minimise the impact and further transmission of HIV, other blood borne viruses and sexually transmissible infections. To reduce social, legal and policy barriers which prevent access to health information and effective support and prevention services.