Throughout the last year the HSE and Government pointed to a demonstration project that was set to “commence later this year or in early 2017.” However in the MI article Fiona Lyons, clinical lead for the implementation of the National Sexual Health Strategy, admits that “the window of opportunity for doing a PrEP demonstration project has closed.” This means that until the HSE provides PrEP, the only option for people to access PrEP in Ireland will continue to be self-sourcing affordable generic versions.
Unfortunately, as the MI also reports, that is becoming more difficult. Customs has been seizing shipments of generic PrEP coming into Ireland and the Health Products Regulatory Agency (HPRA) has been investigating the sources that people are using to obtain these drugs. This has resulted in the primary supplier of generic PrEP suspending shipments to Irish addresses, leaving current and potential PrEP users scrambling to find other ways to access the medications.
Following contact with the HPRA, the HSE PrEP Working Group recently circulated recommendations to healthcare providers to discourage patients from self-sourcing PrEP. They specifically request that they “do not direct patients” to iwantprepnow.co.uk, one of the most comprehensive and respected sources for information about how to use PrEP, how to self-source it safely, and how to make sure you get the proper medical support.
The working group’s email doesn’t mention that the generic versions and suppliers listed at iwantprepnow.co.uk are the same ones that the 56 Dean Street clinic in London tested and found, in every case, to be genuine. To this point the HPRA have offered no evidence that would suggest that anything has changed since the 56 Dean Street testing occurred or that anyone who is self-sourcing PrEP has obtained anything but the real thing.
All of this underscores the urgent need for HSE to provide PrEP through conventional channels. In one significant step towards that, Gilead in June applied to the HSE for reimbursement for Truvada as PrEP. This initiates a process where the costs involved in providing PrEP are analysed by the National Centre for Pharmacoeconomics (NCPE).
After an initial rapid review—which is supposed to take “approximately 4 weeks“—the NCPE will either approve Truvada for reimbursement, or (much more likely) will require a full pharmacoeconomic assessment. This process is supposed to take no more than 3 months from the formal submission of evidence, but before that happens there’s a period of notifications and consultations.
Overall, it seems unlikely that PrEP would be available until 2019 if nothing is done to accelerate this process or to provide PrEP on an interim basis. According to a July 26th written answer from Catherine Byrne to a Dáil question, the time frame for the HSE reimbursement process “would be in the order of at least 6 to 12 months.”
However, even when that is concluded, funding needs to be budgeted for PrEP and for the support services that will be required to make it available. That is unlikely to happen mid-year, so even if things go relatively smoothly in the reimbursement approval process, we’re likely to have to wait until the 2019 budget to see funding for PrEP.
One further wrinkle is that Gilead Sciences, the maker of Truvada, has filed suit in the High Court to block generic manufacturers from entering the market in Ireland with significantly cheaper generic versions of Truvada. The original patent for Truvada expired this month, but Gilead has obtained extended protection with a Supplementary Protection Certificate. A lawsuit over the validity of that SPC is currently awaiting a hearing at the European Court of Justice, but a decision isn’t expected before mid-2018.
It’s not clear whether an SPC is currently in force in Ireland or what the basis of the Gilead lawsuit is, but it seems clear that Gilead is not going to allow their patent to expire without a fight.
A lower price for the medication would mean much faster provision of PrEP by HSE and other European national health systems. So the outcome of the suit before the EU Court of Justice is being watched closely across the continent.