Tuvada’s RTU for pre-exposure HIV prophylaxis expires on March 1. Negotiations around the price and reimbursement are still ongoing.
In a short week, Truvada will be available as a preventative treatment for HIV. This drug, designed to treat infections with the virus, has also been shown to be effective in pre-exposure prophylaxis (PreP). Taken before risky sex (with an HIV-positive person, for example), it helps prevent contamination of the HIV-negative partner.
Truvada is currently subject to an RTU (Temporary Recommendation for Use), associated with monitoring and strict prescription conditions. But in August 2016 he obtained the green light from the European authorities for use in PrEP. France will apply this extension of MA (marketing authorization) from 1er March, date of the end of the RTU. Anyone at high risk of infection through sexual intercourse may therefore be prescribed the drug.
There remain the technical details and, in particular, the crucial question of price and reimbursement, as well as the terms of administration. Negotiations are ongoing; according to our information, they are bitter. However, the deadlines are tight since at 1er March, it will be necessary to be fixed… Explanations.
- 65% refund
The Gilead laboratory has submitted a request for reimbursement to the Haute Autorité de Santé (HAS). On January 25, 2017, the Transparency Committee examined the file. During these meetings, it issues two notes to the medication: the SMR (Service Médical Rendu) and the ASMR (Improvement of the Service Médical Rendu). The first takes into account the intrinsic qualities of the drug and makes it possible to set its reimbursement rate. The second is a relative score compared to other existing treatments and constitutes a criterion for setting the price of the drug.
According to our information, the AB of Truvada in PrEP will remain unchanged, ie, “important” – which implies a reimbursement rate of 65% by the Health Insurance (ie the maximum for a drug). Currently, patients with HIV are reimbursed 100% when treated with Truvada, since they are among the long-term conditions (ALD). People who take it in a preventive setting should be reimbursed at 65%, unless the Ministry of Health decides to apply full support, as is the case in the RTU.
- Price: it stuck
Regarding ASMR, HAS and Gilead have not yet reached an agreement. The laboratory requests the highest score, ASMR 1, which would allow it to negotiate a higher price thereafter. The HAS only concedes an ASMR 5, the worst, but identical to that of Truvada in curative treatment of HIV (and obtained by the majority of drugs, given that in a saturated market, it is difficult to innovate).
This “bad” rating may be linked to the existence of less toxic alternatives on the market, such as condoms – Truvada has indeed proven toxicity on the kidneys. In addition, the drug is already available in town, at around 400 euros for 30 tablets. This is not a new molecule, but an extension of use. Finally, the number of people who could take Truvada is potentially high – more, in any case, than the number of HIV patients treated with Truvada. All these elements can explain ASMR 5, leading to a lower price than that expected by the laboratory.
- What about the deadlines?
Gilead has only a few hours left to indicate whether he accepts the HAS rating or contests it. In this case, a new hearing will take place, during which the manufacturer will present his arguments.
When this procedure is complete, the lab will have several choices. He will be able to definitively refuse the opinion of the HAS, suspend his marketing project in France or set his own price without claiming a refund – patients will then have to pay out of pocket. Otherwise, the laboratory can accept the note; the file then passes into the hands of CEPS, the body responsible for negotiating prices, which has three months to complete the procedure.
Which takes us well beyond the 1er March. To avoid a disruption of support, the Ministry of Health indicates that the “post-RTU” device will apply, namely that as long as the negotiations are not completed, the conditions of the RTU will continue to apply with 100% reimbursement of PrEP.
- Take: 2 validated diagrams
Truvada in PrEP has obtained Marketing Authorization for a continuous administration schedule (continuous intake). However, the Ipergay study demonstrated equivalent efficacy for a sequential administration regimen (occasional intake, before and after a risky relationship). This scheme, less expensive and invasive, is theoretically not indicated but in fact, many people will adopt it.
The Minister of Health has therefore instructed the HAS to write good use sheets for prescribing doctors and people who will use Truvada as PrEP. These documents present the protocol for both regimens, precautions, side effects etc. They were drafted and validated this Wednesday. Marisol Touraine should receive them on her desk in the next few hours.
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