The Transparency Committee has issued its opinion on Truvada for pre-exposure prophylaxis for HIV.
Green light for the Truvada. The drug went before the Transparency Commission of the High Authority of Health (HAS), which has just made public its opinion. As we announced to you on this site, the PrEP (pre-exposure prophylaxis) obtained the best mark concerning its actual benefit (SMR) and the worst concerning the improvement of the actual benefit (ASMR).
The first assessment takes into account the intrinsic qualities of the drug and makes it possible to set its reimbursement rate. The HAS judged the SMR “important”; this paves the way for the highest reimbursement rate, namely, 65%. “The actual benefit of TRUVADA, in addition to a comprehensive prevention strategy, is important in pre-exposure prophylaxis to reduce the risk of HIV-1 infection through sexual contact in adults at high risk of infection”, can we thus read.
65% support
Currently, people who took Truvada under the Temporary Recommendation for Use were reimbursed 100%. As long as the price of preventive treatment is not fixed, full support remains in place according to a “post-RTU” device, the Ministry of Health indicated earlier. Once the price has been fixed, the 65% support should apply, except for special arrangements.
The second assessment, ASMR, is a relative score compared to other existing treatments. It makes it possible to fix the price of the drug, which will be discussed with the Gilead laboratory within the CEPS (Economic Committee for Health Products) within a maximum period of three months.
However, the Truvada received the lowest rating for several reasons. The HAS Transparency Committee takes note of “the efficacy demonstrated in studies in terms of reducing the incidence of HIV infection in subjects at high risk of infection”.
A low price in sight
However, she recalls that Truvada “provides partial protection against HIV strongly dependent on compliance (relative risk reduction of 44 to 86% depending on the studies), without preventive effect on other Sexually Transmitted Infections”.
In addition, the HAS underlines that the drug “exposes non-sick people to toxicity, particularly kidney and bone” and, moreover, that “the condom remains the most effective prevention tool against HIV infection and other STIs ”.
Thus, the Commission considers that Truvada “does not improve the actual benefit (ASMR V) in the overall HIV prevention strategy, the central tool of which must remain the condom”. In other words, the Commission considers that Truvada is very effective, hence the excellent AB, but that there are other alternative preventive treatments, less toxic and even more effective, which justifies an ASMR V ( absence of ASMR) and a lower price per box.
Two administration schedules have been validated. The first corresponds to the official indication, the marketing authorization. This is a continuous engagement pattern. The second, less expensive and invasive, is outside the indication but its effectiveness has been validated by studies. It corresponds to an occasional intake, before and after risky sexual intercourse. HAS has drawn up good use sheets for prescribing physicians and people who will use Truvada as PrEP, in order to present the protocol for the two schedules, the precautions and the side effects.
.
