News Release 

New branded PrEP not worth the high cost compared with generic formulation

American College of Physicians

Below please find a summary of new article that will be published in the next issue of Annals of Internal Medicine. The summary is not intended to substitute for the full article as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent.

1. New branded PrEP not worth the high cost compared with generic formulation

Abstract: http://annals.org/aim/article/doi/10.7326/M19-3478
Editorial: http://annals.org/aim/article/doi/10.7326/M20-0799
URL goes live when the embargo lifts

A newly approved drug for HIV pre-exposure prophylaxis (or PrEP) may undermine efforts to expand access to HIV prevention for the nation's most vulnerable populations, experts say. Findings from a cost-effectiveness study are published in Annals of Internal Medicine and will be presented at the Conference on Retroviruses and Opportunistic Infections (CROI) meeting in Boston.

PrEP, a pill taken once a day, reduces the risk of HIV infection via sex or injection drug use by up to 99 percent. Since 2012, there has been one FDA-approved PrEP formulation, the combination of tenofovir/emtricitabine (F/TDF). The availability of a less expensive generic formulation later this year is highly anticipated, as it may help to expand access to PrEP to some of the most difficult-to-reach segments of the at-risk population. Enthusiasm is tempered, however, by the introduction of a pricey new branded formulation, emtricitabine/tenofovir alafenamide (F/TAF), which was recently approved for PrEP in MSM. Determining the cost-effectiveness of F/TAF versus generic F/TDF is important for clinical decision-making and policymakers.

Researchers from Massachusetts General Hospital and Yale School of Public Health reviewed published research and data obtained from recently completed clinical trials to evaluate the cost-effectiveness of F/TAF for PrEP and to identify the highest possible price premium that branded F/TAF could command, even under the very best of circumstances, over generic F/TDF. The authors intentionally overstated the adverse clinical and economic consequences of generic F/TDF, inflating rates of bone and kidney disease incidence, assuming that all fractures would require surgical repair and that all cases of kidney disease would require dialysis and be irreversible. They found that even when they positioned branded F/TAF in the most favorable light possible, there was no plausible scenario under which F/TAF for PrEP would be a cost-effective alternative to generic F/TDF. According to the researchers, these findings suggest that branded F/TAF is not worth the high cost. They warn that if branded F/TAF drives out generic F/TDF and inhibits acceptability, access, and uptake, of the scale-up of PrEP in vulnerable populations, could stall, and F/TAF could end up causing more avoidable HIV transmissions than it prevents.

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Media contacts: For an embargoed PDF please contact Lauren Evans at laevans@acponline.org. To speak with the lead author, Rochelle P. Walensky, MD, MPH, please contact Noah Brown at nbrown9@partners.org.

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