An influential guidelines body in the United States has put its full weight behind pre-exposure prophylaxis (PrEP) to people at high risk of HIV. The grade A recommendation of the United States Prevention Services Task Force (USPSTF), published in the Journal of the American Medical Association today, means that private insurers must now, by law, pay for PrEP, without any deductibles, co-pays or co-insurance costs falling on the consumer.
This is likely to help promote PrEP and encourage primary care clinicians to offer it.
“The significance of the new recommendations lies in the large number of individuals in the United States whose insurance coverage for HIV preventive services, notably PrEP, will be favorably affected,” comment Dr Rochelle Walensky and Dr David Paltiel in an editorial. “The USPSTF has taken an important step in securing access to services that will hasten the end of the HIV epidemic in the United States by 2030" – although, as they point out, many adherence, retention and implementation challenges will remain.
The recommendation will be particularly helpful for those with private insurance. Whereas people with health coverage through Medicaid and other government programmes do not usually have any out-of-pocket costs for PrEP or other prescriptions, individuals covered by private or commercial insurance have often been faced with monthly co-payments between $50 and $500 until now. Gilead offers co-payment cards to cover this, but they aren't universally accepted and add to the administrative hurdles that PrEP users have needed to negotiate.
A recent study from Los Angeles found that, compared to people whose PrEP was covered by a government programme, discontinuation from PrEP was higher in individuals with private insurance (adjusted risk ratio 1.4) and people with no insurance (adjusted risk ratio 4.5). The same study found that annual HIV incidence was 0.1% among those still taking PrEP, compared to 2.1% among people who discontinued.
The Affordable Care Act ('Obamacare') mandated that users of grade A and B recommended strategies should not be asked for co-payments or other cost sharing. Now the USPSTF has made such a recommendation, privately insured PrEP users should no longer be subject to co-pays. However, they may still be required to contribute towards the cost of blood tests and clinic visits.
The new guidelines recommend that clinicians offer PrEP to people at high risk of HIV acquisition, specifically men who have sex with men (reporting condomless sex, a recent STI or an HIV-positive partner), heterosexual men and women (similar criteria, except that condomless sex must be with a high-risk partner), injecting drug users, people engaging in transactional sex or sex work, and transgender people.
While the USPSTF has a reputation for being conservative in its guidelines and attentive to unintended consequences, it judged that PrEP’s benefits clearly outweigh any harms. It noted the potential for kidney and gastrointestinal side-effects, but found that the evidence for other possible harms – such as bone loss, drug resistance and ‘behavioural compensation’ – was weaker.
“The USPSTF concludes with high certainty that the net benefit of the use of PrEP to reduce the risk of acquisition of HIV infection in persons at high risk of HIV infection is substantial,” it says.