Agency Recommendation On PrEP To Go In Effect 2021

Agency Recommendation On PrEP To Go In Effect 2021

Corey Walsh was able to attain a prescription called Truvada to prevent HIV infection with the help of his parents’ health insurance policy. However, the Food and Drug Administration approved drug cost him $400 more each month than he could pay for. He eventually joined a clinical trial that took over the costs.

Agency Makes Recommendation for PrEP Drugs

The experience Walsh had with the high out-of-pocket costs isn’t new. In fact, the advocates say, it’s very, very common. And, now with the U.S. Preventive Services Task Force suggesting clinicians provide pre-exposure prophylaxis (PrEP) to anyone who may be at high risk for getting HIV. This means, beginning in 2021, the majority of health plans must cover the drugs that can prevent HIV, and patients cannot be charged out-of-pocket costs.

The recommendation does not extend to lab or other clinical services that may be needed for people using PrEP. Besides the ancillary charges, there are other obstacles for people who want to use PrEP could face.

NASTAD Senior Director of Health Systems Amy Killelea said getting rid of the cost-sharing will help to give people access to the drug where they were unable to before. However, increasing that access to those who do need it most – black, Latino, young or gay men – means dealing with the other challenges such as structural or systemic obstacles. This includes the willingness of doctors to prescribe the drug and the stigma associated with using it.

In his February State of the Union address, U.S. President Donald Trump highlighted there was a great need to continue fighting the HIV epidemic with a vow to eliminate its transmission by the year 2030.

Gilead is the producer of Truvada, and it’s the one drug that’s been approved to stop the transmission of HIV. It’s a once-a-day pill that is about 90 percent effective in high-risk groups such as men who have sex with both men and women and just men. It’s also given to women who have sex with partners who are HIV positive. It’s about 70 percent effective in drug addicts.

Gilead said about 200,000 people use Truvada, both the Centers for Disease Control and Prevention said 1.1 million people in American could use and benefit from it.

The Cost of PrEP Drugs

However, the monthly cost of PrEP is about $2,000, and many private health plans have put PrEP into a specialty drug category that includes high coinsurance and copayments. The payments will end once the task force’s suggestions go into effect.

Many state Medicaid program cover Truvada, including the lab and clinical work that goes into it. However, in the southern part of the U.S. where states have failed to expand their Medicaid programs under the Affordable Care Act, and the rate of HIV infection is high, there may not be very many people who can access Truvada.

Gilead does provide a medication assistance program for the uninsured and copay assistance program for people whose private insurance has gaps.

Gilead is working on submitting its HIV drug Descovy to the FDA for approval for PrEP, and a generic Truvada version is in the works. It’s not clear how these options will affect the access and affordability.

Kaiser Family Foundation Senior Vice President Jennifer Kates said it tends to take more than one generic drug to get the drug prices to drop.

Advocates are concerned that the new requirement for preventive coverage, it could lead the Medicaid program and private insurers to limit access by enacting prior authorization requirements. Insurers may demand doctors to show proof of a patient’s HIV status and implement risk criteria before they’ll approve the medication and pay for it.

This, they say, could lead to major repercussions.

AIDS Foundation of Chicago CEO and President John Peller said a delay in the pharmacy or on the part of the provider could result in patients giving up in trying to get the drug.

Written by Mark Riegel, MD

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