The Food and Drug Administration finalized two guidances to support drugmakers developing new versions of HIV antiretroviral medications, HHS Secretary Alex Azar said on Tuesday.
Pledging to make eliminating the HIV epidemic a priority of his tenure, Azar said the FDA guidances focus on drugs to treat pediatric HIV infections as well as new long-acting forms of pre-exposure prophylaxis, or PrEP.
"PrEP is a key tool that we need for the third strategy we're pursuing, which is to protect individuals from HIV by using proven prevention approaches," Azar said at the 2019 .
The recommends drugmakers consider whether characteristics like how often a patient has to take the treatment could affect adherence.
Currently there is only one FDA-approved PrEP medication on the market, Gilead Sciences' Truvada. It must be taken once every day and can reduce the risk of getting HIV from sex by more than 90% and lower the risk by more than 70% among those who inject drugs.
But Truvada's adoption has been limited since its approval for HIV prevention in 2012. Only 90,000 of the 1.1 million people who could benefit from the drug have filled prescriptions, according to the .
A big barrier to greater adoption of PrEP has been the drug's cost. The average price of a one-month supply of Truvada is around $1,700. PrEP is covered by both public and commercial insurance, and Gilead offers some co-pay assistance. But many health plans have their programs so that copay assistance from the drug manufacturer no longer counts toward reducing a patient's deductible, meaning they are liable for the full out-of-pocket expense once their copay assistance expires.
"For many of these highest-risk people, not coincidentally they also happen to be the ones who are the least plugged in to care," said Dr. Carlos Malvestutto, assistant professor of infectious diseases at Ohio State University Wexner Medical Center, in Columbus. "Many of them are uninsured and they primarily get their healthcare through emergency department visits."
Those high out-of-pocket costs were behind the Trump administration's proposed rule change that the CMS issued in January to Medicare Part D, Azar said. That would give drug plans more power to negotiate discounts on HIV medications.
HIV advocates worry the change would effectively end coverage protections for HIV medications and allow insurers to impose access restrictions, such as prior authorization and step therapy. Medicare Part D provides antiretroviral medications for one-quarter of U.S. HIV patients, according to the Kaiser Family Foundation.
"We put forth the proposals that we have on drug pricing because we want to expand access to antiretrovirals and other expensive drugs by driving down prices for patients," Azar said. "If any utilization management such as prior authorization would reduce adherence to HIV treatment that would defeat the point of our efforts."
Under the guidance for developing , the FDA recommended that clinical trials include adolescents, something that has not been required in the past. Dosing recommendations for children and adults are similar, the document said.
President Donald Trump highlighted the fight against HIV in his State of the Union address in February, announcing a multiagency strategy to reduce new HIV infections by 90% by 2030.
Azar said the administration's prevention effort will extend to trying to limit the spread of HIV among those who inject drugs, with the CDC providing support to local health departments to establish syringe service programs, which provide clean needles to drug users.
Azar made a point of differentiating syringe service programs from safe injection sites, an idea that has being considered in several cities but has been opposed by the Trump administration.
"Syringe service programs aren't necessarily the first thing that comes to mind when you think about a Republican health secretary," Azar said. "But we're in a battle between sickness and health, between life and death."
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