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ILong-awaited, a federal advisory committee recommends that physicians be encouraged to offer an HIV prevention pill, which would quickly expand insurance coverage for a drug that some people had difficulty accessing because of its cost.
In explaining its decision, the US Prevention Services Working Group determined that it was "highly likely" that the use of the pill would provide a "substantial" benefit to those at high risk of becoming infected with HIV. HIV, the virus that causes AIDS. The independent expert group reported that it had found "adequate epidemiological data" on the risk factors that can be used to identify people at high risk of acquiring HIV.
If doctors adopt the recommendation, the drug could finally fulfill its potential. Known as PrEP but commercially marketed as Truvada by Gilead Sciences (GILD), the pill was approved to treat HIV and approved for prevention in 2012. However, the panel noted that About 1.1 million people in the United States currently live with HIV.
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The committee also noted that the CDC had estimated that 1.2 million people were eligible for the pill three years ago, although only 78,300 used the drug in 2016, while about 40,000 had been diagnosed with HIV. Since 2012, use has increased from 3.3 people per 100,000 population to 36.7% in 2017, an increase of 56%, according to a study published earlier this year in Annals of Epidemiology.
Nevertheless, patient advocates say that cost has been a problem.
When the pill was approved for the first time in 2004 for HIV treatment, the wholesale price for a monthly supply was $ 650, according to Truven Health Analytics, a unit of IBM. By the time prevention was also approved in 2012, the price had risen to $ 1,159. Gilead has increased the price each year and last January, the price was raised to $ 1,675, an increase of 45% in six years.
For this reason, the new recommendation has been widely solicited by patient advocates.
"This is great news, but long overdue," said James Krellenstein, a founding member of the HIV Prevention Action Group of ACT UP / New York, the advocacy organization. "If the recommendation is adopted, all insurance companies will have to cover PrEP and will not be able to charge for cost sharing," says insurance copays and franchises.
"But since the FDA's approval (for prevention) so far, more than 200,000 people in the United States have been diagnosed with HIV. These could have been avoided because there was evidence five years ago to make this recommendation, based on pivotal trials conducted by the NIH and the Gates Foundation. This shows that a laissez-faire approach to increasing PrEP endangers many Americans. "
For its part, keeping costs at Gilead was not an obstacle. In a note to us, a spokesman for the company cited a study done by CDC staff last year to say that less than 1% of people likely to benefit from the pill needed 39, financial assistance. He added that Gilead maintained support programs for uninsured and underinsured patients, including a copay card for which annual assistance was recently increased from $ 4,800 to $ 7,200.
The spokesman acknowledged that "many people … still have difficulty accessing the pill," he said. "One of the biggest hurdles" is the "limited awareness" that PrEP can prevent HIV, as well as the lack of access to health care services. "We engage regularly with public health officials, lawyers and physicians to better understand and, to the extent possible, help address these challenges," he wrote.
Krellenstein, meanwhile, noted that insurers may still require prior authorization, which refers to the steps that doctors and patients must take before a prescription is covered. An example might be to ask patients to prove that they are at high risk of being infected with HIV, which he termed as "perhaps the biggest obstacle to access." trade regimes ".
At the same time, Carl Schmid, head of the AIDS Institute, a nonprofit research and advocacy group, said in a statement: "Once finalized, clinicians should no longer have any excuse for not recommending PrEP to those at risk of contracting HIV ". added that final adoption should create "Medicaid coverage opportunities, as well as Medicare after a separate coverage determination".
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