(Adds results of FDA advisory committee vote)
By Deena Beasley
LOS ANGELES, Aug 7 (Reuters) - Gilead Sciences Inc hopes to soon introduce a pricey new pill to prevent HIV in people at risk of contracting the infection, but the drugmaker faces opposition from an unusual source: patient advocates.
Such groups have traditionally lobbied for insurance coverage of newer HIV drugs regardless of expense. But at least three U.S. organizations now question whether Gilead’s Descovy would be the best option for most people at risk of exposure.
A generic version of the current prevention pill, Truvada, is due in the United States in September 2020, which should bring down costs and give many more people access to the therapy, they say.
Their resistance is being echoed by some insurers, which are hinting that price will be a barrier to providing coverage for Descovy.
"Based on the science that we have seen thus far, there is no indication that everyone needs to be taking Descovy," Tim Horn, director of medication access and pricing at the National Alliance of State and Territorial AIDS Directors (NASTAD) told Reuters.
"We see no reason to push back against commercial payers or Medicaid programs that would move to prefer generic Truvada (for prevention), provided there are guard-rails that do not deny access to Descovy for those who need Descovy," he said.
Truvada, also made by Gilead, has been used to treat people infected with HIV since 2004. It was approved as a daily pill for pre-exposure prophylaxis, or PrEP, in 2012, and remains the only preventive therapy on the U.S. market.
Descovy, shown to be less toxic than Truvada to the kidneys and bones in clinical trials, was approved in 2016 for people already infected with HIV. Advisers to the U.S. Food and Drug Administration recommended on Wednesday that the agency approve Descovy to reduce the risk of sexually acquired HIV infection in men and transgender women who have sex with men.
When asked about the patient groups' criticism, Gilead said Descovy is safer than Truvada and offers more efficient delivery of its antiviral component, resulting in greater concentration of the drug in cells where HIV infection can occur.
The Centers for Disease Control and Prevention estimates that 1.1 million people in the United States could benefit from PrEP. High-risk populations include people having sex with someone who is infected with HIV or who share injection needle equipment. Gilead said 213,000 people were taking Truvada for HIV prevention in the second quarter of this year.
The company has pledged to help the Trump administration achieve a goal of stopping the spread of HIV in the United States within a decade. In May, Gilead said it would donate enough Truvada annually to supply 200,000 uninsured Americans with PrEP until Descovy is approved for HIV prevention, then switch patients to the new drug.
HIV drugmakers have largely been shielded from generic competition. Each time one of their therapies came close to losing patent protection, scientific advances allowed them to introduce a new drug that improved on its predecessor, often with a higher price.
Both Truvada and Descovy are priced at $21,000 per year, before discounts provided to public and private health insurers. In the first half of 2019, Gilead's Truvada sales totaled $1.3 billion. Descovy sales amounted to $700 million and are expected to rise to $3 billion dollars annually by 2024, according to IBES data from Refinitiv.
Teva Pharmaceutical Industries Ltd is due to sell a generic version of Truvada next year. More significant price competition is expected when other competitors emerge in 2021.
Teva's Chief Executive Kare Schultz expressed confidence that he will find a market for generic Truvada, and said the company has held preliminary talks with U.S. payers.
Health insurers "will normally say that if there was something that was the gold standard then they will prefer to use the generic for the gold standard rather than switch to a new product," Schultz told Reuters.
Some prominent patient advocates, including community-based Treatment Action Group (TAG) and NASTAD, which advocates for public health, told Reuters that Gilead has not proven the newer treatment provides enough of a benefit to justify its use beyond people at risk of kidney or bone density problems. At a time when HIV drug prices are soaring, their views may provide support to health insurers who routinely push generic drug use to curb costs.
Jeremiah Johnson, HIV project director at TAG, told Reuters he is open to a conversation about health plans requiring individuals try a generic drug before using a significantly more expensive regimen like Descovy.
TAG and PrEP4All Collaboration, which aims to expand access to PrEP for all Americans, earlier this year called for the FDA to convene the advisory committee review of Descovy, citing concerns over Gilead's trial data and pricing practices.
Not all experts are as vocal in questioning Gilead's aims. Dr. Paul Volberding, director of the AIDS Research Institute at the University of California, San Francisco, told Reuters that Descovy for PrEP should be made available to people that have insurance to pay for it, while a generic could make sense for people with less access to coverage.
"The safety difference is small, but real," he said.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told Reuters that Descovy may provide an advantage because it remains in the body for longer than Truvada. "If you miss a dose or two it is unlikely that there is going to be a gap in protection," he said.
But some health insurers, which largely cover Truvada for PrEP, are not convinced of a significant benefit from Descovy.
"Based on the current information and data available to us at this time, we believe generic Truvada will be the most cost effective option for PrEP," said David Lassen, chief clinical officer at Prime Therapeutics, which manages pharmacy benefits for Blue Cross Blue Shield health plans.
Express Scripts, the pharmacy benefit manager owned by Cigna Corp, said cost is a big barrier to U.S. use of Truvada for PrEP.
"We would certainly look to leverage cost savings from generic Truvada to help improve affordability for patients and payers," the company told Reuters. (Editing by Michele Gershberg and Edward Tobin; additional reporting by Steven Scheer in Tel Aviv)