Gilead Sciences is working toward offering a new expensive pill that can prevent people from contracting HIV, but its patient advocates that are thwarting the manufacturer’s plan.
Patient advocacy groups have often argued that insurance coverage should include coverage for new HIV drugs no matter what the expense. However, there are three U.S. organizations that have questioned if Descovy is the best option for people who are at risk of catching the disease.
There is also going to be a generic version of Truvada, set to be released in the U.S. in September 2020. This should drive costs down and open access to even more individuals who want the therapy.
Some insurers are also echoing the patient advocacy groups, saying the price is going to be a coverage barrier to patients prescribed Descovy.
National Alliance of State and Territorial AIDS Director of Medication Access and Pricing Tim Horn said there is no scientific evidence of individuals needing to take Descovy. He said there was no reason to push back against Medicaid programs or commercial payers that want to use a genetic prevention product like Truvada so long as there are safety protocols that ensure access to Descovy isn’t denied for those who need it.
Gilead also makes Truvada, which has been available since 2004. In 2012, it began the only approve preventive therapy on the market and is taken daily as a pre-exposure prophylaxis. In 2016, clinical studies showed that Descovy was not as toxic on the kidneys and bones of HIV sufferers as Truvada.
The U.S. Food and Drug Administration approved the use of Descvoy to decrease the chance for HIV infections in both transgender women and men.
Gilead said Descovy compared to Truvada was safer and provided more efficient delivery of the antiviral aspect, which means more of the drug gets into the cells where the infection takes place.
The U.S. Centers for Disease Control and Prevention feels 1.1 million people in the U.S. could reap the benefits of PrEP, including high populations (individuals who have sex with somebody infected with the disease). According to Gilead, there are 213,000 people who use Truvada as an HIV prevention pill.
The company is working with the Trump Administration to stop the HIV spread within 10 years. In May, the drug manufacturer said it was donating a supply of Truvada to 200,000 insured Americans each year until Descovy became improved for HIV prevention and patients were switched to the drug.
HIV drug manufacturers have typically been protected from generic competition. Every time a therapy has gotten close to losing its patent protection, new scientific advances enable them to bring forth a new drug better than the one before it, but much higher in price.
The cost for both Truvada and Descovy is $21,000 a year before discounts are given to private and public health insurers. For the first half of 2019, Truvada sales hit $1.3 billion. Descoy sales were $700 million but, by 2024, is expected to hit $3 billion a year.
Teva Pharmaceutical Industries, Ltd. is set to offer a generic Truvada version in 2020, which means even more competition for 2021.
Kare Schultz, Teva chief executive, said he’s confident there will be a market for a generic Truvada. He said the company has spoken preliminary with payers across the U.S.
Schultz said health insurers typically want to use a generic version of a gold standard drug rather than something new altogether.
A few prominent patient advocates, including NASTAD and Treatment Action Group, said Gilead hasn’t provided evidence that a newer treatment is worth the cost beyond ensuring the lowered risk for bone density and kidney problems. It comes at a time when the prices of HIV drugs are increasing. Their outlook on it may offer health insurers’ support, as they are continually looking to suggest generic drug use to lower the costs.
TAG HIV Project Director Jeremiah Johnson said he’s opening to talking about health plans that require people to try a generic drug before using Descovy.
TAG, as well as PrEP4All Collaboration, which hopes to increase PrEP access for everybody, urged the FDA to gather an advisory committee to look at Descovy with concerns over the trial data and its pricing.
For instance, University of California AIDS Research Institute Director Dr. Paul Volberding said Descovy for PrEP needs to be available for people with insurance that can pay for it while the generic can be used on people who don’t have as much coverage protection.
He called the safety difference minute but real.
National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci, said Decovy is advantageous because it stays in the body far longer than Truvada. If someone misses a doe, there’s not going to be a gap in protection.
Still, some health insurance companies are not convinced about Descovy’s benefit over Truvada. According to current data, Truvada is still considered a cost-effective PrEP option.
Written by Mark Riegel, MD
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