Health insurers are grappling with whether to cover the new pink pill to treat low libido in women, which will hit U.S. pharmacy shelves this year with a prominent warning label for serious side effects such as fainting.
Indianapolis-based Anthem Inc., the third-largest health insurer in the country, said Wednesday it will cover Sprout Pharmaceuticals Inc.’s Addyi in many cases. Insurers Cigna Corp. and Aetna Inc. are still working on their policies, and drug benefits managers including Express Scripts Holding Co. and CVS Health Corp. said they’ll evaluate what to do over the next few weeks.
Getting coverage from insurers is crucial for Sprout, which has fought to get FDA approval for Addyi after the agency rejected the drug in 2010 and 2013. Without help from insurance plans, women will have to consider paying as much as $400 a month for the chance to see whether the drug will work for them. Sprout said Addyi should get reimbursed at the same rate as male sexual-dysfunction drugs.
“Seventy percent of men with insurance have those covered,” Sprout CEO Cindy Whitehead said in an interview on Bloomberg Television. “We would expect parity coverage.”
Insurers will focus on the safety and effectiveness of Sprout’s treatment, also known as flibanserin, which was approved for premenopausal women who want to boost their sexual desire.
Women who participated in clinical trials on Addyi experienced on average 0.5 to one more satisfying sexual experience than those on placebo. Yet the risks include drops in blood pressure and fainting, dangers that are enhanced by alcohol.
Anthem has placed Addyi in its third tier, meaning it will cost patients more than they’re charged for generic medications or preferred brand-name treatments. Anthem also puts the male sexual dysfunction drugs Viagra and Cialis in tier 3.
“Coverage varies by state and by plan as lifestyle drugs are not typically part of the standard benefit,” Kristin Binns, a spokeswoman for Anthem, said in an e-mail.
Cynthia Michener, an Aetna spokeswoman, said most health plans “exclude medications related to sexual performance.” The insurer will review the clinical evidence and decide whether to cover the drug, she said in an email.
Sprout expects most insurers to put the drug in tier 2 or 3 on their formularies with a $30 to $75 copay.
Express Scripts, the largest U.S. pharmacy-benefit manager, will have a coverage recommendation in the next few weeks after Addyi is reviewed by pharmacy advisers, David Whitrap, a spokesman, said in an e-mail. CVS Health and Prime Therapeutics LLC also will wait for advisers to review the drug before making a coverage decision, according to e-mails from both companies.
“I think it’s a mistake for any third-party payer to pay for a medication that doesn’t come with a reasonably solid evidence of value,” said David Juurlink, a physician and professor at the University of Toronto who studies drug safety. “The data for flibanserin make it very clear that the majority of women who take it are not going to experience any meaningful benefit.”
The FDA is requiring doctors to get certified through an online training program to be able to prescribe Addyi, and patients will have to sign a form saying they understand the risks.
Sprout plans to make clear to doctors that only some women will benefit from the drug, Whitehead said Wednesday on a conference call with reporters.
“Addyi is not going to work for all women,” she said.“We’re going to set expectations in the marketplace.”
While Addyi’s label warns about the importance of abstaining from alcohol, some women’s health experts have been skeptical that patients would take caution.
“In real life, women are not going to be compliant like they are in clinical trials,” Vanessa Barnabei, chair of the obstetrics and gynecology department at the State University of New York at Buffalo, said in a phone interview. “They’re going to say, ‘I feel OK. I’m going to have a drink.’ And boom, they go down.”
Barnabei said she doesn’t think doctors will race to get certified to prescribe Addyi because of the time involved in watching a video online and answering questions as well as counseling patients to ensure they need the drug and are aware of the risks.
“My guess is that women are going to have to work hard to find providers that are willing to do this,” she said.