Now that "little pink pill" is approved, cost and coverage questions remain

The drug maker behind the “little pink pill” that aims to boost women’s sex drive wants its medication to be just as accessible to patients who need it as Viagra is for men.

Cindy Whitehead, CEO of Sprout Pharmaceuticals of North Carolina, said the company hasn’t yet set the price of flibanserin, which was approved by the Food and Drug Administration this week and will be marketed under trade name Addyi. And prices can be difficult to compare, since Viagra and similar erectile dysfunction drugs are taken on an as-needed basis before sex, while Addyi is taken daily at bedtime.

But Whitehead said she expects “parity coverage” from insurers, meaning if they pay for the erectile dysfunction drugs, they should pay for Addyi. She said out-of-pocket costs should be similar, too, and the majority of men with private insurance getting Viagra have co-pays ranging from $30 to $75 a month. Whitehead said her company will help with Addyi co-pays initially.

While the drug is expected to hit the market by Oct. 17, it’s still unclear whether and how insurers will cover it.

"Health plans will review the clinical guidelines and medical evidence on Addyi as they develop their coverage decisions,” said Clare Krusing, a spokeswoman for America’s Health Insurance Plans.

"Most health plans exclude medications related to sexual performance," said Cynthia Michener, an Aetna spokeswoman. "We will review the clinical evidence of Addyi along with our benefit design to determine the appropriate coverage in preparation of the drug being available in the marketplace."

John Jaeger, a health care industry analyst and vice president at Decision Resources Group, said the drug “will offer a significant reimbursement challenge for payers and employers looking to set their benefit designs. On one hand, (pharmacy benefit managers) are aggressively narrowing formularies and they have not been very receptive to any medication that could be perceived as lifestyle.

“On the other hand, there could be significant blow back from patients and outside organizations if payers and employers decide to not cover the product, especially if those organizations have traditionally covered erectile dysfunction products.”

Not all plan to keep covering every such drug, however. CVS/Caremark recently announced that beginning in 2016, it will no longer cover Viagra — although it will continue covering Cialis, which it deemed a cheaper yet adequate alternative. It made the move amid a climate of ever-rising drug prices, with spending on prescription drugs last year reaching a record-breaking $374 billion, up 13% from 2013.

Terry O’Neill, president of the National Organization for Women, said she thinks the price of drugs to boost women's libidos will ultimately be determined by the marketplace.

“I believe this is the first but not the last” drug of its kind, O’Neill said, adding that the prices of birth control pills, for example, became very competitive when there were many types on the market.

O’Neill also said that Addyi is an important option for women who need it. The drug isn't for every woman; it's designed to treat premenopausal women with hypoactive sexual desire disorder, or low sexual desire that causes marked distress or interpersonal difficulty. “Those 10% of women are suffering and they need an FDA-vetted medication," O'Neill said.

But critics raise concerns about Addyi's safety and effectiveness. On average, the FDA said, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one more per month over a placebo in studies. And it comes with side effects that can include low blood pressure and fainting. The FDA said these risks are more severe when patients drink alcohol while taking the drug, so the label will include a boxed warning highlighting the risks of interaction.

Sidney Wolfe, founder and senior adviser of Public Citizen’s Health Research Group, released a statement Wednesday calling the approval of flibanserin "FDA's Big Mistake."

“Unfortunately, we haven’t heard the last of this drug,” the statement says. “Expect future news to include stories of women who are harmed needlessly by flibanserin and the eventual agency call for the manufacturer to pull it from pharmacy shelves.”