A pack of the daily contraceptive Opill can be seen in an undated image.
dog | via Reuters
The first birth control pill sold in the US without a prescription could remain out of reach for some women and girls because health insurance companies aren’t required to cover the drug over-the-counter.
The U.S. Food and Drug Administration on Thursday approved the sale of the oral contraceptive Opill without a prescription, a historic decision intended to make birth control pill procurement easier by eliminating the need to visit a doctor’s office and refill prescriptions.
According to a 2016 survey published in the Journal of Women’s Health, one-third of adult women who have ever attempted to obtain prescription contraception have faced barriers to access.
Manufacturer of Opill Perrigo expects the pill to be available in major stores and online by early 2024. Perrigo will announce the price of Opill in a few months before the pill hits stores, Frederique Welgryn, a Perrigo executive, said during a phone call with reporters on Thursday.
Welgryn said the company is committed to making Opill affordable. Perrigo is setting up a patient assistance program so the cost of the pill isn’t a barrier to women struggling to make ends meet.
However, there might still be obstacles for some women and girls to get Opill. The Affordable Care Act does not require private health insurance to cover the cost of the pill if it is taken without a prescription. Most health insurance companies are obliged to offer contraceptives free of charge if prescribed by a doctor.
State Medicaid programs are also generally not required to cover drugs sold without a prescription, according to the Federal Centers for Medicare & Medicaid Services.
Perrigo is working on insurance coverage
Welgryn said Perrigo is working to enlist private insurance and state Medicaid programs to offer over-the-counter Opill to women and girls for free. But she said the Affordable Care Act needed to be adjusted to ensure health insurance covered birth control without a prescription.
Welgryn said it’s unclear if there will be insurance coverage for Opill when the pill goes on sale early next year. “We still have a lot to do to achieve that. It will take time,” she said.
Congressional Democrats and President Joe Biden are pushing to expand access to contraceptives.
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Sen. Patty Murray, D-WA, re-introduced legislation in the Senate in May entitled “Affordability is Access” that would require health insurers to offer oral contraceptives free of charge without a prescription.
Biden in June directed the U.S. Department of Health and Human Services to ensure all FDA-approved contraceptives are available at no cost.
CMS encourages health insurance companies to cover over-the-counter contraceptive products for free, an agency spokesman said Friday. The agency is working on ways to ensure FDA-approved over-the-counter contraceptives are available at no cost, the spokesman said.
Opill is 93% effective in preventing pregnancy. It is the most effective form of over-the-counter birth control in the United States. To ensure effectiveness, Opill should be taken at the same time each day.
Welgryn said 15 million women in the US who are sexually active and don’t want to conceive are using a form of birth control that is less effective than Opill, or are not using birth control at all.
According to the FDA, nearly half of the six million pregnancies in the United States each year are unwanted. According to the agency, unwanted pregnancy is associated with preterm birth, which can lead to bad health outcomes for newborns.