A package of the daily contraceptive Opill is seen in an undated illustration.
Perrigo | via Reuters
The first birth control pill sold without a prescription in the U.S. could remain out of reach for some women and girls because health insurance plans are not required to cover the medication in its over-the-counter form.
The U.S. Food and Drug Administration on Thursday approved the sale of the oral contraceptive Opill without a prescription, a historic decision that should make birth control pills easier to obtain by eliminating the need to visit a doctor’s office and refill prescriptions.
One-third of adult women who have ever tried to obtain prescription contraception have faced barriers to access, according to a survey published in the Journal of Women’s Health in 2016.
Opill’s manufacturer Perrigo expects the pill to be available in major stores and online in early 2024. Perrigo will announce the price of Opill in a couple months before the pill is in stores, said Frederique Welgryn, a Perrigo executive, during a call with journalists Thursday.
Welgryn said the company is committed to ensuring Opill is affordable. Perrigo is setting up a patient assistance program so the cost of the pill is not a barrier for women struggling to make ends meet.
But some women and girls could still face barriers to obtain Opill. The Affordable Care Act does not require private health insurance to cover the cost of the pill when used without a prescription. Most health insurers are required to offer birth control for free when prescribed by a doctor.
State Medicaid programs are also generally not required to cover drugs sold without prescription, according to the federal Centers for Medicare & Medicaid Services.
Perrigo 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 needs to be tweaked to guarantee that health insurance pays for birth control without a prescription.
Welgryn said it is unclear whether insurance coverage for Opill will be in place when the pill is available in stores early next year. “We have some work to do to make that happen. It’s going to take time,” she said.
Democrats in Congress and President Joe Biden are pushing to expand access to contraception.
Sen. Patty Murray, D-WA, reintroduced legislation called Affordability is Access in the Senate in May that would require health insurers to offer oral contraceptives without a prescription for free.
Biden ordered the U.S. Department of Health and Human Services in June to ensure all contraceptives approved by the FDA are available without out-of-pocket costs.
CMS is encouraging health insurance to cover over-the-counter contraceptive products for free, an agency spokesperson said Friday. The agency is working on ways to ensure contraceptives approved by the FDA for use without a prescription are available without cost sharing, the spokesperson said.
Opill is 93% effective at preventing pregnancy. It is the most effective form of over-the-counter contraception in the U.S. Opill should be taken at the same every day to ensure its effectiveness.
Welgryn said 15 million women in the U.S. who are sexually active and don’t want to get pregnant are using a form of contraception that is less effective than Opill or no contraception at all.
Nearly half the six million pregnancies in the U.S. every year are unintended, according to the FDA. Unintended pregnancy is linked to preterm delivery, which can result in poor health outcomes for newborns, according to the agency.