A package of the daily contraceptive Opill is seen in an undated illustration.
Perrigo | via Reuters
The availability of the first over-the-counter birth control pill in the U.S. may still be limited for some women and girls due to insurance coverage issues.
The U.S. Food and Drug Administration recently granted approval for the sale of the oral contraceptive Opill without a prescription. This decision will make it easier for women to obtain birth control pills by eliminating the need for doctor’s visits and prescription refills.
A survey published in the Journal of Women’s Health in 2016 revealed that one-third of adult women who have attempted to obtain prescription contraception faced obstacles in accessing it.
Perrigo, the manufacturer of Opill, expects the pill to be available in major stores and online by early 2024. The pricing details will be announced by Perrigo in the upcoming months. Frederique Welgryn, a Perrigo executive, mentioned during a press call that the company is committed to making Opill affordable. They are establishing a patient assistance program to ensure that the cost of the pill does not pose a barrier for women with financial difficulties.
However, despite these efforts, some women and girls may still encounter difficulties in obtaining Opill. The Affordable Care Act does not mandate private health insurance coverage for over-the-counter birth control. While most health insurers are required to offer free birth control when prescribed by a doctor, the same requirement does not apply to its over-the-counter use. Moreover, state Medicaid programs are generally not obligated to cover non-prescription drugs.
Perrigo’s Efforts for Insurance Coverage
Welgryn stated that Perrigo is actively working on persuading private insurance companies and state Medicaid programs to provide free access to over-the-counter Opill for women and girls. However, she emphasized that the Affordable Care Act needs to be revised to ensure that health insurance covers birth control without a prescription.
Welgryn acknowledged that it remains uncertain whether insurance coverage for Opill will be implemented by the time the pill hits the stores early next year. She noted, “We have some work to do to make that happen. It’s going to take time.”
Efforts to expand contraceptive access are underway, with Democrats in Congress and President Joe Biden pushing for such enhancements.
In May, Sen. Patty Murray reintroduced the Affordability is Access legislation in the Senate. The bill aims to compel health insurers to provide oral contraceptives without a prescription, free of charge. Additionally, President Joe Biden directed the U.S. Department of Health and Human Services in June to ensure that all FDA-approved contraceptives are available without any out-of-pocket costs.
The Centers for Medicare & Medicaid Services (CMS) are encouraging health insurers to cover over-the-counter contraceptive products at no cost. The agency spokesperson stated that efforts are being made to ensure the availability of FDA-approved contraceptives without cost sharing.
Opill is 93% effective in preventing pregnancy and is the most effective over-the-counter contraception in the U.S. It must be taken at the same time every day to ensure its effectiveness.
Welgryn stated that approximately 15 million sexually active women in the U.S. who do not wish to conceive are using less effective forms of contraception or none at all. According to the FDA, nearly half of the six million pregnancies in the U.S. each year are unintended, which can lead to poor health outcomes for newborns, including preterm delivery.
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