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In July 2023, the U.S. Food and Drug Administration (FDA) approved the first over-the-counter (OTC) daily oral contraceptive pill, Opill (nogestrel). This is the first daily oral contraceptive approved in the United States (US) for use without a prescription, available in retail stores and online. The manufacturer began distributing Opill in March 2024 with a suggested retail price of US$19.99 for 1 month’s supply or US$49.99 for 3 months’ supply. However, consumers are ‘cost-sensitive,’ with less than 50% of potential teen users interested in using OTC progestogen-only contraception if the price is greater than US$10 out of pocket.1
One key solution to this affordability gap is to implement required insurance coverage for OTC contraceptives without need for cost sharing or a prescription. This past year, the U.S. Departments of the Treasury, Labor, and Health and Human Services issued a request for information to gather input on the potential benefits and challenges of requiring insurance coverage of OTC preventive items like contraception, which would in turn improve access to contraception, without out-of-pocket expenses, under the Affordable Care Act (ACA).2 While short-term administrative challenges exist to implementation of this policy, the long-term benefits, impacting generations to come, are far more substantial. Several examples demonstrate that policy hurdles can be overcome in the path to guarantee coverage of an OTC product. These include the broad coverage of COVID-19 diagnostic tests during the public health emergency and several states requiring OTC emergency contraception and other contraception more broadly.2
Many of the individual and societal benefits of insurance-covered and OTC contraceptives are evidenced in the US through the impacts of insurance coverage for prescription contraceptives after the ACA. However, the cost of contraceptive visits and methods continue to impede access to contraception. For Black, Indigenous and people of colour in particular, obtaining oral contraceptive pills without a prescription outside clinical settings may mitigate systemic barriers, such as challenges in securing a clinic appointment or transportation, and interpersonal concerns like fear of judgement and lack of privacy.3 Eliminating barriers to contraceptive access via both OTC contraception and concurrent insurance coverage would contribute to improvements in health equity and lead to increased individual and societal economic opportunities.
Globally, people have access to OTC oral contraception pills without a prescription in over 100 nations. To maximise access to OTC contraception, nations frequently implement evidence-based cost coverage schemes. For instance, in February 2024, the Canadian government announced Bill C-64 (Pharmacare Act), making all prescription contraception free, including OTC progestogen-only emergency contraception, through universal single-payer insurance coverage.4 While healthcare financing in the US is markedly more complex, federal departments take the position that requiring plans and issuers to cover, without cost sharing, OTC preventive products without a prescription is an important option to consider for expanding access to contraceptive care.2
The opportunity to support contraception access is particularly urgent in the US given the rapid expansion of abortion restrictions across many states. In June 2022, the Supreme Court of the United States struck down the legal right to abortion at the federal level (Dobbs v. Jackson Women’s Health Organization), giving way to state-level restrictions prohibiting access to abortions across the country. Since Dobbs, individuals in states that both protect and restrict abortion access have experienced difficulties and delays in accessing their preferred contraceptive method in part due to cost and insurance, a gap that can be addressed by enhancing cost coverage.5
Ensuring that OTC contraceptives are covered by insurance is a key part of comprehensive sexual and reproductive healthcare and could fill an important gap in supporting people to plan, prevent and space their pregnancies on their own terms. If US policymakers take the next step and include OTC contraceptives as insurance-covered benefits, as guaranteed by the ACA for prescription-obtained contraception and as offered in nations worldwide, we can expect to see increases in contraceptive use.
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Footnotes
Contributors The letter was conceived by MR. It was jointly planned and drafted by all authors and the final version written by SM.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Provenance and peer review Not commissioned; externally peer reviewed.