PRINCETON - Agile Therapeutics, Inc., (Nasdaq: AGRX), a women's healthcare company, commends the Biden-Harris Administration for their continued commitment to reproductive health including increasing access to no-cost contraception.
Following several months of focus by the Biden Administration and lawmakers on contraception and impermissible barriers to reproductive healthcare, the Departments of Labor, Health and Human Services, and the Treasury (the 'Tri-Agencies') jointly released new guidance in the form of Frequently Asked Questions ('FAQ') on Monday, January 22, 2024. The FAQ outlines a 'new pathway for plans and issuers to meet existing obligations under federal law by covering, at no cost, a broader range of FDA-approved contraceptive drugs and certain devices.'1,2 The Tri-Agencies describe how plans may comply with the ACA requirement to cover contraception without cost sharing by 'covering all [FDA] approved drugs and drug-led devices other than those for which there is a covered therapeutic equivalent' as identified in the Orange Book.1,2 This new pathway comes after reports of many plans and issuers imposing impermissible barriers to no-cost contraceptive coverage.
The new guidance follows the President's Executive Order in June 2023, which directed the Secretaries to consider actions, to the greatest extent permitted by law, that will ensure coverage of comprehensive contraceptive care including all contraceptives approved, granted, or cleared by the Food and Drug Administration, without cost sharing for enrollees, participants, and beneficiaries.3
In concert with the FAQ, Secretary Becerra, the head of Health and Human Services also sent a letter2 to health plans and insurers highlighting the issuance of new guidance and noting that, 'as we have previously made clear, we will continue to call on group health plan sponsors and issuers to remove impermissible barriers and ensure individuals in your plans have access to the contraceptive coverage they need, as required under the law. It is more important than ever to ensure access to contraceptive coverage without cost- sharing, as afforded by the ACA.'
'We recognize the importance of reproductive freedom for women and applaud the administration for taking concrete actions to ensure women have access to the contraceptive product that is right for them without barriers and cost-sharing,' said Agile Therapeutics, Inc.'s Chairperson and Chief Executive Officer Al Altomari. 'We believe the new guidelines take a significant step towards eliminating financial barriers to contraceptives and we look forward to working with patients and providers interested in a low dose patch option like Twirla.'
HHS Secretary Xavier Becerra Announces New Actions to Increase Contraceptive Care Coverage on 51st Anniversary of Roe v. Wade HHS Announces New Actions to Increase Contraceptive Care Coverage January 22 2024
Frequently Asked Questions About the Affordable Care Act Part 64, January 22, 2024 FAQ Part 64 January 22 2024
President Biden Executive Order June 23, 2023 Executive-order-on-strengthening-access-to-affordable-high-quality-contraception-and-family-planning-services June 23, 2023
About Agile Therapeutics, Inc.
Agile Therapeutics is a women's healthcare company dedicated to fulfilling the unmet health needs of today's women. Our product and product candidates are designed to provide women with contraceptive options that offer freedom from taking a daily pill, without committing to a longer-acting method. Our initial product, Twirla, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on our proprietary transdermal patch technology, called Skinfusion, which is designed to allow drug delivery through the skin. The Company may occasionally disseminate material, nonpublic information on the Company's website and LinkedIn account.
About Twirla
Twirla (levonorgestrel and ethinyl estradiol) transdermal system is a once-weekly combined hormonal contraceptive (CHC) patch that contains the active ingredients levonorgestrel (LNG), a type of progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated for use as a method of contraception by women of reproductive potential with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider Twirla's reduced efficacy in women with a BMI 25 to
AGILE THERAPEUTICS, INC. 
