New Report Follows Several Months of Activity by the
Implementation of the Committee’s Recommendation Could Potentially Eliminate Financial Barriers for Contraceptive Products like Twirla® for 49 Million Women
Following several months of focus by the
“We appreciate the continued hard work of the Administration to ensure all women have access to contraceptive care without barriers and cost-sharing,” said Agile Therapeutics Chairperson and Chief Executive Officer
The Company commends Rep.
- The report reinforces the urgent need for revisions to federal guidance. By implementing the Committee’s proposed guidance revisions, the Tri-Departments could potentially ensure that 49 million women of reproductive age have increased access to no-cost contraception.
- The report is a follow-up to, Barriers to Birth Control: An Analysis of Contraceptive Coverage and Costs for Patients with
Private Insurance 2, in which a House Committee investigation found that insurers and PBMs consistently imposed exclusions or cost-sharing requirements for contraceptive products. - The previous investigation resulted in a recommendation that the administration update guidance to address coverage gaps by requiring that all contraceptives without a therapeutic equivalent (generic) are covered on plan formularies. This would ensure that all people have access to the most appropriate contraceptive products without out-of-pocket payment, as required by the ACA.
This new report follows several recent noteworthy efforts from the
After an investigation led by the state finding systemic non-compliance with contraceptive coverage requirements, Vermont Lawmakers requested the Administration provide additional oversight and enforcement of the ACA Contraceptive requirements to ensure health plans and PBMs are following federal and state guidance.
- In a
November 16, 2023 , letter4 to the Secretaries of the Departments responsible for implementation of the ACA contraceptive coverage requirements; the Congressional leaders fromVermont , SenatorsBernie Sanders andPeter Welch and RepresentativeBecca Balint , requested information from the Departments regarding its efforts to enforce the Affordable Care Act’s (ACA) no-cost contraceptive coverage requirement. - The letter highlighted a recent state investigation that found three insurers in Vermont—BCBS VT,
MVP Health Care , and Cigna Healthcare—had failed to provide patients with no-cost contraceptive services in violation of state and federal law and resulted in required restitution of almost$1.5M in inappropriate costs charged to consumers.
- On
October 27, 2023 , the White House convened private sector leaders to discuss efforts to ensure access to affordable, high-quality contraception5. Administration leaders emphasized the importance of continuing to build on the progress that has been made under the ACA. These efforts include robust implementation of the President’s third Executive Order on reproductive health care access, issued inJune 2023 , which directed federal agencies to “ensure coverage of comprehensive contraceptive care, including all contraceptives approved, granted, or cleared by theFood and Drug Administration (FDA), without cost sharing for enrollees, participants, and beneficiaries.” - On
November 8, 2023 , theU.S. Department of Health and Human Services (HHS) SecretaryXavier Becerra 6, hosted a roundtable to hear directly from researchers on the ground about barriers to contraception care in the aftermath of the Dobbs Decision, and reaffirm commitment to expanding access to contraception. This roundtable marked the fourth meeting in a series hosted by the Secretary’sTask Force on Reproductive Health .
1 Staff Analysis: Revised Federal Guidance Regarding Contraceptive Coverage Could Benefit Millions of Women. December 8, 2023 House Committee Contraceptive Guidance Staff Analysis
2 Staff report
3
4 Sanders B, Welch P, Balint B,
5 Readout of White House Meeting on Increasing Contraception Access and Affordability,
6 Readout of HHS Secretary Becerra’s Roundtable on Contraception Access,
About Agile Therapeutics, Inc.
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 <30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in women over 35 years old who smoke.
Cigarette smoking increases the risk of serious cardiovascular events from CHC use. Twirla is designed to be applied once weekly for three weeks, followed by a week without a patch.
Forward-Looking Statements
Certain information contained in this press release includes “forward-looking statements”, within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We may, in some cases use terms such as “predicts,” “believes,” “potential,” “continue,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty of the future events or outcomes to identify these forward-looking statements. Our forward-looking statements are based on current beliefs and expectations of our management team that involve risks, potential changes in circumstances, assumptions, and uncertainties, including statements regarding potential impact of and response to the recent report by the
Contact:
Head of Investor Relations & Corporate Communications
mriley@agiletherapeutics.com
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