Agile Sees Renewed Hope For Even Broader Adoption Of Its Weekly Birth Control Patch After Biden's Latest Executive Order Expanding Contraceptive Coverage

In June, President Biden issued an Executive Order on Strengthening Access to Affordable, High-Quality Contraception and Family Planning Services. It directs the Secretaries of Health and Human Services (HHS), Labor and the Treasury to issue new guidance that ensures all contraceptives approved by the Food and Drug Administration (FDA) are covered without cost-sharing by private health insurance. The order also directs the departments to take multiple other actions aimed at reducing barriers and closing the gaps in access to all forms of contraception and family planning services. 

Agile Therapeutics, Inc. AGRX praised the Biden Administration’s efforts to address these issues and ensure that women have access to as many affordable contraceptive options as possible. For women’s healthcare companies like Agile, the news is a sign that millions more women could soon be able to access birth control options that are currently excluded from coverage by many insurers. 

Birth Control Should Be Covered Automatically, But That Isn’t Always The Reality For Millions of Women

The executive order is the President’s third one aimed at improving access to reproductive healthcare since the Supreme Court’s Dobbs v. Jackson Women’s Health Organization decision that overturned decades of precedent that protected reproductive rights.

In addition to seeking that private insurers cover all FDA-approved contraceptives, the order aims to improve contraception coverage under Medicare, provide new resources to federally-supported family planning clinics and community health centers to offer a broader and better selection of contraceptive options, and other directives in an effort to both protect and expand access to contraception and family planning services.

The order builds on earlier efforts to expand coverage and access after Congress published a report last year finding that most private healthcare plans don’t fully cover about 50% of newer FDA-approved contraceptive products. 

After the report came out, the Biden Administration began investigating insurer noncompliance via audits of many of the offenders named in the report and may eventually levy fines or take other corrective actions.

Sales Of Agile’s Birth Control Patch Could Soar If It Were Universally Covered by Insurance

This executive order along with other recent efforts by the Biden Administration to crack down on non-compliant insurers and expand access to more birth control options could be a breath of fresh air for Agile. The women’s healthcare company developed a weekly contraceptive patch, Twirla® (levonorgestrel and ethinyl estradiol) transdermal system, that was approved by the FDA in 2020. But since that approval, Agile has faced an uphill battle with many insurers reluctant to offer no-cost coverage for the new birth control method. 

While insurers claim to cover Twirla, coverage exclusions and cost-sharing requirements mean that many patients would have to pay as much as $178 per month for the patch. This has rendered the birth control method unaffordable for many women. 

But the Biden Administration’s crackdown on non-compliant insurers and other initiatives to expand access could soon change that. As it does, Agile could see accelerated sales momentum. 

One study found that at least 50% of women using a birth control pill say they have forgotten to take one or more of their daily doses within the last three months. Doing so can increase the risk of unintended pregnancy even while on the pill. The same study found that up to 66% of women desired a birth control method that they didn’t have to think about continuously. 

The Twirla patch, which adheres to the skin and is replaced once a week for three weeks, with no patch worn on the fourth week, may fill this need — and, unlike implants, can be easily stopped when a woman decides she’s ready to start a family. Even without broad insurance coverage, that flexibility has helped demand for the birth control patch climb steadily in the few years it’s been on the market. In the last year alone, demand rose 170% from the first quarter of 2022 to the first quarter of 2023. With better compliance from insurers, Agile is optimistic that demand could climb even faster. 

Featured photo by Reproductive Health Supplies Coalition on Unsplash.

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