For Whitney, the desire to eventually have kids sparked a search for a new type of birth control. Another IUD would prevent pregnancy for too long and she needed an alternative until she was ready for children. In 2020, she finally found an option she liked: a new vaginal ring called Annovera developed by TherapeuticsMD. But there was an issue. After changing jobs, her insurance plan denied coverage.

Her options? Switch contraceptives and risk grueling side effects, or embark on a lengthy appeal process. “I kind of just gave in and just took what they were offering me,” said Whitney, who is 34 years old and lives in Wisconsin.

Whitney, who asked that her last name be withheld for privacy reasons, ended up on a birth control pill. It can be difficult to remember to ingest the pill every day, which once forced her to take Plan B, also known as the “morning-after pill.”

“If I had had the birth control that I wanted, I wouldn’t have been in this situation,” she said. “It’s just frustrating.” Whitney isn’t alone in her frustration.

Getting insurers to cover new contraceptives can be difficult, an issue thrust into the spotlight after the Supreme Court overturned Roe v. Wade. As state laws restricting abortion take effect, women’s health advocates and the federal government are pushing payers to provide as many birth control options as possible, including newer products that often aren’t covered by insurance.

Contraceptives are not one-size-fits all, and what works for one woman may cause side effects in another — ranging from weight gain and mood swings to blood clots.

Biotechs — aided by updated regulations, a federal crackdown and public pressure — say the insurance industry is beginning to show more of a willingness to pay for novel forms of birth control. In a sign of greater investor interest in the space, Agile Therapeutics, a women’s contraception company, recently raised more than $24 million in a public offering.

The Affordable Care Act requires that most insurance plans fully cover contraceptives approved by the FDA and prescribed by a clinician. However, lawmakers and women’s health advocates say that insurers have routinely shirked their responsibilities over the last decade.

Evofem, a biotech that won FDA approval for a non-hormonal birth control gel called Phexxi in 2020, initially struggled to secure insurance coverage. But after the Supreme Court’s draft decision leaked in May and prodding from the federal government, insurers now cover 75% percent of product claims, up from 55% a year ago. That’s according to Evofem CEO Saundra Pelletier, who said there’s more work to do.

“They just weren’t doing the right thing for women,” Pelletier said of some insurers. “But now, when they recognize these attacks on women are real and pervasive and could be increasing, they’re really starting to step up and say, ‘Look, we don’t want to be the holdout.’”

Al Altomari

Agile Therapeutics CEO Al Altomari said that clinicians seem more willing to fight for women’s choice in birth control in recent months, while smaller insurance companies are showing more openness to covering the company’s product. Some of the large pharmacy benefit managers haven’t moved just yet, he added — but he believes eventually they will.

His company’s hormonal birth control patch called Twirla was approved in 2020. Agile touts the product as a lower-dose and more convenient option than other patches and birth control pills. Women apply the patch once a week for three weeks, followed by an off-week when their cycle occurs.

Twirla’s first few quarters on the market were challenging, Altomari said, between struggling with insurers and launching in the middle of a pandemic.

“There has been really a lot of noncompliance by the insurance companies and this has been really a big issue that’s actually ended up in the White House,” he said. “It’s hurting all of our companies, including ours.”

But the Supreme Court decision in ​​Dobbs v. Jackson Women’s Health Organization triggered new interest in the company, fueling Agile’s public offering that raised $24 million earlier this month and another at-the-market raise of $12.8 million.

“We’re growing, we think in the second quarter somewhere between 25 and 30% quarter-on-quarter growth, despite these challenges,” Altomari said. “We think things are going to get a lot better, faster for all of us.”

Some drugmakers argue holes in insurance coverage have stifled innovation. Just look at Big Pharma, which hasn’t made much progress on the contraception front in the last decade or so, Altomari said.

“All the innovation in contraception, in particularly the last 10 to 15 years, has come out of little companies,” he said. “Each one of these companies has passion for the space.”

When its gel launched, Evofem also found itself in insurance purgatory. Some payers didn’t want to cover Phexxi because it didn’t fit into existing birth control categories that are part of a federal list guiding coverage decisions. Pelletier said Evofem asked HHS to update the list, but the agency stated it shouldn’t be a proxy for coverage decisions.

Endpoints reached out to HHS’ Office on Women’s Health, which oversees the guidance, but did not receive a response as of press time.

In January, the Women’s Preventive Services Initiative, which works with HHS, recommended that “any FDA-approved, -granted or -cleared contraceptives” should be made accessible as part of contraceptive care. The language has been widely interpreted to mean insurers should cover birth control.

Mara Gandal-Powers

“It is pretty clear that if something has approval from the FDA, it should be getting coverage,” said Mara Gandal-Powers, director of birth control access at the National Women’s Law Center.

But there still might be exceptions. A plan can charge a cost-sharing fee for birth control filled at an out-of-network pharmacy if they have it covered without cost-sharing at an in-network pharmacy, Gandal-Powers noted. In addition, some employer plans were grandfathered in when the ACA went into effect, and don’t need to cover preventive services.

A 2020 report sponsored by the Kaiser Family Foundation and nonprofit Susan Thompson Buffett Foundation found that the share of oral contraceptive users paying out-of-pocket dropped from 96% in 2010 to 10% in 2018 after the Affordable Care Act passed. But many women are still paying out of pocket for contraception.

Gandal-Powers said that some insurance plans violate HHS’ most recent guidance by requiring patients to try a number of products first before they can get coverage for a newer form of birth control that isn’t on the list. She has seen plans that require women to try eight products before they can get full coverage for their choice, regardless of what a clinician has recommended. And many women don’t realize they can appeal decisions that flat-out deny coverage, she said.

If a woman’s first choice is denied, plans are supposed to have “an easily accessible, transparent, and sufficiently expedient exceptions process that is not unduly burdensome on the individual or a provider,” according to updated 2015 guidance issued by HHS, which allows women to get access with the help of a provider.

“We’re sort of seeing twofold with newer products, that plans are saying they don’t have to cover them because they don’t appear on this outdated list, and plans don’t have the cautionary exceptions process in place,” Gandal-Powers said.

Insurance companies continue to face pressure in the weeks since the Dobbs decision, as the Biden administration has stepped up efforts to compel insurers to cover birth control. Last month, HHS Secretary Xavier Becerra, Treasury Secretary Janet Yellen and Labor Secretary Martin Walsh said in a letter to payers that they’ve received “troubling and persistent reports” of noncompliance.

“For this reason, we are calling on your organizations 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,” they wrote.

If a plan fails to comply with the act, there’s a range of enforcement actions the government can take, including monetary penalties, Gandal-Powers said. For more than 10 years, the National Women’s Law Center has been running a hotline to help women understand what’s covered under their plan, and how to appeal decisions that don’t comply with the ACA.

When asked for comment on their policies around contraceptives, the Blue Cross Blue Shield Association, a federation of locally operated Blue Cross companies, issued a statement:

BCBS companies take compliance with state and federal laws very seriously and are committed to ensuring access to preventative services, including contraception. BCBS companies are reviewing existing policies to make sure there are no unintended barriers to contraceptive access for members.

Aetna International declined to comment, while Humana and UnitedHealth Group did not respond as of press time.

For Evofem and other biotechs, it isn’t just payers that are paying more attention. Women, clinicians and even investors have been more engaged, Pelletier said. Evofem’s stock more than doubled after the Dobbs ruling and has maintained the momentum. Prescriptions are also up, Pelletier noted.

Sabrina Johnson

“It also reinforces for healthcare investors — this is healthcare,” said Daré Bioscience CEO Sabrina Johnson. “All of a sudden we’ve shone a spotlight on the category and it’s becoming noticed.”

Even though Daré’s lead candidate hasn’t yet entered a Phase III trial, Johnson knew the company would need to start conversations with payers and regulators early on. And being differentiated enough from other products should make it easier to get coverage, she said.

The company is working on a vaginal ring called Ovaprene. It’s similar to the NuvaRing in shape and size, but unlike other products, it’s non-hormonal. Ovaprene has a knitted polymer barrier, which is porous but doesn’t allow sperm to reach the cervix. From the center, the ring releases a form of iron that interferes with sperm mobility.

Daré partnered with both Bayer and the National Institutes of Health, which is co-funding the Phase III trial that’s slated to begin this year. Since the Supreme Court decision, the company has also seen heightened interest from additional investors, according to Johnson.

“There are certain investors who have been outspoken about the SCOTUS decision,” she said.

Will that translate to long-term interest? It’s difficult to say, as the field is risky. However, getting on the right birth control early is of increasing concern to the millions of women whose abortion rights have now been revoked or called into question.

TherapeuticsMD, which developed Whitney’s preferred birth control option, did not respond to a request for comment.

Wisconsin, where Whitney lives, adopted an abortion ban in 1849. And though the state’s governor Tony Evers has said the ban won’t be enforced, some clinics have already halted abortions.

“It’s more about having a choice over your body and what’s best for you,” Whitney said. “No one can make that decision better than yourself.”

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