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An over-the-counter birth control pill will be available to Americans for the first time early next year — but it’s not yet clear what it will cost or if insurance will cover it.

The progestin-only pill known as Opill received federal approval Thursday and will be sold in retail pharmacies in early 2024. When taken daily at the same time, the pill is incredibly effective in preventing pregnancy. 

But though the pill’s manufacturer, Perrigo, has said it wants to make the pill “accessible and affordable” to the general public, the company has not yet said what the drug will cost. Frederique Welgryn, Perrigo’s global vice president for women’s health, said that price information will be available in the coming months.

Under the Affordable Care Act, private health insurance plans must cover one method of each form of birth control without charging consumers any out-of-pocket costs, but plans can require that the patient receive a prescription for the medication first. Spokespeople for Perrigo said the company is in talks with private insurance and Medicaid programs, but said that as they understand it, the current law does not appear to require coverage of the over-the-counter pill. That would mean that barring a policy change, those who use the drug would have to pay the yet-undetermined price themselves.

“Today, over-the-counter [drugs] are not covered by private insurance. It would need a change of law to make sure this would be the case,” Welgryn said. “Right now, I think we have some work to do to make that happen.”

Some states have laws that would require health insurance plans to cover over-the-counter contraception. That means people in those states might be able to access Opill through their health insurance plans. Coverage provided through self-insured employers, which makes up more than half of employer-sponsored insurance, is not regulated by state law and would not be addressed by those laws.

Company spokespeople as well as some researchers have suggested that the people more likely to seek an over-the-counter birth control pill are largely those who lack regular access to a physician — people who are uninsured, have lower incomes, or face other challenges in going to the doctor — and minors. But both of those groups are particularly impacted by the potential cost of the pill. Uninsured rates are higher in states that declined the ACA’s optional Medicaid expansion, including Texas and Florida. And rates of uninsurance are significantly higher for American Indian and Alaska Native people, and  for Black people and for Latinx people.

Not everyone believes that the pill wouldn’t be covered under the ACA. Mara Gandal Powers, an attorney with the National Women’s Law Center, said that she believes the federal health law could be interpreted to require insurance coverage of Opill without any out-of-pocket cost. Such a change would require the Biden administration to issue new regulations about how it understands and intends to enforce the law.

“We have to continue to push for the administration to make clear exactly how this is going to work,” she said. “It is really on the administration to bring together some of the key players here — the company, chain pharmacies, consumer groups — to make sure this works. To get everybody at the table and see what needs to happen.”

A spokesperson for the Centers for Medicare and Medicaid Services, a subsidiary of Health and Human Services, said coverage of over-the-counter contraception such as Opill would vary from plan to plan. Currently, the spokesperson noted, Medicaid, which insures low-income people, is not required to cover over-the-counter medication. Private insurance must cover over-the-counter birth control only when it is purchased with a prescription.

“CMS encourages plans and issuers to cover OTC contraceptive products with no cost sharing when they are purchased without a prescription,” the spokesperson added.

Some lawmakers are pushing for new federal protections that could expand access to the pill. In anticipation of the pill’s approval, a group of Democratic senators recently reintroduced legislation that would require most private insurance plans cover over-the-counter contraception. But such a bill’s prospects are slim, given Democrats’ narrow majority in the Senate and Republicans holding control of the House of Representatives.

Perrigo is planning to introduce some form of coupon program for people who want to buy Opill but cannot afford the cost. The company offered few details as to how that program will work in practice, so it’s hard to say how significantly it could expand access to the drug.

Depending on Opill’s price, health insurance may choose to cover the pill, said Cynthia Cox, a vice president at KFF, a nonpartisan health policy research organization. But given how new the drug will be, and the availability of other prescription-based generic options, it’s hard to imagine many plans will voluntarily do so. Currently, the emergency contraception Plan B pill is only covered when prescribed by a doctor. Cox also agrees that it’s not clear that any existing federal law — including the ACA — could be interpreted to guarantee coverage of an over-the-counter birth control drug.

Out-of-pocket costs greater than $10 can substantially deter people from getting medication, especially for Black women and Latinas, who on average earn far less than White women, Powers noted. 

Polling from KFF suggests that interest in using an over-the-counter form of hormonal birth control is similar among low-income and higher-income people. Those who lack any form of health insurance appear more likely than those with coverage to say they would use it: 1 in 4 uninsured women between the ages of 18 and 49 expressed interest, compared to about 1 in 5 of those with private insurance.

Reproductive health advocates, many of whom pushed for Opill’s approval, said that they intend to work with lawmakers both in the Biden administration and Congress to prioritize insurance coverage for the new pill. The administration recently put out an executive order meant to expand access to contraception, including a directive that the secretaries of Treasury, Labor and Health and Human Services consider what could be done to expand access to over-the-counter contraception. Those same departments have been asked to examine whether to put out new guidance ensuring that private insurance covers federally approved contraception.

“It’s obviously critically important that insurance covers an over-the-counter pill to make sure that everybody who wants can use it and doesn’t lose what we have now,” said Kelly Blanchard, president of Ibis Reproductive Health, a research organization that has supported making an over-the-counter pill available.

Barring some kind of federal action, Cox said, it’s difficult to know how many people will be able to use the pill. And its price will be incredibly meaningful.

“Without knowing the price, it’s really hard to say how much this will be used,” she said.