Opill is coming, when are the new over the counter birth control pills available, how much will they cost, will insurance cover them?

The federal Food and Drug Administration has approved the Opill, the first daily oral contraceptive to be available for sale without a prescription, but many details regarding cost and insurance coverage for the over-the-counter pill still need to be worked out.

1. Who is most interested in over-the-counter oral contraceptives like Opill?

For people who are not insured, the new OTC pill will save them the cost of visits to health care providers for prescriptions and the cost of taking time off work or getting child care.

Convenience can also be a factor if, say, you're on vacation and there's no in-store pharmacy nearby or you can't make a doctor's appointment for a few weeks to discuss your options but don't want to be unprotected.

2. Why this pill?

Opill — the trade name for the drug norgestrel — contains only one hormone, progestin. Most of the 60 contraceptive pill formulations currently on the market contain both estrogen and progestin.

The progestin-only pill, sometimes called the mini pill, has some contraindications, meaning that there are some medical circumstances in which taking them would be wrong. For Opill, the main contraindication is if a person has breast cancer or a history of breast cancer.

“Because they do not contain estrogen, they have very few and very rare contraindications, so they are safe and suitable for use by the wider population to prevent pregnancy,” says Dr. Stephanie Sober, a physician and global leader in women's health medical affairs for Perrigo Co., which makes the pills.

Both progestin-only pills and combination pills that contain progestin and estrogen more than 90% effective during normal use.

3. When can you get Opill, and how much does it cost?

The company says Opill will be available in stores and online in early 2024 but hasn't announced how much the monthly pill pack will cost.

The average monthly cost for oral contraceptives now available ranges from zero for a person with health insurance to about $50, said Regan Clawson, senior director of health care access strategy for the Planned Parenthood Federation of America.

Perrigo said he would have a consumer assistance program in place that would allow some people to get Opill for free, but no details were available yet.

4. Does insurance have to cover new pills?

Not necessarily. Under federal The Affordable Care Act prevention service guidelinesmost health plans should cover the entire range of FDA-approved contraceptives, including progestin-only oral contraceptives, without requiring a dispensing out-of-pocket.

But that doesn't mean the plan has to cover every type of pill. Because there's more than one progestin-only pill on the market, it's possible that Opill isn't the pill you'd choose to cover, says Mara Gandal-Powers, director of access to contraception for the National Center for Women's Law.

However, if your doctor and you determine that Opill is medically the best oral contraceptive for you, the health plan should have a process in place that allows you to get the pill without sharing the cost. even if it's not on your plan's list of medicines covered.

5. If you have health insurance and normally don't have to pay anything for your birth control pills, can you just take the Opill off the shelf and not pay for it?

That's the goal, advocates say. Initially, though, you may need a prescription from your doctor to get Opill without paying for it — as long as your package covers it.

Under health laws, insurance companies can require a prescription for oral contraceptives.

Under a recent federal directive, the government reiterated that health plans must cover, without cost-sharing, emergency contraception purchased without a prescription when prescribed. It's encouraging but doesn't require a health plan to do it without a prescription.

Advocate is pushing the federal government to make no-cost, no-prescription coverage an explicit requirement for all over-the-counter contraceptives.

KFF Health News is a national newsroom that produces in-depth journalism on health issues.