A few days ago, the Food and Drug Administration (FDA) approved Opill, the first daily oral contraceptive to be available without a prescription in stores and online. Reproductive health advocates celebrated this historic approval as a step that can help millions of people avoid unwanted pregnancies, which occur almost every half the time in the U.S.
They have long argued that removing the often time-consuming step of seeking a prescription before being able to obtain birth control pills would broaden access and give people more control over their decisions.
Proponents want the FDA approval to signal a trend.
“We hope this is just the beginning of expanding access to a variety of over-the-counter contraceptive options,” said Kelly Blanchard, president of Ibis Reproductive Healthpart of a coalition of advocacy groups that have worked for decades to make contraceptive products available over the counter.
For example, a company called Cadence is working to get FDA approval for a birth control pill with a different formulation that would also be available without a prescription.
But many details related to the cost and coverage of an over-the-counter pill have yet to be worked out. The following are answers to common questions and concerns people may have about the new pill and how to use it with insurance.
- Who might be most interested in an over-the-counter oral contraceptive like Opill?
Anyone could be interested, depending on their circumstances. In a poll conducted last year, more than three-quarters of women of reproductive age said they favored making contraceptives available without a prescription, as long as research showed they were safe and effective.
For the uninsured, the new path will save them the cost of a visit to a health care provider to get a prescription, as well as the expense of taking time off work or getting child care in some cases.
But even people with coverage could be very interested, experts say. For example, teens who are insured under their parents’ plan may not want their parents to know.
“We were especially excited that the FDA approval has no age restrictions,” Blanchard said.
Also, people whose partners do not want them to take contraceptives may choose to prevent them from being included in their coverage.
Ease could be a factor if you’re on vacation and there’s no network pharmacy nearby, for example, or if you can’t get an appointment with your primary care doctor for a few weeks to discuss your options, but you don’t want to be without protection.
2. Why this pill?
Opill (norgestrel) contains only one hormone, progestin, while most of the 60 or so birth control pill formulations on the market contain both estrogen and progestin.
Progestin-only pills, sometimes called mini-pills, have very few contraindications, that is, there are few medical circumstances in which it would be advisable not to use them. For Opill, a major contraindication is if someone has breast cancer or a history of breast cancer.
“Since they do not contain estrogen, they have very few and quite rare contraindications, so they are safe and appropriate for preventing pregnancies in a broader population,” said Stephanie Sober, a physician and global leader of women’s health medical affairs at Perrigo Co., which makes the pill.
Both progestin-only and combination pills containing progestin and estrogen are more than 90% effective during normal use.
3. When can I get Opill and how much will it cost?
The company says that Opill will be available in stores and online in early 2024, but has not yet disclosed how much it will charge for a monthly pack of pills.
The average monthly cost of oral contraceptives ranges from $0 for people with health insurance to about $50, according to Regan Clawson, senior director of healthcare access strategy at Planned Parenthood Federation of America.
Perrigo said the company will have a consumer assistance program that will allow some people to get Opill for free, but no details have been provided yet.
4. Do health plans have to cover the new pill?
Not necessarily. According to the guidelines of Affordable Care Act preventive services (ACA), most health plans are required to cover the full range of FDA-approved contraceptives, including progestin-only oral contraceptives, without requiring any out-of-pocket costs from members.
But that doesn’t mean plans have to cover every type of pill. Since there is more than one progestin-only pill on the market, Opill may not be the one your plan chooses to cover, said Mara Gandal-Powers, director of contraceptive access at the National Women’s Law Center.
However, if you determine with your doctor that Opill is the most medically appropriate oral contraceptive for you, health plans are required to have a process in place that allows you to obtain that pill without cost sharing, even if it is not on your plan’s formulary, or in the list of covered drugs.
5. I have health insurance and usually do not have to pay anything for my birth control pills. Will I be able to pick up Opill straight off the shelf and not pay for it?
Defenders agree that this is the goal. But at first you’ll probably need a prescription to get Opill at no cost (assuming your plan covers it). Under the ACA, health plans may require a prescription for oral contraceptives.
It’s a barrier that goes against the goal of making the pills easier to obtain, advocates said.
“If you buy something straight off the shelf and then have to claim reimbursement, that’s not ‘out of pocket’ to me,” Gandal-Powers said.
However, a recent federal directive could offer clues as to how this might play out. In that guide, the government reiterated that health plans must cover, without cost sharing, emergency contraception. It encouraged, but did not require, health plans to do the same for over-the-counter contraceptives.
The defenders are pressing for the federal government to make no-cost, non-prescription coverage a tacit requirement for all over-the-counter contraceptives.
“There is nothing in the law that requires a prescription to invoke the no-cost-share requirement for preventive drugs and services,” said Dana Singiser, co-founder of the Contraceptive Access Initiative, which has published a report on the subject.
Sara Lonardo, press secretary for the Centers for Medicare & Medicaid Services (CMS), said in a statement that “CMS is working closely with the Departments of Labor and Treasury and is considering ways to ensure that private health insurance covers all FDA-approved contraceptives without cost sharing, even when available without a prescription.”
eight states already require health plans to cover, without a prescription or a copay, at least one over-the-counter method of birth control, such as condoms or spermicide, said Tara Mancini, director of public policy for Power to Decide, an advocacy group that has reviewed state laws.
Three other states and the District of Columbia require over-the-counter contraceptive coverage without a prescription, but do not specify whether a copay may be required. Those laws apply only to state-regulated health plans.
“That’s why federal regulation is so critical,” Singiser said.
2023-07-20 20:42:17
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