Last week, the FDA approved Opill, the first daily oral contraceptive that will be available over the counter in stores and online. Reproductive health advocates hailed the groundbreaking approval as a step that can help millions of people avoid pregnancy, which isn’t intentional almost half the time in the United States.
They have long argued that eliminating the often time-consuming step of requiring women to get a prescription before they can get birth control pills would expand access and give women more control over their contraceptive decisions.
Advocates want FDA approval to signal a trend.
« We hope this is just the beginning of expanding access to a range of over-the-counter contraceptive options, » said Kelly Blanchard, president of Reproductive health of the ibispart of a coalition of advocacy groups that have worked for decades to make over-the-counter contraception available.
For example, a company called Cadence is working on getting FDA approval for a birth control pill with a different formulation that would also be available over the counter without a prescription.
But many details surrounding the cost and coverage of an OTC pill are yet to be clarified. Here are answers to common questions and concerns people might have about the new pill and how to use it with their insurance.
1. Who is most interested in an over-the-counter oral contraceptive like Opill?
Anyone could be affected, depending on the circumstances. In a survey conducted last yearmore than three-quarters of women of reproductive age said they favor making over-the-counter birth control available as long as research demonstrates its safety and effectiveness.
For people who are uninsured, the new route will save them the cost of a visit to a healthcare professional for a prescription and, in some cases, the expense of time off work or child care.
But people with health coverage may also be very interested, experts say. For example, young people who are insured under a parent’s plan may not want insurance notices sent to their parents’ homes.
« We were especially excited that FDA approval came with no age limit, » said Blanchard.
Similarly, women whose partners don’t want them to take birth control may choose to sidestep their coverage.
Simple convenience could be a factor if you’re on vacation and there isn’t a network pharmacy nearby, for example, or if you can’t get an appointment to see your GP for a few weeks to discuss your options but can’t do it I don’t want to be protected.
2. Is this pill safe for most people?
Opill (norgestrel) contains only one hormone, the progestin, while most of the 60 or so contraceptive pill formulations on the market contain both estrogen and progestin.
Progestogen-only pills, sometimes called mini-pills, have very few contraindications, meaning there are few medical circumstances in which taking them would be ill-advised. For Opill, a key contraindication is if someone has breast cancer or a history of breast cancer.
« Because they don’t contain estrogen, they have very few and rather rare contraindications, so they are safe and appropriate for a larger population to use to prevent pregnancy, » said Stephanie Sober, Ph.D. Perrigo Co., which manufactures the pill.
Both progestogen-only pills and combined pills that contain progestogen and estrogen are more than 90% effective. during normal use.
3. When can I get Opill and how much does it cost?
The drugmaker says Opill will be available in stores and online in early 2024, but hasn’t disclosed how much it will charge for a monthly pack of pills.
The average monthly cost for oral contraceptives ranges from $0 for people with health insurance to about $50, said Regan Clawson, senior director of health care access strategy at the 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 are available yet.
4. Do health plans have to cover the new pill?
Not necessarily. Under the Affordable Care Act guidelines for preventive servicesMost health plans must cover the full range of FDA-approved contraceptives, including progestin-only oral contraceptives, without requiring any direct expense from members.
But that doesn’t mean the plans have to cover every single type of pill. Because there’s more than one progestogen-only pill on the market, Opill may not be the one your plan chooses to cover, said Mara Gandal-Powers, director of birth control access at National Women’s Law. center.
However, if you and your doctor determine that Opill is medically the best oral contraceptive for you, health plans must have a process in place that allows you to get that pill without cost sharing. even if it’s not on your plan formor the List of Covered Drugs.
5. I have health insurance and normally don’t have to pay anything for my birth control pills. Will I be able to pull Opill off the shelf and not pay for it?
That’s the goal, advocates agree, but in the beginning, you’ll probably need a prescription from your doctor to get Opill without paying for it (assuming your plan covers it). Under the health law, health plans can require a prescription for oral contraceptives.
It’s a barrier that defeats the goal of making pills easier to obtain, advocates said.
“If you buy something off the shelf and then have to send it in for a refund, that doesn’t mean ‘no out-of-pocket cost’ to me,” said Gandal-Powers.
A recent federal directive, however, could offer clues as to how this might play out. In that guidance, the government reiterated that health plans must cover, without cost sharing, emergency contraception bought over the counter when it is prescribed. He encouraged but did not require health plans to do it without a prescription.
Lawyers are pushing for the federal government make free coverage without a prescription an explicit requirement for all over-the-counter contraceptives.
« There is nothing in the law that requires a prescription to invoke the cost-sharing requirement for preventive services and medications, » said Dana Singiser, co-founder of the Contraceptive Access Initiative, which released a white paper on the topic. .
“CMS is working closely with the Departments of Labor and the Treasury and is evaluating ways to ensure private health insurance under the ACA Market Reforms covers all contraceptives approved, licensed, or licensed by the Food and Drug Administration ( FDA) without cost sharing, even when available over-the-counter and purchased without a prescription, » Sara Lonardo, press secretary at the Centers for Medicare & Medicaid Services, said in a statement.
Eight states already require health plans to cover, without a prescription or co-pay, at least one method of contraception sold over the counter, such as condoms or spermicides, said Tara Mancini, director of public policy at Power to Decide, an advocacy group that has analyzed the laws state . Three other states and the District of Columbia require over-the-counter contraception coverage without a prescription, but do not specify whether a copay might be required. These laws apply only to state-regulated health plans.
« That’s why federal regulation is so critical, » Singiser said.
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