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Opill’s daily contraceptive pack seen in an undated illustration.
dog | via Reuters
The first over-the-counter birth control pill in the United States can remain out of reach for some women and girls because health insurance plans are not required to cover the drug in its over-the-counter form.
The U.S. Food and Drug Administration on Thursday approved Opill oral contraceptives for sale without a prescription, a landmark decision that would make the pill easier to obtain by eliminating the need to visit a doctor’s office and refill prescriptions.
One-third of adult women who have tried to obtain prescription contraception encountered barriers to accessing it, according to a survey published in the Journal of Women’s Health in 2016.
Opel manufacturer Perego It expects the pill to be available in major stores and online in early 2024. Perrigo will announce the price of Opill in two months before the pill hits stores, Perrigo CEO Fredrik Welgren said during a call with reporters Thursday.
Welgren said the company is committed to ensuring that Opill is affordable. Perrigo sets up a program to help patients, so the cost of birth control pills isn’t a barrier for women struggling to make ends meet.
But some women and girls still face obstacles in obtaining an Opel. The Affordable Care Act does not require private health insurance to cover the cost of birth control pills when used without a prescription. Most health insurance companies are required to provide free contraception when prescribed by a doctor.
State Medicaid programs are generally not required to cover over-the-counter drugs, according to the federal Centers for Medicare and Medicaid Services.
Perrigo works on insurance coverage
Welgren said Perego is enlisting private insurance and state Medicare programs to offer over-the-counter Opill to women and girls for free. But she said the Affordable Care Act needs to be amended to ensure that health insurance pays for over-the-counter birth control.
It’s unclear whether insurance coverage for Opel will be in place when the pill is available in stores early next year, Welgren said. “We have some work to do to make that happen. It will take some time,” she said.
Congressional Democrats and President Joe Biden are pushing to expand access to birth control.
Sen. Patty Murray, D-WA, reintroduced legislation called Accessible Affordability in the Senate in May that would require health insurance companies to offer over-the-counter oral contraceptives for free.
Biden ordered the US Department of Health and Human Services in June to ensure that all contraceptives approved by the US Food and Drug Administration are available without out-of-pocket costs.
An agency spokesperson said Friday that CMS encourages health insurance to cover over-the-counter birth control products for free. The spokeswoman said the agency is working on ways to ensure that contraceptives approved by the Food and Drug Administration are available for over-the-counter use without sharing costs.
Opill is 93% effective in preventing pregnancy. It is the most effective form of over-the-counter birth control in the United States, and it must be taken at the same time each day to ensure its effectiveness.
Welgren said that 15 million women in the United States who are sexually active and do not want to become pregnant use a method of contraception less effective than Opal or no method of contraception at all.
Nearly half of the six million pregnancies in the United States each year are unintended, according to the Food and Drug Administration. According to the agency, unintended pregnancy is associated with premature birth, which can lead to poor health outcomes for newborns.
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