America's first over-the-counter birth-control pill adds to expensive and sometimes unreliable options for women

By Zoe Han

'We cannot take away access to abortion care without adequately offering pregnancy-prevention care,' one health advocate said

Starting next year, women in the U.S. will for the first time be able to buy oral contraceptives without a prescription -- at pharmacies, convenience stores, grocery stores and from online retailers -- after the Food and Drug Administration on Thursday approved the over-the-counter sales of Opill.

The approval means many women will be able to avoid the time and expense of visiting a doctor to get a prescription for birth control. It will also help expand birth-control access after the Supreme Court struck down the right to abortion that women had under Roe v. Wade, policy experts say.

"In many of the states that now prohibit abortion care, there are also many people who cannot access contraceptive care," said Adrienne Ton, health director of clinical operations at TBD Health, a sexual-healthcare company based in Stamford, Conn.

She cited challenges in getting access to birth control, including access to a trusted healthcare provider, the cost of care, insurance status, wait times and even fear of a domestic partner. "The barriers can be more complex for those under 18, so this is a huge win for teens especially," she added.

When used as directed, oral contraceptives are safe and would be the most effective birth-control option available over the counter, Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

Condoms, which are currently the most common over-the-counter birth-control option, are less effective than birth-control pills, with a failure rate of 18%, compared with 9% for the pill, according to the American College of Obstetricians and Gynecologists.

Opill: cost and access

Perrigo Co. (PRGO), the manufacturer of Opill, said it will be available in early 2024, and price information will be released in the coming months. The accessibility of Opill will also depend on whether the drug will be covered by insurance companies: Currently, private health-insurance plans are generally not required to cover nonprescription FDA-approved contraceptives.

The cost of birth-control pills ranges from nothing to $50 a month, depending on a person's insurance coverage, according to Planned Parenthood, an organization that supports access to abortion services and birth control. According to GoodRx Health, the average annual out-of-pocket cost for birth-control pills is approximately $268.

As the only over-the-counter option, Opill may not be the cheapest birth-control pill on an annual basis, according to GoodRx Health and Planned Parenthood.

Until now, the most effective contraceptive options required a prescription or a visit to a doctor's office. Those include birth-control pills, patches and rings; intrauterine devices; and implants.

Under the 2010 Affordable Care Act, most insurance plans are required to cover the full cost of birth control for women without charging out-of-pocket fees -- but 41% of women of reproductive age were not aware of that, according to health-policy research organization KFF.

Accessing insurance can be fraught

There are many reasons a young woman might choose not to use insurance for Opill, assuming it's eventually covered by insurance.

An adolescent who needs birth control may not have access to transportation to see the reproductive-healthcare provider and, therefore, over-the-counter access may be easier and more affordable, said Anne-Marie Amies, chair of the Clinical Consensus Committee on Gynecology at the American College of Obstetricians and Gynecologists.

Privacy is also a factor. "We support adolescent confidentiality, but even with state and federal laws surrounding patient privacy, it is hard to keep the fact that a clinic visit happened private when insurance explanations of benefits are mailed home," Amies added.

Other birth-control options

IUD: The device needs to be inserted by a doctor or a nurse. For those without insurance, it can cost more than $1,000; with insurance, the cost ranges from $0 to about $56. Hormonal IUDs must be replaced every 3 to 6 years, while copper devices last up to 10 years.

Implant: This small, rodlike implant releases hormones that prevent pregnancy. It must be implanted into a person's arm by a healthcare provider and it lasts three to four years. It costs up to $1,300 without insurance; with insurance, the out-of-pocket cost is about $91, or about $30 per year.

Vaginal ring: This is another hormone-based contraceptive. A soft plastic ring that is placed inside the vagina, it can be purchased at a pharmacy, but it requires a prescription. It must be replaced every month. While insurance typically covers the full price, the annual cost can still be more than $400, depending on the individual insurance plan. Without insurance, it can cost more than $2,000 a year, or about $167 per month.

Patch: The patch contains estrogen and progestin and can be obtained at a pharmacy with a prescription; like the vaginal ring, it must be replaced monthly. It may be fully or partially covered by insurance, with an annual cost up to $88; without insurance, the cost can be as much as $560 annually.

Injection: The shot, which contains progestin, can be injected by a doctor or nurse or by the user at home. It lasts for 3 months. Without insurance, the annual cost can be as much as $245.

Surgical sterilization: Two common surgeries provide a permanent form of birth control: tubal ligation for women and vasectomy for men. Without insurance, tubal ligation can cost up to $6,000, whereas vasectomy costs around $1,000. With insurance, the out-of-pocket cost can be around $114 for tubal ligation and $327 for vasectomy.

The state of birth control in the U.S.

The reliability of different forms of contraceptives varies considerably. "Birth-control pills are among the most effective types of birth control, alongside the ring, the shot and the patch, as well as intrauterine devices and the implant -- the two most effective options," said Megan N. Freeland, director of health communications at the Planned Parenthood Federation of America.

But it's helpful to have additional over-the-counter options, she added. "Because each person has different needs, priorities, and wants -- all of which can change at different times in their lives -- the more safe and effective birth control options available and accessible, the better," Freeland said.

In addition to providing easier access to birth control, legal protections, better health education and improved access to healthcare providers -- whether in-person or virtual -- are all critical for contraceptive healthcare, health advocates say.

In June 2022, the Supreme Court overturned its 1973 Roe v. Wade decision, saying access to abortion and pregnancy care were for states to decide. More than a dozen states have since banned abortion, and other states have put various restrictions on the abortion services and related care. Supreme Court justices have also suggested that other decisions -- such as one that prohibits states from banning birth control -- could also be overturned.

Abortion care and pregnancy prevention go hand in hand, and access to contraception is especially important now that many people do not have access to abortion care, reproductive health experts say. Nine in 10 women aged 18 to 64 have used contraception at some point during their reproductive years, according to KFF, a nonprofit health-policy research organization.

"As a society, we cannot take away access to abortion care without adequately offering pregnancy-prevention care and social support for people with children," Ton said.

Eleanor Laise and Quentin Fottrell contributed.

-Zoe Han

This content was created by MarketWatch, which is operated by Dow Jones & Co. MarketWatch is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

07-29-23 0956ET

Copyright (c) 2023 Dow Jones & Company, Inc.