The market for oral contraception is being turned upside-down as Perrigo has begun shipping Opill to thousands of retail stores nationwide, to be sold as the first over-the-counter birth control pill in the U.S.
The FDA approved Opill July 2023 as an OTC birth control option for patients 18 and older. Perrigo did not publicly release sales projections for the product, and The Motley Fool reported last July that the company is “quite unlikely” to generate $110 million per quarter—the value needed to “make a significant dent” in overall company revenues.
The current U.S. prescription birth control pill market is likely worth about $3 billion a year, Fady Boctor, president and CEO of men’s health company Petros Pharmaceuticals, estimated based on data showing that pills represent 37% of the $8 billion contraceptive market at large in the country.
For now it remains unclear how much money the new OTC option will siphon away from prescription contraceptives. “It will be interesting to see how does this over-the-counter access increase utilization” of oral contraception, Boctor told BioSpace.
The First OTC Birth Control Pill in the US
Opill is a daily tablet that contains 0.075 mg of norgestrel, a synthetic version of progesterone whose efficacy as a contraceptive was first established with the FDA’s 1973 approval of Pfizer’s Ovrette. Clinical trials showed Opill to be 98% effective at preventing pregnancy when taken as directed.
While Opill is the first OTC option in the U.S., it may not be the only one for long. Cadence OTC has an application in to make its Zena combination oral contraceptive over-the-counter. “The expectation is that [Opill] is just the first one,” said Robyn Elliott, an Annapolis, Md.–based healthcare lobbyist who consults for women’s health advocacy campaign Free the Pill. While no other companies have publicly disclosed their intentions to seek FDA approval at this time, “what is available over the counter in many, many other countries is a wide range of birth control pills. We would expect to see in the future more consideration of other options over the counter," Elliott told BioSpace.
Historically, therapeutic classes have transformed from prescription-only to majority-OTC within a decade, noted David Spangler, senior vice president for legal, government affairs and policy at the Consumer Healthcare Products Association (CHPA). He said it took about four years for OTC to dominate the non-drowsy oral antihistamine market—think Claritin, Zyrtec and Allegra—and more than six years for steroid-based nasal allergy sprays like Flonase, Nasonex and Nasocort to make the transition. Heartburn drugs made the switch over a similar timeframe.
“Here [with birth control], you don’t know exactly how fast you’ll see other switches because the molecule matters,” Spangler told BioSpace.
Opill includes only norgestrel, a progestin, but no estrogen. Fortune Business Insights reported in 2018 that the majority of those on the pill worldwide chose combined progestin-estrogen options. Combination pills have different risk-benefit profiles than progesterone-only, Spangler said.
Boctor noted that due to its contraindications, a combination pill containing estrogen might necessitate consideration of a patient’s medical history, something that might slow the transition of the whole oral birth control market to OTC.
The Future of the Birth Control Pill Market
According to Statista, in 2022, 15% of U.S. adults who used contraception in the previous month chose oral birth control. But to this point, it has not been available without a prescription.
OTC conversions have boosted overall usage in other therapeutic classes by eliminating the time and cost needed to see a physician to obtain that prescription, not to mention potentially uncomfortable conversations about certain health conditions, Spangler said. But Boctor noted that Opill—along with anti-opioid treatment Narcan, which was approved for OTC sales a year ago—represent a “new horizon” of first-in-class compounds to make the OTC transition.
It has taken since approval last summer for Perrigo to ramp up manufacturing and distribution so Opill could appear on retail shelves, so it is too early to gauge sales. A representative from CVS Health told BioSpace that it began selling Opill through its website and CVS Pharmacy app on March 21 and is beginning to offer it in more than 7,500 stores nationwide this month. Other large retailers are also rolling it out.
Price may be a barrier for some Americans, however. Opill has a suggested retail price of $19.99 for a one-month pill pack, $49.99 for three months and $89.99 for a six-month supply containing 168 doses, according to Drugs.com, and no commercial insurer currently covers Opill unless legally required to, Verda Hicks, president of the American College of Obstetricians and Gynecologists, said in a statement. Free the Pill counts eight states that require insurance companies to cover OTC contraception. Not on the list is Wisconsin, where officials announced last month that the state’s ForwardHealth and BadgerCare Plus Medicaid programs will cover Opill, but no other carriers have announced coverage other than in the eight states with statutory mandates.
Perrigo said that it will soon launch a cost-assistance program to help uninsured and low-income Americans receive Opill for free, but the company is leaning on insurers to cover the product. “Perrigo strongly supports efforts to expand coverage for all OTC contraceptives, including Opill, under the Affordable Care Act,” Triona Schmelter, executive vice president of Perrigo and president of the Irish company’s consumer self-care division for the Americas, told BioSpace in an email.
https://www.biospace.com/article/birth-control-market-evolves-as-otc-opill-hits-us-stores/
