Introduction
In July 2022, Perrigo’s HRA Pharma submitted an software to the Meals and Drug Administration (FDA) to make its progestin-only oral contraceptive (Opill) accessible over-the-counter (OTC). The everyday assessment interval is 10 months. If accredited, it could be the primary day by day oral contraceptive tablet accredited for OTC use accessible within the U.S. Though it’s farther behind within the course of, one other pharmaceutical firm, Cadence, is working towards FDA approval of an OTC model of its mixed oral contraceptive tablet (Zena).
Oral contraceptives are essentially the most generally used technique of reversible contraception within the U.S., and research counsel that OTC entry would enhance use of contraception and facilitate continuity of use along with saving time spent on journey, at a physician’s workplace, and off work. The American Medical Affiliation and the American School of Obstetricians and Gynecologists assist efforts to make an oral contraceptive tablet accessible OTC, with out age restrictions.
This transient presents information from the 2022 KFF Ladies’s Well being Survey (WHS) about reproductive age (18-49) females’ preferences for an OTC contraceptive tablet (N = 4,088). The KFF WHS is a nationally consultant survey that features 5,201 females, performed primarily on-line from Might 10, 2022, to June 7, 2022. The survey covers a number of matters associated to reproductive well being and well-being. See the Methodology part for particulars.
Findings
Greater than three-quarters (77%) of reproductive age females favor making contraception capsules accessible over-the-counter and not using a prescription if analysis confirmed they’re protected and efficient (Determine 1). Fifty-six % strongly favor this coverage and 21% considerably favor it, even when they’d not use this feature themselves. Twelve % of females both considerably or strongly oppose this coverage and 11% didn’t know whether or not they favor or oppose it.
Bigger shares of latest oral contraceptive customers (60%) strongly favor making contraception capsules accessible OTC in comparison with those that haven’t used contraception previously 12 months (52%).
About six in ten (59%) White and Hispanic reproductive age females strongly favor making a contraception tablet accessible OTC if analysis confirmed it’s protected and efficient in comparison with lower than half of Black (44%) and Asian/Pacific Islander females (47%). Larger-income (>= 200% FPL) females (62%) are extra seemingly than low-income (< 200% FPL) females (49%) to say that they strongly favor making contraception capsules accessible OTC.
Two in 5 (39%) reproductive age females can be seemingly to make use of OTC contraception capsules that don’t require a prescription if accredited by the FDA (Determine 2). One in 5 can be very seemingly (19%) or considerably seemingly (20%) to make use of them. Virtually half (46%) say they’d be considerably or most unlikely to make use of them and 14% have no idea.
Curiosity is considerably increased amongst females who at the moment use oral contraceptives. Sixty % of reproductive age females who’ve used contraception capsules previously 12 months mentioned they’d be seemingly or very seemingly to make use of OTC contraception capsules in comparison with 40% of different contraceptive customers and 29% of contraceptive non-users.
A better share of reproductive age Hispanic females (25%) say they’d be very seemingly to make use of OTC contraception capsules if accredited by the FDA than their White counterparts (17%). The share of low-income females who can be very seemingly to make use of OTC contraception capsules is much like the share of higher-income females (20% and 19%, respectively). One in 4 (24%) uninsured reproductive age females can be very seemingly to make use of them in comparison with about one in 5 (18%) of these with non-public medical health insurance. A better share of females residing in city/suburban (20%) are very seemingly to make use of OTC contraception capsules than rural females (13%).
Comfort is the main motive that reproductive age females say they’d be considerably or very seemingly to make use of OTC contraception capsules (59%) (Determine 3). Fifteen % imagine it could be quicker; 8% don’t wish to should have a bodily or pelvic examination; 7% say it could be extra confidential; 6% suppose it could lower your expenses; and three% don’t wish to use their medical health insurance to purchase contraception capsules.
Whereas comfort is the main motive for wanting to make use of an OTC contraception tablet throughout demographic teams, there are some variations inside teams. Almost two-thirds (64%) of higher-income (>= 200% FPL) reproductive age females who say they’d be seemingly to make use of OTC contraception capsules cite comfort as their important motive (Desk 1). One in ten Black females (10%) and people ages 18 to 25 (9%) say their important motive is confidentiality, in comparison with 5% of White females and 4% of females ages 36-49. Sixteen % of uninsured females say they’d be seemingly to make use of OTC contraception capsules primarily as a result of they suppose it could lower your expenses, in comparison with 5% of these with non-public medical health insurance. Amongst reproductive age females seemingly to make use of OTC contraception capsules, one in 5 (20%) with Medicaid say that it could be quicker, in comparison with 13% of these with non-public insurance coverage.
Amongst reproductive age females who say they’d be considerably or most unlikely to make use of OTC contraception capsules and not using a prescription, or who aren’t certain, the bulk (53%) say that the principle motive is as a result of they don’t at the moment use contraception capsules or don’t plan to make use of them sooner or later (Determine 4). Sixteen % say that they would like to speak to a well being care supplier earlier than beginning or refilling contraception capsules; 12% cited security considerations as the principle motive they’d be unlikely to make use of them; 3% mentioned they’d be involved about the fee; and three% can be involved about whether or not their medical health insurance would cowl them.
13 % of reproductive age females who’re unlikely to or unsure if they’d use OTC contraception capsules and not using a prescription report that they’re unlikely to make use of them for another motive; widespread causes embrace that they or their accomplice have had a sterilization process or that they like one other technique.
These estimates change, nevertheless, when reproductive age females who’ve used oral contraceptives previously 12 months and people who have used different strategies of contraception. Amongst oral contraceptive customers who say that they’d be unlikely to make use of an OTC oral contraceptive or aren’t certain, the principle motive is that they like to speak to a supplier earlier than beginning or refilling contraception capsules (46%), adopted by security considerations (20%). Amongst customers of different contraceptive strategies who say that they’d be unlikely to make use of an OTC oral contraceptive or aren’t certain, the principle motive is that they don’t use or plan to make use of contraception capsules (55%), adopted by a choice for speaking to a supplier earlier than beginning or refilling contraception capsules (15%).
Amongst reproductive age females who say they’d be unlikely to make use of OTC contraception capsules and not using a prescription, or who aren’t certain, 17% of these ages 18-25 cite security considerations as the principle motive in comparison with 9% of these ages 36-49 (Desk 2). A bigger share of these ages 18 to 25 (25%) cites a choice to speak to a well being care supplier earlier than beginning or refilling contraception than these ages 36-49 (14%). Seventeen % of Black and Asian/Pacific Islander females say that they’ve security considerations, increased than the share of White females (10%) who’ve the identical concern.
Amongst reproductive age females who report being seemingly to make use of OTC contraception capsules, a plurality (39%) can be prepared and capable of pay as much as $10 per 30 days for them (Desk 3). One-third (34%) can be prepared and capable of pay $11-$20 per 30 days and 16% would pay greater than $20. One in ten (11%) say they’re unwilling or unable to pay something for OTC contraception capsules. At present, most non-public insurance policy and Medicaid are required to cowl the complete price of prescribed contraceptives.
Amongst those that say they’re seemingly to make use of OTC contraception capsules, 15% of oral contraceptive customers say they’d be unwilling or unable to pay something for them, in comparison with 7% of contraceptive non-users. Almost one in 5 (21%) uninsured females would pay greater than $20 per 30 days. Notably, there aren’t any statistically vital variations by revenue degree.
Wanting Ahead
There’s broad assist amongst females for an OTC oral contraceptive tablet, and plenty of are seemingly to make use of it. Nonetheless, seemingly customers are cost-sensitive, with the bulk prepared and capable of pay not more than $20 per 30 days for it and a few not prepared or capable of pay something for it.
On the federal degree, the Reasonably priced Care Act requires most non-public medical health insurance plans to cowl FDA-approved contraception for ladies; nevertheless, it have to be prescribed to ensure that it to be coated. The latest steering about ACA implementation, issued by the Departments of Labor and Well being and Human Providers, and the Treasury in July 2022, states that plans and issuers are inspired to cowl OTC emergency contraceptive merchandise with no price sharing when they’re bought and not using a prescription, however the steering doesn’t at the moment require it.
On the state degree, 9 states at the moment require well being plans regulated by the state, together with fully-insured employer plans and particular person plans, to cowl OTC contraceptive drugs with out price sharing, and and not using a prescription from a well being care supplier (three of these state legal guidelines apply to emergency contraception solely). Whereas no-cost protection of prescription contraceptives has been required beneath Medicaid for many years, solely six states and DC report protecting OTC emergency contraception and not using a prescription of their Medicaid applications.
The pharmaceutical firm that submitted an FDA software to modify from prescription-to-OTC standing has not but made value info publicly accessible. Along with the retail price, which will likely be an essential consideration for these not utilizing insurance coverage, ought to a day by day oral contraceptive tablet turn into accessible OTC, accessibility and uptake may also rely on whether or not non-public medical health insurance and Medicaid cowl it and not using a prescription.
Except for the fee points, many reproductive age girls say they’d nonetheless choose to speak to a well being care supplier earlier than beginning or refilling contraception and others say they’d nonetheless have security considerations. These findings point out that outreach and training may also play an essential function in serving to girls perceive their choices in utilizing an OTC oral contraceptive tablet ought to the FDA approve the change in standing.
This work was supported partly by Arnold Ventures. KFF maintains full editorial management over all of its coverage evaluation, polling, and journalism actions.