Preventing unintended pregnancies with an OTC progestin-only pill

“Previous models had attempted to estimate the potential impact of a prescription (Rx)-to-OTC switch of an oral contraceptive on the number of unintended pregnancies in the U.S.,” said co-author Helene Guillard, PharmD, global Rx-to-OTC switch director at HRA Pharma, headquartered in Paris, France, which is the company that sponsored the clinical study on which the model is based, as well as the sponsor of an application that was submitted earlier this year to the U.S. Food and Drug Administration (FDA) to request a change of its POP minipill Opill from Rx to OTC.

“Our model is unique because it uses data on the contraceptive method mix used by women who chose to purchase and use a POP in a simulated OTC setting in an actual-use trial2 at the time they agreed to participate in our study,” Guillard told Contemporary OB/GYN. “This population likely best represents the potential actual users of an OTC POP. By using this data and varying the inputs, our model demonstrates the magnitude of the potential impact for the population who would choose to use an OTC POP.”

Employing standard typical use failure rates, including 7% for POPs, the investigators compared the expected number of unintended pregnancies for two theoretical cohorts of 100,000 women. The first cohort used an OTC POP exclusively for contraception, whereas the second cohort used contraceptive methods at the same percentages obtained from the actual-use clinical trial simulating OTC use of norgestrel 0.075 mg.

Overall, 35% of individuals in the latter cohort used no method, compared to only 19% using hormonal contraception or long-acting contraceptives.

Sensitivity analyses were conducted using alternative model inputs, like different failure rates for OTC POPs and an alternative contraceptive method mix.

An estimated 37,624 unintended pregnancies would occur annually if 100,000 women continued their usual contraceptive method.

However, this estimate would be reduced by 81%, or to 7,000 pregnancies total, by solely using an OTC POP, for a net reduction of 30,624 unintended pregnancies annually.

“It may surprise some clinicians that even with the most conservative model inputs, there is still a demonstrated benefit of a reduced number of unintended pregnancies with the use of an OTC POP, compared to what women currently use,” Guillard said. “Clinicians also need to realize that 90% of the pregnancies prevented by the use of an OTC POP in the model occurred among women previously using either no contraception or one of the least effective methods.”

The study’s main outcome – a reduction in the overall number of unintended pregnancies – remains true across a wide range of modeled scenarios, including with the most conservative inputs, according to Guillard.

The number of unintended pregnancies prevented varied from 1,461 to 34,124 yearly as the model parameters were modified.

“The potential benefit to individuals and overall public health by a reduction in unintended pregnancies, as suggested by the estimates in our model, supports an OTC switch for a POP,” Guillard said.

Guillard is an employee of HRA Pharma.

References

1. Guillard H, Laurora I, Sober S, et al. Modeling the potential benefit of an over-the-counter progestin-only pill in preventing unintended pregnancies in the U.S. Contraception. Published online October 15, 2022. doi:org/10.1016/j.contraception.2022.10.006

2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT04112095, Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS); https://clinicaltrials.gov/ct2/ show/NCT04112095