OTC Oral Contraceptive Coming in 2024

Oral contraceptives are a safe, affordable, and effective way of preventing pregnancy.

In July 2023, the FDA approved Opill (norgestrel) tablet, the first daily oral contraceptive that will be available for sale in the United States without a prescription. Opill is a new option for individuals who do not have access to a physician and may be the first of many over-the-counter oral contraceptives approved. HRA Pharma, the manufacturer of Opill, is expecting it to be available in the United States in early 2024. Opill, a progestin-only oral contraceptive, will be available over the counter in stores and online. Progestin-only pills, also known as mini-pills, have very few contraindications compared to the majority of oral contraceptives that contain both estrogen and progestin. Opill, when used properly, is safe and effective.

Almost half of all pregnancies in the United States each year are unintended, which have been linked to negative maternal and perinatal outcomes. Research suggests that OTC access would increase the use of contraception, lowering the number of unintended pregnancies. This approval may reduce barriers to access previously seen with prescription-only oral contraceptives. Research also shows that oral contraception generally meets the requirements for the conversion from Rx to OTC:

  • Easily diagnosed
  • Ability to monitor use without clinician screening
  • Low toxicity if overdosed
  • Low potential for abuse or interaction
  • Properties that make it practical for over-the-counter use

HRA Pharma has not released a price and it is unsure if insurance companies will be covering Opill.  According to an article from Planned Parenthood, the typical cost for prescription birth control pills is $0-$50 a month. Insurance plans are not required to cover Opill, and there may be a charge for patients, especially when it is first released. The potential cost of Opill may be a barrier to access for patients, but advocates are pushing the federal government to update the Women’s Preventative Services Guidelines to make all OTC contraceptives available to patients at no charge.

The Affordable Care Act (ACA) requires most private health insurers to provide coverage of women’s preventive services without charging a copayment, including FDA-approved contraceptive methods prescribed by a health care provider. More specifically, 12 states and DC require coverage of methods received over the counter, but the insurer may still require the enrollee to obtain a prescription. Since legislation currently requires coverage for prescription contraceptives at no cost, changes would still be needed to have non-prescribed contraceptives available at no cost.

Because there may be an increased risk of breast cancer or other progestin-sensitive cancers, patients who have or have ever had breast cancer should not use Opill. Currently, Plan B emergency contraception is available OTC. Opill is not intended for use as an emergency contraceptive. Instead, patients should take Opill at the same time every day for pregnancy prevention. It is important for patients to understand this information before purchasing the drug.

 

Posted January 2024

2 responses to “OTC Oral Contraceptive Coming in 2024”

  1. Kyle Spaniol says:

    While I love the idea of oral contraceptives being freely available, I am concerned about the demographic of patients that will turn to OTC oral contraceptives. I’m also concerned with the few but important interactions that contraceptives have with other medications.

    I feel that many teenagers and younger woman will utilize it and many of those patient will also be on treatments for acne, such as doxycycline, and have a false sense of security that they are safe from pregnancy. There is also concern, as you mentioned, with increased risk of breast cancer which is already higher in North America than many other regions.

    • Alan Sekula says:

      Kyle,

      Thanks for reading our blog and providing your comment! We agree that there are both positives and negatives to OTC contraceptives. This appears to us like an area where pharmacists could demonstrate their value and make an impact. Obviously the financials need to be a part of this as well but if patients are avoiding physician copays to obtain OTC contraceptives, the likelihood of paying for pharmacist services in this area feels like a challenge that must be overcome.

      We encourage you to keep reading our posts and please don’t hesitate to send further questions or comments.

      Thanks again,
      The PHSL Team

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