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Around the nation: FDA approves orally dissolving birth control pill


FDA has approved the first orally dissolving birth control pill called Femlyv, in today's bite-sized hospital and health industry news from Maryland, Missouri, and Virginia.  

  • Maryland: Last week, FDA approved the first orally disintegrating birth control pill, which is called Femlyv. "Femlyv is the first FDA approved dissolvable birth control pill, designed for individuals who have trouble swallowing their medication," said Janet Maynard, director of the Office of Rare Diseases, Pediatrics, Urologic, and Reproductive Medicine at FDA's Center for Drug Evaluation and Research. "There are many variables that might cause someone to have difficulty swallowing. This drug provides another treatment option and expands access to this form of contraception for individuals who may have experienced those challenges." Femlyv has been indicated for females of reproductive potential, though the efficacy for individuals with a body mass index greater than 35 has not been established. To use the product, patients should let the tablets dissolve on their tongue before drinking 8 oz of water. (Robertson, MedPage Today, 7/24)
  • Missouri: According to a federal audit, Express Scripts, one of the largest pharmacy benefit managers in the United States, overcharged the U.S. Postal Service (USPS) employees by $45 million during a five-year period. The audit examined drug spending between 2016 and 2021 in the health plan used by more than 200,000 USPS workers, including retirees. Almost half of the overcharges were linked to drug rebates Express Scripts negotiated with pharmaceutical companies. In addition, $16 million of these overcharges were linked to drug rebates kept by Ascent Health Services, which shares the same parent company as Express Scripts, Cigna. In response, Cigna said it disagreed with the audit's findings and had "secured $400 million" in prescription drug savings for post workers since 2016. "In our commitment to transparency, we worked with the OIG [Office of Inspector General] auditors in good faith to show our compliance with our contract, and we do not believe the report accurately reflects the value of the pharmacy services we provided for the nearly 100,000 employees and retired workers enrolled in the American Postal Workers Union Health Plan," said Cigna spokesperson Justine Sessions. (Herman/Silverman, STAT+ [subscription required], 7/22)
  • Virginia: According to a study presented at the American Society of Clinical Oncology's annual meeting, the HPV (human papillomavirus) vaccine has helped significantly reduce the number of head and neck cancers in adolescent boys and men. Although HPV is primarily associated with cervical cancer, it has also been linked with other cancers, including oropharyngeal cancers. In the study, researchers compared EHR data for around 1.7 million patients who received the HPV vaccine with a similar number of age-matched control patients who were not vaccinated. Overall, vaccinated men had 3.4 cases of HPV-linked cancer per 100,000 patients compared to 7.5 per 100,000 unvaccinated men. In addition, vaccinated women had 11.5 cases per 100,000 patients compared to 15.8 per 100,000 unvaccinated women. "We want males to be thinking about HPV vaccination not just as something that protects female patients, but also male patients," said Jefferson DeKloe, a research fellow in the department of otolaryngology at Thomas Jefferson University and one of the study's authors. (Sullivan, NBC News, 5/23; Herper, STAT, 5/23)

Top drivers of change in the maternal and reproductive health market

Maternal and reproductive healthcare is rapidly changing. Health leaders must grapple with worsening maternal health disparities, the nationwide maternal mental health crisis, lasting impacts of the Dobbs v. Jackson  ruling, and the rise of femtech disruptors.  Download our report to learn about four key drivers reshaping maternal and reproductive healthcare delivery.


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