Evofem Biosciences Inc. (NASDAQ: EVFM) has applauded the United States Department of Labour and Health Resources and Services Administration (HRSA) for issuing updated contraceptive access guidance separately.
Insurers and PBMs should cover FDA-approved contraceptives
According to the new guidance, most pharmacy benefit managers (PBMs) and insurers must cover US FDA-approved contraceptive products prescribed by healthcare providers, such as Phexxi (lactic acid, citric acid, and potassium bitartrate), with no out-of-pocket costs for women. Phexxi, the company’s first FDA-approved contraceptive product, is a hormone-free, on-demand prescriptive contraceptive vaginal gel. It is administered 0-60 minutes before every act of sex and arrives in a package of 12 pre-filled applicators. In addition, Evofem is also creating and commercializing novel product candidates addressing women’s reproductive and sexual health needs.
CEO of Evofem Biosciences Saundra Pelletier said, “We believe this is a huge step forward toward ensuring contraceptive access for all women at zero copays under the Affordable Care Act (ACA), further reducing unintended pregnancies in the US, and helping women get access to Phexxi, an innovative hormone-free birth control. As a result, we anticipate that millions more women will be able to access Phexxi at no cost —without overly burdensome denials or being forced to try other products first.”
As per the HRSA’s Women Preventive Services Guidelines, the complete range of US FDA-approved, cleared, or authorized contraceptive products, effective family planning methods, and sterilization practices should be accessible pursuant to the contraceptive care. Equally, the guidelines provided for contraceptives are listed under the FDA’s Birth Control Guide and any other FDA granted, approved, or cleared contraceptives.
New guideline providers for no out of pocket pay for contraceptive
However, according to the US Department of Labor’s update, plans should cover any FDA-cleared, granted, or approved contraceptive provided the provider considers it medically necessary at no out-of-pocket costs irrespective of whether it is or not identified under the present FDA Birth Control Guide. Also, plans should not require patients to fail or try several options within a procedure or force failing or trying other methods, provided the provider considers them medically necessary.