Phexxi Access to Expand under New Government Guidance Stating Insurers Must Cover FDA-approved Contraceptives with No Out-of-Pocket Costs to Women

Rhea-AI Summary

Evofem Biosciences (NASDAQ: EVFM) applauds recent guidance from HRSA and the U.S. Department of Labor, mandating coverage for FDA-approved contraceptives, including its product Phexxi, with no out-of-pocket costs for women. This guidance aims to enhance access to contraceptives under the Affordable Care Act, potentially benefiting millions of women. CEO Saundra Pelletier emphasized the positive impact on reducing unintended pregnancies and improving women's access to hormone-free birth control. The comprehensive coverage includes all FDA-approved contraceptives deemed medically necessary by healthcare providers.

Positive

• New HRSA and Department of Labor guidance mandates $0 cost coverage for FDA-approved contraceptives, including Phexxi.
• Increased access for millions of women could reduce unintended pregnancies in the U.S.

Negative

• None.

SAN DIEGO, Jan. 12, 2022 /PRNewswire/ -- Evofem Biosciences, Inc. (NASDAQ: EVFM) today commended the Health Resources and Services Administration (HRSA) and the U.S. Department of Labor on their separately-issued updated guidance related to contraceptive access. 

The new guidance specifies that most insurers and pharmacy benefit managers (PBMs) must provide coverage, with no out-of-pocket costs to women, for U.S. Food and Drug Administration (FDA)-approved contraceptive products, like Phexxi® (lactic acid, citric acid and potassium bitartrate), prescribed by healthcare providers.

"We believe this is a huge step forward toward ensuring contraceptive access for all women at zero copay under the Affordable Care Act (ACA), further reducing unintended pregnancies in the U.S., and helping women get access to Phexxi, an innovative hormone-free birth control," said Saundra Pelletier, CEO of Evofem Biosciences. "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."

Under the HRSA Women's Preventive Services Guidelines:

• The full range of FDA- approved, -granted, or -cleared contraceptives, effective family planning practices, and sterilization procedures should be available as part of contraceptive care; and,
• The full range of contraceptives includes those currently listed in the FDA's Birth Control Guide and any additional contraceptives approved, granted, or cleared by the FDA.

Under the U.S. Department of Labor FAQ update: 

• Plans are required to cover an FDA- approved, cleared, or granted contraceptive, if a provider deems it medically necessary, at $0 cost share, whether or not it is specifically identified in the current FDA Birth Control Guide.
• Plans may not require patients to try and fail multiple options within a method, or force trying and failing other methods, if a provider deems a product medically necessary

The Department of Labor also established clear communications channels for consumers with concerns about their plan's compliance with HSRA requirements. 

About Evofem Biosciences
Evofem Biosciences, Inc., (NASDAQ: EVFM) is developing and commercializing innovative products and product candidates to address unmet needs in women's sexual and reproductive health, including hormone-free, woman-controlled contraception and protection from certain sexually transmitted infections (chlamydia and gonorrhea). The Company's first FDA-approved product, Phexxi® (lactic acid, citric acid and potassium bitartrate), is a hormone-free, on-demand prescription contraceptive vaginal gel. It comes in a box of 12 pre-filled applicators and is applied 0-60 minutes before each act of sex. Learn more at phexxi.com and evofem.com. 

Phexxi® is a registered trademark of Evofem Biosciences, Inc.

Forward-Looking Statements
This press release includes "forward-looking statements," within the meaning of the safe harbor for forward-looking statements provided by Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements other than historical facts and relate to future events or circumstances and the Company's future performance. These statements include, without limitation, the anticipated future impact of the new guidance from HSRA and Department of Labor, including any potential increased access to and implied demand for Phexxi. These statements and estimates are based on management's current assumptions, expectations and beliefs concerning future developments and their potential effect on the Company's business. You are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Various factors could cause actual results to differ materially from these estimates and those discussed or implied in the forward-looking statements, including market and other conditions and the Company's ability to obtain capital when and as needed to continue its ongoing operations. Other important factors that could cause actual results to differ materially from those discussed or implied in the forward-looking statements, or that could impair the value of Evofem Biosciences' assets and business, are disclosed in the Company's SEC filings, including its Annual Report on Form 10-K for the year ended December 31, 2020, filed with the SEC on March 4, 2021 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, filed with the SEC on November 15, 2021. All forward-looking statements are expressly qualified in their entirety by such factors. The Company does not undertake any duty to update any forward-looking statement except as required by law.

Investor Contact
Amy Raskopf
Evofem Biosciences, Inc.
araskopf@evofem.com
Mobile: (917) 673-5775

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SOURCE Evofem Biosciences, Inc.

FAQ

What recent guidance affects Evofem Biosciences (EVFM)?

The recent HRSA and U.S. Department of Labor guidance requires insurers to cover FDA-approved contraceptives at no out-of-pocket cost.

How does the new guidance impact access to Phexxi for women?

The guidance is expected to improve access to Phexxi, allowing women to obtain it without copays or restrictions on trying other methods.

What is Phexxi and how is it related to the new contraceptive guidance?

Phexxi is an FDA-approved hormone-free contraceptive from Evofem, which will be covered without cost-sharing thanks to the new guidance.

When was the guidance on contraceptive coverage announced?

The guidance was announced on January 12, 2022.

What is the significance of the HRSA Women's Preventive Services Guidelines for Evofem?

The guidelines ensure that FDA-approved contraceptives must be available as part of contraceptive care, directly benefiting Evofem's Phexxi.