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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/phexxi-access-to-expand-under-new-government-guidance-stating-insurers-must-cover-fda-approved-contraceptives-with-no-out-of-pocket-costs-to-women-301459089.html
SOURCE Evofem Biosciences, Inc.