Agile Therapeutics, Inc., (Nasdaq: AGRX), a women's healthcare
company, today provided an update on the actions being taken to
strengthen the Affordable Care Act’s (ACA) no-cost contraceptive
coverage requirement.
Following several months of focus by the Biden Administration
and lawmakers on contraception and reproductive healthcare access
barriers, the House Committee on Oversight and Accountability
issued a new report addressing the topic: Revised Federal Guidance
Regarding Contraceptive Coverage Could Benefit Millions of Women1.
The report highlights the continued barriers to contraceptive care
and inequalities that continue to impact women’s freedom to access
the contraceptive that is best for them.
“We appreciate the continued hard work of the
Administration to ensure all women have access to contraceptive
care without barriers and cost-sharing,” said Agile Therapeutics
Chairperson and Chief Executive Officer Al Altomari. “We look
forward to seeing the outcomes of this work result in meaningful
changes that eliminate the challenges patients and providers face
in accessing reproductive healthcare.”
The Company commends Rep. Jamie Raskin for his efforts to ensure
that women have the healthcare and contraception that they need.
Key highlights from the new report include:
- The report reinforces the urgent
need for revisions to federal guidance. By implementing the
Committee’s proposed guidance revisions, the Tri-Departments could
potentially ensure that 49 million women of reproductive age have
increased access to no-cost contraception.
- The report is a follow-up to,
Barriers to Birth Control: An Analysis of Contraceptive Coverage
and Costs for Patients with Private Insurance2, in which a House
Committee investigation found that insurers and PBMs consistently
imposed exclusions or cost-sharing requirements for contraceptive
products.
- The previous investigation resulted
in a recommendation that the administration update guidance to
address coverage gaps by requiring that all contraceptives without
a therapeutic equivalent (generic) are covered on plan formularies.
This would ensure that all people have access to the most
appropriate contraceptive products without out-of-pocket payment,
as required by the ACA.
This new report follows several recent noteworthy efforts from
the Biden Administration and lawmakers to strengthen access to
contraception as defined in President Biden’s June 23, 2023,
Executive Order: Strengthening Access to Contraceptives3. Recent
efforts include:
After an investigation led by the state finding systemic
non-compliance with contraceptive coverage requirements, Vermont
Lawmakers requested the Administration provide additional oversight
and enforcement of the ACA Contraceptive requirements to ensure
health plans and PBMs are following federal and state
guidance.
- In a November 16, 2023, letter4 to
the Secretaries of the Departments responsible for implementation
of the ACA contraceptive coverage requirements; the Congressional
leaders from Vermont, Senators Bernie Sanders and Peter Welch and
Representative Becca Balint, requested information from the
Departments regarding its efforts to enforce the Affordable Care
Act’s (ACA) no-cost contraceptive coverage requirement.
- The letter highlighted a recent
state investigation that found three insurers in Vermont—BCBS VT,
MVP Health Care, and Cigna Healthcare—had failed to provide
patients with no-cost contraceptive services in violation of state
and federal law and resulted in required restitution of almost
$1.5M in inappropriate costs charged to consumers.
The Biden Administration convened several meetings to
discuss efforts to ensure robust implementation of the President’s
Executive Order on Strengthening Access to Contraceptive
Care.
- On October 27, 2023, the White
House convened private sector leaders to discuss efforts to
ensure access to affordable, high-quality contraception5.
Administration leaders emphasized the importance of continuing to
build on the progress that has been made under the ACA. These
efforts include robust implementation of the President’s third
Executive Order on reproductive health care access, issued in June
2023, which directed federal agencies to “ensure coverage of
comprehensive contraceptive care, including all contraceptives
approved, granted, or cleared by the Food and Drug Administration
(FDA), without cost sharing for enrollees, participants, and
beneficiaries.”
- On November 8, 2023, the U.S.
Department of Health and Human Services (HHS) Secretary Xavier
Becerra6, hosted a roundtable to hear directly from researchers on
the ground about barriers to contraception care in the aftermath of
the Dobbs Decision, and reaffirm commitment to expanding access to
contraception. This roundtable marked the fourth meeting in a
series hosted by the Secretary’s Task Force on Reproductive
Health.
Agile Therapeutics thanks the Administration for
its continued efforts and directing the Secretaries to consider
actions, to the greatest extent permitted by law, that will ensure
coverage of comprehensive contraceptive care including all
contraceptives approved, granted, or cleared by the Food and Drug
Administration, without cost sharing for enrollees, participants,
and beneficiaries.3
1 Staff Analysis: Revised Federal Guidance Regarding
Contraceptive Coverage Could Benefit Millions of Women. December 8,
2023 House Committee Contraceptive Guidance Staff Analysis
December 2023
2 Staff report House Committee on Oversight and Reform, October
22, 2022, House Oversight and Reform Report October 2022 Barriers
to Contraception
3 President Biden Executive Order June 23,2023
Executive-order-on-strengthening-access-to-affordable-high-quality-contraception-and-family-planning-services
June 23, 2023
4 Sanders B, Welch P, Balint B, November 16, 2023 Delegation
letter on VT Contraceptive investigation
5 Readout of White House Meeting on Increasing
Contraception Access and Affordability, October 27,2023, Readout
White House Report October on Contraceptive Access October 27
2023.
6 Readout of HHS Secretary Becerra’s Roundtable on Contraception
Access, November 8, 2023 Readout HHS Roundtable on Contraception
November 8 2023
About Agile
Therapeutics, Inc.Agile
Therapeutics is a women's healthcare company dedicated to
fulfilling the unmet health needs of today’s women. Our product and
product candidates are designed to provide women with contraceptive
options that offer freedom from taking a daily pill, without
committing to a longer-acting method. Our initial product, Twirla®,
(levonorgestrel and ethinyl estradiol), a transdermal system, is a
non-daily prescription contraceptive. Twirla is based on our
proprietary transdermal patch technology, called Skinfusion®, which
is designed to allow drug delivery through the skin. For more
information, please visit the company website at
www.agiletherapeutics.com. The Company may
occasionally disseminate material, nonpublic information on the
Company’s website, Twitter account (@agilether), and LinkedIn
account.
About Twirla®Twirla
(levonorgestrel and ethinyl estradiol) transdermal system is a
once-weekly combined hormonal contraceptive (CHC) patch that
contains the active ingredients levonorgestrel (LNG), a type of
progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla
is indicated for use as a method of contraception by women of
reproductive potential with a body mass index (BMI) < 30 kg/m2
for whom a combined hormonal contraceptive is appropriate.
Healthcare providers (HCPs) are encouraged to consider Twirla’s
reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before
prescribing. Twirla is contraindicated in women with a BMI ≥ 30
kg/m2. Twirla is also contraindicated in women over 35 years old
who smoke.Cigarette smoking increases the risk of serious
cardiovascular events from CHC use. Twirla is designed to be
applied once weekly for three weeks, followed by a week without a
patch.
Forward-Looking
StatementsCertain information contained in this
press release includes “forward-looking statements”, within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
We may, in some cases use terms such as “predicts,” “believes,”
“potential,” “continue,” “anticipates,” “estimates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “likely,” “will,”
“should” or other words that convey uncertainty of the future
events or outcomes to identify these forward-looking statements.
Our forward-looking statements are based on current beliefs and
expectations of our management team that involve risks, potential
changes in circumstances, assumptions, and uncertainties, including
statements regarding potential impact of and response to the recent
report by the House Committee on Oversight and Accountability
including, but not limited to the potential increase in access to
no cost contraception. Any or all of the forward-looking statements
may turn out to be wrong or be affected by inaccurate assumptions
we might make or by known or unknown risks and uncertainties. These
forward-looking statements are subject to risks and uncertainties
including risks related to the likelihood that the Tri-Agencies
will issue revised guidance regarding ACA implementation, the
response of commercial payors to any revised guidance that is
ultimately issued, our ability to successfully enhance the
commercialization of and increase the uptake for Twirla, the size
and growth of the markets for Twirla and our ability to serve those
markets our strategy, business plans and focus, and the other risks
set forth in our filings with the U.S. Securities and Exchange
Commission, including our Annual Report on Form 10-K and our
Quarterly Reports on Form 10-Q. For all these reasons, actual
results and developments could be materially different from those
expressed in or implied by our forward-looking statements. You are
cautioned not to place undue reliance on these forward-looking
statements, which are made only as of the date of this press
release. We undertake no obligation to publicly update such
forward-looking statements to reflect subsequent events or
circumstance.
Contact:Matt RileyHead of Investor Relations
& Corporate
Communicationsmriley@agiletherapeutics.com
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