Viewpoints from Sarah Fleming, PharmD
For over two decades, hormone replacement therapy (HRT) has been shadowed by cautionary tales and black box warnings. These warnings – rooted in early interpretations of the Women’s Health Initiative (WHI) – have shaped prescribing habits, patient perceptions, and even formulary decisions. But today, we stand at a pivotal moment in women’s health: it’s time to rethink how we prioritize HRT.
The WHI and the Black Box Warning
The WHI study, published in 2002, raised alarms about increased risks of breast cancer, stroke, and cardiovascular events associated with estrogen therapy. The U.S. Food and Drug Administration (FDA) responded with a black box warning in 2003 that has since discouraged both clinicians from prescribing and women from taking HRT – even when clinically appropriate [1].
However, the nuance was lost in translation. The WHI primarily studied older women, many years post-menopause, using high-dose equine estrogen and synthetic progestin therapy. These hormones, used in the WHI study, are rarely prescribed anymore. Additionally, the risks identified do not necessarily apply to younger women initiating HRT near the onset of menopause or those using the modern standard: low-dose, bioidentical estrogen and progestin [2].
Emerging Evidence and Clinical Reassessment
Recent data and expert consensus have begun to shift the narrative:
- In July 2025, the FDA hosted the FDA Expert Panel on Menopause and Hormone Replacement Therapy for Women. The panel convened leading experts in gynecology, endocrinology, neurology, and sexual medicine to reassess the safety, labeling, and clinical use of hormone replacement therapy (HRT) for menopausal women. The focus was on modernizing guidance and addressing outdated warnings that may limit access to effective care.
- A 2023 review published in Circulation emphasized that HRT can be safely administered depending on age, time since menopause, and cardiovascular risk profile [3].
- The North American Menopause Society (NAMS) 2022 Position Statement confirms that HRT remains the most effective treatment for vasomotor symptoms and genitourinary syndrome of menopause (GSM), especially for women under 60 or within 10 years of menopause onset [4].
- The Endocrine Society also supports individualized HRT use, noting that benefits outweigh risks for recently menopausal women without contraindications [5].
It appears a change is imminent. Currently, the FDA is in active review of the black box warning that has been in place since 2003 for all estrogen therapies used to treat menopause symptoms. The FDA commissioner stated publicly that the agency is in “serious discussions” and that an announcement is expected soon.
Why Prioritization Matters
Pharmacists are uniquely positioned to bridge the gap between evidence and practice. Rethinking HRT prioritization means:
- Empowering patients with accurate, up-to-date information.
- Supporting prescribers in making confident, individualized decisions.
- Advocating for access to safe and effective therapies, especially in underserved populations.
- Revisiting formularies and coverage policies that may be misaligned with current science.
Pharmacists also play a key role in counseling patients about risks, benefits, and delivery methods of HRT, including systemic vs. local therapies [2]. Pharmacists help patients navigate outdated messaging and make informed choices based on their unique health profiles.
Actionable Strategies for Benefits Leaders
Benefits leaders evaluating hormone replacement therapy (HRT) coverage – especially for women – should consider a range of clinical, regulatory, and equity-focused factors. Some key considerations include:
- Review current formulary tiering and utilization controls for HRT to ensure they align with clinical guidelines.
- Implement clear appeal processes for patients who cannot tolerate preferred formulary options.
- Educate members on documentation requirements for medical necessity appeals.
- Consider equity-focused benefit design, especially for women, transgender individuals, and those with chronic conditions.
- Monitor regulatory changes that may affect coverage mandates or cost-sharing structures.
A Call to Action
The FDA is now considering revisions to the black box warning – a move that could reshape how HRT is perceived and prescribed [1]. But even before regulatory changes take effect, we must lead with education, empathy, and evidence.
Let’s approach this topic with a balanced perspective and move toward a model that prioritizes quality of life, symptom relief, and informed choice. Hormone therapy isn’t a one-size-fits-all solution – but for many women, it’s a vital part of their health journey.
Join our live virtual event on Thursday, November 13, at 1:00 p.m. ET, and learn how forward-thinking employers are investing in women’s health – not only as a matter of equity, but as a strategic opportunity.
We’ll unveil key findings from EPIC’s national survey of benefits leaders, offering insights into how companies are approaching women’s health and addressing gaps in coverage beyond reproductive years. Whether you’re a benefits leader, HR professional, or advocate for health equity, this webinar will provide actionable perspectives and opportunities to close the gender health gap in your organization.
EPIC offers this material for general information only. EPIC does not intend this material to be, nor may any person receiving this information construe or rely on this material as, tax or legal advice. The matters addressed in this document and any related discussions or correspondence should be reviewed and discussed with legal counsel prior to acting or relying on these materials.
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Get in Touch with the Author
Sarah Fleming, PharmD, Senior Pharmacy Benefit Clinical Consultant | EPIC Pharmacy Solutions, powered by PSG | Contact Sarah via email.
