Menopause prescribing patterns are normalising after a decade of post-WHI under-treatment

Reading the signal

The Women's Health Initiative (WHI) readout in 2002 reshaped hormone therapy prescribing globally. Hormone therapy use dropped substantially across major markets within months of the readout and remained suppressed for nearly two decades. The post-WHI period was characterised by guideline-versus-prescribing-practice misalignment in many markets, with accumulating real-world evidence increasingly supporting more nuanced risk-benefit framing than the original WHI readout had enabled.

Two forces are now driving normalisation:

• Real-world safety evidence over twenty years has refined the risk-benefit framing. The conditions under which hormone therapy is favourable (timing relative to menopause onset, route of administration, oestrogen-only versus combined regimens) are now better-defined
• Non-hormonal mechanisms have entered the market. NK3 receptor antagonists (fezolinetant, elinzanetant) provide a non-hormonal vasomotor symptom option, expanding the commercial category beyond hormone therapy

Real-world prescribing data shows hormone therapy initiation rates increasing from the post-WHI lows in major markets, and non-hormonal vasomotor symptom prescribing has emerged as a meaningful commercial category since 2023.

Commercial implications

For sponsors of menopause-related assets and adjacent women's health pipeline:

1. The category is rebuilding faster than many sponsors anticipated. Commercial models that anchor on post-WHI prescribing rates are systematically under-projecting market size for the rebuilt category.
2. Hormone therapy and non-hormonal mechanisms are not direct substitutes. The prescribing decision is being made on patient profile, not on a hormone-versus-non-hormonal dichotomy.
3. The patient-finding pathway is changing. Direct-to-consumer awareness, primary care reactivation of menopause prescribing, and specialist menopause clinics are reshaping the patient journey in ways that the post-WHI period did not see.

What we are watching

• Real-world prescribing data across major markets and the rate of normalisation in each
• Late-stage non-hormonal pipeline (next-generation NK3 antagonists, novel mechanisms) and how they reshape the non-hormonal category
• Direct-to-consumer awareness initiatives and what is driving the patient-initiated conversation about menopause therapy