Report reveals what women’s health innovators get wrong about coverage

A new report explores why so many promising therapies struggle to reach patients and what developers can do pre-launch to prevent this.

The Women’s Health Innovation Summit (WHIS) report distills the insights from one of the most practically valuable sessions at the 2025 event: a candid, unfiltered conversation with Jim Kenney, who spent 38 years on the other side of the table at Harvard Pilgrim Health Care, negotiating the agreements that determine whether drugs get covered, restricted or quietly buried under prior authorisation requirements most patients never overcome.

The report covers:

• Pre-approval information exchange (PIE)
• PDUFA as an engagement anchor
• Outcomes-based contracting in practice
• Practical pitfalls to avoid

What he described should change how every women’s health innovator thinks about commercial strategy.

Read the report here.