Prescription for Change 2025

–Adopt a new pricing and reimbursement value proposition to drive innovation in women-specific conditions. Implementing new pricing structures such as price premiums for underinvested women-specific conditions or even guaranteed payment structures before product development can incentivize the creation of treatments. These pricing strategies reduce the financial risks for manufacturers, encourage innovation and prioritize conditions that exclusively affect women. Additionally, ensuring equality in cost coverage for reproductive procedures addresses the fact that women have disproportionately more out-of- pocket expenses than men.To drive meaningful progress in women’s health research, a combination of three incentives is needed: regulatory, such as disease designation and priority review vouchers; financial, including tax credits; and pricing and reimbursement, such as price premiums. Past experiences show that a strategic blend of these incentives has the power to improve innovation and investment in women’s health research. However, achieving this requires collaboration at every level, including working with: regulatory bodies to establish effective legislative and policy frameworks; governments to secure financial support; and payers to ensure sustainable market incentives. These policies can provide the structural framework needed to implement effective changes. Innovating in women’s health is key to addressing unmet needs and ensuring that all women receive the comprehensive care they deserve for a healthier future. Kelle Moley, Global Vice-President of Clinical and Translational R&D, Reproductive Medicine and Maternal Health, Ferring Women’s health research policy recommendations FIGURE 3 Source: World Economic ForumUnlock innovation in women’s health Introduce regulatory incentives to drive innovation in women-specific conditions Innovation Expand the inclusion of women in clinical trials Create awareness with regulators and investigators to generate women-specific data earlierInclusion Enhance disaggregation of clinical trial data Standardize terminology and data collection to improve women’s health research Data Design clinical trials with women in mind Employ sex-specific biomarkers to understand differences in disease mechanism and manifestationDesign Deepen insights on sex-specific differences Report sex-disaggregated data in scientific publications to improve transparency on insightsInsights Create financial incentives to drive innovation in women’s health Adopt a new pricing and reimbursement value proposition to drive innovation in women-specific conditionsImprove enrolment of women in clinical trials to drive new and effective treatments Introduce a maternal investigation plan to support research for pregnant and lactating women Require research on pregnant and lactating women to close critical data gaps Incentivize research on pregnant and lactating women to advance maternal and infant healthRequire comprehensive sex-specific benefit-risk assessments to close critical gaps in clinical research Adopt flexible methodologies for analysis and global data sharing to maximize insights from limited dataDesign clinical trials to account for sex-based differences in physiological mechanism and manifestation Educate investigators, developers, clinical trial staff and patients to improve research quality and outcomes Ensure access to clinical trials through proactive strategies to recruit and retain women, particularly those from underserved communitiesUpdate clinical guidelines to ensure safe and effective treatments for all patients Ensure transparency in product information for safer, more effective treatments Prescription for Change: Policy Recommendations for Women’s Health Research 11