Opportunities for CMS to Further Specify and Broaden Its Approach to Assessing Unmet Medical Need

Researchers at the University of Colorado Anschutz Medical Campus have published a report analyzing the United States Inflation Reduction Act of 2022's Medicare Drug Price Negotiation Program, highlighting potential gaps in the Centers for Medicare and Medicaid Services' (CMS) approach to assessing unmet medical need (UMN). Through a targeted literature review of 48 original research studies, the team identified 40 potential elements of UMN, which they categorized into seven domains. The study concludes that CMS's current approach to assessing UMN may be limited, particularly in regards to quality of life, economic burdens, societal elements, and treatment administration.

Key Takeaways:

• The United States Inflation Reduction Act of 2022 established the Medicare Drug Price Negotiation Program, requiring CMS to establish "maximum fair prices" for select drugs, considering criteria such as UMN.
• The researchers conducted a targeted literature review of 48 original research studies, identifying 40 potential elements of UMN related to pharmaceuticals, treatment-related barriers, and societal perspectives.
• The team categorized these elements into seven domains: (1) traditional clinical effectiveness, (2) impacts on patient, caregiver, or family quality of life, (3) economic burden on the patient, caregiver, or family, (4) economic burden on society, (5) societal perspective elements, (6) elements of treatment administration, and (7) availability of other treatments.
• The study found potential gaps in the current CMS approach to assessing UMN, particularly in domains 2 through 6, including quality of life, economic burdens, societal elements, and treatment administration.
• The researchers suggest that CMS could further specify and broaden its approach to assessing UMN by considering these domains and factors.

Statistics:

• 48 original research studies were reviewed for the report.
• 40 potential elements of UMN were identified and categorized into seven domains.
• The identified domains include traditional clinical effectiveness, quality of life, economic burdens, societal elements, treatment administration, and availability of other treatments.
• The researchers conclude that the current CMS approach to assessing UMN may be limited in considering these factors.

Sources:

• NewsRx. Reports from University of Colorado Anschutz Medical Campus Describe Recent Advances in Managed Care (Opportunities for CMS to Further Specify and Broaden Its Approach to Assessing Unmet Medical Need in the Context of the Medicare Drug Price ...). Health & Medicine Week. October 24, 2025; p 108.
• Applied Health Economics and Health Policy. Opportunities for CMS to Further Specify and Broaden Its Approach to Assessing Unmet Medical Need in the Context of the Medicare Drug Price Negotiation Program. 2025.