What CMS actually weighs
Under IRA Sections 1191–1198, CMS develops an initial offer for each selected drug informed by clinical benefit relative to therapeutic alternatives, unmet medical need, contribution to addressing unmet need, applicability to specific populations, and effects on the Medicare population — including equity considerations.
Manufacturer-submitted evidence is one input among many, but it is the only input the manufacturer controls. The submission window is short and the format is prescribed. Evidence that is not generated before selection is unlikely to influence the first offer.
What to generate now
Comparative effectiveness against the specific therapeutic alternatives CMS is likely to consider — not just the regulatory comparator. This often means head-to-head RWE against multiple in-class and out-of-class options.
Unmet need evidence: who fails on current standard of care, how often, with what consequences, and what proportion of those patients the selected drug actually reaches.
Equity evidence: outcomes stratified by race, ethnicity, dual-eligibility status, and rural versus urban residence. CMS has been explicit that disparities-reduction evidence is in scope.
What we see manufacturers under-investing in
Patient-experience and caregiver-burden evidence under the 'applicability to specific populations' factor. Quantitative PRO and time-trade-off data here is scarce and disproportionately influential.
Real-world durability of response and treatment-free intervals, especially for oncology and rare disease selected drugs.
Key takeaways
- Identify likely SDL candidates 24+ months ahead and start evidence generation immediately.
- Generate head-to-head RWE against the alternatives CMS will consider, not only the regulatory comparator.
- Disparities-stratified outcomes and PRO/caregiver-burden evidence are the most under-supplied — and the most differentiating.
Want this brief as a PDF, or to discuss it with our team?
We share the full deck and supporting references on request.