Why the scoping phase matters most
ICER's scoping document defines the population, comparators, outcomes, and time horizon for the assessment. Almost everything downstream — including the eventual value-based price benchmark — is locked at scoping.
The public-comment window on the draft scoping document is the single highest-leverage opportunity to influence the report. Manufacturers that wait until the draft evidence report to engage have effectively forfeited this leverage.
What to submit and when
Scoping comments: define the patient subgroups, comparators, and outcomes that matter clinically. Cite guidelines and real-world treatment patterns.
Evidence submission: provide the manufacturer's full economic model, all published and in-preparation clinical evidence, and unpublished subgroup analyses with appropriate confidentiality flags.
Draft report comments: focus on factual errors, methodological choices that diverge from the scoping document, and any new evidence available since submission.
The policy roundtable
The public meeting and policy roundtable are not the place to relitigate the model. They are the place to contextualize the cost-effectiveness result against unmet need, equity, and patient-experience evidence — and to put forward concrete policy recommendations.
Key takeaways
- Engage at scoping, not at draft report — scoping locks the answer.
- Submit the full economic model and unpublished subgroups; partial submissions get partial credit.
- Use the policy roundtable for context and policy recommendations, not model rebuttal.
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