Regulatory and market-access VOI
The fixture-backed value_of_regulatory_market_access method models approval
and reimbursement probabilities across approved, restricted-label,
coverage-with-evidence, and rejected scenarios. It reports regulatory and payer
uncertainty, access delay, evidence-package cost, label expansion, and
price-threshold value.
Calibrated regulatory/payer data, cross-language parity, and mature/stable governance approval remain required before promotion.
Use voiage generate-config regulatory-market-access to create a starting JSON
payload, then run voiage calculate-regulatory-market-access INPUT.json.