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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.