Health Economics, Outcomes Research, and Market Access
What this domain tests
This domain covers the evidence payers use to decide price and access: cost-effectiveness, budget impact, health technology assessment, and the formats in which value is communicated.
Core rules
- Economic evaluation types: cost-minimisation (equal outcomes), cost-effectiveness (natural units, e.g. cost per life-year), cost-utility (cost per QALY), cost-benefit (monetised outcomes).
- Costs depend on perspective (payer versus societal), time horizon, discounting, and inclusion of indirect costs.
- ICER = (cost of new − cost of comparator) ÷ (effect of new − effect of comparator). Budget impact answers a different question: affordability over a defined period for a defined population.
- HTA bodies differ methodologically: NICE (UK), IQWiG/G-BA (Germany), HAS (France), CADTH (Canada), PBAC (Australia). ICER in the US is an independent institute, not a payer authority.
- Access tools include the global value dossier (AMCP Format), payer value communication, pre-approval information exchange with US payers, outcomes-based agreements and patient access programmes.
Worked example
A new therapy costs $120,000 and delivers 6 QALYs; the comparator costs $60,000 and delivers 5 QALYs. ICER = (120,000 − 60,000) ÷ (6 − 5) = $60,000 per QALY gained. Reasoning: you must state perspective and time horizon, and you must not present the ICER as budget impact - a plan covering 1,000 patients still faces an additional $60 million in year one, which may dominate the negotiation.
Traps that cost marks
- Confusing ICER with budget impact or with price.
- Comparing ICERs across countries with different thresholds and methods.
- Assuming a cost-effectiveness result alone secures formulary access.