TABLE 1.
Summary of key features of HTA agencies.
Jurisdiction | Regulatory approval | HTA assessment and appraisal | Main HTA criteria | Influence of HTA on drug pricing | Managed entry scheme |
---|---|---|---|---|---|
Australia | National | National | Clinical, cost effectiveness | Indirectly as it has an impact on ICER | Yes |
Canada | National | National and regional | Clinical, cost effectiveness | Indirectly as it has an impact on ICER | Yes |
England | Pan- European | National | Clinical, cost effectiveness | Indirectly as it has an impact on ICER | Yes |
France | National | Clinical | Yes, ASMR rating used for pricing negotiation | Yes | |
Germany | National | Clinical | Indirectly through the level of added benefit | No | |
Italy | National and regional | Clinical, budget impact | Yes | Yes | |
Spain | National and regional | Clinical, budget impact | Yes | Yes |
Notes: Allen et al. (2017) and Angelis et al. (2018).