Global Health Technology Assessment Road Maps

SPAIN - HEALTH POLICY DECISION PROCESS

Objectives

  • Level 1 define the process at the highest level (i.e. 30,000 ft. view), to provide a baseline understanding of the primary factors which impact decisions, for users who may or may not be familiar with these processes.

  • Level 2 provide additional detail on specific data requirements and tools needed to support these decisions, by country, to support the decision-making process.

Definitions:

  • Decision-Maker (DM):  Defined as the payer (person or organization) who makes final decisions for coverage and payment of a product or technology.
  • Evaluator:  Defined as a person or organization that provides input into the decision-making process via HTA development but does not make final decision for coverage and payment. 
  • Decision-Making Process:  The HTA evaluation process, as defined in the public domain, for emerging new technologies (i.e. medical device, pharmaceutical, diagnostic) in consideration for coverage and payment.

Model Description and Symbols:
The ultimate decision-maker is listed at the top of the model.
Boxes: Decision-making bodies
Circles:  Data requirements, tools, etc. which impact process
Solid Arrows: Required step in decision-making process
Broken Arrows:  May or may not impact decision.

Notes: (explain the flow of the model and the factors involved).

Spain has a decentralized health care system. The National Health System Interterritorial Council is responsible for deciding the inclusion of new technologies in the benefit package of the National Health System. The proposal of inclusion of new technologies that could significantly increase health expenditures also requires approval by the Fiscal and Financial Policy Council (Consejo de Politica Fiscal y Financiera Financial) [Not included in the diagram].

The Central Government established the HTA Agency Instituto de Salud Carlos III. Regional governments may establish regional HTA agencies. Only 5 out of the 17 regions have established their own HTA agencies. The Regional HTA agencies collaborate with the Central HTA Agency.

The proposal of inclusion of new technologies in the national benefit package must include a HTA report completed by the central HTA Agency in collaboration with the regional HTA agencies.

 

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