The Role of Economic Evaluation in HTA in Spain

OBJECTIVES: Since 2013, each drug approved under centralized procedure by the EMA, and to be marketed in the Spanish National Health System (NHS), undergoes an assessment in a Therapeutic Positioning Report (TPR). TRPs aim to position each new drug within clinical practice. In 2020 a new TRP procedure was published and economic evaluation was included. This research analyses the characteristics of the economic evaluations used in the TPRs.

METHODS: Using R, we programmed a scraping tool to find all published TPRs with economic evaluation on the website of the Spanish Health Ministry. Simultaneously, we identified the TRPs in progress up to June 2023, and then, we developed an extraction form to complete (including new drug or indication, orphan designation, therapeutical area, and type of economic analysis and its characteristics, among others). Finally, a descriptive statistical analysis was performed.

RESULTS: 31 TRPs with economic evaluation have been commissioned (16 published, 2 finished but not published, and 13 in progress). Among those published, 69% comprised new drugs, 63% orphan medicines, and the most common area was oncology (31%). All documents contained an ex-novo budget impact analysis, but some comprised additional (ex-novo and/or existing) cost-utility (5), cost-minimization (5) and cost-effectiveness (2) analyses. In many cases, some of the basic characteristics of the models were not reported (for example, the time horizon was not reported in 50% of cases, and sensitivity analyses were not mentioned in 56% of cases). However we detected that some TRPs incorporated more sophisticated methodologies (e.g., partitioned survival, 3, and Markov models, 2) and good practices disclosing methods and results.

CONCLUSIONS: Economic evaluation is increasingly important in the HTA of new drugs in Spain. The inclusion of economic evaluation in TPRs is still in progress, with a trend towards incorporating more sophisticated methods that should be sustained over time.