OBJECTIVES:

To determine the clinical restrictions applied to health technology assessment (HTA) indications for cardiac conditions.

METHODS:

The reimbursement data between 2011 and 2020 from 6 HTA agencies (SMC [Scotland], NICE [United Kingdom], HAS [France], G-BA [Germany], TLV [Sweden], and CADTH [Canada]) for cardiac conditions were included. This data was linked to the indications approved by the regulatory agencies, European Medicines Agency (EMA) and Health Canada (HC). Clinical restrictions were identified and grouped into categories. A chi-squared test was conducted, and the results were reported. HTAs without a decision and ones with deferred decisions were excluded from the analysis.

RESULTS:

A total of 383 HTA reviews were included in the analysis of which, 84.33% (n=323) were recommended and 25.07% (n=81) of the recommended decisions had clinical restrictions. One or more clinical restrictions were applied in these reviews.

The most common restriction regarded patient characteristics, which were found in 50.61% (n=41) of reviews. Other major categories of restrictions were disease severity (33.33%), drug failure (17.28%), adjunct therapy (16.04%), disease definition (14.81%), and prior therapy (11.11%).

The agencies with the most restricted reviews were CADTH (n=15 [50%]) and NICE (n=18 [46%]); G-BA (n= 3 [10%]) and HAS (n=19 [12%]) had the least amount of restricted reviews; and TLV (n=17 [22%]) and SMC (n=9 [21%]) had an average number of restricted reviews. This was tested with a chi-squared test and the differences were significant.

CONCLUSIONS:

Clinical restrictions were not applied to a majority of HTA indications for cardiology. The clinical restrictions in the HTA reviews fell under one or more categories. More research is needed to understand why some agencies restrict more frequently than others.