OBJECTIVES : Health Technology Assessment (HTA) involves the evaluation of all relevant aspects of a health technology and can be used to inform reimbursement decisions. A companion diagnostic (CDx) is an in-vitro diagnostic test that is essential for the safe and effective use of a corresponding medicinal product. Aspects of the CDx’s performance, such as specificity, can impact the outcome of a HTA and should be investigated as part of an evaluation. However, in Ireland little is known about the proportion of HTAs for drugs that are associated with CDx. Our aim is to evaluate submissions to a national HTA agency that are associated with CDx use, and analyse trends over time.

METHODS : We conducted a retrospective analysis of all Rapid Reviews (RRs) commissioned at the National Centre for Pharmacoeconomics (NCPE) from 2012 to 2019, inclusive. For each RR, data was collected on the licensed indication under assessment and if a CDx, as defined by EU regulation, was required. For those associated with CDx use, additional information was collected to further characterize the submissions.

RESULTS : A total of 392 RRs were submitted to the NCPE between 2012 and 2019. Of these, 20.7% were associated with a CDx. Over time, the proportion of RRs associated with a CDx increased from 18.5% in 2012 to 32.8% in 2019. The majority of RRs associated with CDX were for cancer drugs (67.9%).

CONCLUSIONS : These results indicate that the number of submissions for drugs associated with CDx has increased over the last number of years, with the majority of these drugs relating to cancer. Further research is required to investigate if the additional complexity associated with these HTAs is addressed appropriately.