OBJECTIVES:

The number of medicines paired with in vitro diagnostics continues to grow. The role of the diagnostic test in HTAs continues to evolve. Our aim was to examine if payers have used data on subpopulations defined by diagnostics to limit access to innovative oncology medicines and investigate the extent to which the diagnostic is considered during HTAs of the medicine.

METHODS:

Products were selected based on the FDA’s list of oncology products with CDx. Indications authorized by the European Commission (MA population) for each product were compared with the reimbursed population in France, Germany, and the UK. Commentary on the diagnostic was extracted from documents relating to the HTA of the medicine.

RESULTS:

Twenty-four medicines were included in the analysis. Thirty-eight indications across twelve tumor types were represented. Thirteen genes/gene products or chromosomal changes were used as the basis for the CDx test. Not all indications for each medicine required biomarker status.

NICE has restricted the MA population based on the CDx test twice: trastuzumab for gastric cancer and draft guidance for nivolumab in NSCLC. Other NICE technology appraisals discussed the possibility of different clinical benefit in different molecular subpopulations, among other commentary on testing.

The G-BA used CDx tests to define subgroups in assessments of nivolumab, pembrolizumab, and osimertinib; it found additional benefit for afatinib in a subgroup with the Del19 mutation in the EGFR gene, but none for L858R or other EGFR mutations.

There were few examples of the TC considering test status, although it recommended limiting BRCA testing for olaparib to INCa laboratories.

Additional examples will be presented.

CONCLUSIONS:

Payers take varying approaches to CDx within HTAs. There have been few examples of payers restricting access to a narrower group than the MA population. However, this practice may increase in future, reducing treatment options for patients and their physicians.