OBJECTIVES: Companion diagnostics (CDx) present the opportunity to optimise clinical outcomes and reduce healthcare costs by identifying patients most likely to benefit from specific therapies. The goal of this study is to compare and contrast health technology assessment (HTA) and reimbursement processes for CDx in Europe to understand country-specific challenges and opportunities for access.

METHODS: Publicly available guidance documents on HTA and reimbursement processes for CDx in the EU-4 and UK were reviewed and supplemented with insights from interviews with local experts. Key methodological elements were extracted and compared, including the responsible body, coordination of therapy/CDx processes, evidence requirements, source of reimbursement and timelines.

RESULTS: Evaluation of CDx in France (by HAS) and in the UK (by NICE and the SMC) is a transparent, standardised and centralised process, with published guidance available from all three agencies. NICE and SMC assess the value of CDx as part of their appraisal of the associated therapy, and consider diagnostic accuracy and cost of testing in their economic evaluations. In contrast, HAS assess the CDx and therapy separately. CDx do not undergo HTA in Germany, though reimbursement requirements and structures are well defined. CDx reimbursement is provided at the national level for patients with statutory health insurance in Germany, but reimbursement pathways differ for tests used in the outpatient vs inpatient setting. There are no established assessment pathways for CDx in Italy and Spain, and reimbursement is determined at the regional and/or local level.

CONCLUSIONS: Our research outlines the necessary stages and evidence requirements for CDx to achieve market access in the EU-4 and UK. As the healthcare industry evolves towards personalised medicine, including the advent of histology-independent cancer drugs, understanding country specific HTA and reimbursement processes for CDx will be essential to facilitate successful and timely access to innovative targeted therapies.