Langham S, Lewis J. Health technology assessment of companion diagnostics alongside therapeutic agents in oncology: experience of the NICE technology appraisal programme. Value Health 2018;21(Suppl 3):S272

Abstract

Objectives: Companion diagnostics have become increasingly important with the growth in stratified medicines that require the identification of a specified biomarker to support treatment decisions. They have the potential to improve cost effectiveness by focusing treatments on patients most likely to benefit, depending on the cost of testing. The National Institute for Health and Care Excellence (NICE) recently issued guidance on the approach for considering companion diagnostics in its technology appraisal (TA) programme. We undertook an evaluation of recent submissions to assess adherence to the guidance and to highlight common concerns raised in the appraisal process.

Methods: A targeted review of the NICE TA programme website to identify publicly available appraisals over the last two years that had included a biomarker test as part of the submission for a new oncology therapeutic agent.

Results: Twelve oncology TAs requiring a specific biomarker to support treatment decisions were identified. The majority were ‘recommended’ with limitations in the final guidance. Limitations included restrictions on indication and use with agreed discounts in patient access schemes. The remaining appraisals were either ‘recommended for use in the Cancer Drugs Fund’ with limitations and managed care agreements, or ‘not recommended’. Manufacturers, in general, adhered to NICE guidance. However, there were several key concerns regarding the appraisal of the companion diagnostic. These included how to: establish the test as routine in clinical practice; highlight implications of introducing, expanding or speeding up testing; deal with differences between the testing in the pivotal trial and clinical practice; and incorporate the test into the economic case.

Conclusions: Use of stratified medicines is an important area for payers. Company submissions need to deal with the cost implications of companion diagnostics in a transparent manner. Companion diagnostic appraisal alongside therapeutic agents ensures rapid and cost-effective adoption of such technologies onto the market.