Presentation (CTI)

OBJECTIVES: Companion diagnostic (CDx) can generate value for health systems by identifying patients most likely to benefit from treatment (Rx). To achieve timely patient access to CDx and Rx in clinical practice, HTA submissions must meet local requirements. Our objectives were to review country-specific HTA guidelines for Rx-CDx submissions, and HTA reports for oncology analogs recently assessed to understand the Rx-CDx assessment pathways and the type of CDx evidence reported by HTA agencies.
METHODS: HTA guidelines in Canada, UK, France, Germany, Australia, and the USA were reviewed to identify country-specific CDx HTA requirements from their respective agencies. The HTA reports of 4 Rx-CDx analogs in 4 cancer types (breast, prostate, esophagus/gastroesophageal junction, and urothelial) were also analyzed. The concordance between HTA guidelines and the CDx evidence critiqued in these reports was assessed.
RESULTS: The Rx-CDx HTA requirements were analyzed across 28 HTA appraisals for the selected analogs to establish a catalog of Rx-CDx HTA requirements. Our results show that HTA reports mostly discuss CDx availability (incl. impact on laboratory services and implementation challenges), predictive value, Rx-CDx study design, targeted population, and related costs. These aspects were also recognized by 4 consulted HTA experts as being most relevant. Additionally, the concordance between CDx HTA requirements and those mentioned in the HTA reports, and the Rx-CDx HTA assessment pathways (joint, parallel, or distinct processes and agencies) varied by country and HTA agency.
CONCLUSIONS: Considering the global rise of precision medicines, Rx-CDx HTA requirements are specified in most HTA guidelines. Nonetheless, harmonized Rx-CDx assessment pathways and systematic HTA reporting of the CDx evidence are essential to enable optimal Rx-CDx reimbursement conditions, and timely patient access to targeted therapies in oncology.