OBJECTIVES: Companion diagnostic tests (CDx) in oncology are central to personalization of therapy (Rx), therefore, obtaining concurrent reimbursement of Rx and CDx is key to ensuring patient access. We compared the current patient access pathways for novel Rx/CDx pairs in the EU5 (England, France, Germany, Italy, and Spain) and key Asia-Pacific (Japan and Australia) countries to understand current challenges and opportunities for access to personalized therapies in oncology.

METHODS: Published, peer-reviewed literature (2005−2018) and publicly available information on country-specific appraisal and reimbursement processes for oncology CDx were reviewed to identify key parameters (coordination of Rx/CDx health technology assessments [HTAs] at national/regional/local levels, assessment time frames, innovation/value recognition, and impact of orphan indications). Available decisions for the KRAS biomarker were assessed to obtain further insights and research findings were refined via interviews with country-based expert advisors.

RESULTS: In the majority of scope countries CDx are assessed for reimbursement in a centralized, national process, whereas 2 countries may only conduct regional or local assessments. In all countries except England, Rx and CDx assessments are structured independently without assurance of concurrent reimbursement, although specific mechanisms/strategies identified may permit differing levels of concurrent reimbursement in ≥3 countries. Japan showed the shortest timeline for CDx assessments (3 months), while assessments in ≥2 countries could take several years (no clear time limit). The level of innovation and application to orphan indications appeared to positively impact CDx reimbursement decisions in Japan, and showed moderate or no impact in remaining countries.

CONCLUSIONS: Country-specific reimbursement structures and processes evolved over the observed time period, however, compared with other scope countries, patient access to personalized medicine appeared better supported in Japan. Prevalent variability and lack of synchrony in reimbursement appraisals of Rx/CDx pairs in oncology across most scope countries underscores the need for close partnership between developers of Rx and CDx.