CURRENT AND FUTURE EU5 PAYER LANDSCAPE FOR ONCOLOGY SOMATIC MUTATION PANELS
Author(s)
Carlow D1, Infante K2
1Ipsos Healthcare, Natick, MA, USA, 2Ipsos Healthcare, New York, NY, USA
OBJECTIVES: Pharmaceutical companies are exploring somatic mutation panels as a companion diagnostic strategy to evaluate biomarker status and determine eligibility for oncology therapies. This study aims to evaluate the current coverage and reimbursement landscape in France, Germany, Italy, Spain and the United Kingdom (EU5) for somatic mutation panels, as well as to understand payers’ perceptions towards liquid biopsy-based (LBx) somatic mutation panels. METHODS: Secondary desk research was conducted on EU5 payer policies to determine current coverage of somatic mutation panels. In addition, qualitative interviews were conducted with French (n=5) and German (n=4) payers to evaluate awareness and perception of LBx. RESULTS: Among EU5 markets, only France, Germany, and the United Kingdom have national coverage and reimbursement determinations for somatic mutation panels, while the Valencia region of Spain also has a regional coverage and reimbursement determination. Variation in coverage by panel size and specimen type (LBx vs. tissue biopsy) exists among countries and regions with coverage for somatic mutation panels. Overall, payers have a favorable impression of LBx due to the non-invasive nature of the tests and ability to overcome tumor heterogeneity, but accuracy and concordance to tissue remain the top concerns. CONCLUSIONS: Differential access to somatic mutation panels exists across the EU5, which can pose an access challenge for oncology drugs associated with such a companion diagnostic strategy. For LBx-based panels, companies should demonstrate LBx panel accuracy, prove concordance to tissue biopsy and present a concrete value story to encourage more widespread payer coverage.
Conference/Value in Health Info
2019-11, ISPOR Europe 2019, Copenhagen, Denmark
Code
PCN292
Topic
Health Policy & Regulatory, Medical Technologies
Topic Subcategory
Diagnostics & Imaging, Reimbursement & Access Policy
Disease
Personalized and Precision Medicine