Bridging the Gap: Pathways for Regulatory and Health Technology Assessment of Histology Independent Therapies

Rodes Sanchez, M., Henderson, N. and Steuten, L. 

Consulting Report
August 2020

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Histology independent therapies, a new class of medicines that target cancer based on specific genomic or molecular alterations of cancer cells rather than tissue of origin, face significant methodological and policy hurdles related to evidence development and acceptance, value assessment and reimbursement pathways, and diagnostic infrastructure availability. To better understand the specific challenges and opportunities in various countries, we performed an in-dept analysis of (adaptive) pathways for histology independent therapies, using a combination of literature research, expert interviews and case studies.

The results show that while challenges for histology independent therapies are similar in various countries, solutions will likely have to be diverse and include methodological advancements, novel payment models and decision-makers’ willingness to adopt new approaches. The report provides recommendations on each of these this to further stimulate dialogue between the various stakeholders involved.