Histology independent therapies represent a new era in personalized healthcare and drug development while challenging existing diagnostic and value assessment frameworks. Despite generating paradigm shifts in cancer diagnosis and treatment, these therapies face significant methodological and policy challenges related to evidence development, adoption, value assessment, reimbursement pathways, and immature genomic testing infrastructure.
Given the unmet clinical need that exists in patients with rare or ultra-rare diseases, histology independent therapies are able to gain accelerated access through adaptive pathways implemented by regulatory agencies. However, health technology assessment (HTA) bodies pose multiple challenges for evidence requirements to inform coverage and reimbursement decisions. Read more here.
(Source: Dr. Nazneen Fatima Shaikh, Dept. of Pharmaceutical Systems and Policy, West Virginia University; Purva Parab, Virginia Commonwealth University)