Oncology Drug Development: Would A New Pricing Model Help?
A National Academies of Medicine forum on the new, hyper-fast development path for oncology drugs included a surprising amount of discussion about drug pricing; this wasn’t a setting for attacks on drug prices, but instead a recognition that coverage and payment models may make it hard to rely on post-marketing work to support streamlined pre-market development programs.
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Officials are enthusiastic about the possibility of ‘real world evidence’ supporting the regulatory process – but are also eager to tamp down expectations (or fears) that it will make a big difference any time soon.
Modifying existing tumor response criteria or developing novel intermediate endpoints could address shortfalls in immuno-oncology efficacy assessments with traditional endpoints such as overall response rate and progression-free survival.