Oncology Drug Development: Would A New Pricing Model Help?
Executive Summary
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.
You may also be interested in...
Immuno-Oncology’s Revolutionary Impact – On US FDA
Unprecedented wave of cancer immunotherapies is in some ways a mirror image of AIDS crisis as FDA explores new tools to accelerate drug development, including modeling techniques and statistical approaches to efficacy. It's an effort to encourage a regulatory revolution in response to a massive number of products in development as opposed to the AIDS-era effort to get products studied.
Real World Evidence: ‘Hot Topic’ At US FDA, But Not On Front Burner
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.
Cancer Immunotherapies Have FDA, Industry Looking For New Endpoints
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.