10 May Article – Practical and Ethical Challenges Funding Personalized Medicine
Medical regulators and funders worldwide face seemingly impossible challenges stemming from advances in medical science, such as PMs, but limited capacity to approve and fund all such advances. It is essential that decisions regarding the regulation and funding of any new medical therapies be made on the basis of clear criteria and according to processes that are transparent and ethically justifiable. Until recently, HTA has relied on RCTs, systematic reviews, meta analyses, and cost-effectiveness analyses, all conducted before market entry. Such methods are, however, particularly difficult to apply to medicines for patients with orphan diseases and to some PMs— particularly given the lack of clarity as to how the worth of PMs should be determined and the lack of transparency surrounding both the setting of drug prices and negotiations between industry and third party
payers. To strike a balance between the needs of patients, physicians, funders, and industry, different mechanisms for evaluation and translation need to be used. These include alternative forms of clinical trial design, such as observational research and single-arm studies, and flexible strategies for managing access to market, such as CED.
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Coverage With Evidence Development and Managed Entry in the Funding of Personalized Medicine: Practical and
Ethical Challenges for Oncology