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Favorable Regulatory Environment and Reimbursement Support
Regulators in the major pharma markets have adopted an accommodative stance to fast-track approval of innovative melanoma drugs. They acknowledge the traditional lack of good treatment options and high unmet need. Developers of targeted therapies and immunotherapies have greatly benefitted from this supportive regulatory environment. For example, the U.S. FDA and EMA, European Medicines Agency have approved several new drug applications based on early clinical trial data, omitting the need for phase III studies in some cases. The priority review and approval designations help reach patients sooner. This encourages continued research and commercialization of new therapeutic entities. On the reimbursement front, private and government payers seem willing to cover the high costs of modern melanoma medicines. The improved outcomes and survival benefits demonstrated in clinical testing help justify good reimbursement decisions. Coverage policies also consider the economic burden of advanced melanoma and high total healthcare spending in the absence of effective treatments. Higher drug prices are considered acceptable due to the benefits of new mechanisms and smaller subsequent healthcare resource use.
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