Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

No clinical benefit demonstrated in the next-line treatment of advanced melanoma after failure of immunotherapies and/or therapies targeted at B-RAF mutations.

Insufficient actual benefit in other situations, especially in first–line treatment, due to the role of immunotherapy and therapies targeting B-RAF mutations.

  • Before the availability of immunotherapy and so-called targeted therapies in 2012, dacarbazine was commonly used as a first-line treatment for advanced melanoma, despite the absence of any demonstrated effect on survival.
  • Immunotherapy and anti-BRAF therapies alone or in combination with anti-MEK agents have supplanted dacarbazine due to the demonstration of a superior efficacy in terms of disease-free survival and/or overall survival.
  • Cytotoxic agents, including dacarbazine, are now a last-line treatment.

 

 

 

 

 


Clinical Benefit

Moderate

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Insufficient

Clinical Added Value

no clinical added value

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