Reason for request

Reassessment of the IAB

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Clinical Benefit

Substantial

the actual benefit of MUPHORAN is substantial in the indication “metastatic melanoma” and  “primary brain tumours”.


Clinical Added Value

no clinical added value

Metastatic melanoma indication :

Taking into account :

  • the available data, based primarily on a comparative study versus dacarbazine that showed a modest increase in the overall response rate with no demonstrated improvement in clinical criteria such as progression-free survival or overall survival

and

  • developments in the therapeutic strategy, with chemotherapy playing an increasingly limited role in favour of targeted therapies and immunotherapy,

the Committee considers that MUPHORAN does not provide any improvement in actual benefit (level V, non-existent) in the management of metastatic melanoma.

Primary brain tumours indication :

As the data available are limited to non-comparative studies and there are no comparisons with the available treatments in this indication, the Committee considers that MUPHORAN does not provide any improvement in actual benefit (level V, non-existent) in the management of primary brain tumours.