Reason for request

Inclusion on list

Summary of opinion

Favourable opinion for reimbursement in the treatment of peripheral neuropathic pain in diabetes either alone or in combination with other medicinal products for the treatment of pain.


Clinical Benefit

Low

The clinical benefit of QUTENZA 179 mg (capsaicin) cutaneous patch is low in the treatment of peripheral neuropathic pain in diabetes either alone or in combination with other medicinal products for the treatment of pain.


Clinical Added Value

no clinical added value

Considering:

  • the low level of evidence of the efficacy studies and the low effect size observed versus placebo in diabetic patients;
  • the lack of comparative data versus the other treatments, particularly local, available inperipheral neuropathy in these patients;
  • the frequency of adverse effects observed following application of the capsaicin 8% patch;

the Committee deems that QUTENZA 179 mg (capsaicin) cutaneous patch provides no clinical added value (CAV V) in the treatment of peripheral neuropathic pain in diabetes either alone or in combination with other medicinal products for the treatment of pain.


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