Reason for request

Extension of indication

Insufficient actual benefit to justify its inclusion on the list of reimbursable products for peripheral neuropathic pain in diabetic patients due to low efficacy, that is not clinically relevant, and demonstrated only versus placebo.

 

  • QUTENZA now has Marketing Authorisation in the treatment of peripheral neuropathic pain in adults with diabetes.
  • Its efficacy in these patients was assessed versus placebo. It is low and is not clinically relevant. Its efficacy has not been assessed versus other alternatives available even though this comparison was feasible.
  • Its use is commonly associated with painful reactions at the application site.
  • Its methods of application are restrictive and require training of the staff.

 

 

 

 


Clinical Benefit

Insufficient

Le service médical rendu par QUTENZA est insuffisant au regard des thérapies disponibles pour justifier d’une prise en charge par la solidarité nationale dans le traitement des douleurs neuropathiques diabétiques périphériques chez les adultes, seul ou en association avec d’autres médicaments antidouleur.


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