Reason for request

Re-assessment of the Actual Benefit of strong opioids indicated in chronic non-cancer and non-neuropathic pain at the Committee’s request, in compliance with article R-163-21 of the French Social Security Code

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Clinical Benefit

Substantial

The actual benefit of the proprietary medicinal products ACTISKENAN, hard capsules and SKENAN, prolonged-release microgranules in hard capsules is :

- substantial in the management of severe and/or intractable pain occurring in the context of osteoarthritis of the knee or hip and chronic lumbar pain, as a last-resort treatment, at a stage where surgery is planned or in patients who are not candidates (due to refusal or contraindication) for prosthetic joint replacement surgery (in osteoarthritis of the hip or knee), and for the shortestduration possible due to the risk of serious adverse effects and the absenceof long-term data. This therapeutic category should be used as little as possible, after the other pharmacological treatments and physiotherapy recommended in these indications have failed ;

Insufficient

- insufficient in severe and/or intractable pain occurring in any other chronic non-cancer and non-neuropathic pain context, particularly chronic inflammatory rheumatic disease, primarily consisting of rheumatoid arthritis and spondyloarthritis.