Reason for request
Re-assessment of the Actual Benefit of strong opioids indicated in chronic non-cancer and non-neuropathic pains at the Committee’s request, in compliance with article R-163-21 of the French Social Security Code
The actual benefit of the proprietary medicinal product ORAMORPH oral solution is :
- substantial in the management of severe and/or intractable pain occurring in the context of osteoarthritis of the knee or hip and chronic low back pain, as a last-resort treatment, at a stage where surgery is planned and 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 shortest possible duration due to the risk of serious adverse effects and the absence of long-term data. This therapeutic category should be used as limited as possible, after the other pharmacological treatments and physiotherapy recommended in these indications have failed ;
- insufficient in severe and/or intractable pain occurring in any other chronic non-cancer and non-neuropathic pain context, particularly chronic inflammatory rheumatic diseases, primarily consisting of rheumatoid arthritis and spondyloarthritis.