CORTIMENT 9 mg (budésonide) (traitement d’induction d’une rémission chez des patients souffrant d’une colite microscopique active)
Reason for request
Unfavourable opinion for reimbursement in the induction of remission in patients with active microscopic colitis (MC).
Role in the care pathway?
In clinical practice and taking into account current guidelines (see Medical need section), collagenous colitis and lymphocytic colitis are two microscopic colitis entities for which the management is similar, bearing in mind that the level of evidence of the efficacy results is lower in lymphocytic colitis than in collagenous colitis.
It is first necessary to identify and eradicate triggering factors (medicinal products potentially implicated and smoking) and to try a non-specific symptomatic treatment for diarrhoea (to slow intestinal transit). If these measures fail, budesonide is the only medicinal product with an MA in microscopic colitis. The recommended induction treatment duration is 8 weeks.
In mild forms, other symptomatic treatments may be considered although they do not have a specific MA (5 ASA, cholestyramine).
In the event of relapse following discontinuation of budesonide, the latter may be used again, either intermittently, or continuously at a low dose. In the event of insufficient response to budesonide, alternatives such as cholestyramine, 5-ASAs off-label (mesalazine et sulfasalazine off-label) or bismuth subsalicylate (off-label, available as a pharmacy compounded preparation) may be considered, only if the symptoms are minor.
In the event of refractory microscopic colitis, immunosuppressants (such as azathioprine, 6-mercaptopurin, methotrexate, TNF inhibitors, all off-label), may be considered although the level of evidence for their efficacy is low. Surgery may also be considered as a last resort.
Role of the medicinal product in the care pathway
The Transparency Committee considers that CORTIMENT (budesonide) has no role in the treatment of active microscopic colitis in adults insofar as :
- the 9-mg strength in the form of non-divisible, film-coated, gastro-resistant prolonged-release tablets does not enable the recommended dosage reduction to be implemented due to its non-divisible nature (see SPC); it requires treatment to be changed if a reduction in daily doses is implemented, despite the fact that such reductions are common in routine practice, and
- it is not demonstrated that the delivery form of this medicinal product provides a clinical benefit for the patient compared to the other budesonide products already available in France (ENTOCORT and MIKICORT); no clinical studies having been conducted with the CORTIMENT medicinal product.
The Committee deems that the clinical benefit of CORTIMENT (budesonide) is insufficient to justify public funding cover in this indi-cation extension in view of the available alternatives.