TREMFYA PUSHPEN (guselkumab) - Anti-IL23
Reason for request
Summary of opinion
Favourable opinion for reimbursement in:
- plaque psoriasis in adults (for more information see the MA),
- psoriatic arthritis in adults (for more information see the MA),
- ulcerative colitis in adults only in moderately to severely active disease in patients who have had an inadequate response, lost response, or were intolerant to conventional therapy, at least one prior anti-TNFα agent and vedolizumab,
- moderately to severely active Crohn's disease in adults who have had an inadequate response to, lost response to, or were intolerant to conventional therapy (corticosteroids or immunosuppressants) and at least one anti-TNFα agent, or who have a medical contraindication to these treatments.
Unfavourable opinion for reimbursement in the other clinical situations of the ulcerative colitis and Crohn’s disease indications.
No clinical added value of the new TREMFYA 100 mg PUSHPEN (guselkumab) solution for injection in pre-filled pen form compared to the pre-filled pen and syringe forms already available.
Clinical Benefit
| Substantial |
The clinical benefit of TREMFYA 100 mg PUSHPEN (guselkumab) solution for injection in pre-filled pen is moderate only in the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional therapy, at least one prior anti-TNFα agent and vedolizumab. |
| Moderate | |
| Insufficient |
Clinical Added Value
| no clinical added value |
TREMFYA 100 mg (guselkumab), solution injectable présenté en stylo prérempli PushPen est un complément de gamme qui n’apporte pas d’amélioration du service médical rendu (ASMR V) par rapport aux présentations en stylo injectable OnePress ou en seringue préremplie, déjà inscrites. |
