Listen
BCG MAJORELLE (Bacillus Calmette-Guérin) - (Bladder cancer)
Reason for request
Summary of opinion
Favourable opinion for reimbursement in:
“Treatment of non-invasive urothelial bladder carcinoma:
- Curative treatment of carcinoma in situ;
- Prophylactic treatment of recurrence of:
- urothelial carcinoma limited to mucosa:
- pTa G1-G2 if multifocal and/or recurrent tumour;
- pTa G3.
- urothelial carcinoma in lamina propria but not in muscularis propria of the bladder (pT1);
- carcinoma in situ.”
- urothelial carcinoma limited to mucosa:
No clinical added value of BCG MAJORELLE 100 mg powder and solvent for intravesical suspension compared to the other proprietary medicinal products containing BCG for intravesical instillation already available.
Clinical Benefit
| Substantial |
The Committee considers that the clinical benefit of BCG MAJORELLE 100 mg powder and solvent for intravesical suspension is substantial in the MA indications.
|
Clinical Added Value
| no clinical added value |
BCG MAJORELLE 100 mg powder and solvent for intravesical suspension medicinal products provide no clinical added value (CAV V) compared to the medicinal products already listed, i.e. IMMUCYST 81 mg powder for intravesical suspension and BCG‑MEDAC powder and solvent for intravesical suspension. |
