Favourable opinion for reimbursement only in the treatment of superficial basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Unfavourable opinion for reimbursement in the other clinical situations covered by the MA, in particular in the treatment of nodular basal cell carcinoma in adults.
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of AMELUZ (5-aminolevulinic acid) 78 mg/g gel is substantial only in the treatment of superficial basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
Insufficient
The Committee deems that the clinical benefit of AMELUZ (5-aminolevulinic acid) 78 mg/g gel is insufficient to justify public funding in view of the available alternatives in the other clinical situations covered by the MA, in particular in the treatment of nodular basal cell carcinoma in adults.
Clinical Added Value
no clinical added value
Considering:
demonstration in a phase 3 clinical study in adults with non-aggressive superficial or nodular basal cell carcinoma (BCC) of the non-inferiority of 5-aminolevulinic acid compared to methyl aminolevulinate (METVIXIA) on complete clearance of all treated lesions assessed 12 weeks after the last photodynamic therapy (PDT; two sessions with an interval of one week between sessions, that may be repeated in the event of non-response or an inadequate response at week 12),
recurrences with 5-aminolevulinic acid (2.9% and 6.7% of lesions, respectively, 6 and 12 months after the last PDT) comparable with methyl aminolevulinate (4.3% and 8.2% of lesions, respectively, 6 and 12 months after the last PDT),
the similar safety profile to that of methyl aminolevulinate, primarily including local reactions, such as irritation, erythema and pain,
the Committee deems that AMELUZ (5-aminolevulinic acid) 78 mg/g gel provides no clinical added value (CAV V) compared to METVIXIA (methyl aminolevulinate) in the treatment of superficial basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.
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