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5 aminolaevulinic acid (Ameluz)

Advice

following a full submission:

5‑aminolaevulinic acid (as hydrochloride) (Ameluz®) is not recommended for use within NHS Scotland.

Indication under review: Treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.

In a phase III study of patients with BCC, up to two cycles of photodynamic therapy (PDT) with 5‑aminolaevulinic acid gel was non-inferior to PDT with an alternative photosensitising agent for the primary endpoint, complete clearance, defined as clearance of all treated lesions, assessed visually at 12 weeks after the last PDT.

The submitting company did not present a sufficiently robust economic case to gain acceptance by SMC.

Drug Details

Drug Name: 5 aminolaevulinic acid (Ameluz)
SMC Drug ID: 1260/17
Manufacturer: Biofrontera Bioscience GmbH
Indication: treatment of superficial and / or nodular basal cell carcinoma (BCC) unsuitable for surgical treatment due to possible treatment-related morbidity and / or poor cosmetic outcome in adults.
BNF Category:
Submission Type: Full submission
Status: Not Recommended
Date Advice Published: 7 August 2017

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