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1 Recommendations

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2 Information about imlifidase

Marketing authorisation indication

2.1 Imlifidase (Idefirix, Hansa Biopharma) is indicated for 'desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.' The marketing authorisation for imlifidase is conditional based on trial results being provided in 2023 and 2025.

Dosage in the marketing authorisation

2.2 The dosage schedule is available in the summary of product characteristics for imlifidase.

Price

2.3 The proposed list price for imlifidase is £135,000 per 11 mg vial. An average course of treatment is expected to cost £300,490 at list price.

The company has a commercial arrangement, which would have applied if the technology had been recommended.