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    Has all of the relevant evidence been taken into account?

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    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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2 Information about pegcetacoplan

Anticipated marketing authorisation indication

2.1

Pegcetacoplan (Aspaveli, Sobi) does not have a marketing authorisation in the UK yet. The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of a marketing authorisation for the medicinal product pegcetacoplan, intended for treating C3 glomerulopathy or primary immune-complex membranoproliferative glomerulonephritis.

Dosage in the marketing authorisation

2.2

The dosage schedule will be available in the summary of product characteristics for pegcetacoplan.

Price

2.3

The list price for pegcetacoplan is £3,100 per 1,080 mg/20 ml vial (excluding VAT; sourced from company submission).

2.4

The company has a commercial arrangement. This makes pegcetacoplan available to the NHS with a discount and it would have also applied to this indication if pegcetacoplan had been recommended. The size of the discount is commercial in confidence.

Sustainability

2.5

Information on the Carbon Reduction Plan for UK carbon emissions for SOBI will be included here when guidance is published.