Reason for request

Inclusion

First assessment.

Key points

Unfavourable opinion on reimbursement in the MA indication: "Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN)".

Role in the care pathway?

LUPKYNIS (voclosporin) does not have a role in the care pathway in view of its poorly established efficacy.


Clinical Benefit

Insufficient

The clinical benefit provided by LUPKYNIS 7.9 mg (voclosporin), soft capsule is insufficient in the MA indication to be covered by national solidarity schemes given the available alternatives.


Clinical Added Value

Not applicable

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