bimekizumab (Bimzelx)

following a full submission:

bimekizumab (Bimzelx®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of active moderate to severe hidradenitis
suppurativa (HS) (acne inversa) in adults with an inadequate response to conventional
systemic HS therapy.

SMC restriction: for use in adult patients with active moderate to severe HS for whom
adalimumab is contraindicated or otherwise unsuitable, including those who have failed to
respond or have lost response to prior adalimumab treatment.

In two phase III studies in patients with moderate to severe HS, significantly more patients
achieved a clinical response (defined as ≥50% decrease in abscess and inflammatory nodule
[AN] count with no increase in the number of abscesses and/or in the number of draining
fistulae) with bimekizumab (every two weeks) compared with placebo at week 16.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme
(PAS) arrangement delivering the cost-effectiveness results upon which the decision was
based, or a PAS/ list price that is equivalent or lower.