1 Recommendations
1.1
Bimekizumab alone or with methotrexate, is recommended as an option for treating active psoriatic arthritis (defined as peripheral arthritis with 3 or more tender joints and 3 or more swollen joints) in adults whose condition has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have had 2 conventional DMARDs and:
1.2
Assess response to bimekizumab after 16 weeks of treatment. Stop bimekizumab if the psoriatic arthritis has not responded adequately using the Psoriatic Arthritis Response Criteria (PsARC; an adequate response is an improvement in at least 2 of the 4 criteria, 1 of which must be joint tenderness or swelling score, with no worsening in any of the 4 criteria). If the PsARC response is not adequate but there is a Psoriasis Area and Severity Index (PASI) 75 response, a dermatologist should decide whether continuing treatment is appropriate based on skin response.
1.3
Take into account any physical, sensory or learning disabilities, or communication difficulties that could affect the responses to the PsARC and make any adjustments needed.
1.4
Take into account how skin colour could affect the PASI score and make any adjustments needed
1.5
If people with the condition and their clinicians consider bimekizumab to be 1 of a range of suitable treatments (including ixekizumab and secukinumab), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements.
1.6
These recommendations are not intended to affect treatment with bimekizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why these recommendations were made
Usual treatment for psoriatic arthritis is DMARDS, including biological DMARDs such as ixekizumab and secukinumab. Bimekizumab works in a similar way to these 2 treatments, and would be offered to the same population.
Clinical evidence shows that bimekizumab is more effective than placebo. Bimekizumab has not been compared directly with ixekizumab. But the results of an indirect comparison suggest that it is as effective as ixekizumab, and likely has similar safety.
A cost comparison suggests bimekizumab has lower costs than ixekizumab. Using NICE's cost comparison methods, bimekizumab only needs to cost less than 1 relevant comparator which is established practice in the NHS, to be recommended as a treatment option. So bimekizumab is recommended.
For all evidence see the committee papers. To see what NICE did for ixekizumab and secukinumab, see the committee discussion section in NICE's technology appraisal guidance on ixekizumab and secukinumab.