the disease is severe, as defined by a total Psoriasis Area and Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and
the disease has not responded to other systemic treatments, including ciclosporin, methotrexate and phototherapy, or these options are contraindicated or not tolerated and
the lowest maintenance dosage of certolizumab pegol is used (200 mg every 2 weeks) after the loading dosage and
the company provides the drug according to the commercial arrangement.
1.2 Stop certolizumab pegol at 16 weeks if the psoriasis has not responded adequately. An adequate response is defined as:
a 75% reduction in the PASI score (PASI 75) from when treatment started or
a 50% reduction in the PASI score (PASI 50) and a 5‑point reduction in DLQI from when treatment started.
1.3 If patients and their clinicians consider certolizumab pegol to be one of a range of suitable treatments, the least expensive should be chosen (taking into account administration costs, dosage, price per dose and commercial arrangements).
1.4 When using the PASI, healthcare professionals should take into account skin colour and how this could affect the PASI score, and make the clinical adjustments they consider appropriate.
1.5 When using the DLQI, healthcare professionals should take into account any physical, psychological, sensory or learning disabilities, or communication difficulties that could affect the responses to the DLQI and make any adjustments they consider appropriate.
1.6 These recommendations are not intended to affect treatment with certolizumab pegol 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 the committee made these recommendations
Certolizumab pegol is proposed as an alternative to other biological treatments already recommended by NICE for treating severe plaque psoriasis in adults. It is also proposed as an alternative to systemic non-biological treatments such as methotrexate, ciclosporin and acitretin in adults who have not had systemic treatment.
Clinical trial results show that certolizumab pegol improves severe plaque psoriasis more than either placebo or etanercept. When compared indirectly, it appears to be as effective as other biological treatments for the condition, and also appears to be more effective than non-biological treatments.
Cost-effectiveness estimates for certolizumab pegol show that:
For people who have not had previous systemic non-biological treatments, the lowest licensed maintenance dose (200 mg) is not cost effective compared with systemic non-biological treatments.
For people who have had systemic non-biological treatments and whose psoriasis has not responded, the lowest licensed maintenance dose (200 mg) has a similar cost effectiveness to other biological treatments.
For people whose psoriasis has partially responded to the lowest licensed maintenance dose, increasing to the highest licensed dose (400 mg) is not cost effective compared with switching to an alternative biological treatment.
Therefore, certolizumab pegol at its lowest licensed maintenance dosage (200 mg) is recommended as an option for use in the NHS for severe psoriasis that has not responded to systemic non-biological treatments, or if these are contraindicated or not tolerated.