1 Recommendations

1.1 Tildrakizumab is recommended as an option for treating plaque psoriasis in adults, only if:

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 company provides the drug according to the commercial arrangement.

1.2 Consider stopping tildrakizumab between 12 weeks and 28 weeks if there has not been at least a 50% reduction in the PASI score from when treatment started.

1.3 Stop tildrakizumab at 28 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.

1.4 If patients and their clinicians consider tildrakizumab 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).

1.5 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.

1.6 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.

1.7 These recommendations are not intended to affect treatment with tildrakizumab 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

Treatment for moderate to severe plaque psoriasis includes systemic biological treatments for disease that does not respond to systemic non-biological treatments. Tildrakizumab is proposed as an alternative to other systemic biological treatments already recommended by NICE.

Clinical trial results show that tildrakizumab improves severe plaque psoriasis compared with placebo or etanercept. More improvement is usually seen at 28 weeks compared with 12 weeks of treatment. When compared indirectly, tildrakizumab appears to be as effective as adalimumab and ustekinumab but not as effective as other biological treatments.

The most plausible cost-effectiveness estimates for tildrakizumab compared with most other available biological treatments show that it is generally cost effective. Therefore, tildrakizumab 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.