NICE guidance & SMC approval of Tremfya▼ for plaque psoriasis

The National Institute for Health and Care Excellence (NICE) has issued their Technology Appraisal Guidance (TAG) recommending guselkumab as an option for treating plaque psoriasis in adults.

The recommendation applies 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
• The disease has not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation), or these options are contraindicated or not tolerated
• The company provides the drug with the discount agreed in the patient access scheme

Psoriasis affects up to 1.8 million people in the UK and can have a considerable impact on physical and psychological wellbeing, with one third of patients experiencing depression and anxiety. The visible nature of psoriasis can result in self-consciousness and low self-esteem.

The NICE TAG and preceding EMA approval were based on data from two Phase III clinical studies: the VOYAGE 1 and 2 trials, which compared guselkumab with placebo and Humira® (adalimumab). The data showed high levels of skin clearance after 16 weeks. Longer term data also demonstrated consistent rates of skin clearance in patients with moderate to severe psoriasis treated with guselkumab through week 100.

The Scottish Medicines Consortium (SMC) has also recommended guselkumab for the treatment of adults with moderate to severe plaque psoriasis.

Jennifer Lee, Director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy, Janssen-Cilag Ltd said, “We are delighted with the NICE and SMC decisions, extending access to guselkumab for people suffering with psoriasis in the UK. There is still a need for new treatment options that improve long-term outcomes for patients, who so often have to deal with the psychological as well as the physical impact of this disease.”