The National Institute for Health and Care Excellence (NICE) has granted Final Appraisal Determination (FAD) to Janssen Pharmaceutical’s psoriasis drug Tremfya (guselkumab) to treat moderate to severe plaque psoriasis.
Guselkumab is the first biologic to selectively target interleukin (IL)-23, a key protein involved in the immune inflammatory response in psoriasis, with evidence showing superior efficacy compared with a biologic standard of care.
Issued as part of the Fast Track Appraisal procedure, FAD is the NICE appraisal committee’s final draft guidance about using a treatment or group of treatments in the NHS. It should speed up the process by which eligible patients are able to access the drug.
The NICE FAD was fast-tracked following European Commission approval in November last year, based on Phase III trials comparing guselkumab with placebo and Humira (adalimumab). Guselkumab demonstrated high levels of skin clearance after 16 weeks.
A PASI 90 score (at least a 90% reduction in the Psoriasis Area and Severity Index) was recorded in 73.3% and 70.0% of patients who received guselkumab, compared with 49.7% and 46.8% in patients receiving Humira (adalimumab) respectively.
The NICE recommendation states that guselkumab is recommended 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 101. It is also approved for patients who have not responded to other systemic therapies, including ciclosporin, methotrexate and PUVA (psoralen and long-wave ultraviolet A radiation).
Plaque psoriasis is a condition in which sufferers have dry, red skin lesions, which are covered in silver scales and known as plaques. Psoriasis affects up to 1.8 million people in the UK, and one third of patients with psoriasis experience depression and anxiety. There is currently no cure.
Guselkumab received approval for the same indication from the US Food and Drugs Administration in July 2017.
Jannsen-Cliag director of health economics, market access and reimbursement and advocacy Jennifer Lee said: “we are delighted that NICE is recommending guselkumab be made available to patients in the UK. There remains a need for new treatment options that improve long-term outcomes. Patients with moderate to severe plaque psoriasis may now benefit from this new treatment option, which has been shown to have a clinically meaningful effect on their disease.”