The Janssen Pharmaceutical Companies of Johnson & Johnson have announced that NICE has issued its Final Appraisal Determination (FAD) recommending Tremfya®▼ (guselkumab) for treatment of adults with moderate to severe plaque psoriasis.
The NICE recommendation states that guselkumab 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 101 and
• 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 tolerated1 and
• The company provides the drug with the discount agreed in the patient access scheme.
Affecting up to 1.8 million people in the UK psoriasis can have a considerable impact on physical and psychological well-being, with approximately one third of patients experiencing depression and anxiety. Due to the visible nature of the disease, psoriasis can lead to social isolation, due to self-consciousness and low self-esteem.
Guselkumab is the first biologic to selectively target interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response in psoriasis. Guselkumab can offer patients both effective and sustained control of this debilitating disease, with evidence showing superior efficacy compared with a biologic standard of care. It is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
The NICE FAD was fast-tracked following European Commission approval in November 2017, based on data from Phase 3 clinical studies. The VOYAGE 1 and 2 trials, which compared guselkumab with placebo and Humira® (adalimumab), showed high levels of skin clearance after 16 weeks. Guselkumab is an injectable treatment for psoriasis and can be self-administered following training.
Professor Chris Griffiths, Foundation Professor of Dermatology at The University of Manchester, said “Guselkumab provides a significant and welcome advance in our management of psoriasis with a high percentage of patients achieving clear or nearly clear skin over the long-term”.