The National Institute for Health and Care Excellence (NICE) has issued its final appraisal determination (FAD) to Janssen recommending Tremfya (guselkumab) for treatment of adults with moderate to severe plaque psoriasis.
Psoriasis
Guselkumab is a biologic that selectively targets interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response in psoriasis. It 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.
This latest recommendation from NICE 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 10 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 tolerated and
- the company provides the drug with the discount agreed in the patient access scheme.
“Psoriasis is a serious long-term condition with important comorbidities that can impact patients’ daily lives,” said Professor Chris Griffiths, foundation professor of Dermatology at The University of Manchester, UK and VOYAGE 1 study steering committee member. “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.”
Jennifer Lee, director of Health Economics, Market Access and Reimbursement (HEMAR) and Advocacy, Janssen-Cilag commented on the NICE approval: “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. At Janssen, we remain committed to developing innovative therapies to improve the lives of those living with these debilitating diseases.”
Following the European Commission approval of the therapy in November last year (2017) — which was based on the data from Phase III clinical trials — the FAD from NICE was fast-tracked. This fast track process means that eligible patients will be able to access the treatment more quickly.