The National Institute for Health and Care Excellence (NICE) has published its positive guidance for the first selective interleukin (IL)-23 inhibitor to treat moderate to severe plaque psoriasis.
approval
This decision follows from the positive Final Appraisal Determination on Janssen’s Tremfya (guselkumab) and means that patients with moderate to severe plaque psoriasis will have access to the therapy on the NHS in England and Wales.
Additionally, last month (17 May 2018), Germany’s drug reimbursement body, The Federal Joint Committee (Gemeinsamer Bundesausschuss; G-BA) published its decision stating that guselkumab offered ‘substantial additional therapeutic benefits’ compared to treatment with comparators for all patient populations assessed. This is the first time a biologic treatment for psoriasis has been awarded this level of benefit.
“The swift decision by two of Europe’s key Health Technology Assessment bodies reflects the positive results demonstrated in clinical studies of guselkumab for the treatment of moderate to severe plaque psoriasis,” said Dr Jaime Oliver, medical lead for Janssen Immunology, EMEA. “Psoriasis can be a painful, debilitating condition with severe psychological repercussions, often causing patients to feel self-conscious, isolated and depressed. Providing a new therapeutic option may help to alleviate some of the physical and emotional burden of this disease. We are therefore working hard to ensure that eligible patients in Europe can access guselkumab as quickly as possible.”
These are the first two positive Health Technology Assessments (HTAs) in Europe for guselkumab after its Marketing Authorisation was granted by the European Commission in November 2017. Both decisions were based on data from Phase III clinical studies — the VOYAGE 1 and 2 trials — which compared guselkumab with placebo and Humira (adalimumab) and 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 who received treatment with guselkumab for almost two years.
Guselkumab is the first biologic to selectively target interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response in psoriasis. It is offered as a subcutaneous injectable treatment for psoriasis and can be self-administered following training. Treatment requires two starter doses, one initially and the other four weeks later, followed by a maintenance dose once every eight weeks (q8w) thereafter.