Janssen’s Tremfya (guselkumab) receives its first two positive Health Technology Assessments in Europe
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has published positive guidance for Tremfya (guselkumab), following its positive Final Appraisal Determination delivered on 2 May 2018.1,2 This means that adults with moderate to severe plaque psoriasis will now have access to guselkumab through the National Health Service (NHS) in England and Wales.
Additionally, on 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.
Dr Jaime Oliver, Medical Lead for Janssen Immunology, EMEA said: “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. 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 announcements mark 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. Further assessments of guselkumab are currently underway in a number of other countries in the European Union, with decisions anticipated later in the year.
Guselkumab is the first biologic to selectively target interleukin (IL)-23, a key protein that initiates a specific immune inflammatory response in psoriasis. Guselkumab may offer patients both effective and sustained control of this debilitating disease which affects approximately 14 million people across Europe.
The NICE guidance and the G-BA endorsement for guselkumab are based on data from Phase 3 clinical studies. The VOYAGE 1 and 2 trials compared guselkumab with placebo and Humira (adalimumab), and showed high levels of skin clearance after 16 weeks, with a PASI 90 score in around 7 out of 10 patients receiving guselkumab, compared with approximately 5 out of 10 patients receiving adalimumab, respectively (P<0.001). 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.
During the clinical development for guselkumab in psoriasis, there were no signals of increased risk of malignancy, major cardiovascular events or serious infections. Adverse events reported in at least 1 out of 20 of guselkumab-treated patients during the first 16 weeks in the VOYAGE 1 and 2 trials included: nasopharyngitis, upper respiratory tract infection, injection site erythema, headache, arthralgia, pruritus and back pain. The types of adverse events reported remained generally consistent through 48 weeks of treatment.
Guselkumab is 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.