The recommendation is the first step toward making the therapy widely available to patients in England and Wales.
Sanofi’s sarilumab, approved earlier this year by both FDA and European regulators to treat severe, active rheumatoid arthritis (RA), has cleared a key access hurdle after receiving a positive recommendation from the United Kingdom’s National Institute for Health and Care Excellence (NICE).
The draft recommendation, called a final appraisal determination, finds that sarilumab, sold as Kevzara, is a cost-effective treatment when given with methotrexate to patients with acute RA who either cannot take other disease-modifying anti-rheumatic drugs (DMARDs) or whose disease has already not responded to another biological DMARD. The draft calls for allowing sarilumab to be given as monotherapy for patients who cannot take methotrexate if tests for disease severity and other conditions are met.
The appraisal document outlines how patients can gain access to the treatment through the UK’s National Health Service under a discount agreement. A 15-day comment period on the draft ends Friday; final documents anticipated on November 1, 2017, according to the NICE website.
The decision brings Sanofi one step closer to making sarilumab available in England and Wales. NICE acted based on results of the MONARCH study, which found that sarilumab made “clinically meaningful improvements” in patients with RA, compared with another biological therapy. Sarilumab is a fully human monoclonal antibody that binds to the interleukin-6 receptor and blocks signaling from the IL-6 protein that produces inflammation and joint damage that are the hallmarks of RA.
“Over the years, we have made great progress in the diagnosis and management of RA, yet many patients still do not achieve symptom control despite the treatment choices available. NICE’s recommendation of sarilumab is good news for people with RA and their specialists as it potentially adds another treatment option,” Ernest Choy, MB BCh, MD, FRCP , consultant rheumatologist, University of Cardiff, said in a statement. “Rheumatoid arthritis is an unpredictable chronic disease. It strikes at any age, often during working life. It causes severe pain and comorbidities, which can have a huge impact on all aspects of their daily life including psychological wellbeing.”
Peter Kuiper, general manager for UL and Ireland at Sanofi Genzyme, said, “This recommendation brings us one step closer to making Kevzara available to adult patients with severe RA and reinforces Sanofi’s ongoing commitment to helping people impacted by often complex, misunderstood and debilitating diseases.”
Sarilumab was approved by FDA for US patients on May 22, 2017.