Some patients with rheumatoid arthritis living in England and Wales should get ‘routine’ NHS access to Sanofi’s Kevzara after cost regulators issued draft guidelines deeming the drug cost effective.
The National Institute for Health and Care Excellence is backing use of Kevzara (sarilumab) with methotrexate as an option for treating severe active rheumatoid arthritis in adults whose disease has responded inadequately to intensive therapy with a combination of conventional disease-modifying antirheumatic drugs (DMARDs).
It’s also being recommended for adults with severe RA who have had an inadequate response to, or who cannot have other DMARDs, including at least one biological DMARD, and who cannot have rituximab.
The draft guidance also back use of Kevzara with methotrexate as an option for adults with severe active RA when their disease has responded inadequately to rituximab and at least one biological DMARD, and as monotherapy for those who can’t take methotrexate.
Sanofi has agreed a patient access scheme that will reduce the cost of the drug to the NHS, but the details are confidential.
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that attacks the tissues of the joints, causing inflammation, pain, and eventually joint damage and disability, which affects around 450,000 people in the UK, of whom around 15 percent have the severe form of the disease.
As many patient fail to respond adequately to existing therapies or experience loss of response over time new treatment options are urgently needed.
“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,” said Professor Ernest Choy, consultant Rheumatologist, University of Cardiff.
“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.”
Kevzara is a human monoclonal antibody that binds to the interleukin-6 receptor (IL-6R), and has been shown to inhibit IL-6R mediated signalling. In excess and over time, IL-6 can contribute to the inflammation associated with RA.
The drug’s approval in Europe in June was based on results from seven Phase III trials in the global SARIL-RA clinical development programme of more than 3,300 adults with moderately to severely active RA who have had an inadequate response or intolerance to one or more biologic or non-biologic DMARDs, which showed that the drug induced statistically significant, clinically-meaningful improvements in patients.
Improvement in signs and symptoms of RA at 24 weeks, as measured by the American College of Rheumatology score of 20 percent improvement (ACR20), were: 61 percent in the sarilumab 200mg group; 56 percent in the sarilumab 150mg group; and 34 percent in the placebo group, all in combination with DMARD therapy.