New guidelines for the treatment of severe ankylosing spondylitis (AS) have been published by the UK National Institute for Health and Care Excellence (NICE). The guidelines recommend infliximab for use within its marketing authorisation, as a potential treatment in adults whose disease has not responded adequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs.
A prior 2008 NICE review found that infliximab was not a cost-effective treatment for AS. The UK release of biosimilar infliximab, however, has enabled NICE to promote the treatment, if it “is started with the least expensive infliximab produce”.
This recommendation was made possible by NICE’s consideration of the acquisition costs of the medicine, rather than the list price alone, according to a press release. The biosimilar medicines have been made available at significant discounts through the regional tendering processes.
Biosimilar infliximab, the first biosimilar monoclonal antibody, became available in the UK earlier this year, for the treatment of AS and other inflammatory autoimmune diseases, including rheumatoid arthritis (RA) and inflammatory bowel disease (IBD).
In February 2015, the annual NHS spend on anti-TNF biological medicines alone was reported to be £918.45 million. This is set to continue to increase, so there is a significant financial need for the successful uptake of biosimilar medicines in the UK. According to a press release, uptake of biosimilar infliximab in the UK is geographically variable and the pace of change has so far been slow compared with some EU countries, including Denmark and Norway, but it is gradually increasing.
“We strongly welcome this new guidance because it expands the treatment options available to patients with severe AS, and sends a strong signal that biosimilar infliximab is recommended for use within the NHS”, says Andrew Roberts, director of Market Access at Napp Pharmaceuticals Limited. “Biosimilar medicines present a huge opportunity for the NHS. With their reduced cost, they could improve patient care through wider or earlier access for appropriate patients, and the money saved from wider uptake could be reinvested back into local services for patients or used to improve funding for innovative new medicines. The new NICE guidance around AS is a very welcome step towards this. We have seen some areas already taking advantage of the opportunity, but there are still many clinical commissioning groups and trusts who could be benefitting.”
In addition to today’s guidance, NICE published an adoption resource in July 2015, “Introducing biosimilar versions of infliximab: Inflectra and Remsima,” which provides practical advice on how to introduce biosimilars into clinical practice (NICE Technology Appraisal Support (HTTA329).