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NICE guidance increases treatment options for patients with severe ankylosing spondylitis

The National Institute for Health and Care Excellence (NICE) has published guidance recommending infliximab for use within its marketing authorisation as an option for treating severe active ankylosing spondylitis (AS) in adults whose disease has responded inadequately to, or who cannot tolerate, non-steroidal anti-inflammatory drugs.1

NICE last reviewed infliximab for AS in 2008 and decided that it was not cost-effective.2 However, the recent availability of biosimilar infliximab medicines in the UK has enabled NICE to recommend infliximab in its latest guidance for treating severe active AS “if treatment is started with the least expensive infliximab product”.1 This change was possible because, for the first time, NICE took into consideration the acquisition costs rather than the list price alone, and the biosimilar medicines have been made available at significant discounts through the regional tendering processes.

This is a significant milestone, not just for patients with severe AS, who now have more options, but also for the wider NHS. Biological medicines have transformed the treatment of auto-inflammatory diseases such as AS, but high costs and finite NHS budgets have limited their use and, in some cases, meant that patients who could benefit from them have not had access.3

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). Remsima® (infliximab) is a biosimilar version of the tumour necrosis factor-? (TNF?) inhibitor, Remicade® (infliximab; trademark of Merck, Sharp and Dohme)4,5 and is potentially available at 40 – 50% below the Remicade NHS list price, depending on local contracts and agreements in place for both the originator and the biosimilar.

In February 2015, the annual NHS spend on anti-TNF biological medicines alone was reported to be £918.45 million6 and this is set to continue to increase, so there is a significant financial need for the successful uptake of biosimilar medicines in the UK. 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,7 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”, said 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 CCGs 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).8