Cost regulators for the National Health Service in England and Wales have expanded treatment options for patients with ankylosing spondylitis.

The National Institute for Health and Care Excellence has now published guidelines recommending TNF-alpha inhibitors -adalimumab (AbbVie’s Humira), certolizumab pegol (UCB Pharma’s Cimzia), etanercept (Pfizer’s Enbrel), golimumab (MSD’s Simponi) and infliximab (MSD’s Remicade, Napp Pharmaceuticals’ Remsima, and Hospira’s Inflectra) - for the condition.

The drugs are endorsed for people with severe active ankylosing spondylitis (ax-SpA) and, for the first time, severe non_radiographic axial spondyloarthritis (nr-axSpA), in whom treatment with non_steroidal anti_inflammatory drugs (NSAIDs) hasn’t worked.

The updated recommendations also endorse the use of infliximab for the first time, having deemed the drug too expensive in previous guidelines published in 2008, with NICE has stipulating that it is recommended if treatment is started with the least expensive product. 

According to Napp, who market the Celltrion-manufactured infliximab biosimilar Remsima in the UK, this change was possible because, for the first time, the acquisition cost of the drug was taken into account instead of just its list price, and biosimilars “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,” it noted.

Greater patient involvement

Also, the guidelines state that choice of therapy should take into account any associated conditions including extra-articular manifestations (EAMs) and should involve discussion with patients on the best option for them, and NICE now also recommends switching to another TNF-alpha inhibitor in adults whose disease does not respond or stops doing so after an initial response.

‘‘We hope that the recommendations will enable broader and earlier access to TNF-alpha inhibitors, taking into account other associated conditions and allowing people to have more say in their treatment,” said Debbie Cook, chief executive of the National Ankylosing Spondylitis Society. “Permitting treatment switching is also good news for patients as it reduces the fear and anxiety associated with only having one option.”

“The new recommendations represent a significant step forward in the treatment of axSpA,” said Raj Sengupta, consultant rheumatologist and lead consultant for Ankylosing Spondylitis at the Royal National Hospital for Rheumatic Diseases, Bath. “The inclusion of nr-axSpA in the guidelines will mean a broader group of patients will have access to these important medicines.”