NICE Increases Access to Ankylosing Spondylitis Therapy

Cost regulators for the NHS England and Wales have expanded treatment options for patients with ankylosing spondylitis.

NICE 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 have severe active ankylosing spondylitis (ax-SpA) and those with 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 stipulated 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 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.

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. NICE now also recommends switching to another TNF-alpha inhibitor in adults whose disease does not respond or stops doing so after the 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.”


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