NICE Denies Infliximab For The Treatment Of Ankylosing Spondylitis, UK

Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics
Article Date: 30 May 2008 - 1:00 PDT

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Schering-Plough is extremely disappointed with the outcome of the National Institute for Health and Clinical Excellence (NICE) appeal panel with regards to the Final Guidance (FAD) around infliximab for the treatment of ankylosing spondylitis (AS).

Schering-Plough believes that the economic modelling supporting the Institute's recommendations was highly unsatisfactory. Indeed, this was the focus of a number of Schering-Plough's points of appeal. It is very disappointing that a fully-executable version of the economic model used by the Institute was not released to consultees during this appraisal. Following the recent Court of Appeal ruling in relation to NICE's release of economic models, Schering-Plough will be writing to the Institute to request a fully-executable version of its model for review.

As stated throughout the appraisal and appeal process, Schering-Plough believes strongly in the safety and efficacy of infliximab for the treatment of AS, as well as the cost effectiveness of infliximab in a number of patient sub-groups. As such, Schering-Plough feel NICE have made the wrong decision for thousands of patients with this painful and debilitating inflammatory disease.

Many AS patients also suffer from extra-articular manifestations such as Crohn's Disease, which infliximab is also licensed to treat. This guidance denies clinicians the opportunity to prescribe a treatment they feel could be most appropriate based on clinical effectiveness.

Schering-Plough is committed to exploring a range of options to ensure patients are able to access infliximab and will be considering how best to achieve this goal.

Background information:

About Ankylosing Spondylitis

Ankylosing Spondylitis (AS) is a painful and progressive rheumatic disease that causes some or all of the sacroiliac joints in the spine to fuse together.1,2 In addition to the spine, about 20% of individuals have significant involvement of peripheral joints, including the hips, knees and shoulders. AS can also affect other parts of the body, including the eyes, lungs, bowel and heart. The joint pain of AS can impact a patient's ability to perform normal daily activities, limit job opportunities, and make family and household responsibilities a challenge.

About Schering-Plough

Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription and consumer products as well as to animal health products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world.

Schering-Plough