NICE Admits Previous Guidance Around Sequential Use Of Anti-TNF Therapies In Rheumatoid Arthritis Unfair

Main Category: Arthritis / Rheumatology
Also Included In: Regulatory Affairs / Drug Approvals;  Pain / Anesthetics;  Immune System / Vaccines
Article Date: 24 Nov 2008 - 7:00 PDT

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The National Institute of Health and Clinical Excellence (NICE) has today published findings of its appeal panel around the use of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis (RA) after failure of a previous TNF-α inhibitor (sequential use), deciding their previous guidance had been 'unfair' and 'perverse'1.

Within a 24 page document, published today on the Institute's website, the appeal panel (which included Sir Michael Rawlins, chairman of NICE) upheld numerous appeal points around the previously issued Final Appraisal Document (TA130). These included decisions around the Institute failing to act fairly and in accordance with its published procedures and preparing guidance that is perverse in light of the evidence submitted.

"The panel's decision to uphold these appeal points is very good news for thousands of rheumatoid arthritis patients ", explained Dr Brian Muller, Medical Director, Schering-Plough UK and Ireland, "In effect, NICE has returned some flexibility for Rheumatologists in the UK to make prescribing decisions about anti-TNF therapies based on both clinical and cost effectiveness grounds. We believe the NICE Appeal Panel have reached the right decision, and look forward to participating fully in any future appraisal".

He continued, "As we have consistently stated, Schering-Plough believes that, based on the supporting evidence, all patients should have the right to access the anti-TNF therapy their clinician feels is most effective for them, at whatever stage of their treatment pathway is deemed clinically appropriate. We hope the Appraisal Committee and the Institute will take every possible step to complete a re-appraisal as quickly and as efficiently as possible".

NICE has written to the Department of Health to seek advice about next steps around re-appraising sequential use of anti-TNF therapies for the treatment of RA. In the interim, all previous guidance around the sequential use of these medicines is now obsolete and should not be used by any healthcare professionals / prescribing advisors in making treatment decisions for patients with RA.

Further information about the NICE appeal is available online here.

-- An Appeal Panel was convened on 29th September 2008 to consider an appeal against the Institute's Final Appraisal Determination, to the NHS, on the use of adalimumab, etanercept and infliximab for the treatment of rheumatoid arthritis after failure of a previous TNF-α inhibitor (sequential use).

-- The Panel considered appeals submitted by:
- Abbott Laboratories
- Arthritis and Musculoskeletal Alliance
- National Rheumatoid Arthritis Society
- Royal College of Nursing
- Schering Plough
- Wyeth Pharmaceuticals

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, animal health and consumer health care 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. The company is based in Kenilworth, N.J., and its Web site is http://www.schering-plough.com

References

1. NICE - Rheumatoid Arthritis Adalimumab Appeal Pane lDecision. (PDF), accessed 24 November 2008

http://www.schering-plough.com