NICE Guidance on COX-2: details of companies' rejected appeals

The UK government has welcomed the National Institute for ClinicalExcellence's new Guidance which says that the use of four COX-2-selective inhibitors to treat rheumatoid arthritis and osteoarthritis should be limited to high-risk patients (Marketletter July 30). Health Minister Lord Philip Hunt said the Guidance will help ensure more equal access to treatment for arthritis, and was a "clear indication" of the government's "determination to stamp out the postcode lottery of care."

However, the makers of two of the drugs, Pharmacia and Pfizer with Celebrex (celecoxib) and Merck & Co with Vioxx (rofecoxib), are considering applying for a judicial review, notes the Financial Times, rather than waiting for the NICE to revisit the Guidance in May 2004, after their appeals against the Final Appraisal Determination on the drugs were rejected. While there can be no further appeal against a NICE Appeal Panel's decision, it and the NICE's decision to issue the Guidance may be challenged through an application to the High Court for permission to apply for judicial review, to be made within three months.

The appeal by Pharmacia and Pfizer queried how the Appraisal Committee had used the evaluation report in its deliberations, particularly with respect to the different methodologies and analyses employed in evidence submitted. However, the Appeal Panel said it was satisfied that the Committee had considered all evidence submitted, and rejected the companies' claims that: