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NICE finally approves glioma drugs after finding error in its calculations

Posted on: 04/18/2007


The UK health spending watchdog is set to approve two drugs for the treatment of high-grade glioma, overturning its earlier provisional 'no' to the products after it discovered its initial calculations were not sound.

In a final appraisal document, the National Institute for Health and Clinical Excellence (NICE) said it would recommend Schering-Plough's Temodal (temozolomide) for the treatment of newly-diagnosed glioblastoma multiforme (GBM) as well as Link Pharmaceutical's Gliadel (carmustine implant) in a subgroup of patients.

In February 2006, in its initial assessment, NICE came out firmly against the products. However, in September it was forced to go back and resume its calculations after an error was found in its glioma cost-effectiveness model.

Charity Cancer Research UK, which is a co-developer of Temodal, welcomed NICE's new stance but slated the body for the time it had taken to come to the decision.

In a statement the charity's medical director, professor John Toy said NICE's decision was: "Very good news … However, it's completely unacceptable that NICE has taken well over two years to finally arrive at this decision."

He continued: "Research on temozolomide suggests that it improves the two year survival rate for patients by 16%. We can't say how many lives have been cut shorter in the time it has taken NICE to approve the use of temozolomide."

In a statement Schering-Plough also welcomed NICE's belated change of heart.

On its website NICE stressed the two drugs had been appraised independently rather than for sequential use.

It said temozolomide was recommended as an option for the treatment of newly-diagnosed GBM patients with a WHO performance status of 0 or 1.

Carmustine implants are recommended as an option for the treatment of newly diagnosed high-grade glioma only for patients in whom 90% or more of the tumour has been resected.

Temozolomide was developed with Cancer Research UK funding and taken by the charity as far as early Phase II. Based on promising data in glioma and melanoma Schering-Plough then licensed the drug.

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