NICE reassessment of Schering Plough’s Temodal welcomed

NICE’s decision to return the final appraisal determination (FAD) for Temodal (temozolomide), Schering-Plough’s anti-brain tumour therapy, has been welcomed by Brain Tumour UK, a charity.

The drug regulatory body for England and Wales had concluded that the use of Temodal on the NHS should be restricted to newly diagnosed patients with a high grade of malignant brain tumour.

Additionally, NICE ruled that carmustine implants, marketed by MGI Pharma, should not be recommended at all for NHS use in patients with high grade brain gliomas.

Nine groups appealed the decisions and now NICE has said that the therapies are now being re-examined because of an error made in the glioma models created by the assessment committee.

A statement from Brain Cancer UK read: “As representatives of brain tumour patients, their families and carers, we very much welcome NICE’s decision to fully investigate this miscalculation further and revise its analysis.”

The charity added that primary care trusts could still “make up their own minds” about treatment funding and were still free to stock these drugs.

Brain Cancer UK said that this would comply with government policy, which states that the NHS should not necessarily refuse to supply drugs that have not received a final appraisal from NICE.

It concluded by saying that trusts should allow access to Temodal and carmustine implants, which are considered to be standard therapies elsewhere in the world.

Temodal, marketed in some countries as Temodar, is one of four oncology drugs currently sold by Schering-Plough.

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