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UK's NICE rejects higher doses of Novartis' Glivec

* NICE not recommending higher doses of Novartis’ Glivec

* Says not enough data on clinical and cost effectiveness

LONDON, Sept 16 (Reuters) - Novartis's NOVN.VX Glivec should not be used in higher doses for patients with gastrointestinal stromal tumours (GIST) that cannot be treated with surgery and have failed to respond to lower doses, Britain's health cost watchdog said on Thursday.

The National Institute for Health and Clinical Excellence (NICE), which decides whether drugs should be paid for on the state-funded National Health Service, said it would not recommend Glivec at 600 or 800 mg per day doses for people with GIST whose disease has progressed after treatment with 400 mg.

Glivec, known generically as imatinib, is already recommended for use in patients with chronic myeloid leukaemia and for those with GIST who are unsuited for surgery.

NICE also recommends Pfizer's PFE.N Sutent, or sunitinib, for GIST patients for whom treatment with 400mg a day of imatinib has not worked or is not suitable.

“There have been no new good quality clinical and cost effectiveness data produced on doses of 600 or 800 mg per day imatinib given after disease progression on a dose of 400 mg per day,” said NICE chief executive Andrew Dillon.

“On this basis, we cannot recommend these higher doses of imatinib for use on the NHS.”

GISTs are rare tumours which occur mostly in the stomach or bowel. Many of these tumours can be removed by surgery but some cannot and are known as unresectable tumours. Without treatment, unresectable GISTs grow and will eventually spread.

NICE said in June that Glivec should not be given to Gist patients whose tumours have been removed by surgery, since there was not enough evidence about the drug’s effectiveness in this setting. [ID:nLDE65N1RW]

“At about 19,500 pounds ($29,200) per patient per year, this is a relatively expensive drug and we need to be sure about how well it works and what its side-effects are before we can recommend it as cost-effective,” Dillon said at the time. (Reporting by Kate Kelland, editing by Louise Heavens)

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