High dose Glivec not recommended by NICE

The National Institute for Health and Clinical Excellence (NICE) has issued a preliminary view not to recommend a higher dose of Novartis' Glivec (imatinib) for the treatment of patients with gastrointestinal stromal tumours (GISTs) that are metastatic or can't be surgically removed, and who do not respond to standard dose imatinib.

"NICE already recommends imatinib at a dose of 400 mg per day for patients with gastrointestinal stromal tumours that cannot be removed by surgery," said Andrew Dillon, chief executive of NICE.

"However, since the appraisal was published in October 2004, there has been no new good quality clinical and cost effectiveness data produced on doses of 600 or 800 mg per day. On this basis, we cannot recommend these higher doses of imatinib for use on the NHS."

At standard dose, the drug costs around £19,500 per patient each year. This would increase to £29,300 per patient annually for a 600mg per day dose, and £39,067 per patient annually for a dose of 800mg per day.

From the available data, these figures were not seen as cost-effective by NICE. There are almost 800 incidents of GISTs per year in England and Wales, with around two thirds of these unable to be resolved surgically.

In its response to the decision, Novartis said that it was "not possible to conduct a robust health economic assessment" of the treatment, with no studies specifically designed to assess the clinical effects of dose escalation.

"Novartis Oncology acknowledges the difficulties in developing a cost effectiveness analysis given the limitations of the available data, and flagged the specific challenges for this appraisal at its outset," said Panos Alexakos, oncology general manager for Novartis UK and Ireland.

"We are deeply concerned however, that NICE chose to disregard the available clinical evidence, clinicians views and patients' needs by issuing this guidance."

Novartis are able to present its comments on the decision up to July 20, 2010, with a second appraisal meeting in August.

NICE has previously recommended Pfizer's Sutent (sunitinib) as a treatment for patients with unresectable or metastatic malignant GISTs for whom standard dose imatinib is ineffective or unsuitable.