NICE rejects Glivec as adjuvant therapy
pharmafile | June 24, 2010 | News story | Sales and Marketing |Â Â Glivec, NICE, NovartisÂ
NICE has rejected the use of Novartis’ Glivec as an adjuvant treatment for people who have had a gastrointestinal stromal tumour (GIST) removed and who are at risk of the cancer recurring.
The draft guidance concluded that there is evidence to show that giving Glivec (imatinib) after surgery (as adjuvant therapy) can delay the recurrence of GIST, but said there was a lack of evidence about key aspects of the clinical effectiveness of imatinib, in particular whether adjuvant imatinib extends life expectancy, how long treatment should be continued and whether resistance to the drug develops.
NICE says that if resistance develops as a result of treatment after surgery it could reduce the benefits of Glivec if a patient needs it at a later stage after their cancer has recurred.
The cost-effectiveness body says more mature evidence is expected in 2011 and its Appraisal Committee therefore recommends the appraisal is reviewed shortly after this time.
Andrew Dillon, chief executive of NICE, said: “NICE already recommends imatinib for patients with chronic myeloid leukaemia and for those with gastrointestinal stromal tumours that cannot be removed by surgery. There is some evidence that imatinib may delay cancer recurring in certain people who have had surgery to remove their tumours, but it is not clear that it increases survival or that it improves patients’ quality of life.
“The Appraisal Committee did, however, recommend that an early review date should be set for this appraisal so that evidence on the impact of adjuvant imatinib treatment on overall survival can be considered as soon as results from ongoing trials become available.
“At about £19,500 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 for use in the NHS.”
The draft guidance has now been put out to consultation.
Andrew McConaghie
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