‘Weak’ evidence leads to NICE no for three leukaemia drugs

pharmafile | May 6, 2011 | News story | Sales and Marketing Glivec, NICE, Sprycel, Tasigna 

NICE has not recommended three major drugs for the rare blood cancer chronic myeloid leukaemia.

In draft guidance on treating CML that’s resistant to the standard dose of Glivec, NICE refused to back Bristol-Myers Squibb’s Sprycel (dasatinib), Novartis’s Tasigna (nilotinib) and a higher dose form of Novartis’s Glivec (imatinib).

All three are high cost drugs, with Sprycel and Tasigna costing £30,000 per patient, per year.

The higher dose of Glivec – which is also licenced to treat a form of stomach cancer – has now increased in price to over £40,000 per year, per patient, NICE said.

Sir Andrew Dillon, chief executive at NICE, said: “The evidence for the effectiveness of dasatinib, high-dose imatinib and nilotinib is very weak.

“When we recommend the use of very expensive treatments, we need to be confident that they bring sufficient additional benefit to justify their cost.”

NICE added that because chronic myeloid leukaemia (CML) is a chronic condition, the drugs would be used for a longer period of time, making them a greater expense for the NHS. 

A standard dose of Glivec was recommended by the Institute as a first-line treatment of CML in 2003, and has remained as the standard treatment for the disease.

A higher dose form was considered during the 2003 appraisal, but NICE restricted its access to clinical trial use.

Currently if patients become resistant to a standard dose of Glivec, their options are limited to treatment with interferon-alfa, hydroxycarbamide or a bone marrow transplant.

Neither company has as yet offered a patient access scheme for their drugs.

There are also two additional ongoing appraisals, with the first looking at Sprycel and Tasigna for the treatment of CML in patients who are intolerant of Glivec.

The second looks at Sprycel, Tasigna and standard-dose Glivec for the first-line treatment of CML.

Ben Adams

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