NICE says yes to Tasigna for resistant disease

pharmafile | January 13, 2012 | News story | Sales and Marketing BMS, Glivec, NICE, Novartis, Tasigna 

NICE is recommending Novartis’ Tasigna for chronic myeloid leukaemia patients that can no longer use Glivec.

In final guidance it has recommended Tasigna (nilotinib) for the treatment of the chronic and accelerated phases of CML that is resistant or intolerant to standard-dose Glivec, which is also made by Novartis.

This means Tasigna could be used if patients become resistant or intolerant to Glivec (imatinib), which happens in around 40% of cases.

NICE said it was able to recommend the drug after Novartis agreed a discount on its treatment, details of which remains confidential.

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Professor Carole Longson, health technology evaluation centre director at NICE, said: “We are very pleased to be able to recommend nilotinib as a treatment option for the chronic and accelerated phases in people who are resistant or intolerant to standard dose imatinib.

“CML is a chronic condition, meaning the drugs will be used for a long period of time and at over £30,000 per patient per year, nilotinib is expensive. 

“However, the manufacturer has agreed to provide it to the NHS at a discounted price. This reduction in cost enabled the independent committee to approve nilotinib for use.”

NICE no for Sprycel and high-dose Glivec

But the watchdog has said no to Bristol-Myers Squibb’s Sprycel (dasatinib) and a high-dose form of Novartis’ Glivec (imatinib) in this setting, as they were both deemed too costly.   

The committee noted that Glivec 800mg was both more expensive and less effective than the other treatments.

The drug’s price also went up last year – from £30,000 per patient to around £40,000, and NICE says this has made the drug even less cost effective.

Consequently, the Institute decided not to recommend the higher dose, and is sticking to its original 2003 guidance that only backed the standard 400mg dose form of Glivec as a first line treatment.

NICE also noted that Bristol-Myers Squibb’s Sprycel (dasatinib) is more effective than high-dose Glivec, but it still not recommended, as evidence for its cost effectiveness remains ‘very weak’. 

BMS also failed to offer a patient access scheme as Novartis has done, further reducing its cost effectiveness.

The Institute received two appeals on its final draft guidance for the CML appraisal, but dismissed both on all counts.

Ben Adams 

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