Xalkori image

NICE: final ‘no’ for Xalkori

pharmafile | September 25, 2013 | News story | Sales and Marketing NICE, NSCLC, Pfizer, Xalkori 

Pfizer’s worst fears have been confirmed today by NICE, which has rejected its new lung cancer drug Xalkori because of its high cost.

Draft guidance in August signalled that NICE was heading in this direction, but the confirmation will be a blow for Pfizer, giving the brand little scope for benefiting now from the lucrative NHS market.

Xalkori (crizotinib) had been under review for patients with previously-treated anaplastic-lymphoma-kinase-positive (ALK) advanced non-small cell lung cancer (NSCLC).

Pfizer had even agreed a cost-cutting scheme with the Department of Health and revised its own cost effectiveness analysis – but the pricing watchdog has simply concluded it does not represent value for money for the taxpayer.

“Having already recommended a number of treatments for the various stages of NSCLC, we are disappointed not to be able to add crizotinib as a treatment option for patients,” said NICE chief executive Sir Andrew Dillon.

There is no doubt over the tyrosine kinase inhibitor’s clinical effectiveness, since it has shown a median gain of 5.1 months in progression free survival compared with chemotherapy agent docetaxel – even though there is uncertainty about its effect on overall survival.

However, it “could not be considered a cost effective use of NHS resources, even when taking into consideration the manufacturer’s patient access scheme”, Sir Andrew concluded.

Xalkori works by blocking enzymes which can stimulate cancers to grow, specifically ALK, which is present in some types of NSCLC.

Current NICE-approved rivals for NSCLC include AstraZeneca’s Iressa (gefitinib) and Roche’s Tarceva (erlotinib) – both EGFR mutation positive treatments – but none are on NICE’s list for ALK-positive forms of the disease. 

Before the discount, a month’s worth of Xalkori costs £4,689 and NICE estimates the average cost of a course of treatment would be between £37,512 and £46,890.

Assuming treatment after disease progression, this would rise to more than £51,000.

NICE thought the cost per QALY would be greater than £100,000 per QALY gained, and for Xalkori compared with best supportive care it would be more than £50,200 per QALY gained.

This put the drug into a cost bracket which NICE has often shown itself unwilling to contemplate – although that knowledge is unlikely to assuage Pfizer’s disappointment.

Adam Hill

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