Cost gatekeepers give final 'no' to Pfizer's targeted cancer drug Xalkori

Clinically effective but not cost-effective. That's what U.K. watchdogs have determined about Pfizer's ($PFE) targeted lung cancer drug, Xalkori. Despite a discount offer from Pfizer, the National Institute for Health and Care Excellence still believes Xalkori isn't a good value.

The Pfizer drug, approved by FDA in 2011 and in Europe last year, is a tyrosine kinase inhibitor that targets cancers that test positive for ALK-gene rearrangements. That covers only a small fraction of patients with non-small cell lung cancer. NICE delivered its first rejection on the drug in March, but Pfizer had some reason to hope; late last year, NICE reversed itself on Roche's ($RHHBY) Zelboraf, another targeted cancer drug with a steep price.

Xalkori's list price runs about £37,512 to £46,890 for a course of treatment in the U.K., NICE figures, and up to £51,579 if treatment continues after the cancer progresses. That's about $82,780 on the high end. Pfizer offered a "patient access scheme"--a.k.a. discount--but apparently the cut wasn't big enough.

"Although the independent committee that considered the evidence found crizotinib to be clinically effective treatment ... [it] could not be considered a cost-effective use of NHS resources," even after Pfizer's confidential discount offer was applied, NICE chief Sir Andrew Dillon said in a statement.

Xalkori has had a difficult time of it with European cost regulators. Germany's strict Institute for Quality and Efficiency in Health Care (IQWiG) decided that Xalkori delivered no additional benefit compared with currently available treatments, basically because comparative data was lacking.

But because Xalkori is effective in only a small subset of patients--and only those patients are eligible for the drug--direct comparisons with other NSCLC drugs are dicey. Pfizer has said that the current cost-evaluation systems are problematic for highly targeted drugs like Xalkori. Other companies working on targeted cancer meds might agree. Whether authorities will rework their strategies remains to be seen.

- read the NICE release

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