In the past, the U.K.'s cost-effectiveness gatekeeper has shown that it will bend preliminary draft guidance decisions if the price is right. But for Pfizer ($PFE), which slashed costs on its targeted lung cancer drug Xalkori in hopes of gaining recommendation for its use in Britain's National Health Service (NHS), that price wasn't low enough.
As PharmaTimes reports, The National Institute for Health and Clinical Excellence (NICE) has nixed the drug once again in its final draft guidance. The regulatory body noted that even with evidence for Xalkori as a clinically effective treatment for anaplastic-lymphoma-kinase-positive advanced non-small-cell lung cancer (NSCLC) and a manufacturer's discount, the med couldn't be considered a "cost-effective use of NHS resources."
Dr. David Montgomery, the medical director at Pfizer Oncology UK, expressed disagreement with the assessment of Xalkori, which was developed for patients with a specific type of NSCLC present in only 5% of cases. "Today's decision is another example of NICE declining a medicine which we strongly believe is a clinically and cost effective treatment. If this trend of negative decisions continues, we could see the U.K. fall even further behind other European countries for cancer survival rates," he said, as quoted by Medical News Today.
Xalkori works in a high percentage of patients who qualify for treatment with the med, and the small patient pool was the rationale behind the price tag NICE originally rejected in March--£4,689 (about $7,079) for a month's supply, much more than the priciest end-of-life treatment under the agency's quality-adjusted life year analysis. But after that failed to get past the cost watchdog, PharmaTimes says Pfizer submitted a patient access scheme involving discounted prices for the NHS, as well as a revised cost-effectiveness analysis.
The U.K. is not the first government that has given Pfizer regulatory trouble with regards to Xalkori. In February, Germany's Institute for Quality and Efficiency in Health Care (IQWiG) gave the drug a thumbs-down, determining that it didn't provide an additional benefit over existing treatments based on a dearth of data comparing Xalkori's side effects to those from other NSCLC chemotherapies. Pfizer is hoping there aren't more to follow, as NICE's decisions have been known to impact healthcare systems in other countries.