Cost watchdog nixes Pfizer's new CML drug Bosulif


With the prices of cancer drugs skyrocketing, the U.K.'s National Institute for Health and Care Excellence (NICE) has put its foot down. These days, drugmakers almost always offer discounts to get their products cleared by the cost-effectiveness watchdog. But even that's not a sure bet for winning approval. Such was the case with Pfizer's ($PFE) Bosulif, rejected today for the treatment of chronic myeloid leukemia (CML).

In draft guidance, the healthcare guidance body said that despite Pfizer's proposed patient-access scheme, which reduces the overall cost of treatment, Bosulif benefits weren't worth the price--especially because CML is a chronic condition and drugs are used for long periods of time.

NICE also cited questionable evidence that Bosulif provides an edge over its competitors. "Limitations in the evidence provided by the manufacturer meant that the actual benefit compared to other treatments in terms of estimated effect on overall survival was unclear," NICE Chief Executive Sir Andrew Dillon said in a statement.

Those other treatments include drugs like Novartis' ($NVS) Glivec and its follow-up, Tasigna, both of which already have the OK from the regulatory body. And Bosulif is not the only CML drug NICE has turned away. Last year a discount propelled Tasigna past Bristol-Myers Squibb's ($BMY) Sprycel, which still doesn't have NICE's blessing. Pfizer itself has found success with NICE by cutting costs; in 2008, it snuck past kidney cancer competitors by offering to pay for the first cycle of treatment for its therapy Sutent.

But this time, a discount wasn't enough. According to Pharmafile, the annual cost of Bosulif at its recommended dose is £44,799, or $67,730--meaning even a discount would still leave the U.K.'s National Health Service with a hefty financial burden. Though Dillon said it was disappointing to forego a third CML treatment, "NHS resources are limited and NICE has to decide what treatments represent best value to the patient as well as to the NHS," he said.

Pfizer and other consultants, professionals and members of the public will now have a chance to add their two cents before a final decision is reached. And while the word from NICE only directly affects U.K. patients, other countries are following closely, especially as many begin to scrutinize and reassess their healthcare costs.

- here's the release
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