In the first about-face since the National Institute for Health and Care Excellence began its overhaul of the overburdened Cancer Drugs Fund, England’s cost watchdogs are recommending Pfizer’s Bosulif, with a new discount, for patients who have few other options.
With NICE's final approval, Bosulif will be routinely available via England's National Health Service for Philadelphia chromosome–positive chronic myeloid leukemia patients who've either failed on other treatments or suffered side effects too severe to continue. That's about 80 new patients per year, NICE said. Previously, patients could only win access to Bosulif after application to the CDF.
It's a landmark decision, because Bosulif is the first drug to be reexamined and approved since NICE’s takeover of the financially strained CDF. The CDF, set up in 2010 to pay for drugs NICE refused to deem cost-effective, quickly outgrew its budget.
In response to those continuous budget overruns--and vocal criticism of the system over the past few years--NICE said last summer it would turn CDF into a "managed access" fund for oncology drugs. The idea was to establish "clear entry and exit criteria" for treatments. As part of the process, the cost agency planned to reassess 47 drugs then available only through CDF, suggesting that some products might be axed.
Instead, Pfizer’s Bosulif becomes the first to survive that reassessment process, thanks in part to a “further discount” the New York pharma provided during the reappraisal, NICE said.
“The company positively engaged with our CDF reconsideration process and demonstrated that their drug can be cost effective, which resulted in a positive recommendation,” Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said in a statement. “This decision, when implemented, frees up funding in the CDF which can be spent on other new and innovative cancer treatments.”
In this instance, the company did everything in its power to ensure patient access for the med, Pfizer UK’s Medical Director of Oncology, Dr. David Montgomery, said in a statement, but it’s “not sustainable” to continuously ask drugmakers to lower their prices.
While praising the decision, Montgomery said NICE has not “adapted its assessment methods at the same pace” as scientific advancement in targeted medicines. It’s a common complaint by drugmakers, which have argued that targeted medicines, while costing more, zero in on patients who are most likely to benefit and in turn waste less money on patients who won’t respond.
NICE first turned down Bosulif in November 2013, citing benefits it said weren’t worth the costs, despite a patient access scheme proposed by Pfizer.