- Pfizer's leukemia drug Bosulif has been approved by the U.K.'s cost watchdog for coverage through the National Health Service, reversing a 2013 rejection by the same agency. Bosulif had been available through the U.K.'s Cancer Drugs Fund and is the first drug to be reappraised for new approval.
- The reappraisal comes in the wake of of changes to the Cancer Drugs Fund, which traditionally has covered cancer drugs rejected by the cost agency, the National Institute for Health and Care Excellence (NICE).
- NICE estimates roughly 80 patients in England and Wales would now be eligible for Bosulif each year. Pfizer has agreed to provide a discount for Bosulif, which has a list price of £45,000 per patient per year.
NICE announced reforms to the Cancer Drugs Fund (CDF) back in March, aiming to speed up its decision-making on the cost-effectiveness of new oncology drugs. Rather than waiting until after marketing approval in the U.K. is granted, NICE will now issue draft guidance on new drugs before approval. Any drug with a positive recommendation would be immediately covered if licensed for use in the U.K.
As a corollary to the changes, NICE can now decide to issue conditional approval for a drug with less evidence of efficacy and price-effectiveness. That drug would then be covered through the Cancer Drugs Fund for up to 2 years, allowing drugmakers to submit more evidence to support a product's efficacy or cost-effectiveness.
NICE is notorious for rigorous cost-effectiveness analyses and has held back coverage for a number of oncology drugs for not meetings certain thresholds. Just this week the agency issued draft guidance recommending Bristol-Myers Squibb's Opdivo not be covered for use against kidney cancer.
The CDF's budget has been stretched recently by the rising cost of some new drugs not recommended for coverage by NICE. Costs doubled to £416 million pounds in the year ending in March, a significant increase from the £175 million spent a year prior, according to Bloomberg.
This increased expenditure put the fund at risk of exhausting its resources, leading to the recently announced reforms to the CDF.
NICE is now going back and revisiting drugs listed on the CDF under the old system. Bosulif is the first, but there are another 30 previously rejected drugs on the docket.
“The company positively engaged with our CDF reconsideration process and demonstrated that their drug can be cost effective, which resulted in a positive recommendation," said Carole Langson, director for the Center for Health Technology Evaluation at NICE.
“This decision, when implemented, frees up funding in the CDF which can be spent on other new and innovative cancer treatments," Langson continued.