NICE approves first drug from old Cancer Drugs Fund

Dozens of patients with leukaemia will now have an automatic right to the drug bosutinib rather than having to apply to the Cancer Drugs Fund for it.

NICE – the National Institute for Health and Care Excellence – has approved bosutinib (Bosulif, Pfizer) which treats some people chronic myeloid leukaemia (CML).

It means the drug will become available through normal NHS funding channels where as previously it was only available through the Cancer Drugs Fund (CDF).

Following the decision to reform the old CDF earlier this year, NICE began to reappraise all drugs currently in the CDF in April. Bosutinib is the first drug to be looked at through this rapid reconsideration process.

The current list price is £45,000 per patient per year, however the NHS has been offered a discount by Pfizer – the manufacturer.

Original NICE guidance looked at bosutinib in November 2013; the drug was not recommended for use on the NHS at that time as it was not considered cost effective. It was then made available to patients in the CDF.

As part of the reappraisal process this year, the manufacturer offered a further discount which, when considering there are limited treatment options for CML patients, meant that the independent committee could recommend bosutinib as cost effective.

Bosutinib is a tyrosine kinase inhibitor therapy targets the abnormal chromosome – called the Philadelphia chromosome – that causes the overproduction of white blood cells in people with CML.

Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE, said: “People with this type of chronic myeloid leukaemia, who haven’t responded to first and second line treatment or who experience severe side effects, have few or no treatment options left.

“New patients who need this drug can be reassured that bosutinib should be made available for routine use within the NHS.”

It is estimated that around 80 new patients in England and Wales could be eligible for this treatment each year.

Prof Carole Longson continued: “The company positively engaged with our CDF reconsideration process and demonstrated that their drug can be cost effective, which resulted in a positive recommendation.

“This decision, when implemented, frees up funding in the CDF which can be spent on other new and innovative cancer treatments.”

Dr David Montgomery, medical director of oncology at Pfizer UK called the decision “great news” for eligible patients. He added: “In the era of Tyrosine Kinase Inhibitor therapy, the lives of people living with chronic myeloid leukaemia have been greatly improved and near normal life expectancy can be expected in the majority.”

The final draft guidance is now with consultees who have the opportunity to appeal against the decision or notify NICE of any factual errors. Until the final decision is published, bosutinib will still be available to new and existing patients through the old CDF.