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Bosutinib approved for CML patients in England following policy reform

written by

Leukaemia Care, Charity

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It was announced last week that bosutinib will now be routinely funded by the NHS for patients in England with chronic myeloid leukaemia (CML) as a follow-up line of treatment should their existing one stop working, and other options are not appropriate. This comes after a submission by Leukaemia CARE and CML Support, as well as an agreement between NICE and the drug’s manufacturer, Pfizer.

This is a very welcome result following growing uncertainty about future access to CML treatments with recent changes to how drugs are appraised for patient use in England being carried out this month.

The Cancer Drugs Fund (CDF)

The Cancer Drugs Fund (CDF), created in 2011, was a separate pot of money ring-fenced for cancer treatments to help increase access to drugs that could not be routinely funded by NHS England. Since its creation in 2011, over 84,000 patients have benefitted from the CDF. However because of recent changes to the CDF process and the introduction of a new system, all cancer drugs currently funded this way are being reviewed by the National Institute for Health and Care Excellence (NICE – the body who decide what drugs are funded in England and Wales).

This review process will decide if each drug should receive ongoing funding permanently by NHS England (if they are considered to be a cost effective use of limited NHS resources) for newly diagnosed patients or new treatments for existing patients. This is with an aim to make the CDF more financially sustainable. Bosutinib is the first drug to have confirmed ongoing routine funding.

Bosutinib recommendation  

Following its re-appraisal, where Leukaemia CARE and CML Support submitted a response to ensure that patient views were represented during the process, NICE announced that bosutinib (a tyrosine kinase inhibitor – TKI) would be recommended as a treatment option “for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia (CML) in adults”. Access will be restricted to those patients who have previously had one or more TKI’s and if imatinib, nilotinib and dasatinib (other TKI CML treatments) are not suitable. The decision was also made following an offer from Pfizer (the company who developed the drug) to discount the price of the drug in a Patient Access Scheme (PAS). NICE has estimated that around 80 new patients in England and Wales could be eligible for this treatment each year.

Patient views

Fran Woodcock, a CML patient currently taking bosutinib, comments: “I'm delighted that CML patients will no longer have to fight, often in vain, to get bosutinib when their other drugs have failed them. There's a long way to go before all those with rarer cancers will have their treatment routinely funded, but this result is a fantastic breakthrough which I hope will pave the way for many other drugs currently denied to those who most need them." 

Many of the drugs on the original CDF list had not been routinely funded by NHS England in the first place because they were not cost effective enough. Although the appraisal process has been reformed, the system used to appraise drugs has not been changed. As such, it is a growing concern for patient organisations like Leukaemia CARE that many of these drugs under review will still not be recommended for routine use under the new system. With no back-up funding solution available, this could mean that the future of access to some blood cancer drugs is uncertain, with some patients missing out on clinically effective, life-extending treatment options.

Leukaemia CARE has worked alongside patients and other patient organisations to ensure that the patient voice is heard when decisions about the future access of life-extending treatments are made.

Zack Pemberton-Whiteley, Head of Campaigns and Advocacy, commented: “Whilst Leukaemia CARE welcome the result that bosutinib will soon be available to patients who have exhausted other treatment options, there are still several blood cancer drugs being reviewed and the future of their access to those patients that require them is less certain. We continue to be involved with the rapid reconsideration of blood cancer drugs and hope that these too receive positive recommendations to ensure more patients have access to the life-extending treatments that they need.”

If you would like more information on what these changes mean, please contact our Campaigns and Advocacy team at or call 01905 755 977