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CML drug recommended for routine use in England and Wales after changes to the Cancer Drugs Fund

written by

Leukaemia Care, Charity

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It was announced today that dasatinib, a tyrosine kinase inhibitor, has been recommended by the National Institute for Health and Care Excellence (NICE) for routine funding by the NHS as first and second line treatment options for chronic myeloid leukaemia (CML) patients in England and Wales. The details of the recommendations are:

Dasatinib is recommended within its marketing authorisation as options for “untreated chronic-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults” and

Dasatinib is recommended as options for treating only “chronic-or accelerated-phase Philadelphia-chromosome-positive chronic myeloid leukaemia in adults” if “they cannot have imatinib, or their disease is imatinib-resistant”.

This positive decision follows an appraisal of the drug as part of the Cancer Drugs Fund (CDF) review process. The CDF, introduced in 2011, was a separate pot of money to fund cancer drugs that would not otherwise have been routinely available on the NHS because of uncertainty around their cost and clinical effectiveness. Treatments for rarer cancers are usually affected, due to the small patient numbers involved – there is less clinical data available to prove they are cost and clinically effective enough to be funded. As such, a significant number of drugs were funded by the CDF, including several treatments for CML including dasatinib, bosutinib and ponatinib.

By 2015, the CDF had been severely overspent and it had become clear to the government and NHS England that it was unsustainable and the system needed to change. Changes to the appraisal process were explored and put into place and, as a result, all cancer drugs funded by the CDF are being reviewed by NICE. 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.

The dasatinib appraisals involved patient organisation submissions from Leukaemia CARE, which was an opportunity to ensure that patient views were represented in the decision making process of whether the drug should be routinely available moving forward. This was in addition to the manufacturer company submission and a patient access scheme agreement between the company and NHS England.

Kris Griffin, a CML patient and patient advocate, comments:

“I'm delighted to hear that CML patients will be able to access dasatinib as first and second line treatment. I know, from personal experience, that dasatinib is a drug that, for people who have failed imatinib or another drug, gives us another opportunity to live a normal, event-free life. 

However, I am concerned that dasatinib has not been recommended for use in blast phase because of the small patient population. This is a problem we come across time and time again and it's about time the system reflected upon its ability to serve all patient groups fairly.

More patients will access dasatinib and I'm very happy about this and whilst I commend much of the decision-making process in this instance, there is still a way to go. This decision shows the importance of stakeholders such as Leukaemia Care who keep the pressure on and ensure that the needs of blood cancer patients are met.”

Whilst it is a welcome outcome that NICE consider dasatinib to be clinically effective and have recommended it for routine use first line for chronic-phase CML patients and second line for chronic and accelerated phase patients, it has not been recommended for blast-phase CML patients. The final appraisal determination, the document that sets out NICE’s decision, explains that this was due to the limited data available to confirm dasatnib’s clinical effectiveness for patients at this stage of the disease. Treatment in this instance would usually be intensive chemotherapy, which is similar to treating an acute leukaemia. As such, NICE could not recommend dasatinib as a cost effective use of NHS resources for CML patients in blast-phase.

More positively, following the NICE recommendation of dasatinib for clinical use in England and Wales, the drug will now be available to all NHS patients who meet the criteria of the recommendation, securing an additional treatment for CML patients should they need it.

Zack Pemberton-Whiteley, Head of Campaigns and Advocacy, comments:

“We are extremely happy that patients in England and Wales are able to access this clinically effective CML treatment – already available in Scotland. Leukaemia CARE was involved in the original NICE assessment of dasatinib in 2009. It was thoroughly disappointing that it was not recommended at the time. We have ensured that we have been involved with the consultation of the CDF restructure and the review of the CML drugs that were funded this way and are delighted that dasatinib has now been recommended for patients moving forward. Increased access to blood cancer treatments can only help to improve patient outcomes and their quality of life.”