Chris West
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NICE publishes guidance for leukaemia treatment

Chris West
Posted by
18 Aug 2017

The National Institute for Health and Care Excellence (NICE) has today published guidance on the use of the drug inotuzumab ozogamincin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL).  Unfortunately for patients, they have not recommended the drug for routine use in the NHS in England.

The National Institute for Health and Care Excellence (NICE) has today published guidance on the use of the drug inotuzumab ozogamincin for treating relapsed or refractory B-cell acute lymphoblastic leukaemia (ALL).  Unfortunately for patients, they have not recommended the drug for routine use in the NHS in England.

We are very concerned and disappointed about this decision.  Inotuzumab has been shown to improve treatment of ALL compared to current treatment.  If we are to continue to make advances in how we treat ALL, and all blood cancers, it is essential that new and effective medicines are made available to patients.

Of particular concern in this instance is that the methodology used by NICE appears to be flawed.  When making their assessment, NICE made the assumption that all patients would receive six rounds of inotuzumab, concluding that this would not be cost effective.  However, clinical data suggests that a majority will receive no more than two cycles, with guidance stating that patients should receive a maximum of three cycles if patients are to undergo stem cell transplantation.  This means NICE did not make accurate assumptions when assessing inotuzumab, as two to three cycles of treatment will be less costly than six

Professor Adele Fielding, currently chair the UK National Cancer Research Institute Adult ALL group and a member of Bloodwise’s Medical Advisory Panel, told us: “Inotuzumab is very active in relapsed ALL and showed response and survival benefit, compared to standard-of-care chemotherapy in a large, international, randomised controlled trial, in which UK hospitals and patients participated. The data were recently published in the New England Journal of Medicine. The drug has been granted a marketing authorisation on the basis of these data. I am very concerned, on behalf of our patients, by the recent decision from NICE not to recommend that this therapy be funded. Patients have recently been able to access the agent under a compassionate access scheme provided by the manufacturer, but now, it will no longer be available. This sort of decision undoubtedly has a considerable negative emotional impact on patients, the families and the leukaemia research community who work very hard together to develop and test new treatments. However, appeals will be made against the NICE decision, based on facts and interpretation of the evidence. 

What happens next?

As mentioned by Dr Fielding, there will now be official appeals by the drug’s manufacturer, clinicians and patient representatives.  Bloodwise will be working alongside other charities and clinicians to ensure we co-ordinate our efforts to get this decision overturned.  Outside the formal appeal process, we will be supporting media activity and communicating to NICE and other decision makers that in order to improve patient outcomes, we have to ensure the latest and most effective treatments are available to NHS patients.

 

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