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Positive recommendation of bosutinib (Bosulif) from NICE CDF Rapid Reconsideration

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We are very pleased that the outcome of the NICE Cancer Drugs Fund Rapid Reconsideration of bosutinib has resulted in a positive recommendation for its routine use in the NHSE in England for all the treatments it has a license for.                                                                                                                                                                                     In detail, bosutinib is now recommended as a treatment for adult patients in England in all three phases (chronic, accelerated and blast) of CML, provided they have been previously been treated with one or more TKIs and where imatinib (Glivec), nilotinib (Tasigna) or dasatinib (Sprycel) are not considered appropriate treatment options.

This rather convoluted language is designed to introduce considerable flexibility into your doctor’s decision making as to which TKI would suit a particular patient and which TKI a patient would feel best suited them.

If the wording is unpicked, it would be possible for bosutinib to be a second line treatment for CML after an initial treatment with either imatinib or nilotinib.

However, clinicians present at the NICE committee meeting stressed that bosutinib would be much more likely to be prescribed as a third or even fourth line TKI treatment.  

For those who follow the detail closely, I will post a more lengthy in depth comment at some point over the next couple of days. 

For now I’d just like to thank the patient who attended the Committee meeting who spoke so eloquently, cogently and succinctly about his experiences, not just with bosutinib but also with the other TKIs he has been treated with. 

We owe so much to all the patients who volunteer to participate in this process. Without them our task would be so much more difficult.

We expect the NICE Committee Rapid Reconsideration meeting for 1st or 2nd line dasatinib treatment to be held in late September this year. We are hopeful that a positive recommendation for both treatment lines will be the outcome of that meeting.   

David Ryner 

Read the NICE press release:  https://www.nice.org.uk/news/article/nice-approves-first-drug-from-old-cancer-drugs-fund#.V35OhXrx6UQ.email

Hi David, that is very good news, thank you for the update, and all you have done, along with our patient representative in getting the rapid review through, and with a positive outcome. May I just check something so that all, me included fully understand. This means Bosutinib will still only be available on the CDF, at this time, so as mentioned as second / third line treatment, after an application is made and criteria met for it, rather than full NICE approval for general prescription ?

Also, the link at the bottom of your post seems to be broken. Thanks again. Nigel 

Hi Nigel,

I have now fixed the link to the NICE press release- and yes, for the moment it is only available through the CDF until the FAD is implemented which I think is within 90 days? -

see statement from NICE below:

......"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."

Hi David and Sandy

Thank you very much for all you have done and great news on the NICE decision. It feels safer to have more options on the meds. front.  I certainly feel happier to now there is  one more line of defence in the CML arsenal.

best

Chrissie