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Great news on the availability of bosutinib in England

As of tomorrow bosutinib will be available for all its licensed indications rather than the more recent heavily restricted limitations placed on its use via the current Cancer Drugs Fund (CDF).

For clarity bosutinib will now be available for the treatment of adult patients in England:

* in either chronic, accelerated or blast phases of CML

*provided they have been treated previously with one or more of the TKIs for CML

* where imatinib, nilotinib and dasatinib are not considered appropriate treatment options

Funding for treatment will be under an Interim Funding Agreement (IFA) which is one of the novel components of the 'new' Cancer Drugs Fund that will replace the current CDF which expires at midnight tonight. 

As you will know from my previous post; following a recent review NICE have now recommended bosutinib for routine treatment in the NHS.

The IFA is a temporary funding arrangement operative for 90 days starting tomorrow and, in this use, its function is to allow the NHS across England to gear up for the start of routine prescribing use once the 90 day period finishes.

The only circumstances that could halt this process would be for some person or body the appeal against this move into routine commissioning. The possibility of this occurring is, for me, unimaginable.

So a very good day for patients in England.      

 

 

 

That is excellent news. 

If I read this correctly, does that mean that a patient would still need to be treated on imatinib or nilotinib before being eligible for hosting?

 

David 

Yes David you are correct.

A criteria an adult patient would have to meet in order to be treated with bosutinib is a previous treatment with at least one TKI.

Currently in England this effectively limits the choice available to imatinib or nilotinib.  

In reality the overwhelming majority of patients would be treated with imatinib as a first TKI treatment. 

When the same real world experience is applied to bosutinib this would almost always result in its use as a 3rd or even 4th treatment.

Taking account of what's set out in previous NICE evaluations and if I'm in NICE mode, the figure I use is of some 90% of patients being treated with imatinib as a first TKI treatment with the treatment sequence for bosutinib being as above. 

Should dasatinib receive a positive recommendation from the current NICE evaluation of its use as a first TKI treatment later this year, I don't think this will change what's described above very much if at all.

That said, if dasatinib also receives a positive recommendation for its use in any of the three CML phases following TKI treatment failure, be that based on resistance or intolerance, then a patient could be treated with dasatinib as a second TKI treatment. I think this much more likely to change the treatment some patients receive.

The more fundamental point is that what is an effective TKI varies from patient to patient with a consideration of quality of life being especially important given treatment for the vast majority of patients is daily and forever.

In the context of NICE evaluations its difficult to get decision makers to understand for example, and limiting this to the quality of life point above, the impact a decades long regime of daily fasting makes on someone's life especially if they are still working and even more if work schedules vary and little control can be exerted over them.  

That's why this Discussion Forum is so important because its a spontaneous record, generally from patients, of life on treatment and, as important, its historical. There are rarely any survey type carefully pre prepared questions put up for people to answer and never any limited choice questions that attempt a single shot capture of reality before translating that into a statement about what the experience of a particular TKI treatment is like for everyone.

For me that's a crude method of describing what's a very personal experience and its vital that a qualifying brake be placed on exercises of this type.

It would, I think, be of less importance if treatment was brief (as most chemotherapy cycles are and remembering that technically TKIs are regarded as chemotherapy) but for CML this does not apply.          

 

 

 

 

NICE has today published their Guidance document for bosutinib. You can access it here: https://www.nice.org.uk/guidance/ta401

My previous posts have given details of the clinical criteria that would now allow a patient to receive treatment with bosutinib for their CML and these remain unchanged.

A successful conclusion and we hope for the same outcome for dasatinib later this year and ponatinib early next year.