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Bosutinib: Good news for CML patients in England

Good news for CML patients in England

On Tuesday this week the NHS announced that bosutinib is to be made accessible to CML patients via the Cancer Drugs Fund (CDF).
There are a total of six treatments described for each of the three phases of CML, each with specific criteria that a patient would need to meet in order to access bosutinib (Bosulif).
The really good news is; that both intolerance and resistance are covered in all 3 phases of Ph+ CML.
For all 3 phases of CML, imatinib, nilotinib and dasatinib resistance is covered, as is ‘significant intolerance’ (grades 3 or 4) to imatinib and/or dasatinib.
This will primarily affect patients in chronic stage, but the fact that there is provision included for both accelerated and blast phase patients provides a very comprehensive access package.
It is worth noting that patients who are currently receiving dasatinib via the CDF will be allowed to transfer over to bosutinib within the Fund.
There is a more technical description of the above available at the link below (see pages 14 & 15) but the above summary captures the essentials.

http://www.england.nhs.uk/wp-content/uploads/2013/05/ncdf-list.pdf

Hammersmith’s Professor Jane Apperley we are sure would have represented patients’ interests with her usual eloquence and passion. Thanks go to Pfizer, the manufacturer of bosutinib, as well as the NHS Specialised Services clinical lead panel, who assessed the application for the inclusion of bosutinib on the national CDF list.

That is another excellent addition to the TKI arsenal and great news for all CML patients. Well done Prof Apperley for championing the drug and helping get it through NICE.

Looking forward, all we need is a little more certainty about the future accessibility if the CDF is combined/evolved instead of extended in its current form.

Thanks for posting Sandy!

Chris

Great news, the more options people have the better. It will be interesting to see if Ponatinib makes it onto the list in the near future as well.

K

Hi Chris and Karen,
just to be clear NICE have not yet appraised bosutinib- we are due to attend the appraisal committee meeting on June 13th, unless it is delayed for some reason.

The CDF in its present form will finish in at the end of March 2014, but we (and others) expect there will be another fund to replace it.

There are criteria for a drug to enter the list but you cannot get CDF reimbursement if a drug already has a positive recommendation by NICE- so for instance if at some point in the future, dasatinib is offered up with a PAS, then it would become available through the NHS and taken off the CDF list.

So CMLSg, like you, take the view that the acceptance of any 'un-NICED or 'yet-to-be-NICED' TKI onto the CDF list is a good thing for CML patients in England, although I have seen on other forums that some individuals have a different view. We do hope that bosutinib will be approved by NICE, but as we have all learned - that depends on other factors like positive data and price etc.

As far as ponatinb goes- it is expected that the EMA will give a marketing licence in the 3rd Q this year, then we expect it will go into the first part of the NICE process quite quickly and be 'Scoped' by the end of the year- but there is no guarantee of those timelines as there is always the potential for delay in these things.

Nevertheless, at least for patients in England, this is good news.
For patients in Scotland, Wales and Northern Ireland- now all devolved administrations- there are different mechanisms in place which are fairly complex, but maybe others could comment on that better than I.

Best... Sandy