NICE (National Institute for Health & Care Excellence), as part of their Rapid Reconsideration programme for drugs on the CDF list, has today published their draft Guidance for dasatinib.
In essence their recommendations are that dasatinib should become routinely available in the NHS as both a 1st line treatment for adult patients in chronic phase and also as a 2nd line treatment for adult patients in either chronic or accelerated phases.
Practically this will now make imatinib, dasatinib and nilotinib available as first treatments for chronic phase CML with nilotinib and dasatinib available as second treatments for chronic phase patients experiencing intolerance or resistance to imatinib.
Dasatinib would also join nilotinib in being available as a second treatment to patients in accelerated phase.
It is highly unlikely that there will be any appeal against either or both of these decisions and we are confident that the final Guidance will be as described as above.
The company, Bristol Myers Squibb (BMS), that manufactures dasatinib has reached agreement with NHS England so that doctors acting on behalf of those patients who are eligible for dasatinib treatment can ensure they can receive treatment immediately.
The agreement will cover the period that begins today and ends three months after final Guidance is published. After that time, dasatinib will be available on the same basis as imatinib and nilotinib.
Overall, access to TKIs for CML is now much improved compared to last year.
We remain optimistic that ponatinib will emerge from the NICE process in the Spring of next year with a positive recommendation.
Should this occur, all five TKIs for CML will at last be routinely available to qualifying CML patients in England.
For those with an interest here are the links to the NICe documents:
For 1st line use: https://www.nice.org.uk/guidance/indevelopment/gid-ta10042
For 2nd line use: https://www.nice.org.uk/guidance/indevelopment/gid-ta10041