We have finished our appeal letter and will send it to NICE within the deadline.-2nd September.
This is quite a difficult process and needs to be entirely within the process as published by NICE. We must wait until the appeal committee Chair considers our letter and deems it follows the correct procedure before we are accepted as 'appellants'.
There are 3 grounds that we can appeal on. We have decided that we can appeal on 2 of them. It has been hard- we are not experts- but David has done a sterling job and we can only keep our fingers crossed that it will be enough! We cannot afford the advice of a Barrister and anyway have little time to consult one if we did!
I can only hope that this appeal proves successful......... but not holding my breath..... if not this is what is at stake for patients in England and Wales:
Welsh health authority would be expected to withdraw their present agreement to offer patients resident in Wales access to 2nd gen TKI's- including HD imatinib.
As for newly diagnosed patients and those who might need to change therapy after the TAG-
- Ist chance with 400mg imatinib,
- 2nd chance with 400mg BID nilotinib.....
- if dasatinib is needed then a visit to the CDF- cancer drugs fund-
- if unseccessful or if CDF has reached its limit for that year...
- enrol in clincal trial- or
- stem cell transplant if a donor can be identified
- or.....palliative care!- hydroxycarbamide
- Oh sorry I forgot to mention interferon!
As for Scotland- have greater autonomy than Wales, so we are not so sure that the SMC (Scottish medical consortium) would do a U-turn on their present reimbursement decisions re: dasatinib/HD imatinib/nilotinib... including nilotinib for first line use as announced last week. I don't think a U-turn would go down too well with Scottish citizens and patients!
Should the various appeals against this FAD be unsuccessful, NICE will publish the TAG (technology appraisal guidance) at some point in November 2011.
Sandy