Given the imminent publication by NICE of their draft appraisal document for dasatinib, nilotinib and imatinib in 1st line use, I thought it a good idea to update you all on CMLSg's campaigning activities during the latter half of this year.
FAD: MTA dasatinib, nilotinib and high dose imatinib as 2nd line therapy.
Following the FAD, we appealed the decision of the appraisal committee. Our grounds for appeal centred on the use of hydroxycarbamide as an appropriate comparator to the TKI's in question. Our grounds were accepted as legitimate by the appeal panel chair. David Ryner, Rachel Bamford and myself attended the appeal meeting in Manchester on 4th November.
We felt that our points of appeal were noted by the appeal panel and although we could not afford a barrister to speak for us, David did very well in putting out case over. The panel seemed to us to give a fair hearing to both appellants (CMLSg and Bristol Myers Squib) as well as the Chair and other representatives of the NICE appraisal committee who were there to defend their negative recommendation of dasatinib and high dose imatinib in the 2nd line setting.
The appeal process is very rigorous and the panel will publish their decision within the 2nd week of January 2012.
Until that time it is CMLSg's considered opinion that there is nothing to be gained by lobbying further against this FAD. When the appeal judgment is published we will re-consider our options should it be negative.
Of course we join with others in urging the manufacturers of dasatinib to offer the Department of health either a discounted price or follow Novartis' lead and offer a similar PAS- Patient Assistance Scheme, (already accepted by the DH and therefore taken into consideration by the NICE appraisal committee. It is not within our power to affect how any one company deals with the emerging situation regarding health care cost cutting, but for the good of all CML patients we hope that all manufacturers of 2nd generation and 3rd generation TKI's consider the global financial situation and its effect on the pricing of their products.
Assessment of dasatinib, nilotinib and imatinib in the 1st line setting.
After submitting a lengthy and detailed response the the PenTag assessment report, we attended the subsequent appraisal committee meeting in Manchester on 8th November in order to give evidence.
FYI: The CMLSg response to the assessment will be available to read on the NICE website after their publication of the draft ACD on Tuesday 6th December.
We were surprised that no other patient advocacy group who are on the list of consultees sent a response.
Sandy and Richard were the patient experts who attended that day with David observing the proceedings in the public gallery. Professors Jane Apperley (Imperial College, Hammersmith Hospital) and Richard Clark (Liverpool Royal, University Hospital) were the expert clinicians.
The committee's draft ACD will be published on Tuesday 6th January and until that time CMLSg can make no public comment.
However, we hope to see a good outcome for patients. As outlined above, we hope that given the financial constraints increasingly imposed we would like to see a privately agreed PAS with the DoH.
If that is not the case, then we will launch an active campaign in order to persuade all stakeholders involved in this process, to consider the situation for CML patients in the UK and provide access to all TKI therapies.
Sandy, on behalf of the CML Support Group,
November 30th 2011.
