Summary:
NICE Final Appraisal Determination (FAD) meeting for the use of
dasatinib, nilotinib and standard dose imatinib for first line treatment of
CML.
The Appraisal Committee meeting was at the NICE office in Manchester on
8th February to consider the comments made in response to the
publication of the Appraisal Consultation Document (ACD) in late 2011.
CML Support Group, exercising our rights as official consultees, were the
only patient group that submitted comments on the ACD. These were
considered by the Committee together with submissions from CML
clinicians and other professional bodies. We attended the 8th February
meeting in the public gallery to witness the Appraisal Committee’s
responses.
We were pleased that not only had our comments been noted, but the
further modeling work we had requested had been undertaken by the
Assessment Group to align their model to approximate clinical reality.
Although the assessment group's re-modeling was not exhaustive, it was
nevertheless a huge improvement to the previous model that was
originally preferred by the Committee.
There was also extensive discussion of some of the other issues we had
raised in our comment.
These include:
-
equality issues regarding the availability of SCT for only a small number
-
of patients
-
the suitability of dasatinib for CML patients with particular IM and NI
-
resistant mutations
-
co-morbidities
and
-
which TKI could appear in a particular treatment line.
However, the outcome of the re-modeling work still leaves dasatinib as
lacking in cost effectiveness compared to the other two TKIs.
The decision taken by Novartis to offer a confidential discount in the form
of a Patient Access Scheme (PAS) for nilotinib (NI) as second line therapy,
was crucial to their obtaining a positive recommendation for its use as first
line,as is standard dose imatinib. Either drug will be available for chronic
phase CML as first line therapy.
In our opinion, the only way to ensure patients have access to dasatinib at
least as first line therapy, is for BMS is to offer a PAS similar to that for
nilotinib, since we do not believe that the Committee will reverse its
recently published Technology Appraisal Guidance (TAG), which does not
recommend dasatinib for NHS use as a second line therapy following
imatinib intolerance and/or resistance in CML.
Cost is the only substantial issue here as there is agreement by all parties
involved in both second and first line appraisals, that dasatinib has equal
clinical effectiveness to nilotinib.
In November 2011, we made a suggestion that BMS might consider a PAS
similar to that offered by Novartis.
We have since done so again and have discussed our views in more detail
with representatives of the company. We remain cautiously hopeful of a
positive outcome.
We are equally convinced of the value of our remaining fully engaged with
the NICE HTA process. Our careful reading of the documents and analyses
of all comments made at the meetings as well as the work commissioned
in response, leads us to conclude that the HTA landscape for CML is now
much more tightly defined than it was only a year ago.
The CMLS group would like to thank our members, individual CML patients,
their carers and supporters, who committed so much of their valuable time
and did so much to assist us in what has been a long, and sometimes
disappointing, struggle in order to ensure all CML patients present and
future, have access to the best possible choice of therapy.
We could not have made the progress we have made to date, without their
support and commitment.
