Bosutinib (Pfizer Ltd):
It is expected that bosutinib will complete its passage through the European Medicines Agency’s (EMA) marketing authorisation process at some point this year. This will establish bosutinib as a safe and clinically effective treatment for Ph+CML.
NICE Heath Technology Appraisal:
The draft 'Scope' is the initial stage of the NICE health technology appraisal (HTA) process. The appraisal of bosutinib will be as a Single Technology Appraisal (STA) rather than the two previous Multiple Technology Appraisals (MTA) that we have been engaged in, over the last 18 months.
We expect the NICE Appraisal Committee (AC) to make their recommendation on the cost and clinical effectiveness of bosutinib at some point this year (2013)
The CMLSGroup, as an official NICE consultee, was invited to comment on the 'draft scope' for bosutinib in November (2012).
Our comment primarily focused on the treatments that are to be used as comparators to bosutinib in this STA assessment process.
The comparators listed in the 'draft scope' are for the treatment of adults in any CML phase ‘after previous treatment’ (italics are used in the exact scope wording):
The four comparators for patients in chronic and accelerated stages are:
a) hydroxyurea (HU) now referred to as hydroxycarbamide
b) interferon alpha (IFN)
c) allogeneic stem cell transplantation -SCT (HLA matched donor)
d) best supportive care.
The two comparators for patients in blast phase are:
a) chemotherapy followed by allogeneic SCT (HLA matched donor)
b) best supportive care.
Members might be surprised that neither imatinib nor nilotinib, the two tyrosine kinase inhibitors currently recommended by NICE for the treatment of CML in both 1st and 2nd lines, have been included on the list of comparator treatments in this STA.
We argued that, for various reasons specific to each one, the comparators listed for chronic and accelerated phase CML would not be described as ‘standard treatment(s) currently used in the NHS’ - the criteria used for inclusion of any treatment(s) that might act as a comparator to the subject of an appraisal (HTA), in this case bosutinib.
On the NICE response form under the ‘equalities’ and ‘innovation’ sections we set out some further (minor) comments and added that our understanding of the use of the phrase ‘after previous treatment‘ , is that this could refer to any ‘treatment line’ given subsequent to a ‘first treatment’, which in turn may be a multiple rather than a single line of treatment.
Note: regarding SCT, we recognize that this is a 'standard treatment' option within the NHS, but have argued here that allogeneic SCT is in reality a procedure that is not 'routinely available' to the majority of CML patients, which NICE have recognized in their scoping document.