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NICE- dasatinib/nilotinib

Dear All,
Owing to the comments received by NICE on the comparators used in the ACD the appraisal committee have decided to separate patients who show imatinib 'intolerance' from those who show imatinib 'resistance'.

see details published on the NICE website below.

http://guidance.nice.org.uk/TA/Wave17/18

NICE say that:

In order to inform the MTA (multiple technology appraisal) of dasatinib and nilotinib for people who are ‘resistant’ to imatinib, and for whom high dose imatinib is the comparator, there is a need to review the evidence on high dose imatinib. The review of imatinib for chronic myeloid leukaemia (TA70) is due to start shortly.

High dose imatinib is now considered as one of the comparators for dasatinib and nilotinib for people who are ‘resistant’ to imatinib. Many ACD comments were received - on the subject of comparators for people ‘resistant’ to imatinib, these included i) high dose imatinib should be the comparator, as this is what is used in current UK clinical practice and ii) hydroxycarbamide and interferon-alpha are not appropriate comparators as they are not effective/do not cure disease.

As a result both NICE and Committee members have agreed that it is preferable to combine an appraisal of the three technologies, imatinib high dose (800mg), dasatinib and nilotinib, to establish their comparative incremental cost-effectiveness.
Therefore the following actions will be implemented:
· The current dasatinib and nilotinib multiple technology appraisal will continue for ‘imatinib intolerant’ people with chronic myeloid leukaemia.
· The dasatinib and nilotinib multiple technology appraisal for ‘imatinib resistant’ people will be rescheduled into the review of TA70, specifically related to high dose imatinib. An updated draft scope will be issued shortly for consultation for the review of TA70 focussing on ‘resistant’ people to include the following interventions: ‘high-dose’ imatinib, dasatinib and nilotinib.

Sandy

OK Sandy
can we have that in 'normal person' speak please !!! I know you will be able to tell us what this means in practice for patients.

How are they going to differentiate between intolerant and resistant? What if a patient can't tolerate high dose imatinib?

Many thanks Pennie

Dear Pennie,
still thinking about it but for a start it seems that they have been forced to listen to some of the pressure, but only some. Because NICE refused to accept high dose IM as a comparator they have now had to concede that point....but only in IM resistance.
I will think about the consequences some more over the weekend and get back to you.
Sandy

Makes sense not to include high dose imatinib as a comparator for imatinib intolerant patients, but equally makes sense at least partially (eg if the reason is effective dose for a given patient) for resistant patients for the reasons they give.

The other point that I think is interesting is the apparent concession that hydroxycarbimide and interferon alpha are not effective. If that's the case, their per-QALY cost is infinite....

May have the wrong end of the stick here but some progress better than none.

Since I first read the news I have been trying to follow the logic of this.

If they are no longer going to compare nilotinib and dasatinib with the ineffective but cheap hydroxycarbimide and interferon alfa, surely this must help us. The cost of high dose imatinib must be similar to the two new drugs so the cost effectiveness of the new drugs must look more favourable. Presumably they will have to adjust their "models" to allow for this.

Also if hydroxycarbimide and interferon alfa are no longer an appropriate comparator for imatinib resistant patients, surely they cannot continue to say it is an appropriate comparator for imatinib intolerant patients. Again this must improve the relative cost effectiveness of dasatinib and nilotinib for these patients too.

I am no doubt looking at this through rose tinted glasses but I am hopeful. My concern is that they have not said how they are going to deal with imatinib intolerant patients at the same time as they set out the next step for resistant ones.

Simon

These are the same conclusions I came to. Also I agree with your comments with concern at the 'split' in logic between intolerant and resistant.

I guess NICE is allowed to split logic !!

Perhaps they don't realise that if someone is intolerant - then has to stop Imatinib, they are likely to become resistant and / or advanced in the disease.

Another of my concerns is the comment that InfA and Hydroxy don't act as 'cure' - we all know no drugs do so. YET.

It worries me that somewhere along this line of thinking there is a huge misunderstanding of both the nature of CML, and of the treatment potentials of TKIs.

Oh I hate being at the wrong end of monolithical institutions.

Pennie