Hi everyone i read posts on here but dont normally post but
I am very worried about this coming in january as i am currently doing very well on glivec. I was under the impression by my hospital that the makers of glivec would prob reduce price so not to worry.
But now after watching conference i am in a state if panic!
I have read that in canada people did lose response i feel this is an unsafe position to put us in. And could end up pushing me to a more potent 2nd gen tki which again worries me.
Anyone have any info?
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Generic Imatinib
Hello Bob,
From my understanding about the situation in the UK, there will definitely be pressure exerted on clinicians to change people who are currently treated with the branded imatinib (Glivec) to whichever generic imatinib that NH England commission for use via the NHS. Generic imatinib poses no risk for those people who are in chronic phase and who have no issues with their response to branded imatinib (Glivec).
I am not sure where you heard that patients in Canada (which was one of the first countries to have access generic imatinib) had relapsed on a generic, nor the source that this information was taken from, but we have been assured by specialist CML clinicians that there is no difference in efficacy between Glivec and a generic imatinib - the only difference is that the price of a generic will be substantially lower than Glivec. Prof. Richard Clarke (Royal UH, Liverpool) referred to the (likely) difference in price at the UK CML Patient Day in Manchester.
Based on the worries and concerns about generic imatinib of patients currently treated with Glivec, CMLSg have requested that the NCRI CML Subgroup (on which we sit as a patient representative member) put together an overview of the introduction of generic imatinib. We are confident that this will reassure most patients. It should be ready to publish by November, so by the time generics are introduced next year in the UK late (late December 2016 is when the manufacturers patent lapses) we should all be more reliably informed. Meanwhile, you can be confident that UK CML specialist clinicians have their patients best interests as their central focus - especially where generics are involved.
Newly diagnosed patients will no doubt start therapy with one of the generics. However those diagnosed with 'high risk' CML (high to med Sokal score), will be monitored very closely for sub-optimal responses aligned to the ELNet treatment recommendations and in patients who do not respond optimally to imatinib (generic) within the timelines, as is the case currently, will be given the option to change therapy to a 2nd Generation TKI.
I hope this is more reassuring,
Sandy
Hi
I watched the presentation on generic imatinib with interest, including the Q&A. The sense I got was very much that experience elsewhere is positive with the generics. That's the situation in the UK with generic medicines generally. There were a couple of things I thought were either not that clear or maybe not 100% accurate (not that it makes any difference to the overall position which is that generic imatinib approved in Europe should be fine).
To be authorised in Europe, generics must be the same (not similar - the same) active substance as the original drug and what's called "bioequivalent" to it. The latter is to make sure the formulation (the make up of the pill) is basically the same and it requires that the same amount of active drug gets into your system in essentially the same time frame as the original. That may have to be shown using some clinical data but not full efficacy/safety trials since the generics can rely on that data from the original drug, which will have been shown to be safe and efficacious. This is how all generics qualify - in effect they piggy back on the original drug's trial data and, so long as they are the same active and their formulation is bioequivalent, there is no reason to think they won't be as safe or work as well as the original.
The patent which expires in December is for the chemical entity - the compound itself (what the molecule is). It isn't for the crystalline form - there is another patent which covers Glivec's crystalline form which expires a few years down the line (2019 I think). This means that the generics will be the same chemical compound but the actual drug powder in the pill will be in a different crystalline form - glivec is the so called "beta" form and the generics will be "alpha". (For those interested, the difference is simply how the molecules align in an individual crystal - the molecules themselves are exactly the same, they just pack together in different ways and possibly different numbers in the different crystalline forms).
The bit about crystalline forms was part of the discussion as to which there is apparently no evidence that the different forms act any differently in the body - this makes sense to me because once you take the pill, the crystals dissolve and release the molecules, which are of course the same. Neither the molecules nor the body know how the molecules were packed together before the crystal dissolved... I suppose you could think of this as big vs small crystals of sugar in your tea (not strictly correct but the point is once the crystal dissolves the crystal the active molecules came from is irrelevant... )
I suspect I may be lucky enough not to worry about generic imatinib but if I do end up back on it, I would not be too concerned. Bearing in mind what it does however I would probably want to be monitored every couple of months to begin with, to put my mind at rest.
Richard
Excellent topic and comments, well explained and some comprehensive points. I share the view that Generics will be fine. I am sure our excellent NHS will not allow us anything that is not first class. Having looked at this myself as well, and having spoken at length with CML advocates from Canada, and other speakers both this year and last at the Horizons meeting my mind was very much put to rest that these replacements will be good. I however also would like the reassurance of regular PCR’s rather than drifting to 6 months as seems to be the case more.