How is generic imatinib likely to change clinical practice in CML from a UK perspective? It would be interesting to collate the views of members of this forum on how comfortable you are, or you think other patients treated with imatinib might be, with the prospect of converting from imatinib (Glivec) to one of the generic versions in 2016? * What are your specific concerns about this prospect? * If you are taking one of the other TKis - How do you think you would feel about a possible switch to a generic form of that drug in the future? Sandy
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Question 1: How do you feel about generic imatinib being introduced after the patent expires in 2016?
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I'm not on imatinib, but if a generic version of dasatinib was available and it made a significant cost saving for the NHS I'd be totally willing to switch to it.
I would be nervous about it though - so I think I'd probably want more frequent PCR testing for a while. Perhaps every month for the first 3 months rather than the usual quarterly one I have. Not sure if that's clinically necessary really, but it would put my mind at rest.
David.
Unless a "generic" is the same, tested to the same standard. No different in any way whatsoever, I'd not be happy at all. Indeed I'd be extremely dissatisfied.
I've had reassurance when starting the stupidly named DESTINY trial that I'll remain on glyvec and if at any time I decide to come off the trial even if its "just because" that I can and will stay on glyvec.
I feel I "served my time" having every trial treatment possible. Having had the likes of MUD BMT and a host of truly dreadful stuff before, I'd not be prepared to give something a go just to save money.
Cancer and leukaemia research in effect paid for most of everything I ever had and got me to this point 20 years later. I trust them. Frankly I don't trust the NHS.
hi, everybody. here in brazil we have generic imatinib. when i was on imatinib i had 2 and a half months on the generic version and changed to the original due to my doctor's concerns. actually, another doctor of mine told me that there is no problem on the generic version because imatinib isn't a very hard medication to be copied. he's concerns is if the government will always use the same dose or - due to economic problems - will put less imatinib on the "standard dose". another problem here was that there weren't clinical trials with the generic version and we have no data about the patients. despite all that, most of patients here do well on the generic version. cheers.
There is no reason to think that generic imatinib will be any less effective than Glivec.
In order to be approved for use in the EU, a generic manufactuer must do two things - show its pill has the same active ingredient, and show the pharmacokinetics are the same (I.e the same amount of the active gets into your system in essentially the same time as is the case with the reference drug, here meaning Glivec). What generics don't have to do is all the phase 1, 2 and 3 studies that the reference drug has to go through for first approval. There is no need to do that if the pharmacokinetics are the same, and it's the same active. The generic can "piggy back" on the original data because it is essentially the same thing.
Imatinib is what's known as a small molecule drug - it's a chemical compound (as opposed to a biological). As such it's pretty simple to copy, and no doubt then formulate. I can't think of a good reason why a generic approved in the EU should work any less well than Glivec.
We're all used to taking generics in other areas and think nothing of it. Of course, imatinib isn't used for headaches and naturally patients (myself included) have doubts because of this context. That is entirely natural though I do feel my own doubts are irrational. My generic omeprazole - also a groundbreaking drug although in a rather different area - works just fine.
Ultimately, whether it's the NHS or a private payer footing the bill, a shift to generics is inevitable, and necessary. Otherwise we will find treatments - especially new ones - won't be available. Once imatinib goes generic I would expect the guidance on its use to change. I find it hard to imagine that general policy on generic substitution will not apply to imatinib.
Personally, as others have said I have no big issue so long as all remains as original. I would expect the UK and EU would have excellent regulation that will ensure this is the case. If not then I would be as other nervous and resistant of a change. The price difference will no doubt make it inevitable.
My concern is Nilotinib, as both are available as first line treatment, will this change if Imatinib drops say 70%, will there not be pressure to prescribe Imatinib only - a change with NICE ?
I'd have thought so saying as the NHS is in the state it is.
My wife has to buy a medication abroad because it costs a massive £6 per month more than the generic stuff that causes her to have severe contraindication.
Hi Nigel,
Yes, NICE review all their recommendations periodically- TKIs for CML in both first and second lines were reviewed last year (September 2014).
TA251-1st line and TA241-2nd line are on what is called a 'static guidance list', which means that at the time they were reviewed there was no new cost or clinical evidence to change the recommendation up to that point.... however,
the effect of the low cost generic on NICEs' health economic models will be transformative, so my fear is- as you have already intimated- NICE will revisit TA251 for 1st line use, re-evaluate nilotinib (they do not appraise generics), find it more costly and recommend generic imatinib as first line therapy for CML.
Then there is another question- what will happen to Glivec in this scenario? No one can second guess how the manufacturer plans to handle the situation once the patent expires in the EU, but no doubt that some serious thought is being given to this. Glivec is the brand name and no one else can use it, so maybe we might see them enter the generic imatinib market?
Of course, all those patients who are already treated with Glivec will NOT be subjected to undue pressure to change to a generic imatinib - at least it would be very surprising if they were. So we are talking here about first line therapy for the newly diagnosed. Should they not reach the various response goals within the required timelines recommended by ELNet, then nilotinib (and dasatinib, bosutinib via the CDF) will come into the picture, although the clinical parameters that identify patients as intolerant and/or resistant may become less elastic.
I have one more point: I think we should remember that we are taxpayers (either now or at some point in the past) as well as 'patients' and the NHS drugs bill is:
a. Capped - with any overpayments returned on a quarterly basis by the manufacturers to the Treasury which then goes by some circuitous route back to DH and on to the devolved NHS's
b. The total (drugs) bill is around 10% of the whole NHS budget in England.
Sandy
My concern is that the NHS is so dysfunctional when it comes to procurement and management. Also so wasteful. They're over complicated, bureaucratic. No-one takes responsibility. They're awash with broken and flawed processes and frankly I wouldn't trust the judgement of NICE and the people who provide their "evidence" at all.
But then I was diagnosed and commenced treatment 20 years ago and throughout have been kept alive because of stuff NICE said wasn't worth it.
I also got caught in the Healthcare at Home fiasco. Frankly the NHS procurement function couldn't manage buying and distributing anything effectively and efficiently.
They p money away every day wastefully They won't \ can't tackle that so they make crass judgement calls buying "cheaper" things and to heck with the consequences .
It will be interesting to see what does happen with patients already on Glivec. Doctors in the UK prescribe generically ie they write down "imatinib 400mg", not "Glivec 400mg". All things being equal, that means the pharmacy can fulfil the prescription with any imatinib. And they will use the generic, when available. This is all part of keeping the drugs bill down. Only if a branded drug is specifically prescribed must the pharmacy fulfil the prescription with the brand.
When there is a change to generics the physician will explain to the patient that the drug may look different to what went before but that it is the same thing. The physicians do have pressure to prescribe generically and I bet that will flow down. It has to, really. So automatically being able to stay on Glivec? I wonder. The pressure to change on the hospitals will be substantial as there are many patients on Glivec and the cost reduction will be significant. That cost reduction allows newer, expensive drugs to be available more easily. For example, ponatinib (I know that's approved but the point is it is easier to justify if the overall bill is reduced) - or any one of the many new therapies for cancers that have unmet need. The NHS budget needs room to pay for these, and there are patients in dire straits who need them.
There are exceptions for drugs where it is know that patients respond differently to different formulations (epilepsy drugs for example) but those are very much the exception. Oh and those on Destiny must stay on Glivec since they can't add a variable to the trial - it would invalidate the data. Same with other trials involving Glivec.
What is interesting with imatinib is what it does. It's a life saver, basically, and patients will naturally be cautious about a change. But generics (and biosimilars) for life threatening conditions are very much coming, and I'm not aware of any demonstrable issue of efficacy with the generic imatinib already available abroad. I might ask Prof Apperly about this next time I see her.
One thing I would add is that although the extended patent protection for Glivec expires in 2016 in the EU, that may not necessarily mean the generics are available then. This may depend on a lot of things. We may know more from the US since the basic patent expires there during the course of this year.
As for other first line drugs, what I can see happening possibly is a change in guidance especially if the comparator becomes imatinib and that is substantially cheaper. I agree with Sandy. I see some of the current research into early identification of patients who need to switch as addressing that possible issue (it could also be so in the US under pressure from the insurers). What might happen therefore is that imatinib is indeed the first line choice but there is a clear means of identification of patients who need to switch early on, and that means patients who need nilotinib can get it as early as that need becomes apparent. Something like that is forseeable.
I would expect any generic drugs that are available through official UK channels to have the same quality control as the original drug. As such my wife would be happy to take the generic version of Imatinib if and when it becomes available through the NHS. I think this is almost inevitable unless any new entrant prices their version close to Gleevec or the price of Gleevec is reduced to close to the competition. The money for the drug has to come from the overall NHS budget and we are very grateful that Gleevec was funded when it was very expensive so any saving can hopefully go to fund another expensive drug for someone else.