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Generic Imatinib now being issued in the UK

Generic Imatinib. So I attended QE Birmingham yesterday for my 3 month appointment. A few things, first PCR 0.02 so 3.8 log drop and a nice fall since restarting Imatinib after stopping for DESTINY trial.

QE have taken the step for good responders that are “well” to now not see a Doctor. I didn’t know this till I was called in and saw Tim, the principle pharmacist. Very nice guy, and had a good chat. He explained this move is to free up time for the doctors, and reduce the wait time for others, eg I was seen in 30 minutes. I can see why this is done, and don’t have an issue, there are doctors about if I did have an issue of any kind. I know others patients see specialist nurses instead of doctors already.

As he is a pharmacist he knew all about generic Imatinib, I am the first he has prescribed for, great ! Anyway he called the chemist first to see if I would get it and yes as they have no Novartis Glivec on the shelf for CML, it will still be used for GIST as not off patent for that yet.

I am now on 6 month PCR’s but said I wanted a 3 month one as now on a generic, he said this should be fine, and noted the file. I will push at next appointment if not offered a PCR, and all of us should I feel while generics bed in in the UK.

My generic is made by Intrapharma and is smaller than Glivec, it looks like, and is the size of an Ibroprophen tablet. There are a few generics that we will have, he said each region will buy their own type so we could get whatever, they are 400Mg Imatinib, and should work no differently. I know from the Facebook group a member there has been given Actatis as the generic from a different hospital,- much bigger than Glivec tablet.

I have quite a number of the branded Glivec but felt I should start the generic rightaway as only delaying the inevitable. So yesterday I took my first. No issue so far. In many ways, and I mean this the right way, I am an ideal patient, just chance my appointment was early on. Reason, well I have little to no side effects, therefore if I get some, well not good, if I don’t then bodes well for others……. Will keep you posted.

So looks like all of us on Glivec in the UK will be changed on their next appointment as it seems any branded drug will be held by clinic for GIST patients. Branded will not be available he said, and yes a region may change suppliers in time.

On last thing which was not good, the leaflet in the box said “  in adult patients Imatinib is used to treat late stage of Chronic Myeloid Leukaemia called Blast Crisis.  In children and adolescents however it may be used to treat all stages of the illness ” .

It does make you wonder, presuming there is not a real reason eg this generic is for blast crisis, then how the manufacturer can get the information in the covering leaflet wrong is appalling really. I have emailed the hospital and written to the makers today to clarify if this is wrong, as I feel it is, and ask the leaflet be changed, or ask why it is for Blast Crisis only in adult cml patients.

 Nigel

That is all very interesting, Nigel.  I have two questions - which you may well not be able to answer, but someone else may.

1. Is generic imatinib available in other dosages than 400mg?  I am currently on 200 and certainly would not want to have to cut a pill in half.

2. Will Scotland follow the rest of the UK in moving to generic imatinib?  I don't see why they shouldn't, and have no reason to think that it will be any less effective than Glivec, but I'd like to know.

Thanks for keeping us informed.

Olivia

Hi Nigel,

Thanks for this update......very interesting that QE have already organised their generic imatinib and I suspect most if not all other regions are up to speed. When you think of the difference in price it is not surprising that the pharmacies have already run down their stock of branded imatinib (Glivec) apart from that used to treat GIST etc. 

As you know we have been putting together our own leaflet about generic imatinib and I am very hopeful that the final draft will be signed off and published by the end of this month. I will try to find out about the smaller doses that Olivia asked about. It will be interesting to see which regions buy which particular generic brand. I think most will be looking for the cheapest? 

I am really surprised though about the info re: the particular brand being for BC CML! As most of us are aware imatinib is not considered very effective for treating Blast phase. Interesting to see what response you get from the manufacturer.

Sandy

Hi Olivia

I did a quick search for generic imatinib UK and came up with the following .... it seems Intrapharm ltd. is producing both 100mg and 400mg tablets for NHS use in the CESW region (Central and South West). See here: Oxford Pharmacy Store

I think it is likely that Northern Regions including Scotland will be using a different generic company. I will try to find out

Sandy

Another search produced a list of companies who are producing generic imatinib in the UK.... Sandoz (Novartis' generics company) is one. The products will be tendered to each region in the UK, so depends on which company is the most competitive. 

See EMC list of companies producing generic IM by searching for imatinib mesilate here  - you will find the list and links. Link to Sandoz IM page here .... interestingly but not surprisingly Sandoz (Novartis' generics company) has the leaflet information right if a little out of date regarding the requirement of a trial of interferon first. 

4.1 Therapeutic indications

Imatinib is indicated for the treatment of

• adult and paediatric patients with newly diagnosed Philadelphia chromosome (bcr-abl) positive (Ph+) chronic myeloid leukaemia (CML) for whom bone marrow transplantation is not considered as the first line of treatment.

• adult and paediatric patients with Ph+ CML in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis.

Sandy

Thanks, Sandy.

I will ask about it at my next check-up in March - things may be a bit clearer by then.

Olivia

EMC list of generic Imatinib

It is interesting to check the EMC list referred to by Sandy because it shows that Novartis who have always produced the branded Glivec are now in  the list of generic producers of Imatinib through Sandoz which was set up in 2003 as its generics division.In 1996 the original Sandoz  had merged with Ciba-Geigy to form Novartis.If you have read the book "The Philadelphia Chromosome" by Jessica Wapner you will be aware of how the decision  in the late 1990s to run clinical trials for STI-571 was "allowed" by the newly appointed CEO of Novartis  Daniel Vasella after intense pressure from clinicians and others.This was against the intense pressure from some sections of the organisation against going ahead as the market for a rare cancer was seen to be not large enough and previous animal studies tests had demonstrated substantial side effects from the new drug plus the potential of a tyrosine kinase inhibitor were not fully appreciated.Quite salutary to think that it was an unusual decision to have gone ahead given the circumstances.

One might have expected Novartis to still want to maintain a slice of the action via their generics arm.If I had a choice of which generic to take I might have some confidence in the Sandoz version.

Does anyone have information on the pricing of the new generics?

 Best wishes

John

Licensing issues with Imatinib generics

Just a few more contributions to make asa follow up to my previous post. I had a discussion with a senior pharmacist that works in the private hospital sector and he alerted me to some licensing issues with imatinib generics.Looking in  more depth at the product information of Intrapharma it seems that the marketing authorisation is held by them but the manufacturers are different and the license is held by Actavis UK Ltd .The leaflet is shoddy as it is not all in English.

It is useful to look at the website of the UK MHRA-Medicines and Healthcare Products-Regulatory Agency  and to seek out the various public assessment reports or sometimes called scientific discussions which have been undertaken for each of those who hold marketing and product authorisations .I came across a document for Teva in UK dated 2013  where it states that imatinib is only to be used in the chronic phase where the patient has proven to be unsuitable for a transplant or there has been a previous failure on interferon alpha.The Sandoz i ( part of Novartis ) imatinib public assessment report states "The product is indicated for adult patients with Ph+ CML in blast crisis" Another one I tracked was for Woekhardt UK which does not yet seem to be in production yet but it seems that they hold or have applied for marketing authorisation and they state "In adult patients imatinib is used to treat a late stage of C M L called blast crisis.Dr Reddys imatinib contains similar provisions.

So Nigel it seems that there is not a mistake in your Intrapharma product literature and that for some reason few or none of the generic imatinib providers have applied for their drug to be used in chronic phase CML.Is this just a tactic to evade the need to undertake rigid testing of their product or what.?There has to be a reason for this licensing pattern emerging.My pharmacy contact would not prescribe a generic imatinib unless the licensing documents specifically permitted its use in the chronic phase of CMlL So how have QE bi -passed this ?

On the pricing I was told that there is now a market out there for generic imatinib and deals will be done;initially it might start off at the same price level as the branded Glivec and then find a level according to contracts and volume taken.QE might try to evade a Freedom of Information Request if one sought details of the deal done with Intrapharma-confidential I guess in the  same way that NHS did a deal with the producers of Tasigna /nilotinib at the time of the NICE submission.Of course current government has always wanted a thriving market for medical drugs and it seems one will emerge for generic imatinib.

I wonder if David might be able to throw some light on what is happening in terms of the marketing and product authorisations for generic imatinibs and the licensing position for CML chronic phase.

With best wishes

John

 

Hi John,

Thank you very much for your response, sorry it’s taken me a few days to come back to you, however I have been speaking with the QE once more who are in contact with the manufacturer; I have also received a letters from them in reply.

Indeed it is not an error in the leaflet, it was unlikely to have been so but it did surprise me in respect of the indication being for blast crisis in adults.

I am not quite sure why, and we are investigating further, however it seems to actually be related to nilotonib somehow I am being told as Nilotinib an orphan drug, as was imatinib of course. I really cannot see how this is the case and Nilotinib effects the indication for Imatinib generic but apparently so, indeed it does seem that a few of the generic imatinibs are stating for Blast crisis, i assume for the same reason, whatever that is. Not good as those with a little knowledge will read the leaflet and be unhappy if given the copy as the indication is wrong. Once I have further information I will of course revert.

Many thanks for your reply in the meantime.

Nigel

I've read this thread with interest - it seems odd that the generics would have indications that are not as extensive as Glivec.  A look at the EMA site suggests that some have mirrored their indications on that for Glivec (Imatinib Teva has exactly the same list as Glivec, for leukaemia at least, including CML). 

Others do rather oddly not refer to them being indicated for use in adults with chronic phase CML.  It may be something to do with the timing of the particular application for authorisations (which happened some years ago).  That may lie in very specific details of regulatory law that I'm not wholly familiar with (not to do with the suitability of the product for the indication but time limited restrictions on use of relevant data for authorisation). Not sure - however, the authorised indications seem to mirror what each the generics applied for so no suggestion that there was some sort of "limitation" on their applications.  Bottom line though is that for all the generics, the EMA says they are bioequivalent to Glivec.  Whether the pharmacies should be fulfilling prescriptions with generics other than Teva, for adults in chronic phase, is a different matter but this sort of thing can and does happen.  I suspect things will change - meaning the other generics will sort this out.  there seem to be various changes to documents pending although I don't see relevant changes to the indications in the authorisations themselves. 

Re pricing, the price is usually inversely proportional to the number of generics on the market.  Nothing surprising in that of course but typically in the early days, the price difference from the reference product is quite small but increases dramatically as time goes on. 

 

Olivia, I understand that Scotland will be prescribing the generic imatinib manufactured by Sandoz. 

Sandy

Thanks Sandy.  I see from earlier in this thread that Sandos is part of Novartis, so I assume it's good news and there won't be much if any difference?  Apart from price, that is.

Olivia

I've just received my first delivery of the new Imatinib, made by Sandoz.  I'm in North East England but get my deliveries from Alcura.

 

The tablets look almost the same as the normal Imatinib.

Just a brief word on pricing for generic imatinib to add to that already set out in the previous posts. I'm not an expert on what's called the 'dark art' of pricing but what follows is my best shot at describing the current situation. 

In England, the commissioner (payer) for all chemotherapy is NHS England (NHSE). All CML TKIs fall (somewhat uncomfortably) in the chemotherapy category.

The relevant unit within NHSE favours a tendering process for situations like that for generic imatinib and in particular prefers regional tendering to secure better prices since it enables them to play the generics companies off against each other more effectively than would be the case with national tendering.

This would explain the variation in generic manufacturer amongst patients at different (Trust) hospitals in England. In much the same way, any variation across the other NHS systems, like NHS Scotland, that cover the UK would be due to different procurement regimes generating different outcomes for the generic selected.

There are moves in England to move to national procurement of chemotherapy but this depends on NHSE being capable of generating accurate forecasts of likely volumes in order to negotiate on a best price basis. Although much talked about, this seems unlikely to occur in the near future.  

Finally, my understanding is that in England a financial incentive (a CQUIN payment) has also been, or is to be offered, to hospitals to switch qualifying patients over to the generic with payments linked to the % switched.

The upper limit for the full payment of the incentive is said to be 90% (ie a 10% allowance has been made for patients for whom imatinib TKI treatment is not appropriate even though they might be eligible; for example a newly diagnosed chronic phase patient defined as high risk by a SOKAL score) with a lower (I'm not sure what this is but I'm told it's well above 50%) limit beyond which no payment would be forthcoming.

Its worth remembering that some 30% + of chronic phase patients are not treated with imatinib in first line even though they are eligible. Although these would include those for whom imatinib is not appropriate, they also include those being treated with a TKI (other than imatinib) recommended by NICE for 1st line use (currently nilotinib and dasatinib).  

In short, approaches have been taken by NHSE to address both demand and supply.    

   

Hi Nigel,

Digging up an oldish topic here, but in clinic the other day my doctor and I got talking on the topic of generic imatinib. At Barts they are still prescribing branded Glivec because of the issue with the indication on the generics. My doctor reckoned there was a good case to say nobody should prescribe something "off label" when there is an "on label" alternative available. So because of that, it's branded Glivec at Barts until this generics receive the correct labelling / indication.

David.