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Generic imatinib again -some updates

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Hi All,

There have been a few threads on this before and this included a posting from myself so no apologies for another separate thread as this for many of us will probably involve a switch from branded Glivec to a generic Imatinib within 12 to 15 months from now-it seems that the patent for the alpha crystalline formulation of IM held by Novartis expires in UK towards the end of 2016.They still hold a patent for the beta crystalline form that is the current Glivec and this expires in Canada in 2018 and we assume in UK later..So is there a difference between the branded Glivec and the many and new generics?

Just to place generics and Imatinib  into context:

  • India has been producing a range of TKIs for many years and Novartis challenged these manufacturers in a patent law case but lost-they put forward a case indicating that the beta form was a new formulation I believe .They did not argue that the beta formulation had greater efficacy though-some say it was an attempt at evergreening so as to extend the life of the patent via small change in formulation..Many of the generic IMs are being  produced in India and sell at a rate of 20 to 40 percent of the price of branded Glivec.
  • In April 2013 Health Canada because the patent had expired  funded only generic forms of IM such as the brands Teva and Apotex.The CML Society of Canada being a similar patient advocacy group as ours has been active in eliciting views from patients on the issues surrounding the introduction of generics versus the branded Imatinib Glivec.A look into their website  specifically refers to some current issues http://cmlsociety.org/generic-tyrosine-kinase-inhibitors-tkis-arrive-incanada/
  • BC (British Columbia,Canada )  Cancer Agency produced a document titled Generic Imatinib :Review of the Literature on Clinical Efficacy and indicated that the generic was similar in terms of bio-availability to the branded Glivec.:well worth a read..However what the article did not say was that the basis of the  Canadian authorities decision to approve Teva and Apotex was based on so called trials at Mc Gill University,Canada on healthy individuals to measure blood plasma levels and absorption of branded Glivec versus generic IMs :no  tests were undertaken on actual CML patients yet authorities approved such results.
  • In USA generic IM will be introduced in February 2016 approved by FDA and supplied  by Sun Pharma.This must be good news to patients in USA who if in work not only pay a premium from salary but also a co- payment for TKI drugs of say 20 percent of costs.Currently Novartis price Gleevec  in USA at £100,000 p.a.meaning a payment of say $20,000 p.a. from the patient. Just think of the benefits of the NHS.!  What happens in USA  if you have CML and are out of work???
  • http://cml.advocates.net/generics is a useful source as it indicates some of the issues that face patients in countries that are offered only generics as an option for treatment of CML.They have produced an unofficial register of of generics for treatment of CMl and their argument is that patients must fight for good generics.they suggest that because IM has a narrow therapeutic range we need to be vigilant against switching to generics for non medical reasons i.e.costs .If we are switched to generics then we need to have regular monitoring i.e.PCR s every month for a period of 3/6 months.If greater toxicities are indicated then there must be an option to return to the branded Glivec .Finally if one is on generics it is important to not switch generic brands/manufacturer -keep the same label..

So, in terms of ourselves in UK and from point of view of this forum do we need to take any  further action?

1.At the Hammersmith November 2015  Conference there was a presentation by Professor Mhaira Copland that covered some aspects of generics and my interpretation of her conclusions were that in terms of efficacy of the  IM drug there were fewer concerns than  in relation to a a newer and variable side effect profile which needed to be monitored-one of her last slides suggested that we need to involve everyone in the monitoring of new and different side effects as a result of any generic versus a branded Glivec- so everyone means patients, patient advocacy groups and clinicians plus Pharma?

.2.Just one very important and relevant practice  from Health Canada-Canada is insurance based and has a number of Provinces that vary slightly  in terms of operations.In Quebec they have a scheme whereby a clinician may indicate on a prescription for.only the issuance of  Glivec -do not substitute, plus a code relating to an intolerance or a new side effect resulting from use of a generic.Interesting because it indicates greater  or different side effects of generics.So are there new intolerances from generics?

3.Some academic papers have hinted at the instability within the body of the different forms of alpha crystalline forms of  generic Imatinib leading to new and different side effects- protaginists for generics suggest this is only heresay and so is non scientific feedback.Patients and patient groups though have expressed real concern .

3.Conclusion:

I suggest that if you are on Glivec :

-ask your clinician if late 2016 or early 2017 they will prescribe generic IM or they will be compelled to do so?

-if so, request monthly PCRs on the basis that this is a new drug

-check your prescription and ask if it is for Glivec or for Imatinib-if it reads Imatinib it will be for a generic

-if on a generic ,check with the pharmacy that the brand /generic/manufacturer/label is the same each prescription:if not decline and then ask for the same as before.Insist the pharmacy place a note on your file for same label .

-keep a record of your PCR if offered a generic-if it changes ask your clinician to  refer back to the branded Glivec if NICE allows!

-if there is intolerance be wary of moving on to another TKI such as Nilotinib that has a different dosing regime,is hard on the heart and may have many other and different side effects that are not able to be predicted:a total nightmare.!

Finally would it be an idea for CML Support to set up a feedback system similar to CML Society Canada?

Best wishes

John

Thank you for posting this. This is something im very worried about i was diagnosed july last year and doing well last pcr 6 months 0.067%

Can we really ask for monthly pcrs if changed to the generic form, or should i say when
changed to it.
I appreciate there are lots of other medications that are generic now like paracetamol as ive been told but to b fair that doesnt make me worry less about generic imatinib, my imatinib is keeping me alive so bit different.

Hi Moirah,

Thanks for reading my posting and replying .Welcome to the CML/Glivec club -yes it certainly keeps us alive .Trust you are doing well in your first year which can be quite challenging.I have been on Glivec for 9 years now and apart from eye issues and some dreadful night cramps seem to be doing very well.

In the posting I tried to summarise some of the concerns that patients and patient groups had expressed in countries where generic imatinib had been introduced and in particular Canada.Next week shall be seeing my clinician and will take up the subject of generics and whether more frequent PCRs might be offered with introduction of generic imatinib in about a years time;he always has time to consider and discuss  interesting issues.One factor of  course is that the PCR is quite an expensive test-costs about £300 I believe.It has been suggested that generic imatinib will be priced at anything from 20 percent up to 40 percent of the current price of Glivec which over time will be a considerable saving for the NHS and insurers.

One senior hospital pharmacist that I talked with indicated that there is a list of drugs that have "Do not substitute" attached to them.I asked an opinion from my partners neurologist who suggested that in the past some generics developed for elilepsy were in fact quite dangerous.

As we know some CML patients cannot tolerate a particular TKI so I guess we need to be prepared in the event that a new generic leads to new or more severe individual side effects

With best wishes

John

Hi John

Thanks for a very interesting and detailed post and synopsis with regard to Generic Imatinib. I likewise shared your concerns with regard to the potential change that is on the way. However I was lucky enough to attend CML Horizons 2014 at which one of the main topics was generics. The talk was very interesting and did give me quite some reassurance on formula.

We are fortunate in the United Kingdom, as in Canada likewise, to have a very good health system that will undoubtedly scrutinise any drugs that are placed on to the market prior to them being given to the general public. Whilst I don’t want to be naïve, and maybe I am being, I do have good faith in the system that we have here to protect the general public.

Clearly cost is very important but unlike other places in the World where cost is the absolute only, and over-riding concern, I believe the formulation that will ultimately be provided to us will have the efficacy to be effective. So many drugs we take in the UK both over the counter and prescription are generic. We also have the advantage of being 2 or 3 years behind other countries, so perhaps they are our “Guinea pigs”.

Whilst in an ideal World we would like to have PCR testing done on a monthly basis once the drug comes in, I think it is unlikely with such a large patient population in the UK that this will take place. No doubt there will be some patients tested monthly to ensure efficacy, but not all I guess.

On speaking with the clinicians from Hammersmith Hospital at last year’s Patients Conference, I was told a PCR test is charged out at around £200. Clearly a significant saving will be made by the NHS potentially by taking generic drugs but I guess it is unlikely that they will take a wider view at this saving and think yes we will pay for additional PCR testing. The reality of our drug is a PCR test costs in all likelihood approximately three days Imatinib supply of drug, however no doubt this will not be given consideration.

Speaking with the Canadian Advocates, during one of the breaks at the Conference in 2014, I was given further reassurance that the drug seemed to be working well and whilst there has been a slightly different side effect profile, things were looking good.

No doubt we will have a system in place to report side effects as I think the data will be important. Will we be able to insist on branded Glivec, unlikely but perhaps those on it will remain on it…..

I have to say my biggest concern about generic drugs is not the drug itself, I think the far bigger question is ‘will we be left with only one treatment option’? Currently Nilotinib and Imatinib cost the NHS the same. When we see generic Imatinib at potentially 20 to 40% of its current retail value, will the NHS insist on all newly diagnosed patients being placed on to this new drug, and Nilotinib only become available should this new first line of treatment not work, an interesting question as Nilotinib is NICE approved and therefore NHS funded, it may not be the case in time due to cost. So, my question once more is with generic Imatinib coming to the market, we will as a patient group find our options significantly reduced, I hope not.

Thread continued from: 
Question 1: How do you feel about generic imatinib being introduced after the patent expires in 2016?