Which brand of Imatinib

Hi ,
For all of us on long term use of tkis that we were placed on first line treatment which at the time I guess was branded Gleevec and the generic name being imatinib.When the manufacturer Novartis lost its patent a range of generics hit the market and most insurers and for instance in the UK the National Health Service did deals with these new incumbents such as Teva ,Accord and so on-and saved substantial amounts.
In Canada for instance patients supported by the CML society lobbied against this as many experienced different and more acute side effects.On this forum some complained that the side effects of Accord for instance were more extreme.
Some patients placed on generics would be switched every 2/3 months from generic to generic according to what was available or the cheapest at the time of the prescription being fulfilled -many complained of new and different and disturbing new side effects.
There has been a lot of discussion about how each new generic/potential market licence holder tested their new product before being given the go ahead-some argued that trials/tests were made on healthy volunteer students as opposed to CML patients .Some say the bar was set quite low (versus Glivec) in terms of allowable toxitic effects of a new market entrant.
My haematologist told me that in his experience the original Glivec is still the gold standard but not far behind is "Sandoz" generic.The history behind this generic is that it is manufactured by Novartis who were and still are the producers of branded Glivec.Novartis was formed by the merger of the old company Ceiba -Geigy and Sandoz (which was of Spanish origin)-hence the generic name being used I assume.When they lost their patent Novartis still wanted some considerable slice of the generic market.You can still find branded Glivec but there is a price differential versus the generics.
Over my 16 years on imatinib in the early years only Glivec was available and I rotated from private insurance in UK to NHS then back again ;at present I am on private insurance until such time as I cannot afford the escalating premiums any more-then the NHS will look after me.At present I am able to specify Sandoz generic as the preferred one and I am used to the side effects and can manage them quite well.Each of us will have different types and levels of side effects I believe.
In terms of price most people in UK who are on the government or NHS free at point of use medical scheme will not be aware of the true cost of Gleevec nor the generics.Different hospital groups in UK will do a deal with a market provider of a generic imatinib so it is not easy to access these confidential agreements.
I was told that historically my Glivec cost the NHS about £24k per annum (plus VAT at 20% if prescribed by a NHS hospital pharmacy-not reclaimable).Private hospitals always try to charge more to the insurers as they always want a margin for dispensing.At present my Sandoz imatinib if sourced from a high street pharmacy such as Boots on a private basis costs about £12000 per annum so some generics have not come down in price as much as it was estimated.
Currently my private hospital in the Circle Health Group owned by a private equity group tries to charge the private healthcare insurer (owned by another private equity group) £34k per annum but according to a contract between the two parties only settles for a lesser amount like £12k per annum or less-they fight each other over this on a regular basis but there is no patient liability so I dont have to make up the shortfall.
My understanding of US healthcare is limited but I know Novartis charges about $120,000 US per annum for branded Glivec and the generics are variously priced but not cheap;I gather that over the border in Canada prices are cheaper so one can do border running of prescription drugs or is it now illegal? Generics from India apparently are often priced at a few hundred dollars per annum that is if one can access a reliable supplier.So if you are in a country with a patient co pay system say of 20% patient contribution to be made on prescribed drugs if the generic costs $50,000 per annum that is $10,000 per annum to find on top of your healthcare insurance premiums.Having CML and having to take imatinib for life is some commitment for sure!
Some on forum will quote studies that try to disprove that there is any difference between generics or that they are any different to branded Clivec but you might find individual patients who have experienced new side effects form being paced on a different generic.
Apparently there is a difference between branded Glivec and generics in term of one being an alpha formulation and the other a beta formulation(any difference?) but others say this was part of a guise by Novartis to maintain its patent in India where government ruled against it in a law suit or similar;Novartis lost.
Best seasonal wishes,
John

Yes Buzz in UK the The Medicines and Healthcare products Regulatory Agency (MHRA) have the same restriction, as does the European Medicines Agency (EMA) for the European Union.

Evie, nothing will reduce side-effects more than reducing your TKI dosage. If I recall correctly your PCR reading is already quite low. Talk to your doctor about allowing you to reduce your TKI dosage. Contrary to popular belief it isn't necessary to reach undetected before beginning to gradually reduce TKI dosage.

Buzz

Evie, I would suggest that you find another consultant. There isn't a set rule that you have to be on the full dosage of any TKI for five years before reducing dosage. That's ridiculous.

Buzz

That is a good explanation.

When I took Imatinib generics, I did suffer different side effects from brand to brand, particularly gastro symptoms. Accord was the worst.

I believe that it is a fact that each brand delivers the same amount of imatinib into the blood. So, we might consider the incipient argument.

Now, each month, I take home a bag full of medicines from the pharmacy, each containing incipients. The incipients, if listed, are no different from the incipients contained in the various Imatinibs. There must be something else going on.

I am curious; now that I am taking generic dasatinib, I have no issue whatsoever with the generics.

Probably the best way to take a TKI would be to have it tailor made to your body. That is not done at this time to my knowledge. From a layman’s perspective I believe that body weight plays a significant role in side effects. 400mg of Gleevec for a 67 kilo person will be different than for a 87 kilogram person. Another thing about generics, I do believe one of the main reasons why generics are different than many brand names is due in part to the cost of testing. Novartis and other pharmaceutical companies do not make their drugs available at a discount to their competition. And finally, Evie if you do get into the practice of experimenting with your Gleevec tablet I would reccomend buying a pair of tablet shears to cut your pill in half as they work the best. The other type of tablet cutting tools just mangle the tablet. Of course always ask your doctor before trying anything out like that.