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End of STI-571 (GLIVEC) trial

I was put on the Glivec trial through Addenbrookes in Cambridge almost 7 years ago and luckily , have been in remission for 6 and a half of these years . However , on a recent check , i was told that the trial was now effectively over .
I live in Peterborough which is in a different primary care trust area and was told that Addenbrookes would no longer prescribe Glivec to me but they would write to Peterborough and let me know the outcome . (Due to individual budgets)
I have been told that although Glivec is approved etc , some care trusts do not prescribe it until closer to the end stage due to cost.
Forgive me if i'm wrong ,but for those of you who were also on this trial at a similar time , weren't we told that as a kind of thank you for been a guinea pig , we would get Glivec given to us , at no cost to the NHS whilst we continued to benefit from it ! Sadly , this isn't stated anywhere on all those forms we had to sign at the beginning !
Any thoughts ? Am i mistaked ?
By the way , nice to be back and see so many old familiar names !! Thanks

Hi, I am writing from the US and many Gleevec trials here have ended....such as the phase 1. Once a drug is approved, there still has to be some follow-up for the FDA, but only from a limited number of patients (early phase 2 in the US is still being followed, and it started in late 1999, early 2000).

I hope you will get your drug provided for you. It makes no sense at all to say that this drug is for later stage CML. It seems that you should be able to argue that this is considered to be 'front line treatment for CML'.

Best wishes to you,
Nancy C.

As far as I'm aware if NICE have approved the drug then the PCT cannot refuse to meet your prescription.

Marian

hi keith,
which trial ...0106?
i do know that novartis have not closed this trial.... but they have updated the contract which you will be asked to resign. NICE gave its approval for Glivec back in 2001/2. pct are LEGALLY obliged to fund Glivec. your pct can and should be challenged.
sandy C ;o)

Hi Keith,

I live in Wales, and the Health Service is organised a little differently here - we don't have PCT's but do have the equivalen LHB's who are not really involved in funding Glivec, it is the NHS Trusts which do that, as prescribing is as far as I know restricted to Hospital Doctors.
I assume you will continue to be seen, monitored etc by a consultant Haematologist/Oncologist even if it is more local to you? This should give you the opportunity to have the drug prescribed by them.

My wife is seen at University Hospital of Wales, and all prescribing of Glivec continues to be by the Haematologist. However, recently supply has been from a local community pharmacy rather than the hospital pharmacy. Thus, the NHS Trust still funds the drug but actually makes a saving of 17.5% vat on the cost by having the supply from 'outside' the hospital.

Prescribing of Glivec for patients in chronic phase of cml is a NICE recommendation, and Trusts should therefore find funding for the drug.

I hope that these comments help.

Paul

Dear Keith, I want to say hello to a fellow 106 trialist. The facts of the matter are as follows: Trial 106 will end in 2008. In 2006 the trial, which was originally for five and a half years, was extended and patients were asked to re-sign - not resign - the consent form.

You dont say which hospital monitors your trial but I am at Hammersmith and have had the most wonderful treatment and care there. I have been through the protocol documents very carefully after being told that the cost of my 600 mgd Glivec will be passed to the PCT during 2008 at the end of the trial. The Hammersmith document dated 25 May,2000 in Paragraph 14 clearly states that (and I quote) "you may continue to take a study treatment for as long as you are benefiting from the treatmnt."

Under Paragraph 18 headed "Who is organising and funding the research?" it clearly states that Novartis AG, Basle, Switzerland will reimburse the hospital.

The exact wording was confirmed in a document to 106 trial patients at Hammersmith dated 25 March, 2001 Version 5 so I cannot see that there can be any dispute as to what the intention was.

I have written to Hammersmith about my concern and am awaiting a reply; I have been told my letter has been passed to Novartis. I cannot imagine that great organisation would risk a potential PR disaster and bring clinical trials into disrepute by not honouring their comittment to those of us who took, what was then a huge risk, to trial a drug that had not then been tested as primary treatment on newly diagnosed patients. The recent leukaemia drug trial disaster in North London brings into perspective the risk we took in 2000 .

Everyone now knows, of course, of the brilliant success of Glivec both clinically and commercially and I am very proud to have been a small part of that success. However, when I read that new cancer drugs are not being offered by PCTs because of budget restrictions I felt strongly that I did not want the costs of my (and my fellow trialists') Glivec to be added to the PCT's already stretched finances. Hence, the action I have taken by writing to Hammersmith.

All the statistics regarding the success of Glivec come from the 1106 patients who were recruited around the world for the 106 trial The trial also goes under the name of IRIS (International Randomised Interferon Study) because the trial was randomised so that only every other patient got the new compound which was then known as STI 571 (Signal Transduction Inhibitor?) Most of the 553 patients who drew Interferon on the trial crossed over to the STI 571 leg once the first stunning results started coming through early in 2001.

I hope that the above will in some way put your mind at rest - your supply is assured but who will pay for it has not yet been resolved.

Hi Peter , Many thanks for your reply . I have finally managed to find my forms . However , i appear to have lost page 5 of 8 of the original consent form that includes paragraph 14 ! I knew I'd seen something about continuing to get the drugs whilst continuing to benefit from it !
The form i was asked to sign at the end of 2006 does not fill me with joy . It states that the study ends around 31st july 2008 and supplies will stop , however , you may be able to continue getting Glivec on prescription from your doctor . The word MAY worries me !
I agree with you wholeheartedly , the goal posts have been moved unfairly .
I must admit to not reading the form properly before signing it because i was once told by my research nurse at Addenbrookes that they would never allow me to sign anything that was detremental to my well-being , but i guess that i could've been removed from the trial for not signing it anyway as i would not be agreeing to their terms !
I would be extremely grateful if you could let me know what you receive in reply to your letter , would you suggest i do something similar ?
Thanks , Keith

Thanks for your comments Sandy .
Yes i am from 0106 .
Hopefully it won't come to having to challenge any funding decisions but it's nice to know that it is an option if things go that far !
Waiting to hear what Addenbrookes and Peterborough decide before my next choice is made .

I have just come back from a week's holiday so trying to catch up on the website.
This issue was raised by a patient earlier on last month and I queried this with Novartis who were adamant that the 106 patients, 18 in the UK, would carry on getting free supply of Glivec for as long as Glivec was working for them. New paperwork has been sent to the clinicians and they will in turn inform their patients. There was some delay in the paperwork being issued to the clinicians which resulted in these unfounded fears of the supply being passed to the PCTs for 106 patients. By now I expect most of you will have been informed by your clinician that you will continue getting free supply of Glivec for as long as you benefit from it.
I hope this clears this issue. If anyone has any problems, do get in touch.
Elizabeth

Have just read through these stories and am greatly relieved to hear your news Elizabeth. It has restored my faith in human nature. Well done Novartis - I have always trusted you - on Glivec since 2001. With kind regards to all my old/new colleagues on this wonderful site. Pat

Thank you very much Elizabeth , that's wonderful to hear and a great worry off my mind !! Hope to get that confirmed sooner rather than later !
Thank you Novartis for your fantastic drug !

Hi: I was in the clinical trial in the U.S., and when the FDA approved the Gleevec I was told if I ever ran into a problem due to finances that I was entitled to free pills. My insurance was paying for it, but then we had a lull with finances. I filled out a form with Novartis Pharmaceutical and they sent me free prescription every month until we got back on our feet. When I had the coverage I was paying $25.00 a month.
I have not received my new script under the new plan yet, but I am sure it will be affordable. Anyone having financial problems, just check into ways to get help.
Suzzie