update/Tarceva appeal Hearing 6th June

[Deanne Jenkyns]

I received this information from Susan today.

chief executive Mike Unger has been in contact with NICE re the erlotinib appeal. Their response was as follows:

‘I’ve checked on progress with the appeal, and the appeal outcome has not yet been submitted to the Institute’s Guidance Executive. This means that in theory the earliest it could be considered by Guidance Executive is next Tuesday, and once considered by Guidance Executive it could be published the following week. On this basis, I think it would be safe for you to post a note on your website along the following lines:



“The Roy Castle Lung Foundation does not anticipate receiving any further information about the NICE appeal on erlotinib (Tarceva) before mid-September at the earliest. As soon as further information is available we will publish it on our website.”



Unfortunately I can’t give you any further information about when we anticipate the appeal will be submitted to Guidance Executive. ‘



Mike Unger will be following this up again w/c 17th September. As soon as I have any further news I will let you.

[Deanne Jenkyns]

It is not acceptable that NICE are dragging this out for so long! Time is precious for cancer patients. NICE are supposed to fast track drugs for cancer patients. When I attended the meeting June 6th we were told a decision would be in three weeks?? We are now into September!! Patients are dying before they get the chance to try this drug becasue they are unable to raise the funds!

[wendy]

I looked on the NICE yesterday evening and was horrified to see that all appeals have been turned down. Am i right in this?

[dtay]

Hi Wendy
I looked on the NICE website and it certainly looks like most of the appeals were dismissed. Not sure what it all mean tho - Deanne and Jimmy might have a better idea.
Dawn

[wendy]

I E-mailed NICE the other evening and received this reply yesterday

'Thank you for contacting NICE. .........I hope that I can clarify our position.
It is the responsibility of NICE to assess both the clinical and cost effectiveness of drugs and devices referred by the Department of Health, and to make a recommendation to the NHS about their use.
We take this responsibility very seriously and therefore consult widely at all stages of the appraisal process. Appeals were made against our draft guidance for erlotinib and subsequently an appeal hearing was held. Several of the points raised at the appeal were upheld. This includes points relating to side-effects, which you mention. Because of this, we will be conducting further examinations of the evidence for consideration by the Independent Appraisal Committee. The Independent Appraisal Committee will then make any necessary changes to the draft guidance.
It is important to note that we have not yet issued final guidance on the use of erlotinib for non small-cell lung cancer and that there is no ban on prescribing licensed drugs where a NICE appraisal is in progress. The Department of Health has made it clear that funding for newly licensed treatments should not be withheld because guidance from NICE is unavailable. In these circumstances, the Department of Health expects primary care trusts (PCTs) to make their own assessment of available evidence before deciding how and if to fund the drug locally. (Rosie Winterton, Minister of State for Health - Commons Hansard, June 7 2005, Column 426W).
I hope I have been able to clearly explain our position to you. If you have any concerns about the treatment you are receiving, please contact the Patient Advice and Liaison Service (PALS) at your local hospital. You can find their details at:
www.pals.nhs.uk'

'I am sorry if I jumped the gun' however i did reply to say that i hoped the outcome would e good but I wasn't too hopeful as it all seems to centre of cost-effectiveness

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From: knowles [mailto:[e-mail]]
Sent: 07 October 2007 20:31
To: NICE Mail
Subject: erlotinib



I have just finished reading NICE's response to the appeals on the drug erlotinib and feel that you have just put a nail in my coffin.

I am a lifelong non smoker who was diagnosed with adenocarcenoma in January 2007.Can anyone at NICE imagine the horror at being given such news.

I have worked hard all my life and was due to retire from teaching in April 2007.

The past few months have been a round of scans, appointments, and chemotherapy. Has anyone there ever had chemotherapy? The feeling of exhaustion after a session of chemo. The impact on lifestyle, continually watching out for infections.

Your response to the appeal was negative in all aspects and it is apparent to me that you are guarding the Treasury's coffers and giving no consideration to patients suffering from am awful disease.

Your suggestions of the alternative treatment with its known side-effects shows callousness in the extreme.

I doubt you would make the same decision if members of your respective families were in the same positiion.

Why cant the experts namely the consultants who specialise in the treatment of lung cancer make appropriate decisions on individual cases.

If as you state I and people like me do not have long to survive I will have saved the country my pension and any benefits I might have claim to.

I doubt that anyone will have the decency to reply to this letter as I am just another statistic in your eyes.

Yours sincerely

Wendy Diane Knowles

I am sending copies of this letter to Gordon Brown, Tom Levitt MP, David Cameron, Ming Campbell


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[Deanne Jenkyns]

Hiya Wendy,
1st of all welcome to the site glad you have decided to join us, but at the same time sad you have to be here at all The more voices we have however the better. I have just posted some information about Tarceva on this thread supplied to me via email from Susan Christie from the RCLCF

deannejenkyns.proboards46.com/index.cgi?action=display&board=tarceva&thread=1192359067

How are you doing on Tarceva, do you have the rash? If so how are you managing with it?

Take Care
Deanne
xxx