Novartis Blood Serum Level monitoring - long

[Guest guest]

Hello All,

In response to your questions, here is what Novartis presented at their

booth at ASH. I have all the documentation and I will be happy to scan it

and put it up here on the site.

Everything in quotes is exactly as it is on the written material, these are

Novartis' words not mine:

" CML Alliance, a new support program designed to help optimize outcomes in

patients with Ph+ chronic myeloid leukemia (CML) "

" CML ALLIANCE is currently for US health care providers and their patients

only "

" Program under development and subject to regulatory approval "

CML ALLIANCE - a unique program offering important support for health

care providers who treat Ph+CML and their patients "

" Novartis, the global leader in Ph+ CML therapy, has been working with

health care providers and patients worldwide for more than 5 years to

improve treatment of Ph+ CML. "

" Novartis now introduces CML ALLIANCE, a unique support program designed to

help health care providers optimize outcomes in Ph+ CML patients. "

" SUPPORT FOR HEALTH CARE PROVIDERS "

" Standardized blood level testing to help identify nonadherence as a cause

of suboptimal response* "

" Access to reimbursement support and information "

" Access to educational information on the molecular biology and management

of Ph+ CML "

" Access to information on all clinical trials of new and existing Novartis

Ph+ CML therapies "

" SUPPORT FOR PATIENTS "

" Unique programs designed to help improve adherence to Ph+CML therapy "

" Access to reimbursement support information "

" Valuable educational information on living with Ph+ CML, including

www.livingwithCML.com "

" Additional features will be added in the future "

" Improving adherence to therapy is a key goal of CML ALLIANCE "

" Nonadherence has been identified as a significant barrier to the effective

use of oral cancer therapies (1,2) "

" Oral cancer therapies continue to be developed and their use will continue

to increase (1) "

" One of the first large studies (N-4043) of adherence to oral cancer

medication found:

- on average, patients took only 75% of their prescribed oral cancer

medication over the 24 moth study period(1)

- only 41% of patients took >90% of their prescribed medication (1)

- A >95% adherence rate is generally considered to be the minimum

standard for patients with life-threatening conditions(4)

- The average patient consumed ~ 20% less than his or her prescribed dose of

medication (3)

- Patients were on therapy an average of 62% of the study period (255 days

out of 24 months)(3)

- After 4 months of treatment, adherence began to decline (3) "

So, now these are my words, this program is a result of market research (I

know because this is what I do) based on the amount of CML patients and

looking at the sales figures for actual drug sales to pharmacists. This is

how Novartis or any drug company can track compliance. They base their

calculations based on average monthly doses, add up the sales and see where

the gaps are.

As well, Novartis is concerned that the higher incidence of resistance and

relapse might really be a function of lack of adherence to the drug. Just

for the record, during the sessions at ASH doctors all agreed that the blood

serum level should be done more out of a need to monitor toxicity then

" pushing " the compliance issue. Not one of our doctors out there think this

ought to be used as an issue of compliance. I agree with them too!

So, I think that in my own personal case, because of problems with my

kidneys, if I were on Gleevec (I am on IFN and LOVING it) then I would have

my blood serum level tested to see what the optimal dose of Gleevec would be

for me.

For the record, if I was a patient that did not respond to 400mg of Gleevec

and was switched over to 800mg of Gleevec, I would be inclined, based on the

data I saw at ASH which is posted on the www.cmlsociety.org website, to

switch to Dasatinib, and most preferably, I would go to the 100mg daily

dose. I am speaking purely as a patient, the data that Dr. Shah presented

made a very compelling case for the switch. To be fair the data for Tasigna

is also very good, but it isn't approved yet, so it is harder to switch just

now.

Please do not hesitate to contact me if you have any questions. By the way,

it is my understanding that this program will also happen in Canada.

Cheers,

Cheryl-Anne