Access Denied: Albertans with Chronic Kidney Disease face treatment obstacles



    
    Restrictive public coverage prevents patients from receiving important
    therapy
    

    EDMONTON, June 10 /CNW/ - Patients from Alberta living with Chronic
Kidney Disease (CKD) on dialysis are at a clear disadvantage versus their
fellow patients across the rest of the country when it comes to controlling
high phosphate levels. Where all other provinces and territories in Canada
allow some form of access to alternate therapy choices, Alberta is the only
province where Renagel, an effective and safe therapy to control phosphorous
levels in dialysis patients, is not publicly reimbursed, thus limiting the
specialists' access to it.
    "A clear divide in the equality of treatment availability for patients in
Alberta is unmistakably evident," says Dr. Nairne Scott-Douglas, Medical
Director of the Southern Alberta Renal Program. "As nephrologists, all that we
ask is to have access to all therapy options in our armamentarium and then let
us use our training and expertise to prescribe the best solution for each
individual patient in appropriate clinical situations."
    The impact of limiting access is apparent; a nation-wide study of
dialysis patients suggests that those in Alberta are receiving, on average,
twice the amount of daily calcium recommended by Health Canada while some are
ingesting up to four times the suggested dosage largely due to the absorption
of calcium from their phosphate binders.(1) According to Health Canada, the
adequate intake level for calcium supplements in healthy adult Canadians is
1,000 to 1,200 mg per day, up to a maximum of 1,500 mg.(2) These levels are
listed for healthy Canadians who are able to excrete excess minerals from
their bodies; people with impaired kidney function cannot. As such, as calcium
accumulates in the body, the risk of vascular calcification, hypercalcemia
(elevated calcium levels in the blood), calcium deposits and cardiovascular
events increases.
    Carroll Thorowsky, a caregiver from Edmonton, Alberta, knows first hand
the risks of ingesting high levels of calcium to help control phosphorous. In
the spring of 2008, Carroll's husband, Marshall, experienced calciphylaxis
(the formation of calcified tissue in the body) after only two years of taking
high doses of calcium, causing him to almost lose his right leg through
amputation in the process. "It's a double-edged sword," says Carroll. "We know
it's imperative to control phosphorous in order to avoid future heart disease.
But, by managing the disease one way, we are causing damage in another. What
is truly upsetting is that there are therapies available that may have avoided
this incident, but we unfortunately never knew they were an option." Marshall
has since recovered from his calciphylaxis and currently takes Renagel, paid
for by Genzyme Canada, to help control his phosphorous levels.
    Where calcium poses a potential risk, Renagel has an established safety
profile and has been successfully used in more than 1 million patients
worldwide over the last 10 years. Although calcium binders are effective,
there are inherent mineral absorption risks that can increase the possibility
of calcification.
    "It is dangerous for such a vulnerable patient population to unknowingly
consume large amounts of calcium that are far greater than the recommended
limits for healthy Canadians," states Dr. Amin Pisani, a nephrologist with the
Northern Alberta Renal Program and the Royal Alexandra Hospital Department of
Nephrology. "We have to remember that CKD patients do not have the capability
to excrete minerals from their body the same way as the rest of us. As such,
large amounts of calcium may be placing them at a higher risk for developing
calcium deposits in the body, which is a very dangerous path to follow. That
is why it is imperative we have access to all non-calcium phosphate binders in
Alberta."
    Despite numerous appeals to Alberta Health & Wellness Drug Benefit
(AHWDB), Renagel is still not publically reimbursed by the province. However,
this has never wavered the commitment of Genzyme Canada, the makers of
Renagel, to dialysis patients in Alberta.
    Genzyme has provided Alberta nephrologists with approximately $2 million
in compassionate access to Renagel since coming to market in 2001. "Genzyme is
committed to providing patients with access to therapies that can greatly
improve their quality of life regardless of patient or provincial
reimbursement," says Brian Lewis, General Manager, Genzyme Canada.
"Nephrologists approach us because they believe in the value of providing
therapeutic options to their patients despite the position of the provincial
formulary."

    About Chronic Kidney Disease

    Chronic Kidney Disease (CKD) is the presence of kidney damage or a
decreased level of kidney function for a period of three months or more. This
disease affects more than 2 million Canadians. Diabetes, high blood pressure,
anaemia and cardiovascular disease are the most common causes of CKD. The
disease is divided into five stages depending on the severity of the damage to
the kidneys.

    
    Stage 1: Patients have more than 90 per cent kidney function
             Treatment - Identify and try to reverse the cause of decreased
             kidney function.

    Stage 2: Patients have 60 to 89 per cent kidney function
             Treatment - Try to stem the progression of the disease

    Stage 3: Patients have 30 to 59 per cent kidney function
             Treatment - Try to stem the progression of the disease

    Stage 4: Patients have 15 to 29 per cent kidney function
             Treatment - Explore dialysis and transplant options

    Stage 5: Patients have less than 15 per cent kidney function
             Treatment - Dialysis or transplant required to sustain life
    

    Not all CKD patients progress through all five stages of the disease. In
patients with Stage 4 kidney disease, death is a more common outcome (45.7 per
cent) than dialysis (19.9 per cent).(3) In other cases, patients remain stable
at Stage 4 or benefit from a successful kidney transplant.
    There is no cure for CKD, but it is possible to prevent or delay disease
progression(4) through early detection, access to therapeutic intervention and
lifestyle changes.

    About Renagel

    Renagel (sevelamer hydrochloride) is a non-calcium, non-metal phosphate
binder that helps to control phosphorous levels in CKD patients on dialysis.
It is as effective as calcium binders but has the distinct advantage of not
being absorbed by or accumulated in the body and reduces the risk of
calcification.

    About Genzyme

    Genzyme Corporation is a biotechnology and health care products company
that develops innovative products and services for major unmet medical needs
in the areas of renal, cancer, osteoarthritis and lysosomal storage diseases.
Celebrating thirteen years in Canada, Genzyme Canada Inc., located in
Mississauga, Ontario is the Canadian affiliate of Genzyme Corp., headquartered
in Cambridge, Massachusetts.

    For more information or to arrange an interview with a nephrologist or a
spokesperson from Genzyme Canada, please contact:

    
    ----------------------
    (1) Mendelssohn, D., Lebner, A., et al. "Restricted access to drugs is
        associated with less optimal mineral metabolism in hemodialysis
        Patients." CADTH Poster Presentation, 2009.
    (2) Health Canada. Calcium Monograph. November 14, 2007.
    (3) Keith et al. Arch Intern Med. 2004;164:659
    (4) "Kidney Disease - Am I at Risk?", The Kidney Foundation of Canada;
        http://www.kidney.ca/files/Kidney/a28640_Risk_Eng.pdf (accessed on
        January 26, 2009)
    





For further information:

For further information: or to arrange an interview with a nephrologist
or a spokesperson from Genzyme Canada, please contact: Chrome Communications,
(905) 567-1406: Alon Barmapov, ext. 223, (647) 405-1352,
alon@chromecommunications.ca; Lyndsay Carter, ext. 225, (416) 899-7837,
lyndsay@chromecommunications.ca

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