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Quebec Lowers Restrictions on Prescribing Cholesterol Lowering Medication

Quebec Lowers Restrictions on Prescribing Cholesterol Lowering Medication 
While uneven access in Ontario leaves some out in the cold 
LAVAL, QC, Dec. 20, 2013 /CNW/ - Quebec patients now have a better access to 
cholesterol-lowering medication, following the decision from the Régie de 
l'assurance maladie du Québec (RAMQ). In other provinces, uneven access to 
such therapeutic options leaves other patients in the cold despite the current 
care gap. 
On December 12, the RAMQ announced that physicians may now prescribe LODALIS 
(colesevelam hydrochloride)* without having to fill out a special 
authorization form. While the Quebec Government recognizes the value of 
increasing access to cholesterol-lowering medication, such as Lodalis, the 
Ontario Government has yet to consider this a priority. 
"High cholesterol is a serious health issue, and it is critical that patients 
have access to any treatment option that can help them reach target," says Dr. 
Alice Cheng, Endocrinologist at Trillium Health Partners and St. Michael's 
Hospital, and Assistant Professor at the University of Toronto. "It is 
important that doctors are able to use every tool available, knowing that 
patients will be able to access them, to optimize care for all Ontarians 
living with high cholesterol." 
Statins are the standard of care for high cholesterol, but while they are 
effective for many, up to ten per cent of patients cannot tolerate statins.(i) 
Furthermore, more than one-in-three (37 per cent) do not reach target 
cholesterol levels on statin treatment alone,(ii) and may require adjunct 
therapy to achieve lower cholesterol. This means that in Ontario, where an 
estimated 5.4 million Ontarians have high cholesterol,(iii) as many as 2 
million will not be able to lower their cholesterol sufficiently using statins 
alone.(iv) 
Access to alternate and adjunct treatment options is also vital for Canadians 
over the age of 65, as they typically face a more acute prognosis and higher 
mortality rate for heart disease, can benefit most from treatment,(v) and 
often financially rely on provincial drug coverage to access much needed 
medications. While LODALIS is covered under many health insurance plans, 61 
per cent of the patient population that might need LODALIS do not have private 
insurance,(vi) making it difficult for them to access the treatment if and 
when they need it.(vii) 
"Unmanaged high cholesterol puts patients at risk for serious complications 
like heart disease and stroke. This is especially true for high-risk patients, 
like those with diabetes and the elderly," says Dr. Cheng. "We need to ensure 
that all Ontarians have access to treatments they need to manage their 
high-cholesterol, including statin and non-statin therapies." 
About LODALIS 
LODALIS (colesevelam hydrochloride) is a bile acid sequestrant indicated for 
the reduction of cholesterol blood level in patients with 
hypercholesterolemia, as an adjunct to diet and lifestyle changes, in patients 
who are not adequately controlled with an HMG-CoA reductase inhibitors 
(statins) alone, or who are unable to tolerate a statin.(viii) 
In clinical trials of patients with primary hypercholesterolemia, LODALIS at a 
3.8 or 4.5 g dose decreased LDL-C levels by 15 to 18 per cent within two weeks 
of administration. The most common adverse events with LODALIS (colesevelam) 
were constipation (11 per cent), dyspepsia (8.3 per cent), and nausea (4.2 per 
cent).(ix) 
About Valeant Canada 
Valeant Canada is a subsidiary of Valeant Pharmaceuticals International, Inc., 
a multinational specialty pharmaceutical company that develops manufactures 
and markets a broad range of pharmaceutical products primarily in the areas of 
dermatology, eye health, neurology, and branded generics. Proudly Canadian, 
Valeant is the only branded pharmaceutical company with its global head 
office in Canada. More information about Valeant Canada can be found at 
www.valeantcanada.com. 
*Note: 
CV Code 163: for the treatment of hypercholesterolemia in people where 
cardiovascular risk is high: 


    --  in combination with an HMG -CoA reductase inhibitor (statin) in
        optimal dose or low dose in case of intolerance;
    --  in the case where an HMG -CoA reductase inhibitor (statin) is
        not indicated;
    --  in the case of an intolerance leading to discontinuation of
        treatment of at least 2 HMG -CoA reductase inhibitor (statin).

Note: The use of colesevelam for people whose cardiovascular risk is low or 
medium does not match the indication of payment. The RAMQ suggests the 
prescriber to write the code "XX" on the prescription in order to inform the 
pharmacist that this cannot be subject to codification. However, if the 
circumstances where the insured person meets the requirements of the 
measurement of patient exception, a request may be sent to the RAMQ using the 
form Mesure du patient d'exception - Demande d'autorisation de paiement (no 
3996).

References 
_______________________________

(i) Rajesh K Nair RK, Karadi RL et al. Managing patients with 'statin 
intolerance': a retrospective study. The British Journal of Cardiology. May 
2008; 16(3): 158-160
(ii) Goodman SG, Langer A, Bastien NR, et al. Prevalence of dyslipidemia in 
statin‐treated patients in Canada: results of the DYSlipidemia International 
Study (DYSIS). The Canadian journal of cardiology. Nov 2010;26(9):e330‐335.
(iii) Heart and Stroke Foundation. 2012 Statistics. Accessed December 9, 2013. 
http://www.heartandstroke.com/site/c.ikIQLcMWJtE/b.3483991/k.34A8/Statistics.ht
m#bloodcholesterol
(iv) Goodman SG, Langer A, Bastien NR, et al. Prevalence of dyslipidemia in 
statin‐treated patients in Canada: results of the DYSlipidemia International 
Study (DYSIS). The Canadian journal of cardiology. Nov 2010;26(9):e330‐335.
(v) David Fitchett, Kenneth Rockwood. Management of Heart Disease in the 
Elderly Patient. CCS 2002 conference. 
http://www.ccs.ca/download/consensus_conference/consensus_conference_archives/2
002_ES_final.pdf Accessed December 12, 2013.
(vi) Sunlife Canadian Health Index 2013. Accessed December 9, 2013. 
http://cdn.sunlife.com/static/canada/sunlifeca/About%20us/Canadian%20Health%20I
ndex/Canadian_Health_Index_2013_en.pdf?wt.ac=en-ca:Web:SLF_evergreen:CHI_HP:CHI
:2013_Report
(vii) TELUS Health Product Coverage Report, Lodalis, October, 2012
(viii) LODALIS Product Monograph.
(ix) LODALIS Product Monograph.



SOURCE  Valeant Canada 
Sarah Bannoff NATIONAL Public Relations 416-848-9851 sbannoff@national.ca 
To view this news release in HTML formatting, please use the following URL: 
http://www.newswire.ca/en/releases/archive/December2013/20/c6193.html 
CO: Valeant Canada
ST: Quebec
NI: HEA  
-0- Dec/20/2013 17:54 GMT
 
 
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