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
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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.htm#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/2002_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%20Index/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
[email protected]