Novartis heart failure treatment (Pr)Entresto™ (sacubitril/valsartan) now covered by the Régie de l'assurance maladie du Québec (RAMQ)*

Entresto™ has been shown to reduce the risk of cardiovascular death and hospitalization¹ in heart failure with reduced ejection fraction

DORVAL, QC, March 23, 2017 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that the heart failure treatment Entresto™ (sacubitril/valsartan) is covered by the RAMQ, as an exceptional medication benefit and can be prescribed and reimbursed for patients with NYHA (New York Heart Association) Class II or III heart failure with left ventricular systolic dysfunction (with ejection fraction ≤ 40%):

• in combination with a beta blocker unless contraindicated or not tolerated and
• in replacement of current treatment with an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) treatment taken for at least four weeks

Ejection fraction is a measurement that defines how well the heart is pumping blood.² About half of heart failure patients have a reduced ejection fraction.³

Heart failure is a debilitating and life-threatening disease in which the heart cannot pump enough blood around the body. Symptoms of heart failure such as breathlessness, fatigue and fluid retention can appear slowly and worsen over time, significantly impacting quality of life.⁴

"The decision to have Entresto™ available as a treatment through the drug plan is a positive step forward.  We have data that shows Entresto™ not only helps patients live longer but it also keeps them out of hospital and allows them to accomplish more of their daily tasks, making it an important addition to how we treat heart failure," said Dr. Serge Lepage, professor and director of the heart failure clinic at the University of Sherbrooke. "Heart failure is a growing problem because of our aging population.  Any intervention that can ease the burden of heart failure on patients and their families and reduce hospitalizations related to this condition is most welcome."

Quebec is the first province to add Entresto™ to its public formulary. Novartis continues to work with the remaining provinces through their respective public formularies to ensure eligible heart failure patients across Canada also have access to Entresto™ as soon as possible.

"The reimbursement of Entresto™ in Quebec is an important milestone for heart failure patients in Quebec," said Timothy Maloney, President, Novartis Pharmaceuticals Canada Inc. "Novartis is committed to a collaborative approach with governments in the remaining provinces to enable broader reimbursement to this important treatment across Canada."

Heart failure in Canada
More than 600,000 Canadians have heart failure⁵ and it is responsible for 9% of all deaths in Canada, or about 22,000 per year,⁶ which is almost equal to the number of deaths from breast, colorectal, prostate and pancreatic cancer combined.⁷ It is the second leading cause of hospitalization in Canada for patients over 65⁸ and resulted in estimated direct costs of $2.89 billion in 2012.⁹

About Entresto™
Entresto™ is a first-in-class medicine containing sacubitril, a neutral endopeptidase inhibitor and valsartan, an angiotensin II AT₁ receptor blocker.  A twice-a-day tablet, it has a unique mode of action impacting the neurohormonal systems of the heart. It is thought to reduce the strain of the failing heart by enhancing the protective natriuretic peptide system while simultaneously suppressing the compensatory renin–angiotensin–aldosterone system  which can be harmful over time.^10,11,12

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2015, the company invested $53 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs more than 700 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

Entresto is a trademark of Novartis Pharmaceuticals Canada Inc.

*Official Mark of the Régie de l'assurance maladie du Québec.

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¹ McMurray JJV, Packer M, Desai AS, et al. Angiotensin-Neprilysin Inhibition versus Enalapril in Heart Failure, N Engl J Med 2014;371:993-1004. DOI: 10.1056/NEJMoa1409077.
² American Heart Association, heart.org, Ejection Fraction Heart Failure Measurement, accessed at: http://www.heart.org/HEARTORG/Conditions/HeartFailure/SymptomsDiagnosisofHeartFailure/Ejection-Fraction-Heart-Failure-Measurement_UCM_306339_Article.jsp#
³ Owan TE et al, Trends in Prevalence and Outcome of Heart Failure with Preserved Ejection Fraction, N Engl J Med 2006; 355:251-259July 20, 2006DOI: 10.1056/NEJMoa052256
⁴ Fauci A, Longo D. Disorders of the Heart. Harrison's Principles of Internal Medicine. 17th ed. 2008;4:1442-55.
⁵ Blais C, et al. Assessing the burden of hospitalized and community-care heart failure in Canada. Can J Cardiol. 2014 Mar; 30(3):352-8 and Statistics Canada, Population by sex and age group, 2013, accessed at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/demo10a-eng.htm
⁶ Brophy JM. Epidemiology of congestive heart failure: Canadian data from 1970 to 1989. Can J Cardiol 1992;8:495-498 and Statistics Canada, Leading Causes of deaths in Canada, CANSIM Table 102-0561 at: http://www.statcan.gc.ca/tables-tableaux/sum-som/l01/cst01/hlth36a-eng.htm
⁷ Canadian Cancer Society's Advisory Committee on Cancer Statistics. Canadian Cancer Statistics 2016, p. 50, Toronto: Canadian Cancer Society; 2016
⁸ Canadian Institute for Health Information (CIHI), A Snapshot of Health in Canada as Demonstrated by Top 10 Lists, 2011, p. 10, accessed at: https://secure.cihi.ca/free_products/Top10ReportEN-Web.pdf.
⁹ Cook C. et al., The Annual Global Economic Burden of Heart Failure, Int J Cardiol (2014), Table 5.
¹⁰ McMurray JJ, Packer M, Desai AS, et al. Dual angiotensin receptor and neprilysin inhibition as an alternative to angiotensin-converting enzyme inhibition in patients with chronic systolic heart failure: rationale for and design of the Prospective comparison of ARNI with ACEI to Determine Impact on Global Mortality and morbidity in Heart Failure trial (PARADIGM-HF). Eur J Heart Fail 2013;15,1062–1073 (doi:10.1093/eurjhf/hft052).
¹¹ Langenickel TH, Dole WP. Angiotensin receptor-neprilysin inhibition with LCZ696: a novel approach for the treatment of heart failure. Drug Discovery Today: Therapeutic Strategies.2012, Vol 9. No.4.
¹² Solomon SD et al. The angiotensin receptor neprilysin inhibitor LCZ696 in heart failure with preserved ejection fraction: a phase 2 double-blind randomised controlled trial. Lancet. 2012;380:1387–95.

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations, Patricia Tiramani, Novartis Pharma Communications, [phone], E-mail: [email protected]; Spectrum Advisors, [phone], [email protected]