Novartis heart failure treatment (Pr)Entresto™ (sacubitril/valsartan) now available to patients in Ontario through the public provincial drug plan

• Entresto™ has been shown to reduce the risk of cardiovascular death and hospitalization in heart failure (HF) with reduced ejection fraction¹

DORVAL, QC, May 9, 2017 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that the heart failure treatment Entresto™ (sacubitril/valsartan) is now reimbursed by the public provincial drug plan in Ontario.  

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 life². Ejection fraction is a measurement that defines how well the heart is pumping blood³. About half of heart failure patients have a reduced ejection fraction⁴.

"One in every five Canadians is affected by heart failure and it is a major health challenge because patients are frequently hospitalized, which has a major impact on the Canadian healthcare system," said Dr. Diego Delgado, Heart Failure and Transplant Cardiologist at the Peter Munk Cardiac Centre at Toronto General Hospital. "Entresto™ is an important new therapy that has been shown to help keep patients alive, out of hospital and able to perform more acts of daily living. This decision by the Ontario drug plan is very encouraging and I hope the remaining provinces follow its lead."

Entresto™ can be prescribed and reimbursed for the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with New York Heart Association (NYHA) class II or III HF to reduce the incidence of cardiovascular (CV) death and HF hospitalization, if all of the following clinical criteria are met: reduced left ventricular ejection fraction (LVEF) less than 40%; with NYHA Class II to III symptoms despite at least four weeks of treatment with a stable dose of an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB); and in combination with a beta blocker and other recommended therapies, including an aldosterone antagonist (if tolerable).

Entresto™ is also available through the public drug plans in Quebec, Saskatchewan and the Yukon. Novartis continues to work with other provinces to ensure eligible heart failure patients across Canada have equal access to Entresto™ as soon as possible.

"The reimbursement of Entresto™ through the Ontario Public Drug Program is an important milestone for people in Ontario with heart failure. We are pleased that the Ontario government is making this new treatment option available for those who will benefit," said Janice Murray, President, Novartis Pharmaceuticals Canada Inc. "Novartis is continuing to work collaboratively with drug programs in the remaining provinces to enable reimbursement of this important treatment across Canada."

About 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 23,000 per year,⁶ which is almost equal to the number of deaths from breast, colorectal, prostate and pancreatic cancer combined⁷. 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 2012⁹.

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.

About Novartis Pharmaceuticals Canada 
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 2016, the company invested $48.8 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 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 www.novartis.com.

Entresto™ is a trademark of Novartis Pharmaceuticals Canada Inc.

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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	Fauci A, Longo D. Disorders of the Heart. Harrison's Principles of Internal Medicine. 17th ed. 2008; 4:1442-55.
3	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#
4	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
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, 2016, 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, 2013; 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.

SOURCE Novartis Pharmaceuticals Canada Inc.

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