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EMD Serono Canada Inc. Applauds the Government of Ontario for its Innovative General Benefit Listing of Raptiva(R), a Biologic Treatment for Psoriasis
(Canada Newswire English Via Acquire Media NewsEdge) Attention Assignment/Health Editors
TORONTO, Dec. 3 /CNW/ - EMD Serono Canada Inc. announces that Raptiva(R) (efalizumab), an innovative biologic that treats severe plaque psoriasis, was approved for coverage as a General Benefit on the Ontario Drug Benefit Formulary.
Effective December 3, 2008, the Ontario Public Drugs Program will provide coverage for Raptiva(R) for the treatment of severe plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies.
"Dermatologists are excited about the Government of Ontario's leadership in ensuring that psoriasis patients have access to Raptiva(R)," said Dr. Kim Papp Assistant Clinical Professor of Medicine at the University of Western Ontario and President of Probity Medical Research in Waterloo, Ontario. "Psoriasis is a condition in which an individual's immune system reacts against their own tissues, triggering painful inflammation of the skin. But the effects of psoriasis go far beyond inflammation. Psoriasis has a profound effect on a patient's physical, social and mental well-being. By providing patients with a more effective and convenient treatment versus traditional therapies, the Ontario government is in turn giving these people a chance at a much higher quality of life."
"As a leader in the Canadian biotech pharmaceutical industry, EMD Serono is driven to improve the quality of patients' lives," said Deborah Brown, President at EMD Serono Canada Inc. "We applaud the Government of Ontario for its innovative General Benefit Listing of Raptiva. This important step provides Ontarians with access to new innovative treatment solutions."
Executive Director of the Canadian Skin Patient Alliance, Christine Jackson, echoes that "this is wonderful news for psoriasis patients in Ontario. Severe psoriasis can be extremely debilitating, affecting all aspects of a patients' life. It is great to see that the government is leading the way to ensure access to this class of drugs for psoriasis patients in Ontario who do not have private insurance."
Raptiva(R) was approved by Health Canada in October 2005, and in August 2006 and again in July 2007 the Common Drug Review's (CDR) Canadian Expert Drug Advisory Committee (CEDAC) recommended Raptiva(R) be included on both federal and provincial drug formularies for Canadians with severe, debilitating psoriasis who have had an inadequate response to older systemic therapies. Raptiva(R) is the first biologic treatment in Canada to receive this positive CDR/CEDAC recommendation. Raptiva(R) is now included as part of Health Canada's Non-Insured Health Benefits (NIHB) Program, and is included on provincial formularies in Ontario, New Brunswick, Nova Scotia, Newfoundland & Labrador, Alberta and Saskatchewan. EMD Serono Canada Inc. is currently in discussions with other provinces to include Raptiva(R) on their formularies.
The Government of Ontario is receptive to psoriasis patients' needs. The Ontario Public Drugs Program provides prescription drug benefits to eligible residents of Ontario who fall within defined beneficiary groups. For more information, please visit their website at:
http://www.health.gov.on.ca/english/public/program/drugs/funded_drug/funded_drug
.html.
EMD Serono Canada Inc. Reimbursement Assistance
The Clear Support Program(TM) is a free and confidential patient support initiative that provides Raptiva(R) patients with comprehensive assistance throughout their therapy including help with insurance coverage, psoriasis education, and therapy initiation support. The Program also gives patients access to registered nurses for counseling and on-going support while on therapy. The Clear Support Program(TM) meant to be complementary to the care provided by healthcare professionals and is not meant to replace the care that they provide. The reimbursement specialists at the Clear Support Program(TM) can provide reimbursement counseling and ongoing assistance with the administrative process for reimbursement of Raptiva(R) under the respective provincial formularies. The Clear Support Program's(TM) reimbursement specialists are available to answer questions at 1.866.440.4245.
About EMD Serono Canada Inc.
Raptiva(R) is marketed in Canada by EMD Serono Canada Inc. As a leader in the Canadian biotech pharmaceutical industry, EMD Serono Canada Inc. is driven to improve the quality of patients' lives through the integration of cutting-edge science with state-of-the-art patient support. The company's commitment to discovering and developing innovative products that address unmet medical needs has lead EMD Serono to market seven biotech drug therapies in the areas of Neurodegenerative Diseases, Fertility, Endocrinology, and Dermatology. EMD Serono Canada Inc. is an affiliate of Merck Serono S.A., Geneva, Switzerland. Merck Serono is a division of Merck KGaA, Darmstadt, Germany. In Canada, Merck Serono operates as EMD Serono. For more information, please go to www.emdserono.ca.
About Merck KGaA
Merck is a global pharmaceutical and chemical company with total revenues of (euro) 7.1 billion in 2007, a history that began in 1668, and a future shaped by 32,458 employees in 59 countries. Its success is characterized by innovations from entrepreneurial employees. Merck's operating activities come under the umbrella of Merck KGaA, in which the Merck family holds an approximately 70% interest and free shareholders own the remaining approximately 30%. In 1917 the U.S. subsidiary Merck & Co. was expropriated and has been an independent company ever since. Today, Merck & Co. holds the North American rights to the name, and Merck KGaA holds the rights to the name Merck in the rest of the world. Merck & Co. and Merck Frosst have no affiliation with EMD Serono or Merck KGaA. For more information, please visit www.merck.de.
About Raptiva(R)
Raptiva(R) is a humanized therapeutic antibody that can provide patients with safe and effective long-term continuous control of their psoriasis. It can be self-administered by patients at home through a single, once-weekly, subcutaneous (under the skin) injection.
Raptiva(R) is generally well tolerated. The most common adverse events observed during Raptiva(R) therapy were mild to moderate flu-like symptoms, headache, fever, chills, nausea, and myalgia. These reactions were greatest with administration of the first dose, decreasing with the second and subsequent doses. Serious adverse events were infrequent and occurred at only a slightly greater frequency in the Raptiva(R) group (2%) than in the placebo group (1%). No cumulative end-organ toxicity or increased malignancy or infection was apparent in patients taking Raptiva(R) in short-term or long-term studies.(1)
Indications: Raptiva(R) is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.(1)
Contraindications: Raptiva(R) is contraindicated in: patients who are hypersensitive to efalizumab, or to any ingredient in the formulation, or Chinese Hamster Ovary cell proteins; patients with history of malignancies or existing malignancies; patients with immunodeficiencies; patients with active tuberculosis and other severe infections.(1)
Adverse Events: The most serious adverse drug reactions (ADRs) observed during treatment with Raptiva(R) in clinical trials or from post-marketing experience are: serious infections, malignancies, thrombocytopenia, hemolytic anemia, arthritis events, and psoriasis worsening and variants. The most common ADRs observed during Raptiva(R) therapy were mild to moderate dose-related acute flu-like symptoms including headache (32%), fever (7%), chills (13%), nausea (11%) and myalgia (8%). In large placebo-controlled clinical studies, these reactions were observed in approximately 41% of Raptiva(R)-treated patients and in 24% of placebo-treated patients over 12 weeks of treatment. Headache was the most prevalent type of flu-like symptoms. These reactions were greatest with the first dose administration, decreasing with the second and subsequent doses. Severe acute events of headache, chills, fever and myalgia were reported only in the Raptiva(R)-treated subjects affecting 3.6% of subjects.(1) - Observational, open-label, multi-centre, phase IV study of subcutaneously administered Raptiva(R) (efalizumab) in the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for treatment with Raptiva(R).
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REFERENCES:
1. Raptiva(R) Product Monograph, EMD Serono Canada Inc., July 2007.
Raptiva(R) and the Clear Support Program(TM) are registered
trademarks of EMD Serono Canada Inc.
>>
EMD Serono Canada Inc. Contact: Barbara Fry, Director, Communications and Strategic Alliances, (905) 919-0163
Copyright ? 2008 Canada Newswire Ltd. All Rights Reserved.
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