(Pr)Xolair® added to seven Canadian public drug plans to treat chronic idiopathic urticaria (hives)

  • First treatment for CIU added to public drug plans in Ontario, Quebec, Manitoba, Saskatchewan, Nova Scotia, the Yukon and the NIHB Benefits List

  • Itchy hives or welts and swelling can have severe impact on quality of life and often don't resolve with oral antihistamines, making additional treatment option necessary1

DORVAL, QC, June 19, 2017 /CNW/ - Novartis Pharmaceuticals Canada Inc. (Novartis) is pleased to announce that Canadians in five provinces, the Yukon and those covered under the Non-Insured Health Benefit's (NIHB) Program now have access to Xolair® (omalizumab) through their public drug plans to treat chronic idiopathic urticaria (CIU, also known as chronic spontaneous urticaria, or hives) that is unresponsive to antihistamines.

CIU is a skin disease that occurs without known cause (idiopathic) or warning and can be challenging to treat. Its itchy hives and swelling (angioedema) can significantly interfere with almost every aspect of a person's life – how they sleep, eat, work and interact with others1. The hives can appear on any part of the body, including inside the throat, which can cause difficulty breathing2. Initial treatment is with oral antihistamines, however, the majority of patients do not respond to them, even at three to four times their normal dose3.

The specific criteria for reimbursement vary slightly in each jurisdiction but generally apply to patients who remain symptomatic despite optimum management with oral therapies and a review of symptoms and effectiveness at specified intervals to evaluate the need for continuing therapy4.

"This is exciting news for many Canadians who are in need of relief from their CIU symptoms despite having tried traditional antihistamines," said Dr. Dawn Bell, Chief Scientific Officer and Vice President Medical Affairs of Novartis Pharmaceuticals Canada Inc. "CIU is often confused with allergic reactions until patients receive a correct diagnosis likely from their allergist or dermatologist. Xolair® offers these patients an important option to discuss with their health care provider to help manage the often-debilitating symptoms of this chronic disease."

Six weeks is the minimum time for the condition to be considered chronic, but CIU can persist for years. The average duration is between one to five years and up to 14% of the patients can have CIU for more than five years1. The symptoms can cause major disability, emotional distress and decreased productivity1. At any time, 0.5-1% of the population suffers from CIU and although all age groups can be affected, the peak incidence is in young adults between age 20 and 40 and women suffer from urticaria nearly twice as much as men do5.

"This is an important milestone for Canadians living with CIU. The negative impact this disease can have weighs heavily on an individual. The hives and itching can be so severe, causing despair to the people living with CIU," said Kathryn Andrews-Clay, Executive Director, Canadian Skin Patient Alliance. "It is important for people with CIU to know there is now another treatment option available to them. We hope the remaining provinces will act quickly to add Xolair® to their public drug plans as well."

To access the specific reimbursement criteria for Xolair® (omalizumab) in each jurisdiction, click on the following: Quebec, Manitoba, Saskatchewan, Nova Scotia and the Yukon. Benefit Updates to the NIHB Drug Benefit List are generally issued on a quarterly basis and updates to the Ontario Exceptional Access Program (EAP) criteria are made periodically.

About Xolair® (omalizumab)
Xolair® is an injectable prescription medicine which blocks a substance called immunoglobulin E (also known simply as IgE) which is produced by your body6. Xolair® is approved by Health Canada for the treatment of adults and adolescents (12 years of age and above) with chronic idiopathic urticaria (CIU) who remain symptomatic despite H1-antihistamine treatment6.

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 http://www.novartis.com.

®Xolair is a registered trademark of Novartis Pharmaceuticals Canada Inc.

References

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1 Sussman G, Hébert J, Barron C, et al. Real-life experiences with omalizumab for the treatment of chronic urticaria, American College of Allergy, Asthma and Immunology. 2014; 170-174.
2 What is CIU? accessed May 16, 2017, at: http://www.itchingforanswers.ca/what-is-ciu
3 Maurer M, Rosén K, Hsieh HJ, et al. Omalizumab for the treatment of chronic idiopathic or spontaneous urticaria. N Engl J Med 2013; 368: 924-35.
4 Yukon criteria accessed May 16, 2017, at: http://apps.gov.yk.ca/drugs/f?p=161:9000:1196068956388401
Saskatchewan criteria accessed May 16, 2017, at:
http://formulary.drugplan.health.gov.sk.ca/Bulletins/Bulletin163Jan2017.pdf 
Manitoba criteria accessed May 16, 2017, at
https://www.gov.mb.ca/health/mdbif/docs/bulletins/bulletin91.pdf 
Nova Scotia criteria accessed May 16, 2017, at
https://novascotia.ca/dhw/pharmacare/documents/Criteria-for-Exception-Status-Coverage.pdf  
5 Maurer M, Weller K, Bindslev-Jensen C, et al. Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report. Allergy. 2011; 66: 317–330.
6 Novartis Pharmaceuticals Canada Inc., Xolair® (omalizumab) Product Monograph, April 12, 2017 page 3 and 57.

 

SOURCE Novartis Pharmaceuticals Canada Inc.

For further information: Novartis Media Relations, Julie Schneiderman, Novartis Pharmaceuticals Communications, +1 514 633-7873, E-mail: camlph.communications@novartis.com; Spectrum Advisors, +1 514 234 4095, mediarelations@spectrumadvisors.ca


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