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Cystic Fibrosis Canada welcomes Health Canada's approval of KALYDECO™

Calling for the manufacturer and drug insurance plans to ensure CF patients receive equitable and affordable access to KALYDECO

TORONTO, Dec. 3, 2012 /CNW/ - Health Canada has issued a Notice of Compliance (NOC) for KALYDECO™, approving the drug for use in Canada. This gives Canadian cystic fibrosis (CF) patients with the G551D mutation (ages six and older) a chance to gain access to this new, breakthrough treatment. Cystic Fibrosis Canada calls on Vertex Pharmaceuticals Inc. and drug plan administrators to work together to resolve the high price of KALYDECO™ so that CF patients can access this drug in an equitable and affordable way.

"The approval of KALYDECO™ is just the first step in bringing this new, breakthrough therapy to CF patients," said Ken Chan, Vice President, Advocacy, Research and Healthcare. "As one of the most expensive drugs in the world, CF patients simply cannot afford to pay for this much-needed medicine. Cystic Fibrosis Canada is calling for a compassionate approach from manufacturers and drug plan administrators when it comes to making new, life-changing medicines accessible to CF patients."

KALYDECO™ is the first therapy that targets the underlying cause of cystic fibrosis. This drug helps to improve the function of the defective protein, leading to better lung function, weight gain and lower sweat chloride levels. For a CF patient with the specific G551D mutation, access to KALYDECO™ could lead to a healthier, longer life. Canada now joins the United States and the European Union in making KALYDECO™ available for use for CF patients. The G551D mutation is present in roughly 100 Canadians with cystic fibrosis.

"When the gene responsible for cystic fibrosis was discovered in Canada back in 1989, one could only imagine the moment when that discovery would lead to a drug like KALYDECO™, said Cystic Fibrosis Canada President and CEO Maureen Adamson. "This is the beginning of good news for Canadian CF patients, and I look forward to even better news when this drug will be affordable and accessible to the patients who will benefit from it." Cystic Fibrosis Canada helped fund the international team that discovered the CF gene under the leadership of Dr. Lap-Chee Tsui at the Hospital for Sick Children in Toronto.

Key opinion leaders throughout the Canadian CF clinical community also strongly support giving patients access to this drug.

"KALYDECO™ is an incredible leap forward in CF therapy," said Dr. Larry Lands, CF Clinic Director at Montreal Children's Hospital. "Even though KALYDECO™ as a stand-alone treatment will only help a limited segment of affected patients, it shows promise as a combination therapy for other patients with cystic fibrosis, and points the way towards the development of tailored treatments that will correct the underlying problem for each and every affected person with cystic fibrosis."

"This treatment represents a paradigm shift in therapy; it's the first one to target the basic defect in the cells of CF patients," said Dr. Elizabeth Tullis, Head of Respirology and Director of the Adult Cystic Fibrosis Program at St. Michael's Hospital in Toronto. "While KALYDECO™ is currently applicable only to a small proportion of CF patients; it gives us hope that a similar approach can be developed for all people with cystic fibrosis."

"The future of some babies diagnosed through CF newborn screening is going to be revolutionized by KALYDECO™," said Dr. Mark Chilvers, CF Clinic Director, BC Children's Hospital. "CF Clinicians now have access to a life-changing therapy that targets this specific genetic mutation."

In October 2012, Cystic Fibrosis Canada made a submission to the Common Drug Review (CDR) process in an effort to convince provincial drug plans to provide Canadian CF patients with access to KALYDECO™. Testimonials submitted for affected patients who are currently being treated with KALYDECO™ were compelling. They report transitions from debilitating illness and exhaustion to having more energy, being able to finally exercise, being able to spend more time with their families, and an overall enhanced quality of life. Many patients strongly believe that using KALYDECO™ will allow them to avoid lung transplantation for end-stage lung disease. Cystic Fibrosis Canada is awaiting the CDR recommendation before deciding on next steps.

Background: Access to KALYDECO™ in Canada
Of the 4,000 Canadians living with this devastating disease, about 100 CF patients in Canada have the specific G551D mutation of the CFTR gene that can be treated by KALYDECO™. (Source: Canadian Patient Data Registry). When taken twice a day with fat-containing food, KALYDECO™ helps the protein made by the CFTR gene function better, improving lung function and weight gain. (Source: FDA)

The Common Drug Review (CDR) was established by the federal, provincial, and territorial government to provide publicly-funded drug plans (except Quebec) with high-quality drug reviews that will inform their decision making.

The high price of KALYDECO™ has meant CF patients in certain jurisdictions face barriers to accessing the drug despite KALYDECO™ receiving regulatory approval. For example, in England where KALYDECO™ has been approved for use since July 2012, the drug still remains out of reach to CF patients because of its cost ― estimated at over £180,000 per patient per year. In the U.S., KALYDECO™ costs around $294,000 per patient per year.

Vertex, the manufacturer of KALYDECO™, has submitted the drug to the CDR, a process run by the Canadian Agency for Drugs and Technologies in Health (CADTH). A team of independent experts will review KALYDECO™, and compare how well the drug works to current CF treatments, and whether the drug provides value for money. Based on their findings, a recommendation on whether or not drug plans should cover the drug will be issued. After the CDR recommendation has been made, provincial health ministries (except for Quebec, which has a separate process) will review KALYDECO™ for reimbursement by publicly funded drug plans.

Cystic Fibrosis
Cystic fibrosis is the most common fatal genetic disease affecting Canadian children and young adults. It is a multi-system disease that affects mainly the lungs and the digestive system. In the lungs, where the effects are most devastating, a build-up of thick mucus causes severe respiratory problems. Mucus and protein also build up in the digestive tract, making it difficult to digest and absorb nutrients from food. As improved therapies have helped to address the malnutrition issues, ultimately most deaths related to cystic fibrosis are due to lung disease. Currently, there is no cure.

Cystic Fibrosis Canada
Cystic Fibrosis Canada is one of the world's top three charitable organizations committed to finding a cure for cystic fibrosis and is an internationally-recognized leader in funding CF research, innovation, and clinical care. We invest more funding in life-saving CF research and care than any other non-governmental agency in Canada. Since 1960, Cystic Fibrosis Canada has invested more than $140 million in leading research and care, resulting in one of the world's highest survival rates for Canadians living with cystic fibrosis. For more information, visit www.cysticfibrosis.ca.



SOURCE Cystic Fibrosis Canada

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