The Canadian Agency for Drugs and Technologies in Health (CADTH) announced today that the submission for ORKAMBI™ (lumacaftor/ivacaftor) will be reconsidered at an upcoming meeting of the Canadian Expert Drug Committee (CDEC).
The Potential to Change Lives
ORKAMBI™ is a new medication indicated for people with cystic fibrosis (CF) ages 12 and older who have two copies of the F508del mutation. Clinical trials indicate that ORKAMBI™ can improve lung function and reduce the number of pulmonary exacerbations, which can lead to frequent hospitalizations and accelerated lung disease.
“My daughter was fortunate enough to participate in a clinical trial for ORKAMBI™. We have seen a dramatic improvement in her lung function and a reduction in her infections and illnesses – which is hugely important for people with CF,” said Ron Anderson, the father of a 15-year-old girl living with CF. “We feel ORKAMBI™ has arrested the progression of the disease. We were hopeful that we could plan for the future in a way that we previously couldn’t. This news is certainly a setback.”
The Time is Now
We are urging decision-makers to act quickly. Cystic Fibrosis Canada is calling for the reconsideration of ORKAMBI™ to happen at the earliest opportunity, which is the next CDEC meeting in September. Cystic Fibrosis Canada, who made a submission to CADTH’s CDEC regarding ORKAMBI™, is also calling on the CDEC to carefully consider the recommendations for the clinical use of ORKAMBI™ that were developed by Cystic Fibrosis Canada’s CF Physician Panel on lumacaftor/ivacaftor endorsed by 26 CF physicians across Canada.
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