WHAT IS ORKAMBI?
ORKAMBI® is a drug developed to treat cystic fibrosis. It was approved for use in Canada in January 2016. It significantly improves lung function, reduces the number of lung flare-ups, and improves the nutritional status of some people who have two copies of the most common mutation of cystic fibrosis: F508del.
LATEST NEWS ABOUT ORKAMBI
On June 12, 2020 the pan-Canadian Pharmaceutical Alliance (pCPA) agreed to enter negotiations with Vertex Pharmaceuticals on Orkambi and Kalydeco. Cystic Fibrosis Canada is calling on governments and Vertex to get through these negotiations quickly and to work together to fast-track access to Trikafta. For more information see our Q&A.
On February 20, 2019 the governments of Saskatchewan, Alberta and Ontario announced prescribing criteria for pediatric patients to qualify for public coverage of ORKAMBI. Details of the criteria include:
- Case-by-case access for ORKAMBI will be considered for pediatric patients between 6-17 years old in Saskatchewan, Ontario and Alberta who have experienced at least a 20 percent relative decrease in ppFEV1 in the last six months sustained for at least six weeks despite appropriate treatment.
This announcement is the result of diligent advocacy work by Cystic Fibrosis Canada and the Canadian cystic fibrosis community. For more information on this update please view the news release.
Presently, in Quebec Orkambi is available through the province's patient d'exception program, however the access criteria is not publicly accessible.
On Thursday, October 4, 2018, the Canadian Agency for Drugs and Technologies in Health (CADTH) recommended that the cystic fibrosis (CF) drug ORKAMBI® not be reimbursed by federal, provincial and territorial drug programs. Quebec has a separate review body – The National Institute of Excellence in Health and Social Services (INESSS), and on Thursday, October 18, 2018, INESSS also announced it would not recommend ORKAMBI® for public coverage, the recommendation was endorsed by Quebec Health Minister, Danielle McCann. As well, the British Columbia Pharmacare program is undertaking its own review, other provinces may also choose to.
Cystic Fibrosis Canada completely disagrees with both the CADTH and INESSS recommendations and cautions that they could have deadly consequences for some Canadians with CF for years to come. Read our news release on the CADTH recommendation.
Frequently Asked Questions
What is CADTH?
CADTH is an independent, not-for-profit organization responsible for providing informed decisions about the optimal use of drugs and medical devices in Canada. Through its Common Drug Review (CDR), CADTH provides recommendations to federal, provincial and territorial governments on whether or not to cover the cost of medications through their public plans.
What is INESSS?
The Institut national d'excellence en santé et en services sociaux (INESSS) is an organization composed of health and social service professionals, researchers, clinicians and managers, all driven by the pursuit of clinical excellence on behalf of the Québec population. INESSS’s mission is to assess the clinical advantages and the costs of the technologies, medications and interventions used in health care and personal social services. It issues recommendations concerning their adoption, use and coverage by the public plan, and develops guides to clinical practice in order to ensure their optimal use.
Does this apply to my province?
That depends on where you live. CADTH recommendations are relevant for all Canadian provinces, except Quebec, which has its own review board, INESSS. Some provinces, like B.C., also have province specific reviews; unlike Quebec, these provinces also rely on the CADTH decision to inform their reimbursement decisions. That said, provinces do not have to adhere to the recommendations, which are non-binding, and can decide to cover drugs individually.
How much does Orkambi cost?
Orkambi® costs approximately $250,000.00 per patient, per year. Provinces can work together to lower this price through negotiations with the manufacturer. Without support from private or public drug plans, it is inaccessible.
What was recommended?
CADTH and INESSS have both recommended that government drug plans do not cover the cost Orkambi.
What does this mean?
It is possible that access through public plans may not happen at all. Half of the CF population in Canada could potentially benefit from Orkambi and without coverage from government plans, the drug is unattainable.
How can I access the drug?
There is a small chance that governments would provide access on a case-by-case basis for those who are very ill, as is the case in Quebec. This is unlikely given the cost of the drug and the recommendations that state there is no, or limited, clinical benefit.
What can I do to help advocate for Orkambi?
Write to your Health Minister and elected provincial legislature representative today, and tell them to cover Orkambi anyway; that the recommendation is non-binding and they can do right by their citizens with CF by negotiating a fair price to publicly cover this medication.
What is Cystic Fibrosis Canada doing next to advocate for Orkambi?
As this is a non-binding recommendation (meaning the provincial drug plans do not have to adhere to the recommendation), Cystic Fibrosis Canada urges both the manufacturer and the provincial governments to expedite negotiations for a fair price and do the right thing for the 2,100 Canadians whose lives could potentially be changed by accessing this drug.
How do I become involved in Cystic Fibrosis Canada’s Advocacy efforts?
INTERESTED IN ADVOCATING FOR BETTER ACCESS TO ORKAMBI?
Contact our advocacy team at email@example.com to see how you can help. Or check out the toolkit below to help your advocacy efforts.
Orkambi advocates toolkit: