A class action lawsuit filed by a group of patients in British Columbia against the federal minister of health alleges that the government’s decision not to cover the costs of a cystic fibrosis (CF) drug violates the Charter of Rights and Freedoms. The plaintiffs are seeking $60 million in damages for the denial of coverage.

The Drug: Orkambi

The drug in question, Orkambi, was approved for use in Canada in January 2016. It targets the underlying cause of CF and is intended to correct defective cystic fibrosis transmembrance conductance regulator (CFTR) proteins. In CF patients, the absence of CFTR results in thick, sticky, mucus in the lungs and other parts of the body.

Orkambi is intended for CF patients (aged 12 and older) who have two copies of a specific mutation. There are approximately 1,550 patients in Canada who may be eligible to use this drug.

The drug has had a positive impact on many CF patients. Melissa Verleg, a B.C. mother and one of the lead plaintiffs in the class action called the drug “life-changing”. Verleg told CBC News that the drug made it possible for her to get out of bed, feed her children, and take them to school, noting that “for the first time in a long time, I got to be a mother to [my kids].”

Lila Zaharevia, the second lead plaintiff, says that Orkambi stopped years of steep decline in her health, which, at one point, looked like it would require a lung transplant. Like Verleg, she notes that the drug changed her life, saying that in the year prior to taking it she could “hardly walk between…classes without feeling short of breath.” Since then, Vertex Pharmaceuticals, the company who makes the drug has granted her access to it on compassionate grounds.

The drug is expensive, costing about $170.54 per pill or about $250,000 annually, per patient. B.C. and other provinces currently do not provide coverage for this medication. While Orkambi has been approved for use by Health Canada, it is ultimately up to each province to decide what they will cover under provincial health plans, like OHIP. In making such decisions, the provinces take guidance from the Canadian Agency for Drugs and Technologies in Health (CADTH), a federal drug review body.

Coverage for the Drug

B.C. made the decision not to cover Orkambi in March 2017, claiming that it was “not-cost effective” given its price and the “modest improvement in lung function” that the government said it provided.

An earlier review by the CADTH had made the same conclusion, noting that while two double-blind randomized controlled trials had shown statistically significant improvements in lung function, the level of improvement had “uncertain clinical significance”.

Earlier this year, Verleg’s extended health plan also deemed Orkambi to be too expensive and did not provide coverage either. Verleg ceased use of the medication. Since then, she says that her lung function has become unstable and that she spends half of each day on IV antibiotics.

The Lawsuit

The lawsuit disputes the decisions of the CADTH and the B.C. government, claiming that Orkambi is medically necessary for the approximately 200 patients in B.C. who have the specific type of CF that the drug treats. It also claims that the failure to cover a medically necessary treatment violates the Charter rights of these patients.

Beyond the financial relief requested, the suit also wants a more “transparent, objective and evidence-based system” for drug approval in Canada and wants B.C. to negotiate with Vertex.

B.C. was chosen as the jurisdiction where the suit was launched because of successful Charter challenges in the province in the past, including related to medical assistance in dying (MAID). However, other provinces also do not provide coverage.

The Government’s Position

The B.C. Ministry of Health has said that it will not comment on the lawsuit, but did defend their original coverage decision, re-iterating that there is “insufficient evidence” that would justify paying the drugs high cost. It further noted that “this process ensures that important drug listing decisions are based on evidence-based, clinical analysis involving patient groups and are not the result of political lobbying”.

The CADTH is currently re-reviewing the drug, after its manufacturer provided new evidence that the the B.C. government recommended be considered.

The federal minister of health declined to comment.

We will continue to follow developments in this matter and will provide updates as they become available.

Wise Health Law was founded in 2013 by Valerie Wise and has offices in both Toronto and Oakville, Ontario. Our team of trusted health lawyers in health and administrative law, and focuses on helping health professionals, public hospitals, and national and provincial health professional associations, among others, find solutions to their legal and regulatory problems. With offices in both Toronto and Oakville, Ontario we are easily accessible. Contact us online, or at 416-915-4234for a consultation.

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