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UVic student takes lead in $60-million class-action suit over costly drug

A University of Victoria student with a rare strain of cystic fibrosis is one of the lead plaintiffs in a class-action lawsuit against the B.C.
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Lilia Zaharieva, 31, and Melissa Verleg of Vernon are seeking $60 million in damages for what they allege are flawed drug approval processes.

A University of Victoria student with a rare strain of cystic fibrosis is one of the lead plaintiffs in a class-action lawsuit against the B.C. government, the federal government and two drug- approval bodies for failing to provide coverage for Orkambi under public drug plans.

Lilia Zaharieva, a 31-year-old Saanich woman, and Melissa Verleg, a 34-year-old mother of two in Vernon, are seeking $60 million damages as a result of what they allege are flawed drug-approval processes that have led the provincial government to refuse to cover the $250,000-a-year medication Orkambi.

The lawsuit alleges the decision not to fund the drug infringes on patients’ Charter of Rights to health, access to care and equal treatment.

Zaharieva and Verleg both have a strain of cystic fibrosis called Double Delta F508 and they say Orkambi increases their lung capacity and lengthens their lifespan.

“I see this step as an unfortunate last resort,” Zaharieva told the Times Colonist after a news conference in Vancouver.

“I’ve been trying to meet with [Health Minister] Adrian Dix, I’ve held rallies, I’ve had people send letters. I see this as necessary in terms of making the kind of change that would make this medication available to everyone who needs it.”

Their lawyer, Chris MacLeod, who is also the chair of the Canadian Cystic Fibrosis Treatment Council, said there are more than 200 people in B.C. with the specific genetic mutation. Some patients who take Orkambi, manufactured by Vertex Pharmaceuticals, are covered by their private insurance plans.

Zaharieva was on her last week’s supply of Orkambi in March when she found out that Vertex would provide the drug for free under compassionate coverage. The coverage is temporary, however, and Zaharieva has no idea how long it will last. Verleg has been without Orkambi since February and said her lung capacity has declined dramatically.

The two drug approval bodies named in the lawsuit are the Canadian Agency for Drugs and Technologies in Health (CADTH), which assess whether a medication should be covered by provincial drug plans, and the Pan Canadian Pharmaceutical Alliance (pCPA), which negotiates prices for publicly covered drugs on behalf of the provinces and territories.

Despite being approved by Health Canada, CADTH and B.C.’s Drug Benefit Council recommended against coverage of Orkambi because of insufficient clinical evidence and its high price tag.

MacLeod said the CADTH drug-approval process is opaque and discriminates against patients with rare diseases.

As well as damages, the lawsuit requests an injunction compelling the B.C. government to cover Orkambi under Pharmacare.

The lawsuit was filed Tuesday morning and has not yet been served, MacLeod said.

The Healthy Ministry said in a statement that since the matter will soon be before the courts, it cannot comment on the specific details of this case.

The ministry did say: “British Columbia is fully committed to an evidence-based process which includes consideration of recommendations by the Canadian Agency for Drugs and Technologies in Health (CADTH) on a drug’s clinical efficacy and cost effectiveness, followed by a review by the provincial Drug Benefit Council.

“While Health Canada provides federal market authorization to sell a drug — this approval does not mean that the drug has been analyzed by Health Canada as being effective or cost-efficient. It is simply an initial first step that means that the drug is able to move forward in the review process, because it is safe as a placebo.

“Once Health Canada approves a drug to be sold, the manufacturer submits it to the Canadian Agency for Drugs and Technologies in Health (CADTH) for the drug to be considered for potential coverage by provincial drug plans. 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 Health Ministry said the cost for funding Orkambi for about 120 patients in B.C. would be $85.5 million over three years. It also said the price of Orkambi in Canada is under investigation by the Patented Medicines Price Review Board, Canada’s drug pricing watchdog.

Orkambi is publicly covered in Ireland, the United States, Germany and France.

CADTH is in the middle of a third review on Orkambi, initiated after pressure from the B.C. government to revise its submission process which allowed Vertex to submit additional clinical data to support the drug’s effectiveness.

When asked why the lawsuit is being launched before the third review is complete, MacLeod said: “Because time, in our view, has run out.”