U.S. drug company gives UVic student reprieve for now
Insurer no longer covers medication necessary to treat her cystic fibrosis
VICTORIA A University of Victoria student fighting for the province to pay for an expensive, but life-enhancing, drug to treat her cystic fibrosis has received compassionate coverage from the drug ’s manufacturer.
Lilia Zaharieva was on her last week’s supply of Orkambi, a $250,000-a-year medication that aims to treat a rare strain of cystic fibrosis called Double Delta F508, when she found out the American pharmaceutical company Vertex would give her the drug free of charge.
“I was ready to give up. I knew I was running out of options,” she said.
That arrangement is temporary, however, and Zaharieva hasn’t been told how long the coverage will last.
“I hope it’s forever, I haven’t been given an end date,” said the 30-year-old. “But I do know I’m at the mercy of this corporate generosity and discretion. But I feel grateful, I feel hopeful.”
Vertex had previously denied Zaharieva’s request to access the medication free of charge on compassionate grounds.
The company did send Zaharieva an exceptional 12-week supply of the medication that lasted until this month.
Zaharieva has been taking Orkambi since 2016 and says it increases her lung capacity and reduces her risk of infection.
Cystic fibrosis is a genetic and irreversible disease that can clog the airways, making it difficult to breathe.
In September, she lost her insurance coverage for the drug after the University of Victoria Students Society changed its health-benefits plan.
Health Minister Adrian Dix has previously said the province covers drugs under the Pharmacare program only after an evidence-based review proves their efficacy. Dix said in November that Vertex Pharmaceuticals is trying to flout the rules through political pressure and lobbying.
Canada’s Common Drug Review Board and B.C.’s Drug Benefit Council, which assess whether a medication should be covered by provincial drug plans, recommended against coverage of Orkambi because of insufficient clinical evidence and its high price tag.
In November, after pressure from the province, the board revised its submission process to allow Vertex to submit additional clinical data to support the drug ’s effectiveness.
“The re-submission to the (Common Drug Review) doesn’t guarantee that the drug will be approved. Decisions are going to be made based on the evidence and by health professionals — not politically,” the Ministry of Health said in a statement.
“We are pleased that Vertex has decided to provide compassionate access — that is entirely appropriate, as B.C. awaits for the re-submission and review process to move ahead. All jurisdictions respect the CDR process and we have full confidence that CDR is aware of the particular circumstances surrounding Orkambi.”
Zaharieva hopes to see an expedited review process, which could help Melissa Verleg, a Vernon mother with the same strain of cystic fibrosis who has also lost her coverage for Orkambi.
Canada is the only G7 country that hasn’t publicly funded Orkambi or started negotiations to do so.
University of Victoria medical ethicist Dr. Eike-Henner Kluge said people with rare diseases are often caught between pharmaceutical companies, which charge high prices to turn a profit, and provincial governments, which aren’t mandated by the Canada Health Act to cover medications.
“There’s an old ethical saying: ‘Not everything that’s tragic is unethical.’ And truly we’re dealing with a tragedy here.”
Kluge laid out the dilemma from both sides.
Pharmaceutical companies spend years of research and hundreds of millions of dollars to bring a single drug to market, he said, and as a result, they charge steep prices to recoup those costs.
“The obligation of a pharmaceutical company is not to take care of the health of people,” Kluge said.
“They are there to make money for the stockholders.”
It’s “praiseworthy” that Vertex agreed to provide Orkambi to Zaharieva on a compassionate basis, Kluge said, but if they did this for everyone, they wouldn’t have the capital to develop new drugs, “in which case, everyone loses.”
The Ministry of Health has the discretion to fund drugs not covered by Pharmacare on a caseby-case basis, but Kluge points out that “if the province pays for this individual, there are lots of other individuals standing in the wings who also need funding and it reduces the available money for health care in general.”
“In the context of limited resources, always someone is going to lose,” he said.
“It tugs at our heartstrings, of course. Health-care issues hit us right where we live, because we live.”