In the Journals

Canadian Patients With HCV Often Restricted From DAA Treatment

Despite the availability of effective treatments for hepatitis C virus infection, Canadian researchers showed that restrictions imposed by governments often hinder patient access to direct-acting antivirals.

“We found that 85% to 92% of the provinces and territories in Canada restrict access to these medications to persons with moderate fibrosis,” Alison Marshall, MA, PhD student from the Kirby Institute, University of New South Wales, Australia, said in a press release.

Marshall and colleagues reviewed the criteria for reimbursement of Olysio (simeprevir, Janssen Therapeutics), Sovaldi (sofosbuvir, Gilead Sciences), Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) and Viekira Pak (paritaprevir/ritonavir/ombitasvir plus dasabuvir, AbbVie) throughout Canada from April 2015 to June 2016. Specifically, they considered restrictions based on fibrosis stage, drug and alcohol use, HIV coinfection and prescriber.

Restrictions to DAA therapy based on patients’ fibrosis scores were prevalent, the researchers found. For example, in looking at simeprevir, sofosbuvir and sofosbuvir/ledipasvir, 92% of jurisdictions required a fibrosis stage of F2 or greater for reimbursement. Although Medicaid beneficiaries face similar restrictions in the United States, clinical guidelines state that all patients with HCV — regardless of fibrosis stage — should be treated, according to the study.

Though there were no universal restrictions on drug or alcohol use, these were often left to physician discretion. In British Columbia, for example, ledipasvir/sofosbuvir would not be eligible for reimbursement in “patients who are at high risk for noncompliance.”

Quebec was the only province to not reimburse for simeprevir or sofosbuvir when a patient had HIV coinfection, while Prince Edward Island required patients with coinfection to seek treatment “off-island.”

Researchers found that 23% to 42% of the territories restricted prescriber type to specialists, dependent upon the medication in question, while others allowed for prescriptions from general practitioners.

“Even though health care is the responsibility of the provinces and we have 13 public health insurance plans in Canada, we need a national plan and shared goals that can be adapted to local realities. We did it for HIV and we should also do it for hepatitis C,” Naglaa Shoukry, BPharm, PhD, researcher at the University of Montreal Hospital Research Centre and director of the Canadian Network on Hepatitis C, said in the release. “At the present time in Canada, it's the law of supply and demand; there are negotiations on a company-by-company, pill-by-pill basis. There is no transparency and we don't really know how much the new antivirals really cost. The only way to eliminate hepatitis C is by adopting a national strategy to screen and treat all infected individuals, particularly people who inject drugs.” – by Katrina Altersitz

Disclosure: Marshall and Shoukry report no relevant financial disclosures. Please see study for full list of financial disclosures.

Despite the availability of effective treatments for hepatitis C virus infection, Canadian researchers showed that restrictions imposed by governments often hinder patient access to direct-acting antivirals.

“We found that 85% to 92% of the provinces and territories in Canada restrict access to these medications to persons with moderate fibrosis,” Alison Marshall, MA, PhD student from the Kirby Institute, University of New South Wales, Australia, said in a press release.

Marshall and colleagues reviewed the criteria for reimbursement of Olysio (simeprevir, Janssen Therapeutics), Sovaldi (sofosbuvir, Gilead Sciences), Harvoni (sofosbuvir/ledipasvir, Gilead Sciences) and Viekira Pak (paritaprevir/ritonavir/ombitasvir plus dasabuvir, AbbVie) throughout Canada from April 2015 to June 2016. Specifically, they considered restrictions based on fibrosis stage, drug and alcohol use, HIV coinfection and prescriber.

Restrictions to DAA therapy based on patients’ fibrosis scores were prevalent, the researchers found. For example, in looking at simeprevir, sofosbuvir and sofosbuvir/ledipasvir, 92% of jurisdictions required a fibrosis stage of F2 or greater for reimbursement. Although Medicaid beneficiaries face similar restrictions in the United States, clinical guidelines state that all patients with HCV — regardless of fibrosis stage — should be treated, according to the study.

Though there were no universal restrictions on drug or alcohol use, these were often left to physician discretion. In British Columbia, for example, ledipasvir/sofosbuvir would not be eligible for reimbursement in “patients who are at high risk for noncompliance.”

Quebec was the only province to not reimburse for simeprevir or sofosbuvir when a patient had HIV coinfection, while Prince Edward Island required patients with coinfection to seek treatment “off-island.”

Researchers found that 23% to 42% of the territories restricted prescriber type to specialists, dependent upon the medication in question, while others allowed for prescriptions from general practitioners.

“Even though health care is the responsibility of the provinces and we have 13 public health insurance plans in Canada, we need a national plan and shared goals that can be adapted to local realities. We did it for HIV and we should also do it for hepatitis C,” Naglaa Shoukry, BPharm, PhD, researcher at the University of Montreal Hospital Research Centre and director of the Canadian Network on Hepatitis C, said in the release. “At the present time in Canada, it's the law of supply and demand; there are negotiations on a company-by-company, pill-by-pill basis. There is no transparency and we don't really know how much the new antivirals really cost. The only way to eliminate hepatitis C is by adopting a national strategy to screen and treat all infected individuals, particularly people who inject drugs.” – by Katrina Altersitz

Disclosure: Marshall and Shoukry report no relevant financial disclosures. Please see study for full list of financial disclosures.