Spotlight Series on Hepatitis C


Researchers Call for Easing Restrictions on Access to Hepatitis C Treatment in Canada

October 26, 2016

Hepatitis C virus (HCV) infects the liver, causing inflammation. As this infection continues, healthy liver tissue is gradually replaced with useless scar tissue in a process called fibrosis. As more of the liver becomes scarred it increasingly becomes dysfunctional. This leads to complications, including an increased risk for internal bleeding and serious infections. What's more, as scar tissue accumulates in the liver, the risk of cancer developing in this organ increases. Eventually, when the liver has largely been transformed into scar tissue, cirrhosis has been established, along with the risk of serious complications and death.

Researchers with the Public Health Agency of Canada estimate that there are about 220,000 people with chronic HCV infection in this country. Furthermore, other researchers estimate that about one-quarter of this population will develop cirrhosis by the year 2035. In 2013, the cost of caring for Canadians with HCV-related cirrhosis was $161 million. By 2035, the cost of care will likely rise to about $260 million per year.

For many years HCV treatment was centred on weekly injections of interferon, a treatment that was not highly effective and carried many side effects, some of which were distressing. However, in the past several years the treatment of HCV has been revolutionized with the introduction of a group of drugs known as direct-acting antivirals (DAAs). These drugs, which are taken orally and in combination, are well tolerated and highly effective. In clinical trials the rate of cure with the latest DAAs is usually around 95%.

The list price for a 12-week course of DAAs tends to be around $60,000 per person. This is an enormous barrier for the average person with chronic HCV. Canada's provincial and territorial Ministries of Health therefore subsidize the cost of treatment. However, they also often place restrictions on who can get access to such treatment.

A team of researchers in Canada and Australia recently reviewed criteria under which Canada's provinces and territories (as well as some federal drug subsidy plans for Indigenous people and prisoners) cover the cost of DAA regimens in widespread use.


Key Findings

  • The team found that, overall, 85% to 92% of Ministries of Health restricted access to HCV treatment by requiring that patients must have at least a moderate degree of liver fibrosis. The medical short-form for this degree of injury is "F2."
  • Patients who had drug and/or alcohol dependency were not barred from receiving treatment.
  • Restrictions on the use of DAAs by people co-infected with HIV and HCV were "mostly non-existent," according to the researchers.
  • Between 23% and 43% of Ministries of Health restricted the prescribing of DAAs to specialists.

Restrictions Not Evidence-Based

The team noted that the restrictions on treatment access based on the degree of fibrosis are not grounded in data obtained from clinical trials. Indeed, in the treatment guidelines developed by leading associations of researchers, liver, gastrointestinal and infectious disease specialists, there was no firm evidence to support such restrictions . Furthermore, the team stated, "a review by the Canadian Agency for Drugs and Technologies in Health showed that treating patients across all fibrosis stages is cost effective." They also noted that several U.S. states have removed fibrosis restrictions on access to DAAs following "potential lawsuits from patients." The research team stated that the province of Quebec is gradually lifting restrictions on access to DAAs based on fibrosis stage.

Specific populations

Federal drug coverage plans that focus on Indigenous people (the Non-Insured Health Benefits Program) and the drug plan for people in federal prisons require that patients have at least a moderate degree of fibrosis before they can receive treatment. Furthermore, the researchers stated, Correctional Services Canada advise that "directly observed therapy was mandatory" when it comes to treating prisoners with HCV.

Reducing Barriers to Access

The research team made several suggestions for reducing barriers to accessing HCV treatment in Canada:

  1. The team called on Ministries of Health to review restrictions based on fibrosis stage, as these are "neither cost effective nor evidence-based."
  2. Health authorities should provide general practitioners with "education, training and linkage to HCV specialists." This could be especially helpful in parts of Canada where access to such specialists is limited. The researchers noted that "in Australia all general practitioners can prescribe HCV therapies in consultation with a specialist (for example, via email), a practice that could be emulated in Canada."
  3. The researchers stated: "Since March 2016, the Australian government has provided universal access to HCV treatments with no restrictions based on liver disease stage, recent drug use, HIV coinfection or specialist prescribing." To support this access, the Australian government has committed $1 billion over the next five years. The researchers noted that "the development of a national drug formulary in Canada could allow for greater standardization of treatment reimbursement and perhaps greater "buying power" in negotiating prices for new therapies [from pharmaceutical companies]." They added that "the development and adaptation of a national HCV strategy in Canada, akin to those in Australia and Scotland, could facilitate volume-based discounting, reduce [differences in HCV drug coverage between the provinces], direct treatment to at-risk populations and broaden equitable access to enable the elimination of HCV infection in Canada."


Starting to think about the end of the hepatitis C epidemic -- CATIE News

U.S. researchers model impact of interventions to shrink hepatitis C epidemic -- CATIE News

Considering ways to shrink the hepatitis C epidemic in British Columbia -- CATIE News

CATIE's hepatitis C information


  1. Marshall AD, Saeed S, Barrett L, et al. Restrictions for reimbursement of direct-acting antiviral treatment for hepatitis C virus infection in Canada: a descriptive study. CMAJ Open. 2016; in press.
  2. Barua S, Greenwald R, Grebely J, et al. Restrictions for Medicaid reimbursement of sofosbuvir for the treatment of hepatitis C virus infection in the United States. Annals of Internal Medicine. 2015 Aug 4;163(3):215-23.

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This article was provided by Canadian AIDS Treatment Information Exchange. It is a part of the publication CATIE News. Visit CATIE's Web site to find out more about their activities, publications and services.

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