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