DAA treatment restricted for Canadian hepatitis C patients

Patients infected by hepatitis C virus (HCV) in Canada have limited access to direct-acting antiviral (DAA) agents, according to a new study.

“There are many new DAAs, marketed by different pharmaceutical companies. We studied reimbursement practices for simeprevir, sofosbuvir, ledipasvir-sofosbuvir and paritaprevir-ritonavir-ombitasvir plus dasabuvir. We found that 85% to 92% of the provinces and territories in Canada restrict access to these medications to persons with moderate fibrosis,” lead author Alison Marshall from the Kirby Institute at the University of New South Wales-Australia, told Medical Economics.

Marshall and colleagues reviewed the reimbursement criteria for those DAAs in Canada’s 10 provinces and three territories. Although Canada's 10 provinces and three territories are collectively governed by the Canada Health Act, every jurisdiction administers its own health plan.

There were no drug and alcohol use restrictions. However, several criteria, such as active injection drug use, were left to the discretion of the physician, she said.

Quebec did not reimburse simeprevir and sofosbuvir for people co-infected with HIV, but the province is gradually lifting restrictions on access to DAAs based on fibrosis stage. No restrictions were found in the remaining jurisdictions. Prescriber type was restricted to specialists in up to 42% of provinces/territories.

The researchers published their results on October 14, 2016 in CMAJ Open.

The study authors, including researchers at the University of Montreal Hospital Research Centre, the Kirby Institute and the Canadian Network on Hepatitis C, estimate that there are about 220,000 patients with chronic HCV infection in Canada. It is estimated 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 is expected to rise to about $258 million per year.

In contrast to Canada, about three-quarters of state fee-for-service Medicaid plans in the U.S. limit reimbursement to patients with evidence of advanced fibrosis or cirrhosis (stage F3 or F4). “Clinical guidelines state that all patients with chronic HCV infection, irrespective of disease stage, should receive treatment, including prioritization of treatment for populations at risk of transmitting HCV, that is, people who inject drugs,” the researchers stated.

A review by the Canadian Agency for Drugs and Technologies in Health showed that treating patients across all fibrosis stages is cost-effective. Also, several U.S. states have removed fibrosis stage restrictions following potential lawsuits from patients. “Considering that treatment of HCV infection for people who inject drugs is safe and effective, is cost-effective and would prevent HCV transmission, removal of these restrictions is warranted,” they stated.

Up to half of Canadian jurisdictions restrict prescriber type to specialists. Specialists may be better trained to oversee DAA-based therapy in selected circumstances, such as decompensated cirrhosis, but the researchers suggest that general practitioners should be provided with education, training and linkage to HCV specialists to broaden access to therapy.