Moving towards Universal Coverage of Direct-Acting Antiviral Therapies for Hepatitis C Infection in Canada: An Environmental Scan of Canadian Provinces and International Jurisdictions

Background: Direct-acting antivirals (DAAs) have become the standard treatment for patients with chronic hepatitis C infections because of their high cure rates and favourable side effect profiles; however, access to this new class of agents has been limited because of its high cost. Public payers across Canada have implemented strict criteria for drug coverage in order to contain expenditures. Efforts have been made to improve access to medication for this high-burden condition. Recent coverage criteria across national and international jurisdictions have been compared. Methods: Coverage criteria for several DAAs were reviewed by accessing Canadian provincial drug formularies. International coverage (e.g., Europe, Australia, United States, Egypt, India) was reviewed by searching available literature. Results: Coverage criteria vary across Canada. By April 2018, most Canadian jurisdictions had removed the stage 2 liver fibrosis requirement for patients to be eligible for coverage. Internationally, patients’ access to DAAs differs significantly. Many jurisdictions restrict DAA prescribing authority to specialists and request documentation of chronic hepatitis C. In the US, considerable gaps of coverage are identifiable and patients might face significant financial burden to receive treatment. Conclusion: DAAs appear to be generally accessible through public drug plans in Canada compared to other countries. __________________________________________________________________________________________


INTRODUCTION
With the emergence of oral direct-acting antivirals (DAAs) such as Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir), and Epclusa (sofosbuvir/velpatasvir), chronic hepatitis C (CHC) have gone from a once unsettling diagnosis to a curable disease. Approximately 71 million people globally are currently affected by CHC. 1 Hepatitis C virus (HCV) is a bloodborne virus which can cause acute and chronic disease; highest-risk factors for infection include intravenous drug use, needlestick injuries, blood transfusions received before 1992, and receiving unsterile tattoos or body piercings. 2 Acute HCV infection is often asymptomatic and rarely associated with life-threatening disease. While between 15 and 45% of infected persons spontaneously clear the virus within 6 months of infection without any treatment, the remaining 60-80% of persons develop CHC, which, if untreated, develops in 15-30% of the cases into cirrhosis of the liver within 20 years 1 .
Treatment for CHC may vary according to virus genotype. In Canada, genotype 1 makes up about 65% of the patients infected with HCV (genotype 1a accounts for 56% and genotype 1b for 33%, with approximately 10% unspecified or mixed genotype 3 ) , genotype 2 makes up approximately 14% of HCV cases, while genotype 3 makes up roughly 20%. 3 Genotypes 4, 5, 6, are quite rare, only accounting for <1% of the infections in Canada. 3 DAAs either work to inhibit the NS5A protein, NS3/4A protease, or NS5B RNA polymerase. 4 All of these mechanisms of action ultimately result in inhibiting processes that are necessary for viral replication. 4 Not only do these therapies help control the spread of the virus, they also reduce the incidence of CHC complications such as liver cirrhosis and hepatocellular carcinoma. 3 Before DAAs, the standard treatment for CHC was interferon (IFN) therapy. This consisted of low cure rates (<10%) 5 and severe side effects including fatigue, headache, nausea, dizziness, depression. 6 Interferon therapy was then combined with ribavirin which increased cure rates to 34-42%. 5

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The substitution of IFN with PEGylated IFN resulted in sustained virologic response (SVR) rates ranging from 45-80%. 5 The first DAAs, Victrelis (boceprevir) and Incivek (telaprevir), were released in 2011, and showed cure rates of 70-80%. 5 In 2014, the newer class of DAAs were released, all producing SVRs of >90%. 7,8 Compared to earlier interferon-containing regimens, not only do DAAs have increased SVR rates, they also have fewer side effects, making them much more tolerable courses of treatment. The only issue with these innovative drugs is the high price tag attached to them. As a result, both private and public insurers initially had to establish eligibility requirements that prioritized patients with liver damage, and those who had failed to respond to less costly treatments. Currently, criteria for coverage are changing globally, improving patients' access to DAAs. However, changes are occurring at different rates across the globe and access to treatment varies among countries. Previous treatments, liver fibrosis levels, degree of liver damage, or drug/alcohol use are still considered in coverage criteria. The purpose of this paper is to describe coverage criteria and cost differences across provinces and territories in Canada, as well as to explore how DAAs are covered in international jurisdictions.

METHODS
A systematic search of existing literature and Canadian provincial drug formularies was conducted between May and August 2018 to determine coverage criteria and prices of DAAs in various jurisdictions. Medications available on the Canadian market included Daklinza (daclatasvir), Epclusa (sofosbuvir/velpatasvir), Sunvepra (asunaprevir), Galexos (simeprevir), Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir), Holkira Pak(dasabuvir, ombitasvir, paritaprevir, and ritonavir), Zepatier (elbasvir/grazoprevir), Maviret (glecaprevir/pibrentasvir), Technivie (ombitasvir, paritaprevir, and ritonavir), and Vosevi (sofosbuvir/velpatasvir/voxilaprevir). Information not available online was obtained from government agencies through phone conversations. Drugs not available in Canada, but available in other jurisdictions were also considered. A scan of current national and international media coverage on access to treatment, recommendations, and pricing regarding hepatitis C treatment was also performed and discussed. The recommendations of the Canadian Drug Expert Committee (CDEC) (the national committee providing recommendations to provincial/territorial/federal drug programs in Canada) for reimbursement of each DAA were also analyzed.

International comparison
An economic analysis looking at new medications for hepatitis C published by Iyengar 9 in 2016 compared the costs for 12-week courses of Sovaldi (sofosbuvir) or Harvoni (ledipasvir/sofosbuvir) in 30 different countries (including Japan, Poland, Greece, Turkey, United States, Brazil, Egypt). The study showed that prices for these medications varied significantly among countries and estimated that total cost of treating all patients with CHC would be at least a tenth of the current annual drug spending in all of the 30 countries. 9 In certain countries where the prices of medications and disease prevalence is high, the total cost of treating all patients would be more than the current annual drug spending of all other medications. 9 Another observation was that if a patient had to pay out of pocket for the medication, the total cost of a 12-week course of sofosbuvir alone was equivalent to one year or more of earnings from an average salary in 12 of the 30 countries included in the study. 9 The overall conclusion of this article was that the new medications for hepatitis C were "globally unaffordable". 9 As a consequence of the high prices, payers in high-income countries have been restricting coverage (e.g., United States), negotiating public deals, private discounts, and rebates with the manufacturer (e.g., France and Germany), or delaying reimbursement until a reasonable price has been negotiated (e.g., Australia). 9 In low-and low-middle-income countries, where pricing negotiations have been undertaken or generic formulations of DAAs have been made available, access to treatment has vastly improved. The World Health Organization (WHO) published a progress report on Access to Hepatitis C Treatment focusing on low-and middle-income countries in March 2018. This publication described the steps that needed to be taken towards developing universal coverage for hepatitis C treatment, which included access to affordable treatment as the primary step as well as the need for strong government involvement in order to ensure that prevention measures and adequate screening protocols were implemented globally. 10 In uppermiddle-and high-income countries, prices of DAAs remain high with access to generic formulations very limited. While the price of DAAs is still extreme in high-income countries, diagnostic services are more easily accessible compared to low-income countries.
Many factors play a role in determining the cost of newly approved medications. They include investment in research and development, production costs, efficacy, safety, ease of administration, duration of treatment, features of treatment comparators, innovation, international benchmarking, market size and market value. 5 It has been shown that the cost of treating hepatitis C is incremental, but so is the cost of treating the complications that will arise later on if left untreated. In fact, while prevalence of hepatitis C is declining, probably due to better education on prevention and to the availability of DAAs, the CHC population is aging and the rate of complications is increasing. It has been estimated that, in Canada, direct costs associated with CHC (not including cost of antivirals) would increase from an estimated $161 million in 2013 to more than $258 million at the peak in 2032. 11 In June 2015, prices for sofosbuvir, daclatasvir, simeprevir, ledipasvir/sofosbuvir and ombitasvir/paritaprevir/ritonavir were surveyed in various jurisdictions in a study published in November 2015 entitled "Disparity in market prices for hepatitis C virus direct-acting drugs". 12 Thirtyeight countries were included: 14 were high-income countries, 9 were upper-middle-income countries, 11 were lower-middle income countries, and 4 were low-income countries. Classification was based on their GNI per capita (in U.S. dollars, converted from local currency). 12 The price per bottle of sofosbuvir was $300 in India and Pakistan and $20,590 in Switzerland. The cost per bottle of daclatasvir was $175 in Egypt and $14,899 in Germany. Simeprevir ranged from $241per bottle in Egypt to $14,865 in Australia. 12 Ledipasvir/sofosbuvir costs were $400 per bottle in Egypt and Mongolia but $24,890 per bottle in Germany. 12 Finally, ombitasvir/paritaprevir/ritonavir costs were $400 per bottle in Egypt but $20,215 per bottle in Switzerland. 12 This study concluded that prices of DAAs in low-income and middle-income countries were substantially lower compared to high-income countries, with few exceptions. This survey stressed the concept that these medications were unaffordable for patients who have to pay out of pocket in highincome countries or if large populations require treatment paid by a government payer. 12 Australia Australia has established a cost-appropriate plan for the treatment of CHC. The Pharmaceutical Benefits Scheme (PBS) is a program that negotiates prices with manufacturers on behalf of the residents of Australia. On March 1, 2016, all HCV patients were able to access available DAAs through the PBS. 13 The Australian government made a deal with PBS to pay 1 billion Australian dollars over 5 years to subsidise DAAs. 13 A year after this change was made, a study entitled "Implementation of hepatitis C cure in Australia: one year on" was published in the Journal of Virus Eradication (Richmond &Wallace, 2018) 14 . The conclusion was that the goal to eliminate HCV in Australia had become a realistic possibility. 14 By making DAAs more accessible, the percentage of Australians being tested and diagnosed had also increased. 14 As of 2018, approximately 227,306 people were living with HCV in Australia. 13 Because of the increased access to DAAs through the PBS, an estimated 43,360 Australians (approximately 19% of the CHC population) were started on DAA therapy between March 2016 and June 2017. 14 For Epclusa, which is effective against all genotypes of HCV, patients were only required to pay $6.30 if they were "concessional" patients and $38.80 in all other cases. 11 A concessional patient is one who holds any of the following cards: Pensioner Concession Card, Australian Seniors Health Card, Health Care Card, or a Department of Veterans' Affairs (DVA) Gold, Orange, or White Card. 15 DAAs available to patients through the PBS as of August 1, 2018 included the following: Daklinza, Epclusa, Harvoni, Maviret, Sovaldi, Viekira-Pak, Viekira-Pak with RBV, and Zepatier. 16 Australia has a program of unrestricted access to DAAs, the only criterion requires for the patient to be an adult diagnosed with CHC. This is in contrast to most countries that have programs of restricted access that would only allow those with advanced disease or those previously treated with other therapy to be eligible for coverage. In other countries, patients might be denied access if they are abusing drugs or alcohol. "The key to this universal access was the Australian government's capacity to negotiate much lower drug prices than in other high-income countries, following strong advocacy from the hepatitis C sector. For instance, Australia paid an estimated ten-fold lower price per patient treated in 2016 than did Germany." 17 France and Scotland have a process similar to the Australian process that provides payment for all CHC patients with minimal co-payments. 18

Europe
As of March 2018, approximately 36% of Europeans with CHC infection had been diagnosed, and approximately 5% had received treatment. 19 The WHO has set a goal to eliminate hepatitis B and C as a public health threat by 2030. In order to reach that target, 90% of people living with CHC will have to be diagnosed and 80% of those diagnosed will have to be treated with DAAs. 10 High-risk populations need to be tested in order to increase diagnoses and restrictions to DAA treatment need to be further removed worldwide in order to increase access to treatment to meet these targets.
Previous restrictions in Europe for DAA prescribing included prioritizing therapy for those who had liver damage and limiting prescribing to specialists (e.g. gastroenterologist, hepatologist, or infectious disease specialist) or physicians with experience treating hepatitis C. 19 Certain restrictions for DAA coverage are slowly being removed across European jurisdictions, increasing access to DAAs. 19 In February 2018, a study entitled "Restrictions for reimbursement of interferon-free direct acting antiviral drugs for CHC infection in Europe" (Marshall, 2018) was published; this study compared reimbursement criteria of DAAs in 35 European countries (which included those in the European Union, European Economic Area and Switzerland) between November 18, 2016 and August 1, 2017. 20 They concluded that 46% of countries in the study still had fibrosis requirements in place in order for patients to receive treatment and 94% of countries restricted prescribing to a specialist; 20 83% of these European countries had no restrictions to limit treatment to those who were abstinent from drugs or alcohol. 20 Only 3% of countries had additional restrictions for those that were co-infected with HIV. 20 This study concluded that these findings had the potential of meeting WHO targets of eradicating HCV as a public health threat by 2030. 20 23 In 2016, an article entitled "Coverage for hepatitis C drugs in Medicare Part D" was published in NCBI which analyzed the spending of insurance plans on HCV drugs and estimated the total patients' out-of-pocket spending. 23 They concluded that "All Part D plans covered at least 1 recently introduced HCV drug, as of July 2015. Nearly all plans charged relatively high co-payments and required prior authorization for newer HCV drugs. For enrollees with no subsidy, the mean out-of-pocket spending ranged from $6,297 to $10,889. For enrollees with a low-income subsidy, out-of-pocket spending varied between $10.80 and $1,191". 23 The authors also found that at the time of the study, all Part D plans covered simeprevir and sofosbuvir and 98% of plans covered ledipasvir/sofosbuvir. 23 Currently, CHC patients with or without subsidy still face sizable financial burdens in the United States. 23 The

India
The Indian population accounts for approximately 12 million out of the 71 million of those infected globally. 26 Sofosbuvir, ledipasvir and daclatasvir are now available as generic alternatives in India, which has greatly improved access to treatment. These three generic medications are available to patients at the reasonable price of approximately $250-$300/bottle. 27 In January 2016, the lowest price for a 28-day supply of a generic combination of sofosbuvir/ledipasvir by Indian licensees of the originator company for the local Indian market was US$205; by April 2016, it had dropped to US$169. 28 The lowest price reported for a 28-day supply of sofosbuvir in January 2016 from a local generic producer was US$15 in Pakistan. 28 Due to generic formulations, price reductions have been obtained, increasing the amount of people able to be treated.

Egypt
As of June 2017, Egypt was reported to be the country with the highest prevalence of hepatitis C in the world at approximately 10%. 29 Upon initial marketing of new DAAs in 2014, Gilead Sciences priced the drug to the U.S. market at $1,000/pill making a 12-week course cost $84,000. 30 Gilead Sciences marketed sofosbuvir combined with ledipasvir (Harvoni) with a 12-week treatment cost of $94,500. 11  Unlike other countries, Canada has no national strategy for eliminating hepatitis C as a public health threat. 32 The Canadian Hemophilia Society describes the five aspects that a national plan must have for population-specific strategies, national targets with well-defined indicators, increased access to treatment, continuum of CHC services and most importantly, adequate resources. 32 What's in the media for Canada The Canadian media is always highly interested in health care issues. Since the first oral DAAs, Victrelis (boceprevir) and Incivek (telaprevir), were approved in 2011, there have been countless news articles regarding hepatitis C treatment, screening, and prices of medications. Incivek was later discontinued from the Canadian market on January 1, 2015 33 and Victrelis was discontinued on March 31, 2016. 34 Reasons for discontinuation included the need for adjunctive treatment with ribavirin and pegylated interferon, increasing costs of therapy and side effects 3,33,34 , and the lower cure rates that they produced compared to the newer DAAs released in 2014 such as sofosbuvir. 3 A Globe and Mail article published in February of 2017 details the negotiations that the pan-Canadian Pharmaceutical Alliance (pCPA) conducted with manufacturers on behalf of the public drug programs. Agreements have been reached with the makers of six hepatitis C medications. The three drug companies involved were Gilead Sciences Canada, Merck Canada, and Bristol-Myers Squibb Canada. The deal further reduced the price of Harvoni and Sovaldi, which were involved in an earlier price reduction agreement, and has more recently reduced prices of Daklinza, Epclusa, Sunvepra, and Zepatier . 35

Provincial comparison
Criteria for coverage differ not only from country to country, but also across Canadian provinces and territories. Setting criteria for reimbursement presents an ethical issue. How can we choose to cover the cost of life-saving treatments for some and not others? Previously, most provincial jurisdictions only covered treatment for those with a certain fibrosis level or liver damage, but not for those with an otherwise healthy liver. Effective April 27, 2018 Alberta, Saskatchewan, Yukon, Manitoba, and the NIHB program (federal drug program covering First Nation populations) cover the cost of hepatitis C treatment without restriction. 36 Before this was implemented, patients in these provinces needed to demonstrate a liver fibrosis stage 2 (even though there was no clinical support for this limitation) or had another health issue such as HIV, hepatitis B virus or diabetes in order to be eligible for coverage. 36 Prince Edward Island, Ontario, British Columbia and Québec had previously lifted restrictions based on liver injury. 36 CDEC recommendations for each DAA were relatively similar. Most recommendations restricted DAA prescribing privileges to a specialist (i.e., gastroenterologist, hepatologist, or infectious disease specialist) or a physician with experience treating hepatitis C and recommended a reduction in price. Details are reported in Appendix (   Tables 4-12 describe the exact criteria that must be met in order for each DAA to be covered in each province/territory, the approved duration of therapy, and if adjunctive treatment is required. Across the provincial jurisdictions, certain similarities exist regarding coverage criteria. Most require that the treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced in treating hepatitis C, patients must have laboratory confirmed hepatitis C, and confirmed quantitative HCV RNA values within the last 6-12 months. The fibrosis requirement has been removed from all Canadian jurisdictions with the exception of Nova Scotia, New Brunswick, and Newfoundland & Labrador. 36 Alberta, British Columbia, Saskatchewan, Nunavut, and Northwest Territories have the widest range of DAAs available. Sunvepra and Galexos were included in this environmental scan even though they have been removed from the Canadian market, as some provinces still include them on their formulary. Both Maviret, approved in November 2015, and Technivie, approved in September 2017, are not yet covered by any Canadian jurisdiction. A recent study published in January 2018 showed that those treated with Maviret for 8 weeks are showing very similar SVRs as those treated for 12 weeks. 37 Being able to reduce therapy from 12 weeks to 8 weeks while maintaining efficacy will not only reduce costs dramatically, but will also increase the amount of people able to be treated in resource-limited settings. 37 British Columbia B.C. is one of the provinces with a wider range of availability for DAAs. Holkira Pak was previously covered by BC Pharmacare, but as of March 23, 2017, it is not covered for those starting a new therapy. As of March 13, 2018

New Brunswick
There is still a requirement to have a fibrosis level of F2 or greater (Metavir scale or equivalent) in order to receive treatment. New Brunswick formulary includes many DAAs for those who meet the requirements, only excluding Sunvepra and Holkira Pak.

Newfoundland & Labrador
The fibrosis level of F2 or greater (Metavir scale or equivalent) requirement still exists in Newfoundland & Labrador. Similar to PEI, this province has limited options for DAAs (only Daklinza and Zepatier). Coverage is not available for residents of all genotypes: Daklinza is only indicated for those with HCV genotype 1b or 3, and Zepatier is only indicated for those with HCV genotype 1 or 4.

Northwest Territories and Nunavut
These territories follow the criteria listed under NIHB coverage. There is a wide range of DAAs listed on the NIHB formulary, only excluding Sunvepra and Galexos.

Goals for Hepatitis C Treatment
Many countries have set goals to eliminate HCV as a public health threat by a certain year. The National Health Service (NHS) in England set to eliminate HCV by 2025. 41 Australia has set their goal for 2030. 42 Although Canada has not yet put a strategy into place, they have recognized that policy issues must be addressed and have set a goal of treating 80% of cases by the year 2030. 43 Experts say these goals are attainable but it will require intense commitment and resources to accomplish them. As previously mentioned, the WHO has created a movement called "Eliminate Hepatitis" with the goal of eliminating hepatitis B and C by 2030 in 28 countries that make up 70% of hepatitis cases globally. The 28 countries involved in this movement include Egypt, India, China, Mongolia, Nigeria, Brazil, Pakistan, Indonesia, Myanmar, Uganda, Vietnam (these 11 countries make up 50% of the global burden of hepatitis B and C) and Cambodia, Cameroon, Colombia, Ethiopia, Georgia, Kyrgyzstan, Morocco, Nepal, Peru, Philippines, Sierra Leone, South Africa, Tanzania, Thailand, Ukraine, Uzbekistan, and Zimbabwe (these 17 countries have high prevalence and are working to develop national hepatitis responses). 44 In order to reach the 2030 target, 90% of people living with CHC will have to be diagnosed and 80% of those will have to be treated with DAAs. Preventive measures will also have to be put in place to reduce the number of new HCV infections. 10

Global media
Even though these targets were set by WHO in 2016, only a few countries are currently on track to achieving them. Australia, Brazil, Egypt, Georgia, Germany, Iceland, Japan, the Netherlands and Qatar are countries that have been recognized as heading in the right direction to achieve these goals. 45 Egypt has been recognized for their immense efforts in increasing screening and therefore diagnosing, as well as creating generic forms of DAAs at reduced prices for their patients. 45 Brazil has recently opened up hepatitis B vaccination to the whole population, and is now reducing restrictions to DAAs, increasing hepatitis C treatment. 45 As previously discussed, Australia is making immense headway by having a program of unrestricted access and supplying DAAs at reduced prices.

Screening and Access to Treatment
Not all of the estimated 71 million people globally 1 affected by CHC are aware of their disease. Most patients are asymptomatic (and therefore undiagnosed) in the initial stages of the infection. Only when there is advanced liver damage, do patients begin to show symptoms and are more likely to be diagnosed. 22 When initially infected with HCV, most patient's immune system is unable to eradicate the virus causing up to 80% of acute infections to progress to a chronic HCV infection, while the rest resolve on their own without treatment. 22 Because of the efficacy and safety of the new DAAs, Canadian guidelines recommend one-time population-based screening for individuals born between 1945 and 1975 (as the majority of people with hepatitis C were born in these decades) or with risk factors (such as having received a blood transfusion prior to 1992, born or resided in HCV prevalent area, born to HCVinfected mother), and annual screening for patients with ongoing risk factors (such as IVDU, MSM, people with tattoos or body piercings done with unsterile instruments, people who have had unprotected sex with multiple partners). 46 While the treatment is costly, screening is relatively inexpensive, and overall treatment of HCV is costeffective in terms of preventing the complications of HCV such as liver damage or cirrhosis 46 . Patients with mild fibrosis should also be candidates for DAA treatment to improve quality of life 46 . Canada's health care system has been defined as a "patchwork" because of the separate jurisdictional responsibilities for health in each province and territory, and at the federal level; the complexity of public and private drug coverage, and, in some cases, lack of coverage can in fact creates inequality of access to treatment. 43 Nevertheless, the pan-Canadian Pharmaceutical Alliance, which includes provinces and territories as well as the federal government, has been successfully working to negotiate medication prices with manufacturers with the objective of making access to the newest DAAs more affordable. As discussions regarding a national Pharmacare continue, it could be anticipated that further harmonization and pricing negotitions will take place.
In order to reach WHO's 2030 goal, those at risk need to be screened, and treated if necessary. In countries with high prevalence of CHC and very low infection control, it is recommended by WHO that the whole population be screened if resources allow. 47 In 2015, approximately 20% of patients with CHC knew of their diagnosis, and only 7.4% of those diagnosed received treatment. 1 Further government involvement in removing restrictions to treatment is necessary in order to meet WHO goals.

CONCLUSION
With 71 million people currently affected by CHC worldwide 1 , access to DAA treatments must improve drastically in order to reach the global goal of eradicating hepatitis C as a public health threat by the year 2030. In low-income countries, screening and diagnostic protocols need to be implemented, especially since treatment is now affordable for those diagnosed as generics have been created or price reductions have been negotiated. In high-income countries, where screening and diagnosis efforts are already improving, the price of DAAs needs to be negotiated in order to provide treatment to patients at an affordable price.

ACKNOWLEDGMENTS AND DISCLAIMERS
283s patasvir/Voxila previr)  CDEC recommends that ombitasvir/paritaprevir/ritonavir and dasabuvir (OMB/PAR/RIT + DAS) be reimbursed for the treatment of adults with genotype 1 chronic hepatitis C virus (CHC) infection, including those with compensated cirrhosis, if the following conditions are met: -Treatment should be initiated by physicians with experience in the management of CHC patients.  -Genotype 3 patient population duration of therapy: -Treatment-naïve or treatmentexperienced without cirrhosis -12 weeks in combination with sofosbuvir -Treatment-naïve or treatmentexperienced with compensated cirrhosis (5); or decompensated cirrhosis (5); or post-liver transplant -12 weeks in combination with sofosbuvir and ribavirin *Retreatment for failure or reinfection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis.

Ontario
For use as combination therapy with sofosbuvir, alone or with sofosbuvir for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced in treating hepatitis C II) Laboratory confirmed hepatitis C infection with genotype 3; III) Laboratory confirmed quantitative HCV RNA value within the last 6 months Treatment-naïve or treatmentexperienced without cirrhosis: 12 weeks in combination with sofosbuvir (Sovaldi) Treatment-naïve or treatmentexperienced with compensated cirrhosis or decompensated cirrhosis or post liver transplant: 12 weeks in combination with sofosbuvir (Sovaldi) and ribavirin (Ibavyr) *Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a caseby case basis through the Exceptional Access Program.

Quebec
In association with sofosbuvir, for treatment of persons suffering from chronic hepatitis C genotype 3 without cirrhosis: -Who have a contraindication or a serious intolerance to pegylated interferon alfa or ribavirin Or -Who have experienced a therapeutic failure with an association

weeks
Nova Scotia For treatment-naïve or treatment-experienced adult patients with chronic hepatitis C virus (HCV) who meet the following criteria: i) Must be prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other physician experienced in treating a patient with hepatitis C infection) ii) Lab-confirmed hepatitis C genotype 3 iii) Quantitative HCV RNA value within the last 6 months iv) Fibrosis stage must be provided -Patients with diabetes being treated with antihyperglycemic medications -Woman of childbearing age who is planning a pregnancy within the next 12 months Yukon For treatment-naïve or treatment-experienced* adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: i) Treatment is prescribed by a hepatologist, infectious disease specialist or gastroenterologist ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotype iii) Laboratory confirmed quantitative HCV RNA level taken in the last 12 months Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis under the formulary exception process.
All exception requests should include: -Lab-confirmed hepatitis C genotype -Quantitative HCV RNA value within the last 12 months -Fibrosis stage *Treatment-experienced is defined as those who have been previously treated with a PegIFN/RBV regimen (including regimens containing an HCV protease inhibitor), and have not experienced an adequate response.

NWT, Nunavut *NIHB
For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced in treating hepatitis C II) Laboratory confirmed hepatitis C infection with genotype 1, 2, 3, 4, 5, 6, or mixed genotype; III) Laboratory confirmed quantitative HCV RNA value within the last 12 months *Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis. For the treatment of treatment-naïve or treatment-experienced adult patients with CHC genotype 1, 2, 3, 4, 5, 6, or mixed genotype infection who meet ALL of the following criteria: a) Fibrosis stage of F0 or greater (Metavir scale or equivalent). Special Authority requests for patients must include a fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan) and serum biomarker panels (AST-to-Platelet Ratio Index (APRI)) either alone or in combination. Supporting documentation must be submitted. b) Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other physician experienced with treating hepatitis C. c) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, or 6 d) Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months Patient is NOT currently being treated with another hepatitis C directacting antiviral drug Treatment-naïve and treatmentexperienced with no cirrhosis or with compensated cirrhosis: 12 weeks Treatment-naïve and treatmentexperienced with decompensated cirrhosis: 12 weeks with RBV

Alberta, NWT & Nunavut
For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced in treating hepatitis C II) Laboratory confirmed hepatitis C infection with genotype 1, 2, 3, 4, 5, 6, or mixed genotype; III) Laboratory confirmed quantitative HCV RNA value within the last 6-12 months *Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis.
Alberta: -Treatment-naive or treatmentexperienced, without cirrhosis or with compensated cirrhosis: 12 weeks -Treatment-naive or treatmentexperienced, with decompensated cirrhosis: 12 weeks in combination with ribavirin

Saskatchewan
For use as monotherapy or as combination therapy with ribavirin for treatment-naïve or treatment-experienced adult patients with chronic hepatitis C infection according to the following criteria: i) Treatment is prescribed by a hepatologist, gastroenterologist, an infectious disease specialist or other prescriber experienced in treatment hepatitis C ii) Laboratory-confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotypes iii) Laboratory-confirmed quantitative HCV RNA value within the last 6 months Treatment-naïve or treatmentexperienced without cirrhosis or with compensated cirrhosis: 12 weeks Treatment-naïve or treatmentexperienced with decompensated cirrhosis: 12 weeks in combination with ribavirin

Manitoba
For treatment-naïve or treatment-experienced adult patients with chronic hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotypes infection who meet ALL of the following: i) Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotypes iii) Patient has a quantitative HCV RNA value within the last 6 months iv) Fibrosis (2) stage of F0 or greater Metavir scale or equivalent (as of April 2018) Duration of therapy reimbursed: Genotype 1, 2, 3, 4, 5, 6 or mixed patient population duration of therapy: -Treatment-naïve or treatmentexperienced non-cirrhotic or compensated cirrhosis (5) -12 weeks -Treatment-naïve or treatmentexperienced with decompensated cirrhosis (5) -12 weeks in combination with ribavirin *Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a caseby-case basis Ontario For treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: - Yukon For treatment-naïve or treatment-experienced* adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: i) Treatment is prescribed by a hepatologist, infectious disease specialist or gastroenterologist ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotype iii) Laboratory confirmed quantitative HCV RNA level taken in the last 12 months Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis under the formulary exception process.
All exception requests should include: -Lab-confirmed hepatitis C genotype -Quantitative HCV RNA value within the last 12 months -Fibrosis stage *Treatment-experienced is defined as those who have been previously treated with a PegIFN/RBV regimen (including regimens containing an HCV protease inhibitor), and have not experienced an adequate response.   For treatment-naïve/experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet ALL the following criteria: i) Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist ii) Laboratory confirmed hepatitis C genotype 1 iii) Patient has a quantitative HCV RNA value within the last 6 months iv) Fibrosis (2) stage of F0 or greater (Metavir scale or equivalent) including decompensated cirrhosis (As of April 2018) Genotype 1 Patient population duration of therapy reimbursed: -Treatment-naïve, non-cirrhotic, viral load < 6M IU/mL = 8 weeks -Treatment-naïve, non-cirrhotic, viral load > 6M IU/mL or Treatment-naïve, cirrhotic, or Treatment-experienced, non-cirrhotic = 12 weeks -Treatment-naïve or treatmentexperienced with decompensated cirrhosis (5) = 12 weeks in combination with ribavirin -Treatment-naïve or treatmentexperienced liver transplant recipients without cirrhosis or with compensated cirrhosis (5) =12 weeks in combination with ribavirin -Treatment-experienced, cirrhotic = 24 weeks *Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a caseby-case basis.

Ontario
For treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; II) Laboratory confirmed hepatitis C genotype 1; III) Laboratory confirmed quantitative HCV RNA value within the last 6 months Treatment-naïve, non-cirrhotic, recent quantitative hepatitis C viral load less than 6 M IU/mL: 8 weeks Treatment-naïve, without cirrhosis, viral load greater than or equal to 6 M IU/mL; or treatment-naïve with cirrhosis; or treatment-experienced without cirrhosis: 12 weeks Treatment-naïve or treatmentexperienced with decompensated cirrhosis: 12 weeks in combination with ribavirin (Ibavyr) Treatment-naïve or treatmentexperienced liver transplant recipients without cirrhosis or with compensated cirrhosis: 12 weeks in combination with ribavirin (Ibavyr) Treatment-experienced, cirrhotic: 24 weeks *Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a caseby case basis through the Exceptional Access Program.

Quebec
As monotherapy, for treatment of persons suffering from chronic hepatitis C genotype 1 without decompensated cirrhosis, who have never received an anti-SCV treatment. (8-12 weeks) As monotherapy, for treatment of persons suffering from chronic hepatitis C genotype 1 without cirrhosis who have experienced therapeutic failure with an association of ribavirin/pegylated interferon alfa administered alone or combined with a protease inhibitor. (12 weeks) In association with ribavirin, for treatment of chronic hepatitis C genotype 1 in persons: -With compensated cirrhosis and who have experienced therapeutic failure with an association of ribavirin/pegylated interferon alfa administered alone or combined with a protease inhibitor OR -With decompensated cirrhosis OR -Who are waiting for an organ transplant or who have received a transplant (12 weeks) As monotherapy, for treatment of chronic hepatitis C genotype 1 in persons: -With compensated cirrhosis and a contraindication or a serious intolerance to ribavirin and who have experienced therapeutic failure with an association of ribavirin/pegylated interferon alfa administered alone or combined with a protease inhibitor OR -With decompensated cirrhosis and a contraindication or a serious intolerance to ribavirin OR -Who are waiting for an organ transplant or who have received a transplant and who have a contraindication or a serious intolerance to ribavirin.

8-24 weeks
Nova Scotia For treatment-naïve or treatment-experienced* adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: i) Treatment is prescribed by a hepatologist, infectious disease specialist or gastroenterologist ii) Laboratory confirmed hepatitis C genotype 1 iii) Laboratory confirmed quantitative HCV RNA level taken Genotype 1 -Treatment-naïve without cirrhosis, who have pre-treatment HCV RNA level < 6 million IU/mL and mono-HCV infected only: 8 weeks -Treatment-naïve without cirrhosis, who have pre-treatment HCV RNA in the last 6 months iv) Fibrosis stage must be provided For treatment-naïve or treatment-experienced*adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: i) Treatment is prescribed by a hepatologist, infectious disease specialist or gastroenterologist ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotype iii) Laboratory confirmed quantitative HCV RNA level taken in the last 12 months Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis under the formulary exception process.
All exception requests should include: -Lab-confirmed hepatitis C genotype -Quantitative HCV RNA value within the last 12 months -Fibrosis stage *Treatment-experienced is defined as those who have been previously treated with a PegIFN/RBV regimen (including regimens containing an HCV protease inhibitor), and have not experienced an adequate response.

NWT & Nunavut
For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: N/A I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced in treating hepatitis C II) Laboratory confirmed hepatitis C infection with genotype 1, 2, 3, 4, 5, 6, or mixed genotype; III) Laboratory confirmed quantitative HCV RNA value within the last 12 months *Retreatment or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis. . Special Authority requests for patients must include a fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan) and serum biomarker panels (AST-to-Platelet Ratio Index (APRI)) either alone or in combination. Supporting documentation must be submitted. b) Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other physicians experienced with treating hepatitis C c) Laboratory confirmed hepatitis C genotype 2 or 3 d) Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months e) Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug (with the exception of daclatasvir for genotype 3).

PEI, Newfoundland & Labrador
Genotype 2 Treatment-naïve and treatmentexperienced with no cirrhosis or with compensated cirrhosis: 12 weeks with RBV Genotype 3 Treatment-naïve and treatmentexperienced with no cirrhosis or with compensated cirrhosis: 24 weeks with RBV

Alberta
For use as combination therapy with ribavirin or daclatasvir for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; II) Laboratory confirmed hepatitis C genotype 2 or genotype 3; III) Laboratory confirmed quantitative HCV RNA value within the last 6-12 months; IV) Fibrosis stage of F0 or greater (Metavir scale or equivalent); Exclusion criteria for Alberta: -Patients currently being treated with another HCV antiviral agent -Retreatment for failure or re-infection in patients who have received an adequate prior course of an HCV direct-acting antiviral drug regimen may be considered on an exceptional case-by-case basis -Combination therapy with elbasvir/grazoprevir will not be considered -Treatment-naive or treatment experienced genotype 2, without cirrhosis or with compensated cirrhosis: 12 weeks with RBV -Treatment-naive or treatmentexperienced genotype 3, without cirrhosis: 12 weeks with daclatasvir -Treatment-naive or treatmentexperienced genotype 3, without cirrhosis or with compensated cirrhosis: 24 weeks with RBV

Saskatchewan
For use as combination therapy with ribavirin or daclatasvir for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; II) Laboratory confirmed hepatitis C genotype 2 or genotype 3; Genotype 2 -Treatment-naïve or treatment experienced: 12 weeks in combination with ribavirin Genotype 3 III) Laboratory confirmed quantitative HCV RNA value within the last 6 months (For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) or sofosbuvir in combination with daclatasvir (Daklinza) as one of the preferred therapeutic options over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa or Daklinza in combination with sofosbuvir offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections.) -Treatment-naïve or treatmentexperienced without cirrhosis: 12 weeks in combination with daclatasvir OR 24 weeks in combination with ribavirin -Treatment-naïve or treatmentexperienced with compensated or decompensated cirrhosis: 12 weeks in combination with daclatasvir and ribavirin OR 24 weeks in combination with ribavirin -Treatment-naïve or treatmentexperienced post liver transplant: 12 weeks in combination with daclatasvir and ribavirin *Combination therapy with elbasvir/grazoprevir (Zepatier) will not be considered for funding.

Manitoba
In combination with ribavirin or daclatasvir or both for treatment naïve/experienced (1) adult patients with chronic hep C (CHC) infection who meet ALL the following criteria: i) Treatment is prescribed by a hepatologist, gastroenterologist, or infectious disease specialist ii) Lab confirmed hep C genotype 2 or 3 iii) Patient has a quantitative HCV RNA value within the last 6 months iv) Fibrosis (2) stage of F2 or greater (Metavir scale or equivalent) As of April 2018. *For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) or sofosbuvir in combination with daclatasvir (Daklinza) as one of the preferred therapeutic options over sofosbuvir with ribavirin regimens for treatment of gen 2 or 3 patients only. *This recommendation is based on evidence that Epclusa or Daklinza in combo with sofosbuvir offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for gen 3 infections.

Ontario
For use as combination therapy with ribavirin or daclatasvir for treatment-naive or treatment-experienced adult patients with chronic hepatitis C infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; II) Laboratory confirmed hepatitis C genotype 2 or 3 III) Laboratory confirmed quantitative HCV RNA value within the last 6 months For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) or sofosbuvir in combination with daclatasvir (Daklinza) as one of the preferred therapeutic options over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa or Daklinza in combination with sofosbuvir offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections.
Genotype 2 -Treatment-naïve or treatmentexperienced: 12 weeks in combination with ribavirin (Ibavyr) Genotype 3 -Treatment-naïve or treatmentexperienced without cirrhosis: 12 weeks in combination with daclatasvir -Treatment-naïve or treatmentexperienced with compensated cirrhosis or decompensated cirrhosis or post-liver transplant: 12 weeks in combination with daclatasvir and ribavirin -Treatment-naïve or treatmentexperienced without cirrhosis, or with compensated cirrhosis or with decompensated cirrhosis or post-liver transplant: 24 weeks in combination with ribavirin Quebec In association with ribavirin and pegylated interferon alfa, for treatment of persons suffering from chronic hepatitis C genotype 1 or Authorization granted for 12-24 weeks 4, who are not HIV-1 infected and who have never received an anti-HCV treatment (12 weeks).
In association with ribavirin, for treatment of persons suffering from chronic hepatitis C genotype 2, who have never received anti-HCV treatment OR who have a contraindication or a serious intolerance to pegylated interferon alfa OR who have experienced therapeutic failure with an association of ribavirin/pegylated interferon alfa (12 weeks).
In association with ribavirin, for treatment of persons suffering from chronic hepatitis C genotype 3 who have a contraindication or a serious intolerance to pegylated interferon alfa OR who have already experienced therapeutic failure with an association of ribavirin/pegylated interferon alfa (24 weeks).
In association with daclatasvir, for treatment of persons suffering from chronic hepatitis C genotype 3 without cirrhosis who have a contraindication or a serious intolerance to pegylated interferon alfa or ribavirin OR who have experienced therapeutic failure with an association of ribavirin/pegylated interferon alfa (12 weeks).

Nova Scotia & New Brunswick
For treatment-naïve or treatment-experienced adult patients with chronic hepatitis C virus (HCV) who meet the following criteria: -Lab-confirmed hepatitis C genotype 2 and 3 -Quantitative HCV RNA value within the last 6 months -Fibrosis stage must be provided For treatment-naïve or treatment-experienced*adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: i) Treatment is prescribed by a hepatologist, infectious disease specialist or gastroenterologist ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotype iii) Laboratory confirmed quantitative HCV RNA level taken in the last 12 months Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis under the formulary exception process.   As monotherapy or in combination with ribavirin for treatment of persons suffering with chronic hepatitis C genotype 1 or 4 without decompensated cirrhosis.
Authorization is granted for 12-16 weeks.

Nova Scotia
For treatment-naïve or treatment-experienced adult patients with chronic hepatitis C virus (HCV) without cirrhosis or with compensated cirrhosis who meet the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; II)Laboratory confirmed hepatitis C genotype 1 or genotype 4; III) Laboratory confirmed quantitative HCV RNA value within the last 6 months IV) Fibrosis stage must be provided For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C infection who meet all of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or a designated prescriber; II)Laboratory confirmed hepatitis C genotype 1 or genotype 4; III) Laboratory confirmed quantitative HCV RNA value within the last 6 months IV) Fibrosis stage F2 or greater (Metavir scale or equivalent) or Genotype 1 -Treatment-naïve or treatmentexperienced prior relapsers: 12 weeks Genotype 1b -Treatment-experienced on-treatment virologic failures: 12 weeks Fibrosis stage less than F2 (Metavir scale or equivalent) and at least one of the following: -Co-infected with HIV or HBV -Post-organ transplant (liver and/or non-liver transplant) -Extra-hepatic manifestations -Chronic kidney disease stage 3, 4, or 5 as defined by the National Kidney Foundation Kidney Disease Outcomes Quality Initiative -Co-existent liver disease with diagnostic evidence of fatty liver disease (e.g. non-alcoholic steatohepatitis) -Patients with diabetes being treated with antihyperglycemic medications -Woman of childbearing age who is planning a pregnancy within the next 12 months Genotype 1a -Treatment-experienced on-treatment virologic failures: 16 weeks in combination with ribavirin Genotype 4 -Treatment-naïve or treatmentexperienced prior relapsers: 12 weeks -Treatment-experienced on-treatment virologic failures: 16 weeks in combination with ribavirin

Yukon
For treatment-naïve or treatment-experienced* adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: i) Treatment is prescribed by a hepatologist, infectious disease specialist or gastroenterologist ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotype iii) Laboratory confirmed quantitative HCV RNA level taken in the last 12 months Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis under the formulary exception process.
All exception requests should include: -Lab-confirmed hepatitis C genotype -Quantitative HCV RNA value within the last 12 months -Fibrosis stage *Treatment-experienced is defined as those who have been previously treated with a PegIFN/RBV regimen (including regimens containing an HCV protease inhibitor), and have not experienced an adequate response.

NWT & Nunavut
For adult patients with chronic hepatitis C infection at any fibrosis stage (F0-F4) who meet ALL of the following criteria: I) Prescribed by a hepatologist, gastroenterologist, infectious disease specialist, or other prescriber experienced in treating hepatitis C II) Laboratory confirmed hepatitis C infection with genotype 1, 2, 3, 4, 5, 6, or mixed genotype; III) Laboratory confirmed quantitative HCV RNA value within the last 12 months *Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antivirals will be considered on a case-by-case basis. include a fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan) and serum biomarker panels (AST-to-Platelet Ratio Index (APRI)) either alone or in combination. Supporting documentation must be submitted. b) Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist, or other physicians experienced with treating hepatitis C c) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, or 6 d) Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months at SVR12 or SVR24 e) Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug Laboratory-confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotypes iii)

Quebec
As monotherapy, for treatment of persons suffering from chronic hepatitis C, without decompensated cirrhosis, infected by: -Genotype 1, 2, 3, 4, 5, or 6 and having experienced a therapeutic failure with a treatment containing a NS5A inhibitor OR -Genotype 1, 2, 3, or 4 and having experienced a therapeutic failure with a sofosbuvir-based treatment, but without a NS5A inhibitor

weeks
New Brunswick For treatment-experienced adult patients with chronic hepatitis C virus (HCV) who meet the following criteria: Patients with compensated cirrhosis or without cirrhosis: 12 weeks -Must be prescribed by a hepatologist, gastroenterologist, or infectious disease specialist (or other physician experienced in treating a patient with hepatitis C infection) -Lab-confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6, or mixed genotype -Quantitative HCV RNA value within the last 6 months Treatment-experienced is defined as a patient who has been previously treated with an NS5A inhibitor for genotype 1, 2, 3, 4, 5, or 6 or sofosbuvir without an NS5A inhibitor for genotype 1, 2, 3, or 4 and who has not experienced an adequate response.