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Canadian Drug Review Reimbursement Decision


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  Victrelis
Generic Boceprevir
Company Merck Canada Inc.
Indication hepatitis C
Condition Infectious and parasitic diseases
Submission Type
Patient Population Boceprevir has a Health Canada indication for the treatment of chronic hepatitis C genotype 1 infection, in combination with PegIFNα/RBV in adult patients (18 years and older) with compensated liver disease, including cirrhosis, who are previously untreated or who have failed previous therapy. Boceprevir, a protease inhibitor, is available as 200 mg capsules and the Health Canada approved dose is 800 mg three times daily. The product monograph states that boceprevir should not be used as monotherapy, but only in combination with PegIFNα/RBV.
Status Complete
Date of Recommendation 2011-10-24
Recommendation Summary List with criteria/condition
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that boceprevir be listed, for the treatment of chronic hepatitis C genotype 1 infection in patients with compensated liver disease, in combination with peginterferon alpha (PegIFNα)/ribavirin (RBV), if all of the following criteria are met: • a reduced price • detectable levels of hepatitis C virus (HCV) RNA in the last six months • a fibrosis stage, based on liver biopsy, of F2, F3, or F4 • patient not co-infected with HIV • one course of treatment only (up to 44 weeks duration).
Reason for Recommendation 1. In three double-blind, randomized controlled trials (RCTs) comparing placebo (a capsule containing no active medication) with boceprevir, both used in combination with PegIFNa/RBV, a statistically significantly higher percentage of boceprevir-treated patients achieved a sustained virologic response (SVR). The benefit of boceprevir was seen both in patients who had not had treatment before, as well as in patients who had not improved enough, or who had worsened after improvement, on previous PegIFNa/RBV treatment. 2. At the submitted price, boceprevir costs between $25,200 and $46,200 for one 24- to 44-week course of therapy, not including the cost of PegIFNa/RBV or erythropoietin. There was considerable uncertainty around cost-effectiveness estimates for boceprevir. When conservative model inputs were considered, cost per quality-adjusted life-year (QALY) values for boceprevir increased in excess of $100,000 per QALY, particularly in patients with a low degree of liver fibrosis. Of Note: 1. The Committee noted that the cost of boceprevir greatly exceeds that of protease inhibitors used for other indications. 2. The Committee considered response-guided therapy to be more cost-effective than a full course of therapy (44 weeks of boceprevir) in patients for whom response-guided therapy is appropriate. 3. The Committee noted that the product monograph recommends discontinuation of therapy in all patients with: • HCV RNA levels ≥ 100 IU/mL at treatment week 12, or • Confirmed detectable HCV RNA levels at treatment week 24. 4. Patients with HIV infection were excluded from reviewed trials. 5. There are no RCTs which examine the clinical benefit of repeated courses of boceprevir in patients with chronic hepatitis C infection.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.


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