Limited Coverage Drugs – elbasvir-grazoprevir

Generic Name

elbasvir-grazoprevir (for use with or without ribavirin (RBV))

Strength

50 mg, 100 mg

Form

tablet

Special Authority Criteria

For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1 or 4 infection who meet ALL the following criteria:

  1. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist or other physician experienced with treating hepatitis C; AND
  2. Laboratory confirmed hepatitis C genotype 1 or 42; AND
  3. Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months3; AND
  4. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug; AND
  5. Fibrosis stage of  F2 or greater (Metavir scale or equivalent)4; OR

    Fibrosis stage less than F2 (Metavir scale or equivalent)4 AND at least one of the following:
  • Co-infection with HIV or hepatitis B virus
  • Post organ transplant (liver and/or non-liver organ transplant)
  • Extra-hepatic manifestations5
  • Chronic kidney disease stage 3, 4 or 5 as defined by National Kidney Foundation Kidney Disease outcomes Quality Initiative6
  • Co-existent liver disease with diagnosis evidence for fatty liver disease (e.g., non-alcoholic steatohepatitis)7
  • Diabetes receiving treatment with anti-diabetic drugs
  • Women who are planning pregnancy within the next 12 months

Treatment regimen for genotype 1 CHC adult patients with:

Approval Period

  • Treatment-naïve with no cirrhosis or with compensated cirrhosis8
12 weeks9

OR

  • Treatment-experienced (prior relapsers10) with no cirrhosis or with compensated cirrhosis8

OR

  • Genotype 1b treatment-experienced (on-treatment virologic failures10) with no cirrhosis or with compensated cirrhosis8

OR

 
  • Genotype 1a treatment-experienced (on-treatment virologic failures10) with no cirrhosis or with compensated cirrhosis8
16 weeks with RBV

Treatment regimen for genotype 4 CHC adult patients with:

 
  • Treatment-naïve with no cirrhosis or with compensated cirrhosis8

12 weeks

OR

  • Treatment-experienced (prior relapsers10) with no cirrhosis or with compensated cirrhosis8

OR

 
  • Treatment-experienced (on-treatment virologic failures11) patients with no cirrhosis or with compensated cirrhosis8
16 weeks with RBV

NOTES:

  1. “Treatment-experienced” is defined as a patient who has been previously treated with PegIFN/RBV regimen—including regimens containing HCV protease inhibitors (for genotype 1) —and who has not experienced adequate response.
  2. Special Authority requests for patients must include the most recent genotyping test report. ALL patients who had their genotype 1 subtype prior to May 1, 2012 will require a repeat genotyping test, based on information from BC Center for Disease Control (BCCDC). HCV genotype tests for genotype 1, performed after May 1, 2012, involved a different technology that improves the accuracy of the subtyping result.
  3. Special Authority requests for patients must include the most recent HCV RNA test performed in the last 12 months.
  4. Special Authority requests for patients include a fibrosis score test performed in the last 12 months. Acceptable methods include liver biopsy, transient elastography (FibroScan®) and serum biomarker panels (such as AST-to-Platelet Ratio Index (APRI) or Fibrosis-4 (FIB-4) score) either alone or in combination. Supporting documentation must be submitted.
  5. “Extra-hepatic manifestation” includes but is not limited to: symptomatic vasculitis associated with HCV-related mixed cryoglobulinemia, HCV immune complex-related nephropathy and non-Hodgkin B cell lymphoma, porphyria cutanea tarda and glomerulonephritis. Supporting documentation must be submitted.
  6. “Chronic kidney disease” stage 3, 4 or 5 will include patients with glomerular filtration rate (GFR) <60 mL/min/1.73m2 for >=3 months.
  7. Special Authority requests for patients with fibrosis stage less than F2 and fatty liver disease must include a confirmation that ultrasound imaging has been done with diagnosis of fatty liver disease. Additional diagnostic report or document may be requested.
  8. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).
  9. As approved by Health Canada, 8 weeks may be considered in treatment-naïve genotype 1b patients without significant fibrosis or cirrhosis as determined by liver biopsy (i.e., Metavir F0-F2) or by non-invasive tests.
  10. “Treatment-experienced prior relapser” is defined as a patient who has undetectable HCV RNA at the end of previous peginterferon/ribavirin (PegIFN/RBV) therapy, including regimens containing NS3/4A protease inhibitors (for genotype 1), but with a subsequent detectable HCV RNA during follow-up.
  11. “Treatment-experienced on-treatment virologic failure” is defined as a patient who has been previously treated with PegIFN/RBV regimen—including regimens containing HCV protease inhibitors (for genotype 1) —and who has not experienced adequate response, including a null response, partial response or virologic breakthrough or rebound.

Practitioner Exemptions

  • None

Special Notes

  • Special Authority requests for re-treatment for direct-acting antiviral (DAA) treatment failures will be considered on exceptional case-by-case basis. “Direct-acting antiviral treatment failure” is defined as a patient who has been previously treated with any combination of DAA regimen—including regimens containing  NS3/4A protease inhibitors, NS5A inhibitors and NS5B inhibitors—and who has not experienced adequate response. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews all requests for coverage of exceptional cases.

Additional information

Special Authority Request Form(s)