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. Fibrosis stage of  F0 or greater (Metavir scale or equivalent);

    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 (AST-to-Platelet Ratio Index (APRI)) either alone or in combination.  Supporting documentation must be submitted.

    AND
     
  2. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist or other physician experienced with treating hepatitis C;

    AND
     
  3. Laboratory confirmed hepatitis C genotype 12 or 4;

    AND
     
  4. Laboratory confirmed quantitative HCV RNA test must be done within the previous 12 months3;|

    AND
     
  5. Patient is NOT currently being treated with another hepatitis C direct-acting antiviral drug;

Treatment regimen for genotype 1 CHC adult patients with:

Approval Period

Treatment-naïve with no cirrhosis or with compensated cirrhosis4

OR

Treatment-experienced (prior relapsers6) with no cirrhosis or with compensated cirrhosis4

OR

Genotype 1b treatment-experienced (on-treatment virologic failures7) with no cirrhosis or with compensated cirrhosis4

12 weeks5

Genotype 1a treatment-experienced (on-treatment virologic failures7) with no cirrhosis or with compensated cirrhosis4

16 weeks with RBV

Treatment regimen for genotype 4 CHC adult patients with:

 

Treatment-naïve with no cirrhosis or with compensated cirrhosis4

OR

Treatment-experienced (prior relapsers6) with no cirrhosis or with compensated cirrhosis4

12 weeks

Treatment-experienced (on-treatment virologic failures7) patients with no cirrhosis or with compensated cirrhosis6

16 weeks with RBV

 

NOTES:

  1. “Treatment-experienced” is defined as patients who have been previously treated with PegIFN/RBV regimen—including regimens containing HCV protease inhibitors (for genotype 1) —and who have relapsed or not responded.  
     
  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 genotype1, 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. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).
     
  5. 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.
     
  6. “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.
     
  7. “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

  • None

Additional information

Special Authority Request Form(s)