Limited Coverage Drugs – Asunaprevir

Generic Name

asunaprevir (for use in combination with daclatasvir (Daklinza™))

Strength

asunaprevir: 100 mg

Form

tablet

Special Authority Criteria

For the treatment of treatment-naïve or treatment-experienced1 adult patients with chronic hepatitis C (CHC) genotype 1b 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 1b2; 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 (with the exception to daclatasvir); 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 regimens for genotype 1b CHC adult patients:

Approval Period

  • Treatment-naïve and treatment-experienced1 patients with no cirrhosis or with compensated cirrhosis8

24 weeks in combination with daclatasvir

NOTES:

  1. “Treatment-experienced” is defined as a patient who has been previously treated with PegIFN/RBV regimen and who has not experienced adequate response. Treatment-experienced based on previous treatment regimens containing HCV protease inhibitors will not be covered.
  2. Special Authority requests for patients must include the most recent genotyping test. ALL patients who had their genotype 1 subtype determined prior to May 1, 2012, will require a new 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 must include the most recent HCV RNA test report done performed in the last 12 months.
  4. Special Authority requests for patients must include a fibrosis score test report done within the previous 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).

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 have 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)