Limited Coverage Drugs – Ledipasvir-Sofosbuvir

Generic Name

ledipasvir-sofosbuvir (for use with or without ribavirin (RBV))

Strength

90 mg, 400 mg

Form

tablet

Special Authority Criteria

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

  1. Treatment is prescribed by a hepatologist, a gastroenterologist, an infectious disease specialist or other physicians experienced with treating hepatitis C; AND
  2. Laboratory confirmed hepatitis C genotype 12; 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 regimens for genotype 1 CHC adult patients:

 Approval Period

  • Treatment-naïve with no cirrhosis, who have pre-treatment HCV RNA level < 6 million IU/mL, and mono-HCV infected only.

8 weeks or 12 weeks8

OR

 

  • Treatment-naïve with no cirrhosis, who have pre-treatment HCV RNA level  ≥ 6 million IU/mL

12 weeks

OR

  • Treatment-naïve with compensated cirrhosis9

OR

  • Treatment-experienced1 with no cirrhosis

OR

 

  • Treatment-naïve or treatment-experienced1 HCV/HIV-1 co-infected with no cirrhosis or with compensated cirrhosis9

OR

 

  • Treatment-experienced1 with compensated cirrhosis9

24 weeks

OR

 

  • Treatment-naïve and treatment-experienced1 with decompensated cirrhosis10

12 weeks with RBV

OR

 

  • Treatment-naïve and treatment-experiencedliver transplant recipients with no cirrhosis or with compensated cirrhosis9

12 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—and who have 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 determined 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 must 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. For this population cohort, evidence has shown that the SVR rates with 8-week and 12-week treatment regimens are similar. Treatment regimens of up to 12 weeks are recognized by Health Canada as an approved treatment option. PharmaCare may consider 12‑ week coverage for patients with advanced liver fibrosis
  9. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).
  10. “Decompensated cirrhosis” is defined as cirrhosis with a CPS = B or C (7 or above). Special Authority requests for patients with decompensated cirrhosis must include clinical history or ultrasound imaging diagnosis, laboratory test reports and 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.

Practitioner Exemptions

  • None

Special Notes

  • Special Authority requests for re-treatment following direct-acting antiviral (DAA) treatment failures will be considered on exceptional case-by-case basis (see special notes below).  “Direct-acting antiviral treatment failure” is defined as a patient who has been previously treated with any combination of DAAs—including regimens containing NS3/4A protease inhibitors, NS5A inhibitors and NS5B inhibitors—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)

 
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