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. Fibrosis stage of  F0 or greater (Metavir scale or equivalent);
    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 (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 physicians experienced with treating hepatitis C;

    AND
     
  3. Laboratory confirmed hepatitis C genotype 12;

    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 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

8 weeks or 12 weeks4

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

OR

Treatment-naïve with compensated cirrhosis5

OR

Treatment-experienced1 with no cirrhosis

OR

Treatment-naïve or treatment-experienced1 HCV/HIV-1 co-infected with no cirrhosis or with compensated cirrhosis5

12 weeks

Treatment-experienced1 with compensated cirrhosis5

24 weeks

Treatment-naïve and treatment-experienced1 with decompensated cirrhosis6

OR

Treatment-naïve and treatment-experienced1  liver transplant recipients with no cirrhosis or with compensated cirrhosis5

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 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 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. 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
     
  5. “Compensated cirrhosis” is defined as cirrhosis with a Child Pugh Score (CPS) = A (5-6).
     
  6. “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 (AST-to-Platelet Ratio Index (APRI)) either alone or in combination. Supporting documentation must be submitted.

Practitioner Exemptions

  • None

Special Notes

  • None

Additional Information

Special Authority Request Form(s)