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Limited coverage drugs – ledipasvir-sofosbuvir

Last updated on January 26, 2023

Generic name

ledipasvir-sofosbuvir

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 past 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 another prescriber experienced with treating hepatitis C
    AND
  3. Laboratory-confirmed hepatitis C genotype 12
    AND
  4. Laboratory-confirmed quantitative HCV RNA test 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 and treatment-experienced1 HCV/HIV-1 co-infected with no cirrhosis or with compensated cirrhosis

12 weeks

Treatment-experienced1 with compensated cirrhosis5 ​

24 weeks

Treatment-naïve and treatment-experienced1 with decompensated cirrhosis6

12 weeks with RBV

OR

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

12 weeks with RBV

OR

12 weeks

Practitioner exemptions

  • None

Special 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 must include the most recent genotyping test report.
  3. Special Authority requests must include the most recent HCV RNA test performed in the past 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 past 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.

Additional information

Special Authority request form