Limited Coverage Drugs – Ledipasvir-Sofosbuvir

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:

A. 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

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

AND

C. Laboratory confirmed hepatitis C genotype 12;

AND

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

AND

E. 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

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;

OR

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

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.

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