Limited Coverage Drugs - Simeprevir

Generic Name / Strength / Form

simeprevir in combination with peginterferon/ribavirin (PegIFN/RBV)

Special Authority Criteria Approval Period
For the treatment of chronic hepatitis C genotype 1 in patients with no cirrhosis or with compensated cirrhosis1 in:
  • treatment-naive patients

 

OR

 

  • treatment-experienced2 patients who are prior relapsers

 

OR

 

  • treatment experienced2 patients who are partial responders or null responders

AND

Who meet ALL of the following criteria:

  1. Prescribed by a gastroenterologist or an infectious disease specialist or other physicians experienced with treating hepatitis C
  2. Lab-confirmed hepatitis C genotype 1
  3. Lab-confirmed for NS3 Q80K polymorphism negative for patients with hepatitis C genotype 1a subtype or genotype 1 with indeterminate subtype. ALL patients who had their genotype 1 subtype prior to May 1, 2012 will require a new genotyping test (see Note #3 below)
  4. Patient has a quantitative HCV RNA value within the last 6 months
  5. Fibrosis stage F2 or greater (Metavir scale or equivalent). 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
  6. Patient has NOT previously been treated with a HCV NS3/4A protease inhibitor
  7. Patient NOT currently treated with NS5A/NS5B inhibitor

NOTE:

  1. Compensated cirrhosis is defined as cirrhosis with a Child Pugh Score =A (5-6)
  2. For treatment-experienced patients: Prior relapsers are defined as those with undetectable HCV RNA at the end of previous peginterferon/ribavirin (PegIFN/RBV) therapy but with a subsequent detectable HCV RNA during follow-up. Partial responders are defined as those with a decrease of HCV RNA ≥ 2-log10 IU/ml from baseline at week 12 on previous PegIFN/RBV therapy and detectable HCV RNA at the last measurement on treatment. Null responders are defined as those with a decrease in HCV RNA of < 2-log10 IU/ml from baseline at week 12 on previous PegIFN/RBV therapy and detectable HCV RNA at the last measurement on treatment.
  3. Based on information from BC Center for Disease Control (BCCDC) genotyping tests performed prior to May 1, 2012 will need to be repeated. HCV genotype tests performed after May 1, 2012 involved a different technology that improves the accuracy of the subtyping result. NS3 Q80K resistance testing should be requested on all genotype 1a and/or genotype 1 with indeterminate subtype. Alternatively the NS3 Q80K resistance test can be ordered directly.
  4. The treatment Futility Rule applies for ALL patients. If the patient has HCV RNA results ≥ 25 IU/mL at treatment week 4, then discontinue ALL treatment, or if the patient has confirmed detectable HCV RNA at treatment week 12 or 24, then discontinue PegIFN/RBV (treatment with simeprevir is complete at week 12).
  5. Re-treatment requests will NOT be considered.

 

For treatment naïve or prior relapsers: 12 weeks of simeprevir in combination with PegIFN/RBV and an additional 12 weeks of only PegIFN/RBV for patients with undetectable HCV RNA at week 4 or an additional 36 weeks of only PegIFN/RBV for patients with < 25 IU/mL detectable HCV RNA at week 4

 

For partial responders or null responders: 12 weeks of simeprevir in combination with PegIFN/RBV and an additional 36 weeks of only PegIFN/RBV for patients with undetectable or < 25 IU/mL detectable HCV RNA at week 4

Practitioner Exemptions

  • None

Special Notes

  1. In exceptional cases, requests that do not meet established criteria may receive special consideration for coverage if the physician provides additional documentation of disease progression and/or for other patient-specific considerations. The Hepatitis Drug Benefit Adjudication Advisory Committee reviews exceptional case submissions.

Additional information:

Special Authority Request Form(s)