simeprevir (Olysio®)

ORAL ADMINISTRATION

Indications for Prior Authorization:

  • Treatment of chronic hepatitis C genotype 1a or 1b only

All of the following must be met as a condition for coverage:

  • Must not be used as monotherapy
  • Must be used with interferon alfa
  • Must screen for NS3 Q80K polymorphism at baseline
    • Treatment failure associated with HCV resistance to newly developed direct-acting antiviral agents is not an uncommon occurrence and poses a substantial problem to clinicians trying to re-treat patients who have failed available interferon-free treatments.
  • Must have compensated liver disease by ultrasound or biopsy stage F2, F3 or F4
  • Must have FDA recognized contraindication to Zepatier, Viekira Pak and Harvoni for approval

This Medication is Not Approvable for the following condition(s):

  • Hepatitis C with NS3 Q80k polymorphism
  • Any condition not listed above as an approved indication

Duration of Therapy:

Genotype 1

  • simeprevir + interferon alfa + ribavirin for 12 weeks
  • then continue interferon alfa + ribavirin for an additional 12 weeks

Genotype 1 prior partial or non-responders

  • simeprevir + interferon alfa + ribavirin for 12 weeks
  • then continue interferon alfa + ribavirin for an additional 36 weeks

Dosing:

  • 150 mg po daily with food

Discontinuation Schedule:

  • HCV/RNA > 25 IU/ml       at week 4                           discontinue all medications
  • HCV/RNA > 25 IU/ml       at week 12 or 24               discontinue interferon alfa + ribavirin

 

Last review date: March 2, 2015

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