OLYSIO (simeprevir)

OLYSIO (simeprevir)

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
• Trial and failure of preferred agent(s) Epclusa, Harvoni, Vosevi

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