Olysio (simeprevir) — Prior Authorization and Coverage Criteria
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Defines Amerigroup pharmacy coverage, prior authorization, quantity limits, approval durations, and clinical criteria for use of Olysio (simeprevir) in treatment of chronic hepatitis C in adults.
No material clinical or coverage changes in this revision.
Coverage Criteria for Olysio (simeprevir)
Approval Criteria
Covered when ALL of the following are met:
References: AASLD/IDSA 2017, CDC 2013
Prior trial excludes samples/coupons/discount cards.
Olysio (simeprevir) is not approved for certain uses. Requests will be denied when Olysio is used as monotherapy or when the individual has decompensated cirrhosis (see Child Pugh criteria). Use of Olysio in combination with sofosbuvir is not approved for individuals with severe or end‑stage chronic kidney disease (CKD) or those requiring dialysis unless otherwise specified. Requests that propose concurrent therapy with agents that are contraindicated or not recommended with the requested regimen (examples include amiodarone when combined with sofosbuvir, strong CYP inducers such as carbamazepine, phenytoin, phenobarbital, rifampin/rifapentine, or certain protease inhibitors and ritonavir‑boosted antiretrovirals) are excluded from coverage. Additionally, combinations that include another NS3/4A protease inhibitor, a non‑nucleoside NS5B polymerase inhibitor (e.g., dasabuvir), or a NS5A inhibitor are not approved.
Retreatment with a sofosbuvir‑containing regimen that includes Olysio is not approved when the individual previously failed to achieve a sustained virologic response (SVR) (HCV RNA lower limit ≥ 25 IU/mL) or relapsed after achieving SVR on a prior completed regimen that contained an NS3/4A protease inhibitor, an NS5B polymerase inhibitor (such as sofosbuvir or dasabuvir), an NS5A inhibitor, or after prior triple therapy. An exception to this retreatment exclusion is when the request is for retreatment following a post‑liver allograft transplant.
Provider Requirements, Prior Authorization, and Denial Triggers
Prior authorization required; quantity limit = 1 capsule/day
Prior authorization is required for Olysio (simeprevir). A quantity limit of 1 capsule per day applies; approval duration is determined by genotype, treatment status, cirrhosis and transplant status (commonly 12 weeks for the listed regimens).
- Quantity Limit = 1 capsule per day
- Approval duration based on genotype, treatment status, cirrhosis and transplant status (commonly 12 weeks for listed regimens)
Prior trial required: inadequate response to Epclusa or Mavyret
Approval for many Olysio-containing regimens requires documentation of a prior trial and inadequate response to authorized generic Epclusa (sofosbuvir/velpatasvir) OR Mavyret, unless an exception applies (e.g., currently completing the regimen, documented hypersensitivity to preferred agents, or inability to substitute due to contraindicated concomitant therapy).
- Medication samples/coupons/discount cards are excluded from consideration as a prior trial
- Exceptions: currently completing therapy; documented severe hypersensitivity to Epclusa or Mavyret ingredients; concurrent use of an agent that cannot be substituted or temporarily discontinued and is contraindicated with preferred regimens
Required clinical documentation and eligibility info
Providers must submit documentation showing the diagnosis of chronic hepatitis C with genotype and a positive HCV RNA result, confirm the individual is ≥18 years old, and document compensated liver disease and life expectancy and substance-abuse program enrollment when applicable.
- Diagnosis of chronic hepatitis C (CHC) including genotype and positive HCV RNA result
- Individual is 18 years of age or older
- Evidence of compensated liver disease (with or without cirrhosis)
- Documentation individual does not have short life expectancy (<12 months) from non-liver comorbid conditions that cannot be remediated
- If individual abuses alcohol or IV drugs, documentation of enrollment in a substance abuse program
Common denial triggers — therapy, liver and renal contraindications, and drug interactions
Requests may be denied for common, policy-specified reasons including use of Olysio as monotherapy, presence of decompensated cirrhosis, or use with sofosbuvir in individuals with severe or end-stage CKD or on dialysis; concurrent use with listed contraindicated agents or combining with other NS3/4A protease inhibitors or disallowed antiviral classes may also trigger denial.
- Use of Olysio as monotherapy
- Individual has decompensated cirrhosis
- Use with sofosbuvir in individuals with severe (Stage 4) or end-stage (Stage 5) CKD or who require dialysis
- Concurrent therapy with contraindicated/not recommended agents (examples listed in policy: amiodarone with sofosbuvir; strong CYP inducers/inhibitors; certain protease inhibitors; many antiretrovirals)
- Use in combination with another NS3/4A protease inhibitor, NS5A inhibitor, or a non-nucleoside NS5B polymerase inhibitor
Clinical Scores and Coding Definitions
Definitions and Abbreviations
Background on Olysio (simeprevir)
Olysio (simeprevir) is an NS3/4A protease inhibitor indicated for use as part of combination antiviral regimens to treat chronic hepatitis C virus (HCV) infection in adults. It is used alongside other direct‑acting antivirals (and, in some regimens, ribavirin) rather than as a single agent; testing and appropriate monitoring as recommended by AASLD/IDSA guidance should be followed when treating HCV.
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