Harvoni (sofosbuvir/ledipasvir) coverage
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Defines prior authorization, approval durations, and clinical criteria for covering Harvoni (sofosbuvir/ledipasvir) for treatment of chronic hepatitis C in eligible members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Harvoni (sofosbuvir/ledipasvir)
Initial Therapy and Indication-specific Criteria
Covered when ALL of the following are met (and then one of the listed regimen-specific pathways applies):
AASLD/IDSA 2017 referenced
See regimen‑specific nodes in policy chunks
Medication samples/coupons/discount cards are excluded from consideration as a trial
Initial and scenario-specific coverage criteria
Covered when the following genotype/clinical conditions AND prior therapy conditions are met (with listed exceptions):
See chunks 18–21 for specific numbered scenarios (eg. dual P/R 2b treatment‑experienced with compensated cirrhosis and Genotype 4; decompensated cirrhosis across genotypes 1,4,5,6; post‑liver transplant recipients).
Approval of Harvoni requires documentation of chronic hepatitis C infection including genotype and a positive HCV RNA result. In addition, the individual must not have a short life expectancy (<12 months) due to non-liver comorbid conditions that cannot be remediated by treating HCV, transplantation, or other directed therapy. If an 8‑week treatment duration is requested, provide the baseline quantitative HCV RNA to document viremia. Enrollment in a substance abuse program is required for individuals who abuse alcohol or intravenous drugs, and the individual’s liver disease status (compensated or decompensated) must be documented.
Requests may be denied or not approved for individuals with certain comorbid conditions or medication conflicts. Specifically, approval may be precluded for individuals with severe or end-stage CKD (stage 4 or requiring dialysis), for those concurrently using contraindicated or not‑recommended agents (examples include amiodarone; strong CYP/P‑gp inducers such as rifabutin, rifampin, rifapentine, St John’s Wort; certain antiretrovirals and statins listed); for those using incompatible DAA combinations (e.g., non‑nucleoside or duplicate NS5B/NS5A/NS3‑containing regimens); or when re‑treatment is requested after failure to achieve sustained virologic response (SVR defined as HCV RNA above the lower limit of 25 IU/mL) following prior NS5A‑containing therapy. Documented hypersensitivity to comparator agents that is not shared with Harvoni or inability to substitute/temporarily discontinue a concomitant contraindicated agent are recognized exceptions.
Initial Therapy Criteria and Pathways
Initial therapy criteria
Initial therapy coverage pathways by genotype and treatment history
Initial therapy criteria — prior trial requirement
Initial coverage requires prior trial and inadequate response to preferred agents for many scenarios
Medication samples/coupons/discount cards excluded from consideration as a trial.
Continuation of Therapy and Exceptions
Continuation of current therapy
Continuation and exceptions
Continuation therapy — exceptions
Continuation/ongoing therapy exceptions to prior trial requirement
Step Therapy Requirements
| Coverage requirement | Exceptions |
|---|---|
| Prior trial of authorized generic Epclusa (sofosbuvir/velpatasvir) OR Mavyret with documented inadequate response is required for many indications before Harvoni will be approved. | |
| Exceptions to the prior-trial requirement: currently on and completing the requested regimen; documented hypersensitivity to Epclusa or Mavyret ingredients not shared with Harvoni; concurrent use of an agent that cannot be substituted or temporarily discontinued and is contraindicated/not recommended with the preferred regimens. |
| Requirement for Harvoni approval | Allowed exceptions |
|---|---|
| Prior trial and inadequate response to authorized generic Epclusa (sofosbuvir/velpatasvir) OR Mavyret is required before approval of Harvoni in the indicated genotype and clinical scenarios. | |
| Exceptions: member is currently on and completing the requested regimen; documented severe allergic reaction to Epclusa or Mavyret components that are not in Harvoni; or concurrent use of an agent that cannot be substituted/temporarily stopped and is contraindicated with preferred agents. |
Provider Actions, Documentation, and Denial Risks
Prior authorization required; quantity limit = 1 tablet/day
Prior authorization is required for Harvoni and is subject to a quantity limit of 1 tablet per day; approval is contingent on meeting the policy’s clinical criteria including documented diagnosis, genotype, positive HCV RNA, and relevant treatment history.
- Quantity limit: 1 tablet per day
- Approval contingent on meeting listed clinical criteria (diagnosis, genotype, HCV RNA, treatment history)
Prior authorization requires prior trial of preferred agents
Prior authorization requests must demonstrate prior trial and inadequate response to authorized generic Epclusa (sofosbuvir/velpatasvir) or Mavyret for most genotype and clinical scenarios, unless a stated exception applies (currently completing the requested regimen, documented hypersensitivity, or an unavoidable contraindicated concomitant agent).
- Demonstrate prior trial and inadequate response to authorized generic Epclusa OR Mavyret
- Exceptions: currently completing therapy; documented hypersensitivity to preferred agents not shared with Harvoni; concurrent contraindicated agent that cannot be substituted or stopped
Step requirement: prior trial of Epclusa or Mavyret (exceptions apply)
Many indications require a prior trial and inadequate response to a preferred agent (authorized generic Epclusa or Mavyret) before Harvoni will be approved; exceptions include individuals currently completing the requested regimen, documented hypersensitivity to the alternatives, or concurrent use of an agent that cannot be substituted and is contraindicated with preferred regimens.
- Medication samples/coupons/discount cards are excluded from consideration as a prior trial
- Exceptions: currently completing therapy; hypersensitivity to comparator not shared with Harvoni; unavoidable contraindicated concomitant therapy
Harvoni subject to step therapy vs preferred agents
Harvoni is generally non-preferred and approval commonly requires evidence of prior trial and inadequate response to preferred agents (authorized generic Epclusa or Mavyret) except where the policy lists explicit exceptions.
- Harvoni approval contingent on prior trial/inadequate response to preferred agents in many scenarios
- Policy lists specific exceptions to the step requirement
Document CHC diagnosis, genotype, and baseline HCV RNA for 8‑week requests
Provide documentation of chronic hepatitis C infection that includes the HCV genotype and a positive HCV RNA; if an 8‑week duration is requested, include the baseline quantitative HCV RNA result to document baseline viremia.
- Documented chronic hepatitis C diagnosis including genotype and positive HCV RNA
- If requesting 8‑week regimen, submit baseline quantitative HCV RNA test result
Provide documentation for prior-therapy exceptions
When requesting an exception to the prior-therapy requirement, submit documentation showing the prior trial and inadequate response to the preferred alternatives (authorized generic Epclusa [sofosbuvir/velpatasvir] and/or Mavyret), or evidence supporting an applicable exception (current completion of therapy, hypersensitivity, or an unavoidable contraindicated concomitant agent).
- Documentation of prior trial and inadequate response to Epclusa and/or Mavyret when required
- Or documentation supporting an exception: currently completing therapy; documented hypersensitivity to comparator not shared with Harvoni; concurrent contraindicated agent that cannot be stopped or substituted
Denial risk: missing CHC diagnosis or HCV RNA/genotype
Lack of documentation confirming chronic hepatitis C infection (including genotype and a positive HCV RNA) may result in denial of the Harvoni request.
- Must document CHC with genotype and positive HCV RNA to avoid denial
Denial risk: missing prior-trial/inadequate-response documentation
Failure to document a prior trial and inadequate response to authorized generic Epclusa (sofosbuvir/velpatasvir) or Mavyret when the policy requires it may lead to denial of the request unless a policy exception is documented.
- If prior-trial requirement applies, must show trial and inadequate response to Epclusa OR Mavyret
- Document any applicable exception (current therapy completion, hypersensitivity, or unavoidable drug interaction) to avoid denial
Common denial triggers: CKD, contraindicated drugs, incompatible DAA use, prior NS5A failure
Requests may be denied for individuals with severe or end-stage chronic kidney disease (stage 4 or requiring dialysis), for concurrent use with listed contraindicated or not-recommended agents, for use with incompatible DAA combinations, or for re-treatment if prior NS5A-containing therapy failed to achieve SVR (HCV RNA > lower limit of 25 IU/mL) or relapse occurred.
- CKD: severe or end‑stage CKD (stage 4) or dialysis may preclude approval
- Contraindicated concomitant agents (e.g., amiodarone; strong CYP/P‑gp inducers like rifampin, St John's Wort; certain antiretrovirals or statins) may cause denial
- Incompatible DAA combinations or prior NS5A failure/relapse (SVR threshold: HCV RNA 25 IU/mL) are denial triggers
Coding and Virologic Thresholds
Definitions and Diagnostic Requirements
Quantity Limits for Harvoni
Background
Chronic hepatitis C (CHC) management requires confirmation of diagnosis by genotype and a positive HCV RNA prior to selecting antiviral therapy. Harvoni (ledipasvir/sofosbuvir) is an oral direct‑acting antiviral regimen used across multiple genotypes and clinical scenarios; approval is contingent on meeting diagnostic requirements, documenting baseline viremia when shorter courses are requested, and confirming that life expectancy and concomitant conditions do not preclude benefit from therapy.
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