Ledipasvir/sofosbuvir (Harvoni) — Coverage and Dosing
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Medical Mutual - Ohio policy governing prior authorization, dosing, and coverage criteria for ledipasvir/sofosbuvir (Harvoni and authorized generics) for treatment of chronic hepatitis C virus (HCV) in pediatric and adult patients.
No material clinical or coverage changes in this revision.
Recommended Authorization Criteria
Chronic HCV — Genotype 1 (authorization durations)
Approve for the duration noted if the patient meets ALL of the following (A, B, and C):
B: Treatment and clinical criteria determining duration
- i (8 weeks): Patient is treatment-naïve; does not have cirrhosis; does not have HIV; is not awaiting liver transplantation; AND baseline HCV RNA < 6 million IU/mLHCV RNA < 6 million IU/mL
Subcriteria a–e required
- ii (12 weeks): Patient meets ONE of: (a) treatment-naïve who does not meet Bi (includes treatment-naïve with compensated [Child-Pugh A] cirrhosis regardless of baseline HCV RNA, or treatment-naïve without cirrhosis and baseline HCV RNA ≥ 6 million IU/mL); OR (b) previously treated and does not have cirrhosis; OR (c) decompensated (Child-Pugh B or C) cirrhosis and is ribavirin-eligible (medication prescribed with ribavirin)
See document for detailed subgroup notes
- iii (24 weeks): Patient meets ONE of: (a) previously treated with compensated (Child-Pugh A) cirrhosis; OR (b) treatment-naïve or previously treated with decompensated (Child-Pugh B or C) cirrhosis AND is ribavirin-ineligible per prescriber (medication to be prescribed as indicated)
Prescriber to assess ribavirin ineligibility
Chronic HCV — Genotype 4, 5, or 6
Approve for 12 weeks if ALL of the following are met:
Recurrent HCV Post-Liver Transplant — Genotypes 1 or 4
Approve for 12 weeks if ALL of the following are met:
Other supported uses — selected transplant and renal transplant recipients
Approvals for select post-transplant and kidney transplant recipients when criteria met:
Approve for 12 weeks
Approve for 12 weeks
Continuation/Completion of therapy
Patients already started on ledipasvir/sofosbuvir
Approve duration described above to complete prescribed course
Ledipasvir/sofosbuvir is not recommended for use in combination with any other direct-acting antiviral (DAA) regimen that does not include ribavirin. The policy states that ledipasvir/sofosbuvir provides a complete antiviral regimen and should not be combined with other products containing sofosbuvir or additional DAAs for the same course of therapy.
Treatment with ledipasvir/sofosbuvir is not recommended for pediatric patients younger than 3 years of age because safety and efficacy have not been established in this population.
Retreatment using ledipasvir/sofosbuvir in patients who have previously received ledipasvir/sofosbuvir (including prior null responders, prior partial responders, prior relapsers, or patients who did not complete a prior course) is not recommended. The policy notes that alternative direct-acting antivirals exist for patients previously treated with ledipasvir/sofosbuvir.
Coverage is not recommended for circumstances that are not explicitly listed in the Recommended Authorization Criteria. The policy will be updated as new published data become available; only the listed indications and scenarios meet the criteria for approval.
Initial Authorization Criteria
Initial therapy criteria
Initial authorization criteria for ledipasvir/sofosbuvir
Detailed subcriteria determine exact duration
Continuation / Completion Criteria
Completion of therapy
Patients already started on ledipasvir/sofosbuvir
Lab, Diagnostic, and Coding Details
Prescriber and Prior Authorization Requirements
Prior authorization and specialist prescriber required
Prior authorization is recommended for pharmacy benefit coverage of ledipasvir/sofosbuvir. Initial approval requires the medication be prescribed by or in consultation with a physician who specializes in the condition being treated.
Subject to preferred specialty DAA management
Ledipasvir/sofosbuvir is managed under the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy; step edits or preferred-agent placement among DAAs may apply.
Additional documentation may be requested
The Company may request additional documentation to support medical necessity and coverage determinations; providers must make requested materials available.
- Documentation may include patient records, relevant test results, and credentials of the provider ordering or performing the service.
- Provide requested documentation promptly to avoid delays in coverage determination.
Denial triggers and reimbursement risks
The Company may deny reimbursement when the drug or services are not medically necessary, are investigational/experimental, are outside the member's benefits, or when inappropriate or excessive billing patterns are identified.
- Denial may follow if requested documentation does not support medical necessity.
- Services outside the scope of member benefits or experimental uses are denial triggers.
- Patterns of inappropriate or excessive billing may result in denial.
Step Therapy / Placement
| Step | Requirement / note |
|---|---|
| Subject to Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy | |
| Ledipasvir/sofosbuvir is managed under the payer's preferred specialty management policy for HCV DAAs; placement or step edits among direct-acting antivirals may apply per that policy (prior authorization recommended). |
Key Terms and Definitions
Background and Indications
Ledipasvir/sofosbuvir is a fixed-dose combination antiviral that pairs an HCV NS5A inhibitor (ledipasvir) with a NS5B nucleotide polymerase inhibitor (sofosbuvir). It provides a complete oral antiviral regimen for chronic hepatitis C and, per this policy, should be used according to the specified authorization criteria (age thresholds, genotype-specific durations, cirrhosis and transplant considerations).
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