Ledipasvir/Sofosbuvir (Harvoni) — Coverage Criteria
Customize your policy alerts
Sign up for Peach State Health Plan Policy GA.PMN.13 alerts
Get alerted when Policy GA.PMN.13 changes without checking for updates manually.
Monitor payer policy activity
Defines medical necessity, prior authorization requirements, and approval criteria for Harvoni for Peach State Health Plan Medicaid members, including age, genotype, cirrhosis, and alternative-preferred therapy requirements.
Revised policy/criteria section to also include generic ledipasvir/sofosbuvir and removed qualifier of 'chronic' from HCV criteria.
Added Appendix F describing management recommendations for incomplete adherence and treatment interruptions per AASLD-IDSA.
Added unacceptable rationale for not using preferred Epclusa within criteria and added 'clinical documentation required' to initial criteria.
Coverage Criteria
inv-01: Approval Criteria — Hepatitis C Infection (initial)
Harvoni is medically necessary when ALL of the following are met:
Chart note documentation and copies of lab results are required; see Section V and Appendix E for dosing/contraindications.
inv-02: Required use of preferred alternatives before Harvoni
Prior to authorization of Harvoni, the following step requirement must be satisfied:
See Appendix E for acceptable medical justifications and documentation requirements.
inv-03: Coverage criteria by indication
Coverage and dosing are determined by genotype, age/weight, cirrhosis status, and treatment history; preferencing to other DAAs applies where noted.
Refer to Appendix E dosing tables for exact weight/age thresholds and formulation selection.
Pre-treatment quantitative HCV RNA must be documented within the last 6 months.
Post-liver transplant and decompensated cirrhosis dosing considerations are in Appendix E.
inv-04: Preferred-agent bypass rules
Preferencing and medically acceptable justifications
Appendix E lists details and examples of acceptable justifications.
See Appendix E for unacceptable rationales and examples.
If Harvoni is prescribed in combination with ribavirin, all contraindications to ribavirin also apply to the combined Harvoni + ribavirin regimen. This includes, among others, pregnancy or possible pregnancy, significant hemoglobinopathy, hemoglobin below safety thresholds, coadministration with didanosine, unstable or significant cardiac disease, hypersensitivity to ribavirin, and any other contraindication listed for ribavirin in Appendix C.
Post–liver transplant patients are excluded from coverage under this policy unless the prescribed Harvoni regimen specifically designates a post-transplant dosing and indication. Authorization for post-transplant use will only be considered when the regimen and dosing explicitly indicate post-transplant management in the regimen tables or supporting Appendix guidance.
Use of non-preferred agents when preferencing requirements apply may be considered not medically necessary if there is no acceptable medical justification and if the required clinical documentation is not provided. The policy requires trial of preferred products (Mavyret or sofosbuvir/velpatasvir [Epclusa authorized generic]) unless the member has documented clinically significant adverse effects or contraindications to those agents. If both preferred agents are intolerable or contraindicated, an authorized generic Harvoni must be tried before brand Harvoni unless an acceptable justification is documented. Appendix E lists acceptable and unacceptable medical justifications and specifies that certain reasons (for example, coadministration with omeprazole ≤20 mg) are not acceptable justification to avoid Epclusa. Failure to submit the clinical documentation described in the policy (office notes, labs, genotype, treatment history, HBV screening, and documentation of contraindications/intolerance) may result in redirection or denial per the preferencing rules.
Coding and Clinical Thresholds
Provider Actions and Requirements
Prior authorization required — document all approval criteria
Prior authorization is required. Provider must submit documentation showing all approval criteria are met, including a quantitative HCV RNA (within the last 6 months), confirmed genotype (1, 4, 5, or 6), age ≥ 3 years, documentation of cirrhosis and treatment status, life expectancy ≥12 months, HBV status, and regimen consistent with FDA/AASLD-IDSA recommendations.
- Quantitative HCV RNA within last 6 months
- Confirmed HCV genotype (1, 4, 5, or 6)
- Age ≥ 3 years
- Documentation of cirrhosis status and treatment history
- Life expectancy ≥ 12 months
- Regimen consistent with FDA or AASLD-IDSA recommendations
- HBV status documented
Prior authorization requires eligibility and preferencing documentation
Prior authorization decisions require submission of documentation that demonstrates eligibility under the policy and adherence to the preferencing/redirection rules described in the policy (including step requirements to preferred agents and documentation for exceptions).
- Follow preferencing/redirection rules in Appendix E and policy sections
- Provide required clinical documentation to support any bypass of preferred agents
Preferred-product requirement — use Mavyret or Epclusa first
Providers must ensure members have used Mavyret or sofosbuvir/velpatasvir (Epclusa authorized generic) first unless clinically significant adverse effects occur or both are contraindicated; if both are intolerable/contraindicated, the authorized generic Harvoni must be used before brand Harvoni per policy.
- Coadministration with omeprazole ≤20 mg is not acceptable justification to avoid Epclusa
Preferred-agent step requirements — document trial/failure or contraindication
The policy requires preferencing to Mavyret or Epclusa for many FDA-approved indications; trials and documented failure or contraindication to these preferred agents (and to the authorized generic Harvoni when required) must be provided before Harvoni will be authorized.
- Document trial and failure or clinical contraindication to preferred agents per policy
- If preferred products are not usable, provide clinical justification consistent with Appendix E
Required documentation — submit chart notes and lab results
Providers must submit supporting documentation with the prior authorization request, including office chart notes and lab results that verify diagnosis, genotype, treatment status, cirrhosis status, age, recent HCV RNA, and any contraindications or adverse effects to preferred alternatives.
- Office chart notes and copies of lab results (HCV RNA, genotype)
- Documentation of treatment history (naïve or experienced)
- Documentation of cirrhosis status
- Evidence of contraindications or adverse effects to preferred agents when applicable
Clinical documentation required for initial criteria and preferred-agent exceptions
Clinical documentation is required to support initial authorization criteria and to substantiate trial and failure or contraindication to preferred agents (Mavyret, Epclusa, or authorized generic Harvoni) when using those pathways.
- Provide clinical records showing adverse effects, contraindications, or documented failure of preferred agents
HBV screening required prior to HCV treatment
Documentation of Hepatitis B screening is required prior to initiating HCV DAA therapy because HBV reactivation is a boxed warning; patients should be monitored and HBV treated as clinically indicated.
- Document HBV status and, if positive, evidence that HBV is being treated or monitored
Denial risk — missing required documentation may trigger denial
Failure to submit required supporting documentation (office notes and lab results) that demonstrate the member meets all approval criteria may result in denial of the prior authorization request.
- Missing HCV RNA, genotype, or documentation of treatment/cirrhosis status can trigger denial
Denial/redirection risk — lack of acceptable justification for not using preferred agents
Failure to use preferred alternatives (e.g., Epclusa or Mavyret) without an acceptable medical justification as defined in Appendix E may lead to redirection or denial; unacceptable rationales (such as omeprazole ≤20 mg) are specified in the policy.
- Acceptable justifications (e.g., Child-Pugh B/C, specific drug–drug interactions) must be documented
- Unacceptable justification includes coadministration with omeprazole ≤20 mg
Background
Harvoni is a fixed‑dose oral combination of ledipasvir (an NS5A inhibitor) and sofosbuvir (an NS5B polymerase inhibitor) indicated for the treatment of hepatitis C virus (HCV) infection for genotypes 1, 4, 5, and 6 in adults and pediatric patients aged ≥ 3 years. Clinical use follows FDA labeling and AASLD‑IDSA recommendations, with specific dosing and duration determined by genotype, prior treatment status, presence or absence of cirrhosis, and patient age/weight. Note that direct‑acting antiviral therapy, including Harvoni, carries a boxed warning for risk of HBV reactivation; patients should be screened for HBV and monitored during and after HCV treatment.
Definitions
Initial Therapy Criteria
inv-24: Initial Therapy — Initial authorization criteria for Harvoni
Initial authorization criteria for Harvoni
Clinical documentation (office notes and labs) is required to support each element; see Appendix E for preferred-agent trial/exception details.
inv-25: Initial therapy dosing — Initial dosing and duration per AASLD-IDSA and FDA labeling with preferencing considerations
Initial dosing and duration are determined by AASLD-IDSA and FDA labeling with preferencing considerations:
See Appendix E and Section III Dosage and Administration for genotype- and scenario-specific dosing and use of ribavirin.
Preferencing may affect product selection for pediatric age/weight groups as described in Appendix E and policy history.
Continuation and Duration Criteria
inv-26: Duration — Approval duration guidance
Approval duration guidance
Approved duration must match the prescribed AASLD-IDSA/FDA regimen (e.g., 8, 12, or extended durations when indicated).
inv-27: Management of incomplete adherence and treatment interruptions
Management of treatment interruptions per AASLD-IDSA (Appendix F):
Applies to treatment-naïve patients without cirrhosis or with compensated cirrhosis receiving Mavyret or Epclusa; see Appendix F for scope.
Recommendation to extend for genotype 3 and/or cirrhosis; see Appendix F for details.
Refer to Appendix F and AASLD-IDSA retreatment guidance.
Step Therapy and Preferencing
| Step | Requirement | Notes / Documentation |
|---|---|---|
| 1 | Member must use Mavyret OR sofosbuvir/velpatasvir (Epclusa authorized generic) prior to authorization of Harvoni unless clinically significant adverse effects are experienced or both are contraindicated. | If intolerant/contraindicated to both Mavyret and Epclusa (authorized generic), member must use authorized generic Harvoni before brand; clinical documentation required for exceptions. Coadministration with omeprazole ≤20 mg is NOT acceptable justification for inability to use Epclusa. |
| Preferencing statement | Coverage implication | Required justification/documentation |
|---|---|---|
| Preferencing directs use of Mavyret or Epclusa (authorized generic) for many FDA‑approved indications prior to Harvoni. | Harvoni may be authorized only after trial and failure, contraindication, or intolerance to preferred agents (Mavyret, Epclusa authorized generic) per policy; failure to use preferred agents without acceptable medical justification may result in redirection or denial. | Clinical documentation is required to demonstrate trial/failure or acceptable medical justification (see Appendix E for acceptable/unacceptable justifications, including drug‑drug interactions and ribavirin contraindications). |
OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.