Cigna Harvoni Prior Auth Coverage Update

Coverage and Medical Necessity Criteria

Chronic HCV, Genotype 1

Covered when ONE of the listed FDA‑approved indications is met; specific genotype 1 criteria:

Genotype 1 approval

B: treatment status and cirrhosis conditions
- i: 8-week approval: Approve for 8 weeks if ALL: patient is treatment-naïve; patient does not have cirrhosis; patient does not have HIV; patient is not awaiting liver transplantation; AND baseline HCV RNA is < 6 million IU/mL.
- ii: 12-week approval: Approve for 12 weeks if ONE: patient is treatment-naïve AND does not meet Bi (above); OR patient has previously been treated for HCV and does not have cirrhosis; OR patient is treatment‑naïve or previously treated with decompensated cirrhosis AND is ribavirin‑eligible and will receive ribavirin in combination.
- iii: 24-week approval: Approve for 24 weeks if ONE: patient has been previously treated for HCV and has compensated (Child‑Pugh A) cirrhosis; OR patient (treatment‑naïve or previously treated) has decompensated (Child‑Pugh B or C) cirrhosis AND is ribavirin‑ineligible according to the prescriber.

Prescriber requirement: The medication must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician.

Chronic HCV, Genotypes 4, 5, or 6

Covered when BOTH conditions are met:

Genotypes 4/5/6 approval: Patient is ≥ 3 years of age AND the medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician; approve for 12 weeks.

Recurrent HCV Post-Liver Transplant (Genotypes 1 or 4)

Approve for 12 weeks when ALL of the following are met:

Post-transplant criteria: Patient is ≥ 3 years of age; has recurrent HCV after a liver transplantation; the medication will be prescribed in combination with ribavirin; AND the medication is prescribed by or in consultation with a prescriber affiliated with a transplant center (gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician).

Selected FDA-Approved criteria (partial)

FDA‑Approved indications and related duration criteria (partial):

Partial criteria summary: This section contains portions of the multi-part FDA‑approved duration criteria referencing cirrhosis status, prior treatment history, and ribavirin eligibility which determine 8, 12, or 24 week durations per genotype 1 rules. Full criteria are detailed in the Genotype 1 section.

Recurrent HCV post-liver transplant (GT 1 or 4)

Recurrent HCV post‑liver transplantation (genotypes 1 or 4):

Recurrent HCV post-liver transplant (GT 1 or 4): Patient is ≥ 3 years of age; has recurrent HCV after liver transplantation; the medication will be prescribed in combination with ribavirin; AND the medication is prescribed by or in consultation with a transplant‑affiliated prescriber (gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician).age >= 3 years

Approve for 12 weeks.

Other supported indications and continuation

Other uses with supportive evidence (selected) and continuation:

Recurrent HCV post-liver transplant (GT 5 or 6): Patient is ≥ 18 years of age; has recurrent HCV after liver transplantation; the medication will be prescribed in combination with ribavirin; AND the medication is prescribed by or in consultation with a transplant‑affiliated prescriber (gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician).age >= 18 years

Approve for 12 weeks.

HCV in kidney transplant recipients (GT 1 or 4): Patient is ≥ 18 years of age; is a kidney transplant recipient with HCV; AND the medication is prescribed by or in consultation with a transplant‑affiliated prescriber (gastroenterologist, hepatologist, infectious diseases physician, nephrologist, liver transplant physician, or renal transplant physician).age >= 18 years

Approve for 12 weeks.

Completion of started therapy:

Services billed for conditions or diagnoses not covered under this Coverage Policy will be denied. Claims submitted without covered diagnosis or procedure codes under the applicable Coverage Policy will be denied as not covered; when billing, providers must use the most appropriate codes as of the effective date of the submission.

Use of ledipasvir/sofosbuvir with any other direct-acting antivirals (DAAs) is not recommended, and ledipasvir/sofosbuvir should not be combined with other products containing sofosbuvir; ribavirin is the exception when specifically indicated. Ledipasvir/sofosbuvir is not indicated for pediatric patients under 3 years of age because safety and efficacy have not been established. Retreatment with ledipasvir/sofosbuvir in patients previously treated with the same regimen is discouraged; alternative direct-acting antivirals are available for retreatment.

Ledipasvir/sofosbuvir is considered not medically necessary for use in combination with other direct-acting antivirals (excluding ribavirin), for pediatric patients under 3 years of age, and for retreatment in patients who have previously received ledipasvir/sofosbuvir (including prior null responders, partial responders, relapsers, or those who did not complete therapy). Requests meeting these scenarios will be denied as not medically necessary.

Clinical Thresholds and Coding-Relevant Details

inv-10: Baseline HCV RNA

Baseline HCV RNA thresholdBaseline HCV RNA < 6 million IU/mL required for eligibility for an 8‑week course in treatment‑naïve patients without cirrhosis

Context for 8‑week regimen8‑week option applies only to treatment‑naïve patients without cirrhosis who also meet other criteria (no HIV, not awaiting transplant)

Reference to dosing tableSee recommended treatment durations table for age and genotype applicability

inv-11: Age

Minimum age for coveragePatient must be ≥ 3 years of age for covered indications

Pediatric dosing notePediatric dosing of tablets or pellets is weight‑based for patients ≥ 3 years

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for prescription benefit coverage of ledipasvir/sofosbuvir products. All approvals are provided for the duration specified in the policy. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with ledipasvir/sofosbuvir, therapy must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, nephrologist (for kidney transplant recipients), or a liver/renal transplant physician as applicable. NOTE: Use of preferred products is required before approval of the requested product per the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy for Employer Plans (PSM025).

Prior authorization required with documentation that the patient meets age, genotype, transplant status, cirrhosis (including Child-Pugh classification), and ribavirin eligibility criteria as specified in the FDA-Approved Indications and Other Uses with Supportive Evidence sections.
Therapy must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease physician, or a liver transplant physician (and nephrologist or renal transplant physician for kidney transplant recipients) depending on the clinical scenario. Approvals are granted for the duration indicated for the approved indication; partial courses started may be approved to complete the original course.
Step considerations for retreatment: ledipasvir/sofosbuvir is not recommended to be used in combination with other direct-acting antivirals (DAAs) excluding ribavirin. Retreatment requests for patients previously treated with ledipasvir/sofosbuvir (including prior null/partial responders, relapsers, or those who discontinued therapy) are generally considered not medically necessary because alternative DAAs are available and preferred for retreatment.

Initial Therapy Dosing and Duration Requirements

Recommended dosing/duration

Recommended dosing and duration for initial therapy based on genotype, treatment history, and cirrhosis status:

Adult and pediatric dosing: Adults: one tablet orally once daily with or without food. Pediatric dosing for patients ≥ 3 years is weight‑based; pellets available for those who cannot swallow tablets.

Duration by scenario: Durations include: 8 weeks for selected treatment‑naïve patients without cirrhosis and baseline HCV RNA < 6 million IU/mL; 12 weeks for most treatment‑naïve or transplant scenarios and for genotypes 4,5,6; and 24 weeks for certain treatment‑experienced patients with compensated cirrhosis or for ribavirin‑ineligible patients with decompensated cirrhosis.

Initial therapy criteria (partial)

Initial approvals by indication (select):

Chronic HCV (Genotypes 4, 5, 6):

Criteria to Complete or Continue Therapy

Continuation to complete therapy

Completion of a started course:

Complete course if already started: Approve ledipasvir/sofosbuvir to complete a course of therapy consistent with the indication's approved duration (e.g., if a patient should receive 12 weeks and has received 3 weeks, approve the remaining 9 weeks).

Step Therapy and Preferred Product Requirements

Requirement	Details
Preferred product requirement
Policy requires use of preferred products before approval per the Hepatitis C Virus Direct-Acting Antivirals Preferred Specialty Management Policy (PSM025).

Retreatment consideration	Policy guidance
Retreatment with ledipasvir/sofosbuvir
Retreatment with ledipasvir/sofosbuvir in patients previously treated with the same regimen is discouraged; other direct-acting antivirals are available and appropriate for retreatment.

Drug Background

Ledipasvir/sofosbuvir is a fixed‑dose combination of an HCV NS5A inhibitor (ledipasvir) and an HCV NS5B nucleotide polymerase inhibitor (sofosbuvir) indicated for the treatment of chronic Hepatitis C virus (HCV). It is approved for use in patients 3 years and older for genotypes 1, 4, 5, and 6, with genotype- and cirrhosis-specific recommended durations (commonly 8, 12, or 24 weeks) and, in some circumstances, used in combination with ribavirin or adjusted duration for decompensated disease. Prior authorization is required and approvals are provided for specified durations when medical necessity criteria are met.

Clinical Definitions

inv-21: Decompensated cirrhosis

DefinitionDecompensated cirrhosis refers to Child‑Pugh class B or C

Treatment implicationPatients with decompensated cirrhosis often require ledipasvir/sofosbuvir in combination with ribavirin

Ribavirin dosing guidanceRibavirin starting dose for decompensated cirrhosis is 600 mg and may be titrated based on weight and tolerance

inv-22: Compensated cirrhosis

DefinitionCompensated cirrhosis is defined as Child‑Pugh class A

Duration implicationsPatients with compensated (Child‑Pugh A) cirrhosis have genotype‑ and treatment‑history‑dependent durations (commonly 12 weeks; some treatment‑experienced may require 24 weeks)

Policy Revision History

07/01/2025policy_createdLatest

New policy created and published with an effective date of 07/01/2025.

OpenPayer

Harvoni Prior Authorization Policy

Coverage and Medical Necessity Criteria

Clinical Thresholds and Coding-Relevant Details

Authorization, Documentation, and Prescriber Requirements

Initial Therapy Dosing and Duration Requirements

Criteria to Complete or Continue Therapy

Step Therapy and Preferred Product Requirements

Drug Background

Clinical Definitions

Policy Revision History