Mass General Brigham Health Plan Hep C Prior Auth

Coverage Criteria for Hepatitis C Antiviral Medications

Initial Therapy Criteria

Approval will be granted if the member meets ALL of the following and required documentation is submitted:

Initial approval criteria: Member has a diagnosis of chronic hepatitis C (CHC) infection; provider has documented HCV genotype and cirrhosis status; member has a detectable HCV RNA viral load drawn within the last 6 months; member has documented liver disease; member has documentation of stage of hepatic fibrosis by one of: liver biopsy (Metavir stage), transient elastography (FibroScan®), FibroTest/FibroSure, APRI score, or severe extrahepatic manifestations; member (or caregiver) demonstrates understanding of and ability to adhere to the proposed treatment plan and clinical appointments; requested dose and duration of therapy are consistent with FDA label and AASLD guidance; provider will submit HCV RNA (SVR12) 12 weeks after completion of therapy to assess virologic cure; for therapies exceeding 12 weeks, provider will submit HCV RNA at week 4 of treatment and repeat at week 6 if viral load is detectable at week 4; prior treatment history (including prior NS5A inhibitor or sofosbuvir without NS5A exposure) is documented as applicable and consistent with regimen selection.

See genotype- and history-specific regimen tables for recommended agents, durations, and exceptions.

Initial and retreatment regimen selection

Regimen recommendations vary by genotype, prior treatment history, and cirrhosis status. Choose a recommended regimen and duration consistent with the genotype-specific rows in the policy tables.

Genotype-based regimen selection: For each HCV genotype (1–6) select among recommended direct-acting antivirals (examples in tables include sofosbuvir/velpatasvir [Epclusa], glecaprevir/pibrentasvir [Mavyret], ledipasvir/sofosbuvir [Harvoni], sofosbuvir/velpatasvir/voxilaprevir [Vosevi], with or without weight-based ribavirin as indicated). Duration and agent choice depend on treatment-naïve vs experienced status and presence of compensated cirrhosis (many regimens are 8 weeks without cirrhosis and 12 weeks with compensated cirrhosis; prior treatment failures and NS5A exposure modify choices).

Refer to the genotype-specific rows in the policy tables for exact regimen, recommended duration, and evidence class/level.

NS5A inhibitor-experienced patients

Special scenarios and prior NS5A inhibitor failures have specific recommended approaches.

Prior NS5A inhibitor failure: Patients with prior NS5A inhibitor regimen failure should be managed according to the genotype-specific guidance; in several scenarios a retreatment regimen including sofosbuvir/velpatasvir/voxilaprevir (Vosevi) for 12 weeks is the recommended option.

See genotype-specific table rows indicating ‘Prior NS5A inhibitor regimen failed’ and the recommended 12‑week Vosevi regimen.

Co-infection regimen adjustments

HIV/HCV co-infected patients require coordination with the HIV provider and attention to tenofovir exposure and renal function.

Antiretroviral interaction management: Coordinate any antiretroviral (ART) drug switches with the patient’s HIV practitioner; select HCV direct-acting antivirals that are compatible with the patient’s ART; document the ART regimen and any planned switches in the chart; assess tenofovir exposure and renal function when combining DAAs that increase tenofovir levels (e.g., velpatasvir or ledipasvir with tenofovir-containing regimens).CrCl >= 60 mL/min preferred when combining with TDF-containing boosted regimens

Velpatasvir and ledipasvir increase tenofovir levels; avoid combinations when CrCl <60 mL/min where indicated, monitor renal function if used, and consider switching from TDF to TAF when appropriate.

Formulary caution: Mavyret and Zepatier should not be prescribed in patients with any history of prior hepatic decompensation due to reported cases of worsening liver function and liver failure. Vosevi is indicated for patients who previously failed certain HCV regimens but is not recommended in patients with any history of hepatic decompensation unless the expected benefit outweighs the increased risk of liver injury, liver failure, or death.

Ledipasvir/sofosbuvir (Harvoni) increases tenofovir exposure when co-administered with tenofovir-containing antiretroviral regimens. Concomitant use requires assessment of renal function and tenofovir exposure and should be avoided when creatinine clearance is 60 mL/min. When combinations are expected to increase tenofovir levels, baseline and ongoing assessment for tenofovir nephrotoxicity is recommended; consider switching to tenofovir alafenamide (TAF) where appropriate.

Ledipasvir/sofosbuvir given with tenofovir in the context of ritonavir-boosted or cobicistat-boosted antiretroviral regimens potentiates tenofovir exposure. This combination is discouraged and ledipasvir should be avoided when creatinine clearance is 60 mL/min unless the antiretroviral regimen cannot be changed and the urgency of HCV treatment justifies the risk. If used despite interaction risk, implement baseline and ongoing monitoring for tenofovir-associated nephrotoxicity.

Coding and Clinical Thresholds

inv-08: HCV RNA threshold for 8-week Harvoni

HCV RNA thresholdHCV RNA < 6,000,000 IU/mL qualifies for an 8‑week Harvoni (ledipasvir/sofosbuvir) regimen; HCV RNA > 6,000,000 IU/mL indicates a 12‑week duration.

ApplicabilityApplies to treatment‑naïve patients without contraindications as described in the regimen tables.

Documentation neededProvider must document HCV RNA result (within prior 6 months) to support selection of 8‑week vs 12‑week Harvoni.

inv-09: Creatinine clearance (CrCl)

CrCl cutoffAvoid concomitant use of Epclusa (sofosbuvir/velpatasvir) or Harvoni (ledipasvir/sofosbuvir) with tenofovir-containing, ritonavir- or cobicistat-boosted regimens when CrCl < 60 mL/min.

Renal monitoringWhen combinations are expected to increase tenofovir levels, baseline and ongoing assessment for tenofovir nephrotoxicity (renal monitoring) is recommended.

Provider Requirements, Documentation, and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for hepatitis C specialty medications. Approval is contingent on submission of all required documentation listed below; missing or incomplete documentation may result in denial.

All Hepatitis C medications are specialty products and must be dispensed from a contracted specialty pharmacy.
Current prior authorizations will be grandfathered for the life of the prior authorization.

Documentation Required

Document Genotype and Cirrhosis Status

Provider must document the member's HCV genotype and cirrhosis status in the prior authorization request. Documentation of liver disease and stage of hepatic fibrosis must be included (e.g., liver biopsy with Metavir stage, FibroScan score, FibroTest/FibroSure score, APRI score, or evidence of severe extrahepatic manifestations).

Provider has documented genotype and cirrhosis status.

Background and Clinical Context

Clinical rationale: selection of direct-acting antiviral therapy for chronic hepatitis C is guided primarily by the patient’s HCV genotype and cirrhosis status. Regimen choice and duration vary by genotype, prior treatment history, and whether cirrhosis is compensated. Providers must document the patient’s genotype and cirrhosis status and submit a recent HCV RNA (within the prior 6 months) and objective staging of hepatic fibrosis (for example biopsy, FibroScan, FibroTest/FibroSure, APRI, or documentation of severe extrahepatic manifestations) to support medical necessity and appropriate regimen/duration selection.

Documentation expectations: prior authorization requires submission of a confirmed diagnosis of chronic hepatitis C, the patient’s genotype and cirrhosis status, an HCV RNA viral load result within the prior 6 months, evidence of liver disease and fibrosis staging, and relevant treatment history. The provider must also document management plans for interactions with acid-reducing agents when prescribing sofosbuvir-containing regimens and, for HIV/HCV co-infected patients, the antiretroviral regimen and any planned ART switches done in collaboration with the HIV practitioner. Post-treatment, the provider is expected to submit an HCV RNA at 12 weeks after completion of therapy (SVR12) to document virologic cure.

Definitions and Outcome Measures

inv-20: SVR12

DefinitionSustained virologic response at 12 weeks (SVR12) is the HCV RNA viral load measured 12 weeks after completion of therapy to assess virologic cure.

Provider obligationProvider must submit the SVR12 HCV RNA result to document treatment outcome.

Timing for longer therapiesFor therapies exceeding 12 weeks, HCV RNA should also be submitted at week 4 of treatment and repeated at week 6 if detectable at week 4.

inv-09: Non-responder / Null responder

DefinitionNon-responder (null responder): patient who experienced less than a 2 log decline in viral load during a prior 12‑week treatment course; viral load was never undetectable.

ImplicationThese individuals have lower re-treatment success compared with other response types.

OpenPayer

Hepatitis C Medications (Prior Authorization, Specialty Pharmacy)

Coverage Criteria for Hepatitis C Antiviral Medications

Coding and Clinical Thresholds

Provider Requirements, Documentation, and Authorization

Background and Clinical Context

Definitions and Outcome Measures