CurrentMass General Brigham Health PlanPolicy N/A

Hepatitis C Medications Prior Authorization and Coverage

Defines prior authorization, specialty pharmacy dispensing, preferred agents, and clinical coverage criteria for Hepatitis C (HCV) medications for Mass General Brigham Health Plan members.

Policy Summary

PayerMass General Brigham Health Plan

PolicyHepatitis C Medications Prior Authorization and Coverage

Policy CodePolicy N/A

Change TypeNo material change

Effective DateMay 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of genotype, cirrhosis status, and recent HCV RNA (within 6 months); ensure dispensing via a contracted specialty pharmacy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

SpecialtySpecialty

SVR12SVR12 required

6 monthsHCV RNA recency

GenotypeGenotype & cirrhosis

Docs requiredDocumentation requirement added

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Initial approval criteria

Approval will be granted if the member meets ALL of the following criteria and documentation has been submitted:

Initial approval - core requirements: Member has a diagnosis of chronic hepatitis C (CHC) infection; provider has documented HCV genotype and cirrhosis status; member has a detectable HCV RNA drawn within the last 6 months; member has documented liver disease; member has documentation of stage of hepatic fibrosis by transient elastography (FibroScan), liver biopsy with Metavir stage, FibroTest/FibroSure score, or APRI score; member has demonstrated understanding of and ability to adhere to the proposed treatment plan and appointments; provider will submit HCV RNA viral load 12 weeks (SVR12) after completion of therapy to assess virologic cure; the requested dose and duration are consistent with FDA label indications and AASLD published treatment guidelines; 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; also covers members new to the plan who were already started and stabilized on a hepatitis C regimen (document regimen and stability).all listed must be met

See chunks 2–4 for full required documentation and monitoring.

Additional / alternative review

Alternate approval pathway

Case-by-case review: All other requests will be reviewed on a case-by-case basis consistent with approved FDA labeling and/or recognized treatment guidelines.1 of any

Chunk 5.

Genotype- and prior-treatment–based regimen recommendations

Regimens and durations recommended vary by HCV genotype, presence of compensated cirrhosis, and prior treatment history (treatment‑naive, prior PEG‑IFN + RBV failure, prior sofosbuvir failure, prior NS5A inhibitor failure).

Regimen tables: Table entries list preferred direct-acting antiviral (DAA) oral regimens (including Epclusa, Mavyret, Harvoni, Vosevi, Zepatier and others) with recommended treatment durations (commonly 8–12 weeks; in some prior-treatment scenarios up to 16 weeks) depending on genotype, compensated cirrhosis status, and specific prior treatment failures.

See Table 1 (chunks 18–27) for genotype- and prior-treatment–specific regimen and duration mappings.

Resistance-associated variant (RAV) testing note

Y93H RAV testing: Resistance-associated variant (RAV) testing for Y93H is recommended; if Y93H is present, include ribavirin in the regimen.

Chunk 22.

Antiretroviral and tenofovir interaction considerations

Tenofovir interactions: Velpatasvir (in sofosbuvir/velpatasvir) and ledipasvir (in ledipasvir/sofosbuvir) increase tenofovir levels; concomitant use requires consideration of renal function and should be avoided in patients with CrCl < 60 mL/min; when used with ritonavir- or cobicistat-boosted regimens, monitor for tenofovir nephrotoxicity and consider TAF as an alternative to TDF.CrCl < 60 mL/min

Chunks 28–29.

Daklinza dosing adjustments: Daclatasvir (Daklinza) requires dose adjustment when coadministered with certain antiretrovirals: decrease dose with ritonavir‑boosted atazanavir (to 30 mg daily) and increase dose with efavirenz or etravirine; coordinate any antiretroviral switches with the patient's HIV practitioner.

Chunk 28.

FDA safety reports note rare cases of worsening liver function or liver failure when Mavyret, Zepatier, or Vosevi are used to treat chronic hepatitis C in patients with moderate to severe liver impairment. As a result, Mavyret and Zepatier should not be prescribed for members with any history of prior hepatic decompensation. Vosevi is indicated for certain previously treated patients but is not recommended in those with a history of hepatic decompensation unless the expected benefit clearly outweighs the increased risk of liver injury, liver failure, or death.

If source-specific coverage language for this criterion is not provided, requests that do not meet the standard initial approval requirements will be reviewed on a case-by-case basis consistent with FDA labeling and recognized treatment guidelines. Providers should submit all required documentation (genotype, cirrhosis status, recent HCV RNA, fibrosis staging, and treatment plan) to support medical necessity.

When explicit coverage criteria are not available in the source document, clinical review will follow established guidance: approval requires documentation of diagnosis, genotype, cirrhosis status, recent detectable HCV RNA (within 6 months), fibrosis staging, and an appropriate regimen and duration per FDA labeling and AASLD guidance; otherwise requests will be evaluated on a case-by-case basis.

inv-09: HCV RNA recency — detectable HCV RNA within last 6 months requirement.

RequirementDetectable HCV RNA viral load drawn within the last 6 months is required for initial approval.

Timing for new-to-plan membersMembers new to the plan already started and stabilized on therapy must have documentation of regimen and stabilization plus a detectable HCV RNA within the last 6 months.

Supporting documentationProvider must also document genotype, cirrhosis status, liver disease and stage of hepatic fibrosis (FibroScan, liver biopsy Metavir, FibroTest/FibroSure, or APRI).

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Specialty Dispensing

Prior authorization required. All Hepatitis C (HCV) medications are designated specialty and must be dispensed from a contracted specialty pharmacy.

Prior authorization required for all HCV medications
All HCV medications are specialty and must be filled at a contracted specialty pharmacy

Prior Authorization

Prior Authorization: Genotype, Cirrhosis, and Interaction Plan

Provider must document genotype, cirrhosis status, and a plan to manage drug interactions (specifically for antacids, H2 blockers, and proton pump inhibitors) when requesting regimens that include sofosbuvir/velpatasvir or ledipasvir/sofosbuvir.

Documentation of HCV genotype
Documentation of cirrhosis status
Documented plan for managing interactions with antacids, H2 antagonists, or PPIs for sofosbuvir/velpatasvir or ledipasvir/sofosbuvir regimens

Note

Preferred / Non-Preferred Agents

Preferred and non-preferred agent guidance: Harvoni (all dosage forms, including oral pellets) is the preferred combination agent for genotypes 1, 4, 5, and 6; Epclusa (all dosage forms, including oral pellets) is the preferred combination agent for genotypes 2 and 3. Vosevi is a non-preferred agent and will be reviewed case-by-case for members previously treated with an NSSA inhibitor or with sofosbuvir without an NSSA inhibitor. Sovaldi (sofosbuvir) is a single-agent formulary product for genotypes 1, 4, 5, and 6 and will be reviewed case-by-case for medical necessity over standard-of-care regimens.

Harvoni preferred for Genotypes 1, 4, 5, 6
Epclusa preferred for Genotypes 2 and 3
Vosevi is non-preferred; reviewed case-by-case for prior NSSA exposure or prior sofosbuvir without NSSA
Sovaldi is single-agent formulary for genotypes 1,4,5,6; case-by-case review for medical necessity

Documentation Required

Required Clinical Documentation

Provider must submit clinical documentation to support approval: genotype, cirrhosis status, recent detectable HCV RNA (within 6 months), documentation of liver disease and stage of hepatic fibrosis (eg, FibroScan score, biopsy confirming Metavir stage, FibroTest/FibroSure, APRI), and documentation of severe extrahepatic manifestations or prior treatment history as applicable. For members already started and stabilized on therapy prior to plan enrollment, document the prior regimen, dose, and treatment duration.

HCV RNA viral load drawn within the last 6 months
Documentation of liver disease and stage of hepatic fibrosis (FibroScan, biopsy, FibroTest, APRI)
Documentation of severe extrahepatic manifestations/symptoms when applicable
If member is new to plan and already on therapy, document the existing regimen, dose, duration, and stabilization

Denial Risk

Denial Triggers

Approval will be granted only if all criteria are met and required documentation is provided. Requests that fail to meet criteria or lack required documentation may be denied.

Approval contingent on meeting all criteria and submission of required documentation
Incomplete or non‑compliant requests may be denied

Denial Risk

Drug Interaction Documentation

For patients taking antacids, H2 antagonists, or proton pump inhibitors who require a sofosbuvir/velpatasvir or ledipasvir/sofosbuvir-containing regimen, documentation of how the drug interaction will be managed must be provided; failure to supply this documentation may result in denial.

Document the management strategy for antacid/H2/PPI interactions with sofosbuvir/velpatasvir or ledipasvir/sofosbuvir
Lack of interaction-management documentation may lead to denial

Definitions

inv-19: NSSA inhibitors — list of single agents (daclatasvir, ombitasvir, ledipasvir, elbasvir) and context.

Included single agentsDaclatasvir (Daklinza), ombitasvir (component of Viekira-Pak), ledipasvir (component of Harvoni), and elbasvir (component of Zepatier).

Class contextThese agents are listed as NS5A (NSSA) inhibitors referenced when prior NS5A inhibitor failure influences regimen selection in Table 1.

Dose considerationsDaclatasvir (Daklinza) may require dose adjustment when used with CYP3A4 inducers or inhibitors; coordinate with HIV practitioner for antiretroviral switches.

inv-20: Specialty product — designation that HCV medications are specialty and must be filled at contracted specialty pharmacy.

DesignationAll Hepatitis C medications are designated specialty products.

Dispensing requirementSpecialty HCV medications must be dispensed only when obtained from a contracted specialty pharmacy.

Coverage notePrior authorization is required for HCV medications and dispensing is limited to contracted specialty pharmacies per policy.

inv-21: Non-responder (null responder) definition.

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).

Clinical implicationThese patients had minimal virologic response during prior therapy and have lower likelihood of response to re-treatment compared with relapsers.

Usage in policyUsed to classify prior treatment failure in regimen selection tables and coverage decisions.

inv-22: Partial responder definition.

DefinitionPartial responder: patient who experienced greater viral load suppression than non-responders but viral load was never undetectable during treatment.

Clinical implicationPartial responders have lower re-treatment success than relapsers.

Policy roleIdentified in notes to inform expected re-treatment outcomes and regimen selection.

inv-23: Relapser definition.

DefinitionRelapser: patient who achieved undetectable HCV RNA during prior treatment but relapsed after cessation of therapy.

Clinical implicationRelapsers should be treated as if treatment-naive for re-treatment and tend to respond well to re-treatment.

Policy roleUsed to guide regimen recommendations and expected success with subsequent therapy.

OpenPayer

Hepatitis C Medications Prior Authorization and Coverage

Coverage Criteria for Hepatitis C Medications

Provider Actions, Prior Authorization, and Documentation Requirements

Coding and Lab Documentation Requirements

Background and Clinical Context

Definitions

Revision History