CurrentMedStar Family Choice, Inc.Policy N/A

Clinical Criteria for Hepatitis C (HCV) Therapy

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This policy governs prior authorization for hepatitis C antiviral therapy, including treatment-naive and treatment-experienced patients, pediatric patients, patients with cirrhosis, and recipients of non-liver organs from HCV-viremic donors.

Policy Summary

PayerMedStar Family Choice, Inc.

PolicyClinical Criteria for Hepatitis C (HCV) Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization documentation establishing chronic HCV infection, required laboratory and fibrosis results, treatment history, and an FDA-approved regimen appropriate to the patient.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

180 daysMaximum HCV RNA age before application

90 daysMaximum baseline laboratory age for cirrhosis

2 formsRequired contraception forms with ribavirin

6 monthsPost-treatment ribavirin contraception duration

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CurrentMedStar Family Choice, Inc.Policy N/A

Clinical Criteria for Hepatitis C (HCV) Therapy

Customize your policy alerts

Sign up for all medstarfamilychoicemaryland policy alerts

Know when medstarfamilychoicemaryland releases new policies or updates existing guidance.

Monitor payer policy activity

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Policy Summary

PayerMedStar Family Choice, Inc.

PolicyClinical Criteria for Hepatitis C (HCV) Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

180 daysMaximum HCV RNA age before application

90 daysMaximum baseline laboratory age for cirrhosis

2 formsRequired contraception forms with ribavirin

6 monthsPost-treatment ribavirin contraception duration

≥3 yearsMinimum pediatric treatment age

8–24 weeksCovered treatment duration range

Coverage Criteria

General Prior Authorization Requirements

Coverage requires prior authorization documentation sufficient to establish clinical eligibility, treatment safety, and the requested regimen.

ALL of the following

Document chronic hepatitis C and HCV genotype and sub-genotype, except genotype testing is not required for approval of pangenotypic regimens or for treatment of HCV-uninfected recipients of non-liver organs from HCV-viremic donors.
For patients with prior DAA exposure, document the pre-DAA genotype and post-DAA genotype.
Submit quantitative HCV RNA obtained within 180 days before the application; for patients with cirrhosis, baseline laboratory values must be within 90 days of the prior authorization request.
Submit liver biopsy or another accepted fibrosis assessment, such as FibroSure, HepaScore/FibroScore, FibroScan, point shear-wave elastography, or acoustic radiation force impulse imaging, except for treatment of HCV-uninfected recipients of non-liver organs from HCV-viremic donors.
Document prior HCV treatment history and outcome.
Document HIV status; if HIV-positive, provide the current antiretroviral regimen and degree of viral suppression within 6 months before application.
Document HBV status; if active HBV disease, provide the current antiviral regimen and degree of viral suppression within 6 months before application.
The treating provider must assess and document the patient's ability to adhere to therapy.
Submit drug-resistance testing when clinically indicated.
Develop and submit a treatment plan from the treating clinician; sample treatment-plan documents may be used.
Use the requested drug in accordance with FDA-approved indications.

Regimen Eligibility

Regimen selection must be supported by the patient's genotype, cirrhosis status, treatment experience, resistance findings, age, and other clinical characteristics.

ALL applicable eligibility factors

Genotype and disease status
- Genotype 1a, 1b, 2, 3, 4, 5, or 6 with the applicable cirrhosis category documented.
- Multiple or undetermined genotype when a pangenotypic regimen is selected.
- HCV-uninfected recipient of a non-liver organ from an HCV-viremic donor.
Cirrhosis status
- No cirrhosis.

Treatment Regimen Pathways

Coverage follows the genotype- and treatment-history pathways below. “RBV” means ribavirin; “CTP” means Child-Turcotte-Pugh; “RAS” means resistance-associated substitution; and “wks” means weeks.

Select the applicable pathway

Treatment-naive or standard initial-therapy pathways
- Genotype 1a, no cirrhosis: Epclusa (sofosbuvir/velpatasvir) 12 wks; Harvoni (ledipasvir/sofosbuvir) 8 wks if HCV RNA <6 million, or 12 wks; Mavyret (glecaprevir/pibrentasvir) 8 wks; or Zepatier (elbasvir/grazoprevir) 12 wks if no NS5A RAS. If NS5A RAS is present, alternative Zepatier plus RBV 16 wks.
- Genotype 1a, compensated cirrhosis: Epclusa 12 wks; Harvoni 12 wks; Mavyret 8 wks; or Zepatier 12 wks if no NS5A RAS. With NS5A RAS, alternative Zepatier plus RBV 16 wks.
- Genotype 1a, decompensated cirrhosis (CTP B or C): Epclusa plus RBV 12 wks or Harvoni plus RBV 12 wks; alternatives include Epclusa 24 wks or Harvoni 24 wks.
- Genotype 1b, no cirrhosis: Epclusa 12 wks; Harvoni 8 wks if HCV RNA <6 million, or 12 wks; Mavyret 8 wks; or Zepatier 12 wks. For specified alternative pathways, Epclusa or Harvoni may be used for 24 wks.

For treatment of HCV-uninfected recipients of non-liver organs from HCV-viremic donors, HCV genotype and fibrosis testing are not required for approval. Covered treatment options are Epclusa (sofosbuvir/velpatasvir) for 12 weeks or Mavyret (glecaprevir/pibrentasvir) for 8 weeks.

Laboratory and Course Parameters

Quantitative HCV RNA timing

Noncirrhotic patientsQuantitative HCV RNA must be obtained within 180 days of the therapy application.

Cirrhotic patientsBaseline laboratory values must be obtained within 90 days of the prior authorization request.

Required testQuantitative HCV RNA is required for the pretreatment evaluation.

Shortened Harvoni course

MedicationHarvoni (ledipasvir/sofosbuvir).

Shortened course8 weeks.

HCV RNA requirement

Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Hepatitis C therapy. Submit the completed Hepatitis C treatment PA form with clinical documentation supporting the diagnosis, treatment history, regimen selection, and FDA-approved indication.

Include the patient's genotype/sub-genotype, cirrhosis status and fibrosis assessment, quantitative HCV RNA, HIV/HBV status, prior treatment history, resistance results when indicated, adherence assessment, and proposed treatment plan.
Genotype documentation is not required when a pangenotypic regimen is prescribed, except where the clinical scenario or regimen-specific criteria require additional resistance or prior-treatment information.
The fibrosis-test and genotype requirements are not required for treatment of HCV-uninfected recipients of non-liver organs from HCV-viremic donors.

Documentation Required

Document HCV Diagnosis and Genotype

Document chronic hepatitis C and the HCV genotype and sub-genotype before requesting therapy. Genotype documentation is not required for approval with pangenotypic regimens.

Policy Background

The policy organizes hepatitis C treatment according to genotype, cirrhosis status, prior interferon or direct-acting antiviral exposure, and resistance-associated substitutions. Initial pathways for genotypes 1 through 6 include Epclusa, Harvoni, Mavyret, and selected Zepatier regimens, with choices varying for patients without cirrhosis, with compensated cirrhosis, or with decompensated cirrhosis (Child-Turcotte-Pugh class B or C).

Treatment-experienced patients may require extended or alternative therapy based on the prior regimen and treatment outcome. Listed options include Vosevi for specified DAA-, NS5A-, sofosbuvir-, or NS3 protease inhibitor-experienced pathways, Mavyret for selected 16-week courses, and ribavirin-containing alternatives. Resistance findings, including NS5A or Y93 substitutions, may change the eligible regimen; some genotype, treatment-history, cirrhosis, and resistance combinations have no currently FDA-approved treatment regimen. Retreatment and reinfection are distinguished using post-treatment HCV RNA, genotype comparison, and the duration of the current infection.

Terms and Classifications

RBV

AbbreviationRBV.

MeaningRibavirin.

Policy useRBV appears in ribavirin-containing HCV treatment regimens.

IFN

AbbreviationIFN.

MeaningInterferon.

Policy useIFN is referenced in interferon-experienced treatment pathways.

Initial Treatment by Genotype and Cirrhosis

Initial treatment options vary by genotype and cirrhosis status.

Genotype 1: Listed options include Epclusa, Harvoni, Mavyret, and Zepatier for no cirrhosis or compensated cirrhosis, with selected 8-, 12-, or 16-week courses. Decompensated cirrhosis uses Epclusa or Harvoni with ribavirin for 12 weeks or specified 24-week alternatives.8, 12, 16, or 24 weeks

Zepatier and alternative regimens may depend on NS5A RAS status.

Genotype 2: Listed options include Epclusa or Mavyret for no cirrhosis or compensated cirrhosis. Decompensated cirrhosis uses Epclusa plus ribavirin for 12 weeks or specified 24-week alternatives.8, 12, or 24 weeks

The exact table row controls the selected duration.

Step Therapy Pathways

Step	Clinical situation	Primary regimen	Alternative regimen
1	DAA-experienced pathway, including listed genotype 1a or 1b scenarios	Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for 12 weeks	Mavyret (glecaprevir/pibrentasvir) for 16 weeks in specified alternative scenarios
1	NS5A-, SOF-, or NS3 PI-experienced pathway	Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for 12 weeks when listed	Mavyret (glecaprevir/pibrentasvir) for 16 weeks when listed as an alternative
1	DAA-experienced genotype 3 pathway	Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for 12 weeks when listed	Mavyret (glecaprevir/pibrentasvir) for 16 weeks when listed
1	DAA-experienced genotype 4, 5, or 6 pathway	Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for 12 weeks	No currently FDA-approved treatment regimen where identified in the table

Treatment Duration Limits

HCV antiviral regimen durations

Covered duration rangeCourse durations range from 8 to 24 weeks.

Durations listedThe policy lists 8-, 12-, 16-, and 24-week courses.

Clinical scenariosDuration depends on genotype, cirrhosis status, treatment experience, resistance findings, and the specific regimen pathway.

Policy Summary

PayerMedStar Family Choice, Inc.

PolicyClinical Criteria for Hepatitis C (HCV) Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

SourceLink

On This Page

Compensated cirrhosis.

Decompensated cirrhosis, Child-Turcotte-Pugh (CTP) class B or C.

Treatment history

Treatment-naive.
Prior interferon plus ribavirin (IFN/RBV) experience.
Prior NS3 protease-inhibitor experience.
Prior DAA experience, including sofosbuvir (SOF) experience with NS5A-naive status, NS5A experience, or other DAA-experienced status.

Resistance findings when applicable

No relevant NS5A resistance-associated substitutions (RAS).
NS5A RAS present, requiring the specified alternative regimen.
No Y93 RAS.
Y93 RAS present, requiring the specified alternative regimen.

Age and pediatric eligibility

Patient is at least 3 years old for pediatric Epclusa, Harvoni, or Mavyret pathways, with product-specific weight-based dosing when applicable.
Adult patient meeting the applicable regimen criteria.

If an RBV-containing regimen is prescribed and the patient or partner is of childbearing age, use at least two forms of contraception throughout therapy and for 6 months after completion.

Genotype 1b, compensated cirrhosis: Epclusa 12 wks, Harvoni 12 wks, or Mavyret 8 wks. Genotype 1b, decompensated cirrhosis: Harvoni 24 wks or Epclusa plus RBV 12 wks; alternative Epclusa or Harvoni 24 wks.

Genotype 2, no cirrhosis or compensated cirrhosis: Epclusa 12 wks or Mavyret 8 wks. Decompensated cirrhosis: Harvoni 24 wks or Epclusa plus RBV 12 wks; alternative Epclusa 24 wks.

Genotype 3, no cirrhosis: Epclusa 12 wks or Mavyret 8 wks. Compensated cirrhosis: Epclusa 12 wks if no Y93 RAS or Mavyret 8 wks. Decompensated cirrhosis: Epclusa 12 wks if no Y93 RAS or Epclusa plus RBV 12 wks; with Y93 RAS, alternative Epclusa plus RBV 12 wks or Epclusa 24 wks.

Genotype 4, no cirrhosis or compensated cirrhosis: Epclusa 12 wks, Harvoni 12 wks, Mavyret 8 wks, or Zepatier 12 wks. Decompensated cirrhosis: Epclusa plus RBV 12 wks or Harvoni plus RBV 12 wks; alternatives include Epclusa 24 wks or Harvoni 24 wks.

Genotype 5 or 6, no cirrhosis: Harvoni 12 wks or Mavyret 8 wks. Compensated cirrhosis: Mavyret 8 wks. Decompensated cirrhosis: Harvoni plus RBV 12 wks; alternative Epclusa 24 wks.

Pangenotypic treatment when genotype is not required: no cirrhosis or compensated cirrhosis—Epclusa 12 wks or Mavyret 8 wks; decompensated cirrhosis—Epclusa plus RBV 12 wks, with alternative Epclusa 24 wks.

HCV-uninfected recipient of a non-liver organ from an HCV-viremic donor: Epclusa 12 wks or Mavyret 8 wks.

Treatment-experienced pathways

Prior IFN/RBV experience, genotype 1a: no cirrhosis—Epclusa 12 wks, Harvoni 12 wks, or Zepatier 12 wks if no NS5A RAS; with NS5A RAS, Zepatier plus RBV 16 wks. Compensated cirrhosis—Epclusa 12 wks, Mavyret 8 wks, or Zepatier 12 wks if no NS5A RAS; alternatives include Harvoni plus RBV 12 wks or Zepatier plus RBV 16 wks. Decompensated cirrhosis—Epclusa plus RBV 12 wks or Harvoni plus RBV 12 wks; alternative Epclusa 24 wks.
Prior IFN/RBV experience, genotype 1b: no cirrhosis—Epclusa 12 wks or Harvoni 12 wks; compensated cirrhosis—Harvoni plus RBV 12 wks, Zepatier plus RBV 16 wks if NS5A RAS is present, Epclusa 12 wks, or Mavyret 8 wks; decompensated cirrhosis—Epclusa 24 wks, Harvoni 24 wks, Epclusa plus RBV 12 wks, or Harvoni plus RBV 12 wks.
Prior IFN/RBV experience, genotype 2: no cirrhosis—Epclusa 12 wks; compensated cirrhosis—Epclusa 12 wks or Mavyret 12 wks; decompensated cirrhosis—Epclusa plus RBV 12 wks or alternative Epclusa 24 wks.
Prior IFN/RBV experience, genotype 3: no cirrhosis—Epclusa 12 wks if no Y93 RAS; compensated cirrhosis—Mavyret 16 wks; decompensated cirrhosis—alternative Epclusa 24 wks. If Y93 RAS is present, use Epclusa plus RBV 12 wks where specified.
Prior IFN/RBV experience, genotype 4: no cirrhosis—Epclusa plus RBV 12 wks if Y93 RAS is present, Epclusa 12 wks, Harvoni 12 wks, or Mavyret 8 wks; compensated cirrhosis—Epclusa plus RBV 12 wks, Epclusa 12 wks, Mavyret 12 wks, or Zepatier 12 wks; decompensated cirrhosis—no currently FDA-approved treatment regimen is identified in the source pathway.
NS3 protease-inhibitor experience: no cirrhosis—Epclusa 12 wks, Harvoni 12 wks, or Mavyret 8 wks; compensated cirrhosis—Epclusa 12 wks or Mavyret 8 wks; decompensated cirrhosis—Harvoni plus RBV 12 wks.
SOF-experienced and NS5A-naive: genotype 1—Epclusa 12 wks; genotype 2—no currently FDA-approved treatment regimen identified. Other listed SOF-experienced pathways include Epclusa 12 wks or Mavyret 12 wks where specified.
NS5A-experienced: genotype 1—Vosevi (sofosbuvir/velpatasvir/voxilaprevir) 12 wks; genotype 2—no currently FDA-approved treatment regimen identified. Alternative genotype 1a or 1b pathways include Mavyret 16 wks.
DAA-experienced: Mavyret 16 wks or Vosevi 12 wks where specified; genotype 1, 4, 5, or 6 pathways generally use Vosevi 12 wks, while some genotype 2 pathways have no currently FDA-approved treatment regimen identified.
For specified prior-treatment or resistance pathways, no currently FDA-approved treatment regimen is identified; do not substitute an unlisted regimen without plan review and authorization.

Pediatric pathways

Epclusa and Harvoni are listed for patients at least 3 years old, with product-specific pediatric dosing.
Mavyret is listed for patients at least 3 years old, with weight-based dosing: under 17 kg—150 mg/60 mg once daily; 17 kg to under 30 kg—200 mg/80 mg once daily; at least 30 kg—250 mg/100 mg once daily.
Epclusa pediatric dosing: under 17 kg—150 mg/37.5 mg once daily; 17 kg to under 30 kg—200 mg/50 mg once daily; at least 30 kg—400 mg/100 mg once daily.
Harvoni pediatric dosing is weight-based and must follow the applicable product labeling and requested regimen pathway.

The shortened course applies if HCV RNA is less than 6 million.

Retreatment post-treatment RNA

ClassificationRetreatment is used when prior DAA therapy did not result in sustained virologic response and another course is needed.

Post-treatment RNAHCV RNA is detectable at 12 weeks after treatment.

GenotypeThe HCV genotype is the same before and after the initial treatment regimen.

Reinfection post-treatment RNA

ClassificationReinfection follows an HCV treatment regimen that resulted in sustained virologic response.

Post-treatment RNAHCV RNA is detectable more than 12 weeks after treatment.

GenotypeThe HCV genotype is different after the initial treatment regimen.

Current infectionThe current infection has been present for at least 6 months.

Pediatric treatment age

Minimum ageAt least 3 years old.

Identified regimensPediatric treatment options include Epclusa, Harvoni, and Mavyret, depending on the clinical situation.

Dosing basisPediatric dosing is determined by body-weight bands.

Pediatric body-weight bands

Epclusa and HarvoniLess than 17 kg; 17 kg to less than 30 kg; or at least 30 kg.

MavyretLess than 17 kg; 17 kg to less than 35 kg; or at least 30 kg, as displayed in the source table.

Dosing methodPediatric doses are based on body weight.

For HCV-uninfected recipients of non-liver organs from HCV-viremic donors, covered pangenotypic options include Epclusa for 12 weeks or Mavyret for 8 weeks; genotype documentation is not required.
Document whether the patient has no cirrhosis, compensated cirrhosis, or decompensated cirrhosis (Child-Turcotte-Pugh [CTP] class B or C).

Documentation Required

Provide Recent Viral-Load and Laboratory Results

Submit a quantitative HCV RNA result obtained within 180 days of the therapy application. For patients with cirrhosis, baseline laboratory values must be within 90 days of the prior authorization request.

Clearly identify the collection date and quantitative HCV RNA value.
Include current laboratory results supporting the cirrhosis assessment and treatment plan when applicable.

Documentation Required

Document Fibrosis Assessment

Submit a liver biopsy or another accepted fibrosis assessment to document disease stage and cirrhosis status.

Accepted methods include FibroSure, Hepascore/FibroScore, FibroScan, point shear wave elastography (PSWE), and acoustic radiation force impulse imaging (ARFI).
Identify whether the patient has no cirrhosis, compensated cirrhosis, or decompensated cirrhosis (CTP B or C).
A fibrosis assessment is not required for treatment of HCV-uninfected recipients of non-liver organs from HCV-viremic donors.

Documentation Required

Document Treatment History and Resistance

Provide the patient's complete previous HCV treatment history and treatment outcomes. Include drug-resistance testing when indicated and submit the applicable resistance results.

State whether the patient is treatment-naive, interferon/ribavirin experienced, or experienced with a direct-acting antiviral (DAA).
Document prior treatment failure, relapse, or other outcome and identify the prior regimen when known.
Include relevant NS5A, NS3 protease inhibitor, Y93, or other resistance-associated substitution results when required by the proposed regimen.

Documentation Required

Document HIV and HBV Status

Document HIV and HBV status before therapy. If HIV-positive or if active HBV disease is present, provide the current antiretroviral regimen and degree of viral suppression within 6 months of the therapy application.

For HIV infection, identify the current antiretroviral regimen and viral-suppression status.
For active HBV disease, identify the current antiretroviral regimen and viral-suppression status.
Explain any clinically relevant interaction or coordination considerations between the proposed HCV regimen and antiretroviral therapy.

Documentation Required

Document Adherence and Treatment Plan

The treating provider should develop and submit a treatment plan and assess the patient's ability to adhere to therapy. The plan should identify the regimen, duration, monitoring approach, and any need for ribavirin.

Document the patient's ability to adhere to the full course of treatment and the interventions planned to address adherence barriers.
A sample treatment-plan document may be used.
If a ribavirin-containing regimen is prescribed, document the rationale, monitoring plan, and contraception counseling.

Denial Risk

FDA-Approved Indication Required

Requests may be denied when the proposed drug therapy is not consistent with an FDA-approved indication or when the submitted clinical information does not support the requested use.

Match the requested drug, dose, duration, genotype, cirrhosis status, prior-treatment status, age, and resistance findings to an FDA-approved indication.
RBV means ribavirin; IFN means interferon; CTP means Child-Turcotte-Pugh.
Do not request therapy for unsupported clinical use or a regimen lacking an applicable FDA-approved indication.

Prior Authorization

Classify Prior DAA Exposure

Classify prior DAA exposure and submit both the pre-DAA and post-DAA genotype when the patient has previously received DAA therapy. Use the classification to select the applicable retreatment regimen.

For prior DAA exposure, document the genotype before DAA treatment and the genotype after DAA treatment, as applicable.
Identify the prior exposure category, including sofosbuvir (SOF)-experienced/NS5A-naive, NS5A-experienced, NS3 protease-inhibitor-experienced, or other DAA-experienced status.
For DAA-experienced patients, regimen options in the source include Vosevi (sofosbuvir/velpatasvir/voxilaprevir) for 12 weeks; selected alternatives include Mavyret for 16 weeks. Some retreatment scenarios have no currently FDA-approved regimen.
Do not treat a prior-DAA request as treatment-naive; submit prior regimen, outcome, resistance information, and the applicable pre- and post-DAA genotype documentation.

Step Therapy

Regimen-Specific Restrictions

Select a covered regimen and duration according to genotype, cirrhosis status, treatment history, resistance findings, and prior DAA exposure. The following options and restrictions are identified in the clinical criteria.

Pangenotypic and donor-derived infection: For HCV-uninfected recipients of non-liver organs from HCV-viremic donors, Epclusa (sofosbuvir/velpatasvir) is covered for 12 weeks or Mavyret (glecaprevir/pibrentasvir) for 8 weeks.
Genotypes 1a/1b, treatment-naive: No cirrhosis generally permits Epclusa for 12 weeks, Harvoni (ledipasvir/sofosbuvir) for 8 weeks when HCV RNA is <6 million or for 12 weeks, Mavyret for 8 weeks, and selected Zepatier (elbasvir/grazoprevir) for 12 weeks when no NS5A RAS is present. Compensated cirrhosis generally permits Epclusa for 12 weeks, Harvoni for 12 weeks, Mavyret for 8 weeks, and Zepatier for 12 weeks when no NS5A RAS is present. Decompensated cirrhosis generally requires Epclusa plus ribavirin or Harvoni plus ribavirin for 12 weeks; alternatives include Epclusa or Harvoni for 24 weeks in specified scenarios.
Genotype 2: No cirrhosis or compensated cirrhosis generally permits Epclusa for 12 weeks or Mavyret for 8 weeks. Decompensated cirrhosis generally permits Harvoni for 24 weeks or Epclusa plus ribavirin for 12 weeks; Epclusa for 24 weeks is listed as an alternative in specified scenarios.
Genotype 3: No cirrhosis generally permits Epclusa or Mavyret for 12 weeks. Compensated cirrhosis generally permits Epclusa for 12 weeks when no Y93 RAS is present or Mavyret for 8 weeks. Decompensated cirrhosis generally permits Epclusa for 12 weeks when no Y93 RAS is present or Epclusa plus ribavirin for 12 weeks; Epclusa for 24 weeks is listed as an alternative. When Y93 RAS is present, Epclusa plus ribavirin for 12 weeks is listed in the alternative-regimen criteria.
Genotype 4: No cirrhosis or compensated cirrhosis generally permits Epclusa, Harvoni, or Mavyret for 12, 12, or 8 weeks respectively, with Zepatier for 12 weeks listed in specified scenarios. Decompensated cirrhosis generally requires Epclusa plus ribavirin or Harvoni plus ribavirin for 12 weeks; Epclusa or Harvoni for 24 weeks may be listed as alternatives.
Genotypes 5 or 6: No cirrhosis generally permits Harvoni for 12 weeks or Mavyret for 8 weeks; compensated cirrhosis generally permits Mavyret for 8 weeks. Decompensated cirrhosis generally permits Harvoni plus ribavirin for 12 weeks, with Epclusa for 24 weeks listed as an alternative.
Prior interferon/ribavirin experience: Regimens include Epclusa for 12 weeks, Mavyret for 8 or 12 weeks, and genotype- and cirrhosis-specific Zepatier or Harvoni options; decompensated cirrhosis may require ribavirin-containing therapy. Submit the prior outcome and resistance information.
Prior DAA experience: Retreatment options include Vosevi for 12 weeks and, in specified categories, Mavyret for 16 weeks or Epclusa for 12 weeks. Some combinations of genotype, prior exposure, cirrhosis, and resistance have no currently FDA-approved treatment regimen.
Pediatric use: Epclusa, Harvoni, and Mavyret options are identified for patients at least 3 years old, with dosing determined by product-specific age and body-weight requirements.
Use ribavirin-containing regimens only when the applicable clinical scenario supports them and include the required contraception documentation.

Denial Risk

Ribavirin Contraception Required

When a ribavirin-containing regimen is prescribed and the patient or the patient's partner is of childbearing age, use at least two forms of contraception.

Contraception may be used by the patient or the patient's partner.
Use both forms throughout the duration of ribavirin-containing therapy and for 6 months after the regimen is completed.
Document contraception counseling and the selected methods in the treatment plan.

AbbreviationCTP.

MeaningChild-Turcotte-Pugh classification.

Decompensated cirrhosisThe regimen tables designate decompensated cirrhosis as CTP class B or C.

Retreatment

DefinitionRetreatment follows previous exposure to an HCV direct-acting antiviral regimen that did not result in sustained virologic response.

Current needThe patient requires an additional course of therapy for chronic HCV infection.

Required findingsDetectable HCV RNA at 12 weeks after treatment and the same HCV genotype before and after the initial regimen.

Reinfection

DefinitionReinfection follows an HCV treatment regimen that resulted in sustained virologic response.

Post-treatment RNAHCV RNA is detectable more than 12 weeks after treatment.

GenotypeThe genotype is different after the initial treatment regimen.

Duration of current infectionThe current infection has been present for at least 6 months.

Listed options include Epclusa or Mavyret for no cirrhosis or compensated cirrhosis, with Epclusa plus ribavirin or a 24-week Epclusa alternative for specified decompensated or resistance scenarios.

Y93 RAS status affects some Epclusa pathways.

Genotypes 4, 5, and 6: Listed options include Epclusa, Harvoni, and Mavyret, with Zepatier in selected genotype 4 pathways. Decompensated cirrhosis may require ribavirin-containing therapy or a 24-week alternative.8, 12, or 24 weeks

Genotypes 5 and 6 have more limited listed options.

Pediatric therapy: For pediatric patients who are treatment-naive or interferon-experienced, listed options are Epclusa, Harvoni, and/or Mavyret depending on genotype. Pediatric treatment is identified for patients at least 3 years old and uses body-weight-based dosing.Age ≥3 years

Product-specific pediatric weight bands and doses apply.