CurrentAdvanced HealthPolicy N/A

Hepatitis C Direct-Acting Antiviral Therapy

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Coverage and prior authorization for direct-acting antiviral regimens used to treat hepatitis C infection in adults, adolescents, and children, based on genotype, prior treatment, cirrhosis status, age, and safety considerations.

Policy Summary

PayerAdvanced Health

PolicyHepatitis C Direct-Acting Antiviral Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the diagnosis, ICD-10 code, baseline quantitative HCV RNA level, requested regimen, genotype, age, treatment status, and cirrhosis status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8-24 weeksLength of authorization

1-6Genotypes addressed

Age 3+Pediatric dosing begins

2 formsBirth control methods for ribavirin

CTP B/C

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CurrentAdvanced HealthPolicy N/A

Hepatitis C Direct-Acting Antiviral Therapy

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Sign up for all advancedhealth policy alerts

Know when advancedhealth releases new policies or updates existing guidance.

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Policy Summary

PayerAdvanced Health

PolicyHepatitis C Direct-Acting Antiviral Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the diagnosis, ICD-10 code, baseline quantitative HCV RNA level, requested regimen, genotype, age, treatment status, and cirrhosis status.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

8-24 weeksLength of authorization

1-6Genotypes addressed

Age 3+Pediatric dosing begins

2 formsBirth control methods for ribavirin

CTP B/C

Protease inhibitor restriction

Coverage Criteria

General Approval and Treatment-History Criteria

Coverage requires all applicable criteria below to be met.

ALL applicable criteria

The diagnosis being treated is documented, including the applicable ICD-10 code.
The request is for treatment of hepatitis C virus (HCV) infection.
A baseline quantitative HCV RNA level is documented.
The prescribed regimen is appropriate for the patient's HCV genotype, age, treatment status (treatment-naive, reinfection, or treatment-experienced), and cirrhosis status.
If the patient has prior HCV treatment experience, the prior direct-acting antiviral (DAA) regimen, viral load after treatment, and treatment outcome are documented.
The requested regimen and treatment duration are consistent with the recommended regimen tables and applicable clinical criteria.

Adult and Adolescent Regimen Selection

For adults and adolescents 12 years of age and older, select the recommended regimen according to treatment history and cirrhosis status.

ONE applicable treatment-history pathway

Treatment-naive, confirmed reinfection, or prior pegylated interferon/ribavirin treatment
- Genotype 1–6, non-cirrhotic or compensated cirrhosis: SOF/VEL for 12 weeks or G/P for 8 weeks.
- Genotype 1–6 with compensated cirrhosis after reinfection or prior pegylated interferon/ribavirin treatment: G/P for 8 weeks or SOF/VEL for 12 weeks; SOF/VEL for genotype 3 requires baseline resistance testing as recommended.
- Genotype 1–6 with decompensated cirrhosis: SOF/VEL plus ribavirin for 12 weeks, or SOF/VEL for 24 weeks if ribavirin-ineligible.
Treatment-experienced or DAA treatment failure

Pediatric Regimen Selection

For children ages 3 through 12 years, select the regimen according to treatment history and cirrhosis status.

ONE applicable pediatric pathway

Treatment-naive genotype 1–6 with non-cirrhotic or compensated cirrhosis: SOF/VEL for 12 weeks or G/P for 8 weeks.
Treatment-naive genotype 1–6 with decompensated cirrhosis, confirmed reinfection, or prior pegylated interferon/ribavirin treatment: SOF/VEL plus ribavirin for 12 weeks.
Treatment-experienced pediatric patients previously treated with other DAAs: efficacy and safety data are extremely limited; an adult recommended regimen may be considered only when FDA-approved for pediatric use, with hepatologist consultation.

Regimen-Specific Safety and Resistance Criteria

Additional safety and resistance criteria apply when the requested regimen or clinical history warrants them.

ALL applicable regimen-specific criteria

For specified genotype or treatment-history regimens
- For elbasvir/grazoprevir in genotype 1a infection, ledipasvir/sofosbuvir in genotype 1a treatment-experienced infection, or SOF/VEL in genotype 3 cirrhosis or treatment-experienced infection, a baseline NS5A resistance test is obtained and documents whether a resistance-associated variant is present.
- For SOF/VEL in genotype 3 with compensated cirrhosis, baseline resistance testing is recommended.
If a mixed genotype is identified, a pangenotypic regimen is appropriate because treatment data for mixed genotypes with DAAs are limited.
Ribavirin ineligibility or intolerance, when used to support selection of a ribavirin-free regimen, is documented. Examples include neutrophils below 750/mm3, hemoglobin below 10 g/dL, platelets below 50,000 cells/mm3, autoimmune hepatitis or another autoimmune condition, or hypersensitivity/allergy to ribavirin.

Regimens containing a protease inhibitor—including elbasvir, glecaprevir, simeprevir, paritaprevir, or voxilaprevir—should not be used in patients with moderate to severe hepatic impairment (Child-Turcotte-Pugh class B or C). There are limited data supporting DAA regimens in treatment-experienced patients with decompensated cirrhosis; these cases should be managed individually with the patient, prescriber, and CCO or FFS medical director.

Ribavirin-containing regimens are absolutely contraindicated in pregnant women and in male partners of women who are pregnant. When a ribavirin-containing regimen is selected, documented use of two forms of birth control is required for the patient and applicable sex partners.

Coverage is denied for requests that are not for treatment of HCV infection, lack documentation of the diagnosis or baseline quantitative HCV RNA, or use a regimen inconsistent with the patient's genotype, age, treatment history, reinfection or treatment-failure status, or cirrhosis status. DAA safety and efficacy have not been established in children younger than 3 years; such requests require denial for medical appropriateness unless otherwise supported by applicable FDA approval and clinical review.

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Triggers

Prior authorization is required for preferred regimens when the patient has prior treatment experience with a direct-acting antiviral (DAA), and for non-preferred DAAs.

Preferred regimens for patients with prior DAA treatment experience
Non-preferred direct-acting antivirals (DAAs)

Prior Authorization

Authorization Duration

Authorization duration must match the approved treatment regimen and may range from 8 to 24 weeks.

Approve only for the duration indicated for the approved regimen
Authorization range: 8–24 weeks

Clinical Background

Hepatitis C direct-acting antiviral selection is guided by the patient’s viral genotype, prior treatment exposure, cirrhosis status, age, and resistance considerations. The policy distinguishes treatment-naive, treatment-experienced, reinfection, and prior treatment-failure populations, with regimen selection and duration varying accordingly. Pediatric treatment is addressed for children ages 3 through 12 years; efficacy and safety data are limited for children with prior treatment using other direct-acting antivirals.

Definitions

Treatment-naivePatients without prior HCV treatment.

Definitions

Treat as treatment-naivePatients who discontinued HCV DAA therapy within 4 weeks of initiation or have confirmed reinfection after achieving SVR following HCV treatment.

Definitions

Treatment-experiencedPatients who received more than 4 weeks of HCV DAA therapy.

Definitions

RAV

Initial Therapy

Initial Treatment

Initial therapy is covered when the regimen matches genotype, treatment history, age, and cirrhosis status.

Adult or adolescent initial therapy

For genotypes 1 through 6 with non-cirrhotic or compensated cirrhosis, use SOF/VEL for 12 weeks or G/P for 8 weeks.SOF/VEL x 12 weeks; G/P x 8 weeks
For genotypes 1 through 6 with decompensated cirrhosis, use SOF/VEL plus ribavirin for 12 weeks.SOF/VEL + RBV x 12 weeks

Pediatric initial therapy

The patient is 3 through 12 years of age with genotype 1 through 6 infection.Age 3-12 years; genotypes 1-6

Continuation and Retreatment

Retreatment and Continuation

Continuation or retreatment coverage depends on prior DAA response and documented treatment failure or reinfection.

Reinfection

Reinfection is documented by ongoing hepatitis C reinfection risk or a different genotype than the previous infection.
The patient is treated according to the treatment-naive regimen appropriate for the patient's genotype, age, and cirrhosis status.

Treatment failure

Prior DAA treatment, post-treatment viral load, outcome, and sustained virological response status at week 12 or later are documented.
The current regimen corresponds to the prior failed DAA regimen, genotype, and cirrhosis status, including SOF/VEL/VOX, G/P-based retreatment, or multiple-failure regimens as listed in the policy tables.

Preferred Regimens and Step Therapy

Step	Regimen selection	Prior authorization requirement
1	Use cost-effective treatments supported by medical evidence and select the appropriate regimen based on prior treatment experience and genotype.	Preferred regimens generally follow this approach; PA is required when the patient has prior treatment experience with a DAA.
1	Use the preferred regimen when clinically appropriate.	PA is required for non-preferred direct-acting antivirals.

Policy Summary

PayerAdvanced Health

PolicyHepatitis C Direct-Acting Antiviral Therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionDocument the diagnosis, ICD-10 code, baseline quantitative HCV RNA level, requested regimen, genotype, age, treatment status, and cirrhosis status.

SourceLink

On This Page

Treatment-experienced genotype 1–6 with decompensated cirrhosis: SOF/VEL plus ribavirin for 12 weeks, or SOF/VEL for 24 weeks if ribavirin-ineligible; treatment-experienced patients with decompensated cirrhosis require case-by-case management.

Sofosbuvir-based regimen failure, including failure of sofosbuvir plus ribavirin, ledipasvir/sofosbuvir, or sofosbuvir/velpatasvir, with non-cirrhotic or compensated cirrhosis: SOF/VEL/VOX for 12 weeks or G/P for 16 weeks, except for genotype 3.

Elbasvir/grazoprevir treatment failure with non-cirrhotic or compensated cirrhosis: SOF/VEL/VOX for 12 weeks.

Glecaprevir/pibrentasvir treatment failure with non-cirrhotic or compensated cirrhosis: G/P plus SOF plus ribavirin for 16 weeks, or SOF/VEL/VOX for 12 weeks, with ribavirin added if compensated cirrhosis.

Multiple DAA treatment failures, including failure of SOF/VEL/VOX or G/P plus sofosbuvir, with non-cirrhotic or compensated cirrhosis: G/P plus SOF plus ribavirin for 16–24 weeks, or SOF/VEL/VOX for 24 weeks.

The selected regimen is not being used in a manner inconsistent with the patient's age, cirrhosis status, genotype, or prior DAA exposure.

Documentation Required

Diagnosis and Baseline Viral Load

Document the condition being treated, the applicable ICD-10 code, and the patient’s baseline quantitative HCV RNA level. Requests not treating hepatitis C infection should be denied as medically inappropriate.

Record the diagnosis and ICD-10 code
Document baseline quantitative HCV RNA
If the request is not for hepatitis C infection treatment, deny for medical inappropriateness

Documentation Required

Clinical Treatment History

Document the complete clinical treatment context, including the requested regimen, HCV genotype, patient age, treatment status, and cirrhosis status. Treatment status should distinguish treatment-naïve, retreatment/treatment-experienced, confirmed reinfection, and prior pegylated interferon/ribavirin treatment; pediatric requests require attention to age-specific safety and efficacy.

Requested regimen
HCV genotype
Patient age
Treatment status: treatment-naïve, retreatment/treatment-experienced, or confirmed reinfection
Cirrhosis status, including decompensated cirrhosis

Documentation Required

Prior DAA Response

For patients previously treated with a DAA, document the prior regimen, viral load after treatment, and outcome. Record whether sustained virological response (SVR) was achieved at week 12 or later, and determine whether the current infection represents reinfection or treatment failure so the patient is treated under the appropriate pathway.

Document prior DAA regimen, post-treatment viral load, and outcome when prior DAA treatment is reported
Document SVR status
Evaluate ongoing reinfection risks or a different genotype as evidence of likely reinfection
If SVR was not achieved, document treatment failure and treat as indicated for treatment-experienced infection

Documentation Required

Baseline Resistance Testing

Baseline NS5A resistance testing is required when applicable to the requested regimen. Document the test and its result, including any resistance-associated variant to an agent in the relevant regimen.

Obtain and document baseline NS5A resistance testing
Record whether a resistant variant is present and identify the affected agent

Unsupported block type: denial_risk

A resistance-associated variant identified by baseline NS5A resistance testing.

Cirrhosis status and regimen

For non-cirrhotic or compensated cirrhosis, use SOF/VEL for 12 weeks or G/P for 8 weeks.SOF/VEL x 12 weeks; G/P x 8 weeks
For decompensated cirrhosis, use SOF/VEL plus ribavirin for 12 weeks.SOF/VEL + RBV x 12 weeks