CurrentGeorgia Department of Community HealthPolicy N/A

Hepatitis C Antiviral Agents — Prior Authorization Coverage Criteria

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Defines prior authorization (PA) coverage criteria, exceptions, and quantity limits for hepatitis C antiviral agents for Georgia Medicaid FFS members; applies to providers requesting PA through OptumRx.

Policy Summary

PayerGeorgia Department of Community Health

PolicyHepatitis C Antiviral Agents — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests through the OptumRx PA process; follow the Prior Authorization Request Process Guide.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Multipleantiviral products

Age-specificage-based notes

OptumRxPA process

Quantity limitsQLL referenced

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CurrentGeorgia Department of Community HealthPolicy N/A

Hepatitis C Antiviral Agents — Prior Authorization Coverage Criteria

Customize your policy alerts

Sign up for all Georgia Department of Community Health policy alerts

Know when Georgia Department of Community Health releases new policies or updates existing guidance.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerGeorgia Department of Community Health

PolicyHepatitis C Antiviral Agents — Prior Authorization Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization requests through the OptumRx PA process; follow the Prior Authorization Request Process Guide.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Multipleantiviral products

Age-specificage-based notes

OptumRxPA process

Quantity limitsQLL referenced

Agent-Specific Coverage Criteria

Epclusa

Covered when ALL of the following are met

Epclusa approvals: Member is ≥3 years old with chronic HCV infection AND is treatment-naïve or previously treated with a peginterferon/ribavirin regimen or previously treated with a sofosbuvir- or NS5A inhibitor–based regimenage >= 3 years

Members with decompensated cirrhosis must take Epclusa with ribavirin when clinically appropriate.

Harvoni / Ledipasvir-Sofosbuvir

Covered when ALL of the following are met (agent-specific variations by age and genotype)

Adult general: Member is ≥18 years with chronic HCV infection (genotype 1,4,5,6) without liver transplant and without cirrhosis or with compensated cirrhosis AND is unable to take sofosbuvir/velpatasvir and Mavyretage >= 18 years

Also approvable for post-liver-transplant without cirrhosis or with compensated cirrhosis if unable to take sofosbuvir/velpatasvir and Mavyret.

Decompensated cirrhosis adults: Genotype 1,4,5,6 with decompensated cirrhosis and unable to take sofosbuvir/velpatasvir

Members must take Harvoni or ledipasvir/sofosbuvir with ribavirin when clinically appropriate.

Pediatrics: Members 3–17 years with genotype 1,4,5,6 chronic HCV infection without cirrhosis or with compensated cirrhosis AND unable to take sofosbuvir/velpatasvir and Mavyretage 3-17 years

Must use ribavirin when clinically appropriate.

Sovaldi

Covered when ALL of the following are met (agent- and genotype-specific combinations required)

General: Member is treatment-naïve or previously treated with an interferon-based regimen or previously treated with Mavyret, Vosevi, or Sovaldi+Mavyret

Members must take Sovaldi with peginterferon/ribavirin or ribavirin as specified per genotype.

Adult genotype-specific: Members ≥18 years with chronic HCV without cirrhosis or with compensated cirrhosis meeting genotype-specific requirements (1,2,3,4) and unable to take sofosbuvir/velpatasvir and Mavyret; regimen combinations differ by genotype (see policy).age >= 18 years

Examples: genotype 1 requires inability to take sofosbuvir/velpatasvir and Mavyret and use with peginterferon/ribavirin; genotype 2 or 3 require inability and use with ribavirin; genotype 3 with compensated cirrhosis and prior peginterferon/ribavirin failure must be unable to take Vosevi and use Sovaldi with Zepatier; genotype 4 requires peginterferon/ribavirin.

Pediatrics: Members 3–17 years with genotype 2 or 3 chronic HCV infection without cirrhosis or with compensated cirrhosis and unable to take sofosbuvir/velpatasvir and Mavyret

Zepatier

Covered when ALL of the following are met (age/weight, genotype, prior treatment, and resistance testing as applicable)

Age/weight: Member is ≥12 years old and weighs ≥30 kgage >= 12 years; weight >= 30 kg

Genotype 3 specific: Genotype 3 with compensated cirrhosis and prior failure with peginterferon/ribavirin and unable to take Vosevi; Zepatier must be given with Sovaldi

Genotype 1/4 specific: Genotype 1 (1a or 1b) or 4; for genotype 1a baseline NS5A resistance testing required and member must be unable to take sofosbuvir/velpatasvir and Mavyret

Zepatier must be used with ribavirin if genotype 1a with baseline NS5A polymorphisms or genotype 4 with prior peginterferon/ribavirin failure.

Use of Harvoni (ledipasvir/sofosbuvir), Sovaldi (sofosbuvir), or Zepatier (elbasvir/grazoprevir) is limited when the member is able to take preferred agents. Coverage for these agents requires that the member be unable to take sofosbuvir/velpatasvir (Epclusa) and Mavyret as specified in the drug-specific criteria.

For Harvoni: approvals require that members meeting the agent’s age and genotype criteria must be unable to take sofosbuvir/velpatasvir and Mavyret (see Harvoni criteria for adult and pediatric age ranges and cirrhosis/transplant status).

For Sovaldi: approval requires inability to take sofosbuvir/velpatasvir and Mavyret and the appropriate genotype-specific companion agents (e.g., peginterferon/ribavirin, ribavirin, Zepatier) as outlined in the Sovaldi criteria.

For Zepatier: approval requires that members (including those with genotype 1a or 4 where applicable) be unable to take sofosbuvir/velpatasvir and Mavyret; genotype 1a also requires baseline NS5A resistance testing per the Zepatier criteria.

Prior Authorization and Provider Requirements

Prior Authorization

Prior authorization required

Prior authorization is required for hepatitis C antiviral agents; exceptions to the conditions of coverage are considered through the prior authorization process with OptumRx.

Step Therapy

Coverage depends on prior treatment history

Coverage for each agent is contingent on the member’s prior treatment history (e.g., treatment‑naïve vs previously treated with peginterferon/ribavirin, NS5A‑ or sofosbuvir‑containing regimens, or other specified prior regimens) and inability to take preferred agents (sofosbuvir/velpatasvir, Mavyret) as specified for each drug.

Examples: Epclusa approvable for treatment‑naïve or previously treated with peginterferon/ribavirin or sofosbuvir‑ or NS5A‑based regimens (Epclusa).
Harvoni approvable based on genotype and prior therapy and only if unable to take sofosbuvir/velpatasvir and Mavyret (Harvoni).
Sovaldi approvable for specific prior regimens and genotypes with required companion agents (Sovaldi).
Zepatier approvable with genotype‑ and prior‑treatment–specific requirements including NS5A resistance testing for genotype 1a (Zepatier).

Documentation Required

Submit PA via OptumRx and follow PA Request Process Guide

Submit prior authorization requests through the OptumRx prior authorization process; online guidance and the Prior Authorization (PA) Request Process Guide are available via the DCH website.

Online access: www.dch.georgia.gov/prior-authorization-process-and-criteria and click Prior Authorization (PA) Request Process Guide.
The PA process may be initiated by calling OptumRx at 1-866-525-5827.

Denial Risk

Denial risk if PA criteria not met; exceptions via PA

Requests that do not meet the stated PA criteria may be denied; exceptions can be requested and are considered through the prior authorization process initiated with OptumRx.

Exceptions to conditions of coverage are considered through the PA process.
Contact OptumRx at 1-866-525-5827 to initiate exception review.

Clinical Background

Chronic hepatitis C virus (HCV) treatment selection depends on patient factors including HCV genotype, prior treatment history, presence or absence of cirrhosis (compensated vs decompensated), liver transplant status, and age/weight for pediatric patients. Some regimens also require baseline resistance testing (for example, NS5A testing with Zepatier for genotype 1a) or combination with ribavirin when clinically appropriate.

Therapy choice follows the policy’s agent-specific criteria: Epclusa (sofosbuvir/velpatasvir) is approvable for members ≥3 years and is preferred when clinically indicated; Harvoni and Sovaldi have age-, genotype-, and prior-treatment–specific requirements and are approvable only when members are unable to take sofosbuvir/velpatasvir and Mavyret as specified; Zepatier is approvable for members ≥12 years and ≥30 kg with genotype- and resistance-specific conditions.

Providers must submit prior authorization requests through OptumRx and follow the policy criteria to demonstrate medical necessity for the selected regimen and any required companion agents (e.g., ribavirin), or the request may be denied or considered only as an exception through the PA process.

Key Terms and Testing Requirements

Decompensated cirrhosis — definition and treatment implications

DefinitionLiver disease with evidence of liver function compromise (decompensated cirrhosis).

Treatment implication — EpclusaMembers with decompensated cirrhosis must take Epclusa in combination with ribavirin when clinically appropriate.

General regimen noteSome direct-acting antiviral regimens require addition of ribavirin for members with decompensated cirrhosis when clinically appropriate.

Provider actionAssess cirrhosis status (compensated vs decompensated) before selecting regimen; document need for ribavirin when required by policy.

NS5A resistance testing — Baseline NS5A polymorphism testing required

DefinitionBaseline testing for NS5A resistance-associated polymorphisms (NS5A resistance testing).

When requiredBaseline NS5A resistance testing is required for members with genotype 1a who are to be treated with Zepatier.

Associated treatment implicationIf baseline NS5A polymorphisms are present in genotype 1a, Zepatier must be used in combination with ribavirin.

Eligibility contextRequirement applies to members ≥12 years old and ≥30 kg with genotype 1a (or genotype 1/4 where specified) who are unable to take sofosbuvir/velpatasvir and Mavyret.