CurrentAvMedPolicy N/A

Hepatitis C antiviral pharmacy prior authorization and step-edit

Defines prior authorization, step-therapy, and clinical documentation requirements for direct-acting antiviral (DAA) treatment of hepatitis C virus (HCV) for AvMed members; affects prescribers and pharmacies requesting coverage for listed DAAs.

Policy Summary

PayerAvMed

PolicyHepatitis C antiviral pharmacy prior authorization and step-edit

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed, signed prior authorization form with required documentation including diagnosis, genotype, HCV RNA, treatment history, cirrhosis status, and liver assessment.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

ONE TIMEapproval per member lifetime for any/all DAAs

F0-F4fibrosis scores assessed

8-16 wkstypical regimen durations listed

Prior trialnon-preferred DAA requirement

Coverage and Authorization Criteria

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Initial authorization criteria

Covered when ALL of the following are met

Primary requirements: Provider submits completed, signed prior authorization form with required contact information; medication is prescribed by a gastroenterologist, hepatologist, infectious disease specialist, or transplant specialist; documentation provided (chart notes, laboratory values, test results) confirming diagnosis, genotype, HCV RNA viral load, HCV treatment history, cirrhosis status, and liver assessment (biopsy, FibroScan/Transient elastography, FibroTest/FibroSure, shear wave elastography); for patients <18 years include current weight.

All listed documentation items must be provided; missing items may lead to denial.

Preferred agent trial for non-preferred requests: If requesting a non-preferred DAA, member must have trial and failure, intolerance, or contraindication to BOTH Mavyret and ABA Epclusa or ABA Harvoni (verification via pharmacy paid claims or submitted chart notes).

Preferred agents: Mavyret; ABA Epclusa (sofosbuvir/velpatasvir); ABA Harvoni (ledipasvir/sofosbuvir).

Regimen selection: Regimen and duration are determined by genotype, treatment history (treatment‑naïve or treatment‑experienced, including prior NS5A or NS3/4A PI exposure), cirrhosis status (no cirrhosis, compensated [Child‑Pugh A], decompensated [Child‑Pugh B/C]), transplant status, and pre‑treatment HCV RNA (e.g., Harvoni 8 weeks for genotype 1 treatment‑naïve without cirrhosis and HCV RNA <6 million IU/mL; Harvoni 12 weeks for genotype 1 treatment‑naïve with HCV RNA >6 million IU/mL or compensated cirrhosis).

See drug‑specific regimen guidance for details by agent, genotype, and patient population.

Initial Direct-Acting Antiviral (DAA) Regimen Guidance

Initial DAA regimen guidance

Regimen and duration guidance by drug, genotype, and patient population

Harvoni regimens: Harvoni 8 weeks for genotype 1 treatment‑naïve without cirrhosis and pre‑treatment HCV RNA <6 million IU/mL; Harvoni 12 weeks for genotype 1 treatment‑naïve with HCV RNA >6 million IU/mL or with compensated cirrhosis (Child‑Pugh A); Harvoni 12 weeks for genotype 1 treatment‑experienced without cirrhosis; Harvoni + ribavirin 12 weeks for genotype 1 treatment‑experienced with compensated cirrhosis and for treatment‑naïve or experienced with decompensated cirrhosis (Child‑Pugh B or C); Harvoni + ribavirin 12 weeks for liver transplant recipients without cirrhosis or with compensated cirrhosis for genotypes 1 or 4; Harvoni 12 weeks for genotypes 4, 5, or 6 in treatment‑naïve or experienced without cirrhosis or with compensated cirrhosis.

See document for additional scenarios and ribavirin use.

Mavyret regimens: Mavyret 8 weeks for treatment‑naïve (and certain treatment‑experienced) patients without cirrhosis or with compensated cirrhosis for genotypes 1–6; for certain treatment‑experienced genotype 1 scenarios, durations extend to 12–16 weeks depending on prior NS5A or NS3/4A PI exposure (e.g., treatment‑experienced with prior NS5A inhibitor without prior PI: 16 weeks; prior PI without prior NS5A inhibitor: 12 weeks).

Refer to agent‑specific rows for precise prior‑treatment definitions and durations.

Epclusa regimens: Epclusa 12 weeks for treatment‑naïve and treatment‑experienced patients without cirrhosis and with compensated cirrhosis (Child‑Pugh A) across genotypes 1–6; Epclusa 12 weeks plus ribavirin for decompensated cirrhosis (Child‑Pugh B or C).

See package insert‑based options for other agents (Zepatier, Vosevi, Viekira Pak, Vosevi) where indicated.

Provider Responsibilities, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required for listed direct-acting antivirals (DAAs). Non-preferred medications require documented trial and failure, intolerance, or contraindication to preferred agents before approval.

Prior authorization required for Mavyret, ABA Epclusa, and ABA Harvoni as indicated on the PA form.
Non-preferred DAAs will not be approved without prior authorization and supporting documentation.

Step Therapy

Step Therapy Requirement for Non-Preferred DAAs

If requesting a non-preferred medication, the member must have a trial and failure, intolerance, or contraindication to BOTH Mavyret and ABA Epclusa or ABA Harvoni (as verified by pharmacy paid claims or submitted chart notes).

Verification may be via pharmacy paid claims or submitted chart notes.
Both specified preferred agents must be tried and documented as failed/intolerant/contraindicated for non-preferred coverage.

Documentation Required

Required Clinical Documentation

Provider must submit documentation (chart notes, laboratory values, and test results) to confirm diagnosis, genotype, HCV RNA viral load, HCV treatment history, presence/absence of cirrhosis, liver assessment results, and other relevant information to support the requested treatment and duration.

HCV RNA viral load collected within the previous 6 months.
Liver assessment results (biopsy, FibroScan, FibroTest, shear wave elastography, etc.) and alcohol/toxicology screening when applicable.
CBC and BMP blood test results.
If member <18 years, submit current weight.
Use of samples to initiate therapy does not meet step edit/preauthorization criteria.

Documentation Required

Form Signature and Contact Information

The prescribing physician must sign and clearly print their name on the request form (preprinted stamps are not valid). The form must include office contact name, phone number, fax number, and DEA or NPI. Incomplete contact or signature information may delay processing.

Prescriber signature and printed name (no preprinted stamps).
Office contact name, phone, and fax number must be provided.
DEA or NPI number required on the form.

Denial Risk

Missing or Incomplete Documentation May Delay or Deny Request

Incomplete, incorrect, illegible, or missing required documentation (including signature, contact information, or supporting clinical records) may delay the authorization process or result in denial.

Missing lab results, liver assessment, or HCV RNA viral load may lead to denial.
Incomplete prescriber signature or missing contact/DEA/NPI information may delay processing.

Step Therapy and Non-Preferred Drug Requirements

Requirement	Details
Step therapy requirement for non-preferred DAAs	If requesting a non-preferred medication, the member must have trial and failure, intolerance, or contraindication to BOTH Mavyret and ABA Epclusa or ABA Harvoni (verification via pharmacy paid claims or submitted chart notes).
Preferred agents to trial	Mavyret (glecaprevir/pibrentasvir) and ABA Epclusa or ABA Harvoni — both listed as prior authorization required preferred options that must be tried and failed/intolerant/contraindicated before coverage of a non-preferred DAA.
Authorization note	All supporting documentation (lab results, diagnostics, and chart notes) must be provided to support each criterion; missing documentation may lead to denial or delay.

Clinical Definitions and Treatment History

inv-10: Cirrhosis status — Compensated (Child-Pugh A) and decompensated (Child-Pugh B or C) used to determine regimen and duration

DefinitionsCompensated cirrhosis = Child‑Pugh A; Decompensated cirrhosis = Child‑Pugh B or C

Impact on regimen/durationPresence and stage of cirrhosis (compensated vs decompensated) determine need for longer duration and/or addition of ribavirin (e.g., Harvoni + ribavirin for decompensated disease)

Examples from policyHarvoni: compensated (Child‑Pugh A) → 12 weeks; decompensated (Child‑Pugh B/C) → Harvoni + ribavirin 12 weeks; Epclusa: decompensated → 12 weeks + ribavirin

inv-11: Treatment history — Treatment-naïve vs experienced and prior exposure to NS5A/NS3/4A inhibitors influence recommended regimens

Treatment history categoriesTreatment‑naïve vs treatment‑experienced; prior exposures to NS5A inhibitors or NS3/4A protease inhibitors

Influence on durationPrior treatment experience can lengthen recommended duration (examples: Harvoni 12 weeks for treatment‑experienced without cirrhosis; Mavyret regimens range 8–16 weeks depending on prior exposures)

Specific prior‑exposure scenariosMavyret: treatment‑experienced with prior NS5A but no prior NS3/4A PI → 16 weeks; treatment‑experienced with prior NS3/4A PI but no prior NS5A → 12 weeks

Background on Direct-Acting Antivirals

Direct-acting antivirals (DAAs) are indicated for treatment of chronic hepatitis C virus infection across genotypes and fibrosis stages F0–F4. Regimen selection, treatment duration, and any addition of agents such as ribavirin depend on genotype, prior treatment history (treatment‑naïve vs treatment‑experienced), and cirrhosis status (compensated vs decompensated).

Providers must supply clinical documentation to support DAA therapy, including laboratory results (HCV RNA viral load within the previous 6 months), liver assessment (biopsy, FibroScan or equivalent elastography), CBC, BMP, alcohol/toxicology screening, and for patients under 18 years of age, current weight. These data inform choice of agent and duration (for example, Harvoni duration may be shortened to 8 weeks for certain genotype 1, treatment‑naïve, noncirrhotic patients with low viral load versus 12 weeks in other scenarios).