CurrentUnitedHealthcarePolicy N/A

Prior authorization form for Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C

This prior authorization form documents requirements prescribers must submit to UnitedHealthcare to evaluate coverage for Epclusa in beneficiaries with chronic hepatitis C (all genotypes); it governs clinical, laboratory, and administrative information required for treatment approval.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization form for Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach required documentation including genotype (unless treatment‑naïve) and baseline quantitative HCV RNA within 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6+HCV genotypes listed (1-6)

>=6 yrs / >=17 kgMinimum age/weight

Lab requiredBaseline HCV RNA

RequiredGenotype documentation

12 wksTherapy length option

Coverage Criteria for Epclusa (sofosbuvir/velpatasvir)

Initial Therapy — Covered when ALL of the following are met:

Covered when ALL of the following are met:

Eligibility: Beneficiary is 6 years of age or older AND weight at least 17 kgage >=6 yrs; weight >=17 kg

from form eligibility question

Diagnosis: Documented diagnosis of chronic hepatitis C (CHC) with genotype 1-6 must be submitted (genotype documentation waived for treatment-naïve beneficiaries)genotype documented or treatment-naïve

lab/genotype requirement

Baseline viral load: Documented quantitative HCV RNA at baseline tested within the past 6 months must be submitted

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization form for Epclusa (sofosbuvir/velpatasvir) for chronic hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach required documentation including genotype (unless treatment‑naïve) and baseline quantitative HCV RNA within 6 months.

SourceLink

On This Page

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HCV RNA within 6 months

baseline viral load required

Clinical benefit attestation: Prescriber indicates they are reasonably certain that treatment will improve the beneficiary's overall health status and signs the form (prescriber signature mandatory)signed attestation

prescriber signature mandatory

Contraindications: No unresolved FDA‑labeled contraindications to Epclusano contraindications

provider must confirm

Concurrent sofosbuvir use: Epclusa must not be used in combination with other drugs containing sofosbuvir unless documented and justifiednot used with other sofosbuvir-containing drugs or documentation provided

provider must indicate if used in combination

Prior therapy / step therapy query: Provider documents whether beneficiary has tried and failed 2 preferred medications in this class and provides names or documents contraindications to preferred agents

step therapy information requested on form

Administrative completeness: Completed beneficiary and prescriber information, drug name/strength/quantity, requested length of therapy, and prescriber NPI and fax as applicable are provided on the PA form

required form fields

The form specifically asks whether Epclusa (sofosbuvir/velpatasvir) will be used concurrently with other sofosbuvir-containing drugs and requires the provider to indicate this on the PA request. Use of Epclusa in combination with other drugs that contain sofosbuvir is monitored and must be documented; concurrent use is not permitted without explanation and supporting documentation submitted with the request. The form also requires the prescriber to confirm there are no FDA‑labeled contraindications to Epclusa for the beneficiary and to disclose any such contraindications if present.

Requests that do not include the required supporting documentation — including medical records demonstrating CHC genotype and subtype (unless the beneficiary is treatment‑naïve) and a baseline quantitative HCV RNA performed within the past 6 months — may not be approved. Similarly, requests with unresolved FDA‑labeled contraindications to Epclusa must be addressed before approval; if not resolved, the request may be considered not medically necessary or denied. The prescriber’s mandatory signature and completion of the form fields are required for prior authorization processing.

Coding and Eligibility Basics

No billing codes provided on formmixed

N/A	No CPT/HCPCS/ICD-10/NDC codes listed on the form.

Minimum age and weight

Minimum ageBeneficiary must be 6 years of age or older

Minimum weightBeneficiary must weigh at least 17 kg

Applicable diagnosisDiagnosis of chronic hepatitis C (CHC) required (genotype 1–6)

Provider Actions and Prior Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for therapy. Complete and submit the prior authorization form with all requested fields (beneficiary name, UnitedHealthcare ID, date of birth, prescriber NPI and contact/fax, drug name, strength, quantity, and requested length of therapy). Include prescriber signature and date. Requests lacking a completed PA form will not be processed.

Required form fields: Beneficiary name, Beneficiary ID, DOB, Gender
Prescriber: NPI, fax, requester contact name and phone/extension
Drug: name, strength, quantity per 30 days, length of therapy (e.g., 12 weeks)
Prescriber signature and date (mandatory)

Step Therapy

Step Therapy / Prior Medication Trial

Providers must document prior medication history. If step therapy applies, indicate whether the beneficiary has tried and failed two preferred medications in class or has documented contraindications to those preferred agents. Provide names, treatment dates, and reasons for failure or contraindication on the PA form or in submitted records.

If beneficiary tried and failed 2 preferred medications: list medications, dates, and reasons for failure
If contraindication to preferred medications: provide clinical justification and supporting documentation

Documentation Required

Required Documentation

Attach supporting medical records and laboratory results. Approval requires documentation of chronic hepatitis C diagnosis and supporting labs; genotype/subtype documentation is required except when waived for treatment‑naïve beneficiaries. Missing or incomplete documentation may result in denial.

Medical records documenting CHC diagnosis
Genotype and subtype documentation (waived for treatment‑naïve beneficiaries)
Baseline quantitative HCV RNA performed within the past 6 months (report IU/mL and/or log10)
Documentation of contraindications to Epclusa, if claimed

Denial Risk

Documentation‑Related Denial Risk

Requests may be denied if required lab results or clinical documentation are missing. Common denial risks include absence of a baseline quantitative HCV RNA within 6 months, missing genotype/subtype documentation when not treatment‑naïve, or an unsigned/partially completed PA form.

Missing baseline quantitative HCV RNA within past 6 months
Missing genotype/subtype documentation (when not treatment‑naïve)
Incomplete PA form fields or missing prescriber signature

Definitions and Documentation Requirements

Treatment‑naïve waiver

Waiver conditionDocumentation of HCV genotype is waived for beneficiaries who are treatment‑naïve

When genotype requiredIf not treatment‑naïve, medical records documenting genotype and subtype must be submitted

Attachment requirementLab test results must be attached to the prior authorization for approval

Baseline HCV RNA

Required testDocumented quantitative HCV RNA (IU/mL) at baseline is required

TimingHCV RNA test must have been performed within the past 6 months

DocumentationMedical documentation (lab results) must be submitted with the prior authorization

Background

This prior authorization form governs treatment of chronic hepatitis C (CHC) across genotypes 1–6 with Epclusa (sofosbuvir/velpatasvir). Eligibility requires the beneficiary be at least 6 years of age and weigh at least 17 kg. The form requires submission of medical records documenting CHC with genotype and subtype (the genotype requirement is waived for treatment‑naïve beneficiaries) and a documented quantitative HCV RNA at baseline tested within the past 6 months. The prescriber must attest that treatment will improve the beneficiary’s overall health and must sign the form.