CurrentUnitedHealthcarePolicy N/A

Sofosbuvir‑Velpatasvir (generic Epclusa) prior authorization for chronic hepatitis C

This document governs prior authorization requirements for sofosbuvir‑velpatasvir for treatment of chronic hepatitis C in beneficiaries; it applies to prescribers requesting pharmacy prior approval in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicySofosbuvir‑Velpatasvir prior authorization for chronic hepatitis C

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization form with required documentation including baseline quantitative HCV RNA (within 6 months) and genotype unless treatment‑naive.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 weekstypical length of therapy specified

>=6minimum beneficiary age for treatment

>=17 kgminimum beneficiary weight for treatment

1-6eligible genotypes

within 6 mobaseline HCV RNA required

Coverage Criteria

Initial therapy — covered when ALL of the following are met

Covered when ALL of the following are met:

Age and weight: Beneficiary is 6 years of age or older and weighs at least 17 kg.age >= 6 years; weight >= 17 kg

From PA form eligibility question requiring age >=6 years and weight >=17 kg.

Diagnosis: Medical records documenting chronic hepatitis C diagnosis with genotype and subtype are submitted (genotype documentation waived if treatment‑naive).HCV genotype 1–6

PA form requests documentation of diagnosis and genotype; waiver permitted for treatment‑naive patients.

Baseline viral load:

Policy Summary

PayerUnitedHealthcare

PolicySofosbuvir‑Velpatasvir prior authorization for chronic hepatitis C

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a signed prior authorization form with required documentation including baseline quantitative HCV RNA (within 6 months) and genotype unless treatment‑naive.

SourceLink

On This Page

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Documented quantitative HCV RNA at baseline tested within the past 6 months is provided (attach lab results to the PA).

HCV RNA tested within 6 months

PA form states lab test results must be attached for approval.

Prescriber attestation: Prescriber signature on the prior authorization form certifying information is accurate and that treatment is reasonably expected to improve the beneficiary's overall health status.signed PA form

Prescriber signature is mandatory on the NC prior approval form.

Contraindications: No FDA‑labeled contraindications to sofosbuvir‑velpatasvir are present.no FDA contraindications

PA form asks whether beneficiary has FDA‑labeled contraindications.

Concomitant sofosbuvir products: Sofosbuvir‑velpatasvir will not be used in combination with other drugs containing sofosbuvir.no duplicate sofosbuvir products

PA form queries concurrent use of other sofosbuvir‑containing products and may preclude approval if present.

Requested therapy length: Requested quantity and length of therapy consistent with a 12‑week treatment course as documented on the PA form.12 weeks

PA form indicates typical therapy length of 12 weeks and requests quantity per 30 days/length of therapy.

The prior authorization form does not list any formal exclusions beyond routine safety checks. Requests are evaluated against FDA‑labeled contraindications to sofosbuvir‑velpatasvir and whether the regimen would be used concurrently with other products that contain sofosbuvir; those situations are explicitly queried on the PA form and may preclude approval.

If required documentation is missing or the form indicates an FDA‑labeled contraindication, the request may not meet medical necessity. The PA requires attached medical records and lab test results, including a baseline quantitative HCV RNA tested within the past 6 months, and documentation of genotype/subtype unless the beneficiary is treatment‑naive. Absence of these items or a positive answer to contraindication questions can prevent approval.

Age, Weight, and Testing Requirements

inv-04: Minimum age and weight

Minimum ageBeneficiary is 6 years of age or older

Minimum weightBeneficiary weighs at least 17 kg

Combined requirementAge >= 6 years AND weight >= 17 kg required for coverage consideration

inv-05: Baseline HCV RNA recency requirement

Recency requirementBaseline HCV RNA must have been tested within the past 6 months

DocumentationMedical documentation (lab test results) must be attached to the prior authorization request

Acceptable valuesReport quantitative HCV RNA as IU/ml and/or log10 value

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization form and prescriber signature are required. Submit the NC Pharmacy Prior Approval Request form for sofosbuvir-velpatasvir with the prescriber's signature and the requested quantity (28 per 30 days) and therapy length (12 weeks) documented on the form.

Prescriber signature mandatory on PA form
Document quantity (28 per 30 days) and therapy length (12 weeks) on the PA form

Denial Risk

Concurrent Sofosbuvir Products

Indicate on the PA form whether sofosbuvir-velpatasvir will be used with any other sofosbuvir-containing products. Concurrent use with other sofosbuvir products is specifically queried and may lead to denial if used in combination.

Answer the concurrent sofosbuvir products question on the PA form (Yes/No)
Concurrent use with other sofosbuvir-containing drugs may trigger non-approval

Step Therapy

Step Therapy — Document Prior Therapies

Step therapy requirements must be addressed on the PA form. The form does not specify an explicit step sequence, but providers should confirm and document any prior therapies tried per payer guidance before submission.

Document prior therapies tried if applicable
If a formal step is required by UnitedHealthcare for this medication, provide supporting documentation with the PA

Background

Sofosbuvir‑velpatasvir is an oral antiviral regimen indicated for treatment of chronic hepatitis C across genotypes 1–6. The PA form requires confirmation of chronic HCV infection and baseline viral load (quantitative HCV RNA) and allows genotype documentation to be waived for beneficiaries who are treatment‑naive. The prescriber must attest that treatment is reasonably expected to improve the beneficiary’s overall health status.

Definitions

inv-12: Baseline quantitative HCV RNA (IU/ml and/or log10) tested within 6 months

Test typeQuantitative HCV RNA (reported as IU/ml and/or log10)

TimingTest must have been performed within the past 6 months

SubmissionAttach lab test results to the prior authorization request

inv-13: Definition of treatment‑naive

DefinitionTreatment‑naive: beneficiaries with no prior HCV antiviral therapy

Genotype documentationDocumentation of genotype and subtype is waived if beneficiary is treatment‑naive

Implication for PAIf treatment‑naive, provider need not submit genotype to meet this documentation requirement