CurrentUnitedHealthcarePolicy N/A

Prior authorization requirements for Sovaldi (sofosbuvir)

Defines North Carolina pharmacy prior authorization documentation and clinical criteria required for UnitedHealthcare coverage of Sovaldi (sofosbuvir) for beneficiaries with chronic hepatitis C. Affects prescribers submitting PA requests for Sovaldi in NC.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization requirements for Sovaldi (sofosbuvir)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the NC Pharmacy PA form and attach medical records documenting HCV genotype/subtype and baseline quantitative HCV RNA tested within the past 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12/24/48 wksapproved treatment duration options listed

HCV RNA ≤6 mobaseline quantitative viral load required

1-4genotypes addressed

NCapplicable state

Coverage Criteria for Sovaldi (sofosbuvir)

Initial therapy — Covered when ALL of the following are met and appropriate regimen/duration selected

Covered when ALL of the following are met and appropriate regimen/duration selected:

Overall requirements

Genotype and age-specific eligibility: One of the following must be documented: (1) Genotype 1 or 4 without cirrhosis or with compensated cirrhosis and beneficiary is 18 years of age or older; (2) Genotype 2 or 3 without cirrhosis or with compensated cirrhosis and beneficiary is 3 years of age or older; (3) Chronic hepatitis C with hepatocellular carcinoma awaiting liver transplant.
Lab test results must be attached to the PA to be approved.
Treatment duration selection: Select ONE total length of therapy: 12 weeks (for many genotype 1, 2, or 4 indications and pediatric genotype 2); 24 weeks (for genotype 1 PEG-interferon–ineligible adults and certain genotype 3 indications); or up to 48 weeks for adult beneficiaries with hepatocellular carcinoma awaiting liver transplantation (up to 48 weeks or until transplant).
Length of therapy options are 12, 24, or 48 weeks as indicated on the form.

Policy Summary

PayerUnitedHealthcare

PolicyPrior authorization requirements for Sovaldi (sofosbuvir)

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the NC Pharmacy PA form and attach medical records documenting HCV genotype/subtype and baseline quantitative HCV RNA tested within the past 6 months.

SourceLink

On This Page

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Regimen-specific requirements: Document whether Sovaldi is prescribed with ribavirin and/or pegylated interferon alfa per genotype-specific regimens; if prescribing Sovaldi + ribavirin for genotype 1 PEG-interferon–ineligible patients, submit medical record documentation of prior peginterferon therapy or a reason for ineligibility.

The form queries combination use and PEG-interferon ineligibility; documentation must be provided.

Operational checklist: Complete drug information including drug name, strength, quantity per 30 days, and requested length of therapy on the PA form; answer clinical eligibility questions on the form.

Length of therapy must be selected from the form options (12/24/48 weeks).

Exclusions / Contraindications

Absolute exclusions: Presence of FDA‑labeled contraindications to sofosbuvir; beneficiary is pregnant; severe renal impairment (CrCl < 30 mL/min), end‑stage renal disease, or requires dialysis; beneficiary is a non‑responder to sofosbuvir or previously failed therapy with a regimen that included sofosbuvir; beneficiary has hepatocellular carcinoma and is NOT awaiting a liver transplant.

These conditions are queried on the PA form and may preclude approval.

The following conditions are asked on the PA form and may preclude approval: pregnancy; any FDA‑labeled contraindication to sofosbuvir (Sovaldi); severe renal impairment (CrCl <30 mL/min), end‑stage renal disease, or need for dialysis; and beneficiaries who are non‑responders or previously failed therapy with a sofosbuvir‑containing regimen.

The PA form explicitly queries whether Sovaldi is being used as a single agent or with other sofosbuvir‑containing regimens. Use of Sovaldi as monotherapy is not aligned with the regimen options listed on the form and therefore would not meet the policy’s standard regimen‑specific criteria.

Drug Identification and Diagnostic Timing

Drug identificationNDC

NDC	Not specified on form — drug name, strength, quantity per 30 days requested

Baseline quantitative HCV RNA timing — tested within the past 6 months

RequirementBaseline quantitative HCV RNA must be documented and tested within the past 6 months.

DocumentationMedical records with the baseline quantitative HCV RNA result must be attached to the prior authorization request.

PurposeUsed to establish baseline viral load prior to selecting Sovaldi regimen and treatment duration.

Prior Authorization & Documentation Requirements

Prior Authorization

Administrative information

Prior authorization requires completion of the NC Pharmacy PA form including beneficiary, prescriber, drug, and clinical information. The PA must include beneficiary demographics, prescriber NPI and contact/fax, requester contact, prescriber signature and date. Lab test results and supporting medical records must be attached for review.

Include beneficiary name, ID, DOB, and gender on the PA form.
Include prescriber NPI, provider fax number, requester contact name and phone, and prescriber signature with date (signature mandatory).
Complete drug fields: drug name, strength, quantity per 30 days, and total length of therapy.

Documentation Required

Required diagnostic documentation

Attach medical records documenting chronic hepatitis C diagnosis with genotype and subtype. Baseline quantitative HCV RNA results tested within the past 6 months must be submitted. Lab test results MUST be attached to the PA to be approved.

Documented HCV genotype and subtype in medical records.
Baseline quantitative HCV RNA (IU/mL and/or log10) tested within the past 6 months.
Attach all relevant lab test results and supporting clinical documentation with the PA request.

Denial Risk

Contraindications and exclusions

Do not submit requests for beneficiaries with FDA-labeled contraindications to sofosbuvir, pregnant beneficiaries, those with severe renal impairment (CrCl <30 mL/min), end-stage renal disease or on dialysis, or beneficiaries who are not appropriate candidates per AASLD/IDSA guidance. Document any contraindications or exclusions on the PA form; presence of these conditions may result in denial.

Report any FDA-labeled contraindications to sofosbuvir on the PA form.
Indicate pregnancy status; pregnant beneficiaries are excluded.
Indicate renal function: severe renal impairment (CrCl <30 mL/min), end-stage renal disease, or dialysis — these are exclusions.
Do not use sofosbuvir in beneficiaries with hepatocellular carcinoma who are not awaiting liver transplant (excluded).

Clinical Background

Sovaldi (sofosbuvir) is an oral antiviral indicated for treatment of chronic hepatitis C virus (HCV) infection. The PA form documents clinical details needed to determine regimen and duration and requires the prescriber’s signature. Regimen selection, approved durations, and eligibility depend on genotype, cirrhosis status, prior treatment history, age, transplant status, and presence of exclusionary conditions captured on the form.

Key Definitions Used in This Policy

Compensated cirrhosis (Child-Pugh A)

DefinitionCompensated cirrhosis (Child-Pugh A) indicates beneficiaries with cirrhosis who remain eligible for certain Sovaldi regimens and durations.

Age & Genotype RelevanceBeneficiaries with compensated cirrhosis are eligible for 12-week regimens for genotype 1, 2, or 4 (adults) and genotype 2 (pediatric ≥3 years) as specified.

Treatment Duration ImpactCompensated cirrhosis is included in the criteria that determine whether a 12- or 24-week regimen is appropriate per genotype and prior treatment status.

PEG-interferon ineligible

RequirementWhen prescribing Sovaldi + ribavirin for genotype 1 PEG-interferon–ineligible adults, document PEG-interferon ineligibility or prior peginterferon therapy.

ApplicabilityPEG-interferon ineligibility applies to genotype 1 adult beneficiaries and affects selection of the 24-week regimen option.

Supporting EvidenceDocumentation of ineligibility or prior therapy must be submitted with the PA to justify non-use of peginterferon per regimen-specific requirements.