CurrentUnitedHealthcarePolicy N/A

Sovaldi (sofosbuvir) prior authorization for hepatitis C

Form and clinical criteria governing prior authorization requests for Sovaldi (sofosbuvir) for treatment of chronic hepatitis C in beneficiaries; applicable to prescribers and pharmacists submitting PA in North Carolina.

Policy Summary

PayerUnitedHealthcare

PolicySovaldi (sofosbuvir) prior authorization for hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with genotype, baseline quantitative HCV RNA (within 6 months), treatment duration, and safety/contraindication documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12|24|48authorized total therapy durations listed

1-4HCV genotypes explicitly referenced

3 yrsminimum pediatric age referenced

Pregnancy & CrCl<30explicit contraindication / safety checks

Coverage Criteria for Sovaldi (sofosbuvir)

Coverage — initial therapy

Covered when ALL of the following are met as indicated on the PA form

Diagnosis documented: Medical records document chronic hepatitis C infection with genotype and subtype; baseline quantitative HCV RNA tested within the past 6 months

Lab test results MUST be attached to the PA to be approved.

Duration-specific eligibility

12 weeks: Genotype 1, 2, or 4 for treatment-naïve and treatment-experienced adult beneficiaries without cirrhosis or with compensated cirrhosis (Child‑Pugh A); or genotype 2 for treatment‑naïve and treatment‑experienced pediatric patients (≥3 years) without cirrhosis or with compensated cirrhosis
Also includes genotype 1 previously treated with an NS3/4A protease inhibitor and without prior NS5A inhibitor when appropriate

Policy Summary

PayerUnitedHealthcare

PolicySovaldi (sofosbuvir) prior authorization for hepatitis C

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit prior authorization with genotype, baseline quantitative HCV RNA (within 6 months), treatment duration, and safety/contraindication documentation.

SourceLink

On This Page

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Genotype 1 adult beneficiaries who are PEG‑interferon ineligible; genotype 3 for treatment‑naïve and treatment‑experienced adults without cirrhosis or with compensated cirrhosis (Child‑Pugh A); or genotype 3 for pediatric patients ≥3 years without cirrhosis or with compensated cirrhosis

Document prior peginterferon therapy or reason for ineligibility when prescribing ribavirin combinations

48 weeks: Genotype 1, 2, 3, or 4 adult beneficiaries with hepatocellular carcinoma awaiting liver transplantation (treatment up to 48 weeks or until transplantation, whichever comes first)

Select when beneficiary is awaiting liver transplant

Regimen-specific: Sovaldi must be prescribed in appropriate combination regimens per the form: with ribavirin and pegylated interferon for genotypes 1 and 4 as indicated; with ribavirin for peginterferon‑ineligible genotype 1 and for genotypes 2 and 3 as indicated; Sovaldi should not be used as monotherapy or combined with other sofosbuvir‑containing regimens unless specifically allowed

Form queries use as monotherapy and co-administration with other sofosbuvir-containing regimens; monotherapy is queried as not appropriate

Safety exclusions and contraindications: Beneficiary has no FDA‑labeled contraindications to sofosbuvir; beneficiary is not pregnant; beneficiary does not have severe renal impairment (CrCl <30 mL/min), end‑stage renal disease, or require dialysis unless addressed per guidanceCrCl <30 mL/min

AASLD/IDSA 2014 referenced for renal impairment; form asks these safety questions and indicates these scenarios may trigger denial if present

Prior authorization requires that beneficiaries do not have safety exclusions or contraindications to sofosbuvir. The PA form explicitly asks whether the beneficiary has any FDA‑labeled contraindications to sofosbuvir, whether the beneficiary is pregnant, and whether the beneficiary has severe renal impairment (CrCl less than 30 mL/min), end‑stage renal disease, or requires dialysis (per AASLD/IDSA 2014). Prescriptions indicating these contraindications or pregnancy may trigger denial unless appropriate justification is provided.

The PA form queries whether Sovaldi is being used as monotherapy and whether it is being combined with any other sofosbuvir‑containing regimen. Use of Sovaldi as monotherapy or coadministration with other sofosbuvir regimens is queried as non‑standard and may be considered not appropriate in this prior authorization context; providers should document the intended regimen on the form and avoid monotherapy unless explicitly supported by the clinical documentation and guidelines.

Age, Renal and Other Eligibility Thresholds

Age thresholds — Sovaldi (sofosbuvir)

Adults age requirementBeneficiaries with genotype 1 or 4 must be 18 years of age or older to meet coverage criteria.

Pediatric age requirementBeneficiaries with genotype 2 or 3 must be 3 years of age or older to meet coverage criteria.

Age & cirrhosis linkageAge thresholds apply for beneficiaries without cirrhosis or with compensated cirrhosis (Child‑Pugh A) as indicated on the form.

Renal function threshold

Renal function thresholdSevere renal impairment defined as creatinine clearance (CrCl) less than 30 mL/min.

Advanced renal diseaseIncludes end‑stage renal disease (ESRD) or beneficiaries requiring dialysis.

Safety check on formForm explicitly asks whether beneficiary has severe renal impairment (CrCl <30 mL/min), ESRD, or requires dialysis (AASLD/IDSA 2014).

Provider Requirements, Documentation & Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for Sovaldi (sofosbuvir) — the PA request must include documentation of HCV genotype/subtype, baseline quantitative HCV RNA (tested within the past 6 months), proposed total treatment duration, and any safety concerns or contraindications.

Attach medical records documenting chronic hepatitis C diagnosis, genotype and subtype.
Attach baseline quantitative HCV RNA result tested within the past 6 months (IU/mL and/or log10).
Specify total length of therapy (12, 24, or 48 weeks) with rationale per genotype/circumstance.
Document peginterferon eligibility: if peginterferon-ineligible, submit medical record documentation of prior peginterferon therapy or the reason for ineligibility.
Indicate whether Sovaldi is combined with ribavirin and/or pegylated interferon alfa as applicable.
If Sovaldi is being used with any other sofosbuvir-containing regimen, indicate details.
Disclose if beneficiary is pregnant, has severe renal impairment (CrCl <30 mL/min), end-stage renal disease, or requires dialysis, or has other FDA-labeled contraindications to sofosbuvir.
Failure to attach genotype and baseline quantitative HCV RNA within the past 6 months may result in denial or delay of the PA.

Documentation Required

Required Clinical Documentation

Medical records must be submitted to support clinical criteria. The PA will not be approved without documentation of diagnosis, genotype/subtype, and baseline viral load.

Medical records documenting chronic HCV diagnosis with genotype and subtype.
Baseline quantitative HCV RNA tested within the past 6 months (attach lab report).
Clinical justification that treatment will improve the beneficiary's overall health status.

Denial Risk

Missing Laboratory Documentation Risks Denial or Delay

If laboratory documentation (genotype and baseline quantitative HCV RNA within 6 months) is not attached to the PA request, the request may be denied or delayed until the information is provided.

Attach lab test results for genotype and baseline HCV RNA (IU/mL and/or log10).
If tests are older than 6 months, repeat testing or explanatory documentation is required.

Denial Risk

Contraindications or Non‑Approved Uses

Certain clinical or safety conditions are contraindications or non-approved uses for sofosbuvir and must be indicated on the form. Flagging these will affect PA approval.

Pregnancy: indicate Yes/No. Pregnancy is a contraindication for some combinations — document status.
Severe renal impairment (CrCl <30 mL/min), end-stage renal disease, or dialysis: indicate Yes/No; these may be non-approved.
FDA-labeled contraindications to sofosbuvir: indicate presence and provide details.
Do not use Sovaldi as monotherapy unless specifically indicated; indicate if used as monotherapy.

Documentation Required

Administrative Documentation Required

Administrative fields on the PA form must be completed and the prescriber must sign the form. Incomplete administrative information can delay processing.

Prescribing Provider NPI # must be provided.
Provider fax number and requester contact name/phone/extension should be included.
Prescriber signature and date are mandatory on the form; unsigned forms may be returned.
Include prescriber contact information and NPI to facilitate any follow-up.

Documentation Required

Peginterferon Eligibility Documentation

For beneficiaries who may be peginterferon-ineligible, submit documentation addressing prior peginterferon therapy or the clinical reason for ineligibility.

If prescribing Sovaldi + ribavirin for genotype 1 because the beneficiary is peginterferon-ineligible, attach medical records documenting prior peginterferon therapy or the reason for ineligibility.
Indicate on the form whether the beneficiary is peginterferon-ineligible (Yes/No) and provide supporting records.

Background

Sovaldi (sofosbuvir) is an oral antiviral agent used for the treatment of chronic hepatitis C virus (HCV) infection. On the PA form, Sovaldi is considered for use only as part of specified combination regimens (for example, with ribavirin and pegylated interferon for certain genotypes) with treatment duration determined by genotype, prior treatment history, cirrhosis status, and special situations such as awaiting liver transplantation.

Definitions and Clinical Terms

Compensated cirrhosis (Child‑Pugh A)

DefinitionCompensated cirrhosis is referenced as 'compensated cirrhosis (child‑pugh A)' on the PA form and is used to determine eligible regimens and durations.

Effect on durationPatients without cirrhosis or with compensated cirrhosis (Child‑Pugh A) are eligible for 12‑week regimens for specified genotypes as indicated on the form.

Applies to pediatric and adultThe compensated cirrhosis designation is applied across adult and pediatric age thresholds where specified (e.g., pediatric ≥3 years for genotypes 2 and 3).

Severe renal impairment — definition and safety consideration

Clinical definitionSevere renal impairment is defined on the form as creatinine clearance <30 mL/min, end‑stage renal disease (ESRD), or requiring dialysis.

Safety implicationPresence of severe renal impairment, ESRD, or dialysis is queried as a contraindication/safety consideration and may affect approval.

Reference guidanceThe form cites AASLD/IDSA 2014 in relation to severe renal impairment.