CurrentUnitedHealthcarePolicy N/A

NC Prior Authorization Form — Viekira Pak (paritaprevir/ritonavir/ombitasvir + dasabuvir)

This document is North Carolina's pharmacy prior authorization (PA) request form governing coverage decisions for Viekira (the Viekira Pak regimen) for beneficiaries with chronic hepatitis C genotype 1; it is intended for prescribers to submit supporting clinical and laboratory information to obtain PA from UnitedHealthcare NC.

Policy Summary

PayerUnitedHealthcare

PolicyNC Prior Authorization Form — Viekira Pak

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach medical records showing genotype/subtype and a quantitative HCV RNA within the past 6 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 or 24allowed treatment durations documented on form

18+minimum patient age referenced

within 6 morequired baseline quantitative viral load timing

Child-Pugh B/Ccontraindication for Viekira (decompensated liver disease)

112default quantity per 30 days field shown

Coverage Criteria for Viekira Pak

Initial therapy coverage criteria

Covered when ALL of the following are met:

Age and diagnosis: Beneficiary is 18 years of age or older with a diagnosis of chronic hepatitis C infection with confirmed genotype 1a or 1bage >= 18, documented genotype

checkboxed on form

Treatment length and genotype/cirrhosis mapping: Provider selects 12 weeks for genotype 1a without cirrhosis or genotype 1b with cirrhosis; 24 weeks for genotype 1a with compensated cirrhosistreatment length = 12 or 24 weeks as indicated

form provides mapping (Total Length of Therapy)

Ribavirin use:

Policy Summary

PayerUnitedHealthcare

PolicyNC Prior Authorization Form — Viekira Pak

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the prior authorization form and attach medical records showing genotype/subtype and a quantitative HCV RNA within the past 6 months.

SourceLink

On This Page

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Prior Authorization and Provider Requirements

Prior Authorization

Prior Authorization Required — Complete PA Form and Treatment Selection

Prior authorization is required. Provider must complete the NC Pharmacy Prior Approval (PA) form and select total length of therapy (12 or 24 weeks) and related treatment fields on the form.

Ensure the PA form includes drug name, strength, quantity, and check ONE total length of therapy: 12 weeks or 24 weeks.
If selecting 12 weeks: appropriate for genotype 1a without cirrhosis or genotype 1b with cirrhosis.
If selecting 24 weeks: appropriate for genotype 1a with compensated cirrhosis.

Denial Risk

Contraindicated in Decompensated Hepatic Impairment

VIEKIRA PAK is contraindicated in beneficiaries with decompensated liver disease (Child-Pugh class B or C). Requests for beneficiaries with moderate to severe hepatic impairment will be denied.

PA form asks: "Does the beneficiary have decompensated liver disease as defined by Child-Pugh classification score of Child Class B or C?" — must be answered.
If Yes (Child-Pugh B or C) — do not approve; consider alternative therapies and document rationale.

Documentation Required

Required Clinical Documentation — Labs and Medical Records Must Be Attached

Attach medical records and laboratory documentation to support the request. Missing required clinical documentation will prevent approval.

Documented diagnosis of chronic hepatitis C with genotype and subtype must be submitted.
Quantitative HCV RNA (IU/mL and/or log10) at baseline tested within the past 6 months — results must be attached.
For beneficiaries with cirrhosis: baseline and early (within 4 weeks) hepatic laboratory testing including direct bilirubin, and ongoing monitoring as clinically indicated.

Documentation Required

Prescriber Identification and Mandatory Signature

Prescriber identification and signature are required on the PA form. The signature certifies accuracy and completeness of the information.

Prescribing Provider NPI # and Provider Fax # — include on the form.
Requester contact information (name, phone, ext.) should be provided.
Prescriber signature and date are mandatory; unsigned forms will not be accepted.

Documentation Required

Prior Therapy / Retreatment History Must Be Provided

Document prior therapy and retreatment history on the PA form — this affects eligibility for re-treatment regimens.

Indicate whether the beneficiary previously attempted Viekira Pak.
Indicate prior treatment failures or relapse: mark if prior regimens (e.g., sofosbuvir, ledipasvir-containing regimens) failed to achieve SVR (≤25 IU/mL) or if relapse occurred after prior successful treatment.
If requesting re-treatment, specify prior regimens and SVR status; attach prior treatment records and labs.

Definitions and Clinical Terms

SVR — Sustained virologic response definition

DefinitionSustained virologic response (SVR) is defined on the form as a lower limit HCV RNA of 25 IU/mL.

Form contextQuestion asks whether beneficiary failed to achieve SVR or relapsed after achieving SVR during prior ledipasvir-containing regimen.

Use for retreatmentForm uses the SVR definition to determine if the current request is for re-treatment following failure or relapse.

Decompensated liver disease / Child-Pugh B or C — definition and contraindication

DefinitionDecompensated liver disease is defined by Child-Pugh classification score of Child Class B or C.

ContraindicationVIEKIRA PAK is contraindicated in beneficiaries with moderate to severe hepatic impairment (Child-Pugh B and C).

Form assessmentPA asks whether beneficiary has decompensated liver disease and whether provider has assessed for laboratory and clinical evidence of hepatic decompensation.

Monitoring noteIf cirrhosis is present, form requests baseline hepatic laboratory testing including direct bilirubin and monitoring during first 4 weeks.

OpenPayer

NC Prior Authorization Form — Viekira Pak (paritaprevir/ritonavir/ombitasvir + dasabuvir)

Coverage Criteria for Viekira Pak

Form Fields and Laboratory Coding

Prior Authorization and Provider Requirements

Definitions and Clinical Terms

Background