CurrentColorado Rocky Mountain Health PlansPolicy N/A

Epclusa (sofosbuvir/velpatasvir) prior authorization

Defines prior authorization requirements and coverage criteria for Epclusa (sofosbuvir/velpatasvir) for treatment of chronic hepatitis C in the specified population for Colorado Rocky Mountain Health Plans members.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyEpclusa (sofosbuvir/velpatasvir) prior authorization

Policy CodePolicy N/A

Change TypeRevisedClarified

Effective DateJan 1, 2026

Next Review DateAug 1, 2025

Key ActionObtain prior authorization; approvals issued for up to 12 months when patient has chronic hepatitis C and is not on another HCV direct-acting antiviral.

SourceLink

POLICY UPDATE CHANGES

Removed criteria related to decompensated liver disease status and simplified pangenotypic treatment criteria.

Authorization duration clarified to 12 months.

12 monthsauthorization duration

pangenotypicHCV genotypes covered (1-6)

>= 3 yrsminimum patient age

2025 P 1197-11program number

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Initial Therapy — Epclusa

Epclusa will be approved when ALL of the following are met:

Initial approval: 1) Diagnosis of chronic hepatitis C infection; 2) Patient is not receiving Epclusa in combination with another HCV direct-acting antiviral agent.

Authorization issued for 12 months per program policy.

Use of Epclusa in combination with another HCV direct-acting antiviral agent is excluded. Requests for Epclusa that indicate concurrent use with another HCV direct-acting antiviral (for example, Sovaldi [sofosbuvir]) will not meet coverage criteria.

Initial Therapy

Initial therapy — Initial Coverage Criteria

Initial coverage criteria

COVERAGE CRITERIA: 1) Diagnosis of chronic hepatitis C infection; 2) Patient is not receiving Epclusa in combination with another HCV direct-acting antiviral agent.

Prior authorization required; authorization issued for up to 12 months. Approval decisions may consider prior claim/medication history, diagnosis codes (ICD-10), and/or automated claim logic; supply limits and other utilization management programs may apply.

Provider Actions and Authorization

Prior Authorization

Prior authorization required; 12-month approval when criteria met

Prior authorization is required for Epclusa; approvals are issued for up to 12 months when the patient has a diagnosis of chronic hepatitis C infection and is not receiving Epclusa in combination with another HCV direct-acting antiviral agent.

Note

Automated approval/re-approval may be used

Automated approval and re-approval processes may be used for initial or reauthorization requests; other utilization management programs and program-specific rules may also apply.

Documentation Required

Decisions may use prior claims, ICD‑10, or claim logic

Authorization and reauthorization decisions may be based solely on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic; supply limits and medical necessity rules may also apply.

Decisions can rely on previous claims or medication history.
Diagnosis codes (ICD‑10) and claim logic may be used to approve requests.
Supply limits and medical necessity criteria may affect approvals.

Denial Risk

Denial triggers: missing diagnosis or combination therapy

Requests may be denied if the patient does not have a diagnosis of chronic hepatitis C infection or if Epclusa is requested in combination with another HCV direct-acting antiviral agent.

Lack of a chronic hepatitis C diagnosis will be a basis for denial.
Requests for Epclusa in combination with another HCV direct-acting antiviral (e.g., sofosbuvir products) are excluded and may be denied.

Reauthorization / Continuation Criteria

Reauthorization — Epclusa

Reauthorization/continuation rules

Continuation

Reauthorization considerations: Approvals may be based on prior claims or medication history, diagnosis codes (ICD-10), and/or automated approval processes.

Definitions

inv-08: Drug definition

DrugEpclusa (sofosbuvir/velpatasvir)

CompositionFixed‑dose combination of sofosbuvir (NS5B polymerase inhibitor) and velpatasvir (NS5A inhibitor)

IndicationTreatment of chronic hepatitis C virus (HCV) infection, genotypes 1–6

Age rangeAdults and pediatric patients 3 years of age and older

Cirrhosis guidanceFor use without cirrhosis or with compensated cirrhosis; decompensated cirrhosis use in combination with ribavirin per labeling

Quantity Limits

inv-11: Epclusa (sofosbuvir/velpatasvir) — may be subject to supply limits

Quantity limits noteEpclusa may be subject to supply limits

Authorization dependenciesApprovals and reauthorizations may be issued based on prior claim/medication history, diagnosis codes (ICD‑10), and/or claim logic

AutomationUse of automated approval and re‑approval processes varies by program and/or therapeutic class

Medical necessityMedical necessity requirements may apply

Background

Epclusa is a fixed-dose combination of sofosbuvir (an HCV nucleotide analog NS5B polymerase inhibitor) and velpatasvir (an NS5A inhibitor) indicated for treatment of chronic hepatitis C virus infection of genotypes 1–6 in adults and pediatric patients aged 3 years and older; it is indicated for use both without cirrhosis and with compensated cirrhosis, and for decompensated cirrhosis in combination with ribavirin per product labeling.