CurrentColorado Rocky Mountain Health PlansPolicy 1 = 2025 P 1232-8

Vosevi (sofosbuvir/velpatasvir/voxilaprevir) prior authorization

Prior authorization requirements and medical necessity criteria for Vosevi for treatment of chronic hepatitis C in adults, including genotype- and prior-treatment–based coverage rules. Affects prescribers and pharmacy benefit administrators.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyVosevi (sofosbuvir/velpatasvir/voxilaprevir) prior authorization

Policy CodePolicy 1 = 2025 P 1232-8

Change TypeRevised — authorization duration and pangenotypic criteria

Effective Date1/1/2026

Next Review Date

Key ActionObtain prior authorization; approval granted when all listed criteria for the applicable treatment-experienced group are met.

SourceLink

POLICY UPDATE CHANGES

Authorization duration updated to 12 months.

Simplified pangenotypic treatment criteria were implemented.

12 monthsauthorization duration

Genotypes 1-6indicated genotypes

Child-Pugh Acirrhosis requirement

Prior NS5Aprior regimen required

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Coverage Criteria for Vosevi (sofosbuvir/velpatasvir/voxilaprevir)

Treatment-experienced with NS5A inhibitor

Covered when ALL of the following are met for patients treatment-experienced with an NS5A inhibitor:

Primary NS5A-experienced criteria: 1. Diagnosis of chronic hepatitis C infection

Prior NS5A exposure: 2. Patient has prior treatment experience with an HCV NS5A inhibitor (e.g., daclatasvir, sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, dasabuvir/ombitasvir/paritaprevir/ritonavir, elbasvir/grazoprevir)

Cirrhosis status: 3. One of the following: a. Patient is without cirrhosis OR b. Patient has compensated cirrhosis (Child-Pugh A)

No concurrent DAA: 4. Patient is not receiving Vosevi in combination with another HCV direct acting antiviral agent (examples: Epclusa, Harvoni, Mavyret, Sovaldi, Zepatier)

Sofosbuvir-experienced (no NS5A) genotype 1a or 3

Covered when ALL of the following are met for patients treatment-experienced with sofosbuvir (Sovaldi) without an NS5A inhibitor and genotype 1a or 3:

Diagnosis: 1. Diagnosis of chronic hepatitis C genotype 1a or 3 infection

Prior sofosbuvir exposure without NS5A: 2. Patient has prior treatment experience with a regimen containing Sovaldi (sofosbuvir) without an NS5A inhibitor

Cirrhosis status: 3. One of the following: a. Patient is without cirrhosis OR b. Patient has compensated cirrhosis (Child-Pugh A)

No concurrent DAA: 4. Patient is not receiving Vosevi in combination with another HCV direct acting antiviral agent (examples: Epclusa, Harvoni, Mavyret, Sovaldi, Zepatier)

Clinical evidence and the manufacturer's labeling did not demonstrate an additional benefit of Vosevi over Epclusa (sofosbuvir/velpatasvir) for adults with genotype 1b, 2, 4, 5, or 6 HCV infection who were previously treated with sofosbuvir-containing regimens that did not include an NS5A inhibitor. Consequently, Vosevi is not positioned as superior to Epclusa for these genotype-and-treatment subgroups when making coverage determinations.

Use of Vosevi concurrently with any other HCV direct-acting antiviral (DAA) agent is not allowed and is considered not medically necessary. Examples of DAAs that must not be co-administered with Vosevi include, but are not limited to, Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir), Mavyret (glecaprevir/pibrentasvir), Sovaldi (sofosbuvir), and Zepatier (elbasvir/grazoprevir). Coverage will be denied if Vosevi is prescribed in combination with another HCV DAA.

Initial Therapy Criteria

Initial therapy criteria

Initial approval criteria

Diagnosis: 1. Diagnosis of chronic hepatitis C infection (or genotype-specific diagnosis for sofosbuvir-experienced patients)

Prior treatment requirement: 2. Patient has prior treatment experience with the required prior regimen: either an NS5A-containing regimen (for NS5A-experienced pathway) OR a regimen containing sofosbuvir without an NS5A inhibitor (for genotype 1a or 3 pathway)

Cirrhosis status: 3. Patient is without cirrhosis OR has compensated cirrhosis (Child-Pugh A)

Monotherapy with Vosevi: 4. Patient is not receiving Vosevi in combination with another HCV direct acting antiviral agent

Reauthorization / Continuation Criteria

Authorization duration / continuation

Reauthorization/continuation

Authorization duration: Authorization will be issued for 12 months

Provider Actions and Authorization Notes

Prior Authorization

Prior Authorization Required

Prior authorization is required; approval is granted when all listed criteria for the applicable treatment‑experienced group are met. Authorization will be issued for 12 months.

Prior authorization required for Vosevi (sofosbuvir/velpatasvir/voxilaprevir)
Approval contingent on meeting all applicable coverage criteria for treatment‑experienced patients

Step Therapy

Step‑therapy Note

Policy history notes simplification to pangenotypic treatment criteria and an update to authorization duration, but this document does not specify a step‑therapy sequence or require trial of another specific agent prior to Vosevi within the presented criteria.

Simplified pangenotypic treatment criteria noted in policy history
No explicit step‑therapy sequence specified in this policy section

Key Definitions

Compensated cirrhosis (Child-Pugh A) — definition and eligibility requirement when cirrhosis is present

DefinitionCompensated cirrhosis (Child-Pugh A): liver disease classification indicating cirrhosis with preserved liver function.

Eligibility when cirrhosis is presentVosevi is indicated for adults with compensated cirrhosis (Child-Pugh A); patients with cirrhosis must meet the compensated (Child-Pugh A) classification to be eligible.

Indication contextUsed for chronic HCV infection in adults without cirrhosis or with compensated cirrhosis (Child-Pugh A) who meet prior-treatment criteria (NS5A-experienced or sofosbuvir-experienced genotype 1a/3).

Background

Vosevi is a fixed-dose combination antiviral containing sofosbuvir (an NS5B polymerase inhibitor), velpatasvir (an NS5A inhibitor), and voxilaprevir (an NS3/4A protease inhibitor). It is indicated for treatment of adult patients with chronic hepatitis C infection without cirrhosis or with compensated cirrhosis (Child-Pugh A) who meet the specified prior-treatment criteria, including those previously treated with an NS5A-containing regimen or those with genotype 1a or 3 previously treated with sofosbuvir without an NS5A inhibitor.

Step Therapy / Policy History Notes

Policy history note	Step therapy requirement
Document history records a 10/2025 update: 'Simplified pangenotypic treatment criteria' and authorization updated to 12 months.	No explicit multi‑step or step‑therapy sequence is specified in this document; simplification is noted but specific step requirements are not listed.