Currentmedical mutual - ohioPolicy N/A

Sovaldi (sofosbuvir) coverage for Hepatitis C Virus (HCV)

Defines prior authorization recommendations, coverage criteria, and conditions not recommended for approval for Sovaldi (sofosbuvir) for treatment of chronic HCV, with emphasis on pediatric use (ages ≥3 to <18) in combination with ribavirin. Intended for prescribers and pharmacy/medical benefits reviewers.

Policy Summary

Payermedical mutual - ohio

PolicySovaldi (sofosbuvir) coverage for Hepatitis C Virus (HCV)

Policy CodePolicy N/A

Change TypeAnnual review — no material changes

Effective DateN/A

Next Review DateNov 20, 2025

Key ActionRequest prior authorization and ensure Sovaldi is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician; provide requested clinical documentation to support medical necessity.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2 & 3HCV genotypes specifically approved in this policy (pediatric)

12 wksApproved duration — genotype 2 (pediatric)

24 wksApproved duration — genotype 3 (pediatric)

≥3 to <18Covered pediatric age range

Child-Pugh B/C

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Authorization Criteria for Sovaldi (sofosbuvir)

Recommended Authorization Criteria — Genotype 2 (pediatric)

Approve for 12 weeks if the patient meets ALL of the following criteria (A, B, C, and D):

ALL of the following

Patient is ≥ 3 years of age and < 18 years of age
Policy applies to pediatric patients only for genotype 2
Patient does not have decompensated cirrhosis (Child-Pugh B or C)
Coverage provided for patients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Medication will be prescribed in combination with ribavirin
Sovaldi monotherapy is not recommended
Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician
Specialist involvement required for initial approval

Recommended Authorization Criteria — Genotype 3 (pediatric)

Approve for 24 weeks if the patient meets ALL of the following criteria (A, B, C, and D):

ALL of the following

Patient is ≥ 3 years of age and < 18 years of age
Policy applies to pediatric patients only for genotype 3
Patient does not have decompensated cirrhosis (Child-Pugh B or C)
Coverage provided for patients without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Medication will be prescribed in combination with ribavirin
Sovaldi monotherapy is not recommended
Medication is prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician
Specialist involvement required for initial approval

Other Uses with Supportive Evidence / Continuation

Approve to complete a previously started course when the indication matches an approved indication in this policy:

ALL of the following

Patient has been started on Sovaldi for an FDA‑approved indication or another indication listed in the Recommended Authorization Criteria
Approve remaining duration to complete the course (e.g., remaining weeks)

Conditions Not Recommended for Approval

Sovaldi is not recommended for general approval for the following conditions:

ANY of the following

Use in adults with any genotype in combination with DAAs other than ribavirin (e.g., combining Sovaldi with other DAAs outside recommended regimens)
Evidence not supportive for general approval; retreatment regimens may exist in specific trial contexts but are not generally recommended
Monotherapy with Sovaldi
Sovaldi indicated only as part of combination antiviral therapy
Pediatric patients younger than 3 years of age
Safety and efficacy not established for age <3 years
Circumstances not listed in the Recommended Authorization Criteria
Requests for other uses will be reviewed case-by-case

Drugs Referenced and Coding

Drugs referencedmixed

Sovaldi	sofosbuvir tablets and oral pellets; Gilead, generics for tablets only
Ribavirin	weight-based ribavirin required in combination per policy
Epclusa	sofosbuvir/velpatasvir — guideline-preferred alternative
Mavyret	glecaprevir/pibrentasvir — guideline-preferred alternative
Harvoni	ledipasvir/sofosbuvir — guideline option for certain genotypes
Vosevi	regimen mentioned as recommended in specific retreatment contexts

Prior Authorization, Documentation, and Clinical Requests

Prior Authorization

Prior authorization recommended

Prior authorization is recommended for pharmacy benefit coverage of Sovaldi and requests for uses not listed will be reviewed case-by-case.

Sovaldi

Documentation Required

Specialist prescription/consultation required for initial approval

Initial approval requires Sovaldi to be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or liver transplant physician.

Sovaldi

Documentation Required

Numeric & Clinical Thresholds

Policy Thresholds

Age≥ 3 years and < 18 years

Genotype 2 treatment duration12 weeks

Genotype 3 treatment duration24 weeks

Cirrhosis status allowedNo cirrhosis or compensated cirrhosis (Child-Pugh A). Decompensated (Child-Pugh B or C) excluded.

Policy Definitions

Definitions

Compensated cirrhosisChild-Pugh A classification — eligible for coverage under the policy.

Decompensated cirrhosisChild-Pugh B or C — not eligible for coverage per policy.

Clinical Background

Sovaldi (sofosbuvir) is an NS5B polymerase inhibitor indicated as a component of combination antiviral regimens for chronic hepatitis C virus (HCV) infection. The drug is indicated for adults without cirrhosis or with compensated cirrhosis as part of combination therapy and, in pediatric patients ≥3 years of age, for genotype 2 or 3 when given in combination with ribavirin.

The place in therapy for Sovaldi has greatly lessened due to the availability of more effective pangenotypic direct-acting antivirals (DAAs) such as Epclusa (sofosbuvir/velpatasvir) and Mavyret (glecaprevir/pibrentasvir), which are preferred by current guidelines for children ≥3 years across genotypes; Harvoni (ledipasvir/sofosbuvir) remains an option for some genotypes.

Sovaldi remains an option in specific pediatric circumstances: for genotype 2 pediatric patients aged ≥3 and <18 years in combination with ribavirin for 12 weeks, and for genotype 3 pediatric patients aged ≥3 and <18 years in combination with ribavirin for 24 weeks. Use in these pediatric populations is limited to patients without cirrhosis or with compensated cirrhosis (Child‑Pugh A).

Sovaldi should be used only as part of combination antiviral therapy (not as monotherapy), and requests for coverage are subject to prior authorization and initial prescription or consultation by a specialist in gastroenterology, hepatology, infectious diseases, or liver transplantation.

Sovaldi (sofosbuvir) coverage for Hepatitis C Virus (HCV)

Authorization Criteria for Sovaldi (sofosbuvir)

Drugs Referenced and Coding

Prior Authorization, Documentation, and Clinical Requests

Numeric & Clinical Thresholds

Policy Definitions

Clinical Background

Additional Policies to Review