CurrentViva HealthPolicy IC-0562

Viltepso (viltolarsen) (Intravenous) — Coverage Criteria

This policy governs prior authorization, dosing, and renewal criteria for intravenous Viltepso (viltolarsen) for members with Duchenne muscular dystrophy amenable to exon 53 skipping under Viva Health.

Policy Summary

PayerViva Health

PolicyViltepso (viltolarsen) (Intravenous) — Coverage Criteria

Policy CodePolicy IC-0562

Change TypeNo material changes

Effective DateSep 1, 2020

Next Review DateMay 5, 2026

Key ActionObtain prior authorization: initial approvals provided for 6 months and may be renewed every 12 months with required baseline documentation and laboratory monitoring.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

80 mg/kg wklyrecommended dosing

3700max HCPCS units/28d

6 moinitial auth

12 morenewal auth

J1427HCPCS code

G71.01

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Coverage Criteria for Viltepso (viltolarsen)

Initial Therapy Criteria

Covered when ALL of the following are met

Universal criteria: Member is not on concomitant therapy with other DMD-directed antisense oligonucleotides; member is not on concomitant therapy with delandistrogene moxeparvovec-rokl; member does not have symptomatic cardiomyopathy; serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio (UPCR) are measured prior to starting therapy and periodically during treatment.

DMD-specific criteria: Member has a confirmed mutation of the DMD gene that is amenable to exon 53 skipping; member has been on a stable dose of corticosteroids for at least 3 months unless there is a contraindication or intolerance; member retains meaningful voluntary motor function (e.g., able to speak, manipulate objects, ambulate, etc.); member is receiving physical and/or occupational therapy; baseline documentation includes one or more of the following: dystrophin level OR timed function tests (e.g., 6MWT, TTSTAND, TTRW, TTCLIMB) OR upper limb function (ULM) test OR North Star Ambulatory Assessment (NSAA) score OR Forced Vital Capacity (FVC) percent predicted.

Renewal Criteria

Renewal approved when ALL of the following are met

Continuation requirements: Member continues to meet the universal and indication-specific relevant criteria; absence of unacceptable toxicity (examples include kidney toxicity such as glomerulonephritis, persistent increase in serum cystatin C, proteinuria); and member has shown response to therapy compared to pretreatment baseline evidenced by increase in dystrophin level OR improvement in quality of life OR stability, improvement, or slowed rate of decline in timed function tests, upper limb function (ULM) test, NSAA score, or FVC percent predicted.

Use of viltolarsen is not permitted for members who are receiving concomitant therapy with other DMD-directed antisense oligonucleotides or with delandistrogene moxeparvovec-rokl. Therapy is also contraindicated for members who have symptomatic cardiomyopathy. Prior to initiating treatment and periodically during therapy, serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio (UPCR) must be measured.

Continuation of viltolarsen may be denied if the member demonstrates unacceptable toxicitylack of response compared to pretreatment baseline; acceptable evidence of response includes an increase in dystrophin level, improvement in quality of life, or stability, improvement, or slowed decline on timed function tests, upper limb function testing, NSAA score, or FVC percent predicted.

Coding and Billing

HCPCS CodeHCPCSCovered

J1427

Injection, viltolarsen, 10 mg; 1 billable unit = 10 mg

NDCNDC

73292-0011-xx

Viltepso 250 mg/5 mL single-dose vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

G71.01

Duchenne or Becker muscular dystrophy

Max HCPCS units per 28 days

Maximum HCPCS units3700 billable units every 28 days

HCPCS unit definition1 billable unit = 10 mg (see HCPCS J1427)

Billing intervalMeasured per 28-day period

Provider Actions and Documentation Requirements

Prior Authorization

Prior authorization duration

Prior authorization is required. Initial approvals are provided for 6 months (180 days); renewals may be provided every 12 months (365 days).

Step Therapy

Corticosteroid stability prerequisite

Member must have been on a stable dose of corticosteroids for at least 3 months unless there is a contraindication or intolerance.

Documentation Required

Baseline clinical documentation required

Require baseline objective documentation prior to therapy: one or more of dystrophin level, timed function tests (e.g., 6MWT, TTSTAND, TTRW, TTCLIMB), upper limb function test, North Star Ambulatory Assessment (NSAA) score, or FVC percent predicted.

Background

Viltolarsen (Viltepso) is an intravenous therapy indicated for Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 53 skipping. Candidates for therapy must retain meaningful voluntary motor function, be receiving physical and/or occupational therapy, and have baseline documentation of one or more objective measures such as dystrophin level, timed function tests (e.g., 6-minute walk test), upper limb function testing, NSAA score, or FVC percent predicted. The drug is administered on a recurring schedule to increase dystrophin production and slow functional decline.

Definitions

Amenable to exon 53 skipping

DefinitionA confirmed mutation of the DMD gene that can be targeted by exon 53 skipping therapy (i.e., the patient's DMD mutation is amenable to exon 53 skipping).

Evidence requiredDocumentation of a DMD gene mutation demonstrating amenability to exon 53 skipping.

Related clinical implicationAmenability to exon 53 skipping is an FDA‑approved indication for viltolarsen therapy.

Unacceptable toxicity

Unacceptable toxicity — generalAdverse effects that would preclude continuation of therapy, particularly renal toxicity.

Examples — kidney toxicityGlomerulonephritis or other clinically significant kidney injury during treatment.