CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Viltepso (viltolarsen) (Intravenous) — Coverage Criteria

Criteria and coverage rules for intravenous Viltepso (viltolarsen) for members with Duchenne muscular dystrophy amenable to exon 53 skipping; applies to Medicaid, Commercial, and Medicare lines of business at Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyViltepso (viltolarsen) (Intravenous) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization; initial approval is valid for 6 months and may be renewed.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsLength of authorization

80 mg/kg weeklyRecommended dose

J1427Billing HCPCS code

920 unitsMax units billed

Exon 53 amenableRequired genetic mutation

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Coverage Criteria for Viltepso (viltolarsen)

Initial Therapy

Covered when ALL of the following are met:

Universal criteria: Patient is not receiving other DMD-directed antisense oligonucleotides (e.g., eteplirsen, golodirsen, casimersen); patient has never received and will not receive Elevidys (delandistrogene moxeparvovec-rokl) within 6 months of this request; patient does not have symptomatic cardiomyopathy; required renal and urine monitoring (serum cystatin C, monthly urine dipstick, and urine protein-to-creatinine ratio every three months) will be performed at baseline and during treatment

From Universal Criteria

DMD-specific criteria: Confirmed DMD gene mutation amenable to exon 53 skipping; patient has been on a stable dose of corticosteroids for at least 6 months unless contraindicated or intolerant; patient retains meaningful voluntary motor function (e.g., able to speak, manipulate objects with upper extremities, ambulate); baseline documentation of one or more functional measures (dystrophin level, 6-minute walk test or other timed function tests such as TTSTAND, TTRW, TTCLIMB; upper limb function test; FVC percent predicted; North Star Ambulatory Assessment); and patient should be receiving physical and/or occupational therapy

From DMD-specific list

Continuation Therapy

Renewal is provided when ALL of the following are met:

Renewal criteria: Patient continues to meet the universal and indication-specific criteria listed for initial approval; there is an absence of unacceptable toxicity (examples include renal toxicity or proteinuria); and the patient has demonstrated response compared with pretreatment baseline in one or more measures such as increase in dystrophin level; stability, improvement, or slowed rate of decline in 6MWT or other timed function tests (TTSTAND, TTRW, TTCLIMB); stability, improvement, or slowed decline in upper limb function tests; stability, improvement, or slowed decline in FVC percent predicted; stability, improvement, or slowed decline in NSAA; or improvement in quality of life

From Renewal Criteria

Coverage excludes use of Viltepso in combination with other DMD-directed antisense oligonucleotides (for example, eteplirsen, golodirsen, casimersen) and excludes initiation of Viltepso within 6 months of administration of Elevidys (delandistrogene moxeparvovec-rokl).

Therapy is not covered for patients with symptomatic cardiomyopathy. Requests will also be denied when required baseline and ongoing renal and urine monitoring is not documented; required monitoring includes serum cystatin C, monthly urine dipstick, and urine protein-to-creatinine ratio every 3 months during treatment.

Coding and Dosing Information

Billing HCPCS CodesHCPCSCovered

J1427

Injection, viltolarsen, 10 mg

NDCNDC

73292-0011-xx

Viltepso 250 mg/5 mL single-dose vial NDC

Covered Diagnosis Codes (as listed)ICD-10Covered

671.01	Duchenne or Becker muscular dystrophy
G71.01	Duchenne muscular dystrophy

Dose and billing units — inv-08: Dose and billing units — recommended dose and max billable units.

Recommended dose80 mg/kg administered once weekly

Billing unit descriptionBilled as J1427 (Injection, viltolarsen, 10 mg)

Maximum billable units920 billable units (9200 mg) every 7 days

Per-dose billing equivalenceEach J1427 unit = 10 mg; total weekly dose (mg) should be converted to number of J1427 units for billing

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization and Length of Authorization

Prior authorization required. Initial approval is valid for 6 months. Renewals require documentation meeting renewal criteria and will be reviewed individually.

Initial authorization duration: 6 months
Renewal: requires evidence of continued benefit and absence of unacceptable toxicity

Step Therapy

Therapeutic Step Considerations

Therapeutic step considerations: adhere to FDA-labeled indication and relevant compendia; prefer cost‑effective alternatives when clinically appropriate. For Medicare members, these criteria apply only in the absence of applicable NCD/LCD. Individual consideration may be given based on prescriber-submitted information.

Documentation Required

Required Clinical Documentation

Required clinical documentation must confirm diagnosis and baseline disease status prior to initiation and for renewals. Documentation should include mutation confirmation, functional measures, concomitant therapies, and response measures.

Confirmation of a DMD gene mutation that is amenable to exon 53 skipping
Baseline and follow-up motor function measures (examples: 6‑minute walk test, time to stand [TTSTAND], time to run/walk 10 meters [TTRW], time to climb 4 stairs [TTCLIMB])
Upper limb function (ULM) test and North Star Ambulatory Assessment (NSAA) when applicable
Forced vital capacity (FVC) percent predicted
Baseline dystrophin level if available
Documentation patient retains meaningful voluntary motor function (e.g., able to speak, manipulate objects, ambulate)
Evidence patient has been on a stable corticosteroid dose for at least 6 months unless contraindicated or intolerant
Evidence the patient is receiving physical and/or occupational therapy as appropriate
For renewals: objective evidence of response (increase in dystrophin, stability/improvement or slowed decline in functional tests, or improvement in quality of life) and absence of unacceptable toxicity

Documentation Required

Required Laboratory Monitoring

Required laboratory monitoring to assess for renal toxicity and proteinuria must be performed at baseline and during therapy per schedule below.

Serum cystatin C: measured at baseline and monitored during treatment (per prescriber guidance)
Urine dipstick: monthly
Urine protein-to-creatinine ratio: every 3 months

Denial Risk

Contraindications and Concurrent Therapy Conflicts

Contraindications / concurrent therapy conflicts: therapy will be denied if the patient is receiving other DMD-directed antisense oligonucleotides or has recent/near planned gene therapy that conflicts with treatment timing.

Concomitant use of other DMD-directed antisense oligonucleotides (examples: eteplirsen/Exondys 51, golodirsen/Vyondys 53, casimersen/Amondys 45) is not permitted
Patient must not have received Elevidys (delandistrogene moxeparvovec-rokl) and must not plan to receive Elevidys within 6 months of this request
Presence of symptomatic cardiomyopathy is a contraindication to therapy initiation

Background

Viltepso (viltolarsen) is an intravenous antisense oligonucleotide indicated for the treatment of Duchenne muscular dystrophy in patients with confirmed DMD gene mutations amenable to exon 53 skipping. The recommended dose is 80 mg/kg once weekly, billed using HCPCS code J1427 (Injection, viltolarsen, 10 mg) with a maximum of 920 billable units (9200 mg) every 7 days. Clinical evidence demonstrates improvements in motor function and slowing of disease progression in appropriately selected patients.

Definitions

Exon 53 skipping amenable mutation — inv-15: Exon 53 skipping amenable mutation — definition of amenable to exon 53 skipping.

DefinitionA confirmed DMD gene mutation that can be treated by exon 53 skipping therapy

Documentation requirementGenetic test confirming DMD mutation amenable to exon 53 skipping must be provided for approval

Relation to indicationViltepso (viltolarsen) is indicated for DMD patients with mutations amenable to exon 53 skipping

Supporting clinical evidenceClinical trials demonstrate improvements in motor function and slowed disease progression in patients with exon 53–amenable mutations