CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Viltepso (viltolarsen) — Coverage Criteria for Duchenne Muscular Dystrophy

Policy governs coverage and authorization criteria for intravenous Viltepso (viltolarsen) to treat Duchenne muscular dystrophy in members covered by Medicaid, Commercial, and Medicare plans of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyViltepso (viltolarsen) — Coverage Criteria for Duchenne Muscular Dystrophy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateDec 1, 2020

Next Review DateN/A

Key ActionObtain prior authorization and submit required baseline documentation (e.g., dystrophin level or functional test) and monitoring plan.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthslength of authorization

80 mg/kg weeklyrecommended dose

920 units weeklymax units

G71.01covered dx

Coverage Criteria for Viltepso (viltolarsen)

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Universal criteria: Patient is not on concomitant therapy with 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; and baseline and ongoing renal/protein monitoring will be performed (monthly urine dipstick; serum cystatin C and urine protein-to-creatinine ratio every 3 months).

source: Universal Criteria (chunks 5)

Indication-specific (Duchenne muscular dystrophy) 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); patient should be receiving physical and/or occupational therapy; and baseline documentation of one or more of the following: dystrophin level; 6-minute walk test (6MWT) or other timed function tests (TTSTAND, TTRW, TTCLIMB); upper limb function (ULM) test; North Star Ambulatory Assessment (NSAA); or forced vital capacity (FVC) percent predicted.

source: DMD criteria (chunk 6)

Dosage and billing limits: Recommended dose is 80 mg/kg administered once weekly as a 60-minute IV infusion; maximum billing units 920 billable units (9200 mg) every 7 days.80 mg/kg weekly; max 920 units every 7 days

source: Dosage/Max Units (chunks 8,2)

Renewal Approval

Renewal allowed when ALL of the following are met

Continued eligibility and response: Patient continues to meet universal and indication-specific criteria; there is absence of unacceptable toxicity (e.g., renal toxicity/proteinuria); and the patient has demonstrated response compared to pretreatment baseline in one or more of the following: 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 rate of decline in ULM test; stability, improvement, or slowed rate of decline in NSAA; stability, improvement, or slowed rate of decline in FVC% predicted; or improvement in quality of life.

source: Renewal Criteria (chunk 7)

Coverage exclusion: Viltepso is not covered for treatment of patients who do not have a confirmed DMD gene mutation amenable to exon 53 skipping. It is also not covered for patients who lack meaningful voluntary motor function as defined by the policy (e.g., inability to speak, manipulate objects with upper extremities, ambulate, or otherwise meet the retained motor function criteria).

Billing, NDC, and Diagnosis Codes

Billing CPT/HCPCS CodesHCPCSCovered

J1427

Injection, viltolarsen, 10 mg

NDCNDC

73292-0011-xx

Viltepso 250 mg/5 mL single-dose vial NDC

Covered Diagnosis CodesICD-10Covered

G71.01

Duchenne or Becker muscular dystrophy

inv-08: Max HCPCS units — 920 billable units (9200 mg) every 7 days

Max HCPCS units920 billable units (9200 mg) every 7 days

Equivalent mg per unit10 mg per HCPCS unit (J1427 describes 10 mg)

Maximum frequencyOnce every 7 days (weekly)

Provider Requirements and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization required. Coverage provided when universal and indication-specific criteria are met.

Prior authorization required for initiation and continuation of therapy.
Coverage only when all universal and Duchenne-specific criteria are met as detailed in policy sections IV and V.

Step Therapy

Step Therapy Exception for Prior Users

Medicare members who have previously received this medication within the past 365 days are exempt from step therapy requirements.

Step therapy exception applies only to Medicare members with documented receipt of the same medication within the prior 365 days.

Documentation Required

Required Clinical Documentation and Monitoring

Baseline and ongoing clinical documentation are required to support initiation and renewal of therapy.

Baseline documentation: dystrophin level; 6-minute walk test (6MWT) or other timed function tests (TTSTAND, TTRW, TTCLIMB); upper limb (ULM) test; North Star Ambulatory Assessment (NSAA); forced vital capacity (FVC) percent predicted.
Monitoring: serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio prior to start of therapy and during treatment (monthly urine dipstick; serum cystatin C and urine protein-to-creatinine ratio every 3 months).
Renewal requires evidence of clinical response vs pretreatment baseline (e.g., increase in dystrophin, stability/improvement/slowed decline in 6MWT or other timed tests, ULM, NSAA, FVC% predicted, or quality of life) and absence of unacceptable toxicity (e.g., renal toxicity/proteinuria).

Denial Risk

Triggers for Denial

Requests may be denied when exclusionary conditions are present.

Patient is on concomitant therapy with another DMD-directed antisense oligonucleotide (e.g., eteplirsen, golodirsen, casimersen).
Patient has received Elevidys (delandistrogene moxeparvovec-rokl) within 6 months of the request or will receive Elevidys within 6 months.
Patient has symptomatic cardiomyopathy.
Incomplete baseline or monitoring documentation (missing dystrophin level, baseline timed function tests, or required renal monitoring).
Evidence of unacceptable toxicity (e.g., renal toxicity/proteinuria) without plan for management.

Background

Viltepso (viltolarsen) is indicated for the treatment of Duchenne muscular dystrophy in patients with a confirmed DMD gene mutation amenable to exon 53 skipping. Clinical trial data demonstrate improvements in motor function and slowed disease progression. The recommended dosing for DMD is 80 mg/kg administered once weekly as a 60‑minute IV infusion, with monitoring and baseline assessments (such as dystrophin level or functional measures) required per policy.

Definitions

inv-14: Exon 53 amenable mutation — Definition of a confirmed DMD gene mutation amenable to exon 53 skipping

DefinitionA confirmed mutation of the DMD gene for which exon 53 skipping via antisense oligonucleotide therapy is an appropriate mechanism of action to restore dystrophin production.

Required confirmationMutation must be confirmed (genetic testing) as amenable to exon 53 skipping.

Clinical relevanceApplies to patients meeting FDA‑labeled indication for Viltepso (viltolarsen) for DMD with exon 53‑amenable mutations.

Implication for coverageTreatment is covered only when a confirmed exon 53‑amenable DMD mutation is present as part of indication‑specific criteria.