CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Amondys 45 (casimersen) IV therapy — coverage criteria

Clinical coverage criteria and prior authorization requirements for Amondys 45 (casimersen) for members of Neighborhood Health Plan of Rhode Island across Medicaid, Commercial, and Medicare lines of business.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAmondys 45 (casimersen) IV therapy — coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date05/01/2021

Next Review DateN/A

Key ActionObtain baseline dystrophin level and required timed function tests and renal monitoring before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1400max HCPCS units/28d

30 mg/kg wklydose

J1426HCPCS

G71.01Dx code

Coverage Criteria for Amondys 45 (casimersen)

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Universal criteria: Patient is not on concomitant DMD-directed antisense oligonucleotides (e.g., eteplirsen, golodirsen, viltolarsen); patient has not received Elevidys (delandistrogene moxeparvovec-rokl) within 6 months of this request; and serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio (UPCR) will be measured before starting and periodically during treatment.

From Universal Criteria (document)

DMD-specific criteria: Confirmed Duchenne muscular dystrophy with a mutation of the DMD gene that is amenable to exon 45 skipping; patient has been on a stable dose of corticosteroids unless contraindicated or intolerant; patient retains meaningful voluntary motor function (e.g., able to speak, manipulate objects with upper extremities, ambulate); patient is receiving physical and/or occupational therapy; and baseline documentation includes one or more of the following: dystrophin level, timed function tests (e.g., 6MWT, TTSTAND, TTRW, TTCLIMB), North Star Ambulatory Assessment (NSAA), upper limb function test, or FVC percent predicted.

From Duchenne muscular dystrophy section (document)

Renewal criteria

Renewal covered when ALL of the following are met

Continuation requirements: Patient continues to meet the universal and indication-specific criteria above; there is absence of unacceptable toxicity (examples include severe hypersensitivity reactions or renal toxicity such as glomerulonephritis, persistent increase in serum cystatin C, or proteinuria); and the patient has responded to therapy compared to pretreatment baseline by one or more of the following: increase in dystrophin level; stability, improvement, or slowed rate of decline in timed function tests (e.g., TTSTAND, 6MWT, TTRW, TTCLIMB); stability, improvement, or slowed decline in NSAA score; stability, improvement, or slowed decline in upper limb function; stability, improvement, or slowed decline in FVC percent predicted; or improvement in quality of life.

From Renewal Criteria (document)

Requests for Amondys 45 will be considered not medically necessary for patients who do not have a confirmed DMD mutation amenable to exon 45 skipping. Additionally, requests lacking required baseline documentation or monitoring may be excluded; required baseline documentation includes at least one of the following: dystrophin level, timed function tests (for example, 6-minute walk test, TTSTAND, TTRW, TTCLIMB), North Star Ambulatory Assessment (NSAA), upper limb function test, or forced vital capacity percent predicted (FVC% predicted).

Coding, Dosing, and Billing Limits

Covered HCPCS CodesHCPCSCovered

J1426

injection, casimersen, 10mg

NDCNDC

60923-0227

Amondys 45 100 mL single-dose vial (NDC partial)

Covered Diagnosis CodesICD-10Covered

G71.01

Duchenne or Becker muscular dystrophy

HCPCS dosing cap

HCPCS dosing capMaximum 1400 billable HCPCS units per 28 days

Measurement intervalLimit applies to every 28-day period

Unit typeHCPCS billing units

Dose per administration

Dose per administration30 mg/kg administered via intravenous infusion once weekly

Monitoring at initiationMeasure serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio before starting therapy

Administration routeIntravenous (IV) infusion

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior authorization validity and Medicare note

Authorization is valid for 6 months and may be renewed. Medicare members who have previously received this medication within the past 365 days are not subject to Step Therapy requirements.

Authorization period: 6 months; renewals permitted
Medicare exception: members with receipt of this medication within the prior 365 days are exempt from Step Therapy

Documentation Required

Required documentation and monitoring

Required baseline documentation and ongoing monitoring must be provided to support both initial approval and renewal. Documented evidence of therapeutic response and absence of unacceptable toxicity is required for continued authorization.

Confirmatory genetic testing showing a DMD gene mutation amenable to exon 45 skipping
Baseline assessments (one or more): dystrophin level, timed function tests (examples: 6-minute walk test [6MWT], time to stand [TTSTAND], time to run/walk 10 meters [TTRW], time to climb 4 stairs [TTCLIMB]), North Star Ambulatory Assessment (NSAA), upper limb function (ULM) test, and forced vital capacity (FVC) % predicted
Baseline and periodic laboratory monitoring: serum cystatin C, urine dipstick, and urine protein-to-creatinine ratio (UPCR); consider measuring glomerular filtration rate
Documentation of clinical status: meaningful voluntary motor function, current corticosteroid use (stable dose for at least several months unless contraindicated), and receipt of physical and/or occupational therapy
For renewal: evidence of response compared to pretreatment baseline (e.g., increase in dystrophin level; stability, improvement, or slowed decline in timed function tests, NSAA score, ULM test, or FVC% predicted) and absence of unacceptable toxicity (including severe hypersensitivity reactions, renal toxicity such as glomerulonephritis, persistent increase in serum cystatin C, or significant proteinuria)

Denial Risk

Triggers for denial

Requests may be denied if required documentation or clinical criteria are not met, or if the member is receiving disallowed concomitant therapies.

No confirmed DMD mutation amenable to exon 45 skipping documented
Patient is currently receiving concomitant DMD-directed antisense oligonucleotide therapies (e.g., eteplirsen/Exondys 51, golodirsen/Vyondys 53, viltolarsen/Viltepso) — concomitant use is not permitted
Patient has received Elevidys (delandistrogene moxeparvovec-rokl) within 6 months of this request
Required baseline or monitoring labs/assessments (genetic confirmation, dystrophin level or specified functional tests, serum cystatin C, urine dipstick, UPCR, etc.) are missing or incomplete
Evidence of unacceptable toxicity from the drug (severe hypersensitivity, renal toxicity, persistent proteinuria or rising cystatin C) without appropriate management

Background

Amondys 45 (casimersen) is an antisense oligonucleotide indicated for Duchenne muscular dystrophy and was approved via the accelerated approval pathway based on increased dystrophin as a surrogate endpoint. Clinical data demonstrated increased dystrophin in treated boys; common adverse events reported include upper respiratory infections, cough, fever, headache, arthralgia, and injection-site pain. Use is subject to specific eligibility and monitoring requirements including confirmation of an exon 45–amenable DMD mutation and baseline and periodic renal monitoring.

Definitions

Accelerated approval (context)

DefinitionRegulatory pathway where approval is based on a surrogate endpoint (increased dystrophin) reasonably likely to predict clinical benefit.

Basis for approvalApproval supported by increase in dystrophin protein as a surrogate endpoint (ESSENCE trial showed statistically significant dystrophin increase).

ImplicationPost-approval confirmatory evidence may be required to verify clinical benefit.

Exon 45 skipping amenable mutation

DefinitionA confirmed mutation of the DMD gene that is amenable to exon 45 skipping therapy.

RequirementPatient must have documented confirmation of the DMD mutation amenable to exon 45 skipping to meet coverage criteria.

ContextOne of the indication-specific criteria for initiating Amondys 45 in Duchenne muscular dystrophy.