CurrentCignaPolicy N/A

Vyondys 53 (golodirsen) prior authorization — coverage criteria and prior authorization form

This document is a Cigna prior authorization request form and clinical checklist for Vyondys 53 (golodirsen) to treat patients with Duchenne muscular dystrophy who have a DMD gene variant amenable to exon 53 skipping; it governs clinicians seeking coverage for this medication.

Policy Summary

PayerCigna

PolicyVyondys 53 (golodirsen) prior authorization — coverage criteria and prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAttach medical documentation confirming a pathogenic or likely pathogenic DMD variant amenable to exon 53 skipping when submitting the prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

>=250 m6MWT threshold

<7 sGower's rise time

Exon 53genetic eligibility

Coverage Criteria for Vyondys 53 (golodirsen)

Initial therapy

Covered when ALL of the following are met:

Genetic confirmation: Documentation confirms Duchenne muscular dystrophy with a pathogenic or likely pathogenic DMD gene variant amenable to exon 53 skipping.

Attach genetic test results or equivalent medical documentation; requests may be denied without this.

Baseline ambulatory function: Patient was able to walk at least 250 meters independently over 6 minutes and had a Gower's (rise) time less than 7 seconds.6MWT >= 250 meters; Gower's < 7 seconds

These specific values are queried on the form.

Prescriber specialty: Medication is prescribed by or in consultation with a neurologist, neuromuscular specialist, or a Muscular Dystrophy Association clinic.

Policy Summary

PayerCigna

PolicyVyondys 53 (golodirsen) prior authorization — coverage criteria and prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionAttach medical documentation confirming a pathogenic or likely pathogenic DMD variant amenable to exon 53 skipping when submitting the prior authorization.

SourceLink

On This Page

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Continuation therapy

Covered when ALL of the following are met:

Prior benefit: For continuation, the patient has experienced a beneficial clinical response to golodirsen (Vyondys 53), including continued ability to walk.

Continuation section on the form requires attestation of benefit.

Ongoing specialist involvement: Medication continues to be prescribed by or in consultation with an appropriate specialist (neurologist, neuromuscular specialist, or Muscular Dystrophy Association clinic).

Form queries prescriber specialty for ongoing therapy.

Administrative completeness for continuation: Required form fields and supporting documentation (identifiers, current weight, medication dosing/frequency/duration, ICD‑10) are provided for the continuation request.

Include documentation used to verify prior benefit and current clinical status.

Implicitly excluded are patients who do not have documentation confirming a pathogenic or likely pathogenic DMD gene variant that is amenable to exon 53 skipping. The form expressly requests that medical documentation (for example, chart notes, laboratory results, or genetic test results) be attached and warns that requests may be denied if this confirmation is not provided. In addition, absence of the required baseline ambulatory measures (a 6-minute walk distance of at least 250 meters and a Gower’s rise time less than 7 seconds) undermines the clinical evidence requested on the form and may place the request outside the intended coverage population.

Requests that do not include documentation confirming a Duchenne muscular dystrophy diagnosis with a pathogenic or likely pathogenic DMD variant amenable to exon 53 skipping risk denial; the form requires that supporting medical documentation be attached and contain patient-identifying information. Similarly, requests that lack the required baseline clinical measurements — specifically a 6-minute walk test (6MWT) showing at least 250 meters walked independently and a recorded Gower’s (rise) time under 7 seconds — or that provide no documentation of benefit when submitted as a continuation of therapy, may be considered not medically necessary or denied.

Billing and Clinical Measures

Covered/Requested Drug Billing Code (example)HCPCS

J1428

Injection, golodirsen, 1 mg (example HCPCS code commonly used for golodirsen billing)

inv-06: 6-Minute Walk Test — at least 250 meters independently

6-Minute Walk Test (6MWT)Patient able to walk at least 250 meters independently over 6 minutes (document yes/no on form).

Documentation requirementRecord the measured distance and attach supporting medical documentation (chart notes, test results).

Use for initial eligibilityBaseline 6MWT >= 250 meters is required as part of initial therapy criteria.

inv-07: Gower's (Rise) time — less than 7 seconds

Gower's (Rise) time thresholdPatient had a Rise (Gower's) time less than 7 seconds (document yes/no on form).

Documentation requirementRecord the measured rise time and attach supporting medical documentation (chart notes, test results).

Use for initial eligibilityBaseline Gower's rise time < 7 seconds is required as part of initial therapy criteria.

Provider Actions, Documentation, and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyondys 53 (golodirsen). The request must specify the product, dose, frequency, duration of therapy, and the patient’s current weight. Complete all required patient and prescriber fields on the authorization form (asterisked items).

Medication requested: Vyondys 53 100mg/2ml vial (select as applicable)
Dose (specify mg)
Frequency of therapy (specify dosing interval)
Duration of therapy (specify length of treatment)
Patient current weight (required for dosing)
Complete all asterisked patient and prescriber fields on the form (physician name, DEA/NPI/TIN, patient identifiers, Cigna ID, DOB, etc.)

Documentation Required

Concurrent Exon-Skipping Therapy Disclosure

Disclose whether the requested medication will be used concurrently with other exon-skipping agents for Duchenne muscular dystrophy. Indicate Yes or No on the form and attach supporting clinical documentation.

Clinical question on form: "Will the requested medication be used concurrently with other Exon-skipping Duchenne muscular dystrophy (DMD) agents?" — mark Yes or No
If Yes, identify the other exon-skipping agent(s) and provide rationale and supporting documentation

Documentation Required

Required Genetic and Supporting Documentation

Attach genetic and supporting documentation confirming the diagnosis of Duchenne muscular dystrophy and that the patient has a pathogenic or likely pathogenic DMD variant amenable to exon 53 skipping. Requests may be denied if this documentation is not provided.

Documentation must confirm a pathogenic or likely pathogenic DMD gene variant amenable to exon 53 skipping
Acceptable documentation: genetic test report, chart notes, laboratory results, medical test results, or other records with patient identifiers
Note: Requests missing this documentation may be denied

Note

Administrative Form Completion

Complete all required administrative form fields. Fields marked with an asterisk must be filled to allow the plan to respond via fax and to avoid processing delays.

Patient information: Patient name, Cigna ID, date of birth, address, phone
Prescriber information: Physician name, specialty, DEA/NPI/TIN, office contact, phone, fax, address
Medication request fields: medication selected, dose, frequency, duration, patient weight
Clinical fields: indication/diagnosis, age at therapy start (<16?), ambulatory status (6-minute walk), Gower's time, prescriber specialty/consultation
Attestation and prescriber signature and date

Denial Risk

Documentation Triggers Denial Risk

Requests lacking confirmation of an amenable pathogenic or likely pathogenic DMD variant or missing required documentation are at risk for denial.

Denial risk triggered if genetic documentation confirming an exon 53–amenable pathogenic or likely pathogenic DMD variant is not attached
Incomplete administrative fields (asterisked items) may delay processing or result in denial

Background

Vyondys 53 (golodirsen) is an exon-skipping therapy indicated for patients with Duchenne muscular dystrophy who have a DMD gene variant amenable to exon 53 skipping. The prior authorization form solicits confirmation of that genetic eligibility and requests baseline ambulatory function data (whether the patient can walk at least 250 meters over 6 minutes and whether the patient’s Gower’s rise time is less than 7 seconds). The form also asks whether the medication is prescribed by or in consultation with a neurologist, neuromuscular specialist, or Muscular Dystrophy Association clinic and requires attached supporting documentation to avoid denial.

Definitions

inv-14: Amenable to exon 53 skipping

DefinitionA pathogenic or likely pathogenic variant in the DMD gene that is amenable to exon 53 skipping as documented by genetic testing.

Required evidenceAttach genetic test results or equivalent medical documentation confirming the pathogenic or likely pathogenic DMD variant amenable to exon 53 skipping.

Denial riskRequests may be denied if documentation does not include confirmation of a pathogenic or likely pathogenic DMD variant amenable to exon 53 skipping.

inv-15: Beneficial clinical response (for continuation)

Required demonstration of benefitFor continuation requests, the form requires attestation that the patient has experienced a beneficial clinical response to golodirsen, including the continued ability to walk.

Documentation to attachProvide supporting medical documentation showing clinical improvement or maintained ambulatory function (chart notes, test results).

Prescriber attestationPrescriber must indicate 'Yes' or 'No' on the continuation question regarding beneficial clinical response on the form.