CurrentAetnaPolicy N/A

Vyondys 53 (golodirsen) precertification for injectable medication

Precertification request form and medical necessity criteria for initiation and continuation of Vyondys 53 (golodirsen) for members covered by Aetna; intended for prescribers, infusion sites, and pharmacies completing authorization requests.

Policy Summary

PayerAetna

PolicyVyondys 53 (golodirsen) precertification for injectable medication

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionSubmit precertification with required documentation including genetic testing results confirming an exon 53–amenable DMD mutation, 6-minute walk test distance, and prior therapy history.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

250 m6-minute walk test minimum for initial eligibility

30 mg/kgmaximum dose threshold queried on form

exon 53requires DMD mutation amenable to exon 53 skipping

Medicare Part Bseparate Medicare request form noted

Coverage Criteria for Vyondys 53 (golodirsen)

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Initial Therapy

Initial and continuation authorization require completion of clinical items; coverage is considered when specified criteria are met.

Initial Therapy: Patient has documented diagnosis of Duchenne muscular dystrophy confirmed by genetic testing and identification of a DMD gene mutation amenable to exon 53 skipping.

Form requires documentation that genetic testing was performed to confirm DMD and to identify the specific DMD gene mutation (including whether it is amenable to exon 53 skipping).

Initial Functional Status: Patient is able to achieve an average distance of at least 250 meters on the 6-minute walk test (walking independently for 6 minutes).>= 250 meters

Form asks whether the patient can achieve an average distance of at least 250 meters while walking independently over 6 minutes.

Age and Prior Therapy Considerations: Treatment initiation timing and prior gene therapy must be documented: whether treatment will be initiated prior to 16 years of age and whether the patient has previously received gene replacement therapy for DMD (e.g., Elevidys); if previously treated with gene therapy, documentation of clinical worsening since gene therapy is required for restart.

Form includes checkboxes for initiation prior to age 16 and prior gene replacement therapy and queries worsening in clinical status after gene therapy.

Continuation Therapy

Continuation requests require demonstration of clinical benefit.

Continuation Therapy: Documentation that the patient has demonstrated a response to therapy as evidenced by remaining ambulatory (e.g., able to walk with or without assistance and not wheelchair dependent).ambulatory status

Form explicitly asks whether the patient has demonstrated a response to therapy as evidenced by remaining ambulatory.

Patients with a DMD gene mutation that is not amenable to exon 53 skipping are excluded from eligibility for Vyondys 53 (golodirsen). The precertification form requires documentation of genetic testing that identifies the specific DMD mutation and an explicit indication whether the mutation is amenable to exon 53 skipping; a response of “No” to that question precludes coverage under the form’s initial clinical criteria.

Initiation requests must document functional ability and mutation amenability: the patient must be able to achieve an average distance of at least 250 meters on the 6-minute walk test and must have a DMD mutation amenable to exon 53 skipping. The form also queries whether treatment will be initiated prior to age 16 years and asks about prior gene replacement therapy; failure to meet the stated 6-minute walk threshold or lack of an amenable mutation means the request does not meet the form’s initial clinical criteria.

Initial Authorization Requirements

Initial Therapy Criteria

Initial authorization requires documentation of genetic testing and functional status.

Initial Approval Criteria: Genetic testing confirming the diagnosis of Duchenne muscular dystrophy and identification of the specific DMD gene mutation with confirmation that the mutation is amenable to exon 53 skipping.

Form requires affirmative responses that genetic testing was conducted to confirm DMD and to identify the mutation and whether it is amenable to exon 53 skipping.

Functional Eligibility: Patient must be able to achieve an average distance of at least 250 meters on the 6-minute walk test while walking independently.>= 250 meters

The form queries if the patient can achieve an average distance of at least 250 meters over 6 minutes.

Age and Prior Gene Therapy: Document whether treatment is initiated prior to 16 years of age and whether the patient has previously received gene replacement therapy for DMD; for patients restarting after gene therapy, documentation of clinical worsening since gene therapy is required.

These items are specified on the form for initial and restart-after-gene-therapy requests.

Coding and Test Thresholds

Administration CPT Codes (to be supplied)CPT

Administration code(s) (CPT)

Administration CPT codes to be provided on form

Diagnosis Codes (ICD-10)ICD-10

Primary ICD Code

Primary diagnosis ICD code to be provided

inv-07: 6-Minute Walk Test — >= 250 meters minimum for eligibility.

6-Minute Walk Test thresholdPatient must be able to achieve an average distance of at least 250 meters while walking independently over 6 minutes for initial eligibility.

Applies toInitial requests and patients re-starting therapy after gene replacement therapy — form requires this item for both scenarios.

Evidence requiredDocumented 6-minute walk test distance recorded on the precertification request or supporting clinical records.

inv-08: Dose limit queried — form asks if dose exceeds 30 mg/kg weekly.

Response optionsForm provides a Yes/No checkbox for whether dose exceeds 30 mg/kg weekly.

ImplicationResponses may trigger review for dosing beyond the queried weekly 30 mg/kg threshold.

Actions Required by Prescribers and Providers

Prior Authorization

Precertification required

Precertification through Aetna is required for this medication. For Medicare Advantage Part B requests, use the Medicare request form.

Aetna Precertification Notification: Phone: 1-866-752-7021 (TTY: 711); FAX: 1-888-267-3277
Medicare Advantage Part B requests: Use Medicare Request Form

Documentation Required

Required clinical and administrative documentation

Complete the precertification form in full and include all required administrative information: patient identifiers (name, DOB, contact, weight/height), member insurance and ID, prescriber details (name, specialty, NPI, state license number, phone, fax), and dispensing/provider details. Specify product name, dose, frequency, and primary/other ICD-10 diagnosis codes.

Patient information: full name, DOB, contact information, weight and height
Prescriber information: name, specialty, licensure (St Lic #), NPI, phone, fax, office contact
Product information: Vyondys 53 (golodirsen), dose, frequency
Diagnosis information: primary ICD code and any secondary/other ICD codes

Documentation Required

Concomitant therapy check

Confirm concomitant therapy status. The form specifically asks whether the requested medication will be used concomitantly with viltolarsen; concurrent use may affect authorization decisions.

Will the requested medication be used concomitantly with viltolarsen? Yes / No

Documentation Required

Clinical data required by request type

Complete all required clinical fields for the type of request: - For all requests: indicate outpatient hospital infusion setting status, prior adverse events to the product, venous access issues, behavioral/functional limitations, medical instability (cardiopulmonary/respiratory/renal), documented diagnosis of Duchenne muscular dystrophy (DMD), and whether treatment is prescribed or consulted by a DMD specialist. - For initial or re-starting therapy: provide genetic testing to confirm DMD and mutation type, indicate whether the DMD mutation is amenable to exon 53 skipping, 6-minute walk test result (average ≥250 meters), patient age at initiation (<16 years flagged), and history of prior gene replacement therapy (e.g., Elevidys). - For continuation requests: document clinical response (e.g., patient remains ambulatory).

All requests: outpatient setting, adverse events, venous access issues, behavioral/impairment considerations, medical instability, DMD diagnosis confirmation, DMD specialist involvement
Initial/re-starting: genetic testing confirmation and mutation amenability to exon 53 skipping, 6-minute walk distance (≥250 m), age at initiation, prior gene therapy history
Continuation: documentation of response to therapy (ambulatory status)

Denial Risk

Fraud and false information

Fraudulent or materially false information on the request may lead to criminal and civil penalties, denial of authorization, or requests for additional information or clarification.

Request completed by signature required
Materially false or concealed information may be subject to penalties

Place of Administration

Note

Specify place of administration

Specify the place of administration on the form; options include self-administered, physician’s office, outpatient infusion center, home infusion, or outpatient hospital setting if applicable.

Place of Administration checkboxes on the form: Self-administered, Physician's Office, Outpatient Infusion Center, Home Infusion Center
The form asks if the infusion request is in an outpatient hospital setting and queries clinical reasons (severe adverse events, venous access issues, behavioral or medical instability) that may necessitate outpatient hospital administration

OpenPayer

Vyondys 53 (golodirsen) precertification for injectable medication

Coverage Criteria for Vyondys 53 (golodirsen)

Initial Authorization Requirements

Criteria for Ongoing Therapy

Coding and Test Thresholds

Actions Required by Prescribers and Providers

Place of Administration

Key Definitions

Background

Step Therapy / Concomitant Use Notes