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Vyondys 53 (golodirsen) precertification for injectable medication
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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.
No material clinical or coverage changes in this revision.
Coverage Criteria for Vyondys 53 (golodirsen)
Initial Therapy
Initial and continuation authorization require completion of clinical items; coverage is considered when specified criteria are met.
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).
Form asks whether the patient can achieve an average distance of at least 250 meters while walking independently over 6 minutes.
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.
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.
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.
The form queries if the patient can achieve an average distance of at least 250 meters over 6 minutes.
These items are specified on the form for initial and restart-after-gene-therapy requests.
Criteria for Ongoing Therapy
Continuation
For continuation requests:
Form asks 'Has the patient demonstrated a response to therapy as evidenced by remaining ambulatory?' and requires a Yes/No response.
Coding and Test Thresholds
| Administration code(s) (CPT) | Administration CPT codes to be provided on form |
| Primary ICD Code | Primary diagnosis ICD code to be provided |
Actions Required by Prescribers and Providers
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
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
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
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)
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
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
Key Definitions
Background
Duchenne muscular dystrophy (DMD) is an X-linked, progressive muscle-wasting disorder. Vyondys 53 (golodirsen) is an exon-skipping antisense oligonucleotide indicated for patients with DMD who have a confirmed mutation that is amenable to exon 53 skipping. The Aetna precertification form requires genetic testing to confirm the diagnosis and identify the DMD mutation type, and it requests baseline functional status including the 6-minute walk test as part of the clinical documentation for initial therapy.
Step Therapy / Concomitant Use Notes
| Question | Answer options |
|---|---|
| Will the requested medication be used concomitantly with viltolarsen? | Yes / No |
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