CurrentAetnaPolicy N/A

Viltepso (viltolarsen) Medication Precertification Request

Aetna precertification request form to collect patient, provider, insurance, dispensing, diagnosis, and required clinical information for initiation, continuation, or restart of Viltepso (viltolarsen) therapy; used to support prior authorization review. Not a coverage criteria document but an authorization intake template.

Policy Summary

PayerAetna

PolicyViltepso (viltolarsen) Medication Precertification Request

Policy CodePolicy N/A

Change TypeInformational form (no coverage changes)

Effective Date

Next Review Date

Key ActionComplete and legibly submit all fields on the Viltepso precertification form including required clinical documentation to Aetna Precertification Notification via phone 1-866-752-7021 or fax 1-888-267-3277.

SourceLink

POLICY UPDATE CHANGES

No material clinical/coverage changes

1Form pages

ViltepsoProduct

DMDIntended indication

Policy overview and form summary

Scope: This is an Aetna precertification request form used to collect patient, provider, insurance, dispensing, diagnosis, and required clinical information to support prior authorization review for Viltepso (viltolarsen). It is an authorization intake template, not a coverage policy.

Background: The form gathers standardized information for patients with Duchenne muscular dystrophy (DMD) who are being considered for initiation, continuation, or restart of Viltepso therapy, including demographics, insurance, prescriber and dispensing/administration details, diagnosis codes, and specific clinical items (e.g., genetic testing and ambulatory status).

Form purpose: To collect all required clinical documentation and administrative details (patient and provider data, insurance, product dose/frequency, dispensing and place of administration, ICD diagnosis codes, and therapy-specific items) needed for prior authorization review for start, continuation, or restart of Viltepso therapy.

Coding guidance

Administration code(s) (CPT) - to be provided by requesterCPT

No codes listed

Diagnosis codes - to be provided by requesterICD-10

No codes listed

The requester must indicate administration code(s) (CPT) on the form in the Dispensing Provider/Administration section for billing and authorization purposes.

Actionable requirements for requesters

Prior Authorization

Submit precertification request

Complete and legibly submit all fields on the Viltepso precertification form including clinical documentation to Aetna Precertification Notification. Submit via phone 1-866-752-7021 (TTY: 711) or fax 1-888-267-3277. For Medicare Advantage Part B requests, use the Medicare request form.

Documentation Required

Provide genetic testing and mutation details

For initiation or restarting therapy, submit genetic testing that confirms a diagnosis of Duchenne muscular dystrophy, identifies the specific DMD gene mutation, and indicates whether the mutation is amenable to exon 53 skipping. Include the specific DMD gene mutation on the form.

Documentation Required

Provide ambulatory status for initiation/continuation

Document whether the patient is independently ambulatory (not wheelchair dependent). For initiation, indicate ambulatory status; for continuation requests, provide ambulatory documentation to demonstrate response to therapy (e.g., remains ambulatory).

Documentation Required

Provide history of gene therapy

Document any prior gene replacement therapy (e.g., Elevidys). If applicable, document whether the patient has experienced clinical worsening (for example decline in ambulatory function) since receiving gene replacement therapy.

Documentation Required

Adverse event and stability documentation

Provide history of infusion-related adverse events and indicate whether the event did not respond to conventional interventions or was severe. Document severe venous access issues requiring outpatient hospital setting, significant behavioral/physical/cognitive impairments that impact infusion safety and caregiver access, and any medical instability (respiratory, cardiovascular, renal, or other) that may require an outpatient hospital infusion setting with appropriate personnel/equipment.

Billing Rule

Provide administration CPT codes

Indicate the administration code(s) (CPT) on the precertification form; the requester must supply these codes for billing/authorization purposes.

Key thresholds and safety checks

Thresholds / operational checks

Maximum weekly dose checkPatient dose exceeds 80 mg/kg once weekly (yes/no)

Concomitant therapy noteForm asks if medication will be used concomitantly with golodirsen (yes/no)

Alternate setting requirementForm documents medical instability (respiratory, cardiovascular, renal or other) that may limit tolerance and require management in an alternate setting with appropriate medical personnel and equipment

Background and definitions

This precertification form is used to collect the standardized information required for authorization review of Viltepso (viltolarsen) for patients with Duchenne muscular dystrophy. It collects initiation, continuation, and restart-specific clinical items including confirmation of DMD diagnosis, genetic testing and mutation details, ambulatory status, prior gene therapy history, and documentation of infusion-related issues or medical instability.

The form also collects administrative and logistical data needed for processing: patient demographics (name, address, DOB, weight, height, allergies, contact information), insurance details (Aetna member ID, group number, other coverage, Medicare/Medicaid IDs), prescriber information (name, credentials, NPI, specialty, contact), dispensing provider and place of administration (including administration CPT code(s)), product information (Viltepso dose and frequency), and primary/other ICD diagnosis codes.

For initiation or restart of therapy the form specifically requests whether genetic testing was performed to confirm DMD and identify the DMD gene mutation, whether the mutation is amenable to exon 53 skipping, and whether the patient is independently ambulatory. For continuation, the form requires documentation of response to therapy (e.g., remaining ambulatory). The form also asks about concomitant use with golodirsen and whether the patient's dose exceeds 80 mg/kg once weekly.

DMD: Duchenne muscular dystrophy

Policy Summary

PayerAetna

PolicyViltepso (viltolarsen) Medication Precertification Request

Policy CodePolicy N/A

Change TypeInformational form (no coverage changes)

Effective Date

Next Review Date

SourceLink

On This Page

OpenPayer

Viltepso (viltolarsen) Medication Precertification Request

Policy overview and form summary

General required documentation for all requests

Initiation of therapy - required items

Re-starting therapy after gene therapy - required items

Continuation of therapy - required items

Coding guidance

Actionable requirements for requesters

Key thresholds and safety checks

Background and definitions

Document revision history