CurrentAnthemPolicy N/A

Prior Authorization Form: Antisense oligonucleotides for Duchenne muscular dystrophy

Prior authorization form and requirements for coverage of antisense oligonucleotide exon‑skipping therapies for members with Duchenne muscular dystrophy under Anthem HealthKeepers Medicaid products.

Policy Summary

PayerAnthem

PolicyAntisense oligonucleotides for Duchenne muscular dystrophy (PA form)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the prior authorization form with mutation confirmation, corticosteroid status, monitoring documentation, and prescriber signature to 844-512-7020.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

3pages in the form

3named exon‑skipping products listed

3core renewal criteria items

Coverage Criteria

Initial Therapy

Initial coverage for all medications will be approved when ALL of the following are met:

Initial criteria: (1) Member has a confirmed diagnosis of Duchenne muscular dystrophy (DMD) with a confirmed DMD gene mutation amenable to the specific exon skipping requested: exon 45 for Amondys 45; exon 51 for Exondys 51; exon 53 for Vyondys 53 or Viltepso; (2) Member has been on a stable dose of corticosteroids unless there is a documented contraindication or intolerance; (3) The requested agent will be used as the only exon‑skipping therapy for the member.

All three conditions must be checked 'Yes' on the form and prescriber must sign and date the form.

Continuation/Renewal Therapy

Renewal coverage for all medications will be approved when ALL of the following are met:

Renewal criteria: (1) Member continues to meet the initial criteria; (2) Absence of unacceptable toxicity to the drug; (3) Member is being appropriately monitored for a beneficial response to therapy.

Prescriber must attest (checkboxes) and sign/date the form; attach monitoring documentation as appropriate.

Policy Summary

PayerAnthem

PolicyAntisense oligonucleotides for Duchenne muscular dystrophy (PA form)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete and fax the prior authorization form with mutation confirmation, corticosteroid status, monitoring documentation, and prescriber signature to 844-512-7020.

SourceLink

On This Page

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Requests that do not include confirmation that the member has a DMD gene mutation amenable to the specific exon skip requested, that do not document the member’s corticosteroid status (or a documented contraindication or intolerance to corticosteroids), or that fail to attest that the requested agent will be the sole exon‑skipping therapy for the member will not meet criteria for approval. The prior authorization form requires explicit checkbox confirmation of each of these items for initial coverage: (1) confirmed DMD mutation amenable to the requested exon skip (exon 45 for Amondys 45; exon 51 for Exondys 51; exon 53 for Vyondys 53 or Viltepso), (2) stable corticosteroid use unless contraindicated or intolerant, and (3) use as the only exon‑skipping therapy for the member.

For renewal, the prescriber must confirm continued fulfillment of the initial criteria, attest to an absence of unacceptable drug toxicity, and document that the member is being appropriately monitored for a beneficial response to therapy. Incomplete or missing information will result in denial of the request and a fax requesting additional information will be sent to the prescriber.

Initial Authorization Criteria

Initial authorization

Initial authorization is granted when ALL of the following mutation and clinical criteria are met:

Mutation and clinical criteria: Confirmed DMD gene mutation amenable to the requested exon skip (exon 45 for Amondys 45; exon 51 for Exondys 51; exon 53 for Vyondys 53 or Viltepso); member on a stable dose of corticosteroids unless there is a contraindication or intolerance; requested agent will be used as the sole exon‑skipping therapy for the member.

Form contains checkboxes for each item and requires prescriber signature and date; incomplete information may result in denial.

Renewal / Continuation Requirements

Renewal requirements

Renewal requires ongoing fulfillment of initial criteria plus demonstration of safety and effectiveness:

Renewal requirements: Member continues to meet the initial authorization criteria; there is no unacceptable toxicity to the drug; member is being appropriately monitored for and demonstrating (or expected to demonstrate) a beneficial response to therapy.

Prescriber must attest via the renewal section checkboxes, sign and date the form, and attach monitoring/response documentation as required; incomplete forms may delay or result in denial.

Provider Actions & Prior Authorization Instructions

Prior Authorization

Prior Authorization Required

Prior authorization (PA) is required. Initial approval is conditional and limited pending confirmation of a qualifying DMD mutation and fulfillment of clinical criteria. If the physician does not have the necessary information, the request will be denied and a fax requesting additional information will be sent to the prescriber.

Initial coverage limited pending mutation confirmation and clinical criteria.
Incomplete information will trigger denial and a fax for additional information.

Step Therapy

Single Exon‑Skipping Therapy Requirement

The PA form asks whether the requested antisense oligonucleotide will be used as the only exon‑skipping therapy for the member. The agent must be the sole exon‑skipping therapy for the member to meet this requirement.

Form question: "Will the requested agent be used as the only exon skipping therapy for the member's DMD?" (Yes/No).
Approval requires the agent to be the only exon‑skipping therapy.

Documentation Required

Required Documentation and Submission

Complete and submit the Anthem prior authorization form for antisense oligonucleotides for Duchenne muscular dystrophy. Use one form per member and ensure all fields are complete, correct, and legible to avoid delays.

Include member information: name, Medicaid ID, date of birth, weight (kg).
Include prescriber information: name, NPI, phone, fax, prescriber signature and date.
Include drug information: drug name, form, strength, dosing frequency, length of therapy, quantity, day supply.
For renewals, complete the renewal section on page 3 and include attachments as requested.
Fax the completed form to 844-512-7020.

Denial Risk

Incomplete Information Triggers Denial

If the PA form is incomplete, incorrect, or illegible, the PA process can be delayed; incomplete forms may be denied and a fax requesting additional information will be sent to the prescriber.

Ensure all requested documentation is included; submission does not guarantee coverage.
Initial coverage is limited to members with confirmed DMD mutations amendable to the specified exon skipping (exon 45 for Amondys 45, exon 51 for Exondys 51, exon 53 for Vyondys 53/Viltepso) and other listed clinical criteria.

Definitions

Amenable to exon 45 skipping — definition (Amondys 45)

DefinitionConfirmed mutation of the DMD gene that is amenable to exon 45 skipping (Amondys 45).

Associated productAmondys 45

Documentation requiredConfirmation of DMD mutation amenable to exon 45 skipping must be provided on the prior authorization form.

Amenable to exon 51 skipping — definition (Exondys 51)

DefinitionConfirmed mutation of the DMD gene that is amenable to exon 51 skipping (Exondys 51).

Associated productExondys 51

Documentation requiredConfirmation of DMD mutation amenable to exon 51 skipping must be provided on the prior authorization form.

Amenable to exon 53 skipping — definition (Vyondys 53 or Viltepso)

DefinitionConfirmed mutation of the DMD gene that is amenable to exon 53 skipping (Vyondys 53 or Viltepso).

Associated productsVyondys 53; Viltepso

Documentation requiredConfirmation of DMD mutation amenable to exon 53 skipping must be provided on the prior authorization form.

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