CurrentColorado Rocky Mountain Health PlansPolicy N/A

Exondys 51 (eteplirsen) prior authorization

Prior authorization form and requirements for Exondys 51 (eteplirsen) for Florida Medicaid recipients; governs prescribers and pharmacies submitting PA requests. It covers initiation and continuation requests and required supporting documentation.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyExondys 51 (eteplirsen) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the PA form in full and fax with required genetic and lab documentation to 1-866-940-7328.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsmaximum approval length

5 yearsprovider must retain documentation

1-866-940-7328fax number for PA form

1-800-310-6826Pharmacy PA Call Center

Coverage Criteria and Submission

PA form completion and documentation

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyExondys 51 (eteplirsen) prior authorization

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionComplete the PA form in full and fax with required genetic and lab documentation to 1-866-940-7328.

SourceLink

On This Page

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Form and documentation: PA form completed in full; official genetic test confirming diagnosis provided; official lab reports, recent chart notes, and most recent related labs submitted; provider retains documentation for five years.

Fax completed form and documentation to 1-866-940-7328.

Request type: Request marked as Initiation of Therapy OR Continuation of Therapy on the form.

Functional/respiratory data: Provide Six-Minute Walk Test, Brooke Upper Extremity Function Scale, and Forced Vital Capacity documentation if available; include dates of testing.

Official lab reports and testing must be submitted with the prior authorization request.

The documents accompanying this prior authorization form contain confidential health information that is legally privileged. If you are not the intended recipient, any disclosure, copying, distribution, or action taken in reliance on the contents is strictly prohibited. If the form or related documents were received in error, notify the sender immediately (via return fax) and arrange for the return or destruction of the materials. Distribution, reproduction, or any other use of this transmission by any party other than the intended recipient is strictly prohibited.

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required for initiation or continuation of Exondys 51 (eteplirsen). The PA form must be completed in full and faxed to 1-866-940-7328; incomplete forms may be returned or denied. Maximum length of approval is 6 months.

Fax completed PA form and required documentation to 1-866-940-7328.
Pharmacy PA Call Center: 1-800-310-6826.

Documentation Required

Required Documentation

Required documentation — Official genetic testing confirming the diagnosis and official lab reports must be submitted with the prior authorization request. Include diagnostic evaluations, recent chart notes, and the most recent copies of related labs. The provider must retain copies of all documentation for five years.

Official genetic testing confirming diagnosis (indicate date of test).
Six-Minute Walk Test results (if performed) with date.
Brooke Upper Extremity Function Scale with date (if performed).
Forced Vital Capacity results with date (if performed).
Copies of diagnostic evaluations and recent chart notes.

Denial Risk

Incomplete Submissions May Be Returned or Denied

Incomplete submission triggers denial — An incomplete form or missing required official lab/genetic reports and testing may cause the prior authorization to be returned or not approved. Ensure all required fields on the PA form are completed and all requested documents are included.

If official genetic testing confirming diagnosis is not submitted, the PA may be denied or returned.
Missing recent chart notes or lab data may delay or prevent approval.

Billing Rule

Provider Action / Form Completion

Provider form and fields to complete — Use the Exondys 51 PA form. Key fields include recipient name, Medicaid ID, date of birth, prescriber name and NPI, prescriber phone and fax, medication, quantity, directions, patient weight (with date), diagnosis, provider specialty, indication of initiation vs continuation of therapy, and prescriber's signature and date.

Indicate whether request is for Initiation of Therapy or Continuation of Therapy.
Confirm "Official Genetic Testing Confirming Diagnosis" (Yes/No) and provide Date of Test.
Include objective measures where available: Six-Minute Walk Test, Brooke Upper Extremity Function Scale, Forced Vital Capacity (with dates).
Retain copies of all documentation for five years.

Clinical Background

Exondys 51 (eteplirsen) is an antisense oligonucleotide therapy indicated for patients with Duchenne muscular dystrophy who have a genetic mutation amenable to exon 51 skipping. The prior authorization form is used to document the clinical rationale for either initiation or continuation of therapy and requests both diagnostic and functional information to support coverage decisions.

The form requires official genetic testing confirming the diagnosis and asks for baseline and follow-up functional and respiratory measures — specifically the Six-Minute Walk Test, the Brooke Upper Extremity Function Scale, and Forced Vital Capacity (including dates of testing) — along with recent chart notes and related laboratory results. Completion of the PA form in full and submission of the requested documentation are required for coverage consideration for either Initiation of Therapy or Continuation of Therapy requests.

Initiation of Therapy Requirements

Initiation of Therapy requirements

Initiation requests require genetic confirmation and baseline assessments.

Initiation: Form must be marked 'Initiation of Therapy'; include official genetic testing confirming diagnosis, baseline weight, and baseline functional/respiratory test results if available; submit recent chart notes and the most recent related labs.6 months

Approval may be issued for up to the maximum length of approval (6 months).

Continuation of Therapy Requirements

Continuation of Therapy requirements

Continuation requests must use the same PA form and include recent clinical and testing data.

Continuation: Form must be marked 'Continuation of Therapy' and include updated weight, relevant functional/respiratory tests (Six-Minute Walk Test, Brooke Upper Extremity Function Scale, Forced Vital Capacity) where available, and recent chart notes/labs to support ongoing benefit.6 months

Maximum approval period applies to continuation approvals as well.

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