Prior Authorization of Duchenne Muscular Dystrophy (DMD) Antisense Oligonucleotides - Pharmacy Services
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This bulletin requires prior authorization for prescriptions of DMD antisense oligonucleotides for Pennsylvania Medical Assistance fee-for-service beneficiaries and provides the clinical documentation and review requirements for prescribers and pharmacies.
Prior authorization requirement expanded to include Vyondys 53 (golodirsen) and Viltepso (viltolarsen) and the three drugs are combined into one guideline titled DMD Antisense Oligonucleotides.
Coverage Criteria
Initial Therapy
Covered when ALL of the following are met for initial prior authorization.
If the beneficiary does not meet the clinical review guidelines listed above but, in the professional judgment of the physician reviewer, the services are medically necessary, the request for prior authorization will be approved.
Initial authorization rules
Physician reviewer may approve requests that do not meet these criteria if judged medically necessary.
Continuation / Renewal Therapy
Renewal prior authorization covered when ALL of the following are met:
If the beneficiary does not meet the clinical review guidelines listed above but, in the professional judgment of the physician reviewer, the services are medically necessary, the request for prior authorization will be approved.
There are no additional, separate exclusions beyond the clinical criteria set forth in Section B. Requests that do not meet those criteria are not automatically denied; instead they are handled through the clinical review process described in Section C. Prior authorization personnel will apply the Section B guidelines to the request and, if the request does not meet those guidelines, refer it to a physician reviewer for a medical necessity determination.
If a request fails to meet the clinical guidelines in Section B, it will be referred to a physician reviewer. The physician reviewer will determine whether the requested prescription is medically necessary based on professional judgment; only when the reviewer determines the service is not medically necessary will the request be denied.
Initial Therapy Criteria
Initial authorization rules
Physician reviewer discretion allowed to approve medically necessary requests that do not meet all criteria.
Continuation (Renewal) Criteria
Renewal requirements
Physician reviewer may approve renewals that do not meet these criteria if, in professional judgment, continued therapy is medically necessary.
Provider Actions & Requirements
Prior authorization required — follow SECTION I procedures
Prior authorization is required for all prescriptions for Duchenne Muscular Dystrophy (DMD) antisense oligonucleotides; prescribers must follow the procedures in SECTION I of the Prior Authorization of Pharmaceutical Services Handbook when submitting requests.
- All prescriptions for DMD antisense oligonucleotides must be prior authorized.
- Follow procedures in SECTION I of the Prior Authorization of Pharmaceutical Services Handbook per 55 Pa. Code § 1101.67(a).
Provider submission placeholder — follow handbook and Section B
The policy inventory includes an additional required provider action entry (placeholder) with no unique text in the handbook; follow the handbook submission and documentation requirements outlined in SECTION I and Section B clinical guidelines when preparing requests.
- Use the handbook procedures in SECTION I to submit prior authorization requests.
- Ensure documentation meets the clinical review guidelines in Section B.
Required documentation for initial prior authorization requests
Include documentation showing diagnosis consistent with FDA‑approved labeling or a medically accepted indication, evidence the drug was prescribed by or in consultation with a neurologist experienced in DMD, a baseline evaluation with a standardized motor function assessment by that neurologist, and documentation of concurrent corticosteroid use or a contraindication/intolerance.
- Diagnosis consistent with FDA‑approved labeling or a medically accepted indication.
- Prescribed by or in consultation with a neurologist experienced treating DMD.
- Baseline evaluation including a standardized motor function assessment by that neurologist.
- Documentation that the patient will receive concurrent corticosteroids or has a contraindication/intolerance.
Required documentation for renewal prior authorizations
For renewals, provide documentation that the drug is prescribed by or in consultation with a neurologist experienced in DMD, an annual evaluation including assessment of motor function by that neurologist, evidence the patient continues to benefit per the prescriber, and continued concurrent corticosteroid therapy unless contraindicated or intolerant.
- Prescribed by or in consultation with a neurologist experienced treating DMD.
- Annual neurologist evaluation including assessment of motor function.
- Prescriber documentation that the patient continues to benefit.
- Continued concurrent corticosteroid therapy unless contraindicated or intolerant.
Requests failing Section B are referred to physician reviewer and may be denied
If the request does not meet the Section B clinical guidelines, it will be referred to a physician reviewer and may be denied if the physician reviewer does not determine the service is medically necessary.
- Prior authorization personnel apply Section B guidelines and approve when met.
- Requests not meeting Section B are referred to a physician reviewer for a medical necessity determination and may be denied if not deemed necessary.
Definitions
Background
Duchenne muscular dystrophy (DMD) antisense oligonucleotides are a class of therapies used to treat DMD when the diagnosis and use align with FDA‑approved labeling or a medically accepted indication. Department reviewers will consider neurologist involvement, baseline and annual standardized motor function assessments, and concurrent corticosteroid therapy when evaluating medical necessity for these agents.
Provider-Facing Notes
Quick reference — prior authorization and prescriber requirements
All prescriptions for DMD antisense oligonucleotides require prior authorization and must be submitted per SECTION I; requests should be authored by or in consultation with a neurologist experienced in Duchenne muscular dystrophy to meet Section B review criteria.
- All prescriptions must be prior authorized.
- Use SECTION I procedures in the Prior Authorization Handbook to submit requests.
- Prescriptions should be by or in consultation with a neurologist experienced treating DMD to satisfy clinical review criteria.
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