J1428 — Injection, eteplirsen, 10 mg
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Submission of medical records (e.g., chart notes, laboratory values) confirming the mutation of the DMD gene is amenable to exon 51 skipping.
- Submission of medical records (e.g., chart notes, laboratory values) confirming that the patient has a 6-Minute Walk Test (6MWT) ≥ 300 meters while walking independently prior to beginning Exondys 51 therapy (when that criterion is used).
- Submission of medical records (e.g., chart notes) confirming that the patient is ambulatory without needing an assistive device (when that criterion is used for initial or continuation therapy).
- Submission of medical records (e.g., chart notes) documenting North Star Ambulatory Assessment (NSAA) score > 17 (when that criterion is used).
Key Coverage Criteria
- Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping.
- Diagnosis of Duchenne muscular dystrophy by, or in consultation with, a neurologist with expertise in the diagnosis of DMD (required for initial therapy).
- Initial therapy may be covered when all of the following are met: (a) submission of medical records confirming the mutation of the DMD gene is amenable to exon 51 skipping; and (b) one of the following ambulatory criteria prior to beginning Exondys 51 therapy: patient has a 6-Minute Walk Test (6MWT) ≥ 300 meters while walking independently (e.g., without side-by-side assist, cane, walker, wheelchair, etc.); OR patient is ambulatory without needing an assistive device AND one of the following—NSA [...]
- Initial therapy may be covered when one of the following gene-therapy conditions is met: patient has not previously received gene therapy (e.g., Elevidys); OR if patient has previously received gene therapy (e.g., Elevidys) there is submission of medical records documenting a clinically meaningful functional decline resulting from loss of muscle strength/motor ability (e.g., loss of a motor milestone) since receiving gene replacement therapy.
- Exondys 51 is covered only when prescribed by, or in consultation with, a neurologist with expertise in the treatment of DMD and dosing is in accordance with the United States Food and Drug Administration approved labeling.
- Initial authorization will be for no more than 12 months.
5 Active Policies
UHC-POL-exondys-51-eteplirsen — Exondys 51 (Eteplirsen)
UHC-POL-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
UMR-POL-UMR-exondys-51-eteplirsen — Exondys 51 (Eteplirsen)
UMR-POL-UMR-provider-administered-drugs-soc — Provider Administered Drugs – Site of Care
SUREST-POL-SUREST-exondys-51-eteplirsen
Related Codes
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