J1304, Injection, tofersen, 1 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, previous medical history, diagnostic testing including: imaging, nerve conduction studies, laboratory values) to support the diagnosis of ALS; and
- Submission of medical records confirming mutation in the superoxide dismutase 1 (SOD1) gene; and
- Provider attestation that the patient’s baseline functional ability has been documented prior to initiating treatment (e.g., speech, walking, climbing stairs, etc.); and
- Patient is not dependent on invasive ventilation; and
Key Coverage Criteria
- Coverage of Qalsody (tofersen) for ALS requires: for initial therapy, (1) medical records confirming ALS diagnosis, (2) medical records confirming SOD1 mutation, (3) provider attestation of baseline functional ability prior to initiation, (4) patient not dependent on invasive ventilation, (5) treatment prescribed by or in consultation with a neurologist with ALS expertise, (6) dosing per FDA-approved labeling, and (7) initial authorization no more than 12 months; for continuation, (1) ALS diagno [...]
- Medically necessary when (a) listed in standard reference compendia (DrugDex, AHFS-DI, Clinical Pharmacology, Lexi-Drugs, NCCN) for the prescribed indication OR (b) supported by clinical research in peer-reviewed literature specific to the indication.
- Medically necessary when the FDA-approved drug/biologic/gene therapy is listed in a standard reference compendium as safe and effective for the prescribed indication OR is supported by clinical research in peer-reviewed literature specific for the indication.
- Medically necessary for FDA-approved drugs/biologics/gene therapies when (a) listed in standard reference compendia as safe and effective for the specified indication or (b) supported by peer-reviewed clinical literature specific to the indication.
- Qalsody is medically necessary for ALS if: (a) initial therapy: submission of medical records supporting ALS diagnosis, confirmation of SOD1 mutation, provider attestation of baseline functional ability, patient not invasively ventilated, prescriber or consultant neurologist with ALS expertise, dosing per FDA labeling, and initial authorization up to 12 months; (b) continuation: diagnosis of ALS, patient currently receiving Qalsody, provider attestation of slowed disease progression, patient not [...]
- Qalsody (tofersen) is proven and medically necessary for the treatment of amyotrophic lateral sclerosis (ALS) in patients who meet all of the following criteria.
7 Active Policies
UHC-POL-qalsody, Qalsody (Tofersen)
BCBSIL-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies
BCBSMT-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies
BCBSNM-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies
BCBSOK-RX501.087, FDA - Drugs, Biologicals, Cellular and Gene Therapies
Related Codes
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