J3405, Injection, onasemnogene abeparvovec-brve, per treatment
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Documentation Required
- Submission of medical records (e.g., chart notes, laboratory values) confirming the mutation or deletion of genes in chromosome 5q resulting in one of the following: o Homozygous gene deletion or mutation of survival motor neuron 1 (SMN1) gene (e.g., homozygous deletion of exon 7 at locus 5q13); or o Compound heterozygous mutation of SMN1 gene [e.g., deletion of SMN1 exon 7 (allele 1) and mutation of SMN1 (allele 2)]
- Submission of medical records (e.g., chart notes, laboratory values) confirming that patient has 2 or 3 SMN2 gene copies; and
- Provider attests that the patient will be assessed via the Hammersmith Functional Motor Scale Expanded (HFMSE) scale to establish a baseline functional assessment within the 2 weeks prior to Itvisma administration†; and Provider attests that the patient, while under the care of the provider, will be assessed by (HFMSE) during subsequent office visits†
- Submission of medical records (e.g., chart notes, laboratory values) confirming the mutation or deletion of genes in chromosome 5q resulting in one of the following: o Homozygous gene deletion or mutation of survival motor neuron 1 (SMN1) gene (e.g., homozygous deletion of exon 7 at locus 5q13); or o Compound heterozygous mutation of SMN1 gene [e.g., deletion of SMN1 exon 7 (allele 1) and mutation of SMN1 (allele 2)] and Submission of medical records (e.g., chart notes, laboratory values) confirming that patient has 2 or 3 SMN2 gene copies; and Patient is ≥ 2 years of age; and Patient is not dependent on either of the following: o Invasive ventilation or tracheostomy o Use of non-invasive ventilation beyond use for naps and nighttime sleep and Prescribed by a neurologist with expertise in the treatment of SMA; and
- Patient does not have an elevated anti-AAV9 antibody titer above 1:50; and
- Patient will receive prophylactic prednisolone (or glucocorticoid equivalent) prior to and following receipt of Itvisma in accordance with the United States Food and Drug Administration (FDA) approved Itvisma labeling; and
Key Coverage Criteria
- One treatment per lifetime of Itvisma for SMA in patients meeting: (a) SMN1 gene homozygous deletion/SMN1 homozygous mutation or SMN1 compound heterozygous mutation with 2 or 3 SMN2 copies; (b) age ≥ 2 years; (c) not dependent on invasive ventilation or tracheostomy or non-invasive ventilation beyond naps/nighttime sleep prescribed by SMA-expert neurologist.
- Itvisma® (onasemnogene abeparvovec-brve) has been added to the Review at Launch program. Some members may not be eligible for coverage of this medication at this time. Refer to the Medical Benefit Drug Policy titled Review at Launch for New to Market Medications for additional details.
- Itvisma is proven and medically necessary for one treatment per lifetime for the treatment of spinal muscular atrophy (SMA) in patients who meet all of the following criteria:
- Submission of medical records (e.g., chart notes, laboratory values) confirming the mutation or deletion of genes in chromosome 5q resulting in one of the following: o Homozygous gene deletion or mutation of survival motor neuron 1 (SMN1) gene (e.g., homozygous deletion of exon 7 at locus 5q13); or o Compound heterozygous mutation of SMN1 gene [e.g., deletion of SMN1 exon 7 (allele 1) and mutation of SMN1 (allele 2)]
- and Submission of medical records (e.g., chart notes, laboratory values) confirming that patient has 2 or 3 SMN2 gene copies; and
- Patient is ≥ 2 years of age; and
3 Active Policies
UHC-POL-itvisma, Itvisma (Onasemnogene Abeparvovec-Brve)
UMR-POL-UMR-itvisma, Itvisma (Onasemnogene Abeparvovec-Brve)
SUREST-POL-SUREST-itvisma, Itvisma (Onasemnogene Abeparvovec-Brve)
Related Codes
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