Nusinersen (Spinraza™) is a survival motor neuron-2 (SMN2)-directed antisense oligonucleotide given intrathecally, indicated for the treatment of spinal muscular atrophy (SMA) in pediatric and adult patients.
Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Nusinersen (Spinraza) may be considered medically necessary for individuals with SMA type I, II, or III caused by mutations in chromosome 5q when the following criteria are met:
Continuation of treatment with nusinersen (Spinraza) beyond 6 months after initiation of therapy, and every 6 months thereafter, may be considered medically necessary for the treatment of spinal muscular atrophy when individuals meet BOTH of the following:
The use of nusinersen (Spinraza) for any other indication other than spinal muscular atrophy caused by mutations in chromosome 5q is considered experimental/investigational and therefore non-covered due to the lack of scientific evidence to support efficacy and safety.
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.
Covered Diagnosis Codes for J2326