Summary
Nusinersen (Spinraza) is medically necessary for spinal muscular atrophy when the coverage criteria are met, and it is considered investigational for other conditions. Coverage requires 5q spinal muscular atrophy confirmed by homozygous deletion or dysfunctional mutation of the SMN1 gene, an SMA phenotype I, II or III diagnosis, and either no more than 3 copies of the SMN2 gene or symptomatic disease, with patients who have more than 3 SMN2 copies reviewed case by case. The patient must not have advanced disease, must retain meaningful voluntary motor function, and must not use nusinersen in combination with other SMA agents.
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What to do
Action · 7 steps
01Future transition 2026-12-01: Submit medical records (chart notes) related to the medical necessity criteria with every authorization request, uploaded through the PA web portal or sent by fax, covering diagnosis, step therapy and clinical markers such as genetic and mutational testing.
02Include baseline documentation of one or more of the following: motor function or milestones on validated scales such as HINE, HFMSE, CHOP INTEND, BSID-III, 6-minute walk test, ULM, MFM32 or RULM; respiratory function tests such as FVC; exacerbations requiring hospitalization or antibiotic therapy for respiratory infection in the preceding year; and patient weight for patients without a gastrostomy tube.
03Document a genetic test confirming no more than 3 copies of the SMN2 gene, and for patients who previously received gene therapy, document supportive evidence of response to that gene therapy.
04Perform platelet count, prothrombin time, activated partial thromboplastin time and quantitative spot urine protein testing at baseline and before each administration, obtained within several days before administration.
05The medication must be prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of spinal muscular atrophy.
06Dosing must follow the FDA-approved prescribing information in Appendix A: the low-dose loading regimen is 12 mg (5 mL) on Days 0, 14, 28 and 58, the high-dose loading regimen is 50 mg (5 mL) on Days 0 and 14, and maintenance is 12 mg (low-dose) or 28 mg (high-dose) every 4 months.
07Continuation requests for 12 months require that the patient continues to meet the coverage criteria, shows no unacceptable toxicity such as significant renal toxicity, thrombocytopenia or coagulation abnormalities, and responds to therapy in one or more of these ways: stable or improved net motor function or milestones, stable or improved respiratory function tests, fewer exacerbations requiring hospitalization or antibiotic therapy for respiratory infection, or stable or increased patient weight for patients without a gastrostomy tube.
Original notice
Nusinersen (Spinraza™)
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