risdiplam tab — Blue Cross Blue Shield of Oklahoma

spinal muscular atrophy (SMA)

Initial criteria

The patient has a diagnosis of spinal muscular atrophy (SMA)
The patient has a deletion or mutation at the SMN1 gene on chromosome 5q confirmed by genetic testing (medical records required)
The patient has a diagnosis of probable SMA Type 1, 2, or 3 AND ONE of the following: (A) If symptomatic, symptom onset was evident prior to age 18 years OR (B) If asymptomatic, the patient has no more than 4 copies of SMN2
The patient has had at least ONE of the following baseline (prior to starting therapy) functional assessments based on patient age and motor ability: CHOP-INTEND, HINE-2, HFMSE, 6MWT, BSID, MFM32, or RULM test
The patient does NOT require invasive ventilation or tracheostomy
The patient has NOT received gene therapy for the requested indication (e.g., Zolgensma [onasemnogene abeparvovec-xioi])
If the patient has used SPINRAZA (nusinersen) in the last four months, they will complete a four-month washout period between the last SPINRAZA dose and the initiation of therapy
The patient will NOT be using the requested agent in combination with SPINRAZA (nusinersen)
The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, geneticist) or has consulted with such a specialist
The patient does NOT have any FDA labeled contraindications to the requested agent

The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
The patient has had improvements or stabilization from baseline (prior to starting therapy) as indicated by at least one functional assessment: CHOP-INTEND, HINE-2, HFMSE, 6MWT, BSID, MFM32, or RULM test
The patient does NOT require invasive ventilation or tracheostomy
The patient has NOT received gene therapy for the requested indication (e.g., Zolgensma [onasemnogene abeparvovec-xioi])
The patient will NOT be using the requested agent in combination with SPINRAZA (nusinersen)
The prescriber is a specialist in the area of the patient’s diagnosis or has consulted with such a specialist
The patient does NOT have any FDA labeled contraindications to the requested agent

12 months