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risdiplam for soln — Blue Cross Blue Shield of Texas

spinal muscular atrophy (SMA)

Initial criteria

  • 1. The patient has a diagnosis of spinal muscular atrophy (SMA)
  • 2. The patient has a deletion or mutation at the survival motor neuron 1 (SMN1) gene on chromosome 5q confirmed by genetic testing (medical records required)
  • 3. 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
  • 4. The patient has had at least ONE of the following baseline (prior to starting therapy with the requested agent) functional assessments based on patient age and motor ability: A. Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) B. Hammersmith Infant Neurological Examination (HINE-2) C. Hammersmith Functional Motor Scale-Expanded (HFMSE) D. Six-minute walk test (6MWT) E. Bayley Scales of Infant and Toddler Development (BSID) F. Motor Function Measurement score (MFM32) G. Revised Upper Limb Module (RULM) test
  • 5. The patient does NOT require invasive ventilation or tracheostomy
  • 6. The patient has NOT received gene therapy for the requested indication (e.g., Zolgensma [onasemnogene abeparvovec-xioi])
  • 7. If the patient has used SPINRAZA (nusinersen) in the last four months, they will complete a four-month washout period between the last SPINRAZA (nusinersen) dose and the initiation of therapy with the requested agent
  • 8. The patient will NOT be using the requested agent in combination with SPINRAZA (nusinersen) for the requested indication
  • 9. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
  • 10. The patient does NOT have any FDA labeled contraindications to the requested agent
  • Alternate path (for Ohio members): 1. The member resides in Ohio AND 2. The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following: A. The patient does NOT have any FDA labeled contraindications to the requested agent AND B. ONE of the following applies: 1. The patient has another FDA labeled indication for the requested agent and route of administration OR 2. The patient has another indication that is supported in compendia for the agent and route of administration OR 3. The prescriber has submitted TWO articles from major peer-reviewed medical journals supporting the proposed use(s) as generally safe and effective

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • 2. The patient has had improvements or stabilization from baseline (prior to starting therapy with the requested agent) with the requested agent as indicated by one of the following functional assessments based on patient age and motor ability: A. Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP-INTEND) B. Hammersmith Infant Neurological Examination (HINE-2) C. Hammersmith Functional Motor Scale-Expanded (HFMSE) D. Six-minute walk test (6MWT) E. Bayley Scales of Infant and Toddler Development (BSID) F. Motor Function Measurement score (MFM32) G. Revised Upper Limb Module (RULM) test
  • 3. The patient does NOT require invasive ventilation or tracheostomy
  • 4. The patient has NOT received gene therapy for the requested indication (e.g., Zolgensma [onasemnogene abeparvovec-xioi])
  • 5. The patient will NOT be using the requested agent in combination with SPINRAZA (nusinersen) for the requested indication
  • 6. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist, geneticist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
  • 7. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months