Evrysdi (risdiplam oral solution and tablets – Genentech/Roche) — Cigna

Initial criteria

• 1. Patient has had a genetic test confirming the diagnosis of spinal muscular atrophy with bi-allelic pathogenic variants in the survival motor neuron 1 (SMN1) gene [documentation required]; AND
• 2. Patient meets ONE of the following (a or b): a) Patient has two or three survival motor neuron 2 (SMN2) gene copies [documentation required]; OR b) Patient meets BOTH of the following [(1) and (2)]: (1) Patient has four survival motor neuron 2 (SMN2) gene copies [documentation required]; AND (2) Patient has objective signs consistent with spinal muscular atrophy Types 1, 2, or 3 [documentation required]; AND
• 3. For a patient currently receiving or who has received prior treatment with Spinraza (nusinersen intrathecal injection), the prescribing physician confirms that further therapy with Spinraza will be discontinued; AND
• 4. Patient has not received Zolgensma (onasemnogene abeparvovec-xioi intravenous infusion) in the past [verification in claims history required]; AND Note: If no claim for Zolgensma is present (or if claims history is not available), the prescribing physician confirms that the patient has not previously received Zolgensma; AND
• 5. According to the prescribing physician, a female patient of reproductive potential must meet BOTH of the following (a and b): a) Patient is not currently pregnant; AND b) Effective contraception will be utilized during treatment and for 1 month after the last Evrysdi dose; AND
• 6. Dosing of Evrysdi meets ONE of the following based on the current (within the past 1 month) kg weight of the patient (a, b, c, or d): a) 0.15 mg/kg once daily if the patient is < 2 months of age; OR b) 0.2 mg/kg once daily if the patient is 2 months to < 2 years of age; OR c) 0.25 mg/kg once daily if the patient is ≥ 2 years of age and weighs < 20 kg; OR d) 5 mg once daily if the patient is ≥ 2 years of age and weighs ≥ 20 kg; AND
• 7. The medication is prescribed by a physician who has consulted with a specialist or who specializes in the management of patients with spinal muscular atrophy and/or neuromuscular disorders.

Reauthorization criteria

• 1. Patient has had a genetic test confirming the diagnosis of spinal muscular atrophy with bi-allelic pathogenic variants in the survival motor neuron 1 (SMN1) gene [documentation required]; AND
• 2. Patient meets ONE of the following (a or b): a) Patient has two or three survival motor neuron 2 (SMN2) gene copies [documentation required]; OR b) Patient meets BOTH of the following [(1) and (2)]: (1) Patient has four survival motor neuron 2 (SMN2) gene copies [documentation required]; AND (2) Patient has objective signs consistent with spinal muscular atrophy Types 1, 2, or 3 [documentation required]; AND
• 3. For a patient currently receiving or who has received prior treatment with Spinraza (nusinersen intrathecal injection), the prescribing physician confirms that further therapy with Spinraza will be discontinued; AND
• 4. Patient has not received Zolgensma (onasemnogene abeparvovec-xioi intravenous infusion) in the past [verification in claims history required]; AND Note: If no claim for Zolgensma is present (or if claims history is not available), the prescribing physician confirms that the patient has not previously received Zolgensma; AND
• 5. According to the prescribing physician, a female patient of reproductive potential must meet BOTH of the following (a and b): a) Patient is not currently pregnant; AND b) Effective contraception will be utilized during treatment and for 1 month after the last Evrysdi dose; AND
• 6. Dosing of Evrysdi meets ONE of the following based on the current (within the past 1 month) kg weight of the patient (a, b, c, or d): a) 0.15 mg/kg once daily if the patient is < 2 months of age; OR b) 0.2 mg/kg once daily if the patient is 2 months to < 2 years of age; OR c) 0.25 mg/kg once daily if the patient is ≥ 2 years of age and weighs < 20 kg; OR d) 5 mg once daily if the patient is ≥ 2 years of age and weighs ≥ 20 kg; AND
• 7. The medication is prescribed by a physician who has consulted with a specialist or who specializes in the management of patients with spinal muscular atrophy and/or neuromuscular disorders; AND
• 8. Patient must meet ONE of the following (a or b): a) Patient must have had a positive clinical response (for example, improvement or stabilization) from pretreatment baseline status (i.e., within the past 4 months) with Evrysdi in ONE of the following exams [(1)-(7)] [documentation required]; OR b) According to the prescribing physician, the patient has responded to Evrysdi and continues to benefit from ongoing Evrysdi therapy by the most recent (i.e., within the past 4 months) physician monitoring/assessment tools [documentation required].

Approval duration

initial 4 months; reauthorization 4 months