CurrentCignaPolicy N/A

Spinal Muscle Atrophy - Spinraza Drug Quantity Management Policy - Per Days

Defines drug quantity limits and one-time override criteria for Spinraza (nusinersen 12 mg/5 mL vial) for Cigna-administered health benefit plans, managing premature dose escalation and missed-dose scenarios. Applies to retail and home delivery fills with approvals provided for specified durations.

Policy Summary

PayerCigna

PolicySpinal Muscle Atrophy - Spinraza Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeOverrides added; clarifications; home delivery limit

Effective Date

Next Review Date

Key ActionIf quantity limits are not met at point of service, approve the specified one-time overrides for initiation or missed-dose scenarios (retail or home delivery) and document timing since last dose to support the override.

POLICY UPDATE CHANGES

New overrides added for various missed maintenance dose intervals (2, 3, 4 vial overrides).

Policy updated to include existing quantity limits when product is obtained via home delivery.

Criteria clarified that the one-time override for initiation is a 90-day supply.

1 vialStandard maximum quantity (per 120 days)

4 vialsInitiation one-time override (90-day)

2 vialsMissed dose 8-<16 months

Missed dose 16-<40 months

4 vialsMissed dose >=40 months

Coverage Summary

Spinraza (nusinersen 12 mg/5 mL vial) is covered with criteria under this Drug Quantity Management program for Cigna-administered health benefit plans. The policy applies to both retail and home delivery fills and approvals are provided for the durations outlined in the criteria. Standard quantity limits and one-time override allowances described below govern coverage decisions at point of service.

For context, the recommended dosing schedule is an initial series of four loading doses followed by maintenance dosing every 4 months: three loading doses at 14-day intervals, a fourth loading dose 30 days after the third, then maintenance doses once every 4 months thereafter.

Quantity limits and one-time overrides

Retail/Home Delivery maximum (per 120 days)1 vial

Initiation one-time override4 vials (90-day supply)

Missed maintenance 8 - <16 months override2 vials one-time override

Missed maintenance 16 - <40 months override3 vials one-time override

Missed maintenance >=40 months override4 vials one-time override (restart dosing)

Drug Quantity Limits & One-Time Overrides (Operational Rules)

Drug Quantity Limits and One-Time Override Criteria

Spinraza 12 mg/5 mL vials are covered as medically necessary when any of the following Drug Quantity Management rules / override criteria are met:

Drug Quantity Limits and Overrides

Standard quantity limit: Requested quantity meets the Drug Quantity Management rule (maximum 1 vial per 120 days) and no override is neededRetail/Home Delivery Maximum Quantity per 120 Days = 1 vial
This is a quantity sufficient for a 120-day supply at a dose of 12 mg every 4 months.
Initiating treatment: Patient is initiating Spinraza treatmentOne-time override = 4 vials (90-day supply)
Approve a one-time override of 4 vials at retail or home delivery

Applicable Codes

Drug productNDCCovered

12 mg/5 mL vial (2.4 mg/mL)

Spinraza (nusinersen) single-dose glass vial -- product and strength as specified in policy; covered with quantity limits

Background & Clinical Evidence

Spinraza is a survival motor neuron 2 (SMN2)-directed antisense oligonucleotide indicated for the treatment of spinal muscular atrophy in pediatric and adult patients.

The recommended dosage is 12 mg (5 mL) per administration. Initiate treatment with four loading doses: the first three loading doses at 14-day intervals, and the fourth loading dose 30 days after the third. Thereafter, give a maintenance dose once every 4 months. These dosing intervals inform the Drug Quantity Management rules for standard quantities and one-time overrides when doses are missed or when initiating therapy.

Prescribing information reference: Spinraza intrathecal injection prescribing information, Biogen; February 2023

Definitions

One-time override: A single authorization to exceed the standard quantity limit for specific clinical scenarios (initiation or missed-dose intervals) for retail or home delivery. Examples in this policy include a one-time override of 4 vials for treatment initiation (90-day supply) and overrides of 2, 3, or 4 vials for specified missed maintenance-dose intervals.

Retail/Home Delivery Maximum Quantity per 120 Days: Quantity sufficient for a 120-day supply at a dose of 12 mg every 4 months. The standard maximum quantity is 1 vial per 120 days for both retail and home delivery; one-time overrides may be approved per the listed criteria (initiation or missed maintenance doses).

Revision History

04/12/2023revisedLatest

Policy updated to include existing quantity limits when product is obtained via home delivery; Home Delivery Maximum Quantity per 120 Days = 1 vial.

11/16/2022clarified

Policy statement corrected to state all approvals are for the duration outlined; criteria clarified that the one-time initiation override is a 90-day supply (approve a one-time override of 4 vials).

04/12/2023added

New one-time overrides added for missed maintenance dose intervals: 2 vials for missed ≥8 to <16 months, 3 vials for missed ≥16 to <40 months, and 4 vials for missed ≥40 months (retail or home delivery).

Policy Summary

PayerCigna

PolicySpinal Muscle Atrophy - Spinraza Drug Quantity Management Policy - Per Days

Policy CodePolicy N/A

Change TypeOverrides added; clarifications; home delivery limit

Effective Date

Next Review Date

On This Page

Missed maintenance dose: >=8 months to <16 months: Patient missed a maintenance dose at least 8 months but less than 16 months since last doseOne-time override = 2 vials

Approve a one-time override for 2 vials at retail or home delivery

Missed maintenance dose: >=16 months to <40 months: Patient missed a maintenance dose at least 16 months but less than 40 months since last doseOne-time override = 3 vials

Approve a one-time override for 3 vials at retail or home delivery

Missed maintenance dose: >=40 months: Patient missed a maintenance dose at least 40 months since last doseOne-time override = 4 vials (restart dosing)

Approve a one-time override for 4 vials at retail or home delivery (restart dosing)

Prior Authorization

Quantity limit and override at point of service

If the Drug Quantity Management rule is not met at point of service, coverage will be determined by the criteria; approve specified one-time overrides for initiation or missed-dose scenarios for retail or home delivery fills.

Overrides are approved for initiation or missed-dose scenarios and apply to retail or home delivery fills.

Billing Rule

Maximum quantity per 120 days

Report maximum of 1 vial per 120 days for retail or home delivery unless an approved one-time override applies.

Threshold: 1 vial per 120 days
Home delivery has the same maximum quantity per 120 days as retail (parity).

Documentation Required

Evidence of missed-dose timing

Provider should document timing since last dose to support overrides (e.g., initiation status, months since last maintenance dose).

Examples to document: initiation status
Examples to document: timing since last dose (months since last maintenance dose)