CurrentCignaPolicy N/A

Spinraza (nusinersen) — Drug Quantity Management (Quantity Limits & One‑time Overrides)

Defines quantity limits and one-time override rules for Spinraza (nusinersen intrathecal injection) for Cigna-administered health benefit plans, affecting providers and pharmacies requesting supply via retail or home delivery.

Policy Summary

PayerCigna

PolicySpinraza (nusinersen) — Drug Quantity Management

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionRequest supply per quantity rules: standard limit 1 vial per 120 days; request a one-time override (2–4 vials) when initiating therapy or to cover missed maintenance dosing per specified windows.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 vialretail max /120d

1 vialhome delivery max /120d

4 vialsinitiation override

2 vialsmissed 8–<16 mo

3 vialsmissed 16–<40 mo

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Drug Quantity Limits and Overrides

Covered when ALL of the following Drug Quantity Management rules are met; otherwise requests are considered under the override criteria below.

Standard quantity limit: Maximum quantity is 1 vial per 120 days for Spinraza (12 mg/5 mL) at retail and home delivery.1 vial per 120 days

Any request exceeding this quantity requires evaluation under override rules or is considered not medically necessary.

Any request for Spinraza (nusinersen) supply that does not meet the stated Drug Quantity Management rules — including the standard maximum of 1 vial per 120 days for both retail and home delivery — is considered not medically necessary.

Any exception beyond the specified quantity limits and the listed one-time overrides described in this policy is considered not medically necessary.

Provider Actions & Operational Notes

Billing Rule

Drug Quantity Limits

Drug Quantity Limits: Spinraza (nusinersen injection) 12 mg/5 mL vial — Retail and Home Delivery maximum quantity per 120 days = 1 vial. Coverage beyond these standard maximums requires a one-time override as outlined below; any other exception is considered not medically necessary.

Drug: Spinraza (nusinersen) 12 mg/5 mL vial
Standard max: 1 vial per 120 days (Retail & Home Delivery)
Exceptions: only the one-time overrides listed below are permitted

Prior Authorization

Provider must request prior authorization/override when the Drug Quantity Management rule is not met at point of service. If the rule is not met, coverage will be determined by the criteria in the policy; all approvals are provided for the duration specified in the policy.

Action: Submit prior authorization or quantity-override request when requesting >1 vial per 120 days.
Documentation: Include dosing history and dates of missed maintenance doses to support override request.

Note

Decision Considerations

Decision considerations: Verify the member's specific benefit plan language, applicable laws/regulations, and any relevant collateral source materials (e.g., other coverage policies or delegated vendor guidelines) when making coverage determinations.

Consider the member's benefit plan document as controlling if it conflicts with this policy.
Apply applicable federal/state mandates and any delegated vendor guidelines where relevant.

Denial Risk

Denial Trigger

Denial trigger: If the Drug Quantity Management rule is not met and no allowable one-time override criteria are documented, the request should be denied as not medically necessary.

Deny when request exceeds 1 vial per 120 days and does not meet one-time override conditions.
Ensure denial includes reason and instructions for submitting required documentation to support an override (e.g., initiation status or dates since last dose).

Step Therapy

Override Scenarios (Operational Instructions)

One-time override rules for Spinraza 12 mg/5 mL vials (retail or home delivery):

Initiating treatment: approve a one-time override of 4 vials.
Missed maintenance dose ≥ 8 months but < 16 months since last dose: approve a one-time override of 2 vials.
Missed maintenance dose ≥ 16 months but < 40 months since last dose: approve a one-time override of 3 vials.
Missed maintenance dose ≥ 40 months since last dose: approve a one-time override of 4 vials.

Definitions

Loading dose — definition

DefinitionLoading dose = the initial four 12 mg (5 mL) intrathecal administrations to initiate Spinraza therapy; the first three loading doses are given at 14-day intervals and the fourth loading dose is given 30 days after the third.

Timing detailsFirst three loading doses at 14-day intervals; fourth loading dose 30 days after the third.

Missed loading dose guidanceIf a loading dose (or any of the four loading doses) is missed, administer the missing loading dose as soon as possible and then adjust subsequent dose dates to maintain recommended intervals.

Maintenance dose — definition

DefinitionMaintenance dose = a 12 mg (5 mL) intrathecal administration given once every 4 months after completion of the loading series.

Routine intervalGiven once every 4 months following completion of the four loading doses.

Missed maintenance dosing guidanceIf missed <8 months since last dose: give missed dose ASAP and continue originally scheduled next maintenance if doses are ≥14 days apart; if 8–<16 months: give missed dose ASAP plus one additional dose 14 days later, then resume maintenance every 4 months; if 16–<40 months: give missed dose ASAP plus two additional doses 14 days apart, then resume maintenance every 4 months; if ≥40 months: restart dosing (treat as initiation).

Initial Therapy

Initial treatment requires loading doses; quantity override for initiation supports dispensing the necessary number of vials.

Initiation override: If the patient is initiating treatment, approve a one-time override of 4 vials at retail or home delivery to cover the loading series.4 vials

Supports the four loading doses per dosing guidance (three loading doses at 14-day intervals and a fourth 30 days after the third).

Continuation Therapy

Maintenance dosing and how missed maintenance doses are handled.

Maintenance dosing interval: Maintenance dose given once every 4 months after loading series; missed maintenance dosing windows determine the number of replacement doses needed.every 4 months

If missed <8 months give missed dose ASAP; if 8–<16 months give missed dose plus one additional dose 14 days later; if 16–<40 months give missed dose plus two additional doses 14 days apart; if ≥40 months restart loading (one-time override quantities below).

Missed maintenance one-time overrides

Missed maintenance 8–<16 months: Approve a one-time override for 2 vials.2 vials
Give missed maintenance dose ASAP, plus one additional dose 14 days later; next maintenance dose 4 months thereafter.
Missed maintenance 16–<40 months: Approve a one-time override for 3 vials.3 vials
Give missed maintenance dose ASAP, plus two additional doses 14 days apart; next maintenance dose 4 months thereafter.
Missed maintenance ≥40 months: Approve a one-time override for 4 vials to restart loading.4 vials
Per dosing guidance, restart the loading series.

Step therapy requirement
No step therapy requirements specified; policy focuses on quantity limits and one-time overrides.
If the Drug Quantity Management rule is not met for the requested medication at the point of service, coverage will be determined by the criteria in this policy.

Quantity Limits & Overrides (by site/condition)

Standard quantity (retail & home)

ProductSpinraza (nusinersen) 12 mg/5 mL single-dose vial.

Standard quantity (retail)1 vial per 120 days.

Standard quantity (home delivery)1 vial per 120 days.

One-time override — initiation or ≥40 months missed dose

ScenarioTreatment initiation.

Override allowedOne-time override approving 4 vials at retail or home delivery to cover the loading series.

PurposeSupports dispensing the necessary number of vials for the four loading doses when initiating therapy.

One-time override — missed maintenance 8–<16 months

ScenarioMissed maintenance dose 8–<16 months after last dose.

Override allowedOne-time override approving 2 vials at retail or home delivery.

PurposeCovers the missed maintenance dose plus one additional dose 14 days later per dosing guidance.

One-time override — missed maintenance 16–<40 months

ScenarioMissed maintenance dose 16–<40 months after last dose.

Override allowedOne-time override approving 3 vials at retail or home delivery.

PurposeCovers the missed maintenance dose plus two additional doses 14 days apart to reestablish maintenance schedule.