ModifiedCentenePolicy HIM.PA.134

Spinosad (Natroba) (PDF)

Defines medical necessity, prior authorization criteria, age limits, step-therapy requirements, quantity limits, approval durations, and exclusions for Natroba (spinosad topical suspension) for head lice and scabies across Centene HIM lines of business.

Policy Summary

PayerCentene

PolicySpinosad (Natroba) (PDF)

Policy CodePolicy HIM.PA.134

Change TypeStep therapy bypass added (IL); indication added (scabies); routine updates

Effective DateDec 1, 2017

Next Review Date

Key ActionProvider must submit documentation supporting that member meets all approval criteria prior to approval.

SourceLink

POLICY UPDATE CHANGES

Added step therapy bypass for Illinois HIM per IL HB 5395.

Added criteria for newly approved indication for scabies infestation (2021).

Periodic reference and template updates with no significant clinical changes in 2022, 2023, and 2024.

2Covered Indications (FDA-approved)

14 daysApproval duration (head lice)

No re-authorizationContinued therapy

2026-01-01IL step-therapy bypass effective

Coverage Summary

Spinosad (Natroba) topical suspension is FDA‑approved for the treatment of head lice in patients ≥ 6 months and scabies in patients ≥ 4 years. The policy identifies permethrin as the preferred therapeutic alternative and establishes prior authorization criteria and limits; overall coverage stance is covered_with_criteria.

Key thresholds and quick facts

Age limit — head lice6 months and older

Age limit — scabies4 years and older

Permethrin step therapy (head lice)Failure of permethrin 1% within the last 60 days required (unless contraindicated)

Approval duration (head lice)14 days

Continued therapy / Re-authorizationRe-authorization is not permitted; members must meet initial approval criteria

IL step-therapy bypass effective dateJanuary 1, 2026

Initial Therapy Criteria

Initial Approval Criteria

Provider must submit documentation supporting that member has met all approval criteria. Natroba is medically necessary when the following criteria are met:

C. Other diagnoses/indications (must meet 1 or 2)

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to HIM.PA.33 (formulary) or HIM.PA.103 (non-formulary) as applicable
If requested use is not specifically listed under section III and criterion 1 above does not apply, refer to off-label use policy HIM.PA.154

Continuation Therapy Criteria

Continued Therapy

Re-authorization rules

A. All Indications in Section I (must meet all)

Re-authorization is not permitted. Members must meet the initial approval criteria.

B. Other diagnoses/indications (must meet 1 or 2)

If this drug has recently (within the last 6 months) undergone a label change that is not yet reflected in this policy, refer to HIM.PA.33 (formulary) or HIM.PA.103 (non-formulary) as applicable
If requested use is not specifically listed under section III and criterion 1 above does not apply, refer to off-label use policy HIM.PA.154

Unapproved Indications / Exclusions

Diagnoses/Indications Not Authorized

III. Not authorized

Non-FDA approved indications, which are not addressed in this policy, are not authorized unless there is sufficient documentation of efficacy and safety according to off-label use policy HIM.PA.154 or evidence of coverage documents

Applicable Codes

NDC / ProductNDC

Natroba suspension 9 mg/g in 120 mL bottle

Spinosad topical suspension product availability described in policy

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization and documentation

Provider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member meets all approval criteria prior to approval.

Step Therapy

Step therapy requirement

For head lice: trial and failure of permethrin 1% cream within the last 60 days is required unless contraindicated or clinically significant adverse effects are experienced. For scabies: trial and failure of permethrin 5% cream is required unless contraindicated or clinically significant adverse effects are experienced. Exception: Illinois HIM requests bypass these step therapy requirements as of 2026-01-01 per IL HB 5395.

Clinical Evidence & References

Natroba Prescribing Information, April 2021 (label).

Centers for Disease Control and Prevention treatment guidance for head lice and for scabies (referenced in policy).

Background

Spinosad (Natroba) topical suspension is a pediculicide and scabicide. The FDA‑approved indications include head lice infestations in patients ≥ 6 months and scabies infestations in patients ≥ 4 years. The policy notes permethrin as the preferred therapeutic alternative and provides dosing/regimen details (e.g., Natroba head lice dosing up to 120 mL per application, leave on 10 minutes; scabies—apply to body from neck to toes and leave on for at least 6 hours) and quantity/authorization limits in the approval criteria.

Definitions

TermRe-authorization

DefinitionRe-authorization is not permitted; members must meet the initial approval criteria

Policy locationContinued Therapy section (II.A) states re-authorization is not permitted

Revision History

08.25.25material_changeLatest

3Q 2025 annual review: added step therapy bypass for Illinois HIM per IL HB 5395; P&T Approval Date = 08.25.25; effective bypass date 2026-01-01 noted in body.

08.21.21material_change

3Q 2021 annual review: added criteria for newly approved indication for scabies infestation; P&T Approval Date = 08.21.21.

08.22periodic_update

3Q 2022 annual review: no significant changes; references reviewed and updated; template changes applied.