CurrentCentenePolicy CP PMN.269

Clinical Policy: Ivermectin (Stromectol, Sklice)

Defines medical necessity, approval criteria, dosing, and restrictions for oral ivermectin tablets (Stromectol) and topical ivermectin lotion (Sklice) for members of Centene-affiliated health plans across listed lines of business.

Policy Summary

PayerCentene

PolicyClinical Policy: Ivermectin (Stromectol, Sklice)

Policy CodePolicy CP PMN.269

Change TypeNo material change

Effective DateDec 1, 2021

Next Review DateN/A

Key ActionProvider must submit documentation (office chart notes, lab results, or other clinical information) supporting that the member has met all approval criteria.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2FDA-approved product types covered

14d / 12mApproval durations (lotion/tablet)

Not coveredIvermectin for COVID-19

≥6 monthsMinimum age for topical use

appliesMedicaid precedence note

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Initial approval — Ivermectin lotion (Sklice) for head lice

Covered when ALL of the following are met:

Indication: Request is for ivermectin lotion for head lice diagnosis

Age: Patient is at least 6 months of age>= 6 months

Step therapy: Failure of permethrin 1% cream rinse/lotion used in the last 60 days unless contraindicated or clinically significant adverse effects occurredlast 60 days

Illinois HIM requests exempt as of 1/1/2026 per IL HB 5395

Quantity limit: Request does not exceed 1 tube for a single use<= 1 tube per request

Approval duration: 14 days

Initial approval — Generic oral ivermectin tablets (Stromectol) for FDA‑approved and other authorized indications

Covered when ALL of the following are met:

Product: Request is for generic oral ivermectin tablets

Exclusion for COVID-19: Request is not for the prevention or treatment of coronavirus disease 2019 (COVID-19)

Requests for COVID-19 are not authorized for coverage

Quantity/dose limits: Dose does not exceed health plan quantity limit; if request is for a dose increase, new dose does not exceed health plan quantity limitper plan quantity limits

Approval duration: 12 months

Other diagnoses/indications and formulary handling

Formulary status: For drugs on the formulary or PDL, follow the no coverage criteria policy for the relevant line of business; for drugs not on formulary or PDL, refer to non-formulary policies

Refer to CP.CPA.190, HIM.PA.33, CP PMN.255, HIM.PA.103, CP PMN.16 as applicable

Off-label uses: If requested use is not listed and criterion above does not apply, refer to the off-label use policy for the relevant line of business

Refer to CP.CPA.09, HIM.PA.154, CP PMN.53

Ivermectin tablets for the prevention or treatment of COVID‑19 are not authorized for coverage under this policy. Requests with a listed indication of coronavirus disease 2019 (COVID‑19) for oral ivermectin will be denied.

For members covered under Medicaid, state Medicaid coverage provisions take precedence when they conflict with this clinical policy. Providers should consult the applicable state Medicaid manual for any state-specific coverage rules.

This policy does not authorize ivermectin tablets for COVID‑19 because current external guidance and published reviews do not support its use for prevention or treatment of SARS‑CoV‑2 infection. The World Health Organization recommends against the use of ivermectin tablets for COVID‑19 due to insufficient evidence regarding benefits and harms, and this policy lists ivermectin for COVID‑19 as a non‑covered indication.

Product Presentations, Dosing, and Codes

Product presentations (NDC not provided)mixed

3 mg tablet	Stromectol tablet strength available (product availability)
tube	Sklice lotion tube (topical)

Impacted codes (unspecified in this excerpt)mixed

affected codes

Policy history references additions/changes to criteria affecting unspecified billing or PA codes.

Weight-based dosing thresholds — Stromectol

Onchocerciasis dosingApproximately 150 mcg/kg per single oral dose (maximum 150 mcg/kg/dose), weight‑based tablet counting as specified in prescribing information

Strongyloidiasis dosingApproximately 200 mcg/kg per single oral dose (maximum 200 mcg/kg/dose), weight‑based tablet counting as specified in prescribing information

Dose calculation methodDoses prescribed to provide the target mcg/kg based on patient body weight with number of 3‑mg tablets determined by weight bands in product labeling

AdministrationSingle oral dose for both onchocerciasis and strongyloidiasis as per labeled indications

Prior Authorization, Step Therapy, and Documentation Requirements

Prior Authorization

Prior Authorization May Be Required

Prior authorization may be required for ivermectin products. Providers should verify member benefits and submit a prior authorization request when applicable.

Affected products: ivermectin lotion (Sklice), generic ivermectin tablets (Stromectol/generic)
Approval durations: lotion — 14 days; tablets — up to 12 months

Documentation Required

Documentation Required to Support Approval

Providers must submit documentation (e.g., office chart notes, laboratory results, prescription history, or other clinical information) demonstrating that the member meets all approval criteria. Lack of submitted documentation supporting the criteria may result in denial of the request.

Examples of acceptable documentation: office notes showing diagnosis and prior treatment, documentation of contraindication/intolerance to permethrin when applicable, weight/age for pediatric dosing, prior prescription fills

Step Therapy

Step Therapy for Head Lice Topical Ivermectin

Step therapy applies for topical ivermectin (Sklice) for head lice: a trial and failure of permethrin 1% (appropriate formulation) within the last 60 days is required prior to approval unless permethrin is contraindicated or the member experienced clinically significant adverse effects.

If request is for a single-use ivermectin lotion, prior treatment with permethrin 1% in the prior 60 days is required unless contraindicated
Quantity limit for single-use lotion: do not exceed 1 tube per request; approval duration: 14 days

Note

Step Therapy / Prior Authorization Considerations and Jurisdictional Variations

Step therapy and prior authorization requirements may vary by jurisdiction and line of business. For example, Illinois (per IL HB 5395, effective 01/01/2026) added a step therapy bypass for head lice topical ivermectin; providers should confirm any state-specific exceptions or process changes.

Policy history notes additions and jurisdictional modifications (see policy history)
Verify whether step therapy bypasses or alternative pathways apply for the member's state/line of business before denying or requesting additional information

Background and Therapeutic Context

Oral ivermectin tablets (Stromectol) are FDA‑approved for treatment of intestinal strongyloidiasis and onchocerciasis; dosing is weight‑based (for example, approximately 200 mcg/kg for strongyloidiasis and approximately 150 mcg/kg for onchocerciasis, as reflected in product labeling). Topical ivermectin 0.5% lotion (Sklice) is FDA‑approved for treatment of head lice in patients aged 6 months and older and is supplied as a single‑use tube. Product availability listed in the prescribing information includes Stromectol as a 3 mg tablet and Sklice as a tube; providers should reference the current prescribing information for full dosing and administration details.

Product Definitions and Formulations

Stromectol — oral ivermectin tablets and weight-based dosing summary

Approved indicationsStromectol (oral ivermectin tablets) is FDA‑approved for intestinal strongyloidiasis and onchocerciasis; Sklice (topical ivermectin lotion) is FDA‑approved for head lice in patients ≥ 6 months

Stromectol dosing summaryWeight‑based dosing: ~200 mcg/kg for strongyloidiasis (single dose) and ~150 mcg/kg for onchocerciasis (single dose) per prescribing information

Sklice dosing summaryApply sufficient lotion (up to 1 tube) to coat dry hair and scalp, leave on 10 minutes then rinse; single‑use tube

Sklice — topical ivermectin 0.5% lotion

Approval and ageSklice (ivermectin 0.5% lotion) is FDA‑approved for treatment of head lice in patients 6 months of age and older

Single‑use tube guidanceApply sufficient amount (up to 1 tube) to thoroughly coat dry hair and scalp, leave on for 10 minutes then rinse; product is single use and discard tube after use

Step therapy requirementRequests limited to 1 tube per single use and subject to prior authorization/step therapy (failure of permethrin in last 60 days) per policy

Stromectol formulation details

Dosage form and strengthIvermectin (Stromectol) oral tablets available as 3 mg tablets

Product presentationStromectol presented as 3 mg tablets for oral administration

ReferenceSee Stromectol prescribing information for tablet counting by weight bands

Sklice formulation details

FormulationSklice is provided as a topical ivermectin 0.5% lotion in a single‑use tube for treatment of head lice

Application instructionsApply up to 1 tube to thoroughly coat dry hair and scalp, leave on 10 minutes then rinse; discard tube after use

Product presentationTopical formulation packaged as a tube (single use) per prescribing information

OpenPayer

Clinical Policy: Ivermectin (Stromectol, Sklice)

Coverage Criteria for Ivermectin (Stromectol, Sklice)

Product Presentations, Dosing, and Codes

Prior Authorization, Step Therapy, and Documentation Requirements

Background and Therapeutic Context

Product Definitions and Formulations