CurrentCignaPolicy IP0178

Repository Corticotropin - Acthar Gel

This policy governs prior authorization, coverage, and dosing for Acthar Gel (repository corticotropin) for Cigna-administered health benefit plans, specifying approved and not medically necessary uses and coding guidance. It affects prescribers, facilities, and payers administering benefits under Cigna plans.

Policy Summary

PayerCigna

PolicyRepository Corticotropin - Acthar Gel

Policy CodePolicy IP0178

Change TypeUpdated; material changes include infantile spasms dosing and formulation requirement

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that Acthar Gel will be given intramuscularly using the multidose vial for infantile spasms.

SourceLink

POLICY UPDATE CHANGES

Policy Name updated from 'Repository Corticotropin' to 'Repository Corticotropin - Acthar Gel.'

Infantile Spasms treatment specification added to require approval of the multidose vial formulation and that the single-dose SelfJect Injector for subcutaneous use should not be approved.

Removed statement that repository corticotropin was not demonstrated clinically superior to conventional corticosteroids/immunosuppressive therapy for uses other than infantile spasms.

HCPCS code J0800 removed (code deleted 9/30/2023).

1FDA-approved indication covered (infantile spasms)

1 moInitial approval duration

J0801HCPCS code

Conditions not medically necessary

Coverage Criteria

Infantile Spasms, Treatment (FDA-approved)

Approve Acthar Gel multidose vial for infantile spasms when ALL of the following are met:

Infantile Spasms initial approval: A) Child is less than 2 years of age; AND B) Acthar is being administered as an intramuscular injection; AND C) Medication is prescribed by a physician who has consulted with or specializes in neurology.Approve up to 150 units/m2 per day by intramuscular injection for up to 1 month.

Acthar Gel single-dose pre-filled SelfJect Injector for subcutaneous use should not be approved for infantile spasms.

Acthar Gel (repository corticotropin) is considered not medically necessary for use in indications other than infantile spasms. Specific conditions listed as not covered include: ankylosing spondylitis; dermatomyositis or polymyositis; diabetic nephropathy; glomerular kidney diseases (for example, nephrotic syndrome, membranous nephropathy, IgA nephropathy, minimal change disease, focal segmental glomerulosclerosis, and membranoproliferative glomerulonephritis); gout; juvenile idiopathic arthritis; lupus nephritis; multiple sclerosis (acute exacerbations); ophthalmic conditions; psoriatic arthritis; rheumatoid arthritis; and sarcoidosis.

When a plan’s benefit definition limits coverage to the most cost-effective equivalent therapy, repository corticotropin (Acthar Gel) is not considered medically necessary and may be denied or require the use of alternative, preferred therapies first. Claims for off-label or noncovered indications are subject to denial if the benefit plan requires step therapy or a less costly equivalent treatment prior to authorization of Acthar Gel.

Coding and Dosing

Considered Medically Necessary when criteria metHCPCSCovered

J0801

Injection, corticotropin (acthar gel), up to 40 units

Infantile spasms dosing

Dose150 units/m2 per day, divided into two injections of 75 units/m2 (intramuscular)

DurationApprove for up to 1 month (initial approval)

Administration routeIntramuscular injection required for infantile spasms; SelfJect (subcutaneous) not acceptable

Acthar Gel quantity limits and billing

Daily quantity limitApprove up to 150 units/m2 per day (dosing as specified)

Billing code and unitHCPCS J0801 — Injection, corticotropin (Acthar Gel), up to 40 units per J‑code

Provider Actions & Requirements

Prior Authorization

Prior Authorization Required

Prior Authorization is required for Acthar Gel. Approvals are provided when the policy criteria and dosing are met. Requests for doses outside the established dosing documented in this policy will be reviewed case-by-case by a clinician (Medical Director or Pharmacist). Approvals are provided for the duration specified in the policy; when authorized in months, 1 month = 30 days.

Acthar Gel (repository corticotropin) requires prior authorization
Requests for non‑standard doses will be reviewed individually by a clinician

Step Therapy

Cost‑effectiveness / Step Consideration

Repository corticotropin (Acthar Gel) is considered not medically necessary when the applicable benefit plan limits coverage to the most cost‑effective equivalent therapy.

Initial Therapy — Infantile Spasms

Initial Therapy - Infantile Spasms

Initial therapy criteria for infantile spasms

Initial therapy for infantile spasms: Patient <2 years; intramuscular administration using multidose vial; prescribed by a physician who has consulted with or specializes in neurology.150 units/m2 per day divided twice daily (two injections of 75 units/m2); approve up to 1 month

Acthar Gel single-dose prefilled SelfJect injector (subcutaneous) is not acceptable for this indication; dosing should be tapered after 2 weeks per product instructions.

Step Therapy and Prioritization

Policy statement
Where a health benefit plan's definition of medical necessity limits coverage to the most cost‑effective equivalent treatment, repository corticotropin (Acthar Gel) is not considered medically necessary unless the plan's specified criteria for its use are met.

Definitions and Site of Care

SelfJect

DefinitionActhar Gel single-dose pre-filled SelfJect injector for subcutaneous administration by adults

Usage limitationSelfJect delivers single doses of 40 units or 80 units only

Infantile spasms noteSelfJect is not to be used for the treatment of infantile spasms (subcutaneous only)

Multidose vial

DefinitionActhar Gel multidose vial formulation for intramuscular or subcutaneous injection

Required formulation for infantile spasmsMultidose vial must be used and administered intramuscularly for infantile spasms

Background

Acthar (repository corticotropin) is an adrenocorticotropic hormone (ACTH) analog with an FDA‑approved indication for the treatment of infantile spasms. The product is available as a multidose vial and as a single‑dose SelfJect injector; for infantile spasms this policy requires use of the multidose vial administered intramuscularly rather than the SelfJect subcutaneous injector. Clinical data and guideline references supporting use in other conditions are limited, and Acthar is not prominent in guideline recommendations for many nephrologic, rheumatologic, or ophthalmic diseases.

Policy Summary

PayerCigna

PolicyRepository Corticotropin - Acthar Gel

Policy CodePolicy IP0178

Change TypeUpdated; material changes include infantile spasms dosing and formulation requirement

Effective Date

Next Review Date

Key ActionObtain prior authorization and document that Acthar Gel will be given intramuscularly using the multidose vial for infantile spasms.

SourceLink

On This Page

Approval durationAuthorization provided for up to 1 month when criteria met

Documentation Required

Prescriber and Documentation Requirements

Acthar Gel must be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., neurology for infantile spasms). Documentation should support specialty consultation and, when relevant, the specific dose and route of administration requested.

Specialist prescribing or documented consultation required
Document doses and route; requests outside established dosing require clinical justification

Denial Risk

Denial Triggers / Benefit Plan Dependence

Claims submitted without a covered diagnosis or procedure code per this policy will be denied as not covered. Coverage is subject to the terms of the member's benefit plan; an otherwise approved therapy may be excluded by specific plan language.

Claims lacking covered diagnosis/procedure codes will be denied
Coverage depends on the member's specific benefit plan terms

Dosing guidanceRecommended infantile spasms dosing: 150 units/m2 per day divided twice daily (2 injections of 75 units/m2)

Billing Rule

Site of care and intramuscular dosing for infantile spasms

Dosing and site of care must be reasonable and clinically appropriate; for infantile spasms the Acthar Gel multidose vial must be administered intramuscularly (the single‑dose SelfJect injector is not to be used for infantile spasms).

Infantile spasms dosing: approve up to 150 units/m2 per day divided into two intramuscular injections (75 units/m2 each) for up to 1 month.
Acthar gel single‑dose prefilled SelfJect injector is not to be used for the treatment of infantile spasms; multidose vial intramuscular administration is required.