CurrentUnitedHealthcarePolicy CS2025D0037Y

Repository Corticotropin Injections

Medical benefit drug policy governing coverage and medical necessity criteria for repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) for UnitedHealthcare Community Plan members; includes approved and unproven indications and applicable coding. Affects providers requesting authorization for these products.

Policy Summary

PayerUnitedHealthcare

PolicyRepository Corticotropin Injections

Policy CodePolicy CS2025D0037Y

Change TypeRemoved specific dosingbackground and references updated

Effective Date2025-05

Next Review DateN/A

Key ActionSubmit prior authorization with clinical documentation referencing HCPCS J0801/J0802; authorizations limited to 3 months for commercial coverage.

SourceLink

POLICY UPDATE CHANGES

Removed specific dosage requirements for Acthar Gel (repository corticotropin injection) and Purified Cortrophin Gel (repository corticotropin injection USP); refer to the applicable U.S. FDA approved labeling.

Updated Background, Clinical Evidence, and References sections to reflect the most current information.

2FDA indications

3Max auth (months)

J0801,J0802HCPCS codes

Infantile spasms & OMS

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Coverage and Medical Necessity Criteria

Use of Acthar Gel or Purified Cortrophin Gel for the following conditions is considered unproven and not medically necessary due to lack of supporting clinical evidence and the availability of more cost‑effective alternatives: allergic states (including serum sickness and atopic dermatitis); dermatologic diseases such as severe erythema multiforme, Stevens‑Johnson syndrome, and severe psoriasis; collagen diseases including systemic lupus erythematosus and dermatomyositis/polymyositis; edematous states such as attempts to induce diuresis or remission of proteinuria in nephrotic syndrome without uremia; respiratory disease such as symptomatic sarcoidosis; severe ophthalmic inflammatory conditions (for example, keratitis, iritis, iridocyclitis, posterior uveitis, choroiditis, optic neuritis, and related anterior segment inflammation); and multiple rheumatic disorders including psoriatic arthritis, rheumatoid arthritis (including juvenile rheumatoid arthritis), ankylosing spondylitis, and acute gouty arthritis.

Acthar Gel and Purified Cortrophin Gel are not medically necessary for the treatment of acute exacerbations of multiple sclerosis. In addition, the products are considered unproven and not medically necessary for a range of other listed disorders where the package inserts mention use but clinical evidence is insufficient and less costly alternatives exist.

Coding and Billing

Covered HCPCS / drug codesHCPCSCovered

J0801	Injection, corticotropin (acthar gel), up to 40 units.
J0802	Injection; corticotropin (ani); up to 40 units

Relevant diagnosis codesICD-10

G25.3	Myoclonus
G25.9	Extrapyramidal and movement disorder; unspecified.
G40.821	Epileptic spasms, not intractable, with status epilepticus.
G40.822	Epileptic spasms, not intractable, without status epilepticus.
G40.823	Epileptic spasms, intractable, with status epilepticus.
G40.824	Epileptic spasms, intractable, without status epilepticus.
H55.89	Other irregular eye movements

inv-08: Treatment assessment interval for ACTH in infantile spasms (assess ~2 weeks; taper if effective)

Assessment intervalApproximately 2 weeks after initiating ACTH therapy to assess for cessation of spasms and resolution of hypsarrhythmia

Action if effectiveTaper ACTH following demonstration of clinical response and EEG improvement

Action if not effectivePrompt modification of therapy if no response by the ~2-week assessment to avoid prolonged ineffective treatment

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Acthar Gel and Purified Cortrophin Gel for commercial members. Authorizations for commercial plans will be granted for no longer than 3 months.

Applies to repository corticotropin injections (Acthar Gel, Purified Cortrophin Gel)
Authorizations length: ≤ 3 months

Documentation Required

Treatment Assessment Timing

For infantile spasms treated with ACTH, treatment efficacy should be assessed promptly — about 2 weeks after initiation. If there is no clinical and electroencephalographic response (cessation of spasms and resolution of hypsarrhythmia), the provider should modify therapy rather than continue prolonged trials. Longer treatment trials (greater than ~2 weeks for ACTH) are unlikely to be effective and may increase risk of adverse events.

Assess ACTH response at ~2 weeks (evaluate clinical spasm cessation and EEG)

Initial Therapy Guidance

Continuation and Authorization Length Guidance

Step Therapy and Treatment Modification

Step	Assessment interval / failure criteria	Required action if no response
1	Approximately 2 weeks for ACTH; failure = lack of cessation of spasms and lack of resolution of hypsarrhythmia by ~2 weeks	Prompt modification of therapy (change therapy or escalate per expert consensus); do not continue ineffective ACTH beyond the assessment interval

Background and Clinical Context

Repository corticotropin is an adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone and other steroid hormones. Its pharmacologic effects are mediated both by stimulation of adrenal steroidogenesis and by direct binding to melanocortin receptors, producing trophic effects via intracellular cyclic AMP pathways. Prolonged administration increases endogenous corticosteroid output and has been used historically for select inflammatory and neurologic conditions, with the strongest evidence supporting use in infantile spasms and more limited or unproven evidence in many other disorders.

Definitions

inv-14: Repository corticotropin (ACTH) — definition and brief pharmacology

DefinitionRepository corticotropin is an adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and other hormones

MechanismStimulates adrenal cortical hormone secretion and binds melanocortin receptors; trophic effects on the adrenal cortex mediated in part by cyclic AMP

Clinical use noted in policyUsed primarily for infantile spasms and historically in other conditions though evidence varies by indication

inv-15: Infantile spasms (West Syndrome) — definition and FDA indication note

DefinitionInfantile spasms (West Syndrome) is a pediatric seizure disorder characterized by epileptic spasms and hypsarrhythmia on EEG

FDA indication note

Site-of-Care Notes

Note

Infusion center/site-of-care: informational only

This policy is informational regarding benefit interpretation for infusion center care; it does not specify site-of-care rules or change how federal, state, or contractual coverage requirements govern benefit decisions.

When deciding coverage, reference the applicable federal, state, or contractual benefit requirements.
UnitedHealthcare may use third-party tools (e.g., InterQual) to assist in administering benefits.