Repository Corticotropin (Acthar Gel) Utilization Management
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Defines prior authorization, coverage criteria, dosing, and conditions for approval or non-coverage of Acthar Gel for UCare members; applies to prescribers requesting pharmacy benefit coverage of repository corticotropin (Acthar Gel).
No material clinical or coverage changes in this revision.
Coverage Criteria for Acthar (repository corticotropin)
Infantile Spasms, Treatment (FDA-approved)
Covered when ALL of the following are met:
- A) Child is less than 2 years of age.
- B) Acthar is being administered as an intramuscular injection.
The Acthar gel multidose vial (IM) must be used; the single‑dose SelfJect injector is not to be used for infantile spasms.
- C) Medication is prescribed by a physician who has consulted with or specializes in neurology.
Coverage of Acthar (repository corticotropin) is not recommended for the following conditions: ankylosing spondylitis; dermatomyositis or polymyositis; diabetic nephropathy; and glomerular kidney diseases (including nephrotic syndrome, membranous nephropathy, IgA nephropathy, minimal change disease, infection-related glomerulonephritis, focal segmental glomerulosclerosis, and membranoproliferative glomerulonephritis) due to limited guideline support and lack of quality evidence.
Additional conditions for which coverage is not recommended include gout, juvenile idiopathic arthritis, lupus nephritis, selected ophthalmic conditions (e.g., optic neuritis, keratitis, retinal vasculitis), psoriatic arthritis, and rheumatoid arthritis. For sarcoidosis, repository corticotropin should be reserved for patients who have failed prior therapies (e.g., steroids, antimetabolites) and considered only on a case‑by‑case basis.
Multiple sclerosis acute exacerbations are not recommended for routine approval of Acthar. Short‑term, high‑dose corticosteroids (commonly intravenous methylprednisolone or high‑dose oral prednisolone) are the standard therapies for MS relapses, and available evidence shows that ACTH and high‑dose IV methylprednisolone have similar efficacy, so ACTH is not favored as a routine alternative.
Coding and Billing
| J0800 | Repository corticotropin, for injection (example HCPCS often used for Acthar) — payer lists require prior auth |
Provider Actions, Authorization & Documentation
Prior Authorization Required
Prior Authorization Required — Approval for infantile spasms requires meeting all stated criteria and will be authorized for specified duration.
- Applies to Acthar Gel for infantile spasms
- Approve multidose vial for up to 1 month (1 month = 30 days)
Reserve After Prior Therapy
Reserve repository corticotropin after prior therapy — Use should be reserved for patients who have failed prior treatments and considered on a case-by-case basis when other therapies are not effective or tolerated.
- Examples of prior treatments: corticosteroids, antimetabolites
- Relevant condition example: sarcoidosis
Prescriber and Dosing Documentation
Prescriber and dosing documentation — Approval requires Acthar Gel to be prescribed by or in consultation with a physician who specializes in the condition being treated. Requests for doses outside the established dosing documented in policy will be reviewed case-by-case by a clinician.
- For infantile spasms: child < 2 years, intramuscular administration, prescribed by a physician who has consulted with or specializes in neurology
- Dosing for infantile spasms: up to 150 units/m2 IM per day for up to 1 month
Denial Triggers
Denial Triggers — Requests that do not meet authorization criteria or request nonrecommended formulations are denial risks.
- Do not approve Acthar single-dose pre-filled SelfJect Injector for infantile spasms
- Requests that lack required specialist consultation or appropriate dosing are at risk of denial
Background
Acthar (repository corticotropin) is an adrenocorticotropic hormone (ACTH) analog used in specific indications. The product is indicated for the treatment of infantile spasms in infants and children under age 2 and has other labeled adult indications; the vial formulation may be administered intramuscularly or subcutaneously, while the single‑dose SelfJect prefilled injector is intended for subcutaneous use in adults only and must not be used for infantile spasms.
Clinical evidence for many off‑label uses is limited, and guideline guidance is inconsistent; this supports a focused coverage stance favoring the FDA‑approved infantile spasms indication while generally not recommending routine coverage for other conditions without stronger evidence or guideline support.
Definitions
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