CurrentUnitedHealthcarePolicy N/A

Repository corticotropins (Acthar Gel, Purified Cortrophin Gel) step therapy

Step therapy program governing coverage and prior authorization requirements for repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) for UnitedHealthcare members; applies to prescribing providers and pharmacy benefit management.

Policy Summary

PayerUnitedHealthcare

PolicyRepository corticotropins (Acthar Gel, Purified Cortrophin Gel) step therapy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization; approvals require specified diagnosis/age for infantile spasms or documentation of corticosteroid trial, contraindication, or intolerance for other conditions.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration for approved indications

corticosteroid trialstep therapy requirement for other conditions

2repository corticotropins covered

2026-06-01policy effective date

Coverage Criteria for Repository Corticotropins

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Infantile Spasms

Covered when ALL of the following are met:

Infantile Spasms criteria: (a) Diagnosis of infantile spasms (West Syndrome); AND (b) patient is less than 2 years of age

Authorization issued for 12 months

Opsoclonus-Myoclonus Syndrome

Covered when the following is met:

Opsoclonus-Myoclonus: (a) Diagnosis of opsoclonus-myoclonus syndrome (Kinsbourne Syndrome)

Authorization issued for 12 months

Other Conditions

Covered when ALL of the following are met:

Other conditions: History of failure, contraindication, or intolerance to treatment with corticosteroids

Authorization issued for 12 months; state mandates and member-specific benefit plan coverage may apply

This policy notes that for conditions which are corticosteroid-responsive, corticosteroid therapy is considered the treatment of choice. Coverage for repository corticotropin injections (Acthar Gel, Purified Cortrophin Gel) is therefore limited to situations that meet the specific criteria set forth in this document (for example, FDA‑indicated uses or when there is documented failure, contraindication, or intolerance to corticosteroids for other conditions). The policy also observes that applicable state mandates and member-specific plan limits may apply and can affect coverage decisions.

Initial Therapy Authorization Criteria

Initial Therapy

Initial authorization criteria

Initial approval pathways: (1) Infantile spasms with age <2 years; OR (2) Opsoclonus-myoclonus diagnosis; OR (3) Other conditions with history of failure, contraindication, or intolerance to corticosteroids

Approvals issued for 12 months

Provider Actions, Prior Authorization & Documentation

Prior Authorization

Provider Actions & Prior Authorization

Prior authorization is required for Acthar Gel and Purified Cortrophin Gel. Requests may be denied if prior authorization, step-therapy, supply-limit, or notification rules are not met. UnitedHealthcare may also approve initial or reauthorization requests automatically when prior claim/medication history, diagnosis codes (ICD-10), and/or claim logic satisfy coverage rules.

Prior authorization required for infantile spasms and opsoclonus-myoclonus when diagnostic criteria are met (see clinical criteria).
Step therapy: For corticosteroid-responsive conditions, a history of failure, contraindication, or intolerance to corticosteroids is required prior to approval, unless documentation supports medical inappropriateness.
Supply limits and/or notification rules may apply; approvals may depend on prior claim/medication history and diagnosis codes (ICD-10).
Requests may be denied if prior authorization, supply limits, step-therapy, or notification requirements are not satisfied.
UnitedHealthcare may use automated approval/reauthorization based on prior claims, medication history, diagnosis codes, and claim logic; use of automation varies by program and therapeutic class.

Step Therapy Requirements

Step	Requirement	Supporting details / coverage action
1	A trial of corticosteroids is required (or documentation of contraindication/intolerance)	For corticosteroid-responsive or non–FDA-indicated conditions, Acthar Gel or Purified Cortrophin Gel will be approved only after history of failure, contraindication, or intolerance to corticosteroids is documented; this step-therapy requirement is described in the program background and the 'Other Conditions' approval criteria.

Site of Care Notes

Note

Site-of-care: no specific restrictions stated (supply/notification may apply)

The policy does not specify site-of-care restrictions for infusion centers; however, the program may impose supply limits and notification requirements that affect dispensing or administration at the site of care.

Definitions

repository corticotropin — definition and product names (Acthar Gel, Purified Cortrophin Gel)

DefinitionRepository corticotropin injection: an adrenocorticotropic hormone (ACTH) analogue used as Acthar Gel or Purified Cortrophin Gel

Acthar Gel (repository corticotropin injection)FDA-indicated for infantile spasms (monotherapy for infants and children under 2 years) and for treatment of acute exacerbations of multiple sclerosis in adults

Purified Cortrophin Gel (repository corticotropin injection USP)Indicated for rheumatic disorders and certain collagen diseases per product labeling

ClassAdrenocorticotropic hormone analogues

Background

Repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) are adrenocorticotropic hormone (ACTH) analogues with FDA‑labeled indications that include infantile spasms (West Syndrome) and treatment of acute exacerbations of multiple sclerosis. The agents are also used per labeling for a range of rheumatic, dermatologic, ophthalmic, respiratory, edematous, and other inflammatory or autoimmune conditions. The source material additionally notes evidence supporting use in opsoclonus‑myoclonus syndrome. When a condition is corticosteroid‑responsive, initial therapy with corticosteroids is considered preferred unless there is documented failure, contraindication, or intolerance to corticosteroid treatment.