CurrentUnitedHealthcarePolicy N/A

Repository corticotropin injections (Acthar Gel; Purified Cortrophin Gel) — Coverage Criteria

Prior authorization and coverage criteria for repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) for UnitedHealthcare members; defines indications, initial authorization periods, and reauthorization policies.

Policy Summary

PayerUnitedHealthcare

PolicyRepository corticotropin injections (Acthar Gel; Purified Cortrophin Gel) — Coverage Criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2025

Next Review DateN/A

Key ActionObtain prior authorization for Acthar Gel or Purified Cortrophin Gel per indication-specific criteria before initiating therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4 wkInfantile spasms authorization

3 wkMS exacerbation authorization

3 moOpsoclonus-myoclonus authorization

12 moPurified Cortrophin other indications

DeniedReauthorization policy

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Coverage Criteria

Initial Therapy — Infantile Spasms

Covered when ALL of the following are met:

Infantile spasms criteria: (1) Diagnosis of infantile spasms (West Syndrome) AND (2) Patient is less than 2 years of age

Authorization issued for 4 weeks

Initial Therapy — Multiple Sclerosis Exacerbation

Covered when ANY/ALL as specified below:

MS exacerbation criteria: (1) Diagnosis of acute exacerbation of multiple sclerosis

Initial authorization issued for 3 weeks; reauthorization only for a new (different) episode (3 weeks); reauthorization for same exacerbation denied

Initial Therapy — Opsoclonus-Myoclonus

Covered when the following is met:

OMS criteria: (1) Diagnosis of opsoclonus-myoclonus syndrome (Kinsbourne Syndrome)

Authorization issued for 3 months; reauthorization requests will be denied

Initial Therapy — Purified Cortrophin Gel Indications

Covered when ANY of the following indications are met:

Purified Cortrophin Gel indications: (1) Rheumatic disorders as adjunctive short-term therapy (eg, psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis) OR (2) Collagen diseases during exacerbation or maintenance in selected cases (eg, systemic lupus erythematosus, dermatomyositis/polymyositis) OR (3) Severe dermatologic diseases (eg, Stevens-Johnson syndrome, severe psoriasis) OR (4) Allergic states (eg, atopic dermatitis, serum sickness) OR (5) Severe ophthalmic inflammatory processes (eg, allergic conjunctivitis, keratitis, iritis/iridocyclitis, posterior uveitis/choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation) OR (6) Respiratory disease: symptomatic sarcoidosis OR (7) Edematous states: nephrotic syndrome to induce diuresis/remission of proteinuria

Authorization issued for 12 months; reauthorization requires documentation of positive clinical response

All requests for reauthorization will be denied. Continuation of therapy is not granted through the routine prior authorization process; any request to continue treatment must be submitted through the UnitedHealthcare Pharmacy appeals process for review and determination.

Initial Therapy Criteria

Initial — Infantile Spasms

Initial authorization rules

Infantile spasms initial: Diagnosis of infantile spasms AND patient <2 years of age

Authorization issued for 4 weeks

Initial — Multiple Sclerosis

Initial authorization rules

MS exacerbation initial: Diagnosis of acute exacerbation of multiple sclerosis

Initial authorization issued for 3 weeks; reauthorization only for a new different episode (3 weeks); reauthorization for same exacerbation denied

Initial — Opsoclonus-Myoclonus

Initial authorization rules

Continuation / Reauthorization

Continuation Therapy / Reauthorization

Continuation / reauthorization rules

General continuation: All requests for reauthorization will be denied; continuation of therapy must be pursued through the UnitedHealthcare Pharmacy appeals process

For multiple sclerosis, reauthorization may be approved only for a new (different) exacerbation for 3 weeks; reauthorization for the same exacerbation or other same-episode requests are denied

Provider Actions and Requirements

Prior Authorization

Infantile spasms authorization

Prior authorization required for Acthar Gel and Purified Cortrophin Gel for infantile spasms in patients under 2 years; authorization will be issued for 4 weeks. All requests for reauthorization will be denied. Continuation of therapy must be submitted through the UnitedHealthcare Pharmacy appeals process for consideration.

Diagnosis: infantile spasms (West Syndrome)
Patient age: < 2 years
Authorization duration: 4 weeks
Reauthorization: denied — continuation requires pharmacy appeals

Prior Authorization

Multiple sclerosis exacerbation authorization

Prior authorization required for Acthar Gel and Purified Cortrophin Gel for acute exacerbation of multiple sclerosis. Initial authorization will be issued for 3 weeks. Reauthorization is allowed only for a new, different episode of acute exacerbation (authorization issued for 3 weeks). All requests for reauthorization for treatment of the same exacerbation will be denied; continuation of therapy for the same exacerbation must be submitted through the UnitedHealthcare Pharmacy appeals process for consideration.

Definitions

Acthar Gel / Purified Cortrophin Gel — Definitions

Drug classAdrenocorticotropic hormone (ACTH) analogue (repository corticotropin injections)

ProductsActhar Gel (repository corticotropin injection); Purified Cortrophin Gel (repository corticotropin injection USP)

FDA-indicated uses (Acthar Gel)Infantile spasms (monotherapy in infants and children <2 years); acute exacerbations of multiple sclerosis in adults

Common labeled/non‑labeled usesRheumatic, collagen, dermatologic, allergic, ophthalmic, respiratory, and edematous conditions; additional evidence for opsoclonus-myoclonus syndrome

TerminologyRepository corticotropin injection refers to ACTH analogue formulations (Acthar Gel; Purified Cortrophin Gel)

Background

Acthar Gel and Purified Cortrophin Gel are adrenocorticotropic hormone (ACTH) analogues. Acthar Gel is FDA‑labeled for treatment of infantile spasms (West syndrome) as monotherapy in children under 2 years and for treatment of acute exacerbations of multiple sclerosis in adults; additional evidence supports use in conditions such as opsoclonus‑myoclonus syndrome. Purified Cortrophin Gel is a repository corticotropin preparation with multiple labeled and non‑labeled uses across rheumatic, dermatologic, allergic, ophthalmic, respiratory, and edematous indications.

Step Therapy / Supply Limits

Program note
Supply limits and/or Step Therapy may be in place per program

Prior Authorization

Purified Cortrophin Gel non-neurologic indications

Prior authorization required for Purified Cortrophin Gel for specified non-neurologic indications. Authorization will be issued for 12 months for eligible diagnoses. Reauthorization for continued use requires documentation of positive clinical response; authorization will be issued for 12 months upon approval. State mandates, federal regulatory requirements, and member-specific benefit plan coverage may also impact coverage; other policies and utilization management programs may apply.

Covered non-neurologic indications (examples): rheumatic disorders (psoriatic arthritis, rheumatoid arthritis including juvenile rheumatoid arthritis, ankylosing spondylitis, acute gouty arthritis)
Collagen diseases: systemic lupus erythematosus, systemic dermatomyositis (polymyositis)
Dermatologic diseases: severe erythema multiforme (Stevens-Johnson syndrome), severe psoriasis
Allergic states: atopic dermatitis, serum sickness
Ophthalmic diseases: severe allergic/inflammatory processes of the eye and adnexa (e.g., allergic conjunctivitis, keratitis, iritis/iridocyclitis, posterior uveitis/choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation)
Respiratory diseases: symptomatic sarcoidosis
Edematous states: nephrotic syndrome (to induce diuresis or remission of proteinuria in idiopathic or lupus-related nephrotic syndrome without uremia)
Initial authorization duration: 12 months
Reauthorization requirement: documentation of positive clinical response; authorization issued for 12 months