CurrentAetnaPolicy 0762

Repository Corticotropin Injection (Acthar Gel and Purified Cortrophin Gel)

Defines Aetna's coverage stance, precertification and clinical criteria for repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) for commercial medical plans, including FDA‑approved infantile spasms indication and other indications considered not medically necessary or experimental.

Policy Summary

PayerAetna

PolicyRepository Corticotropin Injection (Acthar Gel and Purified Cortrophin Gel)

Policy CodePolicy 0762

Change TypeNo material changes

Effective DateAug 8, 2008

Next Review DateJul 25, 2024

Key ActionObtain precertification and submit a Statement of Medical Necessity with supporting clinical documentation when requesting prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1FDA‑approved covered indication

2Forms available

requiredPrecertification

150 U/m2Typical infantile spasms dose

Coverage Criteria for Repository Corticotropin Injections

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Initial Approval

Covered when ALL of the following are met:

ALL of the following

Patient is less than 2 years of age.
Diagnosis of infantile spasms (West syndrome).
Repository corticotropin injection = Acthar Gel (Purified Cortrophin Gel not FDA‑approved for this indication).
Precertification obtained as required by the plan (see Policy Scope).
Precertification required of all participating providers and members in applicable plan designs. Call (866) 752-7021 or fax (888) 267-3277.

Continuation Therapy

Covered when ALL of the following are met:

ALL of the following

Member has a diagnosis of infantile spasms (West syndrome).
Member has demonstrated substantial clinical benefit from prior Acthar Gel therapy (clinical improvement in spasms or EEG).
Ongoing use is for the same indication for which initial therapy was approved.

Experimental, Investigational, or Not Medically Necessary

The following uses are considered experimental, investigational, or not medically necessary:

ANY of the following

Use of repository corticotropin injection for diagnostic testing of adrenocortical function (not superior to cosyntropin).
Use of Purified Cortrophin Gel for infantile spasms (not FDA‑approved and lacks compendial support).
Combination use of Acthar Gel with Purified Cortrophin Gel (safety and efficacy not established).
All other indications not supported by established evidence, including but not limited to: amyotrophic lateral sclerosis, dry eye disease, focal segmental glomerulosclerosis, neurosarcoidosis, non-infectious retinal vasculitis, ocular mucous membrane pemphigoid, ocular sarcoidosis, multiple sclerosis exacerbations, and many rheumatic/collagen indications.
Use for indications where evidence consists only of small uncontrolled case series, pilot studies, or limited retrospective case series without adequate randomized controlled trial support.

Infantile Spasms — coverage context

Infantile spasms — coverage context and evidence summary:

ALL of the following

FDA has approved H.P. Acthar Gel for treatment of infantile spasms in infants and children under 2 years of age (FDA, 2010).
Effectiveness demonstrated for cessation of spasms and improvement in EEG; evidence does not establish prevention of other seizure types or improvement in long-term developmental outcomes.
Recommended regimen per labeling: 150 U/m2/day divided into two 75 U/m2 IM injections for 2 weeks, followed by gradual taper over 2 weeks to avoid adrenal insufficiency.
Cochrane review and subsequent analyses indicate ACTH is probably effective in short-term treatment but optimal dose/duration and long-term benefit remain uncertain; further trials with larger samples and longer follow-up are needed.

Collagen diseases — coverage context

Collagen diseases — evidence context:

ANY of the following

Evidence for RCI in refractory collagen diseases (e.g., dermatomyositis/polymyositis, systemic lupus erythematosus) is limited to small open-label trials, series, and post-hoc analyses; some studies report clinical responses and steroid-sparing effects but are limited by small sample sizes and study design.
Preliminary trials in refractory myositis reported response rates but require validation in well-designed randomized studies; follow-up studies showed variable durability of response.
In SLE, some randomized and open-label data suggest immunomodulatory effects and improvements in disease activity measures in select populations, but additional randomized trials are needed to confirm clinical benefit and safety.

Coverage considerations by condition

Coverage considerations by condition — general guidance:

ANY of the following

RCI may be considered for infantile spasms (Acthar Gel) per FDA approval and when criteria above are met.
For other inflammatory or autoimmune conditions (e.g., RA, SLE, DM/PM, nephrotic syndromes, sarcoidosis, uveitis, optic neuritis), evidence is mixed: some real‑world series and trials report benefit in refractory cases, but many studies are small, uncontrolled, or have methodological limitations.
Aetna considers Acthar Gel and Purified Cortrophin Gel not medically necessary for many indications where lower‑cost conventional therapies (corticosteroids, immunosuppressants) provide equivalent therapeutic outcomes and where superiority of RCI is not established.
Emerging evidence for renal indications is unlikely to broadly support RCI over lower‑cost glucocorticoid alternatives; randomized controlled data are lacking or inconclusive for many nephrologic uses.
For sarcoidosis and ocular inflammation, small case series report mixed results; UpToDate reviews do not list RCI as a standard option for refractory pulmonary sarcoidosis.

Coding and Billing for Repository Corticotropin Injections

Other related CPT CodesCPT

96372

Therapeutic, prophylactic, or diagnostic injection; subcutaneous or intramuscular

HCPCS Codes Covered if Selection Criteria Are MetHCPCSCovered

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

ICD-10 Codes Covered if Selection Criteria Are MetICD-10Covered

G40.821 - G40.824

Epileptic spasms [West's syndrome] [Acthar gel only]

ICD-10 Codes Not Covered for Indications Listed in the CPB (selected examples)ICD-10Not Covered

A15.0 - A15.9	Respiratory tuberculosis [when used concurrently with antituberculous chemotherapy]
G35	Multiple sclerosis [acute exacerbations]

Coding Notedmixed

NDC/Historical

No specific NDCs or CPT/HCPCS codes listed in this excerpt

No explicit CPT/HCPCS/NDC/ICD-10 codes in this segmentmixed

No codes listed

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Precertification required

Precertification (prior authorization) is required for repository corticotropin injection (Acthar Gel or Purified Cortrophin Gel) for all Aetna participating providers and members in applicable plan designs. For precertification or Statement of Medical Necessity (SMN) submission, contact Aetna Specialty Pharmacy Precertification.

Precertification phone: (866) 752-7021
Fax: (888) 267-3277
SMN/precertification forms: Specialty Pharmacy Precertification web page

Prior Authorization

Prior authorization for infantile spasms — document FDA‑approved indication and dosing

For infantile spasms (West syndrome) prior authorization, document that the patient is less than 2 years of age, has a diagnosis of infantile spasms/West syndrome, EEG findings supporting the diagnosis, and that dosing follows FDA‑approved labeling (150 U/m2 daily divided as two 75 U/m2 IM injections for 2 weeks with a 2‑week taper). Acthar Gel (only) is the FDA‑approved product for this indication; Purified Cortrophin Gel is not FDA‑approved for infantile spasms.

Age < 2 years
Diagnosis: infantile spasms/West syndrome
EEG evidence consistent with infantile spasms
Dosing per labeling: 150 U/m2/day divided into two 75 U/m2 IM injections for 2 weeks, then taper over 2 weeks
Acthar Gel is the FDA‑approved product for infantile spasms; Purified Cortrophin Gel is not approved for this indication

Documentation Required

Required clinical documentation for nephrotic syndrome cases

When requesting prior authorization for RCI for nephrotic syndrome or other glomerular diseases, provide prior treatment history (including trials of corticosteroids and other immunosuppressive/cytotoxic agents), objective disease measures (proteinuria quantification, urine protein‑to‑creatinine ratio, serum creatinine), and reason for RCI (steroid‑resistant, steroid‑dependent, intolerant to first‑line therapy, or refractory disease).

Prior therapies: corticosteroids, immunosuppressants, cytotoxic agents (list agents, doses, durations)
Objective measures: baseline and recent proteinuria (mg/24 hr or urine PCR), serum creatinine/eGFR
Biopsy findings if available and etiology of nephrotic syndrome
Statement of clinical rationale for RCI (e.g., refractory to first‑line therapy)

Documentation Required

Provide dosing when requesting prior authorization

Provide dosing details when requesting prior authorization — include the proposed RCI product, regimen, route, dose, frequency, planned duration, and tapering plan as applicable. The appendix lists FDA‑recommended dosing regimens (e.g., Acthar Gel 80–120 U daily for MS exacerbation; usual dosing 40–80 U every 24–72 hours for other indications; infantile spasms dosing per labeling).

Specify product (Acthar Gel or Purified Cortrophin Gel)
Proposed dose and frequency (e.g., 80 U daily, 80 U twice weekly, 150 U/m2/day for infantile spasms)
Route: IM or SC
Planned duration and tapering schedule
Reference: Appendix — FDA‑approved dosing recommendations

Note

Prior authorization presence reflected in claims outcomes — retrospective study findings

Claims and retrospective analyses have shown that prior authorization presence affects outcomes: a matched claims study of nephrotic syndrome patients found differences in baseline characteristics between approved and denied patients, and directionally higher healthcare utilization among denied patients (inpatient admissions, dialysis, DVT ultrasounds) and greater corticosteroid use during follow‑up in denied patients. Reasons for denials were not available in the claims data.

Study: Rice et al., retrospective claims analysis (2015–2018), 1,232 NS patients
Matched results: denied patients had directionally more inpatient admissions and higher use of dialysis and DVT ultrasounds
Denied patients had directionally greater corticosteroid use during follow‑up
Claims data did not capture reasons for denial

Documentation Required

Documentation limitations in claims and retrospective analyses

Evidence and documentation limitations in retrospective and claims analyses may constrain interpretation of medical necessity and denial rationales. Claims data often lack laboratory values, complete clinical measures, and explicit reasons for claim denials; retrospective medical record reviews may be incomplete and physician assessments subjective. These limitations should be anticipated when submitting prior authorization documentation and appeals.

Claims datasets may lack lab values (e.g., proteinuria, eGFR) and full claims capture across data streams
Claims do not indicate reasons for prior authorization denials
Retrospective medical record reviews may be incomplete and rely on subjective physician assessments

Step Therapy

Step therapy: standard treatments expected before RCI and place in therapy

Place of RCI in typical step‑therapy sequences: corticosteroids are generally the initial therapy for many conditions (for example, pulmonary sarcoidosis). Cytotoxic or conventional immunosuppressive agents (methotrexate, azathioprine, mycophenolate, leflunomide) are commonly used as second‑line therapy, and biologics (e.g., anti‑TNF agents) and other agents are third‑line. RCI is typically considered after inadequate response, intolerance, or contraindication to first‑line therapies.

First‑line: corticosteroids
Second‑line: cytotoxic/conventional immunosuppressants (methotrexate, azathioprine, mycophenolate, leflunomide)
Third‑line: biologics (eg, anti‑TNF agents) and other agents
RCI generally considered after failure/intolerance to earlier lines of therapy

Documentation Required

Use after failure of first‑line therapies — document prior therapy failures/intolerance

Use of RCI is commonly reported after failure, intolerance, or inadequate response to first‑line therapies. Studies and case series frequently include patients who had failed multiple prior agents or were unable to tolerate standard therapies; prior authorization requests should document these prior treatment failures or contraindications.

Document prior first‑line therapy trials, durations, and reason for discontinuation (inefficacy, intolerance, contraindication)
Note if RCI is used as add‑on therapy or for acute exacerbations
Include objective measures of disease activity where available (SLEDAI, proteinuria, DAS28, visual measures)

Note

No step‑therapy requirements specified in this policy — verify plan benefits

Aetna does not specify universal step‑therapy sequencing for all plans within this policy — some plan designs require precertification or SMN but no single mandatory step‑therapy algorithm is delineated in these policy sections. Check specific benefit plan descriptions for any plan‑level step therapy requirements.

Precertification requirement applies to participating providers and certain plan designs
No explicit, uniform step‑therapy requirement is specified in this policy text — verify member's benefit plan for plan‑specific rules

Note

Brand selection and comparative cost considerations

Brand selection and cost considerations: Acthar Gel and Purified Cortrophin Gel are more costly than conventional therapies (corticosteroids, immunosuppressive agents). When lower‑cost, evidence‑supported alternatives exist and are appropriate for the member, use of the higher‑cost RCI products may be considered not medically necessary.

Acthar Gel and Purified Cortrophin Gel are higher cost versus corticosteroids and conventional immunosuppressants
Aetna considers cost and comparative effectiveness when determining medical necessity

Denial Risk

No explicit single authorization or denial criteria provided in this segment

There are no single explicit authorization approval or denial criteria listed in this section beyond the indication‑specific criteria (infantile spasms) and requirements to submit precertification/SMN and clinical documentation. Denials may result when indications are experimental/investigational, when documentation of prior therapies or objective disease measures is insufficient, or when use is for non‑approved products/indications.

Policy defines medical necessity for infantile spasms (Acthar Gel only) and considers other indications experimental/investigational
No standalone checklist of authorization approval/denial triggers is provided in this policy text
Ensure thorough documentation of prior therapies and objective disease measures to support medical necessity

Background and Context

Repository corticotropin injections (Acthar Gel and Purified Cortrophin Gel) are natural, porcine‑derived ACTH preparations administered by intramuscular or subcutaneous injection. Historically, ACTH products have been used for multiple corticosteroid‑responsive conditions. Acthar Gel has an FDA‑approved indication for treatment of infantile spasms in children under 2 years; Purified Cortrophin Gel is of porcine origin but is not FDA‑approved for that indication. ACTH stimulates adrenal corticosteroid release and can cause steroid‑related adverse effects; therapy should use the lowest effective dose for the shortest duration necessary.

Definitions and Abbreviations

inv-54: Infantile spasms (West syndrome) — definition and clinical features

DefinitionA rare epileptic disorder of infancy (West syndrome) characterized by clusters of flexor/extensor spasms and an EEG pattern called hypsarrhythmia; onset usually in the first year of life with peak incidence at 3–5 months.

Typical courseSeizures often resolve by age 3 years but long-term prognosis is poor with ~70% having severe psychomotor delay and many developing other severe epilepsy types.

Treatment contextOften refractory to conventional antiepileptic drugs; hormonal therapy (ACTH/RCI) is effective for short-term cessation of spasms and resolution of hypsarrhythmia but long-term developmental benefit is unproven.

inv-55: Repository corticotropin injection — product description and administration routes

Product formulationsRepository corticotropin injection is available as Acthar Gel (Mallinckrodt) and Purified Cortrophin Gel (ANI).

Active substance and originNatural adrenocorticotropic hormone (ACTH) product derived from porcine sources formulated in gelatin to provide prolonged release.

Routes and administrationAdministered intramuscularly or subcutaneously; for infantile spasms Acthar Gel must be given intramuscularly per labeling.

inv-56: Infantile spasms — short label entry

Short labelInfantile spasms (West syndrome)

Typical onsetFirst year of life, peak 3–5 months

FDA contextActhar Gel is FDA-approved for treatment of infantile spasms in infants and children under 2 years.

inv-57: Repository corticotropin — product origin and historical note

OriginRepository corticotropin products (Acthar Gel and Purified Cortrophin Gel) are natural ACTH preparations derived from porcine sources.

Formulation noteActhar Gel contains 16% gelatin and Purified Cortrophin Gel contains 15% gelatin to provide prolonged release after IM or SC injection.

Historical contextACTH historically derived from bovine or porcine sources; synthetic alternatives (tetracosactide) are used in some regions due to safety concerns with bovine products.

inv-58: Complete remission (CR) and partial remission (PR) — nephrotic syndrome definitions used in studies

Complete remission (CR)Final proteinuria < 500 mg/day as used in nephrotic syndrome studies.

Partial remission (PR)≥50% reduction in proteinuria from baseline with final proteinuria 500–3,500 mg/day.

Clinical response≥30% reduction in proteinuria from baseline that does not meet CR or PR criteria.

inv-59: Clinical response definitions (used in Madan et al.) — CR and PR thresholds

CR (Madan et al.)Defined as final proteinuria <500 mg/day.

PR (Madan et al.)Defined as ≥50% reduction in proteinuria from baseline with final proteinuria 500–3,500 mg/day.

Clinical response (Madan et al.)≥30% reduction in proteinuria from baseline without meeting CR/PR criteria; no response if criteria not met.

inv-60: RCI — abbreviation definition

AbbreviationRCI = Repository corticotropin injection.

SynonymsAlso referred to as ACTH (adrenocorticotropic hormone) preparation or H.P. Acthar Gel in historical references.

Context of useUsed across multiple inflammatory and autoimmune indications; product actions include stimulation of adrenal corticosteroid release and effects at melanocortin receptors.

inv-61: Acthar Gel — definition and note that FDA dosing is summarized in appendix

DefinitionActhar Gel is a branded repository corticotropin injection formulation (H.P. Acthar Gel) with FDA-approved dosing recommendations summarized in the appendix.

FDA-approved infantile spasms dosingRecommended regimen: 150 U/m2/day divided into twice-daily IM injections of 75 U/m2 for 2 weeks, then tapered over 2 weeks to avoid adrenal insufficiency.

Administrative noteFor infantile spasms, Acthar Gel must be administered intramuscularly per labeling; appendix lists additional FDA dosing regimens for other indications.

inv-62: Purified Cortrophin Gel — alternative formulation and dosing/caution notes

DefinitionPurified Cortrophin Gel is an alternative repository corticotropin formulation (ANI Pharmaceuticals) with similar porcine-derived ACTH in gelatin for prolonged release.

Dosing and administration notesMay be administered intramuscularly or subcutaneously; standard adrenal verification tests may use up to 80 units as a single injection and dosage should be individualized based on disease and patient response.

CautionChronic administration of more than 40 units daily may be associated with uncontrollable adverse effects; dosage reductions should be gradual.

Policy Summary

PayerAetna

PolicyRepository Corticotropin Injection (Acthar Gel and Purified Cortrophin Gel)

Policy CodePolicy 0762

Change TypeNo material changes

Effective DateAug 8, 2008

Next Review DateJul 25, 2024

Key ActionObtain precertification and submit a Statement of Medical Necessity with supporting clinical documentation when requesting prior authorization.

SourceLink

On This Page

OpenPayer

Repository Corticotropin Injection (Acthar Gel and Purified Cortrophin Gel)

Coverage Criteria for Repository Corticotropin Injections

Coding and Billing for Repository Corticotropin Injections

Provider Actions, Prior Authorization and Documentation

Background and Context

Definitions and Abbreviations

Policy Revision History