ModifiedmhnPolicy CP.PHAR.168

Repository Corticotropin Injection (Acthar Gel, Purified Cortrophin Gel)

Medical necessity and prior authorization criteria for repository corticotropin injections for commercial and Medicaid members, covering infantile spasms (West syndrome), acute MS exacerbations, nephrotic syndrome, and other indications with related requirements for prescribers and dosing.

Policy Summary

Payermhn

PolicyRepository Corticotropin Injection (Acthar Gel, Purified Cortrophin Gel)

Policy CodePolicy CP.PHAR.168

Change TypeCoding, duration and documentation updates

Effective Date03.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation confirming indication-specific criteria (including current BSA for infantile spasms) and dosing within policy limits.

SourceLink

POLICY UPDATE CHANGES

Added HCPCS codes J0801 and J0802 and removed J0800.

For infantile spasm reduced approval durations from 3 to 1 month.

For infantile spasm added requirement for documentation of member's current body surface area (BSA) in m2.

Updated product availability to include Acthar pre-filled injector and new Purified Cortrophin Gel single-dose prefilled syringe formulation.

Updated references and wording to use 'Acthar Gel' instead of 'H.P. Acthar Gel'.

1 monthWest syndrome initial approval

120 units/dayMS max daily dose

150 U/m2/dayInfantile spasms max dose

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Not permittedMS re-authorization

Coverage Criteria

Initial Approval — West Syndrome

Covered when ALL of the following are met

West Syndrome Initial: 1. Diagnosis of West syndrome (infantile spasms); 2. Request is for Acthar Gel; 3. Diagnosis is confirmed by electroencephalogram (EEG); 4. Prescribed by or in consultation with a neurologist; 5. Age < 2 years; 6. Documentation of member's current body surface area (BSA) in m2; 7. Dose does not exceed 150 U/m2 per day (divided into twice daily injections of 75 U/m2).dose ≤ 150 U/m2/day

Approval duration: 1 month

Initial Approval — Multiple Sclerosis

Covered when ALL of the following are met

MS Initial: 1. Diagnosis of multiple sclerosis (MS); 2. Prescribed by or in consultation with a neurologist; 3. Age ≥ 18 years; 4. Prescribed for acute exacerbations of MS; 5. Failure of a recent (within the last 30 days) trial of at least a 7-day course of corticosteroid therapy for acute exacerbations of MS, unless contraindicated; 6. Member has not received treatment with Acthar Gel or Purified Cortrophin Gel for the current MS exacerbation; 7. Member has been adherent to disease-modifying therapy for MS; 8. For Acthar Gel requests, member must use Purified Cortrophin Gel, if available, unless contraindicated; 9. Dose does not exceed 120 units (1.5 mL) per day and supply limits (either 6 vials or 20 prefilled syringes of specified strengths).dose ≤ 120 units/day; supply limits apply

Re-authorization not permitted; Acthar not indicated for continuous use

Initial Approval — Nephrotic Syndrome

Covered when ALL of the following are met

Nephrotic Syndrome Initial: 1. Diagnosis of nephrotic syndrome associated with one of the following: idiopathic membranous nephropathy (IMN), focal segmental glomerulosclerosis, minimal change disease (MCD), membranoproliferative glomerulonephritis, lupus nephritis, or IgA nephropathy; 2. Prescribed by or in consultation with a nephrologist; 3. Age > 2 years; 4. Failure of oral corticosteroid therapy unless contraindicated; 5. For IMN and MCD: failure of cyclophosphamide unless contraindicated; 6. Failure of two of the following unless contraindicated: tacrolimus, cyclosporine, mycophenolate, rituximab; 7. For Acthar Gel requests, member must use Purified Cortrophin Gel, if available, unless contraindicated; 8. Dose does not exceed 80 units (1 mL) per day.dose ≤ 80 units/day

Continued Therapy — West Syndrome

Continued therapy covered when ALL of the following are met

West Syndrome Continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or has previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Age < 2 years; 3. Member is responding positively to therapy; 4. Member has not previously had a renewal approved for continued therapy; 5. Documentation of member's current body surface area (BSA) in m2; 6. If request is for a dose increase, new dose does not exceed 150 U/m2 per day (divided into twice daily injections of 75 U/m2).dose ≤ 150 U/m2/day

Approval duration: 1 month (one renewal limit)

Continued Therapy — Multiple Sclerosis

Continued therapy stance

MS Continued: Re-authorization is not permitted. Acthar is not indicated for continuous use for this indication. Members must meet the initial approval criteria.

Approval duration: Not applicable

Continued Therapy — Nephrotic Syndrome

Continued therapy covered when ALL of the following are met

Nephrotic Continued: 1. Member meets one of the following: (a) currently receiving medication via Centene benefit or has previously met initial approval criteria; (b) currently receiving medication and enrolled in a state/product with continuity of care regulations; 2. Member is responding positively to therapy; 3. For Acthar Gel requests, must use Purified Cortrophin Gel, if available, unless contraindicated; 4. If request is for a dose increase, new dose does not exceed 80 units (1 mL) per day.dose ≤ 80 units/day

Approval duration: 3 months

Indication-specific coverage criteria (as stated)

Covered when supporting documentation and indication-specific requirements are met

Infantile spasms (West syndrome): Use Acthar Gel at 150 U/m2 IM divided into twice daily injections for 2 weeks followed by a 2-week taper; BSA in m2 must be documented; maximum 150 U/m2/day.BSA documented

Approval duration reduced from 3 to 1 month per 1Q2024 review.

Acute MS exacerbation: Purified Cortrophin Gel dosing 80-120 units IM/SC daily for 2-3 weeks; member should not have received Acthar Gel or Purified Cortrophin Gel for the current MS exacerbation.no prior treatment for current exacerbation

Indirect evidence suggests methylprednisolone may be more effective; consider alternatives.

Nephrotic syndrome: Purified Cortrophin Gel dosing 40-80 units IM/SC every 24-72 hours; use considered appropriate only after exhausting treatments supported by KDIGO guidelines (e.g., corticosteroids, cyclophosphamide, cyclosporine, tacrolimus, mycophenolate, rituximab).

Non‑FDA approved indications not specifically addressed by this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety consistent with the plan's off‑label use policies (see CP.CPA.09 for commercial and CP.PMN.53 for Medicaid) or other evidence of coverage documents. Requests for off‑label use must include supporting clinical information that demonstrates the indication meets the plan's requirements for off‑label consideration.

Use of repository corticotropin injection is considered experimental/unproven for many conditions where efficacy has not been established in well‑designed clinical trials. The policy therefore does not authorize coverage for these indications absent compelling evidence meeting the plan's requirements.

Examples of conditions considered not proven in adequate clinical trials — and therefore not authorized — include rheumatic disorders (for short‑term adjunctive therapy such as psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, ankylosing spondylitis), collagen diseases (e.g., systemic lupus erythematosus, dermatomyositis/polymyositis), dermatologic diseases (severe erythema multiforme, Stevens‑Johnson syndrome), allergic states (serum sickness), ophthalmic diseases (keratitis, iritis, iridocyclitis, posterior uveitis/choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation), and respiratory diseases such as symptomatic sarcoidosis.

Use of repository corticotropin injection for listed rheumatic, collagen, dermatologic, allergic, ophthalmic, and respiratory conditions is considered experimental/unproven because evidence of benefit has not been demonstrated in well‑designed clinical trials; these indications therefore are not supported by this policy unless specific off‑label documentation meeting plan criteria is provided.

Coding and Dosing References

HCPCS Codes referencedHCPCS

J0801	Injection, corticotropin (Acthar gel), up to 40 units.
J0802	Injection, corticotropin (ANI), up to 40 units.
J3490	Unclassified drugs (used historically for Purified Cortrophin Gel when specific HCPCS not assigned).

HCPCS Codes referenced - historical noteHCPCS

J0800

(Removed)

Age limits and dosing thresholds — summary

West syndrome (Infantile spasms) age limitAge < 2 years; request must be for Acthar Gel

West syndrome dosing thresholdDose does not exceed 150 U/m2 per day (divided into twice daily injections of 75 U/m2)

Multiple sclerosis age limitAge ≥ 18 years; prescribed for acute MS exacerbation

Multiple sclerosis dosing thresholdDose does not exceed 120 units (1.5 mL) per day; supply limits apply (see criteria)

Nephrotic syndrome age limitAge > 2 years; prescribed by or in consultation with a nephrologist

Nephrotic syndrome dosing thresholdDose does not exceed 80 units (1 mL) per day

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for Acthar Gel and Purified Cortrophin Gel. Provider must submit documentation (such as office chart notes, lab results, dosing regimen, product formulation and other clinical information) demonstrating that the member meets all applicable approval criteria before services will be authorized.

Prior authorization required for Acthar Gel and Purified Cortrophin Gel
Submit chart notes, labs, dosing regimen, product formulation (vial or prefilled syringe) and any consultation notes

Denial Risk

Insufficient Documentation or Unmet Criteria

Requests lacking sufficient documentation or that do not meet the policy criteria will be denied. Providers must include all supporting clinical information referenced in the criteria (e.g., EEG for infantile spasms, current BSA in m2 for infant dosing, trials of prior therapies for nephrotic syndrome and MS).

Background

Repository corticotropin injection (Acthar Gel; Purified Cortrophin Gel) is a formulation of adrenocorticotropic hormone (ACTH) in gelatin. Its original approval predates modern requirements for two adequate, well‑controlled trials; the supporting data historically included case reports and dosing guidance rather than contemporary randomized controlled trials.

Definitions

Adrenocorticotropic hormone (ACTH)

TermAdrenocorticotropic hormone (ACTH)

ContextACTH is the active hormone in repository corticotropin injection formulations referenced in this policy

AbbreviationACTH

Electroencephalogram (EEG)

TermElectroencephalogram (EEG)

Use in policyRequired to confirm diagnosis of West syndrome (infantile spasms)

AbbreviationEEG

Revision History

03.13.25added

Purified Cortrophin Gel single‑dose prefilled syringe formulation added to Section VI and MS quantity limits updated to include prefilled syringes.

10.22.24added

Requirement added for infantile spasm requests to include documentation of the member's current body surface area (BSA) in m2.

03.11.24added

Acthar Gel product availability updated to include a prefilled injector and references changed to use 'Acthar Gel' instead of 'H.P. Acthar Gel'.

Policy Summary

Payermhn

PolicyRepository Corticotropin Injection (Acthar Gel, Purified Cortrophin Gel)

Policy CodePolicy CP.PHAR.168

Change TypeCoding, duration and documentation updates

Effective Date03.01.16

Next Review Date

Key ActionSubmit prior authorization with documentation confirming indication-specific criteria (including current BSA for infantile spasms) and dosing within policy limits.

SourceLink

On This Page

failed/contraindication to guideline therapies

Efficacy not established in well-designed trials; consider only after alternatives.

Maximum daily dosing (Infantile spasms)

Maximum daily dose (Infantile spasms)150 U/m2 per day

Standard regimen150 U/m2 IM divided into twice daily injections of 75 U/m2 for 2 weeks, followed by a 2-week taper

Documentation requirementMember's current body surface area (BSA) in m2 must be documented for dosing calculations

MS dosing maximum

Maximum daily dose (MS)120 units (1.5 mL) per day

Supply limitsTotal of either 6 vials or 20 prefilled syringes each of the 40 USP and 80 USP strengths (40 prefilled syringes total)

Prior treatment requirementFailure of a recent (within 30 days) trial of at least a 7-day course of corticosteroids unless contraindicated

Insufficient documentation or unmet criteria will result in denial

Include EEG for West syndrome; current BSA in m2 for infantile spasms; prior therapy trial documentation for MS and nephrotic syndrome

Documentation Required

Product / Dose Documentation

Provide product and dosing details to match available formulations and policy dosing limits. Specify whether the request is for Acthar Gel or Purified Cortrophin Gel, the formulation (multi-dose vial, pre-filled syringe, or injector), and the exact dosing regimen and quantity requested.

Specify product: Acthar Gel or Purified Cortrophin Gel
Specify formulation: multi-dose vial, pre-filled syringe, or pre-filled injector
Provide dosing regimen and confirm doses do not exceed policy maximums (e.g., 150 U/m2/day for West syndrome; 80–120 units/day for MS as applicable; ≤80 units/day for nephrotic syndrome)

Step Therapy

Step Therapy / Prior Medication Trials

Prior medication trials (step therapy) must be documented where required. For multiple sclerosis exacerbations, a recent (within 30 days) trial of at least a 7-day course of corticosteroid therapy is required unless contraindicated. For nephrotic syndrome, document failure of oral corticosteroids and, when indicated, failure of cyclophosphamide; also document failure of two agents from tacrolimus, cyclosporine, mycophenolate, or rituximab unless contraindicated.

MS: recent (within 30 days) trial of at least 7 days of corticosteroid therapy unless contraindicated
Nephrotic syndrome (initial): failure of oral corticosteroids; for IMN and MCD also failure of cyclophosphamide; failure of two of tacrolimus, cyclosporine, mycophenolate, rituximab
Document contraindications or clinically significant adverse effects if prior therapies were not used

Step Therapy

Nephrotic Syndrome Step Therapy

Use ACTH for nephrotic syndrome only after exhausting alternative treatments supported by KDIGO guidelines and as specified in the criteria. Documentation must show prior use and inadequate response or intolerance to higher-evidence options before Acthar or Purified Cortrophin Gel will be authorized.

Nephrotic syndrome: allow ACTH only after exhausting alternatives per KDIGO (e.g., corticosteroids, cyclophosphamide, cyclosporine, tacrolimus, mycophenolate, rituximab)
Include documentation of trials and reasons for failure or intolerance

Idiopathic membranous nephropathy (IMN)

TermIdiopathic membranous nephropathy (IMN)

ContextListed histology under nephrotic syndrome indications for repository corticotropin

AbbreviationIMN

Minimal change disease (MCD)

TermMinimal change disease (MCD)

ContextListed histology under nephrotic syndrome indications; failure of cyclophosphamide required for MCD prior to Acthar unless contraindicated

AbbreviationMCD

Multiple sclerosis (MS)

TermMultiple sclerosis (MS)

ContextIndication addressed in policy for acute exacerbations; requires neurologist involvement and prior corticosteroid trial unless contraindicated

AbbreviationMS

Adrenal insufficiency risk and tapering guidance

RiskProlonged use may lead to adrenal insufficiency or recurrent symptoms

ManagementTaper the dose and gradually discontinue treatment when necessary to reduce risk

Clinical implicationMonitor for symptoms of adrenal insufficiency during and after prolonged therapy

Contraindications

Contraindicated administration routeIntravenous administration is contraindicated

Patient conditions (examples)Patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, peptic ulcer, congestive heart failure, uncontrolled hypertension

Allergy/ sensitivitySensitivity to proteins of porcine origin is a contraindication

Acthar Gel–specificDo not administer live or live-attenuated vaccines to patients receiving immunosuppressive doses of Acthar Gel; children under 2 years with suspected congenital infections

10.26.23added

HCPCS codes J0801 and J0802 were added and code J0800 was removed from the coding list.

10.06.23added

Section VI updated to include revised HCPCS codes (J0801, J0802) and references were reviewed and updated.

01.14.26reviewedLatest

2Q 2026 annual review: references reviewed and updated; no significant clinical changes noted.