CurrentEmblemHealthPolicy MG.MM.PH.09

H.P. Acthar Gel (repository corticotropin) injection

Clinical coverage criteria for H.P. Acthar Gel (repository corticotropin) including indications, limitations, coding, and documentation requirements for EmblemHealth and ConnectiCare members.

Policy Summary

PayerEmblemHealth

PolicyH.P. Acthar Gel (repository corticotropin) injection

Policy CodePolicy MG.MM.PH.09

Change TypeAdded procedure codesannual review

Effective Date

Next Review Date

Key ActionObtain prior authorization with clinical documentation demonstrating the member meets criteria before dispensing Acthar.

SourceLink

POLICY UPDATE CHANGES

Added J code: J0801 Injection, corticotropin (Acthar gel), up to 40 units and J0802 Injection, corticotropin (ani), up to 40 units.

Annual Review: No criteria changes (05/02/2025 and 02/28/2024).

2covered primary indications listed (infantile spasms; corticosteroid-responsive conditions including MS exacerbations)

2J-codes listed

4NDC variants listed for Acthar/cortrophin

5document revision entries shown in history

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Coverage Criteria for H.P. Acthar Gel

Initial Approval Criteria

Covered when ANY of the following are met

Infantile spasms (West syndrome): H.P. Acthar Gel is considered medically necessary for West syndrome (infantile spasms).

Adults with corticosteroid-responsive condition

Adult criteria components: 1) Adult (>=18 years); 2) corticosteroid-responsive condition; 3) no contraindication/intolerance to glucocorticoid effects; 4) documentation why other corticosteroid routes cannot be used.

Acthar (repository corticotropin) is not considered medically necessary for indications other than those specifically listed in this policy. This determination is based on insufficient evidence demonstrating therapeutic value for uses outside the covered indications.

Use of Acthar for conditions beyond infantile spasms and the specified corticosteroid-responsive conditions outlined in the coverage criteria is considered not medically necessary.

Applicable Codes

Applicable Procedure CodesCPTCovered

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

Applicable NDCsNDC

63004-8710-XX	Acthar 80 unit/mL
63004-8711-XX	Acthar Gel 80 unit/mL
63004-8712-XX	Acthar Gel 40 unit/mL
62559-0860-XX	cortrophin 80 unit/mL

ICD-10 Diagnoses (as listed)ICD-10

G35	Multiple sclerosis
P93.5	Epileptic spasms (infantile spasms) — various specificity codes listed

Provider Actions and Documentation Requirements

Documentation Required

Documentation-dependent review

Documentation-dependent review — The treating physician or primary care provider must submit clinical evidence that the member meets the criteria for the requested treatment or procedure. Requests that do not include the required clinical documentation will not be properly reviewed and may be denied. EmblemHealth relies on submitted clinical information (including peer-reviewed literature, guideline support, regulatory status, and treating clinician rationale) to determine medical necessity; absence of adequate documentation prevents a complete clinical review and increases the risk of denial or delay.

Required: clear clinical documentation showing member meets policy criteria
Include: diagnosis, relevant clinical history, prior therapies attempted, reasons standard corticosteroid routes are not appropriate (when applicable), and treating clinician rationale
Note: incomplete requests may be denied or delayed for lack of information

Prior Authorization

Prior authorization required

Prior authorization required — Prior authorization is required for requests for H.P. Acthar Gel. The request must include clinical documentation demonstrating the member meets the applicable criteria (for example, criteria for West syndrome or corticosteroid‑responsive conditions).

A completed prior authorization request form
Supporting clinical notes and test results
Documentation of past treatments and outcomes

Step Therapy

Step/step-down requirement

Step/step-down requirement — When approval is sought based on a corticosteroid‑responsive condition in adults, provide documentation explaining why standard corticosteroid routes (eg, oral prednisone, IV methylprednisolone) are not appropriate, contraindicated, or have been tried and failed or produced unacceptable adverse effects.

List prior corticosteroid therapies tried (dose, duration, response)
Document contraindications or intolerances to standard corticosteroid routes

Documentation Required

Required clinical documentation

Required clinical documentation — The treating physician or PCP must submit clinical evidence that the member meets the policy criteria. This includes diagnosis, age, clinical course, prior and current therapies, contraindications, and the specific rationale supporting use of the requested therapy.

Diagnosis and relevant clinical findings
Age verification (eg, adult status when required)
Prior treatment history and outcomes
Rationale for why alternative standard therapies are not suitable

Background

Repository corticotropin (H.P. Acthar Gel) is an analogue of adrenocorticotropic hormone (ACTH) supplied as a multi-dose preparation. It is indicated as monotherapy for infantile spasms (West syndrome) in infants and children less than 2 years and is also used for treatment of exacerbations of multiple sclerosis and other specified corticosteroid-responsive conditions in adults when criteria are met.

Definitions

Repository corticotropin (H.P. Acthar Gel) — definition entry

Drug class/termRepository corticotropin (H.P. Acthar Gel)

DefinitionAn analogue of adrenocorticotropic hormone (ACTH) indicated as monotherapy for infantile spasms (West syndrome) in infants and children less than 2 years of age, and for treatment of exacerbations of multiple sclerosis in adults.

PresentationSupplied as a 5 mL multi‑dose vial containing 80 USP units per mL.

Common trade nameActhar Gel (repository corticotropin injection)