CurrentMass General Brigham Health PlanPolicy N/A

Acthar Gel and Purified Cortrophin Gel coverage

Defines prior authorization, coverage criteria, limitations, and exclusions for Acthar Gel (repository corticotropin injection) and Purified Cortrophin Gel under Mass General Brigham Health Plan benefits, affecting providers prescribing these products.

Policy Summary

PayerMass General Brigham Health Plan

PolicyActhar Gel and Purified Cortrophin Gel coverage

Policy CodePolicy N/A

Change TypeUpdated exclusionsautoinjector approval limited for MS

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of inadequate response to IV methylprednisolone for MS exacerbations.

SourceLink

POLICY UPDATE CHANGES

Updated Exclusions section to indicate that Acthar Gel autoinjector will only be approved for the treatment of multiple sclerosis.

2FDA-approved indications

4 weeksInfantile Spasms duration

3 weeksMultiple Sclerosis duration

90 daysNew-member review window

SpecialtySpecialty pharmacy

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Coverage and Authorization Criteria

Initial Authorization Criteria by Indication

Authorization may be granted when ALL of the following are met for the specific indication:

Infantile Spasms (Acthar Gel vial only): Member is less than 2 years of age AND Member has a diagnosis of infantile spasms

Acthar Gel vial only; Purified Cortrophin Gel excluded for infantile spasms

Multiple Sclerosis: Member has a diagnosis of acute exacerbations of multiple sclerosis AND Member is >= 18 years of age AND Submission of documentation of member's inadequate response to a trial of IV methylprednisolone for the current exacerbation, including dosage and duration of treatment

Autoinjector approval limited to patients 18 years and older per exclusions

Reauthorization Criteria

Reauthorization may be granted when the following is met:

General continuation: Member is experiencing benefit from therapy as evidenced by disease stability or disease improvement

Duration limits: Initial approvals and reauthorizations for Infantile Spasms will be granted for 4 weeks; Initial approvals and reauthorizations for Multiple Sclerosis will be granted for 3 weeks

The following exclusions and product-specific approval limits apply: Purified Cortrophin Gel is excluded for the treatment of infantile spasms. Additionally, the Acthar Gel autoinjector will only be approved for patients 18 years of age and older. Use of Acthar Gel in combination with Purified Cortrophin Gel is excluded.

Use of Acthar Gel and Purified Cortrophin Gel for indications listed in the FDA product labeling other than infantile spasms (Acthar Gel only) and acute exacerbations of multiple sclerosis in adults has not been shown to be superior to conventional therapies and, because of substantially higher cost, is considered not medically necessary and is not a covered benefit. Examples of labeled indications that are considered not medically necessary include rheumatic disorders, collagen diseases, dermatologic diseases, ophthalmic diseases, allergic states, respiratory diseases, and edematous states as listed in the FDA product labeling.

Provider Requirements and Operational Rules

Prior Authorization

Prior Authorization Required

Prior authorization required. Prior authorization requests for Acthar Gel and Purified Cortrophin Gel must meet the coverage criteria below. For members new to the plan, allow a 90-day review window for prior authorizations as applicable per operational procedures.

Prior authorization required for Acthar Gel and Purified Cortrophin Gel
90-day review window for members new to plan

Step Therapy

Step Therapy for Multiple Sclerosis

Trial of IV methylprednisolone is required and must be documented for authorization of Acthar Gel when requested for treatment of acute multiple sclerosis exacerbations.

Step therapy requirement: documented trial of IV methylprednisolone for the current exacerbation (dose and duration)

Clinical Background

Corticotropin (ACTH) is an adrenocorticotropic hormone that stimulates adrenal cortisol production and is used in select inflammatory and neurologic conditions. Acthar Gel (repository corticotropin injection) has an FDA indication as monotherapy for infantile spasms in infants and children under 2 years of age and for the treatment of acute exacerbations of multiple sclerosis in adults. Other labeled uses for Acthar Gel and for Purified Cortrophin Gel are described in their FDA product labeling but are not considered superior to standard therapies for those conditions.

Key Definitions

Corticotropin — definition

TermCorticotropin

DefinitionAn adrenocorticotropin stimulating hormone

Clinical roleStimulates adrenal cortisol production and used for specific inflammatory and neurologic conditions

Policy Summary

PayerMass General Brigham Health Plan

PolicyActhar Gel and Purified Cortrophin Gel coverage

Policy CodePolicy N/A

Change TypeUpdated exclusionsautoinjector approval limited for MS

Effective DateNov 1, 2024

Next Review DateN/A

Key ActionObtain prior authorization and submit documentation of inadequate response to IV methylprednisolone for MS exacerbations.

SourceLink

On This Page

Documentation Required

Documentation Required for Multiple Sclerosis

For requests for Acthar Gel to treat an acute exacerbation of multiple sclerosis, submit documentation showing inadequate response to a trial of IV methylprednisolone for the current exacerbation, including the dose and duration of treatment.

Documentation must specify IV methylprednisolone dose and duration and explanation of inadequate response for the current exacerbation

Denial Risk

Coverage Limited to Specific Indications

Coverage is limited to the specific FDA-approved indications listed below. Requests for other indications are considered not medically necessary and will be denied or require referral to medical review.

Acthar Gel: treatment of infantile spasms (infants and children <2 years) as monotherapy; treatment of acute exacerbations of multiple sclerosis in adults
Purified Cortrophin Gel: limited to specified labeled indications; use for infantile spasms is excluded (see exclusions)
Use for other labeled indications where not proven superior to standard therapies is not covered

Denial Risk

Exclusions and Operational Notes

Requests for Purified Cortrophin Gel for infantile spasms will be excluded. Acthar Gel autoinjector is only approved for patients 18 years of age and older. Concurrent use of Acthar Gel and Purified Cortrophin Gel is excluded.

Purified Cortrophin Gel for infantile spasms — excluded
Acthar Gel autoinjector — approval limited to patients ≥18 years
Concurrent use of Acthar Gel with Purified Cortrophin Gel — excluded