Acthar Gel (repository corticotropin) prior authorization
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Defines prior authorization criteria for Acthar Gel (repository corticotropin) for members of Curative Health Plan, specifying approved indication (infantile spasms) and that other uses are not considered medically necessary.
No material clinical or coverage changes in this revision.
Coverage Criteria
inv-02: All other indications
Approval duration: n/a.
Use of repository corticotropin (Acthar Gel) for all indications other than infantile spasms is explicitly listed in the policy as an exclusion from coverage.
Repository corticotropin for all other indications is not medically necessary. The policy states that effectiveness has not been demonstrated as clinically superior to conventional corticosteroids and/or immunosuppressive therapy for uses outside of infantile spasms, and therefore such uses are not approved (Approval duration: n/a).
Coding
| Acthar gel (repository corticotropin) | Drug name listed in policy |
Provider Actions / Requirements
Prior authorization required for infantile spasms (approval only if all criteria met)
Prior authorization is required. Approval will be granted only when the requested medication is being used for the FDA‑approved indication of infantile spasms and all listed coverage criteria are met, including age <24 months, EEG confirmation, absence of FDA‑labeled contraindications, prior therapy requirements, and specialist prescriber. Approval duration: 4 weeks.
- Medication must be used for FDA‑approved indication (infantile spasms).
- All coverage criteria in the policy must be satisfied for approval.
- Approval duration: 4 weeks; treatment beyond 4 weeks not supported by FDA labeling.
Document prior therapy failure or contraindication (glucocorticoids or vigabatrin)
Patient must have tried and had an inadequate response or intolerance to glucocorticoids (e.g., prednisolone) OR have an inadequate response to vigabatrin; a documented contraindication to glucocorticoids also meets the requirement.
- Acceptable prior therapy pathway A: inadequate response or intolerance to glucocorticoids (e.g., prednisolone) or documented contraindication to glucocorticoids.
- Acceptable prior therapy pathway B: inadequate response to vigabatrin.
- Documentation of prior trial/failure or contraindication is required in the chart notes.
Required clinical documentation (recent chart notes, EEG, prior trials, prescriber specialty)
Provide chart notes within the past 90 days documenting the diagnosis of infantile spasms, EEG confirmation (hypsarrhythmia, modified hypsarrhythmia, or other epileptic encephalopathy features), documentation of prior trials or contraindications to therapies, and prescriber specialty.
- Chart notes within past 90 days documenting infantile spasms.
- EEG report demonstrating hypsarrhythmia, modified hypsarrhythmia, or other diagnostic epileptic encephalopathy features.
- Documentation of absence of FDA‑labeled contraindications (e.g., suspected congenital infections, systemic fungal infections, recent surgery).
- Prescriber specialty (e.g., neurology or epileptologist).
Non‑covered indications — Acthar Gel not approved for other uses
Requests for Acthar Gel for any indication other than infantile spasms are considered not medically necessary and will not be approved.
- Use of repository corticotropin for all indications other than infantile spasms is not considered medically necessary.
Background
Infantile spasms is an early childhood epileptic encephalopathy characterized by clusters of spasms and distinctive electroencephalographic (EEG) patterns such as hypsarrhythmia or modified hypsarrhythmia. Acthar Gel (repository corticotropin) is indicated for infantile spasms; the policy distinguishes this FDA‑approved indication from all others, for which repository corticotropin has not shown superiority over standard corticosteroid or immunosuppressive treatments.
Definitions
Initial Therapy Criteria
Continuation Therapy Criteria
inv-14: Continuation therapy — treatment beyond the initial approval period and required conditions
Treatment beyond the initial approval period
Step Therapy / Prior Trial Requirements
| Requirement | Details |
|---|---|
| Documentation of prior trial, inadequate response, intolerance, or contraindication | |
| ONE of the following must be documented: (a) tried and had an inadequate response or intolerance to glucocorticoids (e.g., prednisolone) or has a contraindication to glucocorticoids, OR (b) tried and had an inadequate response to vigabatrin. |
Quantity Limits / Dosing
Site of Care
No site‑of‑care restriction (home allowable)
No specific site‑of‑care restriction is stated for treatment of infantile spasms; home administration is listed as an acceptable setting.
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