CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Corticotropin (ACTH) therapy for infantile spasms

Policy governs authorization and coverage criteria for repository corticotropin injections (Acthar Gel, Cortrophin Gel) for treatment of infantile spasms in patients under Medicaid; affects prescribers and prior authorization reviewers.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCorticotropin (ACTH) therapy for infantile spasms

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2018

Next Review DateN/A

Key ActionObtain prior authorization for a 1-month course when patient is <24 months with infantile spasms, used as monotherapy, meets dosing limits, and for Acthar Gel documents prior trial or intolerance to Cortrophin Gel.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

1 monthauthorization duration

<24 moage limit for approval

75 units/m²maximum dose

Acthar & Cortrophinproducts covered

Medicaidpayer scope

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Coverage Criteria for Repository Corticotropin Injections

Initial Therapy - Authorization Criteria

Authorization of 1 month may be granted when ALL of the following are met:

Initial approval criteria

A: Patient is less than 24 months old and has a diagnosis of infantile spasms (West Syndrome);
B: Must be used as monotherapy;
C: Documentation that patient does not have a suspected congenital infection;
D: If the request is for Acthar Gel, the patient must have a documented contraindication, inadequate response or intolerance to Cortrophin Gel;
E: Dose does not exceed 75 units/m² intramuscularly given twice daily for 2 weeks, then taper the dose over a 2-week period (example taper provided: 30 units/m² in the morning for 3 days; 15 units/m² in the morning for 3 days; 10 units/m² in the morning for 3 days; and 10 units/m² every other morning for 6 days).75 units/m² intramuscularly twice daily for 2 weeks then taper

Use of repository corticotropin injections for infantile spasms is limited by age. Approval is only for patients less than 24 months old; use in patients 24 months or older is excluded by the criteria.

Requests that fail to meet the policy criteria will not be approved. Common reasons for denial include: patient age ≥ 24 months; absence of a diagnosis of infantile spasms (West Syndrome); use as combination therapy rather than monotherapy; lack of documentation excluding a suspected congenital infection; dosing that exceeds the policy maximum (75 units/m² intramuscularly twice daily for the initial 2-week period); and, when Acthar Gel is requested, absence of documentation showing a documented contraindication, inadequate response, or intolerance to Cortrophin Gel.

Dosing and Coding Parameters

Maximum dose — dosing limit and taper example

Maximum dose75 units/m² intramuscularly given twice daily for 2 weeks, then taper the dose over a 2‑week period (policy example: 30 units/m² morning x3 days; 15 units/m² morning x3 days; 10 units/m² morning x3 days; 10 units/m² every other morning x6 days)

RouteIntramuscular injection

Frequency during initial periodTwice daily for 2 weeks

Taper durationTaper the dose over a 2‑week period per example provided

Authorization noteDose must not exceed the specified maximum to meet approval criteria for 1‑month authorization

Provider Actions, Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approval of up to 1 month may be granted when all clinical criteria are met.

Approval duration: 1 month when criteria met

Step Therapy

Step Therapy for Acthar Gel

Step therapy applies when Acthar Gel (repository corticotropin injection) is requested. The request must include documentation of a documented contraindication, inadequate response, or intolerance to Cortrophin Gel before Acthar Gel will be approved.

Applies specifically to Acthar Gel requests
Required documentation: contraindication, inadequate response, or intolerance to Cortrophin Gel

Definitions

Infantile spasms (West Syndrome) — policy indication

Indication specifiedInfantile spasms (West Syndrome)

Age requirementPatient must be less than 24 months old

Therapy roleMust be used as monotherapy

Infection exclusionDocumentation required that the patient does not have a suspected congenital infection

Authorization durationApproval of 1 month when all criteria are met

Repository corticotropin injections — products covered

Products included

Background

Infantile spasms (West Syndrome) is a pediatric seizure disorder presenting in infancy for which repository corticotropin injections (such as Acthar Gel or Cortrophin Gel) are used as treatment. The policy specifies that therapy be given as monotherapy in patients under 24 months, with specified dosing to induce remission while limiting exposure. For initial authorization, documentation must confirm the diagnosis, patient age <24 months, absence of suspected congenital infection, adherence to the dosing schedule (not to exceed 75 units/m² intramuscularly twice daily for 2 weeks with a subsequent taper), and, if Acthar Gel is requested, evidence of contraindication, inadequate response, or intolerance to Cortrophin Gel.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyCorticotropin (ACTH) therapy for infantile spasms

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateSep 1, 2018

Next Review DateN/A

SourceLink

On This Page

Documentation Required

Required Documentation

Required documentation must demonstrate all approval criteria are met, including patient age, diagnosis, monotherapy use, absence of suspected congenital infection, and dosing plan.

Patient age: < 24 months
Diagnosis: infantile spasms (West Syndrome)
Therapy: used as monotherapy
No suspected congenital infection documented
If Acthar Gel requested, documentation of contraindication, inadequate response, or intolerance to Cortrophin Gel

Denial Risk

Denial Triggers

Requests that do not meet all approval criteria may be denied. Common denial triggers include age ≥ 24 months, use in combination therapy, suspected congenital infection, dosing above recommended limits, or failure to show prior trial/intolerance of Cortrophin Gel when Acthar Gel is requested.

Age ≥ 24 months
Combination therapy (not monotherapy)
Suspected congenital infection present
Dose exceeds 75 units/m² IM twice daily for 2 weeks with specified taper
Acthar Gel requested without documented contraindication/inadequate response/intolerance to Cortrophin Gel

Acthar Gel (repository corticotropin injection)

Products includedCortrophin Gel (repository corticotropin injection)

Class nameRepository corticotropin injections (ACTH)

Step therapy relevanceIf requesting Acthar Gel, requirement to document contraindication/inadequate response/intolerance to Cortrophin Gel (see approval criteria)