CurrentAvMedPolicy N/A

Repository corticotropin (Acthar/Purified Cortrophin) prior authorization for myositis

Prior authorization and step-edit requirements for repository corticotropin products (Acthar Gel and Purified Cortrophin Gel) for treatment of dermatomyositis or polymyositis (idiopathic inflammatory myopathy) for AvMed members; affects prescribers and specialty pharmacy processing.

Policy Summary

PayerAvMed

PolicyRepository corticotropin (Acthar/Purified Cortrophin) prior authorization for myositis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing trial and failure of preferred Purified Cortrophin Gel and provide signed PA form with supporting clinical documentation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthslook-back window

90 daysimmunosuppressive duration

1-6 monthsIVIG trial duration

11/17/2013; 9/26/2024P&T approval

Coverage Criteria — Repository Corticotropin for Myositis

Approval criteria for repository corticotropin in myositis

Covered when ALL of the following are met (check boxes and provide supporting documentation):

Diagnosis: Member has diagnosis of dermatomyositis OR polymyositis (idiopathic inflammatory myopathy) or refractory/severe organ-threatening myositis.

Check appropriate diagnosis box and supply documentation; to support each line checked, provide labs, diagnostics, and/or chart notes.

Initial requirement for Idiopathic Inflammatory Myopathy

Systemic corticosteroid: Prednisone 0.5-1 mg/kg/day for 2-4 weeks, then taper for 2 weeks.
Concomitant immunosuppressive agent: Prednisone must have been taken concurrently with an immunosuppressive drug for at least 90 days within the past 6 months.

Policy Summary

PayerAvMed

PolicyRepository corticotropin (Acthar/Purified Cortrophin) prior authorization for myositis

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization showing trial and failure of preferred Purified Cortrophin Gel and provide signed PA form with supporting clinical documentation.

SourceLink

On This Page

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Examples: methotrexate (target dose 25 mg/wk); azathioprine 2 mg/kg IBW twice daily; mycophenolate mofetil titrated to 1000 mg twice daily; cyclophosphamide 0.6-1 g/m2 IV q4w or 1-2 mg/kg/day orally (>3 months).

Refractory or severe organ-threatening manifestations: For refractory/severe disease: member must have had high-dose IV corticosteroid AND trial/failure of one listed advanced therapy within the past 6 months.6 months look-back; 90 days trial for listed agents

High-dose IV steroid: methylprednisolone 500-1000 mg/day IV for 1-3 days for 3 months. Listed therapies (trial/failure ≥90 days): IVIG (1 g once monthly for 1-6 months), cyclophosphamide, rituximab, or cyclosporine A (3.0-3.5 mg/kg/day).

Use of patient samples to start therapy is not acceptable documentation for meeting step-edit or prior authorization requirements. Samples do not satisfy the required trial of a preferred product or the documentation needed for PA approval and will not be counted toward step therapy or prior authorization criteria.

Acthar Gel is listed as a non-preferred repository corticotropin product. Coverage of Acthar Gel requires documentation that the member has tried and failed the preferred Purified Cortrophin Gel; without evidence of that trial and failure, coverage of the non-preferred Acthar product may be denied.

Coding — Diagnosis and Key Values

Diagnosis codes (provider-entered)ICD-10

ICD code (provider to supply)

ICD-10 diagnosis code for the indicated myositis (provider must enter)

Required concomitant immunosuppressive duration

Required duration>= 90 days

ContextPrednisone must have been taken concurrently with an immunosuppressive drug for at least 90 days within the past 6 months

Examples of immunosuppressive agentsMethotrexate (target 25 mg/wk); Azathioprine (2 mg/kg IBW twice daily); Mycophenolate mofetil (up to 1000 mg twice daily); Cyclophosphamide (specified dosing)

Provider Actions — Prior Authorization and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for non-preferred repository corticotropin products (including Acthar Gel and Purified Cortrophin Gel). Member must have documentation as specified and meet all clinical criteria for approval. Incomplete or illegible forms, missing required member/prescriber details, or missing supporting documentation may delay or result in denial of the authorization.

Prior authorization required for non-preferred Acthar Gel and Purified Cortrophin Gel.
Member must meet all PA clinical criteria and provide supporting documentation (labs, diagnostics, chart notes).
If information on the PA form is incomplete, incorrect, or illegible, the authorization process can be delayed or denied.

Step Therapy

Step Therapy — Preferred Product Required First

Member must have tried and failed the preferred Purified Cortrophin Gel before Acthar Gel will be approved (step-edit).

Step-edit: trial and failure of preferred Purified Cortrophin Gel required prior to approval of non-preferred Acthar Gel.

Documentation Required

Required Documentation and Prescriber Signature

The prescribing physician must sign and clearly print their name on the PA request (preprinted stamps are not valid). Provide complete member and prescriber information: member name, member ID, date of birth; prescriber name, signature, date; office contact name, phone and fax numbers; and prescriber NPI. Drug details (name, form, strength), dosing schedule, length of therapy, diagnosis and ICD code, weight (if applicable) and date weight was obtained must be included. All required fields should be complete to avoid delays.

Prescriber signature and printed name required on the PA form (no preprinted stamps).
Provide member name, member ID, date of birth.
Provide prescriber name, signature, date, office contact, phone, fax, and NPI.
Include drug name/form/strength, dosing schedule, length of therapy, diagnosis and ICD code, weight and date weight (if applicable).

Denial Risk

Incomplete Documentation May Cause Denial

To support each clinical criterion checked on the form, submit all related documentation (e.g., lab results, diagnostic studies, and chart notes). Requests lacking documentation that substantiates the checked clinical criteria may be denied. Use of samples to initiate therapy does not satisfy step-edit or prior authorization requirements.

All documentation supporting each checked clinical criterion must be provided or request may be denied.
Previous therapies will be verified through pharmacy paid claims or submitted chart notes.
Samples do not meet step-edit/preauthorization criteria.

Definitions — Diagnosis Category

Diagnosis category used to define eligible myositis patients for PA criteria

Diagnosis categoryIdiopathic Inflammatory Myopathy

Included conditionsDermatomyositis or polymyositis (idiopathic inflammatory myopathy) or refractory/severe organ‑threatening myositis

DocumentationCheck diagnosis box and provide supporting documentation (labs, diagnostics, chart notes) for approval

Initial Therapy Requirements

Initial therapy requirements

Initial approval requires documented trials as below within the past 6 months.

Corticosteroid trial: Prednisone 0.5-1 mg/kg/day for 2-4 weeks then taper for 2 weeks.

Must be within the past 6 months and documented.

Concurrent immunosuppressive agent: Concurrent immunosuppressive drug taken with prednisone for at least 90 days within the past 6 months.>=90 days

Examples and target doses: methotrexate 25 mg/wk; azathioprine 2 mg/kg IBW twice daily; mycophenolate mofetil up to 1000 mg twice daily (titrated from 500 mg BID); cyclophosphamide 0.6-1 g/m2 IV q4w or 1-2 mg/kg/day orally (>3 months). Must specify which agent was tried.

Alternate refractory regimen: For refractory/severe cases: methylprednisolone 500-1000 mg/day IV for 1-3 days for 3 months AND trial/failure of one listed therapy for at least 90 days within the past 6 months.IVIG 1 g once monthly for 1-6 months; other agents >=90 days

Listed therapies include IVIG, cyclophosphamide, rituximab, cyclosporine A; document specific therapy and duration.

Step Therapy — Preferred Product Requirement

Step	Requirement
1	Member must have tried and failed preferred Purified Cortrophin Gel before non-preferred Acthar Gel will be approved.

Site of Care / Administration

Note

SelfJect injector intended for subcutaneous use in adults only

Acthar Gel single-dose pre-filled SelfJect injector is for subcutaneous administration by adults only.

Confirm patient is an adult and document subcutaneous administration as intended for the SelfJect injector.

Background

This policy governs prior authorization and step-edit requirements for repository corticotropin (Acthar Gel and Purified Cortrophin Gel) when used to treat dermatomyositis or polymyositis (idiopathic inflammatory myopathy), including refractory or severe organ‑threatening cases. Approval is contingent on meeting all clinical PA criteria, which include documented trials of systemic corticosteroids with a concurrent immunosuppressive agent (with at least 90 days of concomitant immunosuppressive therapy) or, for refractory/severe disease, appropriate IV methylprednisolone and trial/failure of listed advanced therapies. The policy specifies a 6‑month look‑back for required prior therapy documentation and requires full supporting records for each checked criterion.