In a patient with sarcoidosis who has failed methotrexate and has never been treated with oral glucocorticoids (prednisone), will insurance approve repository corticotropin injection (Acthar)?

Insurance Approval for Acthar Without Prior Prednisone Trial

Insurance will almost certainly deny Acthar (repository corticotropin injection) for a sarcoidosis patient who failed methotrexate but never tried prednisone, because this violates the established treatment algorithm that requires glucocorticoid failure before considering advanced therapies.

Standard Treatment Algorithm for Sarcoidosis

The European Respiratory Society guidelines establish a clear stepwise approach that insurance companies follow 1:

• First-line therapy: Glucocorticoids (prednisone) are the initial treatment for symptomatic pulmonary sarcoidosis requiring systemic therapy 1, 2
• Second-line therapy: Methotrexate is added only for patients who have been treated with glucocorticoids and have continued disease or unacceptable glucocorticoid side-effects 1, 2
• Third-line therapy: Infliximab is suggested for patients who have been treated with glucocorticoids or other immunosuppressive agents and have continued disease 1

Why Your Patient Doesn't Meet Criteria

The treatment sequence matters critically for insurance approval. Your patient's treatment history is out of order:

• Methotrexate should only be used after glucocorticoid treatment has been attempted 1, 2
• The guidelines explicitly state methotrexate is for patients "who have been treated with glucocorticoids" 1
• Starting methotrexate without prior glucocorticoid trial represents non-guideline-concordant care that insurers will flag

Acthar's Position in Treatment Guidelines

Repository corticotropin injection (Acthar) occupies a limited role in sarcoidosis management:

• The European Respiratory Society guidelines mention RCI should be used "on a case-by-case basis" only 1
• RCI has demonstrated steroid-sparing properties in retrospective and prospective studies 1, 3
• Despite FDA approval for symptomatic pulmonary sarcoidosis, RCI is "currently quite expensive and the mechanism of action remains unclear" 1
• Guidelines position RCI as a consideration only after standard therapies (glucocorticoids, methotrexate, infliximab) have been attempted 1, 2

What Insurance Will Require

To obtain Acthar approval, insurers typically mandate documentation of:

1. Failed glucocorticoid trial with adequate dose (typically 20-40 mg prednisone daily) and duration (3-6 months minimum) 1
2. Failed or intolerant to methotrexate as second-line therapy 1, 2
3. Failed or contraindicated infliximab as preferred third-line biologic 1, 2
4. Documented disease severity with objective measures (FVC decline, significant symptoms, organ involvement) 1

Critical Exception Scenarios

There are limited circumstances where skipping prednisone might be justified:

• Absolute contraindications to glucocorticoids: Uncontrolled diabetes, severe osteoporosis with fractures, active psychosis, or recent serious infection 2
• Cardiac or neurosarcoidosis: These require immediate glucocorticoid therapy, but this still means the patient should have tried prednisone first 1

Even in these cases, you must document why glucocorticoids were contraindicated and why methotrexate was chosen as initial therapy.

Recommended Action Plan

To maximize approval chances, you need to:

1. Document the rationale for why prednisone was never attempted (contraindication, patient refusal with documentation, etc.)
2. Initiate a prednisone trial now if not contraindicated, even briefly, to demonstrate inadequate response or intolerance 1, 2
3. Consider infliximab before Acthar as it has stronger evidence (low quality vs. very low quality) and is the preferred third-line agent 1, 2
4. Prepare for peer-to-peer review where you'll need to justify deviation from standard treatment algorithm

The Infliximab Alternative

Before pursuing Acthar, strongly consider infliximab:

• Infliximab has conditional recommendation with low-quality evidence for patients failing glucocorticoids and other immunosuppressives 1
• Dosing is 5 mg/kg at weeks 0,2, and 6, then maintenance 2
• Two phase III randomized trials showed FVC improvement as primary endpoint 1
• Insurance approval is more straightforward than Acthar, even with your non-standard treatment sequence 2

The harsh reality: Insurance denials for Acthar are common even with perfect documentation, given its cost exceeds $30,000-40,000 per course and alternatives exist 1, 3. Without prior glucocorticoid failure documented, approval is nearly impossible.