Pharmacy Prior Authorization Criteria

Repository Corticotropin Gel Products - PA, NF

Indications for Prior Authorization

Acthar Gel (repository corticotropin injection)

• For diagnosis of Infantile spasms [2, 3]
  Indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

• For diagnosis of Exacerbations of Multiple Sclerosis [4, 5]
  Indicated for the treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar Gel to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.

• For diagnosis of All Other Disease States [A]
  *Please Note: The request for Acthar for the treatment of a condition other than Infantile Spasms (IS) or Exacerbations of Multiple Sclerosis (MS) is not authorized. There is no consensus in current peer-reviewed medical literature regarding the efficacy, safety, or long-term consequences of using repository corticotropin over conventional corticosteroids in these steroid-responsive conditions.

• For diagnosis of [Non-Approvable Use] Rheumatic Disorders* [6, 7, A]
  As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis.

• For diagnosis of [Non-Approvable Use] Collagen Diseases* [8-10, A]
  During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).

• For diagnosis of [Non-Approvable Use] Dermatologic Diseases* [A]
  Severe erythema multiforme, Stevens-Johnson syndrome.

• For diagnosis of [Non-Approvable Use] Allergic States* [A]
  Serum sickness.

• For diagnosis of [Non-Approvable Use] Ophthalmic Diseases* [14, A]
  Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis; optic neuritis; chorioretinitis; anterior segment inflammation.

• For diagnosis of [Non-Approvable Use] Respiratory Diseases* [11, A]
  Symptomatic sarcoidosis

• For diagnosis of [Non-Approvable Use] Edematous State* [12, 13, 15, A]
  To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Purified Cortrophin Gel (repository corticotropin injection)

• For diagnosis of Infantile spasms [2, 3]
  Indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age.

• For diagnosis of Exacerbations of Multiple Sclerosis [4, 5]
  Indicated for acute exacerbations of multiple sclerosis.

• For diagnosis of All Other Disease States [A]
  *Please Note: The request for Purified Cortrophin Gel for the treatment of a condition other than Infantile Spasms (IS) or Exacerbations of Multiple Sclerosis (MS) is not authorized. There is no consensus in current peer-reviewed medical literature regarding the efficacy, safety, or long-term consequences of using repository corticotropin over conventional corticosteroids in these steroid-responsive conditions.

• For diagnosis of [Non-Approvable Use] Rheumatic Disorders* [6, 7, A]
  Indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis; Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); Ankylosing spondylitis; Acute gouty arthritis.

• For diagnosis of [Non-Approvable Use] Collagen Diseases* [8-10, A]
  Indicated during an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).

• For diagnosis of [Non-Approvable Use] Dermatologic Diseases* [A]
  Indicated for severe erythema multiforme (Stevens-Johnson syndrome), severe psoriasis.

• For diagnosis of [Non-Approvable Use] Allergic States* [A]
  Indicated for atopic dermatitis, serum sickness.

• For diagnosis of [Non-Approvable Use] Ophthalmic Diseases* [14, A]
  Indicated for severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: allergic conjunctivitis, keratitis, iritis and iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation.

• For diagnosis of [Non-Approvable Use] Respiratory Diseases* [11, A]
  Indicated for symptomatic sarcoidosis.

• For diagnosis of [Non-Approvable Use] Edematous States* [12, 13, 15, A]
  Indicated to induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.

Criteria

Acthar Gel 80 unit/mL vial, Purified Cortrophin Gel [off-label]

Prior Authorization

Length of Approval: 4 Week(s)
For diagnosis of Infantile Spasms (West Syndrome)

• Diagnosis of infantile spasms (West Syndrome)
AND
• Prescribed by or in consultation with a neurologist
AND
• Patient is less than 2 years of age

Acthar Gel, Purified Cortrophin Gel

Prior Authorization

Length of Approval: 3 Week(s)
For diagnosis of Multiple Sclerosis

• Diagnosis of acute exacerbation of multiple sclerosis
AND
• Prescribed by or in consultation with a neurologist
AND
• One of the following:
• Both of the following:
• Patient is new to therapy with corticotropin
• Trial and failure, contraindication, or intolerance to treatment with two high dose corticosteroid treatments (e.g., prednisone, IV methylprednisolone)
OR
• All of the following:
• Patient’s multiple sclerosis exacerbations have been treated in the past with corticotropin
• Patient has benefitted from treatment with corticotropin for acute exacerbations of multiple sclerosis
• Medication is being used to treat a new exacerbation of multiple sclerosis

Acthar Gel, Purified Cortrophin Gel

*Other disease states lack published clinical literature to support the use of Acthar or Purified Cortrophin Gel [A]

Prior Authorization

Length of Approval: N/A - Requests for non-approvable diagnoses should not be approved
For diagnosis of All Other Indications [A]

• The request for Acthar Gel and Purified Cortrophin Gel for the treatment of a condition other than Infantile Spasms (IS) or Exacerbations of Multiple Sclerosis (MS) is not authorized and will not be approved. There is no consensus in current peer-reviewed medical literature regarding the efficacy, safety, or long-term consequences of using repository corticotropin over conventional corticosteroids in these steroid-responsive conditions:
• Rheumatic Disorders* [6, 7, A] As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute gouty arthritis.
• Collagen Diseases* [8-10, A] During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).
• Dermatologic Diseases* [A] Severe erythema multiforme, Stevens-Johnson syndrome, Severe psoriasis.
• Allergic States* [A] Serum sickness, Atopic dermatitis.
• Ophthalmic Diseases* [14, A] Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis; optic neuritis; chorioretinitis; anterior segment inflammation; Allergic conjunctivitis.
• Respiratory Diseases* [11, A] Symptomatic sarcoidosis.
• Edematous State* [12, 13, 15, A] To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
• Any other disease state not mentioned [A]*

Acthar Gel 80 unit/mL vial, Purified Cortrophin Gel [off-label]

Non Formulary

Length of Approval: 4 Week(s)
For diagnosis of Infantile Spasms (West Syndrome)

• Submission of medical records (e.g., chart notes) confirming diagnosis of infantile spasms (West Syndrome)
AND
• Prescribed by or in consultation with a neurologist
AND
• Patient is less than 2 years of age

Acthar Gel 40 unit/0.5 mL auto-injector, Acthar gel 80 unit/mL auto-injector

Non Formulary

Length of Approval: 3 Week(s)
For diagnosis of Multiple Sclerosis

• Submission of medical records (e.g., chart notes) confirming diagnosis of acute exacerbation of multiple sclerosis
AND
• Prescribed by or in consultation with a neurologist
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming one of the following:
• Both of the following:
• Patient is new to therapy with corticotropin
• Trial and failure, contraindication, or intolerance to treatment with two high dose corticosteroid treatments (e.g., prednisone, IV methylprednisolone)
OR
• All of the following:
• Patient’s multiple sclerosis exacerbations have been treated in the past with corticotropin
• Patient has benefitted from treatment with corticotropin for acute exacerbations of multiple sclerosis
• Medication is being used to treat a new exacerbation of multiple sclerosis

Acthar Gel 40 unit/0.5 mL auto-injector, Acthar gel 80 unit/mL auto-injector

*Other disease states lack published clinical literature to support the use of Acthar or Purified Cortrophin Gel [A]

Non Formulary

Length of Approval: N/A - Requests for non-approvable diagnoses should not be approved
For diagnosis of All Other Indications [A]

• The request for Acthar Gel and Purified Cortrophin Gel for the treatment of a condition other than Infantile Spasms (IS) or Exacerbations of Multiple Sclerosis (MS) is not authorized and will not be approved. There is no consensus in current peer-reviewed medical literature regarding the efficacy, safety, or long-term consequences of using repository corticotropin over conventional corticosteroids in these steroid-responsive conditions:
• Rheumatic Disorders* [6, 7, A] As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Psoriatic arthritis, Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy), Ankylosing spondylitis, Acute gouty arthritis.
• Collagen Diseases* [8-10, A] During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus, systemic dermatomyositis (polymyositis).
• Dermatologic Diseases* [A] Severe erythema multiforme, Stevens-Johnson syndrome, Severe psoriasis.
• Allergic States* [A] Serum sickness, Atopic dermatitis.
• Ophthalmic Diseases* [14, A] Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis; optic neuritis; chorioretinitis; anterior segment inflammation; Allergic conjunctivitis.
• Respiratory Diseases* [11, A] Symptomatic sarcoidosis.
• Edematous State* [12, 13, 15, A] To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus.
• Any other disease state not mentioned [A]*

P & T Revisions

2024-08-01, 2023-08-02, 2022-08-04, 2022-06-24, 2022-02-18, 2021-10-23, 2021-07-26, 2021-05-25, 2020-07-27, 2019-11-19, 2019-10-11, 2019-08-19

References

1. Acthar prescribing information. Mallinckrodt ARD LLC. Bedminster, NJ. June 2024.
2. Baram TZ, Mitchell WG, Tournay A, et al. High-dose corticotropin (ACTH) versus prednisone for infantile spasms: a prospective, randomized, blinded study. Pediatrics. 1996 Mar: 97(3):375-379.
3. Hrachovy RA, Frost JD, Glaze DG. High-dose, long-duration versus low-dose, short-duration corticotropin therapy for infantile spasms. J Pediatr. 1994 May; 124(5): 803-806.
4. Thompson, AJ. Relative efficacy of IV methylprednisolone vs ACTH in acute relapse of MS. Neurology. 1989 July;39(7):969.
5. Citterio A, La Mantia L, Ciucci G, et al. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database of Systematic Reviews 2000, Issue 4.
6. Gillis T, Crane M, Hinkle C, et al. Repository corticotropin injection as adjunctive therapy in patients with rheumatoid arthritis who have failed previous therapies with at least three different modes of action. Open Access Rheumatol. 2017;9:131-138.
7. Brown, A. Repository corticotropin injection in patients with refractory psoriatic arthritis: a case series. Open Access Rheumatol. 2016;8:97-102.
8. Furie R, Mitrane M, Zhao E, et al. Efficacy and tolerability of repository corticotropin injection in patients with persistently active SLE: results of a phase 4, randomised, controlled pilot study. Lupus Sci Med. 2016;3(1):e000180.
9. Patel A, Seely G, Aggarwal R. Repository corticotropin injection for treatment of idiopathic inflammatory myopathies. Case Rep Rheumatol. 2016;2016:9068061.
10. Aggarwal R, Marder G, Koontz DC, et al. Efficacy and safety of adrenocorticotropic hormone gel in refractory dermatomyositis and polymyositis. Ann Rheum Dis. 2018 May;77(5):720-727.
11. Baughman RP, Sweiss N, Keijsers R, et al. Repository corticotropin for chronic pulmonary sarcoidosis. Lung. 2017;195(3):313-322.
12. Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011;5:147-153.
13. Bomback AS, Canetta PA, Beck Jr LH, et al. Treatment of resistant glomerular diseases with adrenocorticotropic hormone gel: A prospective trial. Am J Nephrol 2012;36:58-67.
14. Sharon Y, Chu DS. Adrenocorticotropic hormone gel for patients with non-infectious uveitis. Am J Ophthalmol Case Rep. 2019;15:100502.
15. Madan A, Mojovic-Das S, Stankovic A, et al. Acthar gel in the treatment of nephrotic syndrome: a multicenter retrospective case series. BMC Nephrol. 2016;17:37.
16. Purified Cortrophin Gel prescribing information. ANI Pharmaceuticals, Inc. Baudette, MN. October 2023.

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Revision History

• 2024-08-01: Annual review: Added new 40 unit/0.5mL SC and 80 unit/mL SC autoinjector strengths to existing criteria for Multiple Sclerosis and “All Other Indications” sections. Clarified which criteria applies to specific formulations. Created NF criteria for auto-injector formulations for Multiple Sclerosis and “All Other Indications” that aligns with existing PA criteria with the addition of paid claims/submission of medical records verbiage. Updated references.
• 2023-08-02: Annual review: No criteria changes. Updated references and background.
• 2022-08-04: Annual Review: No criteria changes. Updated references, indications, and background.
• 2022-06-24: Reattach EHB formulary as NF criteria has been added to guideline
• 2022-02-18: Added cortrophin gel to GL, Updated MS criteria. Updated references and background.
• 2021-10-23: removed EHB formulary
• 2021-07-26: annual review: updated references, no criteria changes
• 2021-05-25: addition of EHB formulary only. no changes to criteria
• 2020-07-27: no criteria changed, references updated
• 2019-11-19: Update approval length
• 2019-10-11: Updated to reflect effective date of 10/1/19, no changes to criteria.
• 2019-08-19: 2019 annual review; no clinical criteria changes. Updated label name to remove "H.P." per new FDA label.

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