• Infantile spasms: Indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age
• Multiple Sclerosis (MS): indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
  

• Diagnosis of West syndrome (infantile spasms)

OR

• Diagnosis of Multiple Sclerosis

AND

• Trial of a minimum 7 day course of corticosteroid therapy for acute exacerbations of multiple sclerosis

AND

• Medical Justification must be provided why patient cannot take corticosteroids

AND

• Prescribed by or in consultation with a neurologist

AND

• Patient is being treated with a relapsing remitting multiple sclerosis agent (e.g., Avonex, Betaseron, Copaxone, Gilenya)

• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.

• Common adverse reactions for H.P. Acthar Gel are similar to those of corticosteroids and include fluid retention, alteration in glucose tolerance, elevation in blood pressure, behavioral and mood changes, increased appetite and weight gain.
• The initial approval of H.P. ACTH gel occurred prior to the Kefauver-Harris amendment to the Federal Food, Drug and Cosmetic Act of 1962, which introduced the requirement of substantial evidence of two adequate and well controlled trials. At the time of the original approval drug manufacturers only had to show the drug was safe for use in humans. The original data included case reports from a few physicians describing patients with conditions originally treated with Acthar powder that were transferred to treatment with Acthar Gel and gave dosing guidance for treatment of these individual conditions.
• The efficacy HP Acthar Gel has in the following conditions has not been proven in well-designed clinical trials and is considered experimental and are not FDA approved indications:
• Rheumatic Disorders: 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
• Collagen Diseases: During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus; Systemic dermatomyositis (polymyositis)
• Dermatologic Diseases: Severe erythema multiforme, Stevens-Johnson syndrome
• Allergic States: Serum sickness
• Ophthalmic Diseases: 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
• Respiratory Diseases: Symptomatic sarcoidosis
• Edematous State: 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
• For acute exacerbations in multiple sclerosis, the results of trials that analyzed direct comparisons have shown no significant differences between ACTH and methylprednisolone (MP) in both rate and degree of recovery after exacerbation. Indirect comparisons suggest a significantly greater effect of MP versus ACTH, with MP conferring greater benefit compared with ACTH (odds ratio (OR) 0.20, 95% CI 0.09 to 0.45 vs OR 0.46, 95% CI 0.28 to 0.77).
• Studies evaluating the use of ACTH in acute exacerbations of multiple sclerosis ranged from 14 to 21 days in length and evaluated one course of therapy. To date, retreatment with ACTH has not been evaluated in clinical trials

1. H.P. Acthar Gel [Prescribing information] Union City, CA: Questor Pharmaceuticals; January 2015.
2. Filippini G, Brusaferri F, Sibley WA, Citterio A. et al. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database Syst Rev. 2000;(4):CD001331.
3. Thompson AJ, Kennard C, Swash M, Summers B, Yuill GM, Shepherd DI, et al. Relative efficacy of intravenous methylprednisolone and ACTH in the treatment of acute relapse inMS. Neurology 1989;39(7):96971.