SPECIALTY GUIDELINE MANAGEMENT - Caremark

1 Acthar HP SGM 2015 Caremark . All rights reserved. This document contains confidential and proprietary information of CVS/ Caremark and cannot be reproduced, distributed or printed without written permission from CVS/ Caremark . This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with CVS/ Caremark . 1 SPECIALTY GUIDELINE MANAGEMENT ACTHAR GEL (repository corticotropin injection) POLICY A. INDICATIONS The indications below including FDA-approved indications and compendial uses are considered covered benefits provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

2 FDA-Approved Indications Infantile spasms: Acthar Gel is indicated as monotherapy for the treatment of infantile spasms in infants and children under 2 years of age Multiple Sclerosis: Acthar Gel is indicated for the treatment of acute exacerbations of multiple sclerosis in adults. 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, 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.

3 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 Compendial Use Diagnostic testing of adrenocortical function All other indications are considered experimental/investigational and are not covered benefits. B. EXCLUSIONS Receipt of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar Gel Suspected congenital infection in infants Scleroderma Osteoporosis Acthar HP SGM 2015 Caremark . All rights reserved. This document contains confidential and proprietary information of CVS/ Caremark and cannot be reproduced, distributed or printed without written permission from CVS/ Caremark .

4 This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with CVS/ Caremark . 2 Systemic fungal infections Peptic ulcer disease (history of or the current presence) Ocular herpes simplex Congestive heart failure Recent surgery Uncontrolled hypertension Known hypersensitivity to porcine proteins Primary adrenocortical insufficiency Adrenocortical hyperfunction C. INITIAL CRITERIA FOR APPROVAL 1. Infantile Spasms Authorization of 6 months may be granted to members who are less than 2 years of age for the treatment of infantile spasms.

5 2. Diagnostic Testing of Adrenocortical Function Authorization of 1 dose may be granted to members who are prescribed Acthar Gel for diagnostic testing of adrenocortical function when member cannot be tested with Cosyntropin. 3. Multiple Sclerosis Authorization of 3 weeks may be granted to members for the treatment of acute exacerbations of multiple sclerosis when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids. 4. Nephrotic Syndrome Authorization of 3 months may be granted to members for the treatment of nephrotic syndrome when Acthar Gel is requested for induction of diuresis or for remission of proteinuria in a member who has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids.

6 5. Rheumatic Disorders Authorization of 3 months may be granted to members who are prescribed Acthar Gel as adjunctive treatment for rheumatic disorders (eg, psoriatic arthritis, rheumatoid arthritis, ankylosing spondylitis) when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids. 6. Collagen Diseases Authorization of 3 months may be granted to members for the treatment of collagen diseases (eg, systemic lupus erythematosus, systemic dermatomyositis, polymyositis) when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids. 7. Dermatologic Diseases Authorization of 3 months may be granted to members for the treatment of dermatologic disorders (eg, severe erythema multiforme, Stevens-Johnson syndrome) when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids.

7 8. Ophthalmic Diseases Authorization of 3 months may be granted to members for the treatment of ophthalmic diseases (eg, keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation) when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids. 9. Symptomatic Sarcoidosis Authorization of 3 months may be granted to members for the treatment of symptomatic sarcoidosis when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids. Acthar HP SGM 2015 Caremark . All rights reserved.

8 This document contains confidential and proprietary information of CVS/ Caremark and cannot be reproduced, distributed or printed without written permission from CVS/ Caremark . This page contains prescription brand name drugs that are trademarks or registered trademarks of pharmaceutical manufacturers that are not affiliated with CVS/ Caremark . 3 10. Serum Sickness Authorization of 1 month may be granted to members for the treatment of serum sickness when the member has had an inadequate response to at least a 3-month trial of parenteral glucocorticoids. D. CONTINUATION OF THERAPY 1. Infantile Spasms Authorization of 6 months may be granted to members requesting Acthar Gel for continuation of therapy when the member has shown substantial clinical benefit from therapy.

9 2. All Other Indications All members (including new members) requesting authorization for continuation of therapy must meet ALL initial authorization criteria. E. DOSAGE AND ADMINISTRATION Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines . 1. The following dosing limits apply: Multiple sclerosis: 120 units per day Nephrotic syndrome: 160 units per 7 days All other diagnoses other than infantile spasms: 80 units per day REFERENCES 1. Acthar Gel [package insert]. Hayward, CA: Questcor Pharmaceuticals, Inc.; September 2012. 2. DRUGDEX System (electronic version).

10 Truven Health Analytics, Greenwood Village, Colorado. Available at Accessed May 12, 2015. 3. American Society of Health System Pharmacists. AHFS Drug Information. Bethesda, MD. Electronic Version 2015. Accessed May 18, 2015. 4. Pellock JM, Hrachovy R, Shinnar S, et al. Infantile spasms: A consensus report. Epilepsia. 2010:51:2175-2189. 5. Go CY, Mackay MT, Weiss SK, et al. Evidence-based GUIDELINE update: Medical treatment of infantile spasms: Report of the GUIDELINE Development Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology. 2012;78:1974-1980. 6. Hancock EC, Osborne JP, Edwards SW.