Acthar Gel. H. P. Acthar Gel (corticotropin; ACTH) Description
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1 Federal Employee Program 1310 G Street, N.W. Washington, D.C Fax Subject: Acthar Gel Page: 1 of 5 Last Review Date: September 18, 2015 Acthar Gel Description H. P. Acthar Gel (corticotropin; ACTH) Background According to the US Food and Drug Administration, H.P. Acthar gel (repository corticotropin injection, ACTH) was approved for marketing in 1952 (1). Since that time Acthar gel has shown to produce positive therapeutic outcomes in disease states such as infantile spasms, nephrotic syndrome, and multiple sclerosis (2). Effectiveness of H.P. Acthar Gel (ACTH) for treatment of infantile spasms was shown in a single blinded clinical trial in which patients received either a 2 week course of treatment with H.P. Acthar Gel or prednisone. The study compared the number of patients in each group who were treatment responders. Acthar had a significantly higher response rate compared to prednisone. (2). Studies have also shown that patients with nephrotic syndrome have had successful outcomes with Acthar Gel after failing other therapies (3,4). Also the Rauen, et al study concluded ACTH treatment produced a lasting remission with few side effects (5). Ponticelli, et al performed a study which compared the combination therapy of methylprednisolone with a cytotoxic agent and monotherapy of ACTH. The findings showed monotherapy ACTH was as effective for nephrotic patients as the combination of methylprednisolone and a cytotoxic agent (6). Filippini, et al produced a study of the use of H.P. Acthar Gel for multiple sclerosis in two randomized, double-blind trials. ACTH showed a protective effect against progression and stabilization of the disease (7). Thompson, et al s trial showed marked improvement in patients with acute relapse of MS after the use of ACTH (8). The study from Hauser, et al determined
2 Subject: Acthar Gel Page: 2 of 5 that combination therapy with cyclophosphamide and ACTH stabilized patients progressive MS (9). Regulatory Status FDA-approved indications: Acthar gel is an adrenocorticotropic hormone (ACTH) which is indicated for: (2) 1. Treatment of infantile spasms in infants and children under 2 years of age 2. Treatment of exacerbations of multiple sclerosis in adults over 18 years of age 3. Treatment of nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus to induce a diuresis or a remission. 4. H.P. Acthar Gel may be used for the following disorders and diseases: rheumatic; collagen; dermatologic; allergic states; ophthalmic; and respiratory. H.P. Acthar Gel should never be given intravenously. Administration of live or live attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of H.P. Acthar Gel (2). H.P. Acthar Gel is contraindicated in patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction or sensitivity to proteins of porcine origin (2). H.P. Acthar Gel is contraindicated in children less than 2 years of age with suspected congenital infections (2). Related policies Ampyra, Aubagio, Gilenya, Tecfidera, Tysabri, MS Injectables Policy This policy statement applies to clinical review performed for pre-service (Prior Approval, Precertification, Advanced Benefit Determination, etc.) and/or post-service claims. H.P. Acthar Gel may be considered medically necessary when prescribed by a neurologist for the treatment of infantile seizures; when prescribed by a neurologist exacerbations of multiple sclerosis must have tried and failed corticosteroid therapy and used in combination with a maintenance MS therapy; when prescribed by a nephrologist nephrotic syndrome must have tried and failed corticosteroid therapy.
3 Subject: Acthar Gel Page: 3 of 5 Acthar gel is considered investigational for all other indications. Prior-Approval Requirements Diagnoses Patient must have ONE of the following: 1. Infantile spasms (in children < 2 years of age) a. Prescribed by a neurologist 2. Exacerbations of multiple sclerosis (in adults 18 years of age) a. Tried and failed corticosteroid therapy b. Prescribed by a neurologist c. Used in combination with a maintenance MS therapy 3. Nephrotic syndrome a. Tried and failed corticosteroid therapy b. Prescribed by a nephrologist Prior Approval Renewal Requirements Same as above Policy Guidelines Pre - PA Allowance None Prior - Approval Limits Duration Infantile spasms Exacerbations of multiple sclerosis Nephrotic syndrome Prior Approval Renewal Limits Duration Infantile spasms 6 months
4 Subject: Acthar Gel Page: 4 of 5 Exacerbations of multiple sclerosis Nephrotic syndrome 6 months Rationale Summary H.P. Acthar Gel stimulates the release of endogenous cortisol. It is approved for a number of indications that are more generally treated with corticosteroids. Indications that are supported by published clinical literature are covered by the prior approval criteria. Prior authorization is required to ensure the safe, clinically appropriate and cost-effective use of H.P. Acthar Gel while maintaining optimal therapeutic outcomes. References 1. Acthar [package insert]. Hayward, CA: Questcor Pharmaceuticals, Inc. September Bomback AS, Tumlin JA, Baranski J, et al. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH) gel. Drug Des Devel Ther. 2011; 14(5): Bomback AS, Radhakrishnan J. Treatment of nephrotic syndrome with adrenocorticotropic hormone (ACTH). Discov. Med. 2011; 12(63): Rauen T, Michaelis A, Floege et al. Case series of idiopathic membranous nephropathy with long-term beneficial effects of ACTH peptide Clin Nephrol. 2009; 71(6): Ponticelli C, Passerini P, Salvadori M, et al. A randomized pilot trial comparing methylprednisolone plus a cytotoxic agent versus synthetic adrenocorticotropic hormone in idiopathic membranous nephropathy. Am J Kidney Dis. 2006;47(2): Filippini G, Brusaferri F, et al. Corticosteroids or ACTH for acute exacerbations in multiple sclerosis. Cochrane Database Syst Rev 2000 CD Thompson AJ, Kennard C, et al. Relative efficacy of intravenous methylprednisolone and ACTH in the treatment of acute relapse in MS. Neurology Jul;39(7); Hauser SL, Dawson DM, et al. Intensive Immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH. N Engl J Med Jan 27; 308(4): Policy History Date Action Reason April 2011 Updated criteria to mirror FDA indications for infantile spasms in infants and children less than 2 years of age and exacerbations of multiple sclerosis in adults.(4) May 2012 March 2013 Updated criteria to include FDA indication for nephrotic syndrome Annual editorial review. Remove tried and failed corticosteroid from infantile spasms. Addition of the following to the criteria: Not intended for
5 Subject: Acthar Gel Page: 5 of 5 June 2013 June 2014 December 2014 March 2015 May 2015 June 2015 September 2015 IV administration, patient must not have scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of or the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, or sensitivity to proteins or porcine origin. No administration of live or live attenuated vaccines with immunosuppressive doses of Acthar Gel. No congenital infections in children under 2 years of age. Revised limitations to 6 months in light of use for nephrotic syndrome and MS. Addition of specialist and change of duration on approvals for MS and infantile spasms Annual review Keywords This policy was approved by the FEP Pharmacy and Medical Policy Committee on September 18, 2015 and is effective October 1, Deborah M. Smith, MD, MPH
Acthar Gel. H. P. Acthar Gel (corticotropin; ACTH) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.10 Subject: Acthar Gel Page: 1 of 5 Last Review Date: December 2, 2016 Acthar Gel Description H. P.
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.10 Subject: Acthar Gel Page: 1 of 6 Last Review Date: December 8, 2017 Acthar Gel Description H. P.
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.30.10 Subject: Acthar Gel Page: 1 of 7 Last Review Date: November 30, 2018 Acthar Gel Description H.
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.27 Subject: Siklos Page: 1 of 5 Last Review Date: November 30, 2018 Siklos Description Siklos (hydroxyurea)
More informationHumatrope*, Norditropin*, Genotropin, Nutropin, Nutropin AQ, Omnitrope, Saizen
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.08.11 Subject: Growth Hormone Adult Page: 1 of 6 Last Review Date: September 15, 2016 Growth Hormone
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.01 Subject: Actimmune Page: 1 of 5 Last Review Date: March 18, 2016 Actimmune Description Actimmune
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 Subject: Nucynta Page: 1 of 7 Last Review Date: March 18, 2016 Nucynta Description Nucynta IR/ Nucynta
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.63 Subject: Duzallo Page: 1 of 5 Last Review Date: December 8, 2017 Duzallo Description Duzallo (lesinurad
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.02 Subsection: Gastrointestinal nts Original Policy Date: May 20, 2011 Subject: Remicade Page: 1 of
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.66 Subject: Imlygic Page: 1 of 5 Last Review Date: June 22, 2017 Imlygic Description Imlygic (talimogene
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.45.05 Subject: Ofev Page: 1 of 5 Last Review Date: March 17, 2017 Ofev Description Ofev (nintedanib)
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.01.19 Subject: Tamiflu Page: 1 of 5 Last Review Date: March 18, 2016 Tamiflu Description Tamiflu (oseltamivir)
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.85.15 Subject: Promacta Page: 1 of 6 Last Review Date: September 20, 2018 Promacta Description Promacta
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.99.06 Subject: Xiaflex Page: 1 of 5 Last Review Date: June 22, 2018 Xiaflex Description Xiaflex (collagenase
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.90.04 Subject: Stelara Page: 1 of 9 Last Review Date: September 20, 2018 Stelara Description Stelara
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.50.06 Subject: Opioid Antagonist Drug Class Page: 1 of 5 Last Review Date: June 22, 2017 Opioid Antagonist
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.70.24 Subject: Xeljanz Page: 1 of 5 Last Review Date: March 18, 2016 Xeljanz Description Xeljanz, Xeljanz
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Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.20.01 Subject: Atgam Page: 1 of 5 Last Review Date: June 24, 2016 Atgam Description Atgam (lymphocyte
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