Clinical Policy: Corticotropin (H.P. Acthar) Reference Number: ERX.SPA.72 Effective Date:

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1 Clinical Plicy: (H.P. Acthar) Reference Number: ERX.SPA.72 Effective Date: Last Review Date: Revisin Lg See Imprtant Reminder at the end f this plicy fr imprtant regulatry and legal infrmatin. Descriptin (H.P. Acthar ) is an adrencrtictrpic hrmne analgue. FDA Apprved Indicatin(s) H.P. Acthar is indicated: Fr the treatment f infantile spasms in infants and children under 2 years f age as mntherapy Fr the treatment f exacerbatins f multiple sclersis (MS) in adults H.P. Acthar Gel may als be used fr the fllwing disrders and diseases: rheumatic, cllagen, dermatlgic, allergic states, phthalmic, respiratry, and edematus state. Plicy/Criteria Prvider must submit dcumentatin (which may include ffice chart ntes and lab results) supprting that member has met all apprval criteria. It is the plicy f health plans affiliated with Envlve Pharmacy Slutins that H.P. Acthar is medically necessary when the fllwing criteria are met: I. Initial Apprval Criteria A. West Syndrme (Infantile Spasms) (must meet all): 1. Diagnsis f West syndrme (infantile spasms); 2. Prescribed by r in cnsultatin with a neurlgist; 3. Age < 2 years; 4. Dse des nt exceed 150 U/m 2 per day (divided int twice daily IM injectins f 75 U/m 2 ). Apprval duratin: 3 mnths B. Multiple Sclersis (must meet all): 1. Diagnsis f MS; 2. Prescribed by r in cnsultatin with a neurlgist; 3. Age 18 years; 4. Prescribed fr acute exacerbatins f MS; 5. Failure f a recent (within the last 30 days) trial f at least 7 day curse f crticsterid therapy fr acute exacerbatins f MS, unless cntraindicated r clinically significant adverse effects are experienced; 6. Dse des nt exceed 120 units per day. Apprval duratin: 1 mnths C. Nephrtic Syndrme (must meet all): a. Diagnsis f nephrtic syndrme and assciated (a r b): a. Systemic lupus erythematsus; b. Idipathic nephrpathy/glmerulnephritis; b. Prescribed by r in cnsultatin with a nephrlgist; c. Age > 2 years; d. Failure f ral sterids, unless cntraindicated r clinically significant adverse effects are experienced; e. Failure f 2 f the fllwing agents: tacrlimus, cyclsprine, mycphenlate, rituximab, unless cntraindicated r clinically significant adverse effects are experienced; f. Dse des nt exceed 80 units given intramuscularly r subcutaneusly every 24 hurs. Page 1 f 5

2 Apprval duratin: 3 mnths B. Other diagnses/indicatins 1. Refer t ERX.PA.01 if diagnsis is NOT specifically listed under sectin III (Diagnses/Indicatins fr which cverage is NOT authrized). II. Cntinued Therapy A. West Syndrme (Infantile Spasms) (must meet all): 1. Currently receiving medicatin via a health plan affiliated with Envlve Pharmacy Slutins r member has previusly met initial apprval criteria; 2. Age is < 2 years ld; 3. Member is respnding psitively t therapy; 4. If request is fr a dse increase, new dse des nt exceed 150 U/m 2 per day (divided int twice daily injectins f 75 U/m 2 ). Apprval duratin: 3 mnths (West syndrme ne renewal limit) B. Multiple Sclersis: HP Acthar is nt indicated fr cntinuus use fr this indicatin. Reauthrizatin requests must be reviewed against the initial apprval criteria. C. Nephrtic Syndrme (must meet all): 1. Currently receiving medicatin via a health plan affiliated with Envlve Pharmacy Slutins r member has previusly met initial apprval criteria; 2. Prescribed by r in cnsultatin with a nephrlgist; 3. Dcumentatin f psitive respnse t therapy; 4. Dse des nt exceed 80 units given intramuscularly r subcutaneusly every 24 hurs. Apprval duratin: 3 mnths D. Other diagnses/indicatins (must meet 1 r 2): 1. Currently receiving medicatin via a health plan affiliated with Envlve Pharmacy Slutins and dcumentatin supprts psitive respnse t therapy. Apprval duratin: Duratin f request r 3 mnths (whichever is less); r 2. Refer t ERX.PA.01 if diagnsis is NOT specifically listed under sectin III (Diagnses/Indicatins fr which cverage is NOT authrized). III. Diagnses/Indicatins fr which cverage is NOT authrized: A. Nn-FDA apprved indicatins, which are nt addressed in this plicy, unless there is sufficient dcumentatin f efficacy and safety accrding t the ff-label use plicy ERX.PA.01 r evidence f cverage dcuments. IV. Appendices/General Infrmatin Appendix A: Abbreviatin/Acrnym Key ACTH: adrencrtictrpic hrmne MS: multiple sclersis Appendix B: Therapeutic Alternatives Nt applicable. Appendix C: General Infrmatin Cmmn adverse reactins fr H.P. Acthar Gel are similar t thse f crticsterids and include fluid retentin, alteratin in glucse tlerance, elevatin in bld pressure, behaviral and md changes, increased appetite and weight gain. The initial apprval f H.P. ACTH gel ccurred prir t the Kefauver-Harris amendment t the Federal Fd, Drug and Csmetic Act f 1962, which intrduced the requirement f substantial evidence f tw adequate and well cntrlled trials. At the time f the riginal apprval drug manufacturers nly had t shw the drug was safe fr use in humans. The riginal data included Page 2 f 5

3 case reprts frm a few physicians describing patients with cnditins riginally treated with Acthar pwder that were transferred t treatment with Acthar Gel and gave dsing guidance fr treatment f these individual cnditins. The efficacy H.P. Acthar Gel in the fllwing cnditins has nt been prven in well-designed clinical trials and its use is cnsidered experimental, They are als nt FDA apprved indicatins: Rheumatic Disrders: As adjunctive therapy fr shrt-term administratin (t tide the patient ver an acute episde r exacerbatin) in: psriatic arthritis, rheumatid arthritis, including juvenile rheumatid arthritis (selected cases may require lw-dse maintenance therapy), ankylsing spndylitis Cllagen Diseases: During an exacerbatin r as maintenance therapy in selected cases f: systemic lupus erythematsus; systemic dermatmysitis (plymysitis) Dermatlgic Diseases: severe erythema multifrme, Stevens-Jhnsn syndrme Allergic States: serum sickness Ophthalmic Diseases: severe acute and chrnic allergic and inflammatry prcesses invlving the eye and its adnexa such as: keratitis, iritis, iridcyclitis, diffuse psterir uveitis and chriditis; ptic neuritis; chriretinitis; anterir segment inflammatin Respiratry Diseases: symptmatic sarcidsis Edematus State: T induce a diuresis r a remissin f prteinuria in the nephrtic syndrme withut uremia f the idipathic type r that due t lupus erythematsus Fr acute exacerbatins in multiple sclersis, the results f trials that analyzed direct cmparisns have shwn n significant differences between ACTH and methylprednislne (MP) in bth rate and degree f recvery after exacerbatin. Indirect cmparisns suggest a significantly greater effect f MP versus ACTH, with MP cnferring greater benefit cmpared with ACTH (dds rati (OR) 0.20, 95% CI 0.09 t 0.45 vs OR 0.46, 95% CI 0.28 t 0.77). Studies evaluating the use f ACTH in acute exacerbatins f multiple sclersis ranged frm 14 t 21 days in length and evaluated ne curse f therapy. T date, retreatment with ACTH has nt been evaluated in clinical trials. V. Dsage and Administratin Indicatin Dsing Regimen Maximum Dse West syndrme (infantile 150 U/m 2 IM divided int twice daily injectins f 150 U/m 2 /day spasms) 75 U/m 2 administered ver a 2-week perid. After 2 weeks, H.P. Acthar shuld be gradually tapered ver a 2-week perid Acute exacerbatin f MS units IM r SC daily fr 2-3 weeks 120 units/day Nephrtic syndrme 80 units IM r SC every 24 hurs 80 units/day VI. Prduct Availability Multi-dse vial: 5 ml cntaining 80 USP units per ml VII. References 1. H.P. Acthar Prescribing Infrmatin. Hazelwd, MO: Mallinckrdt ARD, Inc.; January Available at Accessed Nvember 13, G CY, Mackay MT, Weiss SK, et al. Evidenced-based guideline update: Medical treatment f infantile spasms: Reprt f the guideline develpment subcmmittee f the American Academy f Neurlgy and the Practice Cmmittee f the Child Neurlgy Sciety. Neurlgy. June 12, 2012; 78(24): Reaffirmed July 18, Pellck JM, Hrachvy R, Shinnar S, et al. Infantile spasms: A U.S. cnsensus reprt. Epilepsia. Octber 2010; 51(10): Berkvich R, Agius M. Mechanisms f actin f ACTH in the management f relapsing frms f multiple sclersis. Ther Adv Neurl Disrd. March 2014; 7(2): Filippini G, Brusaferri F, Sibley WA, et al. Crticsterids r ACTH fr acute exacerbatins in multiple sclersis. Cchrane Database Syst Rev. 2000; (4): CD Page 3 f 5

4 6. Berkvich R, Bakshi R, Amezcua L, et al. Adrencrtictrpic hrmne versus methylprednislne added t interfern B in patients with multiple sclersis experiencing breakthrugh disease: A randmized, rater-blinded trial. Ther Adv Neurl Disrd. January 2017; 10(1): Beck L, Bmback AS, Chi M, et al. KDOQI cmmentary n the 2012 KDIGO clinical practice guidelines fr glmerulnephritis. Am J Kidney Dis. 2013: 62(3): Lieberman KV and Pavlva-Wlf A. Adrencrtictrpic hrmne therapy fr the treatment f idipathic nephrtic syndrme in children and yung adults: A systematic review f early clinical studies with cntemprary relevance. J Nephrl. 2017; 30: Hladunewich MA, Cattran D, Beck LH, et al. A pilt study t determine the dse and effectiveness f adrencrtictrphic hrmne (H.P. Acthar Gel) in nephrtic syndrme due t idipathic membranus nephrpathy. Nephrl Dial Transplant. 2014; 29: Hgan J, Bmback AS, Mehta K, et al. Treatment f idipathic FSGS with adrencrtictrpic hrmne gel. Clin J Am Sc Nephrl. December 6, 2013; 8(12): Chen Y, Schieppati A, Cai G, et al. Immunsuppressin fr membranus nephrpathy: A systematic review and meta-analysis f 36 clinical trials. Clin J Am Sc Nephrl. May 7, 2013; 8(5): Madan A, Mijvic-Das S, Stankvic A, et al. Acthar gel in the treatment f nephrtic syndrme: A multicenter retrspective case series. BMC Nephrl. March 31, 2016; 17: Thmpsn AJ, Kennard C, Swash M, Summers B, Yuill GM, Shepherd DI, et al. Relative efficacy f intravenus methylprednislne and ACTH in the treatment f acute relapse in MS. Neurlgy 1989; 39(7): Clinical Pharmaclgy [database nline]. Tampa, FL: Gld Standard, Inc.; Available at: Reviews, Revisins, and Apprvals Date P&T Apprval Date Plicy split frm USS.CP.PHAR.56 H.P. Acthar and Sabril and cnverted t new template. Remved all requests fr dcumentatin and safety criteria. Remved labeled indicatins and criteria that d nt have clinical studies shwing effectiveness and superirity ver crticsterid therapy. Retained criteria fr infantile spasms and MS. Infantile spasms: mdified apprval duratin t 4 weeks. MS: added age/dsing and mdified apprval duratin t max 3 weeks based n PI; added criteria fr failure r cntraindicatin f ral crticsterids fr MS; added requirement fr adherent use f disease mdifying therapy Cnverted t new template Added Nephrtic syndrme and ther indicatins criteria. - Updated references Q18 annual review: - Remved indicatins nt supprted by well-designed clinical trials as nted in Appendix C; retained indicatin due fr nephrtic syndrme in plicy due t appeal verturn reprt - West syndrme remved EEG requirement t cnfirm diagnsis; added neurlgist prescriber requirement. - MS added requirement fr 7 day curse f crticsterid therapy fr acute exacerbatins; apprval duratin reduced t ne mnth fr initial as this medicatin is nt indicated t used chrnically and fr cntinued apprval fr MS was referred t the initial criteria. - References reviewed and updated. Page 4 f 5

5 Imprtant Reminder This clinical plicy has been develped by apprpriately experienced and licensed health care prfessinals based n a review and cnsideratin f currently available generally accepted standards f medical practice; peer-reviewed medical literature; gvernment agency/prgram apprval status; evidence-based guidelines and psitins f leading natinal health prfessinal rganizatins; views f physicians practicing in relevant clinical areas affected by this clinical plicy; and ther available clinical infrmatin. This Clinical Plicy is nt intended t dictate t prviders hw t practice medicine, nr des it cnstitute a cntract r guarantee regarding payment r results. Prviders are expected t exercise prfessinal medical judgment in prviding the mst apprpriate care, and are slely respnsible fr the medical advice and treatment f members. This plicy is the prperty f Envlve Pharmacy Slutins. Unauthrized cpying, use, and distributin f this Plicy r any infrmatin cntained herein is strictly prhibited. By accessing this plicy, yu agree t be bund by the freging terms and cnditins, in additin t the Site Use Agreement fr Health Plans assciated with Envlve Pharmacy Slutins Envlve Pharmacy Slutins. All rights reserved. All materials are exclusively wned by Envlve Pharmacy Slutins and are prtected by United States cpyright law and internatinal cpyright law. N part f this publicatin may be reprduced, cpied, mdified, distributed, displayed, stred in a retrieval system, transmitted in any frm r by any means, r therwise published withut the prir written permissin f Envlve Pharmacy Slutins. Yu may nt alter r remve any trademark, cpyright r ther ntice cntained herein. Page 5 f 5