Subject:
H.P. Acthar Gel
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
H.P. Acthar® Gel (Repository Corticotropin Injection) is a highly purified sterile preparation of the adrenocorticotropic hormone in 16% gelatin to provide a prolonged release after intramuscular or subcutaneous injection. It is indicated for diagnostic testing of adrenocortical function.
ACTH stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances. Although ACTH does stimulate secretion of aldosterone, the rate is relatively independent. Prolonged administration of large doses of ACTH induces hyperplasia and hypertrophy of the adrenal cortex and continuous high output of cortisol, corticosterone and weak androgens. The release of ACTH is under the influence of the nervous system via the corticotropin regulatory hormone released from the hypothalamus and by a negative corticosteroid feedback mechanism. ACTH rapidly disappears from the circulation following its intravenous administration; in man the plasma half-life is about 15 minutes.
As of August 8, 2007, H.P. Acthar Gel® is only available through specialty pharmacy distribution.
Policy:
(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
The requirements of the Horizon BCBSNJ H.P. Acthar Gel Program may require a precertification/prior authorization via MagellanRx Management. These requirements are member-specific: please verify member eligibility and requirements through the Horizon Provider Portal (www.horizonblue.com/provider). Ordering clinicians should request pre-certification from MagellanRx Management at ih.magellanrx.com or call 1-800-424-4508 (when applicable).
1. H.P. Acthar gel is considered medically necessary for the FDA following approved indications:
A. Treatment of infantile spasms (West syndrome) when ALL the following are met:
- Used as monotherapy AND
- Used in infants and children under 2 years of age AND
- Definitive diagnosis as evidenced by hypsarrhythmia made by electroencephalogram (EEG) AND
- The prescriber is a specialist in the area of the patient’s diagnosis (e.g. neurologist) or has consulted with a specialist in the area of the patient’s diagnosis
[INFORMATIONAL NOTE: West syndrome is a seizure disorder of infancy and early childhood. It typically occurs within the first year of life and can be associated with myoclonic seizures, hypsarrhythmia (abnormal, chaotic electroencephalogram), and mental retardation. The spasms are sudden, brief contractions of one or more muscle groups, and may be followed by a longer (less than 10 seconds) tonic phase. Most often the spasms, involving the muscles of the neck, trunk and extremities, occur in clusters. The intensity or the frequency of the spasms may increase progressively to a peak, decline, or cease. The clusters tend to occur soon after arousal from sleep.]
2. H.P Acthar gel is contraindicated based on FDA approved packet insert or not medically necessary in members with any of the following:
- 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 of porcine origin
- Conditions that are accompanied by primary adrenocortical insufficiency or adrenocortical hyperfunction
- When administered intravenous
- Children under 2 years of age with suspected congenital infections
- Receiving live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar
3. Although FDA-approved, Acthar Gel is not considered medically necessary for use in the following conditions:
- Multiple sclerosis: acute exacerbation
- Edematous state: nephrotic syndrome
- Rheumatic disorders- psoriatic arthritis, rheumatoid arthritis, juvenile rheumatoid arthritis, and ankylosing spondylitis
- Collagen diseases - systemic lupus erythematosus, systemic dermatomyositis (polymyositis)
- Dermatologic diseases - severe erythema multiforme, Stevens- Johnson syndrome
- Allergic states - serum sickness
- Ophthalmic diseases - keratitis iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation
- Respiratory diseases - symptomatic sarcoidosis
[INFORMATIONAL NOTE: Acthar gel was approved by the FDA before the implementation of 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. Currently there is insufficient evidence showing that Acthar gel is safe and efficacious for the use in the disease states listed above].
4. When H.P. Acthar gel is considered medically necessary, initial therapy will be eligible for a period of 1 month at the following FDA recommended dosing:
- 150 U/m2 divided into twice daily IM injections of 75 U/m2 for the treatment of infantile spasms and after 2 weeks of treatment, dosing should be gradually tapered and discontinued over a 2-week period. The recommended tapering schedule is: 30 U/m2 in the morning for 3 days, then 15 U/m2 in the morning for 3 days, then 10 U/m2 in the morning for 3 days, then 10 U/m2 every other morning for 6 days.
[INFORMATIONAL NOTE: Standard tests for verification of adrenal responsiveness to corticotropin may utilize as much as 80 units as a single injection or one or more injections of a lesser dosage. Verification tests should be performed prior to treatment with corticotropins. The test should utilize the route(s) of administration proposed for treatment. Following verification, dosage should be individualized according to the disease under treatment and the general medical condition of each patient. Frequency and dose of the drug should be determined by considering severity of the disease, plasma and urine corticosteroid levels and the initial response of the patient. Only gradual change in dosage schedules should be attempted, after full drug effects have become apparent. The chronic administration of more than 40 units daily may be associated with uncontrollable adverse effects.]
5. Continued therapy will be eligible for 1 month at the following FDA recommended dosing:
- Patient continues to meet initiation criteria; AND
- Disease response with treatment as indicated by resolution of symptoms and/or normalization of laboratory tests; AND
- Absence of unacceptable toxicity, including but not limited to, infections, adrenal insufficiency/Cushing’s syndrome, GI bleeding, gastric ulcer, hypertension, hypokalemia, severe depression, frank psychotic manifestations, posterior subcapsular cataracts, glaucoma, and decrease in bone density
6. Other uses for H.P. Acthar gel are considered investigational , including but not limited to, Bell’s palsy, myasthenia gravis, diabetic nephropathy, amyotrophic lateral sclerosis, proteinuria in membranous nephropathy, and Guillain-Barré syndrome.
Medicare Coverage
Per Local Coverage Article A53127 Self-Administered Drug Exclusion List, Medicare covers drugs that are furnished “incident to” a physician’s service provided that the drugs are medically reasonable and necessary, approved by the Food and Drug Administration (FDA) and are not usually administered by the patients who take them. Therefore, Medicare Advantage Products will cover H.P. Acthar Gel when administered by a licensed medical provider as part of a physician service. For members with a Medicare drug plan (Part D) H.P. Acthar Gel may be covered under that plan.
Local Coverage Article: Self-Administered Drug Exclusion List (A53127). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/LcdSearch?_afrLoop=90769712476969#!%40%40%3F_afrLoop%3D90769712476969%26centerWidth%3D100%2525%26leftWidth%3D0%2525%26rightWidth%3D0%2525%26showFooter%3Dfalse%26showHeader%3Dfalse%26_adf.ctrl-state%3D63y7eftob_46
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
H.P. Acthar gel (Repository Corticotropin)
Acthar
Repository Corticotropin (H.P. Acthar Gel)
Corticotropin
References:
1. Questcor Pharmaceuticals, Inc. H.P. Acthar® Gel package insert. Union City, CA March 2019.
2. Micromedex Health Series. Thomson Gateway. Available from: http://www.thomsonhc.com/hcs/librarian/ND_PR/Main/SBK/1/PFPUI/Yn129H229tSmZi/ND_PG/PRIH/CS/291067/ND_T/HCS/ND_P/Main/DUPLICATIONSHIELDSYNC/C1EA56/ND_B/HCS/PFActionId/hcs.common.RetrieveDocumentCommon/DocId/142605/ContentSetId/100/SearchTerm/corticotropin/SearchOption/BeginWith
3. AHFS Drug Information. American Society of Health-System Pharmacists, Inc. 2004.
4. MedicineNet.com. MedTerms Dictionary: Definition of West Syndrome. 2001 Aug [cited 20 Nov 2007] Available from: http://www.medterms.com/script/main/art.asp?articlekey=18072
5. Stedman’s Medical Dictionary. West Syndrome. New York: Lippincott Williams and Wilkins; 2000. P.1771.
6. American Academy of Neurology. Practice Parameter: Medical Treatment of Infantile Spasms: Report of the American Academy of Neurology and the Child Neurology Society. Neurology 2004;62;1668-1681.
7. Salman MS, MacGregor DL. Should children with Bell’s palsy be treated with corticosteroids? A systematic review. J Child Neurol 2001 Aug; 16(8): 565-8.
8. Tiemstra JD, Khatkhate N. Bell’s Palsy: diagnosis and management. Am Fam Physician 2007 Oct; 76(7):997-1002.
9. Schneider-Gold C, Gajdos P, Toyka KV, Hohifeld RR. Corticosteroids for myasthenia gravis. Cochrane Database Syst Rev. 2005 Apr 18;(2):CD002828.
10. Hughes RA, Swan AV, van Koningsveld R, van Doorn PA. Corticosteroids for Guillain-Barré syndrome. Cochrane Database Syst Rev 2006 Apr 19;(2): CD001446.
11. Singer DW, Rabe FE and Haller J. The effect of ACTH therapy upon Infantile spasms. The Journal of Pediatrics Volume 96;March 1980:pp 485-9.
12. Sher PK, Sheikh MR. Therapeutic efficacy of ACTH in symptomatic infantile spasms with hypsarrhythmia. Pediatric Neurology 1993 Nov-Dec; Vol 9:451-6.
13. Kusse MS, Huffelen AC, Nieuwenhuizen O et al. The effect of non-depot ACTH(1-24) on infantile spasms. Dev Med Child Neurol 1993 Dec. Volume 35: pp 1067-73.
14. Hrachovy RA, Frost JD, Kellaway P et al. A controlled study of ACTH therapy in infantile spasms. Epilepsia Dec 1980, Volume 21: pp 631-6. Pediatrics. March 1996; Volume 97: 375-9.
15. Yanagaki S, Oguni H, Hayashi K et al. A comparative study of high-dose and low-dose ACTH therapy for West Syndrome. Brain and Development; 1 October 1999; Volume 21: 461-467.
16. Hrachovy RA, Frost JD, Glaze DG. High-dose, long-duration versus low-dose, short-duration corticotropin therapy for infantile spasms. Journal of Pediatrics 1994 May; Volume 124; pp 803-6.
17. Snead CO, Benton WJ, Hosey CL et al. Treatment of infantile spasms with high-dose ACTH. Neurology 1989; Volume 39: pp 1027.
18. Vigevano F, Cilio MR. Vigabatrin versus ACTH as first-line treatment for infantile spasms: a randomized, prospective study. Epilepsia Dec1997; 38:1270-4.
19. Cossette P, Riviello J, Carmant L. ACTH versus vigabatrin therapy in infantile spasms: A retrospective study. Neurology 12 May 1999; Volume 52: 1691-1694.
20. Grasntrom ML, Gaily E, Liukkonen E, et al. Treatment of infantile spasms: results of a population-based study with vigabatrin as the first drug for spasms. Epilepsia 1999 July; Volume 40: pp 950-7.
21. Appleton RE, Peters AC, Mumford JP, et al. Randomised, placebo-controlled study of vigabatrin as first-line treatment of infantile spasms. Epilepsia 1999 Nov; Volume 40; pp 1627-33.
22. Riikonen R, Simell O. Tuberous sclerosis and infantile spasms. Dev Med Child Nuerol 1990 March. Volume 32; pp 203-9.
23. Chiron C, Dumas C, Jambaque I, et al. Randomized trial comparing vigabatrin and hydrocortisone in infantile spasms due to tuberous sclerosis. Epilepsy Res 1997 Jan; Volume 26: pp 389-95.
24. Nabbout R, Melki I, Gerbaka B, et al. Infantile spasms in Down syndrome: a good response to a short course of vigabatrin. Epilepsis 2001 Dec; Volume 42: pp 1580-3.
25. Baram TZ, Mitchell WG, Tournay A et al. High-dose corticotropin (ACTH) versus prednisone for infantile spasm: A prospective, randomized, blinded study.
26. Hrachovy RA, Frost JD, Kellaway P, et al. Double-lind study of ACTH vs. prednisone therapy in infantile spasms. J Pediatr 1983 Oct; Volume 103: pp 641-5.
27. Snead OC, Benton WJ, Myers JG. ACTH and prednisone in childhood seizure disorders. Neurology 1983; Volume 33: pp 966.
28. ClinicalTrials.gov. ACTH treatment of nephrotic range proteinuria in diabetic nephropathy (ACTH-NRDN). http://www.clinicaltrials.gov/ct2/show/NCT01028287?term=ACTH+gel&rank=5
29. Lowry F. FDA Advisory panel endorses Acthar Gel for infantile spasms. Medscape Medical News 2010. Available from: http://www.medscape.com/viewarticle/721587
30. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations. Corticotropin. Available at: http://www.thomsonhc.com. Accessed February 15, 2011.
31. Center for Drug Evaluation and Research. Approval Package for 022432Orig1s000. Available at http://www.citronresearch.com/wp-content/uploads/2012/07/Questcor-022432Orig1_Original_Approval_Pkg.pdf. Accessed on 8/12/2013
32. Goodin DS, Frohman EM, Garmany GP Jr, et al. Disease modifying therapies in multiple sclerosis: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines. Neurology. 2002 Jan 22;58(2):169-78.
33. Cortese I, Chaudhry V, So Y, Cantor F, Cornblath D, Rae-Grant A. Evidence-based guideline update: Plasmapheresis in neurologic disorders: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Neurology 2011:76(3):294.
34. Abbruzzese G, Gandolfo C, Loeb C. “Bolus” methylprednisolone versus ACTH in the treatment of multiple sclerosis. Ital J Neurol Sci. 1983 Jun; 4(2):169-72.
35. Milanese C, La Mantia L, Salmaggi A, et al. Double-blind randomized trial of ACTH versus dexamethasone versus methylprednisolone in multiple sclerosis bouts. Clinical, cerebrospinal fluid and neurophysiological results. Eur Neurol 1989;29(1):10-4.
36. Barnes M, Bateman D, Cleland P, Dick D, Walls T, Newman P, Saunders m, Tilley P. Intravenous methylprednisolone for multiple sclerosis in relapse. J Neurol Neurosurg Psychiatry 1985: 48(2):157-9.
37. Thompson A, Kennard C, Swash M, et al. Relative efficacy of intravenous methylprednisolone and ACTH in the treatment of acute relapse in MS. Neurology 1989: 39(7):969-71.
38. Mackay MT, et al. Practice parameter: Medical treatment of infantils spasms. Neurology 2004; 62: 1668-1681.
39. Clinical Trials.gov. Acthar Gel. Available at [http://clinicaltrials.gov]. Accessed on January 2020.
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |