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Corticotropin Prior Authorization Program Summary
Policy Number: PH-1046
This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx, and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
10-01-2024 |
04-01-2012 |
FDA LABELED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Acthar® Gel (repository corticotropin) Intramuscular (IM) or Subcutaneous (SQ) injection |
Infantile Spasm (IS) in infants and children under 2 years of age NOTE: Acthar is FDA approved for numerous indications, however, the FDA has only evaluated clinical trials in infants under 2 years of age with infantile spasms (7,8) Indicated in the following disorders:
|
|
1 |
Purified Cortrophin™ Gel (repository corticotropin) Intramuscular (IM) or Subcutaneous (SQ) injection |
Indicated in the following disorders:
|
|
9 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
CLINICAL RATIONALE |
Infantile spasm (IS), also referred to as West Syndrome, is a specific seizure syndrome that is characterized by clinical flexor or extensor spasms, often involving the extremities and head/neck; developmental regression (intellectual disability); and electroencephalography (EEG) finding of hypsarrhythmia (chaotic brain waves).(2,3) Neurological and/or developmental outcomes in patients with IS are usually poor. Children with symptomatic spasms more frequently exhibit neurological deficits and cognitive and developmental delays, while a higher percentage of patients with idiopathic/cryptogenic IS may have a normal or near-normal outcome if appropriate treatment is initiated in a timely fashion. Goals of therapy for IS includes complete cessation of clinical events and resolution of hypsarrhythmia or modified hypsarrhythmia on video EEG.(3)
Guidelines recommend ACTH and vigabatrin for the treatment of infantile spasms. Both ACTH and vigabatrin may be useful for short-term treatment, but ACTH is preferred over vigabatrin, except in patients with tuberous sclerosis. Hormonal therapy (ACTH or prednisolone) has been shown to lead to better neurodevelopmental outcomes in patients with cryptogenic IS when compared to vigabatrin.(2,3) Guidelines recommend treating for 14 days and then tapering down, as response is typically seen within 14 days or sooner. Low dose ACTH is probably as effective as high-dose ACTH therapy and should be considered as an alternative to high dose therapy.(2) A 2010 U.S. consensus statement suggests initiating a taper of ACTH after two weeks of therapy at the maximum dose. No data is available to guide therapy in relapse in patients who responded to an initial treatment course. Typically, a second course (four to six weeks) of the agent that was previously effective in obtaining control is administered.(4) |
Efficacy |
Acthar Gel was first approved in 1952 prior to the 1962 drug amendments requiring clinical trials proving safety and efficacy.(1,5) There are numerous phase 4 clinical trials indicating there is no difference in efficacy between corticosteroids and corticotropin for rheumatoid arthritis, lupus, multiple sclerosis, pulmonary sarcoidosis, and nephrotic syndrome.(6)
The effectiveness of Acthar Gel as a treatment for infantile spasms was demonstrated in a single blinded (video EEG interpreter blinded) clinical trial in which patients were randomized to receive either a 2 week course of treatment with Acthar Gel (75 U/m^2 intramuscular twice daily) or prednisone (1 mg/kg by mouth twice daily). The primary outcome was a comparison of the number of patients in each group who were treatment responders, defined as a patient having complete suppression of both clinical spasms and hypsarrhythmia on a full sleep cycle video EEG performed 2 weeks following treatment initiation, rated by an investigator blinded to treatment. Thirteen of 15 patients (86.7%) responded to Acthar Gel as compared to 4 of 14 patients (28.6%) given prednisone (p<0.002). The 2-week treatment was followed by a 2-week period of taper. Non-responders to the prednisone treatment were eligible to receive Acthar Gel treatment. Seven of 8 patients (87.5%) responded to Acthar Gel after not responding to prednisone. Similarly, the 2 non-responder patients from the Acthar Gel treatment were eligible to receive treatment with prednisone. One of the 2 patients (50%) responded to the prednisone treatment after not responding to Acthar Gel.(1)
A supportive single-blind, randomized clinical trial comparing high-dose, long-duration treatment (150 U/m^2 once daily for 3 weeks, n=30) of Acthar Gel with low-dose, short duration treatment (20 U once daily for 2 weeks, n=29) for the treatment of infantile spasms was also evaluated in infants and children less than 2 years of age. Non-responders (defined as in the previously described study) in the low-dose group received a dose escalation at 2 weeks to 30 U once daily. Nominal statistical superiority of the high dose treatment, as compared to the low dose treatment, was observed for cessation of spasms but not for the resolution of hypsarrhythmia.(1)
There is no clinical data for the FDA indication for Cortrophin Gel. No additional clinical trials for Cortrophin were completed to show efficacy for the approved indications.(9)
|
Safety |
Acthar Gel is contraindicated in the following:(1)
Purified Cortrophin gel is contraindicated in the following:(9)
|
REFERENCES
Number |
Reference |
1 |
Acthar Gel Prescribing Information. Mallinckrodt ARD, Inc. October 2021. |
2 |
Go, CY, Mackay MT, Weiss SK, Weiss SK, et al. Evidence-based guideline update: Medical treatment of infantile spasms: American Academy of Neurology. Neurology 2012;78;1974-1980 |
3 |
Nelson, Gary Rex. Management of Infantile Spasms. Transl Pedatr. 2015;4(4):260-270. |
4 |
Pellock JM, Hrachovy R, Shinnar S, et al. Infantile spasms: a U.S. consensus report. Epilepsia 2010; 51:2175. |
5 |
White Junod, S. (2008). FDA and Clinical Drug Trials: A Short History. Washington. https://www.fda.gov/media/110437/download. |
6 |
Facts About Acthar Gel: Mallinckrodt Pharmaceuticals. Mallinckrodt. (n.d.). https://www.mallinckrodt.com/about/acthar/. |
7 |
U.S. Food and Drug Administration. Center for Drug Evaluation and Research. (2010). Application 022432Orig1s000 Internal Consult on draft labeling (Package Insert) for H.P. Acthar Gel. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432Orig1s000OtherR.pdf |
8 |
8. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. (2010). Application 022432Orig1s000 Action Memo for NDA 22-432, for the use of H.P. Acthar Gel (repository corticotrophin injection) in the treatment of Infantile Spasms (IS). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022432Orig1s0900SumR.pdf |
9 |
Cortrophin Gel prescribing information. ANI Pharmaceuticals, Inc. November 2021. |
10 |
|
POLICY AGENT SUMMARY PRIOR AUTHORIZATION
Target Brand Agent(s) |
Target Generic Agent(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Acthar gel |
corticotropin subcutaneous gel auto-injector |
40 UNIT/0.5ML ; 80 UNIT/ML |
M ; N ; O ; Y |
N |
|
|
Acthar ; Cortrophin |
Corticotropin Inj Gel 80 Unit/ML |
80 UNIT/ML |
M ; N ; O ; Y |
N |
|
1. Preferred |
Acthar ; Cortrophin |
Corticotropin Inj Gel 80 Unit/ML |
80 UNIT/ML |
M ; N ; O ; Y |
N |
|
2. Non-Preferred |
CLIENT SUMMARY – PRIOR AUTHORIZATION
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Acthar gel |
corticotropin subcutaneous gel auto-injector |
40 UNIT/0.5ML ; 80 UNIT/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Acthar ; Cortrophin |
Corticotropin Inj Gel 80 Unit/ML |
80 UNIT/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Acthar ; Cortrophin |
Corticotropin Inj Gel 80 Unit/ML |
80 UNIT/ML |
Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
PRIOR AUTHORIZATION CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||||
|
Target Agent(s) will be approved when ALL of the following are met:
Length of Approval: 6 months *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. Target Agent(s) will NOT be approved and are NOT medically necessary for all other indications including but not limited to:
The effectiveness of repository corticotropin has not been demonstrated as clinically superior to conventional corticosteroids and/or immunosuppressive therapy for uses other than infantile spasms. |
This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.
Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.
ALBP _ Commercial _ CSReg _ Corticotropin__PA _ProgSum_ 10-01-2024 _ © Copyright Prime Therapeutics LLC. July 2024 All Rights Reserved