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Methotrexate Injectable Step Therapy Program Summary
Policy Number: PH-1014
This program applies to Blue Partner, Commercial, NetResults A Series, SourceRx and Health Insurance Marketplace formularies.
POLICY REVIEW CYCLE
Effective Date |
Date of Origin |
04-01-2024 |
07-01-2015 |
FDA APPROVED INDICATIONS AND DOSAGE
Agent(s) |
FDA Indication(s) |
Notes |
Ref# |
Otrexup® |
Management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an inadequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs). |
|
1 |
Rasuvo® |
Management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an inadequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs). |
|
2 |
RediTrex® |
Management of selected adults with severe, active rheumatoid arthritis (RA) (ACR criteria), or children with polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an inadequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs). |
|
7 |
See package insert for FDA prescribing information: https://dailymed.nlm.nih.gov/dailymed/index.cfm
CLINICAL RATIONALE
Methotrexate |
Methotrexate (MTX) is commonly used for the treatment of patients with rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), psoriasis, and other forms of autoimmune disease.(3) Methotrexate inhibits dihydrofolic acid reductase. Dihydrofolates must be reduced to tetrahydrofolates by this enzyme before they can be utilized as carriers of one-carbon groups in the synthesis of purine nucleotides and thymidylate. Therefore, methotrexate interferes with DNA synthesis, repair, and cellular replication. Actively proliferating tissues such as malignant cells, bone marrow, fetal cells, buccal and intestinal mucosa, and cells of the urinary bladder are in general more sensitive to this effect of methotrexate.(1,2,7) |
Safety |
Otrexup, Rasuvo, and RediTrex have a boxed warning for the following:(1,2,7)
Otrexup, Rasuvo, and RediTrex have the following contraindications:(1,2,7)
|
REFERENCES
Number |
Reference |
1 |
Otrexup prescribing information. Antares Pharma, Inc. December 2019. |
2 |
Rasuvo prescribing information. Medac Pharma Inc. March 2020. |
3 |
Vena, G. A., Cassano, N., & Iannone, F. (2018). Update on subcutaneous methotrexate for inflammatory arthritis and psoriasis. Therapeutics and Clinical Risk Management, 14, 105–116. https://doi.org/10.2147/tcrm.s154745 |
4 |
Bianchi, G., Caporali, R., Todoerti, M., & Mattana, P. (2016). Methotrexate and rheumatoid arthritis: Current evidence regarding subcutaneous versus oral routes of administration. Advances in Therapy, 33(3), 369–378. https://doi.org/10.1007/s12325-016-0295-8 |
5 |
Brooks, P. J., Spruill, W. J., Parish, R. C., & Birchmore, D. A. (1990). Pharmacokinetics of Methotrexate Administered by Intramuscular and Subcutaneous Injections in Patients with Rheumatoid Arthritis. Arthritis & Rheumatology, 33(1), 91–94. https://doi.org/10.1002/art.1780330112 |
6 |
Saraux A, Hudry C, Zinovieva E, et al. Use of Auto-Injector for Methotrexate Subcutaneous Self-Injections: High Satisfaction Level and Good Compliance in SELF-I Study, a Randomized, Open-Label, Parallel Group Study. Rheumatol Ther. 2019;6(1):47-60. Available at: www.ncbi.nlm.nih.gov/pmc/articles/PMC6393262/. |
7 |
RediTrex prescribing information. Cumberland Pharmaceuticals Inc. March 2023. |
POLICY AGENT SUMMARY STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Targeted MSC |
Available MSC |
Final Age Limit |
Preferred Status |
|
||||||
Otrexup |
methotrexate soln pf auto-injector |
20 MG/0.4ML |
M ; N ; O |
N |
|
|
Otrexup |
Methotrexate Soln PF Auto-Injector 10 MG/0.4ML |
10 MG/0.4ML |
M ; N ; O |
N |
|
|
Otrexup |
Methotrexate Soln PF Auto-Injector 12.5 MG/0.4ML |
12.5 MG/0.4ML |
M ; N ; O |
N |
|
|
Otrexup |
Methotrexate Soln PF Auto-Injector 15 MG/0.4ML |
15 MG/0.4ML |
M ; N ; O |
N |
|
|
Otrexup |
Methotrexate Soln PF Auto-Injector 17.5 MG/0.4ML |
17.5 MG/0.4ML |
M ; N ; O |
N |
|
|
Otrexup |
Methotrexate Soln PF Auto-Injector 22.5 MG/0.4ML |
22.5 MG/0.4ML |
M ; N ; O |
N |
|
|
Otrexup |
Methotrexate Soln PF Auto-Injector 25 MG/0.4ML |
25 MG/0.4ML |
M ; N ; O |
N |
|
|
Rasuvo |
methotrexate soln pf auto-injector |
20 MG/0.4ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 10 MG/0.2ML |
10 MG/0.2ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 12.5 MG/0.25ML |
12.5 MG/0.25ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 15 MG/0.3ML |
15 MG/0.3ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 17.5 MG/0.35ML |
17.5 MG/0.35ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 22.5 MG/0.45ML |
22.5 MG/0.45ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 25 MG/0.5ML |
25 MG/0.5ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 30 MG/0.6ML |
30 MG/0.6ML |
M ; N ; O |
N |
|
|
Rasuvo |
Methotrexate Soln PF Auto-Injector 7.5 MG/0.15ML |
7.5 MG/0.15ML |
M ; N ; O |
N |
|
|
Reditrex |
methotrexate soln prefilled syringe |
10 MG/0.4ML ; 12.5 MG/0.5ML ; 15 MG/0.6ML ; 17.5 MG/0.7ML ; 20 MG/0.8ML ; 22.5 MG/0.9ML ; 25 MG/ML ; 7.5 MG/0.3ML |
M ; N ; O |
N |
|
|
CLIENT SUMMARY – STEP THERAPY
Target Brand Agent Name(s) |
Target Generic Agent Name(s) |
Strength |
Client Formulary |
Otrexup |
methotrexate soln pf auto-injector |
20 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otrexup |
Methotrexate Soln PF Auto-Injector 10 MG/0.4ML |
10 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otrexup |
Methotrexate Soln PF Auto-Injector 12.5 MG/0.4ML |
12.5 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otrexup |
Methotrexate Soln PF Auto-Injector 15 MG/0.4ML |
15 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otrexup |
Methotrexate Soln PF Auto-Injector 17.5 MG/0.4ML |
17.5 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otrexup |
Methotrexate Soln PF Auto-Injector 22.5 MG/0.4ML |
22.5 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Otrexup |
Methotrexate Soln PF Auto-Injector 25 MG/0.4ML |
25 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
methotrexate soln pf auto-injector |
20 MG/0.4ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 10 MG/0.2ML |
10 MG/0.2ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 12.5 MG/0.25ML |
12.5 MG/0.25ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 15 MG/0.3ML |
15 MG/0.3ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 17.5 MG/0.35ML |
17.5 MG/0.35ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 22.5 MG/0.45ML |
22.5 MG/0.45ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 25 MG/0.5ML |
25 MG/0.5ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 30 MG/0.6ML |
30 MG/0.6ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Rasuvo |
Methotrexate Soln PF Auto-Injector 7.5 MG/0.15ML |
7.5 MG/0.15ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
Reditrex |
methotrexate soln prefilled syringe |
10 MG/0.4ML ; 12.5 MG/0.5ML ; 15 MG/0.6ML ; 17.5 MG/0.7ML ; 20 MG/0.8ML ; 22.5 MG/0.9ML ; 25 MG/ML ; 7.5 MG/0.3ML |
Blue Partner ; Commercial ; Health Insurance Marketplace ; NetResults A Series ; SourceRx |
STEP THERAPY CLINICAL CRITERIA FOR APPROVAL
Module |
Clinical Criteria for Approval |
||
ST (preferred agents) |
TARGET AGENT(S) Preferred Agent(s) Otrexup (methotrexate auto-injector) Non-preferred Agent(s) Rasuvo (methotrexate auto-injector)
Otrexup, RediTrex will be approved when ONE of the following is met:
Length of Approval: 12 months
Rasuvo will be approved when ONE of the following is met:
Length of Approval: 12 months *Step therapy requirement may not apply if a prior health plan paid for the medication - documentation of a paid claim may be required. |
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 _ CS _ Methotrexate_Injectable_ST _ProgSum_ 04-01-2024 _© Copyright Prime Therapeutics LLC. January 2024 All Rights Reserved