methotrexate injectable agents (REDITREX, OTREXUP, RASUVO)

methotrexate injectable agents (REDITREX, OTREXUP, RASUVO) 

Self-Administered - subcutaneous injection

Diagnosis considered for coverage:

• Management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy.
• Symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

Coverage Criteria:

For request of subcutaneous formulation of methotrexate (e.g., Otrexup, Rasuvo, Reditrex):

• Diagnosis of one of the following as supported my medical records:
  • Severe, active rheumatoid arthritis
  • Polyarticular juvenile idiopathic arthritis
  • Severe, recalcitrant, disabling psoriasis; AND
• Intolerant of or had an inadequate response to a first-line therapy for the medical condition; AND
• One of the following:
  • Failure or clinically significant adverse effects to generic methotrexate injection,
  • Medical justification why generic methotrexate injection cannot be used as supported by medical records (e.g. inability to use syringe and vial due to severe disfiguring, disabling condition)

Reauthorization Criteria:

For request of subcutaneous formulation of methotrexate (e.g., Otrexup, Rasuvo, Reditrex):

• Documentation shows a positive clinical response to therapy.

Coverage Duration:

• One year

Authorization is not covered for the following:

• The following conditions, and other uses of this drug for indications not listed in this policy, do not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics Committee.
  • Rasuvo, Otrexup, and Reditrex are not indicated for the treatment of neoplastic diseases.

Additional Information:

• Dose recommendations for subcutaneous methotrexate agents (Otrexup, Rasuvo, and Reditrex):
  • Starting doses:
    • RA: 7.5 mg once weekly
    • pJIA: 10 mg/m² once weekly
    • Psoriasis: 10-25 mg once weekly
  • Adjust dose gradually to achieve an optimal response.
  • Use a different formulation of methotrexate (e.g., oral, intramuscular, intravenous, intra-arterial, or intrathecal) if doses of less than 7.5 mg or greater than 30 mg, or dose adjustments of less than 2.5 mg are needed.
• Availability:
  • Otrexup: Autoinjector that administers a single 0.4 mL dose: 10 mg/0.4mL methotrexate, 15 mg/0.4mL methotrexate, 20 mg/0.4mL methotrexate, 25 mg/0.4mL methotrexate
  • Rasuvo: Preservative-free sterile solution for a single subcutaneous injection: 7.5 mg/0.15 mL, 10 mg/0.20 mL, 12.5 mg/0.25 mL, 15 mg/0.30 mL, 17.5 mg/0.35 mL, 20 mg/0.40 mL, 22.5 mg/0.45 mL, 25 mg/0.5 mL, 27.5 mg/0.55 mL, 30 mg/0.60 mL
  • Reditrex: Preservative-free sterile solution for a single subcutaneous injection: 7.5 mg/0.3 mL, 10 mg/0.4 mL, 12.5 mg/0.5 mL, 15 mg/0.6 mL, 17.5 mg/0.7 mL, 20 mg/0.8 mL, 22.5 mg/0.9 mL, 25 mg/1 mL

Policy Updates:

• 08/28/2020 - no changes to criteria; formatting updated
• 08/16/2022 - removed prior authorization requirement for generic methotrexate injection vials; add Reditrex to existing injectable methotrexate agent policy; add requirement for trial of first-line therapy in line with the packages’ labeling.