Methotrexate Injectables – NC Standard

Restricted Product(s)

• Otrexup (methotrexate) subcutaneous auto-injector 
• Rasuvo (methotrexate) subcutaneous auto-injector 
• Reditrex (methotrexate) subcutaneous pre-filled syringe

FDA Approved Use

• 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. 
• Limitation of Use: Not indicated for the treatment of neoplastic diseases 

Criteria for Approval of Restricted Product(s)

1. The patient is requesting Otrexup (methotrexate) subcutaneous auto-injector or Reditrex (methotrexate) subcutaneous pre-filled syringe; AND 
   1. The patient has tried and failed or has a clinical contraindication/intolerance to generic methotrexate injection; OR 
2. The patient is requesting Rasuvo (methotrexate) subcutaneous auto-injector; AND 
   1. The patient has a diagnosis of severe, active rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), or severe, recalcitrant psoriasis; AND 
   2. The patient has tried and failed or has a clinical contraindication/intolerance to generic methotrexate injection; AND 
   3. The patient has tried and failed or has a clinical contraindication/intolerance to Otrexup (methotrexate) subcutaneous auto-injector; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

February 2025: Criteria change (Rasuvo): Removed Reditrex step requirement from Rasuvo.

June 2021: Criteria change: Reditrex only required to step through generic MTX injection. Rasuvo added requirement to also step through Reditrex. Decreased duration of approval to 365 days.

November 2020: Criteria update: Added new to market Reditrex prefilled syringes to the policy.

November 2020: Criteria update: Annual criteria review: Formatting changes only.

July 2019: Original utilization management criteria issued.