CurrentCignaPolicy ST001

Methotrexate Injection Step Therapy

Defines step therapy requirements for coverage of injectable methotrexate products (generic vials and Rasuvo) under Cigna-administered health benefit plans. Affects prescribers and pharmacists requesting coverage for injectable methotrexate.

Policy Summary

PayerCigna

PolicyMethotrexate Injection Step Therapy

Policy CodePolicy ST001

Change TypeNo material changes

Effective DateApr 15, 2026

Next Review DateMar 26, 2026

Key ActionPrior authorization is required for Step 2 product coverage and prescribers must document a trial of one Step 1 product or inability to administer Step 1 to support approval.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2step levels

1 yearapproval duration

RasuvoStep 2 product

genericStep 1 product

Coverage Criteria

Step Therapy criteria for Step 2 products

Policy Summary

PayerCigna

PolicyMethotrexate Injection Step Therapy

Policy CodePolicy ST001

Change TypeNo material changes

Effective DateApr 15, 2026

Next Review DateMar 26, 2026

Key ActionPrior authorization is required for Step 2 product coverage and prescribers must document a trial of one Step 1 product or inability to administer Step 1 to support approval.

SourceLink

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Step therapy conditions: 1) Patient has tried ONE Step 1 Product (generic methotrexate injection single- or multi-dose vial). 2) Or, prescriber documents that the patient and/or caregiver is/are unable to administer generic methotrexate injection (single- or multi-dose vial) — excludes Otrexup, Rasuvo, and RediTrex.trial = one Step 1 product

Approvals provided for 1 year when criteria met; any other exception is considered not medically necessary.

The policy excludes certain autoinjector or prefilled systems from being treated as a Step 1 product. Specifically, Otrexup, Rasuvo, and RediTrex are not considered Step 1 vials. The program’s Step 1 product is defined as generic methotrexate injection (single- or multi-dose vials), and a formulation other than Otrexup, Rasuvo, or RediTrex should be used when route or dosing increments require it. Note that the policy does not address the use of Otrexup beyond stating it is not included as a Step 1 option. Also, unless administered by a healthcare provider, all injectable methotrexate products require patient or caregiver training in sterile injection technique and sufficient manual dexterity for self-injection.

Initial Therapy (Step 1)

Initial therapy (Step 1)

Step 1 requirement

Initial step: Use of generic methotrexate injection (single- or multi-dose vials) as Step 1 prior to Step 2 products.one trial

Generic injections provide dosing flexibility; approvals for Step 2 are given after trial of one Step 1 product or documented inability to administer the vial.

Step Therapy Requirements

Requirement	Details	Coverage
Trial of Step 1 product
Patient has tried ONE Step 1 Product: generic methotrexate injection (single- or multi-dose vial)
Coverage for Step 2 (Rasuvo) approved when requirement met
Documented inability to administer Step 1
Prescriber documents that the patient and/or caregiver is/are unable to administer generic methotrexate injection vial (excludes Otrexup, Rasuvo, RediTrex)
Coverage for Step 2 (Rasuvo) approved when documented inability is provided
Other exceptions
Any exception other than trial of one Step 1 product or documented inability to administer Step 1 is considered not medically necessary
Coverage when other exceptions claimed
Requests that do not meet the two specified conditions may be denied (not medically necessary)

Provider Actions and Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Step 2 products. Approvals are provided for 1 year when criteria are met.

Step 2 product prior authorization required
Approvals valid for 1 year

Step Therapy

Step Therapy Rule

This program requires use of a Step 1 product before coverage of a Step 2 product, unless a listed exception applies. Step 1 = Generic methotrexate injection (single- or multi-dose vials). Step 2 = Rasuvo. If the Step Therapy rule is not met at point of service, coverage will be determined by the Step Therapy criteria.

Step 1: Generic methotrexate injection (single- or multi-dose vials)
Step 2: Rasuvo
If step therapy rule not met at point of service, evaluate against step criteria

Documentation Required

Required Documentation and Denial Triggers

Prescribers must document either a trial of one Step 1 product or that the patient/caregiver is unable to administer the Step 1 product (excluding Otrexup, Rasuvo, and RediTrex). Requests lacking the required documentation or trial will be denied.

Document trial of ONE Step 1 product (generic methotrexate injection single- or multi-dose vial)
OR document that patient and/or caregiver is unable to administer the Step 1 product (note: excludes Otrexup, Rasuvo, RediTrex)
Requests without required trial or documentation will be denied
All other exceptions are considered not medically necessary

Definitions

Step 1 product definition: Generic methotrexate injection

TermGeneric methotrexate injection (single- or multi-dose vials)

Role in policyDesignated Step 1 product required to be tried before Step 2 (Rasuvo)

FormulationsAvailable as 25 mg/mL solution in single‑dose and multi‑dose vials; provides flexibility for dose adjustments (including 2.5‑mg increments)

Administration noteRequires patient or caregiver training in sterile injection technique and manual dexterity for self‑injection unless administered by a healthcare provider

Exceptions / substitutionsUse a formulation other than preservative‑free single‑dose autoinjectors (Otrexup, Rasuvo, RediTrex) when route or dosing increments require it

Step 2 product definition: Rasuvo

TermRasuvo (methotrexate subcutaneous injection autoinjector)

Role in policyDesignated Step 2 product requiring prior authorization and prior trial of a Step 1 vial (unless documented inability to administer Step 1)

FormulationPreservative‑free, single‑dose subcutaneous autoinjector

Approval durationApprovals provided for 1 year when step therapy criteria are met

Administration noteRequires patient or caregiver training in sterile injection technique and manual dexterity for self‑injection unless administered by a healthcare provider

Site of Care

Note

Require patient/caregiver sterile injection training for home use

Unless administered by a healthcare provider, patient or caregiver must receive training in sterile injection technique and have manual dexterity to self-inject prior to home administration of any injectable methotrexate product.

Applies to Rasuvo, Otrexup, RediTrex, and generic injectable methotrexate.

Background

Methotrexate injectable formulations are used as disease-modifying antirheumatic therapy for inflammatory conditions. This policy distinguishes between vial formulations and autoinjector systems: Step 1 consists of generic methotrexate injection (single- or multi-dose vials), which provide dosing flexibility and are the required initial therapy for the program. Step 2 is represented by Rasuvo (a methotrexate subcutaneous autoinjector). All approvals for Step 2 products are provided for 1 year when step therapy criteria are met. Injectable products, including Rasuvo, require proper patient or caregiver training in sterile injection technique unless administered by a healthcare provider; self-administration also requires adequate manual dexterity. The policy explicitly excludes Otrexup from Step 1 consideration and notes that Otrexup is not otherwise addressed by this policy.