CurrentCignaPolicy ST0001

Methotrexate Injection Step Therapy

Step therapy coverage policy governing use of injectable methotrexate products (generic methotrexate injection and Rasuvo) for Cigna-administered health benefit plans; affects prescribers, patients, and claims/authorization reviewers.

Policy Summary

PayerCigna

PolicyMethotrexate Injection Step Therapy

Policy CodePolicy ST0001

Change TypeNew policy

Effective Date07/01/2025

Next Review Date

Key ActionDocument trial of one Step 1 generic methotrexate injection or a prescriber attestation of inability to administer the Step 1 vial to qualify for Step 2 (Rasuvo) coverage.

SourceLink

POLICY UPDATE CHANGES

New step therapy policy established for methotrexate injection with effective date 07/01/2025.

2Product steps

1 yearApproval duration

07/01/2025Effective

ST0001Policy #

Coverage Criteria — Methotrexate Injection Step Therapy

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Main step therapy requirements: Member meets one of the following: (A) patient has tried ONE Step 1 Product (generic methotrexate injection single- or multi-dose vial), OR (B) prescriber documents the patient and/or caregiver is unable to administer the Step 1 Product (vial; does NOT include Otrexup, Rasuvo, or RediTrex).

Approvals are provided for 1 year; any other exception is considered not medically necessary.

The use of Otrexup is not addressed in this policy. This step therapy program requires that a Step 1 Product (generic methotrexate injection in single- or multi-dose vials) be used prior to a Step 2 Product (Rasuvo) unless an approved exception applies. All approvals granted under this program are for 1 year. Note that, unless administered by a healthcare provider, injectable methotrexate products (including Rasuvo, Otrexup, and RediTrex) require patient training and sufficient manual dexterity for self-administration; inability to safely self-administer should be documented by the prescriber when relevant.

Exceptions to the Step Therapy sequence are limited. Coverage for a Step 2 Product will be approved only when the patient has either (A) tried ONE Step 1 Product (generic methotrexate injection single- or multi-dose vial) or (B) the prescriber documents that the patient and/or caregiver is unable to administer the Step 1 vial. Any other exception is considered not medically necessary and will not justify approval.

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required when the Step Therapy rule is not met at point of service. Coverage for a Step 2 product (Rasuvo) will be determined by the Step Therapy criteria below. All approvals are provided for 1 year in duration.

Approvals valid for 12 months
If Step Therapy rule not met at point of service, prior authorization required

Step Therapy

Defined Step Sequence

A defined two-step sequence must be followed before coverage of Step 2 products is approved. Step 1 must be attempted or documented as not feasible per prescriber statement.

Step 1: Generic methotrexate injection (single- or multi-dose vials)
Step 2: Rasuvo (methotrexate subcutaneous injection autoinjector - Medac)
Otrexup and RediTrex are not considered Step 1 for this policy

Documentation Required

Required Documentation for Approval

The prescriber must document either a trial of one Step 1 product or provide a clinical reason the patient or caregiver is unable to administer a Step 1 product (single- or multi-dose vial). This documentation is required for prior authorization approval.

Document trial of ONE Step 1 product (generic methotrexate injection, single- or multi-dose vial)
OR document why patient/caregiver cannot administer Step 1 (e.g., lack of manual dexterity, inability to be trained)
Note: Otrexup, Rasuvo, and RediTrex are excluded from Step 1 products

Denial Risk

Triggers for Denial

Claims for products/codes not covered by this policy or requests that do not meet the Step Therapy criteria will be denied as not covered.

Claims lacking covered diagnosis or procedure codes will be denied as not covered
Exceptions outside the stated criteria are considered not medically necessary

Key Definitions

inv-09: Step 1 Product — generic methotrexate injection

TermStep 1 Product

DefinitionGeneric methotrexate injection (single- or multi-dose vials).

Clinical noteAvailable as 25 mg/mL injection solution in single-dose and multi-dose vials; provides flexibility for dosing adjustments including 2.5-mg increments.

inv-10: Step 2 Product — Rasuvo

TermStep 2 Product

DefinitionRasuvo (methotrexate subcutaneous injection autoinjector - Medac).

Clinical noteRasuvo is a preservative-free, single-dose subcutaneous autoinjector; requires patient/caregiver manual dexterity and injection training unless administered by a healthcare provider.

inv-11: Otrexup / RediTrex

TermOtrexup / RediTrex

DefinitionAlternate single-dose subcutaneous methotrexate autoinjector products; Otrexup is not addressed by this policy.

Clinical noteOtrexup, Rasuvo, and RediTrex are preservative-free single-dose subcutaneous injections; policy directs use of other formulations when non-subcutaneous routes or dose increments <2.5 mg are needed.

Background

Methotrexate is used in inflammatory conditions such as rheumatoid arthritis, juvenile idiopathic arthritis, and plaque psoriasis and is available in injectable formulations for subcutaneous use. Dosing is typically started low and titrated, with common weekly targets up to about 25–30 mg/week and flexibility in small increments. Injectable products include vials (single- or multi-dose) and single-dose autoinjectors; because some autoinjector products are preservative-free and require patient or caregiver injection ability, prescriber documentation of inability to administer vials is an accepted justification to move to a Step 2 Product under this policy.