CurrentCignaPolicy ST0001

Methotrexate Injection Step Therapy

Cigna step therapy policy governing coverage of injectable methotrexate products for plans that adopt this policy, defining Step 1 (generic methotrexate injection vials) and Step 2 (Rasuvo) requirements and exceptions. Applies to outpatient pharmacy/medical benefit injectable methotrexate when the plan uses this step therapy rule.

Policy Summary

PayerCigna

PolicyMethotrexate Injection Step Therapy

Policy CodePolicy ST0001

Change TypeNew policy

Effective DateJul 1, 2025

Next Review Date

Key ActionIf the Step Therapy rule is not met at point of service, document trial of one Step 1 product or document inability of patient/caregiver to administer generic vial formulations to support approval of a Step 2 product.

POLICY UPDATE CHANGES

New policy effective 07/01/2025.

2Step Levels (Step 1 and Step 2)

1 yearTypical Approval Duration

3Products referenced

Coverage Summary

Coverage stance: covered_with_criteria. Scope: Cigna step therapy policy governing injectable methotrexate for plans that adopt this policy, defining Step 1 (generic methotrexate injection vials) and Step 2 (Rasuvo) requirements and exceptions, and applying to outpatient pharmacy/medical benefit injectable methotrexate when the plan uses this step therapy rule. Effective date: 07/01/2025 (new policy). Key thresholds: approvals are provided for 1 year in duration; typical maximum methotrexate dosing guidance is 25 to 30 mg/week.

Step Therapy / Medical Necessity

Methotrexate Injection Step Therapy Policy products are covered as medically necessary when the following step therapy criteria are met.

ALL of the following

Step Products
- Step 1: Generic methotrexate injection (single- or multi-dose vials)
- Step 2: Rasuvo
Approval conditions (either)
- Condition A: The patient has tried ONE Step 1 Product; approve a Step 2 Product.
- Condition B: According to the prescriber, the patient and/or caregiver is/are unable to administer generic methotrexate injection (single-dose or multi-dose vial NOT including Otrexup, Rasuvo, or RediTrex); approve a Step 2 Product.

Not Medically Necessary

Any exceptions other than the two listed above are considered not medically necessary.

ALL of the following

Not Medically Necessary: Any other exception is considered not medically necessary.

Provider Actions & Billing

Step Therapy

Step Therapy requirement at point of service

If the Step Therapy rule is not met for a Step 2 Product at the point of service, coverage will be determined by the Step Therapy criteria; prescribers must document trial of one Step 1 product or document inability of patient/caregiver to administer generic vial formulations.

Documentation Required

Documentation of administration ability

Prescriber attestation that patient and/or caregiver is unable to administer generic methotrexate injection vials is acceptable for bypassing Step 1 and approving Step 2.

Billing Rule

Use appropriate codes

When billing, providers must use the most appropriate codes as of the effective date; claims without covered diagnosis/procedure codes under this policy will be denied as not covered.

Operational note: All approvals under the Step Therapy rule are issued for 1 year. Per the criteria, a prescriber attestation that the patient and/or caregiver is unable to administer generic methotrexate vial formulations allows bypass of Step 1 and approval of a Step 2 product. This Step Therapy rule applies to outpatient pharmacy/medical benefit injectable methotrexate for plans that adopt the Cigna step therapy policy.

Applicable Codes & Products Referenced

Products referencedmixed

generic methotrexate injection	single-dose and multi-dose vials, methotrexate sodium solution for injection (various manufacturers)
Rasuvo	methotrexate subcutaneous injection autoinjector - Medac (Step 2)
Otrexup	methotrexate subcutaneous injection autoinjector - not addressed by this policy
RediTrex	preservative-free, single-dose injections for subcutaneous use - referenced

Clinical Evidence & Background

Background: Injectable methotrexate is used for inflammatory conditions (for example, rheumatoid arthritis, juvenile idiopathic arthritis, and plaque psoriasis). Dosing is initiated low and titrated gradually to achieve response and tolerability, generally up to about 25 to 30 mg/week, with flexibility for dose adjustments in 2.5-mg increments as needed. Some formulations (Otrexup, Rasuvo, RediTrex) are preservative-free, single-dose subcutaneous injections; generic methotrexate vials (single- and multi-dose) provide flexibility for dose adjustments. All injectable methotrexate products require patient/caregiver manual dexterity and training in sterile injection technique for self-administration.

References: Accord 2021; Otrexup PI 2022; Rasuvo PI 2023; RediTrex PI 2019; Clinical Pharmacology 2024.

Policy Background & Definitions

Scope and payer: This is a Cigna step therapy policy that governs coverage of injectable methotrexate products for plans that adopt the policy. Applicability: outpatient pharmacy/medical benefit injectable methotrexate when the plan uses this step therapy rule.

Term	Definition
Step 1 Product
Generic methotrexate injection (single- or multi-dose vials).
Step 2 Product
Rasuvo (methotrexate subcutaneous autoinjector).