Centene Methotrexate Coverage & Prior Auth Update | OpenPayer

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Centene Methotrexate Coverage & Prior Auth Update | OpenPayer

Initial therapy — Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Covered when ALL of the following are met:

pJIA initial criteria: 1) Diagnosis of polyarticular juvenile idiopathic arthritis (pJIA). 2) Prescribed by or in consultation with a rheumatologist. 3) Product and age requirements: for Otrexup, Rasuvo, or Reditrex: age >= 2 years; for Xatmep or Jylamvo: age < 18 years. 4) For Xatmep or Jylamvo: documentation supports inability to swallow pills. 5) For Otrexup, Rasuvo, or Reditrex: trial and failure of generic methotrexate injection unless contraindicated or clinically significant adverse effects are experienced. 6) Dose does not exceed product-specific limits: Otrexup/Rasuvo/Reditrex: 20 mg per week; Xatmep/Jylamvo: 30 mg per week.see dosing section

Prescriber specialty and prior generic injectable trial requirements apply.

Initial therapy — Rheumatoid Arthritis (RA) or Psoriasis (PsO)

Covered when ALL of the following are met:

RA/PsO initial criteria: 1) Diagnosis of rheumatoid arthritis (RA) or psoriasis (PsO). 2) Request is for Otrexup, Rasuvo, Reditrex, or Jylamvo. 3) Prescribed by or in consultation with an appropriate specialist (RA: rheumatologist; PsO: rheumatologist or dermatologist). 4) Age requirements: for Otrexup, Rasuvo, or Reditrex: age >= 18 years; for Jylamvo: age >= 18 years. 5) For Otrexup, Rasuvo, or Reditrex: trial and failure of generic methotrexate injection unless contraindicated or clinically significant adverse effects are experienced. 6) For Jylamvo: documentation supports inability to swallow pills. 7) Dose does not exceed 30 mg per week.30 mg/week (many adult indications)

Initial therapy — Acute Lymphoblastic Leukemia (ALL)

Covered when ALL of the following are met:

ALL initial criteria: 1) Diagnosis of acute lymphoblastic leukemia (ALL). 2) Request is for Xatmep or Jylamvo. 3) Documentation supports inability to swallow pills. 4) Prescribed by or in consultation with an oncologist or hematologist. 5) Requested dose/regimen is supported by practice guidelines or peer-reviewed literature (prescriber to submit supporting evidence). 6) Dose does not exceed 20 mg/m^2 per week unless supported by guidelines or published literature.20 mg/m^2 per week unless guideline-supported

Prescribed regimen must be FDA‑approved or recommended by NCCN per approval duration guidance.

Initial therapy — Mycosis Fungoides (MF)

Covered when ALL of the following are met:

MF initial criteria: 1) Diagnosis of mycosis fungoides (MF). 2) Request is for Jylamvo. 3) Prescribed by or in consultation with an oncologist or hematologist. 4) Age >= 18 years. 5) Documentation supports inability to swallow pills. 6) Request meets one of the dosing options: a) single-agent dosing does not exceed 75 mg per week; or b) as part of combination chemotherapy, does not exceed 10 mg/m^2 twice weekly; or c) dose/regimen is supported by practice guidelines or peer-reviewed literature (prescriber to submit supporting evidence).75 mg/week (single agent) or 10 mg/m^2 twice weekly (combination)

Initial therapy — Non-Hodgkin Lymphoma (NHL)

Covered when ALL of the following are met:

NHL initial criteria: 1) Diagnosis of relapsed or refractory non-Hodgkin lymphoma (NHL). 2) Request is for Jylamvo. 3) Prescribed by or in consultation with an oncologist or hematologist. 4) Documentation supports inability to swallow pills. 5) Age >= 18 years. 6) Request meets one of the following: a) dose does not exceed 10 mg per week; or b) dose/regimen is supported by practice guidelines or peer-reviewed literature (prescriber to submit supporting evidence).10 mg/week (common limit)

Initial therapy — Other or off-label uses

Covered when one of the following is met:

Other or off-label uses: 1) Use corresponds to a newly approved indication, age expansion, or dosing regimen that is not yet reflected in this policy and the provider follows the referenced no‑coverage or non‑formulary policy for the relevant line of business; OR 2) If the requested use is not listed under this policy, the request follows the applicable off‑label use policy for the line of business (prescriber must submit supporting evidence).N/A

References: CP.CPA.190, HIM.PA.103, CP PMN.16, CP.CPA.09, HIM.PA.154, CP.PMN.53 as applicable.

General coverage conditions — product- and indication-specific; subject to formulary and prior authorization

Coverage is product- and indication-specific and subject to formulary status and prior authorization

General coverage rules: Coverage requires that the requested diagnosis/indication be FDA‑approved for the requested product or supported by documentation per the applicable off‑label policy; non‑formulary uses must follow the referenced non‑formulary/no‑coverage policies; prior authorization is required and approval durations vary by line of business.

See the referenced Centene policies for off‑label and non‑formulary requirements and submit supporting clinical documentation (office notes, labs, etc.).

Otrexup, Rasuvo, and Reditrex are not indicated for the treatment of neoplastic diseases. This limitation of use is specified in the product labeling and applies regardless of requested oncology-related diagnoses; requests for these brand injectable formulations for cancer treatment are not supported by the manufacturers' indications.

Non–FDA‑approved indications that are not specifically addressed in this policy are excluded from coverage unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policy: CP.CPA.09 (commercial), HIM.PA.154 (health insurance marketplace), or CP.PMN.53 (Medicaid). Requests for off‑label use must follow those referenced policies and include supporting clinical evidence as required.

Otrexup, Rasuvo, and Reditrex are not indicated for treatment of neoplastic diseases. This statement is reiterated in the policy's general information appendix to emphasize that these specific branded injectables should not be used for oncology indications absent a separate, supported rationale.

Requests for non‑FDA‑approved uses that lack sufficient evidence per the referenced off‑label policies may be considered not medically necessary. Providers should follow the off‑label use and non‑formulary/no‑coverage policies referenced in this document and submit clinical documentation (office notes, labs, guideline citations) to support any non‑labeled indication.

Initial Therapy — Indication- and Product-specific Criteria

Initial therapy — umbrella prescriber specialty, age, prior generic failure, and product specificity

Initial therapy approvals are indication- and product-specific and require prescriber specialty, age, prior generic failure (for some injectables), and product specificity

Prescriber and product requirements (umbrella): 1) Prescriber specialty requirement: initial requests must be prescribed by or in consultation with the specialty appropriate to the indication (e.g., rheumatologist for pJIA/RA; dermatologist or rheumatologist for PsO; oncologist/hematologist for ALL, MF, NHL). 2) Age and product mapping: apply product‑specific age limits per indication (see per‑indication criteria). 3) For branded injectable products (Otrexup, Rasuvo, Reditrex), prior trial and failure of a generic methotrexate injectable is required unless contraindicated or clinically significant adverse effects are documented. 4) For oral solution products (Xatmep, Jylamvo), document inability to swallow tablets when used for pediatric or other applicable populations.

Refer to indication-specific criteria for exact age and dose limits.

Initial dosing by product/indication

Product- and indication-specific initial dosing is listed in the dosing section; examples summarized below

Initial dosing by product/indication (examples): Examples: Otrexup/Rasuvo/Reditrex (SC injection): pJIA: SC once weekly up to 20 mg/week; RA: 7.5 mg SC once weekly up to 30 mg/week; PsO: 10–25 mg SC once weekly up to 30 mg/week. Xatmep (oral solution): pJIA: 10 mg/m^2 PO once weekly up to 30 mg/week; ALL: 20 mg/m^2 PO once weekly (max 20 mg/m^2 unless guideline‑supported). Jylamvo (oral solution): pJIA: 10 mg PO once weekly up to 30 mg/week; MF: 25–75 mg PO once weekly (single agent) or 10 mg PO twice weekly as combination (max 75 mg/week or 10 mg/m^2 twice weekly); NHL: 2.5 mg PO two to four times weekly (commonly up to 10 mg/week).See dosing section for product‑specific maxima

Dosing varies by indication and product; prescriber must justify doses above listed maxima with guidelines or literature.

Provider Actions and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required. Approvals are granted when indication-specific criteria in the policy are met.

Prior authorization required for Otrexup, Rasuvo, Xatmep, Reditrex, and Jylamvo

Documentation Required

Documentation Requirement

Provider must submit supporting clinical documentation (e.g., office chart notes, lab results, imaging, progress notes) to demonstrate the member meets all approval criteria. Failure to submit required documentation may result in denial or delay of the request.

Examples of acceptable documentation: office notes, laboratory results, imaging reports, specialist consultation notes

Denial Risk

Off‑label Use Denial Risk

Off-label or non‑formulary uses may be denied if the requested indication, age, or dosing regimen is non‑FDA approved and not specifically addressed in this policy unless sufficient documentation of efficacy and safety is provided per the applicable off‑label use policy.

Non‑FDA approved indications not addressed in this policy require evidence per off‑label policy

Note

Formulary / Non‑Formulary Routing

If the requested use is for a drug on the formulary/PDL, follow the no‑coverage criteria policy for the applicable line of business. If the drug is not on the formulary/PDL, route requests to the non‑formulary policy for the applicable line of business.

Formulary routing: follow CP.CPA.190 (commercial), HIM.PA.33 (marketplace), CP.PMN.255 (Medicaid)
Non‑formulary routing: follow CP.CPA.190 (commercial), HIM.PA.103 (marketplace), CP.PMN.16 (Medicaid)

Step Therapy

Step‑Therapy Requirement for Branded Injectables

For branded injectable methotrexate products (Otrexup, Rasuvo, Reditrex), documentation must show failure of a generic methotrexate injectable prior to approval unless the generic is contraindicated or the member experienced clinically significant adverse effects.

Failure of generic methotrexate injection required prior to branded injectable approval unless contraindicated or adverse effects documented

Documentation Required

Required Documentation for Off‑Label or Non‑Formulary Use

For off‑label or non‑formulary requests, submit the same clinical documentation plus literature, study data, or rationale demonstrating efficacy and safety per the referenced off‑label/non‑formulary policies. Refer to the policy specific to the line of business for required evidence standards.

Provide clinical rationale, supporting literature, and prior treatment history for off‑label or non‑formulary use requests

Step Therapy Requirements

Step	Requirement	Notes
1	Prior trial of generic injectable methotrexate required before approval of Otrexup, Rasuvo, or Reditrex	Failure of generic methotrexate injection must be documented unless contraindicated or clinically significant adverse effects occurred (see initial therapy criteria).

Step	Routing requirement	Action
1	Off-formulary, not on PDL, or recent label change (within last 6 months)	Follow the referenced no-coverage, non‑formulary, or off‑label use policy for the applicable line of business (see CP.CPA.190, HIM.PA.103, CP PMN.16, CP.PMN.53, HIMPA.33, CP PMN.255) prior to coverage determination.