CurrentMass General Brigham Health PlanPolicy N/A

Xatmep (methotrexate oral solution) prior authorization

Defines prior authorization requirements for Xatmep (oral methotrexate solution) under the pharmacy benefit for Mass General Brigham Health Plan commercial/exchange members, including indications, continuation, and quantity limits.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXatmep (methotrexate oral solution) prior authorization

Policy CodePolicy N/A

Change TypeRevised

Effective DateJul 1, 2025

Next Review DateJun 11, 2025

Key ActionObtain prior authorization and document that generic methotrexate (oral and injectable) is inappropriate for the patient.

SourceLink

POLICY UPDATE CHANGES

Updated language for members who are new to the Plan specifying authorization may be granted for members new to the plan within the past 90 days who are currently receiving the requested medication.

12 monthsApproval duration

2 mL/dayQuantity limit

<13Age limit

2Covered indications

Coverage Criteria for Xatmep (methotrexate oral solution)

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Initial Therapy

Authorization may be granted when ALL of the following are met:

Initial Authorization for Xatmep: Member is less than 13 years of age

Diagnosis: Member has a diagnosis of acute lymphoblastic leukemia (ALL) OR polyarticular juvenile idiopathic arthritis (pJIA)

Therapeutic rationale: Clinical rationale that generic methotrexate tablets AND generic injectable methotrexate are not appropriate therapies

New-to-Plan Continuation

Covered for members new to the plan within past 90 days when:

New-to-Plan Continuity: Member is new to the plan within the past 90 days AND is currently receiving treatment with the requested medication

Excludes products obtained as samples or via manufacturer's patient assistance program.

Continuation of Therapy

Reauthorization will be approved when ALL of the following are met:

Reauthorization: Documentation of improvement of the member’s condition

Initial approvals and reauthorizations will be approved for 12 months per policy; see quantity limits for daily dosing cap.

Products obtained as samples or provided through a manufacturer's patient assistance program are excluded from the new-to-plan continuity authorization pathway. Authorization for members new to the plan within the past 90 days applies only when the member is currently receiving the requested medication and the product was not acquired as a sample or via the manufacturer's assistance program.

Initial Therapy

Initial authorization criteria

Initial: Member is less than 13 years of age AND Member has a diagnosis of acute lymphoblastic leukemia (ALL) OR polyarticular juvenile idiopathic arthritis (pJIA) AND Clinical rationale that generic methotrexate tablets AND generic injectable methotrexate are not appropriate therapies

Applies under pharmacy benefit prior authorization.

Continuation / Reauthorization

Continuation

Reauthorization criteria and limits

Continuation: Documentation of improvement of the member’s condition

Approvals (initial and reauthorization) are for 12 months; follow quantity limit of 2 mL per day for Xatmep oral solution.

Provider Actions and Requirements

Prior Authorization

Prior Authorization Required

Prior authorization required under the pharmacy benefit for commercial/exchange members.

Effective Date: 2025-07-01
Benefit: Pharmacy Benefit
Program Type: Prior Authorization

Step Therapy

Step therapy

No step therapy program is specified for Xatmep in this policy. Providers should not be expected to complete prior step edits for this product under the policy.

Documentation Required

Reauthorization documentation

For reauthorization, provide documentation of improvement of the member's condition.

Reauthorization requirement applies to continuation of therapy requests

Denial Risk

Failure to justify alternatives

Requests lacking documentation that both generic methotrexate tablets and generic injectable methotrexate are inappropriate may be denied.

Applicable when initial authorization criteria are evaluated: provider must state why both alternatives are unsuitable

Definitions and Indications

ALL — Acute lymphoblastic leukemia (pediatric maintenance)

IndicationAcute lymphoblastic leukemia (ALL) — as part of a combination chemotherapy maintenance regimen

Age requirementMember is less than 13 years of age

Therapy requirementClinical rationale that generic methotrexate tablets and generic injectable methotrexate are not appropriate

Authorization typePrior authorization required under the pharmacy benefit for commercial/exchange members

pJIA — Polyarticular juvenile idiopathic arthritis (pediatric)

IndicationPolyarticular juvenile idiopathic arthritis (pJIA) — pediatric patients with active disease intolerant of or inadequately responsive to first-line therapy

Age requirementMember is less than 13 years of age

Therapy requirementClinical rationale that generic methotrexate tablets and generic injectable methotrexate are not appropriate

Authorization typePrior authorization required under the pharmacy benefit for commercial/exchange members

Background

Methotrexate is a folate analog antimetabolite used in pediatric oncology and rheumatology. In this policy, methotrexate (Xatmep oral solution) is positioned for use in pediatric patients as part of maintenance chemotherapy for acute lymphoblastic leukemia (ALL) and for management of polyarticular juvenile idiopathic arthritis (pJIA) when first-line therapy is inadequate or not tolerated. The oral liquid formulation provides a suitable option for children who cannot reliably take tablets.

Policy Summary

PayerMass General Brigham Health Plan

PolicyXatmep (methotrexate oral solution) prior authorization

Policy CodePolicy N/A

Change TypeRevised

Effective DateJul 1, 2025

Next Review DateJun 11, 2025

Key ActionObtain prior authorization and document that generic methotrexate (oral and injectable) is inappropriate for the patient.

SourceLink

On This Page

OpenPayer

Xatmep (methotrexate oral solution) prior authorization

Coverage Criteria for Xatmep (methotrexate oral solution)

Initial Therapy

Continuation / Reauthorization

Quantity Limits

Provider Actions and Requirements

Definitions and Indications

Background