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CareSource pralatrexate coverage update Prior Auth | OpenPayer

CurrentCareSourcePolicy N/A

Pralatrexate (Folotyn) utilization management

Defines prior authorization criteria, dosing, and coverage decisions for pralatrexate (Folotyn) for T-cell lymphomas and related indications for CareSource members and providers.

Policy Summary

PayerCareSource

PolicyPralatrexate (Folotyn) utilization management

Policy CodePolicy N/A

Change TypeDose additions (material)

Effective DateN/A

Next Review DateJun 5, 2024

Key ActionObtain prior authorization and document that the medication is prescribed by or in consultation with an oncologist and that the patient meets the specified age, diagnosis, line of therapy, single‑agent use, and dosing criteria.

SourceLink

POLICY UPDATE CHANGES

Cutaneous CD30+ T-Cell Lymphoproliferative Disorders: added 15 mg/m2 once weekly for 3 weeks in each 4-week cycle dosing regimen.

Mycosis Fungoides/Sezary Syndrome: added 15 mg/m2 once weekly for 3 weeks in each 4-week cycle dosing regimen.

1 yeartypical approval duration

30 mg/m2primary dosing

15 mg/m2alternate dosing

NCapplicable state

Recommended Authorization Criteria

Policy Summary

PayerCareSource

PolicyPralatrexate (Folotyn) utilization management

Policy CodePolicy N/A

Change TypeDose additions (material)

Effective DateN/A

Next Review DateJun 5, 2024

Key ActionObtain prior authorization and document that the medication is prescribed by or in consultation with an oncologist and that the patient meets the specified age, diagnosis, line of therapy, single‑agent use, and dosing criteria.

SourceLink

On This Page

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FDA-Approved Indication

Approve for 1 year if the patient meets ALL of the following (A–E):

FDA-approved T-cell lymphoma criteria: A) Age >= 18 years; B) Patient has peripheral disease; C) Patient has relapsed or refractory disease; D) Medication is used as a single agent; E) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 30 mg/m2 IV once weekly for 6 weeks in each 7-week cycle.

Other Uses with Supportive Evidence

Approve for 1 year if the patient meets ALL of the following for each listed indication:

Adult T-Cell Leukemia/Lymphoma: A) Age >= 18 years; B) Patient has acute or lymphoma subtype; C) Medication is used as second-line or subsequent therapy; D) Medication is used as a single agent; E) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 30 mg/m2 IV once weekly for 6 weeks in each 7-week cycle.

Breast Implant-Associated Anaplastic Large Cell Lymphoma: A) Age >= 18 years; B) Patient has relapsed or refractory disease; C) Medication is used as a single agent; D) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 30 mg/m2 IV once weekly for 6 weeks in each 7-week cycle.

Cutaneous CD30+ T-Cell Lymphoproliferative Disorders: A) Age >= 18 years; B) Patient has ONE of the following diagnoses: i) Primary cutaneous anaplastic large cell lymphoma with multifocal lesions; OR ii) Cutaneous anaplastic large cell lymphoma with regional nodes; C) Medication is used as a single agent; D) Medication is prescribed by or in consultation with an oncologist or dermatologist.

Dosing: Approve ONE of the following: Option A: up to 30 mg/m2 IV once weekly for 6 weeks in each 7-week cycle; OR Option B: 15 mg/m2 IV once weekly for 3 weeks in each 4-week cycle.

Extranodal NK/T-Cell Lymphoma: A) Age >= 18 years; B) Patient has relapsed/refractory disease following combination asparaginase-based chemotherapy; C) Medication is used as a single agent; D) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 30 mg/m2 IV once weekly for 6 weeks in each 7-week cycle.

Hepatosplenic T-Cell Lymphoma: A) Age >= 18 years; B) Medication is used as second-line or subsequent therapy; C) Medication is used as a single agent; D) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 30 mg/m2 IV once weekly for 6 weeks in each 7-week cycle.

Coverage is not recommended for requests that do not meet the criteria listed in the Recommended Authorization Criteria. Criteria will be updated as new published data become available; until then, requests outside the specified indications, dosing, age, line-of-therapy, or prescriber documentation requirements are not supported for approval.

Dosing Regimens and Administration

Regimen	Dose & Schedule	Indications / Notes
Alternate regimen (cutaneous indications)
15 mg/m2 IV once weekly for 3 weeks of a 4-week cycle
Specific to cutaneous CD30+ T‑cell lymphoproliferative disorders and Mycosis Fungoides/Sezary Syndrome as added in the 2023/2024 revision

Prescriber Requirements and Prior Authorization

Prior Authorization

Prior Authorization Required

Prior authorization is recommended for medical benefit coverage of pralatrexate. Approval is provided when the patient meets the Recommended Authorization Criteria and dosing described in the policy. Requests for doses or regimens outside those documented will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Approvals are time-limited as noted in the criteria. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with pralatrexate, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated (for example, an oncologist; dermatology consultation is acceptable for certain cutaneous indications).

Prior authorization recommended for medical benefit coverage
Prescriber requirement: must be prescribed by or in consultation with an oncologist or appropriate specialist
Requests for off-policy dosing considered case-by-case by clinician

Step Therapy

Line of Therapy Requirements

Line/sequence therapy expectations apply for the supportive-evidence indications listed below. For indications specified as second-line or subsequent therapy, pralatrexate should be used after prior systemic therapy has failed or the disease has relapsed. Where the criteria state the medication is used as a single agent, pralatrexate should not be combined with other anticancer agents for the authorized indication.

Adult T‑Cell Leukemia/Lymphoma: use as second-line or subsequent therapy (must meet criteria)
Hepatosplenic T‑Cell Lymphoma: use as second-line or subsequent therapy (must meet criteria)
Other supportive-evidence indications noted as second-line/subsequent require prior systemic therapy

Documentation Required

Prescriber and Clinical Documentation

Medication must be prescribed by or in consultation with an oncologist (or appropriate specialist for select cutaneous indications). Clinical documentation supporting the diagnosis, prior lines of therapy (when a second-line or subsequent requirement exists), and that the patient meets the specific criteria (age, relapsed/refractory status, single-agent use, dosing) should be provided with the prior authorization request.

Include documentation of diagnosis and disease status (relapsed/refractory)
Document prior therapies when indicated (to meet second-line/subsequent therapy requirement)
Include planned dosing regimen consistent with policy (e.g., 30 mg/m2 IV weekly x6 of each 7-week cycle or alternative 15 mg/m2 schedules where specified)

Denial Risk

Not Recommended Situations

Coverage is not recommended for uses not listed in the Recommended Authorization Criteria. Requests that do not meet the stated criteria (including age, disease subtype, line of therapy, single‑agent use, or prescriber requirements) are not recommended for approval.

Not recommended: indications outside those listed in the Recommended Authorization Criteria
Not recommended: requests lacking required prescriber consultation or supporting clinical documentation