ModifiedCentenePolicy CP PHAR.313

Pralatrexate (Folotyn) coverage for peripheral T-cell lymphoma

Defines medical necessity, prior authorization, and coverage criteria for pralatrexate (Folotyn) for treatment of relapsed or refractory peripheral T‑cell lymphoma and certain NCCN‑recommended off‑label T‑cell lymphoma indications for Centene lines of business.

Policy Summary

PayerCentene

PolicyPralatrexate (Folotyn) coverage for peripheral T-cell lymphoma

Policy CodePolicy CP PHAR.313

Change TypeMaterial revisions and clarifications

Effective DateFeb 1, 2017

Next Review Date

Key ActionProvider must obtain prior authorization and document diagnosis, oncologist/hematologist involvement, prior therapies or intent, and dosing within specified limits.

SourceLink

POLICY UPDATE CHANGES

Revised policy/criteria section to also include generic pralatrexate and for non-cutaneous T-cell lymphomas added requirement that Folotyn be prescribed as a single agent per NCCN.

Updated notation regarding HIM non-formulary status for 40 mg/2 mL vials to exclude HIM FL and AZ per current formulary status.

For PTCL, dosing regimen is until progressive disease or unacceptable toxicity; maximum dose noted as 30 mg once weekly.

30 mgmaximum weekly dose stated

6 monthstypical initial approval duration

12 monthscontinued therapy approval

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Coverage Criteria for Pralatrexate (Folotyn)

inv-01: Initial Therapy (PTCL)

Initial Approval — covered when ALL of the following are met:

Initial Approval for PTCL: 1) Diagnosis of peripheral T‑cell lymphoma (PTCL) (see Appendix D for examples of PTCL subtypes); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) Prescribed as a single agent; 4) Either (a) prescribed as initial palliative‑intent therapy OR (b) failure of at least one prior therapy (see Appendix B for examples); 5) Dose does not exceed 30 mg once weekly for 6 weeks in 7‑week cycles unless the dose is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).maximum dose 30 mg weekly

Prescribed regimen must be FDA‑approved or recommended by NCCN; off‑label dosing requires supporting evidence.

inv-02: NCCN‑Recommended Off‑Label Indications

NCCN‑Recommended Off‑Label Indications — covered when ALL of the following are met:

NCCN off‑label indications: 1) Diagnosis of an NCCN‑listed T‑cell lymphoma (examples include mycosis fungoides or Sezary syndrome; primary cutaneous T‑cell lymphomas; adult T‑cell leukemia/lymphoma (ATLL) after failure of first‑line therapy; extranodal NK/T‑cell lymphoma following asparaginase‑based therapy; hepatosplenic T‑cell lymphoma after failure of two regimens; breast implant‑associated ALCL after failure of first‑line therapy); 2) Prescribed by or in consultation with an oncologist or hematologist; 3) For diagnoses other than mycosis fungoides or Sezary syndrome, prescribed as a single agent; 4) Dose is within FDA maximum limits for any FDA‑approved indication or is supported by practice guidelines or peer‑reviewed literature for the relevant off‑label use (prescriber must submit supporting evidence).

Prior authorization may be required for prior line therapies; prescribed regimen must be FDA‑approved or recommended by NCCN.

inv-03: Continuation Therapy

Continued Therapy — covered when ALL of the following are met:

Continued therapy: 1) Member is currently receiving Folotyn via a Centene benefit or documentation supports that the member has received Folotyn for a covered indication for at least 30 days; 2) Member is responding positively to therapy; 3) If requesting a dose increase, the new dose does not exceed 30 mg once weekly for 6 weeks in 7‑week cycles unless the higher dose is supported by practice guidelines or peer‑reviewed literature (prescriber must submit supporting evidence).

Prescribed regimen must be FDA‑approved or recommended by NCCN; documentation of response required.

inv-04: PTCL Coverage Criteria

Covered when ALL of the following are met

PTCL dosing and agent: Pralatrexate (Folotyn or generic pralatrexate) is prescribed for peripheral T‑cell lymphoma (PTCL) with dosing continued until progressive disease or unacceptable toxicity.maximum 30 mg once weekly

Policy specifies Folotyn or generic pralatrexate and single‑agent requirement for non‑cutaneous T‑cell lymphomas.

Compendia support: Indication and use are supported by the NCCN Drugs and Biologics Compendium or NCCN T‑Cell Lymphomas guidance.

References include NCCN compendium and T‑Cell Lymphomas v4.2024.

Non‑FDA approved indications that are not specifically addressed in this policy are not authorized unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for commercial, HIM.PA.154 for Health Insurance Marketplace, and CP PMN.53 for Medicaid.

For non‑cutaneous T‑cell lymphomas, Folotyn (pralatrexate) must be prescribed as a single agent per NCCN recommendations. The policy language has been updated to explicitly include generic pralatrexate alongside Folotyn and to clarify the single‑agent requirement for these non‑cutaneous T‑cell lymphoma indications.

Uses that are not specifically listed in this policy or that should follow non‑formulary/no‑coverage rules must be processed under the applicable line‑of‑business policies. For formulary products follow the no‑coverage criteria policies (e.g., CP.CPA.190 for commercial, HIM.PA.33 for Health Insurance Marketplace, CP PMN.255 for Medicaid); for non‑formulary requests follow the non‑formulary policies (e.g., HIM.PA.103 for Marketplace non‑formulary). If the use is off‑label and not addressed here, refer to the off‑label use policies (e.g., CP.CPA.09/ HIM.PA.154/ CP PMN.53).

Use of billing codes or products that are not consistent with the policy's stated indications, or that lack appropriate documentation or correct coding, may not be covered. Codes listed in this policy are informational; inclusion does not guarantee coverage and claims may be denied if coding is incorrect.

Approved Dosing and Regimens

Regimen	Notes
Pralatrexate single-agent up to 30 mg once weekly for 6 weeks in 7‑week cycles
Alternative/off-label dosing may be considered only when supported by practice guidelines or peer‑reviewed literature; prescriber must submit supporting evidence

Regimen	Notes
Pralatrexate (Folotyn) 30 mg once weekly (maximum) until disease progression or unacceptable toxicity
Applies to Folotyn and generic pralatrexate; for non‑cutaneous T‑cell lymphomas, agent must be prescribed as a single agent per NCCN

Product and Billing Codes

Product availability / NDC (as stated)NDC

NDC/vial sizes

Single‑dose vials: 20 mg/1 mL, 40 mg/2 mL (product availability)

HCPCS Codes (informational)HCPCS

J9307

Injection, pralatrexate, 1 mg

inv-11: Maximum weekly dose — 30 mg once weekly for 6 weeks in 7‑week cycles

Maximum weekly dose and cycle30 mg once weekly for 6 weeks in 7-week cycles

Use in PTCLDosing applied for peripheral T-cell lymphoma and continued until progression or unacceptable toxicity per policy dosing regimen

Off-label/exception dosingAny dose exceeding 30 mg weekly must be supported by practice guidelines or peer-reviewed literature (prescriber must submit evidence)

inv-12: Maximum single-week dose — 30 mg once weekly

Maximum single-week dose30 mg once weekly

Continuation dose ruleIf requesting dose increase, new dose must not exceed 30 mg once weekly for 6 weeks in 7-week cycles unless supported by guidelines or literature

Prior Authorization, Documentation, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required. Provider must document the diagnosis, involvement of an oncologist or hematologist, prior therapies or intent (e.g., initial palliative intent), and that prescribed regimen is FDA‑approved or supported by NCCN/practice guidelines for off‑label use.

Prior authorization required for pralatrexate (Folotyn) and generics
Provider must document diagnosis and oncologist/hematologist involvement
Provider must document prior therapies or intent (initial palliative use)

Documentation Required

Required Clinical Documentation

Submit supporting clinical documentation with the PA request — examples: office chart notes, pathology reports, relevant lab results, prior therapy records (including dates and responses), and any guideline or literature supporting off‑label dosing. Requests lacking adequate supporting documentation may be denied.

Definitions and References

inv-23: Peripheral T‑cell lymphoma (PTCL) — examples and subtypes listed (Appendix D referenced)

PTCL definition examplesAnaplastic large cell lymphoma; PTCL not otherwise specified; angioimmunoblastic T-cell lymphoma; monomorphic epitheliotropic intestinal T-cell lymphoma; enteropathy-associated T-cell lymphoma; nodal peripheral T-cell lymphoma with TFH phenotype; follicular T-cell lymphoma

Reference for full listSee Appendix D for complete list of PTCL subtypes and histologies per policy Appendix D

Use in criteriaDiagnosis of PTCL (see Appendix D) is required for Initial Approval criteria

inv-24: NCCN compendium reference — NCCN Drugs and Biologics Compendium

Primary compendium referenceNCCN Drugs and Biologics Compendium

Guideline reference

Line-of-Therapy Considerations

inv-25: second-line

Second‑line (general): For FDA‑approved indication: pralatrexate is used in the relapsed or refractory PTCL (relapsed/refractory setting). For NCCN‑recommended off‑label indications, use is generally in later‑line settings (for example: after failure of first‑line therapy for ATLL; following asparaginase‑based therapy for extranodal NK/T‑cell lymphoma; after failure of two regimens for hepatosplenic T‑cell lymphoma).

Policy references prior therapy requirements for many NCCN off‑label indications; see Appendix B for examples of prior regimens.

inv-26: second-line

Second‑line (policy history note): Policy history documents use after prior regimens per NCCN and notes addition of initial palliation option for PTCL; specific line‑of‑therapy approvals should follow NCCN‑based criteria and policy language.

Documented in policy revision history.

Background

Pralatrexate (Folotyn) is a folate‑analog metabolic inhibitor approved for treatment of relapsed or refractory peripheral T‑cell lymphoma (PTCL). The policy has been revised to reference Folotyn and generic pralatrexate products and to align dosing and single‑agent use with NCCN guidance. When submitting requests and claims, use HCPCS code J9307 for pralatrexate injection as an informational billing code.

Policy Revision History

2024-08-07operational/clinicalLatest

Updated policy to include generic pralatrexate, clarified that for non-cutaneous T-cell lymphomas Folotyn must be prescribed as a single agent per NCCN, and removed the 'gamma delta' qualifier for hepatosplenic T-cell lymphoma; formulary notation for HIM 40 mg/2 mL vials was updated to exclude FL and AZ.

2023-06-30annual_review

4Q 2023 annual review: references reviewed and updated with no significant clinical changes recorded.

2022-08-01