CurrentEmblemHealthPolicy MG.MM.PH.146

Medical Policy: Folotyn (pralatrexate) injection

Defines medical necessity, initial and renewal criteria, dosing limits, authorization length, applicable procedure/NDC/ICD-10 codes, and limitations for Folotyn (pralatrexate) injection for treatment of relapsed or refractory peripheral T-cell lymphomas.

Policy Summary

PayerEmblemHealth

PolicyMedical Policy: Folotyn (pralatrexate) injection

Policy CodePolicy MG.MM.PH.146

Change TypeAnnual review; NDC updates; prior criteria revisions

Effective DateApr 8, 2025

Next Review Date

Key ActionSubmit clinical evidence that the member meets the initial approval criteria for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

Annual Review: updated NDC. No criteria changes.

03/01/2024 Annual Review: Added dosing limits and PTCL subtype inclusions; changed initial and renewal criteria wording.

06/29/2023 Annual Review: NDCs removed/added.

6 monthsInitial Authorization Length

30 mg/m2Single Dose Limit

80 units x 6Max Units per Cycle

J9307

Coverage Summary

Policy MG.MM.PH.146 (Folotyn® [pralatrexate] injection) is covered with criteria by EmblemHealth. Subject: Folotyn (pralatrexate) injection. Status: CURRENT. Effective / Last review date: 2025-04-08. Scope: defines medical necessity, initial and renewal criteria, dosing limits, authorization length, applicable procedure/NDC/ICD-10 codes, and limitations for Folotyn for treatment of relapsed or refractory peripheral T-cell lymphomas. Policy number: MG.MM.PH.146.

Authorization & Dosing Summary

Initial Authorization Length6 months

Single dose limit30 mg/m2

Max units per cycle80 billable units weekly x 6 doses in a 7-week cycle (HCPCS unit = 1 mg)

Primary billing codeJ9307 (Injection, pralatrexate, 1 mg per billable unit)

Initial Therapy Criteria

Renewal / Continuation Criteria

Renewal Criteria

Renewal criteria

Continued eligibility: Patient continues to meet INITIAL APPROVAL CRITERIA
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread
Toxicity: Absence of unacceptable toxicity from the drug (examples include: myelosuppression e.g., neutropenia, anemia, and/or thrombocytopenia; mucositis; severe dermatologic reactions; tumor lysis syndrome (TLS); increased risk of toxicity in patients with severe renal impairment; hepatic toxicity)

Limitations and Exclusions (Not Medically Necessary)

Limitations / Exclusions (Not Medically Necessary)

After progression on same regimen: Folotyn is being used after disease progression with the same regimen
Concurrent anticancer therapy: Concurrent use with other anti-cancer therapy
Single dose limit exceeded: Dosing exceeds single dose limit of Folotyn (pralatrexate) 30 mg/m230 mg/m2
Single dose limit
Unsupported indication:

Applicable Codes

Applicable HCPCS (Drug J-code)HCPCSCovered

J9307

Injection, pralatrexate, 1 mg, 1 billable unit = 1 mg

Applicable NDCsNDCCovered

72893-0003-xx	Folotyn 20 mg/ml single use vial
72893-0005-xx	Folotyn 20 mg/ml single use vial
48818-0001-xx	Folotyn 20 mg/mL

Applicable ICD-10 Diagnoses (allowed/related)ICD-10Covered

C82.50-C82.59	Diffuse follicle center lymphoma
C84.00-C84.09	Mycosis fungoides
C84.10-C84.19	Sézary disease
C84.40-C84.49	Peripheral T-cell lymphoma, not classified
C84.60-C84.79	Anaplastic large cell lymphoma
C84.A0-C86.6	Cutaneous T-cell lymphoma unspecified, other mature T/NK-cell lymphomas, other specified and unspecified types of non-Hodgkin lymphoma and other specified types of T/NK-cell lymphoma
C91.50	Adult T-cell lymphoma/leukemia (HTLV-1-associated) not having achieved remission
C91.51	Adult T-cell lymphoma/leukemia (HTLV-1-associated), in remission
C91.52	Adult T-cell lymphoma/leukemia (HTLV-1-associated), in relapse
C91.Z0	Other lymphoid leukemia not having achieved remission

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Provider Actions & Billing Rules

Prior Authorization

Preauthorization required with clinical documentation

Treating physician or primary care provider must submit clinical evidence that the member meets the initial approval criteria for treatment. This documentation is required for preauthorization or may be requested for post-payment review.

Documentation Required

Document relapsed or refractory PTCL subtype and single-agent use

Provider must document the specific PTCL subtype (examples listed in the policy) showing relapsed or refractory disease and confirm that Folotyn is being used as single-agent therapy.

Clinical Evidence & References

Evidence / References cited: Folotyn PI (prescribing information); Clinical Pharmacology; Micromedex; National Comprehensive Cancer Network (NCCN) guidelines and Drugs and Biologics Compendium; AHFS Drug Information.

Background

Background: Folotyn (pralatrexate) is a 10-deazaaminopterin antifolate and competitive inhibitor of dihydrofolate reductase that was designed to have enhanced affinity for the reduced folate carrier and folylpolyglutamyl synthetase, improving intracellular accumulation and polyglutamylation in tumor cells. The policy reflects EmblemHealth clinical review criteria for medical necessity based on available clinical evidence, guidelines, and regulatory status.

Definitions

Folotyn (pralatrexate)A novel 10-deazaaminopterin antifolate; competitive inhibitor of dihydrofolate reductase designed for greater affinity for the reduced folate carrier and folylpolyglutamyl synthetase to enhance intracellular accumulation and polyglutamylation in tumor cells.

Revision History

06/29/2023NDC update

Annual Review: removed NDC 48818-0001-xx and added NDC 72893-0003-xx.

03/01/2024Material revision

Annual Review (material): added dosing limits (max 80 billable units weekly x 6 doses in a 7-week cycle; single dose limit 30 mg/m2), expanded PTCL initial criteria to include 'Nodal peripheral T-Cell lymphoma with TFH phenotype' and 'Follicular T-Cell lymphoma', required use as single-agent therapy, removed 'second line or subsequent therapy' language, and expanded renewal criteria to require disease response and absence of unacceptable toxicity.

04/08/2025NDC updateLatest