CurrentEmblemHealthPolicy MG.MM.PH.426

Axtle (pemetrexed dipotassium) injection

Defines clinical coverage criteria, dosing limits, renewal criteria, exclusions, applicable billing codes and NDCs for Axtle (pemetrexed dipotassium) injection under EmblemHealth medical/pharmacy policy.

Policy Summary

PayerEmblemHealth

PolicyAxtle (pemetrexed dipotassium) injection

Policy CodePolicy MG.MM.PH.426

Change TypeNew Policy

Effective DateJan 30, 2025

Next Review Date

Key ActionTreating physician or primary care provider must submit clinical evidence to EmblemHealth to show member meets criteria for treatment; without documentation EmblemHealth cannot properly review the request for preauthorization or post-payment review.

SourceLink

POLICY UPDATE CHANGES

New policy created for Axtle (pemetrexed dipotassium) with coverage criteria and codes.

2Covered Indications

6ICD-10 diagnosis codes listed

4Applicable NDCs

Coverage Summary & Indications

Scope: Defines clinical coverage criteria, dosing limits, renewal criteria, exclusions, applicable billing codes and NDCs for Axtle (pemetrexed dipotassium) injection under EmblemHealth medical/pharmacy policy. Coverage stance: Covered with criteria for the subject Axtle (pemetrexed dipotassium) injection. Effective/Last review: 01/30/2025. One-line summary: Covered with criteria for non-squamous NSCLC and malignant pleural mesothelioma; see criteria below.

Initial Therapy (non-squamous NSCLC)

Coverage is provided in the following conditions:

ALL of the following

Patient must be 18 years of age
Indication for non-squamous NSCLC
- Patient is diagnosed with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC) AND patient will be using Axtle in combination with cisplatin as initial treatment
- Patient is diagnosed with locally advanced or metastatic non-squamous, non-small cell lung cancer (NSCLC) AND Axtle is being used as a single agent for the maintenance treatment of patients whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
- Patient is diagnosed with recurrent, metastatic non-squamous NSCLC, and Axtle is being used as a single agent after prior chemotherapy

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title

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Initial Therapy (Mesothelioma)

Coverage is provided in malignant pleural mesothelioma when ALL of the following are met:

ALL of the following

Patient must be 18 years of age or older
Patient is diagnosed with malignant pleural mesothelioma
Axtle is being used in combination with cisplatin for initial treatment
Patient's disease is unresectable or patient is otherwise not a candidate for curative surgery

Continuation / Renewal Criteria

Renewal Criteria

Coverage can be renewed when ALL of the following are met:

ALL of the following

Tumor response with stabilization of disease or decrease in size of tumor or tumor spread
Absence of unacceptable toxicity from the drug
Examples of unacceptable toxicity: bone marrow suppression, renal impairment, bullous and exfoliative skin toxicity, interstitial pneumonitis and radiation recall

Applicable Codes

Applicable HCPCS (J-code)HCPCSCovered

J9292

Injection, pemetrexed (avyxa), not therapeutically equivalent to j9305, 10 mg

Applicable NDCsNDCCovered

83831-0111-01	Pemetrexed Dipotassium 100 mg
83831-0112-01	Pemetrexed Dipotassium 500 mg
83831-0131-01	Axtle 100 mg
83831-0132-01	Axtle 500 mg

Applicable ICD-10 Diagnoses (allowed primary diagnoses)ICD-10Covered

C34.90	Malignant neoplasm of unspecified part of unspecified bronchus or lung
C33	Malignant neoplasm of trachea
C34.00	Malignant neoplasm of unspecified main bronchus
C34.01	Malignant neoplasm of right main bronchus
C34.02	Malignant neoplasm of left main bronchus
C34.10	Malignant neoplasm of upper lobe, unspecified bronchus or lung
C34.11	Malignant neoplasm of upper lobe, right bronchus or lung
C34.12	Malignant neoplasm of upper lobe, left bronchus or lung
C34.2	Malignant neoplasm of middle lobe, bronchus or lung
C34.30	Malignant neoplasm of lower lobe, unspecified bronchus or lung

1–10 of 19

1/2

Dosing Limits

Dosing Limits500 mg/m2 every 21 days for up to 6 cycles

Prior Authorization, Documentation & Billing

Prior Authorization

Preauthorization and clinical documentation required

Treating physician or primary care provider must submit clinical evidence to EmblemHealth to show member meets criteria for treatment; without documentation EmblemHealth cannot properly review the request for preauthorization or post-payment review.

J9292

Documentation Required

Renewal documentation

For renewal, provide documentation of tumor response (stabilization or decrease in size/spread) and the absence of unacceptable toxicity to support continued coverage.

Examples of unacceptable toxicity: bone marrow suppression
Examples of unacceptable toxicity: renal impairment
Examples of unacceptable toxicity: bullous and exfoliative skin toxicity
Examples of unacceptable toxicity: interstitial pneumonitis
Examples of unacceptable toxicity: radiation recall

Billing Rule

Use specified HCPCS and NDCs

Bill using HCPCS J9292 and capture provided NDCs for Axtle products.

HCPCS: J9292
NDC: 83831-0111-01
NDC: 83831-0112-01
NDC: 83831-0131-01
NDC: 83831-0132-01

Evidence & Definitions

Prescribing information: Axtle (pemetrexed) [prescribing information], Avyvxa Pharma LLC; 12/2024.

Definition — Pemetrexed: A folate analog metabolic inhibitor that disrupts folate-dependent metabolic processes essential for cell replication.

Background

Background: Pemetrexed is a folate analog metabolic inhibitor used for non-squamous non-small cell lung cancer (NSCLC) and malignant pleural mesothelioma. EmblemHealth bases the criteria on published literature, regulatory status, and clinical guidelines and notes that each benefit program governs actual coverage.

Policy Summary

PayerEmblemHealth

PolicyAxtle (pemetrexed dipotassium) injection

Policy CodePolicy MG.MM.PH.426

Change TypeNew Policy

Effective DateJan 30, 2025

Next Review Date

SourceLink

On This Page

OpenPayer

Axtle (pemetrexed dipotassium) injection

Coverage Summary & Indications

Continuation / Renewal Criteria

Limitations and Exclusions

Applicable Codes

Prior Authorization, Documentation & Billing

Evidence & Definitions

Background

Revision History