CurrentBlueCross BlueShield - TennesseePolicy N/A

Pemetrexed (Alimta®, Pemfexy™, Pemrydi RTU, Axtle™) coverage criteria

Clinical coverage criteria for pemetrexed (Alimta®, Pemfexy™, Pemrydi RTU, Axtle™, and generics) oncology indications, specifying covered FDA and compendial uses, exclusions, authorization durations, quantity/dosing limits, and continuation criteria for BlueCross BlueShield of Tennessee members.

Policy Summary

PayerBlueCross BlueShield - Tennessee

PolicyPemetrexed (Alimta®, Pemfexy™, Pemrydi RTU, Axtle™) coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must obtain authorization for pemetrexed use, documenting the indication and that approval criteria for the specific diagnosis are met.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

FDA + compendialIndications considered covered when criteria met

6 monthsTypical initial authorization period

24 monthsMax continuation when used with pembrolizumab for mesothelioma

500/900 mg/m²Maximum dosing regimens listed (IV q21 days)

Pemetrexed Coverage Criteria

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General coverage statement

Pemetrexed (and listed brand/generic products) is considered a covered benefit for FDA-approved indications and certain compendial uses provided approval criteria are met and no member exclusions apply.

ALL of the following

Indication is an FDA-approved or compendial use listed in this policy
Compendial uses enumerated in policy (see list)
Member has no exclusions to the prescribed therapy

FDA-Approved indications (covered when criteria met)

Pemetrexed is covered for the following FDA-approved indications:

Any of the following FDA-approved indications

In combination with cisplatin for initial treatment of locally advanced or metastatic, nonsquamous NSCLC
In combination with pembrolizumab and platinum chemotherapy for initial treatment of metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations
As single agent for maintenance of locally advanced or metastatic nonsquamous NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy
As single agent for treatment of recurrent, metastatic non-squamous NSCLC after prior chemotherapy
In combination with cisplatin for initial treatment of unresectable malignant pleural mesothelioma

Compendial uses (covered when criteria met)

Pemetrexed may be authorized for the following compendial indications:

ANY of the following

Bladder cancer (transitional cell/urothelial carcinoma) — second-line; authorization of 6 months may be granted
Peritoneal mesothelioma
Pleural mesothelioma
Pericardial mesothelioma
Tunica vaginalis testis mesothelioma

Exclusions / Not medically necessary

Pemetrexed is not covered for the following:

ANY of the following

Squamous cell non-small cell lung cancer — coverage will not be provided
These are considered experimental/investigational and not medically necessary
All other indications not listed as FDA-approved or in the compendial uses section

Pleural or Peritoneal Mesothelioma authorization criteria

Authorization of 6 months may be granted when any of the following are met:

ANY of the following

Requested medication will be used in combination with bevacizumab or durvalumab and either cisplatin or carboplatin
Requested medication will be used as a single agent or in combination with cisplatin or carboplatin
Requested medication will be used as first-line therapy in combination with pembrolizumab and platinum chemotherapy

Thyroid carcinoma authorization criteria

Authorization of 6 months may be granted for progressive and/or symptomatic papillary or follicular thyroid carcinoma when ALL of the following are met:

ALL of the following

Disease is unresectable or metastatic
Requested medication will be used in combination with carboplatin
Disease is not amenable to radioactive iodine (RAI) therapy

Oncocytic/Hürthle cell thyroid carcinoma authorization criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Requested medication will be used in combination with carboplatin
Disease is unresectable or metastatic

Anaplastic thyroid carcinoma authorization criteria

Authorization of 6 months may be granted when ALL of the following are met:

ALL of the following

Requested medication will be used in combination with carboplatin after disease progression following prior treatment
Disease is metastatic

Continuation of therapy

Criteria for reauthorization/continuation:

ALL of the following

Indication is one listed in the coverage criteria section
No evidence of unacceptable toxicity while on the current regimen
No evidence of disease progression while on the current regimen
Duration: Authorization of 6 months may be granted; up to 24 months total when used with pembrolizumab for pleural or peritoneal mesothelioma

Key coverage thresholds

Authorization duration6 months (typical initial authorization)

Maximum continuation with pembrolizumab for mesotheliomaUp to 24 months total

Dose regimensIntravenous every 21 days; 500 mg/m² or 900 mg/m² depending on indication/product

Dosing, Quantity Limits, and Code Groups

Dosing/Quantity limits (product-specific maximum regimens)mixed

Alimta (pemetrexed) IV q21d

500 mg/m² every 21 days for Bladder Cancer; 500 mg/m² every 21 days for NSCLC; 500 mg/m² every 21 days for malignant pleural/peritoneal/pericardial/tunica vaginalis testis mesothelioma; 900 mg/m² every 21 days for Cervical Cancer; 900 mg/m² every 21 days for Ovarian/Fallopian/Primary Peritoneal cancers (policy lists product- and diagnosis-specific maximum dosing regimens; route = Intravenous q21d).

Pemfexy / Pemrydi RTU / Axtle

Product-specific dosing: either 500 mg/m² or 900 mg/m² IV every 21 days depending on diagnosis (policy specifies per-product maximum dosing regimens by diagnosis with IV q21d administration).

What Providers Must Do

Prior Authorization

Authorization required with indication documentation

Providers must obtain authorization for pemetrexed use, documenting the indication and that approval criteria for the specific diagnosis are met (e.g., combination regimen details, unresectable/metastatic status, prior lines of therapy where required).

Documentation Required

Document combination regimens and disease status

For indications with combination requirements (e.g., with cisplatin, carboplatin, pembrolizumab, bevacizumab, durvalumab), document the planned regimen and relevant tumor genomics (e.g., absence of EGFR/ALK aberrations for pembrolizumab-combination NSCLC) and prior therapies when applicable.

Planned regimen (agents and combinations such as cisplatin, carboplatin, pembrolizumab, bevacizumab, durvalumab)
Tumor genomics where required (e.g., no EGFR or ALK genomic tumor aberrations for pembrolizumab-combination NSCLC)
Prior lines of therapy when applicable (e.g., second-line bladder cancer or prior chemotherapy for recurrent NSCLC)

Denial Risk

Risk of denial for excluded indications

Requests for pemetrexed for squamous NSCLC or for indications not listed as FDA-approved or compendial uses will be considered experimental/investigational and not medically necessary and may be denied.

Squamous cell non-small cell lung cancer is excluded from coverage and will not be provided
Other indications not listed among the FDA-approved or compendial uses are considered experimental/investigational and may be denied

Clinical and Administrative Background

Pemetrexed is an antifolate chemotherapy agent approved by the FDA for multiple oncology indications including certain forms of non‑squamous non‑small cell lung cancer (NSCLC) and malignant pleural mesothelioma, with a range of additional recognized uses in authoritative compendia. The policy’s FDA‑approved indications include use in combination with cisplatin for initial treatment of locally advanced or metastatic non‑squamous NSCLC, use in combination with pembrolizumab and platinum chemotherapy for initial treatment of metastatic non‑squamous NSCLC without EGFR or ALK genomic tumor aberrations, single‑agent maintenance for non‑squamous NSCLC after first‑line platinum chemotherapy, treatment of recurrent/metastatic non‑squamous NSCLC after prior chemotherapy, and use with cisplatin for unresectable malignant pleural mesothelioma. (See FDA‑approved indications and compendial uses for full list.)

Defined Terms

Definitions

Compendial usesUses recognized in standard reference compendia (e.g., NCCN Drugs & Biologics Compendium) that may support coverage of off-label drug use under Tennessee law.

Policy Quick Metrics

FDA + compendialIndications considered covered when criteria met

6 monthsTypical initial authorization period

up to 24 monthsMax continuation when used with pembrolizumab for mesothelioma

500 mg/m² or 900 mg/m²Maximum dosing regimens listed (IV q21 days)

Policy Summary

PayerBlueCross BlueShield - Tennessee

PolicyPemetrexed (Alimta®, Pemfexy™, Pemrydi RTU, Axtle™) coverage criteria

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionProviders must obtain authorization for pemetrexed use, documenting the indication and that approval criteria for the specific diagnosis are met.

SourceLink

On This Page

Ovarian, fallopian tube, and primary peritoneal cancers (various epithelial subtypes listed)

Primary central nervous system (CNS) lymphoma

Thymomas and thymic carcinomas

Thyroid carcinoma (papillary, follicular, oncocytic/Hürthle cell, and anaplastic) with restrictions

Cervical cancer (persistent, recurrent, or metastatic)

Vaginal cancer (recurrent or metastatic)

Pemetrexed (Alimta®, Pemfexy™, Pemrydi RTU, Axtle™) coverage criteria

Pemetrexed Coverage Criteria

Dosing, Quantity Limits, and Code Groups

What Providers Must Do

Clinical and Administrative Background

Defined Terms

Policy Quick Metrics

Changes and Cross-References