CurrentCareSourcePolicy N/A

Pemetrexed (injectable) utilization management

Defines prior authorization, coverage criteria, dosing limits, and approved indications for pemetrexed products (Alimta, Pemfexy, Pemrydi RTU and generics) for CareSource members in North Carolina.

Policy Summary

PayerCareSource

PolicyPemetrexed (injectable) utilization management

Policy CodePolicy N/A

Change TypeClinical content and dosing updates (added intrathecal optionexpanded indications)

Effective DateN/A

Next Review DateJan 22, 2025

Key ActionObtain prior authorization and ensure prescription is by or in consultation with an oncologist; approvals typically granted for up to 1 year when criteria are met.

SourceLink

POLICY UPDATE CHANGES

Added intrathecal therapy option and dosing for leptomeningeal metastases; added cervical cancer as a supported condition; clarified NSCLC biomarker descriptors (added exon 21 and other mutation updates).

1 yearTypical approval duration for most indications

≤500 mg/m2IV dosing cap (common)

≤900 mg/m2Higher IV dosing option

Up to 50 mgIntrathecal dosing

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Coverage and Authorization Criteria

Mesothelioma (FDA)

Approve for 1 year if the patient meets ALL of the following (A, B, and C):

Mesothelioma criteria: A) Patient is ≥ 18 years of age; AND B) Patient meets ONE of: i) medication is used for malignant pleural mesothelioma; OR ii) medication is used for malignant peritoneal, pericardial, or tunica vaginalis testis mesothelioma; AND C) Medication is prescribed by or in consultation with an oncologist.age ≥18

Dosing: Approve up to 500 mg/m2 IV q3wk.

Non-Small Cell Lung Cancer (FDA/Supported)

Approve for 1 year if the patient meets ALL of the following (A and B with nested options):

NSCLC top-level: A) Patient is ≥ 18 years of age; AND B) Patient has non-squamous non-small cell lung cancer (includes adenocarcinoma, large cell, NSCLC not otherwise specified) and meets ONE of the options below.age ≥18

Includes non-squamous histologies.

NSCLC B options: i) Medication is used for chemoradiation, perioperative, neoadjuvant, adjuvant, or induction therapy in combination with platinum chemotherapy; OR ii) Medication is used for recurrent, advanced, or metastatic disease and meets additional biomarker/therapy conditions.

NSCLC recurrent/advanced biomarker conditions: For recurrent/advanced/metastatic disease medication may be used if: a) tumor is negative or unknown for targetable mutations and the medication is used as initial therapy in combination regimens or as maintenance/subsequent therapy; OR b) used as first-line therapy when tumor is positive for specified actionable mutations (including EGFR exon 19 deletion, exon 21 L858R, EGFR exon 20 insertion in some contexts, EGFR S768I, L861Q, G719X, ALK rearrangement, RET rearrangement, ROS1 rearrangement, BRAF V600E, MET exon 14 skipping, NTRK fusion, NRG1, ERBB2/HER2 as listed); OR c) used as subsequent therapy when tumor is positive for specified mutations provided the patient has received targeted therapy for that mutation; OR d) used intrathecally for leptomeningeal metastases when the patient has leptomeningeal disease and medication is prescribed by or in consultation with an oncologist.

See document for detailed mutation lists and sequencing; intrathecal dosing described separately (up to 50 mg intrathecal).

Other Uses with Supportive Evidence (NCCN/Clinical)

Approve for 1 year if the patient meets the listed criteria for each condition:

Cervical cancer: A) Patient is ≥ 18 years of age; AND B) Patient has recurrent or metastatic disease; AND C) Medication is used as subsequent therapy; AND D) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 900 mg/m2 IV q3wk.

Ovarian/fallopian tube/primary peritoneal cancer: A) Patient is ≥ 18 years of age; AND B) At least one other systemic chemotherapy regimen has been tried; AND C) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 900 mg/m2 IV q3wk.

Primary CNS lymphoma: A) Patient is ≥ 18 years of age; AND B) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 900 mg/m2 IV q3wk.

Coverage of pemetrexed is limited to the indications and clinical scenarios specified in the Recommended Authorization Criteria. Where the criteria list specific tumor types, lines of therapy, biomarker requirements, prescriber qualifications, and dosing limits, approval is recommended only when those conditions are met. Typical approvals are issued for up to 1 year and dosing should not exceed the limits specified in the criteria (for many indications ≤ 500 mg/m2 IV every 3 weeks, with specified exceptions and intrathecal dosing described elsewhere in the policy).

Pemetrexed is not indicated for treatment of squamous cell NSCLC; requests for that indication should not be approved unless future published evidence and explicit criteria are added to this policy.

Requests for indications, clinical situations, or dosing outside those explicitly listed in the Recommended Authorization Criteria are not recommended for approval. The criteria will be updated as new published data become available; until then, circumstances not specifically covered by the policy should be denied or routed for peer review per normal medical policy exception processes.

Prior authorization is required for medical-benefit coverage; for approvals to be granted the documentation submitted must demonstrate that the patient meets the specific criteria (including age, tumor type and histology, prior therapies when required, biomarker status where applicable, prescriber/consultation by an oncologist, and dosing within stated limits).

Coding and Dosing Information

Covered HCPCS CodesHCPCSCovered

J9305

Injection, pemetrexed, 10 mg

Intrathecal dosing (leptomeningeal metastases)

Intrathecal dose limitUp to 50 mg administered intrathecally

Intrathecal frequency (initial week)No more frequently than twice in the first week of therapy

Maintenance intrathecal frequencyThen no more frequently than once every 3 weeks

IV dosing

Common IV regimen capUp to 500 mg/m2 IV every 3 weeks (approve for many indications)

Higher-dose supportive indicationsSome supportive/off-label indications list dosing up to 900 mg/m2 IV every 3 weeks (e.g., cervical, ovarian, primary CNS lymphoma)

Administration intervalIntravenous infusion not more frequently than once every 3 weeks

Provider Requirements and Authorization Process

Prior Authorization

Prior Authorization Required

Prior authorization is required for medical benefit coverage. Approval is recommended when the patient meets the listed criteria and dosing for the indicated condition. Requests for doses outside the dosing documented in this policy will be considered on a case-by-case basis by a clinician (for example, Medical Director or Pharmacist). All approvals are provided for the duration noted in the policy. Because of the specialized skills required for evaluation, diagnosis, and monitoring of patients treated with this medication, the medication must be prescribed by or in consultation with a physician who specializes in the condition being treated.

Prior Authorization

Prior Chemotherapy Requirement

Some 'Other Uses with Supportive Evidence' (for example, ovarian/fallopian tube/primary peritoneal cancer) require that the patient has tried at least one prior systemic chemotherapy regimen (examples: docetaxel, paclitaxel, gemcitabine, cisplatin, carboplatin) before approval is recommended.

Denial Risk

Denial Triggers

Requests that do not meet the Recommended Authorization Criteria (including FDA‑approved indications and Other Uses with Supportive Evidence) or dosing in this policy are not recommended for approval and may be denied. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria; criteria will be updated as new published data become available.

Background

Pemetrexed is an antifolate chemotherapy agent used intravenously for the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer, and as a single agent for maintenance or subsequent therapy in non-squamous NSCLC. In this policy pemetrexed is also included for certain NCCN-supported and other clinically supported indications across tumor types; an intrathecal administration option for leptomeningeal disease is specified with separate dosing limits.

Typical administration is on a three-week schedule; dosing limits and permitted indications are defined in the Recommended Authorization Criteria and prescribing information. The product is not indicated for squamous cell NSCLC.

Key Definitions

Non-squamous NSCLC — definition

Definition - non-squamous NSCLCNSCLC histologies excluding squamous cell carcinoma (includes adenocarcinoma, large cell, and NSCLC not otherwise specified)

Implication for pemetrexedPemetrexed is indicated for locally advanced or metastatic non-squamous NSCLC and as maintenance therapy after platinum-based first-line chemotherapy

Limitation of useNot indicated for treatment of squamous cell NSCLC

Line of Therapy

first-line | second-line | salvage

Line of therapy options: Used as initial therapy in combination with platinum chemotherapy for advanced/metastatic non-squamous NSCLC; OR used as single-agent maintenance after platinum-based first-line chemotherapy; OR used as subsequent therapy for recurrent/metastatic disease following prior treatments.

Also used in perioperative, neoadjuvant, adjuvant, and chemoradiation settings.

Biomarker and Molecular Testing Requirements

EGFR — relevant alterations

EGFR actionable alterations (list)Exon 19 deletion; exon 21 L858R; exon 20 insertion (in some contexts); S768I; L861Q; G719X

Context of useEGFR alterations are part of the biomarker criteria that can permit pemetrexed use as first-line or subsequent therapy depending on mutation and prior targeted therapy

Requirement for testingTumor mutation status (positive/negative/unknown) is used to determine appropriate pemetrexed therapy per policy criteria

ALK — biomarker requirement

ALK requirementALK rearrangement–positive status is required for biomarker-directed pemetrexed use in NSCLC

Therapy sequencing noteUse as first-line or subsequent therapy depends on the overall mutation profile and prior targeted therapy receipt

Testing implicationDocumented ALK rearrangement in the tumor is a qualifying biomarker per the policy

Other actionable NSCLC alterations

Listed actionable alterationsRET rearrangement; ROS1 rearrangement; BRAF V600E mutation; MET exon 14 skipping mutation; NTRK gene fusion; NRG1 gene fusion

Use implicationsPresence of these alterations can permit pemetrexed use in first-line or subsequent therapy per the detailed NSCLC criteria

Examples in policy textPolicy explicitly lists these alterations among examples of targetable mutations relevant to pemetrexed eligibility

Approved Combination Regimens

Regimen	Applicable setting / notes
Pemetrexed + cisplatin	Initial therapy for non-squamous NSCLC (including adenocarcinoma, large cell, and NSCLC not otherwise specified); may be used in chemoradiation, perioperative, neoadjuvant, adjuvant, or induction settings in combination with platinum chemotherapy.
Pemetrexed + carboplatin	Initial therapy for non-squamous NSCLC; same settings as above as an alternative platinum backbone to cisplatin.
Pemetrexed + cisplatin or carboplatin combined with a PD‑1 inhibitor (e.g., pembrolizumab, nivolumab) or ipilimumab	May be administered per guideline‑described regimens for patients without EGFR or ALK genomic tumor aberrations (and other specified targetable alterations); used as initial cytotoxic therapy options in combination with immunotherapy agents.

Policy Summary

PayerCareSource

PolicyPemetrexed (injectable) utilization management

Policy CodePolicy N/A

Change TypeClinical content and dosing updates (added intrathecal optionexpanded indications)

Effective DateN/A

Next Review DateJan 22, 2025

Key ActionObtain prior authorization and ensure prescription is by or in consultation with an oncologist; approvals typically granted for up to 1 year when criteria are met.

SourceLink

On This Page

Thymic carcinoma or thymoma:

A) Patient is ≥ 18 years of age; AND B) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 500 mg/m2 IV q3wk.

Vaginal cancer: A) Patient is ≥ 18 years of age; AND B) Patient has locoregional recurrence or metastatic disease; AND C) Medication is used as subsequent therapy; AND D) Medication is prescribed by or in consultation with an oncologist.

Dosing: Approve up to 500 mg/m2 IV q3wk.