CurrentViva HealthPolicy IC-0007

pemetrexed (Alimta, Pemfexy, Pemrydi RTU, Axtle, others) intravenous

Defines prior authorization, indications (medical necessity) criteria, dosing/administration, renewal and authorization length, maximum billable units per dose/interval, and HCPCS/NDC billing mappings for intravenous pemetrexed products for Viva Health.

Policy Summary

PayerViva Health

Policypemetrexed (Alimta, Pemfexy, Pemrydi RTU, Axtle, others) intravenous

Policy CodePolicy IC-0007

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required; initial authorization typically valid for 6 months (follow renewal and indication-specific authorization rules as specified).

POLICY UPDATE CHANGES

No material clinical or coverage changes reported in this update.

MultipleIndications covered (tumor types)

6 monthsDefault initial authorization length

CrCl <45 mL/minRenal exclusion threshold

~50ICD-10 codes listed in this part

Coverage Summary

Scope: This policy defines prior authorization and medical necessity criteria for intravenous pemetrexed products (including branded and 505(b)(2) formulations such as Alimta, Pemfexy, Pemrydi RTU, Axtle, and generics), covering indications, dosing/administration, renewal/authorization length, maximum billable units per dosing interval, and HCPCS/NDC billing mappings for Viva Health. Coverage stance: covered with criteria — prior authorization required and granted when the indication- and regimen-specific criteria in the policy are met. Primary guidance sources referenced in the policy include the NCCN Drugs & Biologics Compendium (2025) and manufacturer package inserts for marketed pemetrexed products.

Continuation Therapy Criteria

Prior authorization may be renewed when ALL of the following are met:

Renewal Criteria - top level

Continued indication-specific criteria: Patient continues to meet the indication-specific relevant criteria identified in Initial Approval Criteria (Section III), including concomitant therapy requirements and performance status
Duration not exceeded: Duration of authorization has not been exceeded (refer to Section I Length of Authorization)Refer to Section I
Initial authorizations typically 6 months (exceptions per Section I)
Tolerability: Absence of unacceptable toxicity from the drug (examples: myelosuppression, renal toxicity CrCl < 45 mL/min, severe skin toxicity, interstitial pneumonitis, radiation recall)No unacceptable toxicity; CrCl must remain >= 45 mL/min
Examples listed in policy
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spreadStabilization or tumor decrease

Indications, Limits, and Thresholds

Covered indications (any of the following): Primary central nervous system (CNS) lymphoma (including vitreoretinal/ocular PCNSL variant), limited or extensive brain metastases from EGFR‑sensitizing mutation‑positive NSCLC, leptomeningeal metastases from EGFR mutation‑positive NSCLC, cervical cancer (recurrent/metastatic), peritoneal mesothelioma (PeM) including adjuvant, first‑line and subsequent therapy settings, pleural mesothelioma (referenced), non‑squamous non‑small cell lung cancer (as part of platinum regimens, maintenance, or single‑agent use), thymomas and thymic carcinomas, ovarian/fallopian tube/primary peritoneal cancers, vaginal cancer, and thyroid carcinomas.

Key clinical thresholds

Age>= 18 years

Renal function exclusionDo not administer if creatinine clearance (CrCl) < 45 mL/min

Performance status (for leptomeningeal primary treatment)Karnofsky Performance Status (KPS) >= 60

Provider Actions & Billing Impact

Prior Authorization

Prior authorization required

Prior authorization is required. Initial authorization is typically valid for 6 months. Exceptions: thymomas and thymic carcinomas — initial validity provided for six (6) cycles; mesothelioma when given in combination with bevacizumab + platinum chemotherapy — initial validity provided for six (6) cycles; mesothelioma when given in combination with pembrolizumab + platinum chemotherapy — initial validity provided for six (6) doses. Renewals may be requested every 6 months unless the indication specifically disallows renewal (see Section I). Refer to Section I Length of Authorization for complete details on authorization length and renewal rules.

Documentation Required

Indication and diagnostic testing documentation

Document the patient diagnosis and relevant diagnostic testing when applicable. For indications requiring mutation status, submit FDA-approved or CLIA-compliant test results for EGFR or other actionable mutations. Also document prior therapies where relevant (for example CRS+HIPEC, prior immunotherapy) and the patient performance status when required by the indication.

Billing Rule

Maximum billable units per dosing interval

Adhere to product- and indication-specific maximum billable units per dose and per 21-day interval. The following HCPCS codes are affected: J9304, J9305, J9296, J9297, J9314, J9322, J9324, J9292, J9323, J9294. Examples of specified limits include: Pemfexy (500 mg MDV) — 225 billable units Q21d for several indications and 125 units Q21d for other indications; Pemetrexed generics and other manufacturers (100/500/750/850/1000 mg SDV) — 230 billable units Q21d for several indications and 130 units Q21d for other indications. Follow the policy table for indication-specific unit limits and dosing intervals.

Affected HCPCS codes: J9304, J9305, J9296, J9297, J9314, J9322, J9324, J9292, J9323, J9294
Example limits: Pemfexy 500 mg MDV — 225 units Q21d (certain indications); Pemetrexed generics SDV — 230 units Q21d (certain indications)

Documentation Required

Supplementation and drug administration precautions

Document that folic acid and intramuscular vitamin B12 supplementation are provided to the patient. Note administration precautions: avoid ibuprofen for 2 days before, the day of, and 2 days after pemetrexed administration in patients with creatinine clearance (CrCl) <80 mL/min. Ensure documentation of supplementation and counseling in the medical record.

Denial Risk

Contraindication based on renal function

Claims may be denied if the patient has creatinine clearance (CrCl) less than 45 mL/min because pemetrexed should not be administered in patients with CrCl <45 mL/min. Verify and document renal function prior to administration to avoid claim denials.

Documentation Required

Use of listed ICD-10 codes to support medical necessity

When billing, include one of the listed ICD-10 diagnosis codes from the policy to support medical necessity. Providers must document and submit an appropriate ICD-10 code from the covered diagnosis list and follow applicable Medicare Part B guidance (NCD/LCD/LCA) where relevant for Part B claims.

Applicable Codes

Primary HCPCS codes mapped to pemetrexed productsHCPCSCovered

J9292	Injection, pemetrexed dipotassium, 10 mg
J9294	Injection, pemetrexed (Hospira), 10 mg
J9296	Injection, pemetrexed (Accord/others), 10 mg
J9297	Injection, pemetrexed (Sandoz), 10 mg
J9304	Injection, pemetrexed (Pemfexy), 10 mg
J9305	Injection, pemetrexed, not otherwise specified, 10 mg
J9314	Injection, pemetrexed (Teva), 10 mg
J9322	Injection, pemetrexed (BluePoint), 10 mg
J9323	Injection, pemetrexed ditromethamine, 10 mg
J9324	Injection, pemetrexed (Pemrydi RTU), 10 mg

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Covered ICD-10 diagnosis codesICD-10Covered

C33	Malignant neoplasm of trachea
C34.01	Malignant neoplasm of right main bronchus
C34.12	Malignant neoplasm of upper lobe, left bronchus or lung
C34.32	Malignant neoplasm of lower lobe, left bronchus or lung
C37	Malignant neoplasm of thymus
C45.0	Mesothelioma of pleura
C48.1	Malignant neoplasm of specified parts of peritoneum
C52	Malignant neoplasm of vagina
C53.0	Malignant neoplasm of endocervix
C56.1	Malignant neoplasm of right ovary

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NDC mappings (examples provided)NDC

70121-2453-xx	Pemrydi RTU 100 mg/10 mL SDV (Amneal) - maps to HCPCS J9324
70121-2461-xx	Pemrydi RTU 500 mg/50 mL SDV (Amneal) - maps to HCPCS J9324
70121-2462-xx	Pemrydi RTU 1000 mg/100 mL SDV (Amneal) - maps to HCPCS J9324
00002-7640-xx	Alimta 100 mg powder for inj. (Lilly) - maps to HCPCS J9305
00002-7623-xx	Alimta 500 mg powder for inj. (Lilly) - maps to HCPCS J9305
68001-0543-xx	Pemetrexed 100 mg powder (BluePoint) - maps to HCPCS J9322
68001-0544-xx	Pemetrexed 500 mg powder (BluePoint) - maps to HCPCS J9322
00781-3518-xx	Pemetrexed 100 mg/4 mL inj (Sandoz) - maps to HCPCS J9297
00409-1045-xx	Pemetrexed 100 mg/4 mL inj (Hospira) - maps to HCPCS J9294
42367-0531-xx	Pemfexy 500 mg/20 mL inj (Eagle) - maps to HCPCS J9304

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Covered ICD-10 (appendix excerpts)ICD-10Covered

C34.32	Malignant neoplasm of lower lobe, left bronchus or lung
C34.80	Malignant neoplasm of overlapping sites of unspecified bronchus or lung
C34.81	Malignant neoplasm of overlapping sites of right bronchus and lung
C34.82	Malignant neoplasm of overlapping sites of left bronchus and lung
C34.90	Malignant neoplasm of unspecified part of unspecified bronchus or lung
C37	Malignant neoplasm of thymus
C45.0	Mesothelioma of pleura
C48.1	Malignant neoplasm of specified parts of peritoneum
C52	Malignant neoplasm of vagina
C53.0	Malignant neoplasm of endocervix

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Background & Definitions

Background: Pemetrexed is an intravenous antifolate chemotherapeutic agent available as branded and generic/505(b)(2) formulations (examples: Alimta, Pemfexy, Pemrydi RTU, Axtle, and multiple generics). Common formulations include lyophilized powder and ready‑to‑use solution vials with mapped HCPCS/NDC codes. This policy references the NCCN Compendium and manufacturer package inserts for product‑ and indication‑specific recommendations, dosing, supplementation (folic acid and vitamin B12), and renal function contraindications.

Definitions

High-risk features (Peritoneal Mesothelioma)Ki-67 >9%, nodal metastasis, thrombocytosis, PS=2, high disease burden/incomplete cytoreduction (PCI >17, CC score >1), biphasic/sarcomatoid histology, or bicavitary disease

SDVSingle dose vial

MDVMultiple dose vial

OpenPayer

pemetrexed (Alimta, Pemfexy, Pemrydi RTU, Axtle, others) intravenous

Coverage Summary

Indications, Limits, and Thresholds

Provider Actions & Billing Impact

Applicable Codes

Clinical Evidence & References

Background & Definitions

Revision History