CurrentViva HealthPolicy IC-0007

Pemetrexed (Alimta/Pemfexy/Pemrydi) prior authorization and coverage

Clinical coverage, dosing, authorization length, renewal criteria, and billing/coding for pemetrexed intravenous products for oncology indications. Applies to providers submitting prior authorization requests to Viva Health.

Policy Summary

PayerViva Health

PolicyPemetrexed (Alimta/Pemfexy/Pemrydi) prior authorization and coverage

Policy CodePolicy IC-0007

Change TypeNo material change

Effective Date

Next Review DateSep 4, 2025

Key ActionObtain prior authorization; initial approvals are typically provided for 6 months (some indications/courses specified as 6 cycles or 6 doses).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthstypical initial prior authorization validity

6 cyclesthymomas / some mesothelioma courses

CrCl <45renal contraindication threshold

J9305, J9322, J9324listed HCPCS codes

NCCN (2025)NCCN referenced

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Coverage Criteria for Pemetrexed

General eligibility

Covered when ALL of the following are met

age: Patient is at least 18 years of age

CNS-related indications

Primary CNS lymphoma and EGFR-mutant CNS disease coverage

PCNSL usage: Patient has primary central nervous system (CNS) lymphoma (including vitreoretinal lymphoma/PCNSL ocular variant without other CNS involvement) AND pemetrexed is used as a single agent AND (used as induction therapy in patients unsuitable for or intolerant to high-dose methotrexate OR used for relapsed or refractory disease)

Brain metastases EGFR+ NSCLC: Patient has limited or extensive brain metastases from EGFR‑sensitizing mutation–positive NSCLC as determined by an FDA‑approved or CLIA‑compliant test AND pemetrexed is used in combination with one of the following: platinum-based chemotherapy (cisplatin or carboplatin) plus osimertinib OR carboplatin plus amivantamab (for exon 19 deletion or L858R) AND used for one of: initial treatment for small asymptomatic limited brain metastases, recurrent limited brain metastases, primary treatment for small asymptomatic extensive brain metastases, or recurrent extensive brain metastases with stable systemic disease

Leptomeningeal EGFR+: Patient has leptomeningeal metastases from EGFR mutation–positive NSCLC as determined by an FDA‑approved or CLIA‑compliant test AND pemetrexed is used as a single agent administered intra‑CSF (intra‑cerebrospinal fluid) AND used as primary treatment in patients with good risk status (KPS ≥ 60, no major neurologic deficits, minimal systemic disease, reasonable systemic treatment options) OR used as maintenance treatment in patients with negative CSF cytology or clinically stable patients with persistently positive CSF cytology

Non-squamous NSCLC

Non-squamous NSCLC coverage

combination use: Used in combination with a carboplatin- or cisplatin-containing regimen

maintenance: Used in combination with bevacizumab, pembrolizumab, cemiplimab, or durvalumab for continuation maintenance if previously used first‑line and the patient achieved a tumor response or stable disease following initial therapy

single agent recurrent: Used as a single agent for recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or for mediastinal lymph node recurrence after prior radiation AND may be used as first‑line therapy when tumors are negative for actionable molecular biomarkers OR for tumors with specific driver alterations (EGFR exon 20 insertion, BRAF V600E, NTRK1/2/3 fusions, MET exon 14 skipping, NRG1 fusion, or ERBB2/HER2 mutation) OR used as subsequent therapy or as continuation/switch maintenance after achieving response or stable disease

Peritoneal mesothelioma (PeM)

Mesothelioma and related coverage

Peritoneal mesothelioma adjuvant: Used as adjuvant therapy following cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC) AND patient has surgical/pathologic high‑risk features (e.g., Ki‑67 >9%, nodal metastasis, thrombocytosis, PS=2, high disease burden/incomplete cytoreduction [PCI >17, CC score >1], biphasic/sarcomatoid histology, or bicavitary disease) AND may be used as a single agent or in combination with platinum chemotherapy with or without bevacizumab or pembrolizumab

Peritoneal mesothelioma first-line/induction/subsequent: Used as induction therapy prior to surgical exploration for clinical stage I epithelioid disease OR used as first‑line therapy when medically inoperable disease, incomplete cytoreduction, presence of any high‑risk feature, or disease progression after prior CRS+HIPEC without prior adjuvant systemic therapy apply AND used as a single agent or in combination with platinum chemotherapy with or without bevacizumab or pembrolizumab OR used as subsequent therapy as a single agent or with platinum chemotherapy (with or without bevacizumab) when prior first‑line immunotherapy was given or as a rechallenge if prior pemetrexed‑based first‑line therapy produced a good response

Note: May also be used for pericardial mesothelioma and tunica vaginalis testis mesothelioma.

Thymic malignancies

Thymomas and thymic carcinomas

thymic single agent: Used as a single agent when the patient is unable to tolerate first‑line combination regimens AND may be used as preoperative systemic therapy for surgically resectable disease if R0 resection is uncertain OR used as postoperative treatment after R1 or R2 resection (applies to thymic carcinoma) OR used as first‑line therapy for recurrent, advanced, or metastatic disease OR used as second‑line therapy for unresectable or metastatic disease

Gynecologic and cervical/vaginal cancers

Gynecologic and other tumor types

ovarian-type cancers: Used as a single agent for recurrent or persistent disease in specified ovarian/fallopian tube/primary peritoneal histologies (including Grade 1 endometrioid carcinoma, carcinosarcoma, mucinous neoplasms of the ovary, epithelial ovarian/fallopian tube/primary peritoneal cancer, or clear cell carcinoma of the ovary) AND patient is not experiencing immediate biochemical relapse (rising CA‑125 without radiographic evidence of disease) OR patient has recurrent low‑grade serous carcinoma

vaginal cancer: Used as a single agent as subsequent therapy for recurrent or metastatic vaginal cancer

cervical cancer: Used as a single agent as subsequent therapy for recurrent or metastatic cervical cancer (squamous, adenocarcinoma, adenosquamous histologies)

Thyroid carcinoma indications

Thyroid carcinoma

thyroid combined: Used in combination with carboplatin for follicular or papillary carcinoma that is unresectable, locoregionally recurrent/persistent, or metastatic and refractory to radioactive iodine therapy; OR used for oncocytic carcinoma with progressive disease after prior treatment; OR used as second‑line therapy for anaplastic carcinoma stage IVC

Do not administer pemetrexed to patients with creatinine clearance <45 mL/min. This renal function threshold is an absolute contraindication to dosing and must be verified prior to each planned dose. (See dosing guidance for related precautions including folic acid/B12 supplementation and NSAID avoidance with reduced CrCl.)

Medicare Part B applicability: the clinical guidance and diagnosis lists in this document are intended for non‑Medicare coverage determinations. Compliance with Medicare National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) is required where applicable; providers should consult the CMS coverage database for Part B policy details. The document notes that Medicare Part B Covered Diagnosis Codes are N/A for the appended list.

For ovarian‑type cancers (ovarian, fallopian tube, primary peritoneal), pemetrexed is covered as a single agent for specified recurrent or persistent histologies but is not indicated for immediate biochemical relapse — defined as a rising CA‑125 level without radiographic evidence of disease. Treatment in that biochemical‑only relapse setting does not meet coverage criteria.

Supportive care / Renal function	Recommendation	Contraindications / Precautions
Folate and vitamin B12 supplementation
Supplement with oral folic acid and intramuscular vitamin B12 prior to and during treatment
Do not administer pemetrexed if creatinine clearance (CrCl) <45 mL/min; avoid ibuprofen for 2 days before, the day of, and 2 days after administration in patients with CrCl <80 mL/min.

Prior Authorization, Documentation, and Billing Requirements

Prior Authorization

Prior authorization validity and initial durations

Submit prior authorization; initial approvals are generally provided for 6 months unless otherwise specified. Certain indications have different initial validity (see specific indications for cycle/dose limits).

Initial prior authorization validity: 6 months by default.
Thymomas/thymic carcinomas: initial validity provided for six (6) cycles.
Mesothelioma combinations with bevacizumab + platinum: 6 cycles; with pembrolizumab + platinum: 6 doses.

Prior Authorization

PA consideration for pemetrexed due to cost

Prior authorization may be considered for pemetrexed products due to the drug cost factor identified in the NQTL checklist; follow the payer's prior authorization process when submitting requests.

NQTL checklist: 'Cost of drug, 1 = Yes: Consider for PA'.
Follow payer-specific PA submission procedures where applicable.

Prior Authorization

PA consideration based on indication and NQTL factors

Prior authorization may be considered for this drug/drug group based on indication and cost factors per the NQTL factor checklist; utilization management NQTLs may be applied comparably across benefit types.

Indication and cost were listed among factors leading to consideration for PA in the NQTL checklist.
Utilization management NQTLs apply comparably to MH/SUD and M/S prescription drugs.

Step Therapy

Thymic tumors — single‑agent use when combinations not tolerated

For thymomas and thymic carcinomas, pemetrexed may be used as a single agent when the patient cannot tolerate first‑line combination regimens; it may be used preoperatively, postoperatively (R1/R2 for thymic carcinoma), as first‑line for recurrent/advanced/metastatic disease, or as second‑line for unresectable or metastatic disease.

Use as single agent if patient unable to tolerate first‑line combination regimens.
Allowed as preoperative systemic therapy if R0 resection is uncertain, postoperative after R1/R2 (thymic carcinoma only), first‑line for recurrent/advanced/metastatic disease, or second‑line for unresectable/metastatic disease.

Note

Denial Risk

Renewal denial triggers — duration, toxicity, and response

Renewal may be denied if the duration of authorization has been exceeded, if unacceptable toxicity is present (examples include renal toxicity with CrCl <45 mL/min), or if disease response is not demonstrated.

Duration of authorization must not be exceeded (see Section I for initial validity limits).
Unacceptable toxicities that may trigger denial include myelosuppression, renal toxicity (CrCl <45 mL/min), severe skin toxicity, interstitial pneumonitis, or radiation recall.
Renewal requires evidence of disease response or stabilization.

Prior Authorization

PA consideration due to drug cost (NQTL)

Prior authorization may be considered due to drug cost per the NQTL Factor Checklist; cost was scored as a factor prompting consideration for PA.

Appendix A lists 'Cost of drug, 1 = Yes: Consider for PA'.

Note

NQTL considerations that may prompt PA

Utilization management NQTLs were considered for this drug/drug group; prior authorization may be applied based on indication and cost and must be applied comparably across MH/SUD and medical/surgical drugs.

NQTL checklist describes factors considered (indication, safety/efficacy, cost) and notes comparable application across benefit types.

Billing Rule

Required billing elements — HCPCS J‑code and NDC

When billing pemetrexed, include the appropriate HCPCS J‑code and the product NDC corresponding to the specific manufacturer and presentation (examples shown include J9305, J9322, J9297 and associated NDC entries).

Examples: Alimta 500 mg (HCPCS J9305, NDC 00002-7640-xx / 00002-7623-xx), BluePoint presentations (J9322, NDCs 68001-0543-xx etc.), Sandoz solution (J9297, NDC 00781-3518-xx).
Select the HCPCS code and NDC that match the dispensed product and submit both on the claim.

Documentation Required

Required diagnosis coding — include covered ICD‑10 code

Include an appropriate covered ICD‑10 diagnosis code from the listed oncology codes when submitting claims or authorization requests (examples include C33, multiple C34 subcodes, C37, C45.*, C48.*, C52, C53.*, C56.*, C57.*, C73, C79.31, C79.32, multiple lymphoma codes, D15.0, D38.4, and relevant Z85.* history codes).

Use the diagnosis code that best reflects the treated malignancy (e.g., C37 for thymus, C45.1 for peritoneal mesothelioma, C79.31 for brain metastasis).
Appendix 1 lists the covered ICD‑10 codes to reference when submitting.

Billing and Diagnosis Codes

Covered HCPCS Codes for pemetrexed productsHCPCSCovered

J9324	Pemetrexed disodium solution for injection (multiple RTU products listed)
J9305	Pemetrexed disodium lyophilized powder for injection (Alimta and generics)
J9322	Pemetrexed disodium lyophilized powder for injection (BluePoint branded presentations)
J9297	Pemetrexed disodium solution for injection (Sandoz product listed)

Covered HCPCS Codes for pemetrexed productsHCPCS

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

1–10 of 11

1/2

Covered ICD-10 Diagnosis CodesICD-10Covered

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
C34.31	Malignant neoplasm of lower lobe, right bronchus or lung

1–10 of 68

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inv-14: Creatinine clearance — Do not administer if CrCl < 45 mL/min

Administration thresholdDo not administer pemetrexed in patients with creatinine clearance (CrCl) < 45 mL/min

Ibuprofen guidanceAvoid ibuprofen 2 days before, day of, and 2 days after administration in patients with CrCl < 80 mL/min

SupplementationSupplement with oral folic acid and intramuscular vitamin B12 per dosing guidance

inv-15: Medicare Part B Covered Diagnosis Codes — N/A

Medicare Part B covered codesN/A

NoteAppendix indicates preceding information is intended for non‑Medicare determinations; comply with NCD/LCD where applicable

Reference linkUse CMS coverage database to check applicable NCD/LCD/LCA policies

OpenPayer

Pemetrexed (Alimta/Pemfexy/Pemrydi) prior authorization and coverage

Coverage Criteria for Pemetrexed

Dosing, Cycle Limits, and Supplementation

First-line and Second-line Use

Required Biomarker and Diagnostic Testing

Prior Authorization, Documentation, and Billing Requirements

Billing and Diagnosis Codes

Definitions and Risk Features

Background on Pemetrexed