EmblemHealth Eloxatin Coverage Policy Update

Coverage Criteria for Eloxatin (oxaliplatin)

Initial Approval Criteria

Eloxatin may be considered medically necessary in patients who meet at least one of the following:

Indications list: Patient has clinically documented carcinoma of the colon or rectum OR one of the listed non‑FDA approved tumor types (appendiceal adenocarcinoma; bladder cancer — urothelial or non‑urothelial adenocarcinoma; chronic lymphocytic leukemia/small lymphocytic lymphoma [CLL/SLL] when used for histologic (Richter's) transformation to diffuse large B‑cell lymphoma; advanced gastric carcinoma; esophageal and esophagogastric junction cancer; pancreatic adenocarcinoma; classic Hodgkin lymphoma; B‑cell lymphoma subtypes (including HIV‑related B‑cell lymphoma, diffuse large B‑cell lymphoma including histologic transformation, follicular lymphoma grade 1–2, mantle cell lymphoma, post‑transplant lymphoproliferative disorders [monomorphic], and high‑grade B‑cell lymphoma); T‑cell lymphoma subtypes; neuroendocrine tumors/adrenal tumors; occult primary; small bowel adenocarcinoma; ampullary adenocarcinoma; anal squamous cell carcinoma; testicular cancer; biliary tract/hepatobiliary cancers; primary cutaneous lymphomas; and other solid tumor indications enumerated in the policy).at least one indication

Non‑FDA approved indications are enumerated in the guideline (see policy lists).

Dosing Guidance

Dose schedules vary by indication:

Dose schedules: Provide the indication‑specific mg/m2 dosing and schedule as documented in the policy. Examples: Colorectal cancer, appendiceal adenocarcinoma, neuroendocrine/adrenal tumors, occult primary, small bowel adenocarcinoma, and certain T‑cell lymphomas: 130 mg/m2 IV on day 1 every 3 weeks OR 85 mg/m2 IV on day 1 every 2 weeks. Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) in OFAR regimen: 25–30 mg/m2/day IV for 4 days every 4 weeks (in combination with fludarabine, cytarabine, and rituximab) for up to 6 cycles. B‑cell lymphomas and ovarian/fallopian tube/primary peritoneal cancers: 130 mg/m2 IV on day 1 every 3 weeks. Esophageal/esophagogastric junction and gastric cancers: multiple acceptable schedules including 85 mg/m2 on days 1, 15, and 29 every 35 days OR 85 mg/m2 on day 1 every 2 weeks OR 85 mg/m2 on day 1 every 3 weeks OR 130 mg/m2 on day 1 every 3 weeks. Pancreatic and hepatobiliary/biliary tract cancers, testicular cancer, anal squamous cell carcinoma, ampullary adenocarcinoma, and classic Hodgkin lymphoma have the dosing schedules listed in the policy dosing table.see dosing table

Multiple alternative schedules are provided per indication; follow the exact schedule listed for the requested diagnosis.

Renewal Criteria

Coverage may be renewed when all criteria are met:

Renewal requirements: Patient continues to meet the initial approval criteria; AND disease response to treatment is documented (stabilization of disease or decrease in tumor size or tumor spread); AND absence of unacceptable toxicity from oxaliplatin (examples include hypersensitivity/anaphylaxis, severe myelosuppression such as neutropenia or thrombocytopenia, peripheral sensory neuropathy, Posterior Reversible Encephalopathy Syndrome [PRES], pulmonary toxicity, hepatotoxicity, cardiovascular toxicity including QT prolongation/arrhythmias, rhabdomyolysis, hemorrhage); AND note that coverage for CLL/SLL will not be renewed after the initial authorization period for that diagnosis.all conditions

Renewal requires submission of documentation demonstrating response and tolerability per policy; unacceptable toxicities are examples listed in the policy.

Initial and Renewal Coverage Criteria

Covered when diagnosis and subtype match listed oncology indications and other policy-specific conditions are met (see enumerated subtypes).

General coverage prerequisites: Patient has one of the specified cancer diagnoses or lymphoma subtypes enumerated in the policy (including multiple B‑cell and T‑cell lymphoma subtypes and numerous solid tumor indications); provider documents response to therapy for renewals; and there is absence of unacceptable toxicity to oxaliplatin as defined by the policy.

See policy lists and revision history for full enumeration of ICD‑10 diagnosis codes and subtype definitions (e.g., HIV‑related B‑cell lymphoma language updated in revision history).

Renewal Criteria

Renewal requires ALL of the following

Renewal criteria: Documented disease response to treatment (stabilization or decrease in tumor size or spread); AND absence of unacceptable toxicity from oxaliplatin (examples: hypersensitivity including anaphylaxis; severe myelosuppression including neutropenia or thrombocytopenia; immune‑mediated thrombocytopenia; peripheral sensory neuropathy; Posterior Reversible Encephalopathy Syndrome [PRES]; pulmonary, hepatic, or cardiovascular toxicity including QT prolongation and ventricular arrhythmias; rhabdomyolysis; hemorrhage).

Providers must submit clinical evidence demonstrating response and absence of unacceptable toxicity for renewal requests; CLL/SLL has a non‑renewal rule.

Diagnosis-specific Limits

Authorization limits for specific diagnoses

CLL/SLL authorization: Coverage for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) when used for histologic (Richter's) transformation to diffuse large B‑cell lymphoma (DLBCL) is authorized for up to six 4‑week cycles and will not be renewed.six 4-week cycles

This diagnosis‑specific length‑of‑authorization and non‑renewal rule was added in the policy revision history.

Coverage for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) is limited by a diagnosis‑specific authorization rule. Per the policy revision history and renewal criteria, coverage for CLL/SLL will be provided for six 4‑week cycles and will not be renewed. Renewal requests for CLL/SLL should not be approved beyond this defined authorization period.

The ICD‑10 diagnosis code lists included in this section do not specify additional explicit coverage exclusions beyond those called out elsewhere in the policy. Providers should reference the enumerated ICD‑10 codes when submitting prior authorization requests or claims; absence of a code from the list may require clarification or lead to denial.

The policy revision history includes a specific note regarding ovarian, fallopian tube, and primary peritoneal cancers: the guideline excludes use as immediate treatment of biochemical relapse for these tumor types. This exclusion is documented in the revision notes and applies to requests for immediate treatment in the setting of biochemical relapse.

Use of oxaliplatin as immediate treatment of biochemical relapse in ovarian, fallopian tube, or primary peritoneal cancers is designated as not medically necessary / excluded for that specific clinical scenario. Renewal or authorization for treatment in the immediate biochemical relapse setting should be denied consistent with this policy statement.

Approved Regimens and Dosing Schedules

Indication	Dose (mg/m2)	Schedule / Notes
Colorectal cancer / Appendiceal adenocarcinoma / Neuroendocrine tumors / Adrenal tumors / Occult primary / Small bowel adenocarcinoma / T-cell lymphomas
130 mg/m2 OR 85 mg/m2
130 mg/m2 on day 1 every 3 weeks OR 85 mg/m2 on day 1 every 2 weeks
Esophageal / Esophagogastric junction cancer / Gastric cancer
85 mg/m2 OR 130 mg/m2
85 mg/m2 on days 1, 15, and 29 every 35 days OR 85 mg/m2 on day 1 every 2 weeks OR 85 mg/m2 on day 1 every 3 weeks OR 130 mg/m2 on day 1 every 3 weeks
Pancreatic cancer
100 mg/m2 OR 85 mg/m2
100 mg/m2 on day 2 every 14 days OR 85 mg/m2 on days 8 and 22 every 42 days OR 85 mg/m2 on day 1 every 14 days
Hepatobiliary / Biliary tract cancers
100 mg/m2
100 mg/m2 on days 1 and 15 every 28 days OR 100 mg/m2 on day 2 every 14 days
Testicular cancer
60 mg/m2 OR 130 mg/m2
60 mg/m2 on days 1, 8, and 15 every 4 weeks OR 130 mg/m2 on day 1 every 3 weeks OR 130 mg/m2 on days 1 and 15 every 4 weeks
Anal squamous cell carcinoma
85 mg/m2
85 mg/m2 on day 1 every 2 weeks
Ampullary adenocarcinoma
130 mg/m2
130 mg/m2 on day 1 every 3 weeks
Classic Hodgkin lymphoma (cHL)
100 mg/m2
100 mg/m2 on day 1 every 3 weeks
Other indications (general guidance)
130 mg/m2 OR 85 mg/m2
For all other listed indications: 130 mg/m2 on day 1 every 3 weeks OR 85 mg/m2 on day 1 every 2 weeks (alternative schedules per indication).

Indication	Dose (mg/m2/day)	Regimen / Authorization
Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) — OFAR regimen (Richter's transformation to DLBCL)
25–30 mg/m2/day
Administered for 4 days every 4 weeks in combination with fludarabine, cytarabine, and rituximab (OFAR); up to 6 cycles. Authorization limited to six 4‑week cycles and will not be renewed.

Regimen name / Setting	Oxaliplatin role	Dosing reference / Notes
FOLFOX and other oxaliplatin-containing colorectal regimens
Main cytotoxic component in combination with 5-FU/leucovorin (± irinotecan as specified)
See dosing chart: common colorectal doses include 130 mg/m2 day 1 q3w or 85 mg/m2 day 1 q2w; dosing chart updated in revision history.
OFAR (for Richter's transformation) — hematologic regimen
Used as part of combination with fludarabine, cytarabine, rituximab
Dose: 25–30 mg/m2/day for 4 days every 4 weeks (authorization limited to six 4‑week cycles).
Oxaliplatin-containing regimens for gastric / esophagogastric / pancreatic / biliary / ampullary cancers
Component of multi-agent chemotherapy regimens for gastrointestinal primaries
Refer to dosing table for indication-specific schedules (examples: gastric/esophagogastric — multiple 85 or 130 mg/m2 schedules; pancreatic — 100 mg/m2 or 85 mg/m2 variants).

mixed

Line of therapy: Policy lists multiple indications across lines of therapy; specific line (first‑line, second‑line) is not consistently specified in the policy segment and should be confirmed from the full dosing/regimen table or treating guideline when relevant to the request.

See full policy for line‑specific details where provided; the document's line_of_therapy field is listed as 'mixed'.

Billing and Diagnosis Codes

Covered HCPCS CodesHCPCSCovered

J9263

Injection, 0.5 mg, 1 billable unit (0.5 mg)

NDC CodesNDC

00024-0590-10	Eloxatin 50 mg single use vial; 5 mg/ml solution
00024-0591-20	Eloxatin 100 mg single use vial; 5 mg/ml solution

Applicable NDCsNDC

00024-0590-10	Eloxatin 50 mg single use vial; 5 mg/ml solution
00024-0591-20	Eloxatin 100 mg single use vial; 5 mg/ml solution

Applicable ICD-10 Diagnosis Codes (selected)ICD-10

C15.3	Malignant neoplasm of upper third of esophagus
C15.4	Malignant neoplasm of middle third of esophagus
C15.5	Malignant neoplasm of lower third of esophagus
C15.8	Malignant neoplasm of overlapping sites of esophagus
C15.9	Malignant neoplasm of esophagus, unspecified
C16.0	Malignant neoplasm of cardia
C16.1	Malignant neoplasm of fundus of stomach
C16.2	Malignant neoplasm of body of stomach
C16.3	Malignant neoplasm of pyloric antrum
C16.4	Malignant neoplasm of pylorus

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Selected malignant neoplasm and metastatic site codesICD-10

C48.1	Malignant neoplasm of specified parts of peritoneum
C48.2	Malignant neoplasm of peritoneum, unspecified
C48.8	Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum
C56.1	Malignant neoplasm of right ovary
C56.2	Malignant neoplasm of left ovary
C56.3	Malignant neoplasm of bilateral ovaries
C56.9	Malignant neoplasm of unspecified ovary
C57.00	Malignant neoplasm of unspecified fallopian tube
C57.01	Malignant neoplasm of right fallopian tube
C57.02	Malignant neoplasm of left fallopian tube

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Carcinoid / neuroendocrine tumor codesICD-10

C78.00	Secondary malignant neoplasm of unspecified lung
C78.01	Secondary malignant neoplasm of right lung
C78.02	Secondary malignant neoplasm of left lung
C78.6	Secondary malignant neoplasm of retroperitoneum and peritoneum
C78.7	Secondary malignant neoplasm of liver and intrahepatic bile duct
C80.0	Disseminated malignant neoplasm, unspecified
C80.1	Malignant (primary) neoplasm, unspecified
C7A.00	Malignant carcinoid tumor of unspecified site
C7A.010	Malignant carcinoid tumor of the duodenum
C7A.011	Malignant carcinoid tumor of the jejunum

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Hodgkin lymphoma codes (selection)ICD-10

C81.10	Nodular sclerosis Hodgkin lymphoma, unspecified site
C81.11	Nodular sclerosis Hodgkin lymphoma, lymph nodes of head, face, and neck
C81.12	Nodular sclerosis Hodgkin lymphoma, intrathoracic lymph nodes
C81.13	Nodular sclerosis Hodgkin lymphoma, intra-abdominal lymph nodes
C81.14	Nodular sclerosis Hodgkin lymphoma, lymph nodes of axilla and upper limb
C81.15	Nodular sclerosis Hodgkin lymphoma, lymph nodes of inguinal region and lower limb
C81.16	Nodular sclerosis Hodgkin lymphoma, intrapelvic lymph nodes
C81.17	Nodular sclerosis Hodgkin lymphoma, spleen
C81.18	Nodular sclerosis Hodgkin lymphoma, lymph nodes of multiple sites
C81.19	Nodular sclerosis Hodgkin lymphoma, extranodal and solid organ sites

Follicular and diffuse B-cell lymphoma codes (selection)ICD-10

C82.00	Follicular lymphoma grade I, unspecified site
C82.07	Follicular lymphoma grade I, spleen
C82.50	Diffuse follicle center lymphoma, unspecified site
C82.90	Follicular lymphoma, unspecified, unspecified site
C83.00	Small cell B-cell lymphoma, unspecified site
C83.10	Mantle cell lymphoma, unspecified site
C83.30	Diffuse large B-cell lymphoma, unspecified site
C83.80	Other non-follicular lymphoma, unspecified site
C83.90	Non-follicular (diffuse) lymphoma, unspecified, unspecified site

T-cell, NK-cell, other lymphoma codes (selection)ICD-10

C84.00	Mycosis fungoides, unspecified site
C84.10	Sezary disease
C84.40	Peripheral T-cell lymphoma, not classified, unspecified site
C84.60	Anaplastic large cell lymphoma, ALK-positive, unspecified site
C84.70	Anaplastic large cell lymphoma, ALK-negative, unspecified site
C84.90	Mature T/NK-cell lymphomas, unspecified, unspecified site
C84.20	Other mature T/NK-cell lymphomas, unspecified site

ICD-10 Diagnoses (selected list)ICD-10

C85.10	Unspecified B-cell lymphoma, unspecified site
C85.11	Unspecified B-cell lymphoma, lymph nodes of head, face, and neck
C85.12	Unspecified B-cell lymphoma, intrathoracic lymph nodes
C85.15	Unspecified B-cell lymphoma, lymph nodes of inguinal region and lower limb
C85.16	Unspecified B-cell lymphoma, intrapelvic lymph nodes
C85.17	Unspecified B-cell lymphoma, spleen
C85.18	Unspecified B-cell lymphoma, lymph nodes of multiple sites
C85.19	Unspecified B-cell lymphoma, extranodal and solid organ sites
C85.20	Mediastinal (thymic) large B-cell lymphoma, unspecified site
C85.21	Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face, and neck

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Max Units (per dose and over time) [HCPCS Unit]600 billable units every 14 days

Length of authorization for CLL/SLLsix 4-week cycles

Provider Requirements and Prior Authorization

Documentation Required

Clinical evidence submission

The treating provider must submit clinical evidence that the member meets the criteria for the requested treatment to EmblemHealth for preauthorization and/or post-payment review. Failure to provide sufficient clinical documentation will prevent EmblemHealth from properly reviewing the request.

Include relevant clinical records (history, pathology, imaging, prior therapies, and response assessments) that demonstrate the member meets the policy criteria.

Billing Rule

Diagnosis coding documentation

Providers should document and use an appropriate ICD-10 diagnosis code from the list in this policy when submitting prior authorization requests or claims for related services. Using a diagnosis code not on the policy list may trigger a denial or request for clarification.

Definitions and Key Terms

Eloxatin (oxaliplatin) indication

Indication (adjuvant)Eloxatin used in combination with infusional 5-FU/leucovorin for adjuvant treatment of stage III colon cancer after complete resection

Indication (advanced disease)Also indicated for treatment of advanced carcinoma of the colon or rectum

Combination therapy notePolicy references use in combination with infusional 5-FU/LV; other combination regimens listed elsewhere in dosing guidance

Neuroendocrine/carcinoid tumor codes

ICD-10 code blocksMalignant carcinoid and neuroendocrine tumor codes in policy include C7A.* and CZB.* (detailed site-specific codes listed)

Examples (carcinoid sites)C7A.00 (malignant carcinoid tumor, unspecified site); C7A.020–C7A.026 (appendix, cecum, ascending/transverse/descending/sigmoid colon, rectum)

Clinical Background

Oxaliplatin (Eloxatin) is indicated in combination with infusional 5‑fluorouracil and leucovorin (5‑FU/LV) for adjuvant treatment of stage III colon cancer following complete resection, and for treatment of advanced carcinoma of the colon or rectum. The policy also lists multiple off‑label tumor types for which oxaliplatin may be considered; revision history documents annual updates to dosing guidance and indication lists.

Policy Revision History

2024-03-18dosing_chart_and_limits_updated

Added dosing limits and updated the dosing chart for oxaliplatin-containing regimens; also specified a new length-of-authorization limit for CLL/SLL (six 4-week cycles, not renewable).

2025-04-03annual_review_material_changesLatest

Annual review with removal and addition of diagnosis codes and multiple content updates (diagnosis list changes and wording updates to B‑cell lymphoma subtypes).

2024-03-18

OpenPayer

Eloxatin (oxaliplatin) Intravenous