1. The prescriber is a specialist in the area of the patient’s diagnosis (e.g. oncologist) or has consulted with a specialist in the area of the patient’s diagnosis.

2. Oxaliplatin is considered medically necessary when prescribed by the treating physician for the following FDA approved indications:

A. Adjuvant treatment of stage III colon cancer: In combination with infusional 5-fluorouracil/leucovorin for adjuvant treatment of stage III colon cancer patients who have undergone complete resection of the primary tumor
B. Advanced colorectal cancer: In combination with infusional 5-fluorouracil/leucovorin for the treatment of advanced colorectal cancer

• Day 1: oxaliplatin 85 mg/m² intravenous infusion given over 120 minutes every two weeks
• Reduce the dose of oxaliplatin to 75 mg/m² (adjuvant setting) or 65 mg/m² (advanced colorectal cancer) if there are persistent grade 2 neurosensory events that do not resolve or after recovery from grade 3/4 gastrointestinal toxicities (despite prophylactic treatment) or grade 4 neutropenia or grade 3/4 thrombocytopenia. Delay next dose until neutrophils ≥1.5 × 10⁹/L and platelets ≥75 × 10⁹/L.
• Day 2: leucovorin 200 mg/m2 intravenous infusion over 120 minutes, followed by 5-fluorouracil 400 mg/m2 intravenous bolus given over 2–4 minutes, followed by 5-fluorouracil 600 mg/m2 intravenous infusion in 500 mL 5% Dextrose Injection, USP (recommended) as a 22-hour continuous infusion.

[INFORMATIONAL NOTE: As per the FDA approved package insert, anaphylactic reactions to Eloxatin have been reported, and may occur within minutes of Eloxatin administration. Epinephrine, corticosteroids, and antihistamines have been employed to alleviate symptoms. For patients with severe renal impairment (creatinine clearance <30 mL/min), the initial recommended dose is 65 mg/m²]

• Anal Carcinoma
  • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen for recurrence or progression of metastatic disease
  • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen with or without radiation for primary treatment of metastatic disease
• B-Cell Lymphomas
  • AIDS-Related B-Cell Lymphomas: Second-line or subsequent therapy with or without rituximab for relapse of AIDS-related diffuse large B-cell lymphoma, primary effusion lymphoma, and HHV8-positive diffuse large B-cell lymphoma, not otherwise specified (NOS) or without rituximab for relapse of AIDS-related plasmablastic lymphoma as a component of DHAX (dexamethasone, cytarabine, and oxaliplatin) or GemOX (gemcitabine and oxaliplatin) regimen
  • Diffuse Large B-Cell Lymphoma: Second-line or subsequent therapy with or without rituximab for partial response, no response, relapsed, progressive, or refractory disease
    • preferred in patients with intention to proceed to transplant as a component of•DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
    • in patients with intention to proceed to transplant as a component of GemOX (gemcitabine and oxaliplatin) regimen
    • preferred in non-candidates for transplant as a component of GemOX
  • Follicular Lymphoma (grade 1-2): As a component of DHAX (dexamethasone, cytarabine, and oxaliplatin) with or without rituximab, or as a component of GemOx (gemcitabine and oxaliplatin) with or without rituximab as
    • second-line or subsequent therapy (if not previously given as first-line) for refractory or progressive disease in patients with indications for treatment
    • treatment of histologic transformation to diffuse large B-cell lymphoma in patients who have received multiple lines of chemoimmunotherapy for indolent or transformed disease
  • High-Grade B-Cell Lymphomas: Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease as a component of DHAX (dexamethasone, cytarabine, and oxaliplatin) or GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab
  • Histologic Transformation of Nodal Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma: Treatment with or without rituximab for patients who have received multiple lines of chemoimmunotherapy for indolent or transformed disease as a component of
    • GemOX (gemcitabine and oxaliplatin) regimen
    • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
  • Mantle Cell Lymphoma:
    • Preferred aggressive induction therapy for stage I-II disease that had a partial response, progression, or relapse after initial treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV TP53 mutation negative (aggressive induction therapy followed by HDT/ASCR may not be appropriate for TP53 positive disease. Optimal treatment is unknown) disease in patients who are candidates for high-dose therapy/autologous stem cell rescue (HDT/ASCR) as a component of aggressive therapy with RDHA + platinum (rituximab, dexamethasone, cytarabine, and oxaliplatin) regimen
    • Second-line therapy with or without rituximab for stage I-II, aggressive stage II bulky, III, or IV, or symptomatic indolent stage II bulky, III, or IV disease in patients who have stable disease or partial response with substantial disease after induction therapy, or who have relapsed or progressed following an extended response duration to prior chemoimmunotherapy (> expected median progression free survival) as a component of
      • GemOX (gemcitabine and oxaliplatin) regimen
      • DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen
  • Post-Transplant Lymphoproliferative Disorders: Second-line and subsequent therapy with or without rituximab for patients with partial response, persistent or progressive disease after receiving chemoimmunotherapy as first-line treatment for monomorphic PTLD (B-cell type) as a component of DHAX (dexamethasone, cytarabine, and oxaliplatin) or GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab
• Bladder Cancer
  • Non-Urothelial and Urothelial with Variant Histology: May be considered as a component of FOLFOX (oxaliplatin, leucovorin, fluorouracil)
    • for node-positive disease
    • in select patients with advanced disease
• Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Initial therapy for treatment of histologic (Richter's) transformation to diffuse large B-cell lymphoma (clonally related or unknown clonal status) as a component of OFAR (oxaliplatin, fludarabine, cytarabine, and rituximab) regimen
• Colon Cancer
  • Adjuvant treatment in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen for
    • T3, N0, M0 at high risk for systemic recurrence
    • T4, N0, M0 (MSS/pMMR)
    • T1-3, N1 (low-risk stage III) (preferred)
    • T4, N1-2 or T Any, N2 (high-risk stage III) (preferred)
    • resectable synchronous liver and/or lung metastases (preferred)
    • resectable metachronous metastases following primary treatment with resection and/or local therapy in patients who have not previously received chemotherapy (preferred)
    • resectable metachronous metastases following neoadjuvant chemotherapy and resection and/or local therapy
  • Therapy in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen, FOLFOX with bevacizumab, FOLFOX with cetuximab or panitumumab (KRAS/NRAS/BRAF wild-type gene and left-sided tumors only), CapeOX (capecitabine and oxaliplatin) with or without bevacizumab, or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen (strongly consider for patients with excellent performance status) with or without bevacizumab in patients appropriate for intensive therapy
    • as primary treatment for locally unresectable or medically inoperable disease
    • for unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy
    • as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction
    • for synchronous unresectable metastases of other sites
    • as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy
    • for unresectable metachronous metastases that remain unresectable after primary treatment
    • and progressed on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status
  • Primary treatment in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen as
    • neoadjuvant therapy for bulky nodal disease or clinical T4b disease
    • neoadjuvant or perioperative therapy for resectable synchronous liver and/or lung metastases (both preferred regimens)
    • systemic therapy with or without bevacizumab for unresectable synchronous liver and/or lung metastases
    • systemic therapy (FOLFOX only) with panitumumab or cetuximab for unresectable synchronous liver and/or lung metastases (KRAS/NRAS/BRAF wild-type gene and left-sided tumors only)
    • neoadjuvant therapy for resectable metachronous metastases (both preferred regimens)
  • Subsequent therapy for progression of advanced or metastatic disease not previously treated with oxaliplatin-based therapy
    • in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen
    • in FOLFOX or CapeOX regimen with bevacizumab
    • in combination with irinotecan with or without bevacizumab for disease also not previously treated with irinotecan-based therapy
    • in FOLFOX with cetuximab or panitumumab (KRAS/NRAS/BRAF wild-type only) if previously treated with an irinotecan-based therapy without oxaliplatin
  • Therapy in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen, CapeOX (capecitabine and oxaliplatin) with or without bevacizumab, or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen in patients appropriate for intensive therapy
    • as adjuvant treatment for synchronous liver and/or lung metastases that converted from unresectable to resectable disease after primary treatment
    • as adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases for patients who have received previous chemotherapy
    • as adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment
  • Primary treatment in FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen
    • with or without bevacizumab as systemic therapy for unresectable synchronous liver and/or lung metastases
• Esophageal and Esophagogastric Junction Cancers
  • Concurrent chemoradiation (preferred) in combination with fluorouracil or capecitabine (preferred regimens) for locoregional recurrence in patients who have had esophagectomy but no prior chemoradiation
  • Definitive chemoradiation in combination with fluorouracil or capecitabine (preferred regimens)
    • as primary treatment for patients with pT1b, N0 disease who are medically fit for surgery but decline surgery
    • as primary treatment for patients with cT1b-cT2, N+ or cT3-cT4a, Any N disease who are medically fit for surgery but decline surgery (recommended option for cervical esophagus squamous cell carcinoma)
    • as primary treatment for patients with cT4b disease who are medically fit for surgery
    • consider after endoscopic resection with or without ablation for non-surgical candidates with pT1b, N0 disease and poor prognostic features
    • as primary treatment for non-surgical candidates with cT1b-T4a, N0-N+ or unresectable cT4b disease
  • Preoperative chemoradiation in combination with fluorouracil or capecitabine (preferred regimens) as primary treatment for patients who are medically fit for surgery and have
    • non-cervical esophagus cT1b-cT2, N+ or cT3-cT4a, Any N squamous cell carcinoma
    • cT1b-cT2, N+ or cT3-cT4a, Any N adenocarcinoma (preferred option over definitive chemoradiation, perioperative chemotherapy, or preoperative chemotherapy)
  • Perioperative chemotherapy in combination with fluorouracil or capecitabine, or as a component of FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) regimen (all preferred regimens) for adenocarcinoma of the thoracic esophagus or EGJ
    • as primary treatment prior to esophagectomy in patients who are medically fit for surgery and have cT1b-cT2, N+ or cT3-cT4a, Any N disease
    • as postoperative management following R0 resection in patients who have received preoperative therapy with the same regimen
  • Postoperative chemotherapy in combination with capecitabine following R0 resection in node positive (pTis, pT1, pT2, pT3, or pT4a) adenocarcinoma
  • Postoperative chemotherapy in combination with capecitabine for locoregional recurrence in patients who have had esophagectomy but no prior chemoradiation
  • Palliative therapy for patients who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease and Karnofsky performance score ≥60% or ECOG performance score ≤2 as first-line therapy in combination with fluorouracil or capecitabine (preferred regimens), as a component of modified DCF (docetaxel, oxaliplatin, and fluorouracil) regimen
• Gastric Cancer
  • Postoperative chemotherapy in combination with capecitabine following R0 resection in patients with pT3, pT4, Any N or Any pT, N+ disease who have not received preoperative chemotherapy or chemoradiation and have undergone primary D2 lymph node dissection
  • Perioperative chemotherapy in combination with fluorouracil or capecitabine, or as a component of FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) regimen (all preferred regimens)
    • as primary treatment prior to surgery for potentially resectable locoregional disease (cT2 or higher, any N) in medically fit patients
    • as postoperative management following R0 resection in patients who have received preoperative therapy with the same regimen
  • Palliative chemoradiation in combination with fluorouracil or capecitabine for patients who have locally unresectable disease and chemoradiation has not been previously received and Karnofsky performance score ≥60% or ECOG performance score ≤2
  • Primary treatment as chemoradiation in combination with fluorouracil or capecitabine for medically fit patients with surgically unresectable locoregional disease
  • Primary treatment in combination with fluorouracil or capecitabine (preferred regimens), or as a component of modified DCF (docetaxel, oxaliplatin, and fluorouracil) regimen
  • Palliative therapy for locoregional disease in patients who are not surgical candidates, recurrent, or metastatic disease and Karnofsky performance score ≥60% or ECOG performance score ≤2 as first-line therapy in combination with fluorouracil or capecitabine (preferred regimens), as a component of modified DCF (docetaxel, oxaliplatin, and fluorouracil) regimen
• Hepatobiliary Cancers
  • Extrahepatic Cholangiocarcinoma
    • In combination with gemcitabine as primary treatment for unresectable or metastatic disease
    • In combination with capecitabine or fluorouracil
      • as primary treatment for unresectable or metastatic disease
      • as treatment for resected disease with negative margins (R0) and negative regional nodes, carcinoma in situ at margin, positive margins (R1) positive regional nodes, or gross residual disease (R2)
      • as treatment following fluoropyrimidine chemoradiation for resected disease with positive margins (R1) or positive regional nodes
      • as treatment followed by fluoropyrimidine chemoradiation for resected disease with positive margins (R1) or positive regional nodes
  • Gallbladder Cancer
    • Treatment for resected disease in combination with capecitabine or fluorouracil
      • for negative margins (R0) and negative regional nodes, or carcinoma in situ at margin
      • for positive margins (R1) or positive regional nodes
      • following fluoropyrimidine chemoradiation for positive margins (R1) or positive regional nodes
      • followed by additional fluoropyrimidine chemoradiation for positive margins (R1) or positive regional lymph nodes
      • for gross residual disease (R2)
    • Primary treatment for unresectable or metastatic disease in combination with capecitabine, fluorouracil, or gemcitabine
    • Consider as neoadjuvant chemotherapy for locoregionally advanced disease (big mass invading liver and/or nodal disease, including cystic duct node positive)
  • Intrahepatic Cholangiocarcinoma
    • In combination with capecitabine or fluorouracil as
      • primary treatment for unresectable or metastatic disease
      • treatment for resected disease with no residual local disease (R0 resection), microscopic margins (R1), positive regional nodes or residual local disease (R2 resection)
      • treatment following fluoropyrimidine-based chemoradiation for resected disease with microscopic margins (R1) or positive regional nodes
      • treatment followed by fluoropyrimidine-based chemoradiation for resected disease with microscopic margins (R1) or positive regional nodes
    • In combination with gemcitabine as primary treatment for unresectable or metastatic disease
• Neuroendocrine and Adrenal Tumors
  • Neuroendocrine Tumors of the Pancreas: As a single agent for the management of symptomatic, clinically significant tumor burden or progressive locoregional advanced disease and/or distant metastatic disease
  • Poorly Differentiated (High Grade)/Large or Small Cell: Treatment as part of FOLFOX (fluorouracil, leucovorin, oxaliplatin) regimen
    • as neoadjuvant or adjuvant therapy, or chemotherapy for resectable disease
    • for locoregional unresectable or metastatic disease
• Occult Primary
  • Used as a component of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) regimen (preferred) in symptomatic patients with performance status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for
    • chemoradiation in patients with axillary or inguinal nodal involvement
    • chemotherapy in patients with multiple lung nodules, pleural effusion, or disseminated metastases
  • Chemoradiation as a component of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) regimen (preferred) in symptomatic patients with performance status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for localized disease with inguinal nodal involvement
  • Used in combination with FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) regimen (useful in certain circumstances in patients with presumed GI primary site) in symptomatic patients with performance status (PS) 1 or asymptomatic patients with PS 0 and aggressive disease for
    • axillary involvement in men if clinically indicated
    • lung nodules or breast marker-negative pleural effusion
    • resectable liver disease
    • peritoneal mass or ascites with non-ovarian histology
    • retroperitoneal mass of non-germ cell histology in selected patients
    • unresectable liver disease or disseminated metastases
  • Used as a component of CapeOX (capecitabine and oxaliplatin) (preferred) or mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) regimen (preferred) in symptomatic patients with performance status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for
    • axillary involvement in men if clinically indicated
    • lung nodules or breast marker-negative pleural effusion
    • resectable liver disease
    • peritoneal mass or ascites with non-ovarian histology
    • retroperitoneal mass of non-germ cell histology in selected patients
    • unresectable liver disease or disseminated metastases
• Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer
  • Mucinous Carcinoma
    • Adjuvant treatment in combination with
      • capecitabine for pathologic stage IC-IV disease
      • fluorouracil and leucovorin for pathologic stage IC-IV disease
    • Therapy for persistent disease or recurrence
      • in combination with fluorouracil and leucovorin
      • in combination with capecitabine
• Pancreatic Adenocarcinoma
  • Adjuvant therapy, if clinically indicated, following resection for locally advanced disease in patients with a good performance status and no disease progression after first-line therapy as a component of modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) regimen (preferred regimen) for ECOG performance status (PS) 0-1
  • Adjuvant treatment in patients with no prior neoadjuvant therapy as a component of modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) regimen (preferred regimen) for ECOG performance status (PS) 0-1
  • First-line therapy for metastatic disease in patients with good performance status (ECOG PS 0-1)
    • as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan and oxaliplatin) or modified FOLFIRINOX regimen (both preferred regimens)
  • Preferred neoadjuvant therapy as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) or modified FOLFIRINOX regimen with or without subsequent chemoradiation in patients with an ECOG performance status (PS) 0-1 for
    • resectable disease, particularly in high-risk patients (ie, very highly elevated CA 19-9, large primary tumors, large regional lymph nodes, excessive weight loss, extreme pain)
    • biopsy positive borderline resectable disease
  • Therapy for metastatic disease with or without local recurrence after resection if less than 6 months from completion of primary therapy in patients with good performance status (PS) previously treated with gemcitabine-based therapy
    • as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) or modified FOLFIRINOX regimen if ECOG PS 0-1
    • as a component of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen
    • as a component of OFF (oxaliplatin, fluorouracil, and leucovorin) regimen
    • in combination with capecitabine
  • Therapy with (if not previously done) or without chemoradiation for local recurrence in the pancreatic operative bed after resection or for metastatic disease with or without local recurrence after resection if ≥6 months from completion of primary therapy in patients with good performance status (PS)
    • as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) or modified FOLFIRINOX regimen if ECOG PS 0-1
    • as a component of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen
    • as a component of OFF (oxaliplatin, fluorouracil and leucovorin) regimen
    • in combination with capecitabine
  • Therapy with (if not previously done) or without chemoradiation for local recurrence in the pancreatic operative bed after resection or for metastatic disease with or without local recurrence after resection if ≥6 months from completion of primary therapy in patients with good performance status (PS)
    • as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) or modified FOLFIRINOX regimen if ECOG PS 0-1
    • as a component of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen
    • as a component of OFF (oxaliplatin, fluorouracil and leucovorin) regimen
    • in combination with capecitabine
• Primary Cutaneous Lymphomas
  • Mycosis Fungoides/Sezary Syndrome
    • Systemic therapy in patients with intention to proceed to transplant as a component of GemOx (gemcitabine, oxaliplatin) as primary treatment for
      • stage IV non Sezary or visceral disease (solid organ), with or without radiation therapy for local control (preferred)
      • large cell transformation (LCT) with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy (preferred)
    • Systemic therapy in patients with intention to proceed to transplant as a component of GemOx (gemcitabine, oxaliplatin) as treatment for
      • relapsed or persistent stage IA mycosis fungoides (MF) with B1 blood involvement, with or without skin-directed therapy
      • relapsed or persistent stage IB-IIA MF with B1 blood involvement, with or without skin-directed therapy
      • stage IIB MF with limited tumor lesions refractory to multiple previous therapies, with or without skin-directed therapy
      • relapsed or refractory stage IIB MF with generalized tumor lesions, with or without skin-directed therapies
      • stage IIB MF with generalized tumor lesions that is refractory to multiple previous therapies or progression
      • relapsed or persistent stage III MF, with or without skin-directed therapies
      • stage III MF that is refractory to multiple previous therapies
      • relapsed or persistent stage IV Sezary syndrome
      • relapsed or persistent stage IV non Sezary or visceral disease (solid organ), with or without radiation therapy for local control
      • large cell transformation (LCT) with limited cutaneous lesions that is refractory to multiple previous therapies
      • relapsed or persistent LCT with generalized cutaneous or extracutaneous lesions, with or without skin-directed therapy
  • Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders: Therapy for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional node (N1) (excludes systemic ALCL), as a component of GemOx (gemcitabine, oxaliplatin) for relapsed/refractory disease
• Rectal Cancer
  • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen (both preferred) in patients with resectable metachronous metastases as
    • neoadjuvant treatment
    • adjuvant treatment following primary treatment with resection and/or local therapy in patients who have not previously received chemotherapy
    • adjuvant treatment following primary treatment with neoadjuvant chemotherapy and resection and/or local therapy
  • Therapy in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen, FOLFOX with bevacizumab, FOLFOX with cetuximab or panitumumab (KRAS/NRAS/BRAF wild-type gene only), CapeOX (capecitabine and oxaliplatin) with or without bevacizumab, or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen with or without bevacizumab, in patients appropriate for intensive therapy
    • for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable (with no progression of primary tumor) after primary systemic therapy
    • following palliative radiation therapy (RT) or chemo/RT for synchronous liver only and/or lung only metastases that are unresectable or medically inoperable and remain unresectable (with progression of primary tumor) after primary systemic therapy
    • as primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction
    • as primary treatment for synchronous unresectable metastases of other sites
    • as primary treatment for unresectable metachronous metastases in patients who have not received previous adjuvant FOLFOX or CapeOX within the past 12 months, who have received previous fluorouracil/leucovorin (5-FU/LV) or capecitabine therapy, or who have not received any previous chemotherapy
    • for unresectable metachronous metastases that remain unresectable after primary treatment
    • and progressed on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status
  • Subsequent therapy for progression of advanced or metastatic disease not previously treated with oxaliplatin-based therapy
    • in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen
    • in FOLFOX or CapeOX regimen with bevacizumab
    • in combination with irinotecan with or without bevacizumab for disease also not previously treated with irinotecan-based therapy
    • in FOLFOX with cetuximab or panitumumab (KRAS/NRAS/BRAF wild-type only) if previously treated with an irinotecan-based therapy without oxaliplatin
  • Used in FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen
    • as neoadjuvant therapy for T4, N+ disease
    • as primary treatment of T4, N+ disease if restaging at 6 weeks post completion of neoadjuvant chemoradiation shows involved CRM or bulky residual disease
  • Primary treatment for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease if resection is contraindicated following neoadjuvant therapy in patients appropriate for intensive therapy
    • in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen
    • in CapeOX (capecitabine and oxaliplatin) regimen
    • in FOLFOX or CapeOX regimen with bevacizumab
    • in FOLFOX regimen with cetuximab or panitumumab (KRAS/NRAS/BRAF wild-type gene only)
  • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen (both preferred)
    • following concurrent chemoradiation after transanal local excision if pT1, NX disease with high-risk features or pT2, NX disease
    • as adjuvant treatment for margin negative proximal tumors after transabdominal resection if pT3, N0, M0 disease
    • as adjuvant treatment alone or preceding and/or following concurrent chemoradiation after transabdominal resection if pT4, N0, M0 or pT1-4, N1-2 disease
    • as neoadjuvant therapy with or without a preceding short course of radiation for T3, N Any; T1-2, N1-2; T4, N Any; or locally unresectable or medically inoperable disease
    • as adjuvant treatment of T3, N Any with clear circumferential margin (CRM) (by MRI); or T1-2, N1-2 disease that was treated with neoadjuvant radiation with or without concurrent chemotherapy followed by transabdominal resection
    • as primary treatment of T3, N Any with involved CRM (by MRI); T4, N Any; or locally unresectable or medically inoperable disease if restaging at 6 weeks post completion of neoadjuvant chemoradiation shows involved CRM or bulky residual disease
    • as adjuvant treatment of T3, N Any with involved CRM (by MRI); T4, N Any; or locally unresectable or medically inoperable disease that was treated with neoadjuvant chemoradiation (and chemotherapy if involved CRM or bulky residual disease) followed by transabdominal resection
    • as primary treatment for resectable synchronous liver only and/or lung only metastases
    • as primary treatment for resectable synchronous liver only and/or lung only metastases previously treated with neoadjuvant radiation with or without concurrent chemotherapy
  • Therapy in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen CapeOX (capecitabine and oxaliplatin) without bevacizumab, or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen without bevacizumab in patients appropriate for intensive therapy
    • as adjuvant treatment (following resection and/or local therapy) for resectable metachronous metastases in patients who have received previous chemotherapy
    • as adjuvant treatment for unresectable metachronous metastases that converted to resectable disease after primary treatment. Biologic therapy is only appropriate for continuation of favorable neoadjuvant response.
    • and progressed on non-intensive therapy, except if received previous fluoropyrimidine, with improvement in functional status
• T-Cell Lymphomas
  • Adult T-Cell Leukemia/Lymphoma: Preferred second-line or subsequent therapy as a component of GemOx (gemcitabine, oxaliplatin) for nonresponders to first-line therapy for acute or lymphoma subtypes
  • Extranodal NK/T-Cell Lymphoma, nasal type:
    • As a component of P-GEMOX (gemcitabine, pegaspargase, oxaliplatin) (preferred) for
      • induction therapy as a component of sandwich chemoradiation for stage I-II nasal disease in patients fit for chemotherapy
      • induction therapy as a component of combination chemotherapy with or without radiation for stage IV nasal disease or stage I-IV extranasal disease
      • additional therapy (if regimen not previously used) for patients with a positive biopsy following partial response to induction therapy or no response to induction therapy
      • aggressive NK-cell leukemia (ANKL)
    • Therapy for relapsed/refractory disease following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used as a component of
      • P-GEMOX (gemcitabine, pegaspargase, oxaliplatin) (if not used in first-line therapy)
      • GemOx (gemcitabine, oxaliplatin)
  • Hepatosplenic Gamma-Delta T-Cell Lymphoma
    • Preferred second-line and subsequent therapy for refractory disease after 2 primary treatment regimens in patients with intention to proceed to transplant as a component of GemOx (gemcitabine, oxaliplatin)
    • Consider as an alternate induction regimen as a component of P-GEMOX (gemcitabine, pegaspargase, oxaliplatin) if no response or progressive disease after primary treatment
  • Peripheral T-Cell Lymphomas
    • Second-line and subsequent therapy for relapsed/refractory anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified (preferred), angioimmunoblastic T-cell lymphoma (preferred), enteropathy-associated T-cell lymphoma (preferred), monomorphic epitheliotropic intestinal T-cell lymphoma (preferred), nodal peripheral T-cell lymphoma with TFH phenotype (preferred), or follicular T-cell lymphoma (preferred), in patients with intention to proceed to transplant as a component of GemOx (gemcitabine, oxaliplatin)
  • Testicular Cancer
    • Used as third-line chemotherapy in patients who have progressed during or after one or two conventional dose cisplatin-based chemotherapy regimens and who have already received (preferred) or are unable to receive high-dose chemotherapy, or for late relapse (recurrence >2 years after completion of second-line chemotherapy)
      • in combination with gemcitabine
      • in combination with gemcitabine and paclitaxel

The off-label use of clinical items and services, including the use of the studied drugs oxaliplatin, irinotecan, cetuximab, or bevacizumab, are covered in specific clinical trials identified by the Centers for Medicare & Medicaid Services (CMS). The clinical trials identified by CMS for coverage of clinical items and services are sponsored by the National Cancer Institute (NCI) and study the use of one or more off-label uses of these four drugs in colorectal cancer and in other cancer types.

For additional information, refer to National Coverage Determination (NCD) for Anti-Cancer Chemotherapy for Colorectal Cancer (110.17). Available to be accessed at CMS National Coverage Determinations (NCDs) Alphabetical Index search page: https://www.cms.gov/medicare-coverage-database/indexes/ncd-alphabetical-index.aspx.

Additionally, chemotherapeutic Agents are covered when Local Coverage Article: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049) criteria is met. For additional information and eligibility, refer to Local Coverage Article: Approved Drugs and Biologicals; Includes Cancer Chemotherapeutic Agents (A53049). Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: Available to be accessed at Novitas Solutions, Inc., Medical Policy Search page: https://www.novitas-solutions.com/webcenter/portal/MedicareJL/pagebyid?contentId=00024370.

Medicaid Coverage

For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf

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Horizon BCBSNJ Medical Policy Development Process:

This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.

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Index:
Oxaliplatin (Eloxatin)
Eloxatin (Oxaliplatin)

References:
1. MICROMEDEX® 1.0 (Healthcare Series). DRUGDEX® Evaluations. Oxaliplatin. Available at: http://www.thomsonhc.com. Accessed September 29, 2016.

2. Oxaliplatin. National Comprehensive Cancer Network: Drugs and Biologics Compendium. [Available at http://www.nccn.org/professionals/drug_compendium/MatrixGenerator/Matrix.aspx?AID=9 (accessed February 28, 2020).]

3. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Colon Cancer. Version 2020 http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf Accessed February 28, 2020.

4. Eloxatin® (Oxaliplatin) Prescribing Information. Sanofi-Aventis. Bridgewater, October 2015. Accessed 2/20/2020.

5. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Anal Carcinoma . Version 2020. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed February 28, 2020

6. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: B-cell Lymphomas. Version 2020. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed February 28, 2020

7. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Bladder Cancer. Version 2020. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed February 28, 2020

8. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma. Version.2020. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed March 8, 2018. February 28, 2020.

9. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Esophageal and Esophagogastric Junction Cancers. Version 4.2019. https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. Accessed Febrary 28, 2020.

10. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Gastric Cancer. Version 4.2019. https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf Accessed February 28, 2020

11. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Hepatobiliary Cancer. Version 4.2019. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed February 28, 2020

12. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Neuroendocrine and Adrenal Tumors. Version 1.2019. https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf Accessed February 28, 2020

13. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Occult Primary. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/occult.pdf. Accessed February 28, 2020

14. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Ovarian Cancer. Version 2.2020. https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed February 28, 2020

15. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Pancreatic Adenocarcinoma. Version 1.2020. https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed February 28, 2020

16. Eloxatin. Clinicaltrial.gov. Accessed on 2/28/20 . Available at: https://clinicaltrials.gov/ct2/results?cond=&term=eloxatin&cntry=&state=&city=&dist=

Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)

CPT*

HCPCS

J9263