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Horizon BCBSNJ
Uniform Medical Policy ManualSection:Drugs
Policy Number:094
Effective Date: 04/12/2019
Original Policy Date:06/28/2011
Last Review Date:03/12/2019
Date Published to Web: 03/07/2012
Subject:
Oxaliplatin (Eloxatin)

Description:
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IMPORTANT NOTE:

The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.

Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.

__________________________________________________________________________________________________________________________


Eloxatin (oxaliplatin) is an alkylating agent and platinum analog. Oxaliplatin undergoes nonenzymatic conversion to active derivatives, with several transient reactive species formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules. Both inter- and intrastrand DNA crosslinks are formed between two adjacent guanines (GG), adjacent adenine-guanines (AG), and guanines separated by an intervening nucleotide (GNG). These crosslinks inhibit DNA replication and transcription. Cytotoxicity is cell-cycle nonspecific.

Initially marketed in 2002 by Sanofi-Aventis, Eloxatin is approved for the treatment of colon cancer. An international, multicenter, randomized study compared the efficacy and evaluated the safety of Eloxatin in combination with an infusional schedule of 5-fluorouracil/leucovorin to infusional 5-fluorouracil/leucovorin alone, in patients with stage II (Dukes' B2) or III (Dukes' C) colon cancer who had undergone complete resection of the primary tumor. The primary objective of the study was to compare the 3-year disease-free survival (DFS) in patients receiving Eloxatin and infusional 5-fluorouracil/leucovorin to those receiving 5-fluorouracil/leucovorin alone. Patients were to be treated for a total of 6 months (i.e., 12 cycles). A total of 2246 patients were randomized; 1123 patients per study arm. Overall, the number of deaths in the Eloxatin arm was 245 (21.8%) vs 283 (25.2%) without Eloxatin (HR 95% CI 0.84[0.71, 1.00]). In the overall and stage III colon cancer populations DFS was statistically significantly improved in the Eloxatin combination arm compared to infusional 5-fluorouracil/leucovorin alone. However, a statistically significant improvement in DFS was not noted in Stage II patients.


Policy:

(Note: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)

1. 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

2. When medical necessity criteria are met, oxaliplatin will be approved for six (6) months based on the FDA-recommend dose:
    • 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 symptom]

3. Continued therapy with oxaliplatin (Eloxatin) will be considered every 6 months based on tumor response and disease progression.

4. Oxaliplatin (Eloxatin) is medically necessary for the following off label uses:
    • Colon cancer:
      • Primary treatment in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen as
          • Neoadjuvant therapy for clinical T4b disease OR
          • Neoadjuvant or perioperative therapy for resectable synchronous liver and/or lung metastases (both preferred regimens) OR
          • Systemic therapy with or without bevacizumab for unresectable synchronous liver and/or lung metastases OR
          • Systemic therapy (FOLFOX only) with panitumumab or cetuximab for unresectable synchronous liver and/or lung metastases (KRAS/NRAS wild-type and left-sided tumors only) OR
          • Neoadjuvant therapy for resectable metachronous metastases (both preferred regimens); can also reinitiate or switch to FOLFOX after resection and/or local therapy if no growth on neoadjuvant chemotherapy
      • 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
      • Adjuvant chemotherapy in CapeOX (capecitabine and oxaliplatin), or FOLFOX (fluorouracil, leucovorin, and oxaliplatin;) regimen for
          • T3, N0, M0 with high risk for systemic recurrence
          • T4, N0, M0
          • T1-3, N1,
          • T4, N1-2 or T any, N2
          • Resectable Synchronous liver and/or lung metastases
          • Resectable metachronous metastases following primary treatment with resection and/or local therapy in patients who have not previously received chemotherapy.
      • Used in FOLFOX regimen with or without bevacizumab or with or without cetuximab or panitumumab (KRAS/NRAS wild-type gene only) or in CapeOX (capecitabine and oxaliplatin) regimen with or without bevacizumab or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen with or without bevacizumab as
          • Primary treatment for locally unresectable or medically inoperable disease
          • Unresectable synchronous liver and/or lung metastases that remain unresectable after primary systemic therapy
          • Primary treatment for synchronous abdominal/peritoneal metastases that are nonobstructing, or following local therapy for patients with existing or imminent obstruction
          • Synchronous unresectable metastases of other sites
          • 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
          • Unresectable metachronous metastases that remain unresectable after primary treatment
      • Subsequent therapy for progression of unresectable advanced or metastatic disease in not previously treated with oxaliplatin-based therapy
          • in FOLFOX or CapeOX regimen with bevacizumab
          • in FOLFOX or CapeOX regimen
          • in combination with irinotecan with or without bevacizumab in patients not previously receiving irinotecan- or oxaliplatin-based regimen
    • Esophageal and Esophagogastric junction cancers
      • Preoperative chemoradiation in combination with fluorouracil or capecitabine (preferred regimen) as primary treatment for patients who are medically fit for surgery and have either non-cervical esophagus cT1b-T4a, N0-N+ squamous cell carcinoma OR cT1b-T4a, N0-N+ adenocarcinoma (preferred option over preoperative chemotherapy)
      • Definitive chemoradiation in combination with fluorouracil or capecitabine (preferred regimen) as primary treatment for patients with cT1b-T4a, N0-N+ disease who are medically fit for surgery but decline surgery (recommended option for cervical esophagus squamous cell carcinoma) OR primary treatment for patients with cT4b disease who are medically fit for surgery OR after endoscopic resection with or without ablation for non-surgical candidates with pT1b, N0 disease and poor prognostic features OR as primary treatment for non-surgical candidates with cT1b-T4a, N0-N+ or unresectable cT4b disease
      • PrePerioperative chemotherapy for adenocarcinoma of the thoracic esophagus or esophagogastric junction 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 esophagectomy in medically fit patients with cT1b-T4a, N0-N+ disease
        · As postoperative management following R0 resection in patients who have received preoperative therapy with the same regimen
      • Postoperative chemotherapy, following margin-negative (R0) resection, in combination with capecitabine in node positive adenocarcinoma
      • Concurrent chemoradiation in combination with fluorouracil or capecitabine (preferred regimen) for locoregional recurrence in patients who have had esophagectomy but no prior chemoradiation
      • Palliative therapy for patients with Karnofsky performance score ≥60% or ECOG performance score ≤2 in combination with fluorouracil or capecitabine or modified DCF (docetaxel, oxaliplatin, and fluoruracil) regimens for
          • Unresectable, locally advance, recurrent, or metastatic disease
    • Gastric Cancer
      • Primary treatment as chemoradiation in combination with fluorouracil or capecitabine (preferred regimen) for surgically unresectable locoregional disease OR locoregional disease in non-surgical candidates
      • Preoperative chemoradiation in combination with fluorouracil or capecitabine (preferred regimen) for potentially resectable locoregional disease cT2 or higher, any N) in medically fit patients
      • Postoperative chemotherapy in combination with capecitabine following margin-negative resection (R0) of locoregional disease (pT3 or higher or node positive) in patients who did not receive preoperative chemotherapy or chemoradiation and have undergone primary D2 lymph node dissection
      • Palliative therapy for patients with Karnofsky performance score ≥60% or ECOG performance score ≤2 in combination with fluorouracil or capecitabine or as a component of modified DCF (docetaxel, oxaliplatin, and fluorouracil) regimens:
    • Hepatobiliary Cancer
        • Extrahepatic cholangiocarcinoma: in combination with capecitabine, or fluorouracil, as
          • Primary treatment for unresectable or metastatic disease
          • Treatment for resected disease
          • Treatment following fluoropyrimidine chemoradiation for resected disease with positive margins (R1), gross residual disease (R2), or positive regional nodes
          • Treatment with chemoradiation for resected disease with positive margins (R1), gross residual disease (R2), or positive regional nodes
        • Extrahepatic cholangiocarcinoma: in combination with gemcitabine as primary treatment for unresectable or metastatic disease
        • Gallbladder cancer: primary treatment in combination with capecitabine, fluoruracil, or gemcitabine for patients with unresectable or metastatic disease OR
          • Neoadjuvant chemotherapy for locoregionally advanced disease (big mass invading liver and/or nodal disease, including cystic duct node positve) in combination with capecitabine, fluorouracil, or gemcitabine OR
          • Treatment for resected disease in combination with capecitabine, fluorouracil, or gemcitabine for negative margins (R0) and negative regional nodes, or carcinoma in situ at margin or following fluoropyrimidine chemoradiation for positive margins (R1), gross residual disease (R2), or positive regional nodes or positive margins (R1), gross residual disease (R2), or positive regional lymph nodes with or without chemoradiation
          • Treatment for resected disease in combination with gemcitabine for
            · Negative margins (R0) and negative regional nodes, or carcinoma in situ at margin
            · Following fluoropyrimidine chemoradiation for positive margins (R1), gross residual disease (R2), or positive regional nodes
            · Positive margins (R1), gross residual disease (R2), or positive regional lymph nodes with or without chemoradiation
        • 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
        • Intrahepatic cholangiocarcinoma: in combination with gemcitabine as primary treatment for unresectable or metastatic disease
    • Neuroendocrine Tumors
        • Neuroendocrine Tumors of the Pancreas: as a single agent for the management of bulky, symptomatic, and/or progressive locoregional advanced disease and/or distant metastatic disease.
        • Neuroendocrine Tumors of the Gastrointestinal Tract, Lung, and Thymus: Management of locoregional unresectable or metastatic disease in patients for whom there are no other treatment options
        • Neuroendocrine and Adrenal Tumors - Poorly Differentiated (High Grade)/Large or Small Cell
          • Primary treatment as part of FOLFOX (fluorouracil, leucovorin, oxaliplatin) regimen
            • with or without radiation as neoadjuvant or adjuvant therapy, or chemotherapy for resectable disease
            • with concurrent or sequential radiation for locoregional unresectable disease
            • for locoregional unresectable or metastatic disease
    • B-Cell Lymphomas
        • Adult T-Cell Leukemia/Lymphoma: therapy for non-responders to first-line therapy for acute disease or lymphoma in candidates for transplant as a component of GemOx (gemcitabine and oxaliplatin) regimen
        • AIDS related B-cell lymphoma:Second-line or subsequent therapy 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) as a component of GemOX (gemcitabine and oxaliplatin) regimen, or DHAX (dexamethasone, cytarabine, and oxaliplatin with or without rituximab
        Chronic lymphocytic leukemia/small lymphocytic lymphoma: therapy for relapsed or refractory disease as a component of OFAR (oxaliplatin, fludarabine, cytarabine, and rituximab) regimen in
          • Patients less than age 65 years without significant comorbidities who have indications for treatment with CLL without del(17p)/TP53 mutation
          • Patients with CLL with del(17p)/TP53 mutation
        • Diffuse large B-cell lymphoma: Second-line or subsequent therapy for partial response, no response, relapsed, progressive, or refractory disease as a component of GemOX (gemcitabine and oxaliplatin) regimen or DHAX (dexamethasone, cytarabine, and oxaliplatin regimen in patient with intention to proceed to transplant with or without rituximab
            • Second-line or subsequent therapy for partial response, no response, relapsed, progressive or refractory primary cutaneous diffuse large B-cell lymphoma, leg type as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab
        • 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 GemOX (gemcitabine and oxaliplatin) regimen or DHAX (dexamethasone, cytarabine, and oxaliplatin with or without rituximab
        • B-Cell Lymphomas - 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
        • Extranodal NK/T-cell Lymphoma, nasal type: Used as a component of GELOX (gemcitabine, pegaspargase, and oxaliplatin) regimen as
          • Induction therapy preceding and following radiation for stage I-II nasal disease in select patients who are fit for chemotherapy but are unable to tolerate intense 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 for patients with a positive biopsy following partial response to induction therapy or with refractory disease
        • Extranodal NK/T-cell Lymphoma: Preferred therapy for relapsed/refractory disease following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used in patients with intention to proceed to transplant as a component of GemOx (gemcitabine, oxaliplatin)
        • Follicular lymphoma (grade 1-2) as second line or subsequent therapy for refractory or progressive disease in patients with indications for treatment or for histologic transformation to diffuse large B-cell lymphoma in patients who have received multiple lines of chemoimmunotherapy for indolent or transformed disease as a component of GemOX (gemcitabine and oxaliplatin) regimen with or without rituximab or as a component of DHAX (dexamethasone, cytarabine, and oxaliplatin) with or without rituximab
        • Mantle cell lymphoma: Preferred induction therapy for stage I-II disease following partial response, progression or relapse after treatment with involved site radiation therapy alone, or for aggressive stage II bulky, III, or IV in TP53 mutation negative disease, or symptomatic indolent stage II bulky, III, or IV disease in patients who are candidates for high-dose therapy/autologous stem cell rescue 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 disease, aggressive stage II bulky, III, or IV disease, or symptomatic indolent stage II bulky, III, or IV disease to achieve a complete response following partial response to induction therapy or for relapsed or progressive disease following an extended response duration to prior chemoimmunotherapy (> expected median progression free survival) as a component of GemOX (gemcitabine and oxaliplatin) regimen
        • Peripheral T-cell lymphoma: second line therapy for relapsed or refractory angioimmunoblastic T-cell lymphoma, peripheral T-cell lymphoma not otherwise specified, anaplastic large cell lymphoma, or enteropathy-associated T-cell lymphoma in candidates for transplant as a component of GemOX regimen
        • Primary cutaneous B-cell lymphoma: second line or subsequent therapy for relapsed or refractory primary cutaneous diffuse large B-cell lymphoma leg type as a component of GemOX regimen with or without rituximab
        • Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders: Used as a component of GemOX regimen for relapsed or refractory primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions or cutaneous ALCL with regional nodes (excluded systemic ALCL).
        • Splenic marginal zone lymphoma: second line therapy for progressive disease in patients with the indications for treatment as a component of GemOX regimen with or without rituximab
        • Histologic Transformation of Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma: Second-line or subsequent therapy for histologic transformation to diffuse large B-cell lymphoma in patients who have received multiple lines of chemoimmunotherapy for indolent or transformed disease as a component of GemOX (gemcitabine and oxaliplatin) or DHAX (dexamethasone, cytarabine, and oxaliplatin) regimen with or without rituximab
    • Occult Primary
      • Chemoradiation as a component of CapeOX (capecitabine and oxaliplatin) or mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) regimen in symptomatic patients with performance stats (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for localized disease with inguinal nodal involvement
      • Used as a component of CapeOX (capecitabine and oxaliplatin) or mFOLFOX6 regimen in symptomatic patients with performance status (PS) 1-2 or asymptomatic patients with PS 0 and aggressive disease for
        • Lung nodules or breast marker-negative pleural effusion
        • Resectable liver disease
        • Peritoneal mass or ascites with non-ovarian histology
        • Unresectable liver disease or disseminated metastases
        • Axillary involvement in men if clinically indicated
      • Used as a component of mFOLFOX 6 regimen in symptomatic patients with 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
    • Ovarian Cancer
      • Epithelial Ovarian/Fallopian Tube/Primary peritoneal Cancer: as a single agent therapy for persistent disease or recurrence
      • Adjuvant treatment in combination with capecitabine or with fluorouracil and leucovorin for pathologic stage IC-IV disease
      • Therapy for persistent disease or recurrence in combination with fluorouracil and leucovorin or with capecitabine
    • Pancreatic Adenocarcinoma
      • As a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) with or without subsequent chemoradiation for:
        • Biopsy positive borderline resectable disease
        • Resectable disease with high-risk features (ie, very highly elevated CA 19-9, large primary tumors, large regional lymph nodes, excessive weight loss, extreme pain)
      • 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
      • Adjuvant therapy, if clinically indicated, following resection for locally advanced disease in patients with a good performance status and no disease progression after neoadjuvant therapy as a component of modified FOLFIRINOX (fluorouracil, leucovorin, irinotecan, oxaliplatin) regimen (preferred regimen) for ECOG performance status (PS) 0-1
      • First-line chemotherapy, or as induction therapy followed by chemoradiation in selected patients without systemic metastases, for patients with locally advanced unresectable disease and good performance status as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) regimen
      • First-line therapy for metastatic disease in patients with good performance status (PS) in combination with fluorouracil and leucovorin OR as a component of CapeOx (capecitabine and oxaliplatin) regimen
      • Second-line therapy for locally advanced unresectable or metastatic disease as fluoropyrimidine-based therapy for patients with good performance status and disease progression who were previously treated with gemcitabine-based therapy as a component of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) regimen if KPS ≥70 OR as a component of FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen OR in combination with fluorouracil and leucovorin OR in combination with capecitabine
      • Second-line therapy for recurrence after resection as part of FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) regimen for local recurrence in the pancreatic bed OR for metastatic disease with or without local recurrence
      • 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 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 for metastatic disease with or without local recurrence 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
    • Rectal Cancer
      • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen as
        • Concurrent chemoradiation after transanal excision if T1, NX disease with high-risk features or T2, NX disease
        • Adjuvant treatment alone or preceding and/or following concurrent chemoradiation after transabdominal resection if pT3-4, N0, M0 or pT1-4, N1-2 disease
        • Neoadjuvant therapy for N Any; T1-2, N1-2; T4, N Any; and/or locally unresectable or medically inoperable disease
        • Adjuvant treatment of T3, N Any with clear circumferential margin (CRM) (by MRI); or T1-2, N1-2 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
        • Neoadjuvant treatment for resectable synchronous metastases; can also reinitiate (optional) after radiation with or without concurrent chemotherapy that was followed by resection and/or local therapy for synchronous metastases and resection of rectal lesion
        • Adjuvant treatment of resectable synchronous metastases previously treated with neoadjuvant radiation with or without concurrent chemotherapy followed by resection and/or local therapy for synchronous metastases and resection of rectal lesion
        • 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
        • 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 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 wild-type gene only)
        • Therapy in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen, FOLFOX with bevacizumab, FOLFOX with cetuximab or panitumumab (KRAS/NRAS wild-type gene only), CapeOX (capecitabine and oxaliplatin) with or without bevacizumab, or FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) regimen with or without bevacizumab
          • Ror 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 short-course 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
      • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen (both preferred) in patients with resectable metachronous metastases as neoadjuvant treatment; can also reinitiate or switch to FOLFOX after resection and/or local therapy if no growth on neoadjuvant chemotherapy OR adjuvant treatment following primary treatment with resection and/or local therapy in patients who have not previously received chemotherapy
      • Subsequent therapy for progression of unresectable advanced or metastatic disease not previously treated with oxaliplatin-based therapy in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or CapeOX (capecitabine and oxaliplatin) regimen OR in FOLFOX or CapeOX regimen with bevacizumab OR in combination with irinotecan with or without bevacizumab for disease also not previously treated with irinotecan-based therapy
    • 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
    • Bladder Cancer
      • Urothelial and Urothelial with Variant Histology: May be considered as a component of FOLFOX (oxaliplatin, leucovorin, fluorouracil) for node-positive disease or in select patients with advanced disease
    • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
      • 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
    • Anal carcinoma:
      • Used in FOLFOX (fluorouracil, leucovorin, and oxaliplatin) regimen with or without radiation for metastatic disease
    • T-cell Lymphomas- 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)
      • Preferred second-line or subsequent therapy as a component of GemOx (gemcitabine, oxaliplatin) for nonresponders to first-line therapy for acute or lymphoma subtypes\
    • T-Cell Lymphomas - 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)
    • Primary Cutaneous Lymphomas - Mycosis Fungoides/Sézary 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
6. Other uses of oxaliplatin (Eloxatin) are considered investigational, including but not limited to mesothelioma, neuroblastoma, non-small cell lung cancer.

Medicare Coverage

There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this drug. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ medical policy.

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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 March 8, 2018).]

    3. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Colon Cancer. Version 3.2011. http://www.nccn.org/professionals/physician_gls/pdf/colon.pdf [ [ September 29, 2016].

    4. Eloxatin® (Oxaliplatin) Prescribing Information. Sanofi-Aventis. Bridgewater, October 2015. Accessed 2/20/2019.

    6. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Anal Carcinoma . Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/anal.pdf. Accessed March 8, 2018.

    7. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: B-cell Lymphomas. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/b-cell.pdf. Accessed March 8, 2018.

    8. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Bladder Cancer. Version 2.2018. https://www.nccn.org/professionals/physician_gls/pdf/bladder.pdf. Accessed March 8, 2018.
    9. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma. Version 3.2018. https://www.nccn.org/professionals/physician_gls/pdf/cll.pdf. Accessed March 8, 2018.

    10. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Colon Cancer. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed March 8, 2018.

    11. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Esophageal and Esophagogastric Junction Cancers. Version 4.2017. https://www.nccn.org/professionals/physician_gls/pdf/esophageal.pdf. Accessed March 8, 2018.

    12. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Gastric Cancer. Version 5.2017. https://www.nccn.org/professionals/physician_gls/pdf/gastric.pdf Accessed March 8, 2018.

    13. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Hepatobiliary Cancer. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed March 8, 2018.

    14. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Neuroendocrine Tumors. Version 3.2017. https://www.nccn.org/professionals/physician_gls/pdf/neuroendocrine.pdf Accessed March 8, 2018.

    15. 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 March 8, 2018.

    16. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Ovarian Cancer. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf. Accessed March 8, 2018.

    17. National Comprehensive Cancer Network (NCCN). Practice Guidelines in Oncology: Pancreatic Cancer. Version 1.2018. https://www.nccn.org/professionals/physician_gls/pdf/pancreatic.pdf. Accessed March 8, 2018.

    18. Oxaliplatin. National Comprehensive Cancer Network: Drugs and Biologics Compendium. [Available at https://www.nccn.org/professionals/drug_compendium/content/ (accessed 2/2019).]

    19. Eloxatin. Clinicaltrial.gov. Accessed on 2/20/19 . 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

    * CPT only copyright 2019 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.

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    Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.

    The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy

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