vp-0226
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Opdivo® (nivolumab) (Intravenous)

Policy Number: VP-0226

Last Review Date: 12/01/2020

Date of Origin: 01/06/2015

Dates Reviewed: 03/2015, 07/2015, 10/2015, 11/2015, 02/2016, 05/2016, 08/2016, 10/2016, 11/2016, 02/2017, 05/2017, 08/2017, 10/2017, 01/2018, 02/2018, 05/2018, 08/2018, 09/2018, 10/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 04/2020, 06/2020, 07/2020, 09/2020, 11/2020, 12/2020

I. Length of Authorization 

Coverage will be provided for six months and may be renewed (unless otherwise specified).

  • Adjuvant use in the treatment of melanoma can be authorized up to a maximum of 12 months of therapy.
  • Use in the treatment of NSCLC in combination with ipilimumab can be authorized up to a maximum of 2 years of therapy.
  • Use in the treatment of NSCLC in combination with ipilimumab and two (2) cycles of platinum-doublet chemotherapy can be authorized up to a maximum of 2 years of therapy.
  • Use in the treatment of MPM as initial therapy in combination with ipilimumab can be authorized up to a maximum of 2 years of therapy.
  • Use in the treatment of Vulvar Cancer can be authorized for up to a maximum of 2 years of therapy.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Opdivo 40 mg/4 mL single-use vial: 2 vials per 14 days
  • Opdivo 100 mg/10 mL single-use vial: 2 vials per 14 days
  • Opdivo 240 mg/24 mL single-use vial: 4 vials per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

Indication

Billable Units (BU)

Per unit time (days)

Merkel Cell

340 BU

14 days

Melanoma/HCC (in combination with ipilimumab)

Initial: 140 BU

21 days x 4 doses

Followed by: 480 BU

28 days

Melanoma/RCC/HCC/NSCLC (as a single agent), cHL, SCCHN, MSI-H/dMMR CRC (as a single agent), Anal Carcinoma, Gestational Trophoblastic Tumor, Esophageal Squamous Cell Carcinoma & Urothelial Carcinoma

480 BU

28 days

Metastatic NSCLC with PD-L1 expressing tumors (in combination with ipilimumab)

340 BU

14 days

Metastatic or recurrent NSCLC (in combination with ipilimumab and platinum-doublet chemotherapy

380 BU

21 days

SCLC, Vulvar Cancer

240 BU

14 days

MSI-H/dMMR CRC (in combination with ipilimumab)

Initial: 340 BU

21 days x 4 doses

Followed by: 480 BU

28 days

Small Bowel Adenocarcinoma, CNS Metastases from NSCLC (both as single agents)

340 BU

14 days

Small Bowel Adenocarcinoma (in combination with ipilimumab)

Initial: 340 BU

21 days x 4 doses

Followed by: 340 BU

14 days

RCC (in combination with ipilimumab)

Initial: 340 BU

21 days x 4 doses

Followed by: 480 BU

28 days

MPM (as a single agent or in combination with ipilimumab)

340 BU

14 days

CNS Metastases from Melanoma & Uveal Melanoma (both in combination with ipilimumab)

Initial: 140 BU

21 days x 4 doses

Followed by: 340 BU

14 days

CNS Metastases from Melanoma (as a single agent)

340 BU

14 days

Uveal Melanoma (as a single agent)

1140 BU

14 days

Extranodal NK/ T-Cell Lymphoma

40 BU

14 days

Endometrial Carcinoma

Initial: 340 BU

14 days x 8 doses

Followed by: 480 BU

28 days

  1. Initial Approval Criteria 1
  • Individual is not receiving therapy for an autoimmune disease or chronic condition requiring treatment with a systemic immunosuppressant; AND

Coverage is provided for the following conditions:

  • Patient is at least 18 years of age (unless otherwise specified); AND

Universal Criteria

  • Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., cemiplimab, avelumab, pembrolizumab, atezolizumab, durvalumab, etc.) prior to initiation of therapy, unless otherwise specified; AND

Cutaneous Melanoma Ф 

  • Used as first-line therapy for unresectable or metastatic disease; AND
    • Used as a single agent or in combination with ipilimumab; OR
  • Used as subsequent therapy for unresectable or metastatic* disease; AND
    • Used for retreatment of disease as re-induction as a single agent or in combination with ipilimumab in patients who experienced disease control (i.e., complete or partial response or stable disease) from prior checkpoint inhibitor therapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR
    • Used after disease progression on first-line therapy or maximum clinical benefit from BRAF-targeted therapy (e.g., dabrafenib/trametinib, vemurafenib/cobimetinib, encorafenib/binimetinib, etc.); AND
      • Used as a single agent or in combination with ipilimumab if checkpoint inhibitor immunotherapy was not previously used; OR
      • Used in combination with ipilimumab for patients who progressed on single agent checkpoint inhibitor immunotherapy; OR
  • Used as adjuvant treatment as a single agent; AND
    • Patient has lymph node involvement and has undergone complete resection, complete lymph node dissection (CLND), therapeutic lymph node dissection (TLND), or nodal basin ultrasound surveillance; OR
    • Patient has satellite/in-transit metastases or recurrence and has no evidence of disease after complete excision; OR
    • Patient has undergone TLND and/or complete resection of nodal recurrence; OR
    • Patient has undergone complete resection of distant metastatic disease

*Metastatic disease includes stage III clinical satellite/in transit metastases or local satellite/in-transit recurrence in patients with limited resectable and unresectable disease, unresectable nodal recurrence, and disseminated (unresectable) distant metastatic disease

Uveal Melanoma ‡ 

  • Patient has distant metastatic disease; AND
  • Used as a single agent or in combination with ipilimumab

Hepatocellular Carcinoma (HCC) Ф 

  • Patient has locally advanced, unresectable, inoperable, or metastatic disease; AND
  • Used as subsequent therapy; AND
    • Patient has Child-Pugh Class A or B disease; AND
      • Used as a single agent; OR
    • Patient has Child-Pugh Class A disease; AND
      • Used in combination with ipilimumab

Non-Small Cell Lung Cancer (NSCLC) † 

  • Used as a single-agent or in combination with ipilimumab as first-line therapy; OR
  • Used for recurrent, advanced, or metastatic disease (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease) or mediastinal lymph node recurrence with prior radiation therapy; AND
    • Used as first-line therapy; AND
      • Used for one of the following:
        • Used in patients with PS 0-1 who have EGFR, ALK, ROS1, BRAF, MET exon skipping mutation, and RET rearrangement negative** tumors and PD-L1 expression <1%
        • Used in patients with PS 0-1 who are positive for one of the following molecular biomarkers:  BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, or RET rearrangements
        • Used in patients with PS 0-2 for PD-L1 expression-positive (PD-L1 ≥1%) tumors, as detected by an FDA or CLIA compliant testv, that are EGFR, ALK, ROS1, BRAF, MET exon skipping mutation, and RET rearrangement negative**; AND
  • Used in combination with ipilimumab; OR
  • Used in combination with ipilimumab and platinum-doublet chemotherapy (e.g., pemetrexed and either carboplatin or cisplatin for non-squamous cell histology, paclitaxel and carboplatin for squamous cell histology, etc.); OR
    • Used as subsequent therapy; AND
      • Used as a single agent; OR
      • Used for one of the following:
        • Used in patients with PS 0-1 who have EGFR, ALK, or ROS1 positive tumors and have received prior targeted therapy§
        • Used in patients with PS 0-1 who are positive for one of the following molecular biomarkers:  BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, or RET rearrangements; AND
  • Used in combination with ipilimumab; OR
  • Used in combination with ipilimumab, pemetrexed, and either carboplatin or cisplatin for non-squamous cell histology; OR
  • Used in combination with ipilimumab, paclitaxel, and carboplatin for squamous cell histology

** Note:  If there is insufficient tissue to allow testing for all of the EGFR, ALK, ROS1, BRAF, MET, and RET, repeat biopsy and/or plasma testing should be done.  If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes.

Renal Cell Carcinoma (RCC) † 

  • Used in combination with ipilimumab for clear cell histology; AND
    • Used as first-line therapy in patients with advanced, relapsed, or stage IV disease with intermediate or poor risk; OR
    • Used as first-line therapy in patients with relapsed or stage IV disease with favorable risk; OR
    • Used as subsequent therapy in patients with relapsed or stage IV disease; OR
  • Used as a single agent; AND
    • Used as subsequent therapy in patients with advanced, relapsed, or stage IV disease for clear cell histology; OR
    • Patient has relapsed or stage IV disease and non-clear cell histology

Classical Hodgkin Lymphoma (cHL) † Ф 

  • Used as a single agent; AND
    • Patient age is 18 years and under; AND
      • Used as subsequent therapy for relapsed or refractory disease; AND
      • Used in patients heavily pretreated (with platinum or anthracycline-based chemotherapy) or if a decrease in cardiac function observed; OR
    • Patient is at least 18 years old and has received 2 or more prior lines of therapy OR used as palliative therapy in patients more than 60 years old; AND
      • Patient has relapsed or progressive disease after an autologous hematopoietic stem cell transplantation (HSCT) with or without brentuximab vedotin; OR
      • Patient has relapsed or refractory disease and is either transplant-ineligible based on comorbidities or has failure of second-line chemotherapy; OR
      • Patient is post-allogeneic stem-cell transplant; OR
  • Used in combination with brentuximab vedotin for relapsed or refractory disease; AND
    • Patient is at least 18 years old; AND
      • Used as subsequent therapy (if not previously used); OR
    • Patient age is 18 years and under; AND
      • Used as subsequent therapy for relapsed or refractory disease; AND
  • Used in patients heavily pretreated (with platinum or anthracycline-based chemotherapy) or if a decrease in cardiac function observed; OR
      • Used as re-induction therapy; AND
  • Used in patients heavily pretreated (with platinum or anthracycline-based chemotherapy) or if a decrease in cardiac function observed; OR
  • Used with radiation therapy (ISRT) in highly favorable patients who may avoid autologous stem cell rescue (ASCR) (i.e., initial stage other than IIIB or IVB, no prior exposure to RT, duration of CR1 >1 year, absence of extranodal disease or B symptoms at relapse)

Squamous Cell Carcinoma of the Head and Neck (SCCHN) † 

  • Used as single-agent therapy; AND
  • Patient has unresectable, recurrent, persistent, or metastatic disease; AND
  • Disease has progressed on or after platinum-based therapy; AND
  • Patient does not have nasopharyngeal disease

Urothelial Carcinoma (Bladder Cancer) † 

  • Used as a single agent; AND
  • Used as subsequent systemic therapy after previous platinum treatment*; AND
  • Patient has one of the following diagnoses:
    • Locally advanced or metastatic urothelial carcinoma; OR
    • Local bladder cancer recurrence or persistent disease in a preserved bladder ; OR
    • Local or metastatic bladder cancer recurrence post-cystectomy ; OR
    • Recurrent or metastatic primary carcinoma of the urethra ; AND
      • Patient does not have recurrence of stage T3-4 disease or palpable inguinal lymph nodes; OR
    • Metastatic upper genitourinary (GU) tract tumors ; OR
    • Metastatic urothelial carcinoma of the prostate

* Note:

  • If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum-based therapy if the patient is still platinum eligible (see below for cisplatin- or carboplatin-ineligible comorbidities).
  • Cisplatin-ineligible comorbidities may include the following:  GFR < 60 mL/min, PS ≥ 2, hearing loss of ≥ 25 decibels (dB) at two contiguous frequencies, or grades ≥ 2 peripheral neuropathy. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.
  • Carboplatin-ineligible comorbidities may include the following: GFR < 30 mL/min, PS ≥ 3, grade ≥ 3 peripheral neuropathy, or NYHA class ≥ 3, etc.

Small Cell Lung Cancer (SCLC) Ф 

  • Used as subsequent systemic therapy; AND
    • Used as a single agent for metastatic disease with progression after platinum-based treatment and at least one other line of therapy ; OR
    • Used as a single agent ; AND
      • Used for relapse within 6 months following complete response, partial response, or stable disease with initial treatment; AND
        • Patient did not relapse while on maintenance atezolizumab or durvalumab; OR
      • Used for primary progressive disease

Colorectal Cancer (CRC) † 

  • Patient is at least 12 years of age; AND
  • Patient’s disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND
      • Used as a single agent or in combination with ipilimumab as subsequent therapy for advanced or metastatic disease that progressed following treatment with a fluoropyrimidine-, oxaliplatin-, and/or irinotecan-based chemotherapy; OR
      • Used as a single agent or in combination with ipilimumab as primary treatment for unresectable or metastatic disease after previous adjuvant FOLFOX (fluorouracil, leucovorin and oxaliplatin) or CapeOX (capecitabine-oxaliplatin) in the past 12 months ; OR
      • Used as a single agent as primary treatment for unresectable or metastatic disease in patients who are not candidates for intensive therapy ; OR
      • Used as a single agent for unresectable or metastatic disease that remains unresectable after primary treatment in patients who are not candidates for intensive therapy

Merkel Cell Carcinoma ‡ 

  • Used as a single agent; AND
  • Patient has disseminated metastatic disease

Central Nervous System (CNS) Cancer ‡ 

  • Used in one of the following treatment settings:
    • Used as initial treatment in patients with small asymptomatic brain metastases; OR
    • Used for relapsed disease in patients with limited brain metastases and stable systemic disease or reasonable treatment options; OR
    • Patient has recurrent limited brain metastases; OR
    • Used for recurrent disease in patients with extensive brain metastases and stable systemic disease or reasonable systemic treatment options; AND
  • Used as a single-agent or in combination with ipilimumab for the treatment of brain metastases in patients with melanoma; OR
  • Used as a single-agent for the treatment of brain metastases in patients with PD-L1 positive non-small cell lung cancer (NSCLC)

Anal Carcinoma ‡ 

  • Patient has metastatic squamous cell disease; AND
  • Used as a single agent for subsequent therapy

Gestational Trophoblastic Neoplasia ‡ 

  • Used as single-agent therapy for multiagent chemotherapy resistant disease; AND
    • Patient has intermediate placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT); AND
      • Patient has recurrent or progressive disease; AND
      • Patient was previously treated with a platinum/etoposide containing regimen; OR
    • Patient has methotrexate-resistant high risk disease (i.e., FIGO stages II-III and ≥7 Prognostic score OR FIGO stage IV disease)

Malignant Pleural Mesothelioma ‡ 

  • Used as a single agent or in combination with ipilimumab as subsequent therapy; OR
  • Used in combination with ipilimumab as first-line therapy in patients with unresectable disease

Small Bowel Adenocarcinoma ‡ 

  • Patient has advanced or metastatic disease that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND
  • Used as a single agent or in combination with ipilimumab in one of the following settings:
    • As subsequent therapy; OR
    • As initial therapy in patients with prior oxaliplatin exposure in the adjuvant setting or contraindication

Extranodal NK/ T-Cell Lymphoma ‡ 

  • Used as a single agent for relapsed or refractory nasal type disease; AND
  • Disease progressed following additional treatment with an alternative asparaginase-based chemotherapy regimen not previously used; AND
  • Participation in a clinical trial is unavailable

Esophageal Squamous Cell Carcinoma (ESCC) † Ф 

  • Used as a single agent; AND
  • Used as subsequent therapy for unresectable advanced (or is not a surgical candidate), recurrent, or metastatic disease

Endometrial Carcinoma (Uterine Neoplasms) ‡ 

  • Used as a single agent; AND
  • Used as second-line therapy for mismatch repair deficient (dMMR) recurrent, metastatic, or high-risk disease

Vulvar Cancer (Squamous Cell Carcinoma) ‡ 

  • Used as a single agent; AND
  • Used as second-line therapy for HPV-related advanced, recurrent, or metastatic disease

 

v If confirmed using an immunotherapy assay-http://www.fda.gov/CompanionDiagnostics

FDA Approved Indication(s); Compendia recommended indication(s); Ф Orphan Drug

Genomic Aberration/Mutational Driver Targeted Therapies (Note: not all inclusive, refer to guidelines for appropriate use) §

Sensitizing EGFR mutation-positive tumors

  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib

ALK rearrangement-positive tumors

  • Alectinib
  • Brigatinib
  • Ceritinib
  • Crizotinib
  • Lorlatinib

ROS1 rearrangement-positive tumors

  • Ceritinib
  • Crizotinib 
  • Entrectinib

BRAF V600E-mutation positive tumors

  • Dabrafenib ± Trametinib
  • Vemurafenib

NTRK Gene Fusion positive tumors

  • Larotrectinib
  • Entrectinib

PD-1/PD-L1 expression-positive tumors (≥1%)

  • Pembrolizumab
  • Atezolizumab
  • Nivolumab ± ipilimumab

MET Exon-14 skipping mutations

  • Capmatinib
  • Crizotinib

RET rearrangement-positive tumors

  • Selpercatinib
  • Cabozantinib
  • Vandetanib
  1. Renewal Criteria 1,2,4-6,15-42,49

Authorizations can be renewed based on the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), severe immune-mediated adverse reactions (i.e. pneumonitis, colitis, hepatitis, endocrinopathies, nephritis/renal dysfunction, adverse skin reactions/rash, encephalitis), etc.; AND
  • Disease response with treatment defined as stabilization of disease or decrease in size of tumor or tumor spread; AND

Cutaneous Melanoma (adjuvant therapy)

        • Patient has not exceeded a maximum of twelve (12) months of therapy

NSCLC (in combination with ipilimumab or in combination with ipilimumab and two (2) cycles of platinum-doublet chemotherapy)

        • Patient has not exceeded a maximum of two (2) years of therapy

MPM (initial therapy in combination with ipilimumab)

        • Patient has not exceeded a maximum of two (2) years of therapy

Vulvar Cancer

  • Patient has not exceeded a maximum of two (2) years of therapy

Cutaneous Melanoma Re-induction

        • Refer to Section III for criteria (see Melanoma – Used for retreatment of disease as re-induction)

V. Dosage/Administration

Indication

Dose

Merkel Cell

Administer 240 mg intravenously every 2 weeks or 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

Anal Cancer

Administer 240 mg intravenously every 2 weeks, 480 mg intravenously every 4 weeks, or 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

Cutaneous Melanoma

Single agent (excluding adjuvant therapy):

  • Administer 240 mg intravenously every 2 weeks OR 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab (excluding adjuvant therapy):

  • Administer 1 mg/kg intravenously, with ipilimumab on the same day, every 3 weeks for 4 doses, then follow with single agent regimen

Adjuvant treatment:

  • Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease recurrence or unacceptable toxicity for up to 1 year

Uveal Melanoma

Single agent:

  • Administer up to 10 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

  • Administer 1 mg/kg intravenously, with ipilimumab on the same day, every 3 weeks for 4 doses, then 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

NSCLC

Single agent:

  • Administer 240 mg intravenously every 2 weeks OR 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

  • Administer 3 mg/kg intravenously every 2 weeks, with ipilimumab 1 mg/kg every 6 weeks, until disease progression or unacceptable toxicity for up to 2 years

In combination with ipilimumab and platinum-doublet chemotherapy for metastatic or recurrent disease:

  • Administer 360 mg intravenously every 3 weeks, with ipilimumab 1 mg/kg every 6 weeks and histology-based platinum-doublet chemotherapy every 3 weeks for 2 cycles, until disease progression or unacceptable toxicity for up to 2 years

cHL, SCCHN, Urothelial Carcinoma, Esophageal Squamous Cell Carcinoma, & Gestational Trophoblastic Neoplasia (GTN)

Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

MSI-H/dMMR CRC

Adult patients and for pediatric patients ≥ 12 years and ≥ 40 kg

  • As a single agent: Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity
  • In combination with ipilimumab: Administer 3 mg/kg intravenously, with ipilimumab 1 mg/kg on the same day, every 3 weeks for 4 doses, then follow with the single agent regimen

Pediatric patients ≥ 12 years and < 40 kg

  • As a single agent: Administer 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity
  • In combination with ipilimumab: Administer 3 mg/kg intravenously, with ipilimumab 1 mg/kg on the same day, every 3 weeks for 4 doses, then follow with the single agent regimen

SCLC

Administer 240 mg intravenously every 2 weeks until disease progression or unacceptable toxicity

Renal Cell Carcinoma (RCC)

Single-agent:

  • Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

  • Administer 3 mg/kg intravenously, with ipilimumab on the same day, every 3 weeks for 4 doses, then follow with single-agent regimen

Hepatocellular Carcinoma (HCC)

Single-agent:

  • Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

  • Administer 1 mg/kg intravenously, with ipilimumab on the same day, every 3 weeks for 4 doses, then follow with single-agent regimen

Malignant Pleural Mesothelioma (MPM)

Single agent:

  • Administer 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

  • Subsequent Therapy
    • Administer 3 mg/kg intravenously every 2 weeks, with ipilimumab 1 mg/kg every 6 weeks, until disease progression or unacceptable toxicity OR
    • Administer 240 mg intravenously every 2 weeks, with ipilimumab 1 mg/kg every 6 weeks (for a total of 4 ipilimumab doses); treatment with nivolumab is continued for up to 2 years or until disease progression or unacceptable toxicity
  • Initial Therapy
    • Administer 360 mg intravenously every 3 weeks, with ipilimumab 1 mg/kg every 6 weeks; treatment with nivolumab is continued for up to 2 years or until disease progression or unacceptable toxicity

CNS Metastases from Melanoma

Single agent:

  • Administer 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

  • Administer 1 mg/kg intravenously, with ipilimumab on the same day, every 3 weeks for 4 doses, then 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

CNS Metastases from NSCLC

Administer 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

Small Bowel Adenocarcinoma

Single agent:

  • Administer 3 mg/kg intravenously every 2 weeks, or 240 mg intravenously every 2 weeks, or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

 In combination with ipilimumab:

  • Administer 3 mg/kg intravenously, with ipilimumab on the same day, every 3 weeks for 4 doses, then 3 mg/kg or 240 mg intravenously every 2 weeks until disease progression or unacceptable toxicity

Extranodal NK/ T-Cell Lymphoma

Administer 40 mg intravenously every 2 weeks until disease progression or unacceptable toxicity

Endometrial Carcinoma

Administer 3 mg/kg intravenously every 2 weeks for 8 doses and then 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

Vulvar Cancer

Administer 240 mg intravenously every 2 weeks; treatment is continued for up to 2 years or until disease progression or unacceptable toxicity

Dosing should be calculated using actual body weight and not flat dosing (as applicable) based on the following:

Weight ≥ 74 kg:

  • Standard dose 480 mg IV every 4 weeks

Weight is 67 kg to 73 kg:

  • Use 440 mg IV every 4 weeks

Weight is ≤ 66kg:

  • Use 400 mg IV every 4 weeks

-OR-

Weight > 67 kg:

  • Standard dose 240 mg IV every 2 weeks

Weight is 53 kg to 67 kg:

  • Use 200 mg IV every 2 weeks

Weight is < 53kg:

  • Use 160 mg IV every 2 weeks

Note: This information is not meant to replace clinical decision making when initiating or modifying medication therapy and should only be used as a guide. Patient-specific variables should be taken into account.

VI. Billing Code/Availability Information

HCPCS Code:

  • J9299 - Injection, nivolumab, 1 mg; 1 billable unit = 1 mg

NDC:

  • Opdivo 40 mg/4 mL single-use vial: 00003-3772-xx
  • Opdivo 100 mg/10 mL single-use vial: 00003-3774-xx
  • Opdivo 240 mg/24 mL single-use vial: 00003-3734-xx

VII. References

  1. Opdivo [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; November 2020. Accessed November 2020.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) nivolumab. National Comprehensive Cancer Network, 2020. The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed November 2020.
  3. Scherpereel A, Mazieres J, Greillier L, et al. Second- or third-line nivolumab (Nivo) versus nivo plus ipilimumab (Ipi) in malignant pleural mesothelioma (MPM) patients: Results of the IFCT-1501 MAPS2 randomized phase II trial. [Abstract]. J Clin Oncol 2017;35: Abstract LBA 8507.
  4. Walocko FM, Scheier BY, Harms PW, et al. Metastatic Merkel cell carcinoma response to nivolumab. J Immunother Cancer. 2016 Nov 15;4:79.
  5. Tawbi HA-H, Forsyth PAJ, Algazi AP, et al. Efficacy and safety of nivolumab (NIVO) plus ipilimumab (IPI) in patients with melanoma (MEL) metastatic to the brain: Results of the phase II study CheckMate 204. J Clin Oncol 2017;35(15_suppl):abstr 9507.
  6. Morris VK, Salem ME, Nimeiri H, et al.  Nivolumab for previously treated unresectable metastatic anal cancer (NCI9673): a multicentre, single-arm, phase 2 study. Lancet Oncol. 2017 Apr;18(4):446-453. doi: 10.1016/S1470-2045(17)30104-3. Epub 2017 Feb 18.
  7. Zhao X, Ivaturi V, Gopalakrishnan M, et al. Abstract CT 101: A model-based exposure-response (E-R) assessment of a nivolumab (NIVO) 4-weekly (Q4W) dosing schedule across multiple tumor types. Cancer Res July 1 2017 (77) (13 Supplement) CT101; DOI: 10.1158/1538-7445.AM2017-CT101.
  8. Zhao X, Suryawanshi M, Hruska M, et al. Assessment of nivolumab benefit-risk profile of a 240 mg flat dose relative to a 3 mg/kg dosing regimen in patients with advanced tumors. Ann Oncol2017; 28:2002-2008.
  9. Feng Y, Xiaoning W, Bajaj G, et al. Nivolumab exposure-response analyses of efficacy and safety in previously treated squamous or nonsquamous non-small cell lung cancer. ClinCa Res 2017;23(18): 5394-5405.
  10. Gupta S, Sonpavde G, Grivas P, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2019 Mar 1;37(7_suppl):451.
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  30. Kato K, Cho BC, Takahashi M, et al. Nivolumab versus chemotherapy in patients with advanced esophageal squamous cell carcinoma refractory or intolerant to previous chemotherapy (ATTRACTION-3): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2019;20(11):15061517. doi:10.1016/S1470-2045(19)30626-6.
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Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C00.0

Malignant neoplasm of external upper lip

C00.1

Malignant neoplasm of external lower lip

C00.2

Malignant neoplasm of external lip, unspecified

C00.3

Malignant neoplasm of upper lip, inner aspect

C00.4

Malignant neoplasm of lower lip, inner aspect

C00.5

Malignant neoplasm of lip, unspecified, inner aspect

C00.6

Malignant neoplasm of commissure of lip, unspecified

C00.8

Malignant neoplasm of overlapping sites of lip

C01

Malignant neoplasm of base of tongue

C02.0

Malignant neoplasm of dorsal surface of tongue

C02.1

Malignant neoplasm of border of tongue

C02.2

Malignant neoplasm of ventral surface of tongue

C02.3

Malignant neoplasm of anterior two-thirds of tongue, part unspecified

C02.4

Malignant neoplasm of lingual tonsil

C02.8

Malignant neoplasm of overlapping sites of tongue

C02.9

Malignant neoplasm of tongue, unspecified

C03.0

Malignant neoplasm of upper gum

C03.1

Malignant neoplasm of lower gum

C03.9

Malignant neoplasm of gum, unspecified

C04.0

Malignant neoplasm of anterior floor of mouth

C04.1

Malignant neoplasm of lateral floor of mouth

C04.8

Malignant neoplasm of overlapping sites of floor of mouth

C04.9

Malignant neoplasm of floor of mouth, unspecified

C05.0

Malignant neoplasm of hard palate

C05.1

Malignant neoplasm of soft palate

C06.0

Malignant neoplasm of cheek mucosa

C06.2

Malignant neoplasm of retromolar area

C06.8

Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89

Malignant neoplasm of overlapping sites of other parts of mouth

C06.9

Malignant neoplasm of mouth, unspecified

C09.0

Malignant neoplasm of tonsillar fossa

C09.1

Malignant neoplasm of tonsillar pillar (anterior) (posterior)

C09.8

Malignant neoplasm of overlapping sites of tonsil

C09.9

Malignant neoplasm of tonsil, unspecified

C10.3

Malignant neoplasm of posterior wall of oropharynx

C12

Malignant neoplasm of pyriform sinus

C13.0

Malignant neoplasm of postcricoid region

C13.1

Malignant neoplasm of aryepiglottic fold, hypopharyngeal aspect

C13.2

Malignant neoplasm of posterior wall of hypopharynx

C13.8

Malignant neoplasm of overlapping sites of hypopharynx

C13.9

Malignant neoplasm of hypopharynx, unspecified

C14.0

Malignant neoplasm of pharynx, unspecified

C14.2

Malignant neoplasm of Waldeyer’s ring

C14.8

Malignant neoplasm of overlapping sites of lip, oral cavity and pharynx

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

C17.0

Malignant neoplasm of duodenum

C17.1

Malignant neoplasm of jejunum

C17.2

Malignant neoplasm of ileum

C17.3

Meckel’s diverticulum, malignant

C17.8

Malignant neoplasm of overlapping sites of small intestine

C17.9

Malignant neoplasm of small intestine, unspecified

C18.0

Malignant neoplasm of cecum

C18.1

Malignant neoplasm of appendix

C18.2

Malignant neoplasm of ascending colon

C18.3

Malignant neoplasm of hepatic flexure

C18.4

Malignant neoplasm of transverse colon

C18.5

Malignant neoplasm of splenic flexure

C18.6

Malignant neoplasm of descending colon

C18.7

Malignant neoplasm of sigmoid colon

C18.8

Malignant neoplasm of overlapping sites of colon

C18.9

Malignant neoplasm of colon, unspecified

C19

Malignant neoplasm of rectosigmoid junction

C20

Malignant neoplasm of rectum

C21.0

Malignant neoplasm of anus, unspecified

C21.1

Malignant neoplasm of anal canal

C21.2

Malignant neoplasm of cloacogenic zone

C21.8

Malignant neoplasm of overlapping sites of rectum, anus and anal canal

C22.0

Liver cell carcinoma

C22.8

Malignant neoplasm of liver, primary, unspecified as to type

C22.9

Malignant neoplasm of liver, not specified as primary or secondary

C31.0

Malignant neoplasm of maxillary sinus

C31.1

Malignant neoplasm of ethmoidal sinus

C32.0

Malignant neoplasm of glottis

C32.1

Malignant neoplasm of supraglottis

C32.2

Malignant neoplasm of subglottis

C32.3

Malignant neoplasm of laryngeal cartilage

C32.8

Malignant neoplasm of overlapping sites of larynx

C32.9

Malignant neoplasm of larynx, unspecified

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C38.4

Malignant neoplasm of pleura

C43.0

Malignant melanoma of lip

C43.10

Malignant melanoma of unspecified eyelid, including canthus

C43.111

Malignant melanoma of right upper eyelid, including canthus

C43.112

Malignant melanoma of right lower eyelid, including canthus

C43.121

Malignant melanoma of left upper eyelid, including canthus

C43.122

Malignant melanoma of left lower eyelid, including canthus

C43.20

Malignant melanoma of unspecified ear and external auricular canal

C43.21

Malignant melanoma of right ear and external auricular canal

C43.22

Malignant melanoma of left ear and external auricular canal

C43.30

Malignant melanoma of unspecified part of face

C43.31

Malignant melanoma of nose

C43.39

 Malignant melanoma of other parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.59

Malignant melanoma of other part of trunk

C43.60

Malignant melanoma of unspecified upper limb, including shoulder

C43.61

Malignant melanoma of right upper limb, including shoulder

C43.62

Malignant melanoma of left upper limb, including shoulder

C43.70

Malignant melanoma of unspecified lower limb, including hip

C43.71

Malignant melanoma of right lower limb, including hip

C43.72

Malignant melanoma of left lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

C44.00

Unspecified malignant neoplasm of skin of lip

C44.02

Squamous cell carcinoma of skin of lip

C44.09

Other specified malignant neoplasm of skin of lip

C45.0

Mesothelioma of pleura

C4A.0

Merkel cell carcinoma of lip

C4A.10

Merkel cell carcinoma of eyelid, including canthus

C4A.111

Merkel cell carcinoma of right upper eyelid, including canthus

C4A.112

Merkel cell carcinoma of right lower eyelid, including canthus

C4A.121

Merkel cell carcinoma of left upper eyelid, including canthus

C4A.122

Merkel cell carcinoma of left lower eyelid, including canthus

C4A.20

Merkel cell carcinoma of unspecified ear and external auricular canal

C4A.21

Merkel cell carcinoma of right ear and external auricular canal

C4A.22

Merkel cell carcinoma of left ear and external auricular canal

C4A.30

Merkel cell carcinoma of unspecified part of face

C4A.31

Merkel cell carcinoma of nose

C4A.39

Merkel cell carcinoma of other parts of face

C4A.4

Merkel cell carcinoma of scalp and neck

C4A.51

Merkel cell carcinoma of anal skin

C4A.52

Merkel cell carcinoma of skin of breast

C4A.59

Merkel cell carcinoma of other part of trunk

C4A.60

Merkel cell carcinoma of unspecified upper limb, including shoulder

C4A.61

Merkel cell carcinoma of right upper limb, including shoulder

C4A.62

Merkel cell carcinoma of left upper limb, including shoulder

C4A.70

Merkel cell carcinoma of unspecified lower limb, including hip

C4A.71

Merkel cell carcinoma of right lower limb, including hip

C4A.72

Merkel cell carcinoma of left lower limb, including hip

C4A.8

Merkel cell carcinoma of overlapping sites

C4A.9

Merkel cell carcinoma, unspecified

C51.0

Malignant neoplasm of labium majus

C51.1

Malignant neoplasm of labium minus

C51.2

Malignant neoplasm of clitoris

C51.8

Malignant neoplasm of overlapping sites of vulva

C51.9

Malignant neoplasm of vulva, unspecified

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C55

Malignant neoplasm of uterus, part unspecified

C61

Malignant neoplasm of prostate

C64.1

Malignant neoplasm of right kidney, except renal pelvis

C64.2

Malignant neoplasm of left kidney, except renal pelvis

C64.9

Malignant neoplasm of unspecified kidney, except renal pelvis

C65.1

Malignant neoplasm of right renal pelvis

C65.2

Malignant neoplasm of left renal pelvis

C65.9

Malignant neoplasm of unspecified renal pelvis

C66.1

Malignant neoplasm of right ureter

C66.2

Malignant neoplasm of left ureter

C66.9

Malignant neoplasm of unspecified ureter

C67.0

Malignant neoplasm of trigone of bladder

C67.1

Malignant neoplasm of dome of bladder

C67.2

Malignant neoplasm of lateral wall of bladder

C67.3

Malignant neoplasm of anterior wall of bladder

C67.4

Malignant neoplasm of posterior wall of bladder

C67.5

Malignant neoplasm of bladder neck

C67.6

Malignant neoplasm of ureteric orifice

C67.7

Malignant neoplasm of urachus

C67.8

Malignant neoplasm of overlapping sites of bladder

C67.9

Malignant neoplasm of bladder, unspecified

C68.0

Malignant neoplasm of urethra

C69.30

Malignant neoplasm of unspecified choroid

C69.31

Malignant neoplasm of right choroid

C69.32

Malignant neoplasm of left choroid

C69.40

Malignant neoplasm of unspecified ciliary body

C69.41

Malignant neoplasm of right ciliary body

C69.42

Malignant neoplasm of left ciliary body

C69.60

Malignant neoplasm of unspecified orbit

C69.61

Malignant neoplasm of right orbit

C69.62

Malignant neoplasm of left orbit

C76.0

Malignant neoplasm of head, face and neck

C77.0

Secondary and unspecified malignant neoplasm of lymph nodes of head, face and neck

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

C78.89

Secondary malignant neoplasm of other digestive organs

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

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

C81.20

Mixed cellularity Hodgkin lymphoma, unspecified site

C81.21

Mixed cellularity Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.22

Mixed cellularity Hodgkin lymphoma, intrathoracic lymph nodes

C81.23

Mixed cellularity Hodgkin lymphoma, intra-abdominal lymph nodes

C81.24

Mixed cellularity Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.25

Mixed cellularity Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.26

Mixed cellularity Hodgkin lymphoma, intrapelvic lymph nodes

C81.27

Mixed cellularity Hodgkin lymphoma, spleen

C81.28

Mixed cellularity Hodgkin lymphoma, lymph nodes of multiple sites

C81.29

Mixed cellularity Hodgkin lymphoma, extranodal and solid organ sites

C81.30

Lymphocyte depleted Hodgkin lymphoma, unspecified site

C81.31

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.32

Lymphocyte depleted Hodgkin lymphoma, intrathoracic lymph nodes

C81.33

Lymphocyte depleted Hodgkin lymphoma, intra-abdominal lymph nodes

C81.34

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.35

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.36

Lymphocyte depleted Hodgkin lymphoma, intrapelvic lymph nodes

C81.37

Lymphocyte depleted Hodgkin lymphoma, spleen

C81.38

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of multiple sites

C81.39

Lymphocyte depleted Hodgkin lymphoma, extranodal and solid organ sites

C81.40

Lymphocyte-rich Hodgkin lymphoma, unspecified site

C81.41

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.42

Lymphocyte-rich Hodgkin lymphoma, intrathoracic lymph nodes

C81.43

Lymphocyte-rich Hodgkin lymphoma, intra-abdominal lymph nodes

C81.44

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.45

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.46

Lymphocyte-rich Hodgkin lymphoma, intrapelvic lymph nodes

C81.47

Lymphocyte-rich Hodgkin lymphoma, spleen

C81.48

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of multiple sites

C81.49

Lymphocyte-rich Hodgkin lymphoma, extranodal and solid organ sites

C81.70

Other Hodgkin lymphoma unspecified site

C81.71

Other Hodgkin lymphoma lymph nodes of head, face, and neck

C81.72

Other Hodgkin lymphoma intrathoracic lymph nodes

C81.73

Other Hodgkin lymphoma intra-abdominal lymph nodes

C81.74

Other Hodgkin lymphoma lymph nodes of axilla and upper limb

C81.75

Other Hodgkin lymphoma lymph nodes of inguinal region and lower limb

C81.76

Other Hodgkin lymphoma intrapelvic lymph nodes

C81.77

Other Hodgkin lymphoma spleen

C81.78

Other Hodgkin lymphoma lymph nodes of multiple sites

C81.79

Other Hodgkin lymphoma extranodal and solid organ sites

C81.90

Hodgkin lymphoma, unspecified  site

C81.91

Hodgkin lymphoma, unspecified lymph nodes of head, face, and neck

C81.92

Hodgkin lymphoma, unspecified intrathoracic lymph nodes

C81.93

Hodgkin lymphoma, unspecified intra-abdominal lymph nodes

C81.94

Hodgkin lymphoma, unspecified lymph nodes of axilla and upper limb

C81.95

Hodgkin lymphoma, unspecified lymph nodes of inguinal region and lower limb

C81.96

Hodgkin lymphoma, unspecified intrapelvic lymph nodes

C81.97

Hodgkin lymphoma, unspecified spleen

C81.98

Hodgkin lymphoma, unspecified lymph nodes of multiple sites

C81.99

Hodgkin lymphoma, unspecified extranodal and solid organ sites

C84.90

Mature T/NK-cell lymphomas, unspecified, unspecified site

C84.91

Mature T/NK-cell lymphomas, unspecified, lymph nodes of head, face, and neck

C84.92

Mature T/NK-cell lymphomas, unspecified, intrathoracic lymph nodes

C84.93

Mature T/NK-cell lymphomas, unspecified, intra-abdominal lymph nodes

C84.94

Mature T/NK-cell lymphomas, unspecified, lymph nodes of axilla and upper limb

C84.95

Mature T/NK-cell lymphomas, unspecified, lymph nodes of inguinal region and lower limb

C84.96

Mature T/NK-cell lymphomas, unspecified, intrapelvic lymph nodes

C84.97

Mature T/NK-cell lymphomas, unspecified, spleen

C84.98

Mature T/NK-cell lymphomas, unspecified, lymph nodes of multiple sites

C84.99

Mature T/NK-cell lymphomas, unspecified, extranodal and solid organ sites

C84.Z0

Other mature T/NK-cell lymphomas, unspecified site

C84.Z1

Other mature T/NK-cell lymphomas, lymph nodes of head, face, and neck

C84.Z2

Other mature T/NK-cell lymphomas, intrathoracic lymph nodes

C84.Z3

Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes

C84.Z4

Other mature T/NK-cell lymphomas, lymph nodes of axilla and upper limb

C84.Z5

Other mature T/NK-cell lymphomas, lymph nodes of inguinal region and lower limb

C84.Z6

Other mature T/NK-cell lymphomas, intrapelvic lymph nodes

C84.Z7

Other mature T/NK-cell lymphomas, spleen

C84.Z8

Other mature T/NK-cell lymphomas, lymph nodes of multiple sites

C84.Z9

Other mature T/NK-cell lymphomas, extranodal and solid organ sites

C86.0

Extranodal NK/T-cell lymphoma, nasal type

D09.0

Carcinoma in situ of bladder

D37.01

Neoplasm of uncertain behavior of lip

D37.02

Neoplasm of uncertain behavior of tongue

D37.05

Neoplasm of uncertain behavior of pharynx

D37.09

Neoplasm of uncertain behavior of other specified sites of the oral cavity

D37.8

Neoplasm of uncertain behavior of other specified digestive organs

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

D38.0

Neoplasm of uncertain behavior of larynx

D38.5

Neoplasm of uncertain behavior of other respiratory organs

D38.6

Neoplasm of uncertain behavior of respiratory organ, unspecified

D39.2

Neoplasm of uncertain behavior of placenta

D39.8

Neoplasm of uncertain behavior of other specified female genital organs

D39.9

Neoplasm of uncertain behavior of female genital organ, unspecified

Z85.00

Personal history of malignant neoplasm of unspecified digestive organ

Z85.01

Personal history of malignant neoplasm of esophagus

Z85.038

Personal history of other malignant neoplasm of large intestine

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.21

Personal history of malignant neoplasm of larynx

Z85.22

Personal history of malignant neoplasm of nasal cavities, middle ear, and accessory sinuses

Z85.51

Personal history of malignant neoplasm of bladder

Z85.59

Personal history of malignant neoplasm of other urinary tract organ

Z85.71

Personal history of Hodgkin lymphoma

Z85.810

Personal history of malignant neoplasm of tongue

Z85.818

Personal history of malignant neoplasm of other sites of lip, oral cavity and pharynx

Z85.819

Personal history of malignant neoplasm of unspecified site of lip, oral cavity and pharynx

Z85.820

Personal history of malignant melanoma of skin                                                                      

Z85.821

Personal history of Merkel cell carcinoma

Appendix 2 – Centers for Medicare and Medicaid Services (CMS)

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

Medicare Part B Covered Diagnosis Codes (applicable to existing NCD/LCD/LCA):

Jurisdiction(s): 6, K

NCD/LCD/Article Document (s): A54862

   

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A54862&bc=gAAAAAAAAAAAAA==

     

Jurisdiction(s): J&M

NCD/LCD/Article Document (s): A56141

https://www.cms.gov/medicare-coverage-database/search/article-date-search.aspx?DocID=A56141&bc=gAAAAAAAAAAA

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

CGS Administrators, LLC