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Opdivo® (nivolumab)

Policy Number: VP-0226

(Intravenous)

 

Last Review Date: 03/05/2024

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, 01/2021, 02/2021, 05/2021, 06/2021, 09/2021, 12/2021, 03/2022, 04/2022, 06/2022, 07/2022, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 11/2023, 12/2023, 03/2024

FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill.

  1. Length of Authorization 1,43,47,49,50,52-54,65,68,72,73,79,81,82,89

Coverage will be provided for 6 months and may be renewed (unless otherwise specified).

  • Use in the treatment of Classical Hodgkin Lymphoma:
    • In combination with brentuximab vedotin can be authorized up to a maximum of 12 weeks of therapy (4 doses) and may NOT be renewed.
    • In combination with ICE (ifosfamide, carboplatin, etoposide) can be authorized up to a maximum of 12 weeks of therapy (6 doses) and may NOT be renewed.
  • Neoadjuvant or Perioperative Therapy of MSI-H/dMMR Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancer can be authorized for a maximum of 12 weeks of pre-operative therapy (6 doses), followed by a maximum of 36 weeks (9 doses) of postoperative therapy after surgery
  • Neoadjuvant treatment of Merkel Cell Carcinoma can be authorized up to a maximum of two (2) doses and may NOT be renewed.
  • Neoadjuvant treatment of NSCLC in combination with platinum-doublet chemotherapy may be authorized for a maximum of three (3) doses and may NOT be renewed.
  • Neoadjuvant treatment of Cutaneous Melanoma in combination with ipilimumab may be authorized for a maximum of three (3) doses and may NOT be renewed.
  • Neoadjuvant treatment of Cutaneous Melanoma as a single agent may be authorized for a maximum of four (4) doses and may NOT be renewed.
  • Adjuvant treatment of Cutaneous Melanoma in combination with ipilimumab may be authorized for a maximum of four (4) doses and may NOT be renewed.
  • Adjuvant treatment of the following indications may be renewed up to a maximum of one (1) year of therapy*:
    • Cutaneous Melanoma (single agent)
    • Esophageal and Esophagogastric/Gastroesophageal Junction Cancer
    • Urothelial Carcinoma
  • The following indications may be renewed up to a maximum of two (2) years of therapy*:
    • Biliary Tract Cancer
    • Bone Cancer
    • Cervical Cancer
    • Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (first-line therapy)
    • MSI-H/dMMR Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancer (first-line or subsequent therapy)
    • Gastric Cancer (in combination with fluoropyrimidine- and platinum-containing chemotherapy OR ipilimumab)
    • Kaposi Sarcoma
    • Renal Cell Carcinoma (in combination with cabozantinib)
    • Malignant Pleural Mesothelioma (initial therapy in combination with ipilimumab)
    • Malignant Peritoneal Mesothelioma (initial therapy in combination with ipilimumab)
    • Non-Small Cell Lung Cancer (in combination with ipilimumab with or without platinum-doublet chemotherapy)
  • Vulvar Cancer
  • Urothelial Carcinoma (first line systemic therapy in combination with gemcitabine and cisplatin, followed by nivolumab maintenance therapy)

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Opdivo 40 mg/4 mL single-dose vial: 2 vials per 14 days
  • Opdivo 100 mg/10 mL single-dose vial: 3 vials per 14 days
  • Opdivo 120 mg/12 mL single-dose vial: 3 vials per 14 days
  • Opdivo 240 mg/24 mL single-dose vial: 4 vials per 14 days
  1. Max Units (per dose and over time) [HCPCS Unit]:

Indication

Billable Units (BU)

Per unit time (days)

CNS Cancer, HCC, Cutaneous Melanoma, Uveal Melanoma, & MCC

120 BU

21 days

Anal Cancer, Biliary Tract Cancer (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma), Bladder/Urothelial Cancer, Bone Cancer, CRC, Appendiceal Adenocarcinoma, Esophageal Cancer, GEJ Cancer, Gastric, GTN, SCCHN, HCC, cHL, Kaposi Sarcoma, RCC, MPM, MPeM, Cutaneous Melanoma, MCC, NSCLC, SBA, STS, Vulvar Cancer, & Cervical Cancer, Thyroid Carcinoma

240 BU

14 days

Ampullary Adenocarcinoma, Anal Carcinoma, CNS Cancer, CRC, Appendiceal Adenocarcinoma, Esophageal Cancer, MPM, MPeM, Uveal Melanoma, MCC, Cutaneous Melanoma, PMBCL, SBA, SCLC, & Endometrial Carcinoma (Uterine Neoplasms)

340 BU

14 days

Ampullary Adenocarcinoma, CRC, Appendiceal Adenocarcinoma, cHL, RCC, & SBA

340 BU

21 days

Esophageal Cancer, GEJ Cancer, Gastric Cancer, MPM, MPeM, & NSCLC

360 BU

21 days

Anal Carcinoma, Urothelial (Bladder) Cancer, Bone Cancer, CRC, Appendiceal Adenocarcinoma, Esophageal Cancer, GEJ Cancer, GTN, SCCHN, HCC, cHL, RCC, Cutaneous Melanoma, NSCLC, SBA, STS, & Endometrial Carcinoma (Uterine Neoplasms)

480 BU

28 days

Uveal Melanoma

1140 BU

14 days

Extranodal NK/ T-Cell Lymphoma

40 BU

14 days

  1. Initial Approval Criteria 1

Coverage is provided for the following conditions:

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

  • 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, dostarlimab, nivolumab/relatlimab-rmbw, retifanlimab, toripalimab, etc.), unless otherwise specified ; AND

Ampullary Adenocarcinoma ‡ 2

  • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used in combination with ipilimumab; AND
    • Used as first-line therapy for unresectable or metastatic intestinal type disease; OR
    • Used as subsequent therapy for disease progression

Anal Carcinoma ‡ 2,6,35

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

Biliary Tract Cancers (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma) ‡ 2,72

  • Patient has tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used as subsequent treatment for progression on or after systemic treatment for unresectable, resected gross residual (R2), or metastatic disease; AND
  • Used in combination with ipilimumab; AND
  • Disease is refractory to standard therapies or there are no standard treatment options available

Urothelial Carcinoma (Bladder Cancer) 1,2,30,51,62,92

  • Used as a single agent; AND
    • Used for disease that progressed during or following platinum-containing chemotherapy* OR as second-line treatment after chemotherapy other than a platinum; AND
      • Patient has one of the following diagnoses:
  • Locally advanced or metastatic urothelial carcinoma
  • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder
  • Metastatic or local bladder cancer recurrence post-cystectomy
  • Recurrent or metastatic primary carcinoma of the urethra; AND
  • Patient does not have recurrence of stage T3-4 disease or palpable inguinal lymph nodes
  • Metastatic upper genitourinary (GU) tract tumors
  • Metastatic urothelial carcinoma of the prostate; OR
    • Used as adjuvant therapy ; AND
      • Patient has urothelial carcinoma of the bladder, bulbar urethra, prostate with stromal invasion, ureter, or renal pelvis; AND
      • Patient underwent radical surgical resection; AND
      • Patient is at high risk for disease recurrence**; OR
  • Used in combination with cisplatin and gemcitabine followed by nivolumab maintenance therapy; AND
    • Used as first-line systemic therapy in cisplatin eligible patients*; AND
      • Patient has one of the following diagnoses:
  • Locally advanced or metastatic urothelial carcinoma
  • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder
  • Metastatic or local bladder cancer recurrence post-cystectomy
  • Recurrent or metastatic primary carcinoma of the urethra; AND
  • Patient does not have recurrence of stage T3-4 disease or palpable inguinal lymph nodes
  • Metastatic upper genitourinary (GU) tract tumors
  • Metastatic urothelial carcinoma of the prostate

* Note: 10,51,60,70

  • If patient was progression free for >12 months after platinum therapy, consider re-treatment with platinum-based therapy if the patient is still platinum eligible (see below for cisplatin- or platinum-ineligible comorbidities).
  • Cisplatin-ineligible comorbidities may include the following: CrCl < 60 mL/min, ECOG PS ≥ 2 or KPS ≤ 70%, hearing loss of ≥ 25 decibels (dB) at two contiguous frequencies, grade ≥ 2 peripheral neuropathy, or NYHA Heart Failure class ≥ 3. Carboplatin may be substituted for cisplatin in the metastatic setting for cisplatin-ineligible patients such as those with a GFR less than 60 mL/min.
  • Platinum-ineligible comorbidities may include the following: CrCl < 30 mL/min, ECOG PS ≥ 3, grade ≥ 2 peripheral neuropathy, or NYHA Heart Failure class > 3, etc.

** Note: 1,62

  • High risk for disease recurrence is defined as:
  • ypT2-ypT4a or ypN+ for patients who received neoadjuvant cisplatin (excluding prostate with stromal invasion); OR
  • pT3-pT4a or pN+ for patients who did not receive neoadjuvant cisplatin and are also ineligible for or refused adjuvant cisplatin therapy (excluding ureter or renal pelvis)

Bone Cancers ‡ 2,72

  • Patient has one of the following: Ewing Sarcoma, Chondrosarcoma (excluding mesenchymal chondrosarcoma), Osteosarcoma, or Chordoma; AND
  • Patient has tumor mutation burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used in combination with ipilimumab; AND
  • Patient has unresectable or metastatic disease that progressed following prior treatment; AND
  • Patient has no satisfactory alternative treatment options

Adult Central Nervous System (CNS) Cancers ‡ 2,5,34,41,42

  • Used in one of the following treatment settings:
  • Used as initial treatment in patients with small asymptomatic brain metastases
  • Used for relapsed limited brain metastases with either stable systemic disease or reasonable systemic treatment options
  • Patient has recurrent limited brain metastases
  • Used for recurrent extensive brain metastases with 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 BRAF non-specific melanoma; OR
  • Used as a single-agent for the treatment of brain metastases in patients with PD-L1 positive (Tumor Proportion Score [TPS] ≥1%) non-small cell lung cancer (NSCLC)

Pediatric Central Nervous System (CNS) Cancers ‡ 2,71

  • Patient is ≤ 18 years of age; AND
  • Patient has hypermutated diffuse high-grade glioma; AND
    • Used for recurrent or progressive disease as a single agent (excluding oligodendroglioma, IDH-mutant and 1p/19q co-deleted or astrocytoma IDH-mutant); OR
    • Used as adjuvant therapy (excluding diffuse midline glioma, H3 K27-altered or pontine location); AND
    • Patient is < 3 years of age and used as a single agent; OR
    • Patient is ≥ 3 years of age and used following standard brain radiation therapy (RT) with or without concurrent temozolomide

Cervical Cancer 2,49,63

  • Used as subsequent therapy as a single agent; AND
  • Patient has recurrent or metastatic disease; AND
  • Tumor expresses PD-L1 (e.g., CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv

Colorectal Cancer (CRC) 1,2,31,32

  • Patient is at least 12 years of age; AND
  • Patient has microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) disease OR polymerase epsilon/delta (POLE/POLD1) mutation as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used as a single agent or in combination with ipilimumab*; AND
    • Used as subsequent therapy; AND
    • Patient has metastatic, unresectable, or medically inoperable disease; OR
    • Used as primary or initial treatment; AND
    • Used for isolated pelvic/anastomotic recurrence of rectal cancer; OR
    • Patient has T3, N Any; T1-2, N1-2; T4, N Any rectal cancer; OR
    • Patient has metastatic, unresectable, or medically inoperable disease; OR
    • Used as neoadjuvant therapy; AND
    • Patient has clinical T4b colon cancer (for dMMR/MSI-H disease ONLY); OR
    • Patent has resectable liver and/or lung metastases; OR
    • Patient has T3, N Any; T1-2, N1-2; T4, N Any, locally unresectable, or medically inoperable rectal cancer (single agent therapy for dMMR/MSI-H disease ONLY)

* Single agent nivolumab should be used in patients who are not candidates for intensive therapy.

Appendiceal Adenocarcinoma – Colon Cancer ‡ 2

  • Patient has microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) disease OR polymerase epsilon/delta (POLE/POLD1) mutation as determined by an FDA-approved or CLIA-compliant testv;AND
  • Used as a single agent or in combination with ipilimumab*; AND
  • Patient has advanced or metastatic disease; AND
    • Used as primary or initial treatment; OR
    • Used as subsequent treatment

      * Single agent nivolumab should be used in patients who are not candidates for intensive therapy.

Esophageal Cancer and Esophagogastric/Gastroesophageal Junction Cancers ‡ Ф 1,2,44,52,56,69

  • Used as first-line therapy; AND
    • Patient has squamous cell carcinoma ; AND
      • Patient is not a surgical candidate or has unresectable advanced, recurrent, or metastatic disease; AND
  • Used in combination with ipilimumab*; OR
  • Used in combination with fluoropyrimidine- and platinum-containing chemotherapy*; OR
    • Patient has adenocarcinoma; AND
      • Patient is not a surgical candidate or has unresectable advanced, recurrent, or metastatic disease; AND
        • Used in combination with fluoropyrimidine- and platinum-containing chemotherapy*; OR
        • Used in combination with ipilimumab; AND
              • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; OR
  • Used as subsequent therapy; AND
    • Patient has squamous cell carcinoma; AND
      • Patient is not a surgical candidate or has unresectable advanced, recurrent, or metastatic disease; AND
  • Used as a single agent; OR
  • Used in combination with ipilimumab; AND
              • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; OR
    • Patient has adenocarcinoma; AND
      • Patient is not a surgical candidate or has unresectable locally advanced, recurrent, or metastatic disease; AND
      • Used in combination with ipilimumab; AND
      • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; OR
  • Used as adjuvant treatment of completely resected disease ; AND
    • Used as a single agent in patients with residual disease following neoadjuvant chemoradiotherapy (CRT); OR
  • Used as neoadjuvant or perioperative therapy; AND
    • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; AND
    • Patient has adenocarcinoma; AND
      • Used in combination with ipilimumab; AND
  • Used as primary treatment for patients who are medically fit for surgery with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease; OR
    • Used as a single agent ; AND
  • Used as postoperative management following R0 resection in patients who have received preoperative therapy with nivolumab and ipilimumab

*Note: Combination therapy with ipilimumab OR oxaliplatin and fluorouracil or capecitabine may also be used for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv

Gastric Cancer † ‡ Ф 1,2,53,56

  • Used as first-line therapy; AND
  • Patient is not a surgical candidate or has unresectable, advanced, recurrent, or metastatic disease; AND
    • Used in combination with fluoropyrimidine- and platinum-containing chemotherapy*; OR
        • Used in combination with ipilimumab; AND
  • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; OR
  • Used as subsequent therapy; AND
    • Patient is not a surgical candidate or has unresectable locally advanced, recurrent, or metastatic disease; AND
    • Used in combination with ipilimumab; AND
    • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; OR
  • Used as neoadjuvant or perioperative therapy; AND
    • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv; AND
      • Used in combination with ipilimumab; AND
  • Used as primary treatment prior to surgery for potentially resectable locoregional disease (cT2 or higher, any N) in patients who are medically fit for surgery; OR
    • Used as a single agent; AND
              • Used as postoperative management following R0 resection in patients who have received preoperative therapy with nivolumab and ipilimumab

*Note: Combination therapy with oxaliplatin and fluorouracil or capecitabine may also be used for patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv

Gestational Trophoblastic Neoplasia ‡ 2,36

  • 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; OR
    • Patient has high risk disease (i.e., ≥7 Prognostic score or stage IV disease)

Squamous Cell Carcinoma of the Head and Neck (SCCHN) 1,2,29,78

Patient must have failed or have a contraindication or intolerance to Loqtorzi when used as first line therapy in combination with chemotherapy for nasopharyngeal carcinoma (NPC); AND

  • Patient has Cancer of the Nasopharynx; AND
    • Used in combination with cisplatin and gemcitabine for oligometastatic or metastatic disease; OR
  • Patient has Very Advanced Head and Neck Cancer*; AND
    • Patient has nasopharyngeal cancer; AND
      • Used in combination with cisplatin and gemcitabine for patients with performance status (PS) 0-1; AND
      • Used for one of the following:
  • Unresectable locoregional recurrence with prior radiation therapy (RT)
  • Unresectable second primary with prior RT
  • Unresectable persistent disease with prior RT
  • Recurrent/persistent disease with distant metastases; OR
    • Patient has NON-nasopharyngeal cancer; AND
      • Used as a single agent; AND
  • Patient has unresectable, recurrent, persistent, or metastatic disease; AND
  • Disease has progressed on or after platinum-containing chemotherapy; OR
    • Used in combination with cetuximab for patients with performance status (PS) 0-1; AND
      • Used for one of the following:
    • Metastatic disease at initial presentation
    • Recurrent/persistent disease with distant metastases
    • Unresectable locoregional recurrence with prior RT
    • Unresectable second primary with prior RT
    • Unresectable persistent disease with prior RT

* Very Advanced Head and Neck Cancer includes: newly diagnosed locally advanced T4b (M0) disease, newly diagnosed unresectable regional nodal disease (typically N3), metastatic disease at initial presentation (M1), or recurrent or persistent disease.

Hepatocellular Carcinoma (HCC) ‡ Ф 1,2,21,86,87

  • Used for one of the following:
    • Patient was previously treated with sorafenib (for use in combination with ipilimumab ONLY)
    • Patient has unresectable disease and is not a transplant candidate
    • Patient has liver-confined disease that is inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic-disease
    • Patient has metastatic disease or extensive liver tumor burden; AND
    • Used in combination with ipilimumab; AND
      • Patient has Child-Pugh Class A hepatic impairment; AND
      • Used as subsequent therapy for progressive disease; OR
    • Used as a single agent; AND
      • Patient has Child-Pugh Class B hepatic impairment

Adult Classical Hodgkin Lymphoma (cHL) † ‡ Ф 1,2,27,28,73

  • Used as a single agent; AND
    • Patient has relapsed or progressive disease after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin ; OR
    • Used for disease that is refractory to at least 3 prior lines of therapy including autologous HSCT ; OR
  • Used as palliative therapy in patients > 60 years of age or with poor performance status or with substantial comorbidities; AND
    • Patient has relapsed or refractory disease; OR
  • Used in combination with brentuximab vedotin or ICE (ifosfamide, carboplatin, etoposide) in patients 18 to 60 years of age; AND
  • Used as second-line therapy for relapsed or refractory disease; OR
  • Used as subsequent therapy (if not previously used) for relapsed or refractory disease; AND
    • Patient has a Deauville scale score of 4 or 5 following restaging with FDG-PET/CT

Pediatric Classical Hodgkin Lymphoma (cHL) ‡ 2,27,28

  • Patient is ≤ 18 years of age*; AND
  • Patient has relapsed or refractory disease; AND
  • Used in patients heavily pretreated with platinum or anthracycline-based chemotherapy or if a decrease in cardiac function was observed; AND
    • Used as subsequent therapy (if not previously used); AND
      • Used as a single agent or in combination with brentuximab vedotin; OR
    • Used as re-induction therapy; AND
      • Used in combination with brentuximab vedotin; OR
      • Used in combination with brentuximab vedotin and 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)

* Pediatric Hodgkin Lymphoma may be applicable to adolescent and young adult (AYA) patients up to the age of 39 years.

Kaposi Sarcoma ‡ 2,79

  • Used in combination with ipilimumab as subsequent therapy; AND
  • Patient has classic disease; AND
  • Used for relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease; AND
  • Disease has progressed on or not responded to first-line therapy; AND
  • Disease has progressed on alternate first-line therapy

Renal Cell Carcinoma (RCC) 1,2,25,26

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

Cutaneous Melanoma † ‡ Ф 1,2,15-18,82,93

  • Used as first-line therapy for unresectable or metastatic* disease; AND
    • Patient is at least 12 years of age; AND
    • Used as a single agent or in combination with ipilimumab; OR
  • Used as initial therapy for limited resectable disease; AND
    • Used as a single agent; AND
      • Patient has stage III disease with clinical satellite/in-transit metastases; OR
      • Patient has local satellite/in-transit recurrence; OR
  • Used as subsequent therapy for unresectable or metastatic* disease; AND
    • Patient is at least 12 years of age; AND
      • Used as re-induction therapy in patients who experienced disease control (i.e., complete or partial response or stable disease) and no residual toxicity from prior anti-PD-1 immunotherapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; AND
  • Used as a single agent or in combination with ipilimumab; OR
    • Used after disease progression, intolerance, and/or projected risk of progression with BRAF-targeted therapy (e.g., dabrafenib/trametinib, vemurafenib/cobimetinib, encorafenib/binimetinib, etc.); AND
  • Used as a single agent or in combination with ipilimumab if anti-PD-1 therapy was not previously used; OR
  • Used in combination with ipilimumab for disease progression on single agent anti-PD-1 therapy; OR
  • Used as adjuvant treatment; AND
    • Used as a single agent; AND
      • Patient is at least 12 years of age; AND
  • Patient has stage IIB, stage IIC, or metastatic disease and has undergone complete resection ; OR
  • Patient has stage III disease; AND
    • Patient has undergone complete resection ; OR
    • Patient has sentinel node positive disease either during observation without additional nodal surgery and with mandatory radiographic nodal surveillance OR after complete lymph node dissection (CLND); OR
    • Patient has clinically positive node(s) following wide excision of the primary tumor and therapeutic lymph node dissection (TLND) OR following neoadjuvant therapy; OR
    • Patient has clinical satellite/in-transit metastases and has no evidence of disease (NED) after complete excision; OR
    • Used following wide excision alone (stage IIIB/C/D disease only); OR
    • Used following wide excision with negative sentinel lymph node biopsy; OR
    • Used for disease that is sentinel lymph node negative or sentinel lymph node biopsy not performed (stage IIIB/C/D disease only); OR
  • Patient has local satellite/in-transit recurrence and has NED after complete excision; OR
  • Patient has resectable disease limited to nodal recurrence following excision and complete TLND OR following neoadjuvant therapy; OR
  • Patient has oligometastatic disease and NED following metastasis-directed therapy (i.e., stereotactic ablative therapy or complete resection) or systemic therapy followed by resection; OR
        • Used in combination with ipilimumab; AND
          • Patient has oligometastatic disease and no evidence of disease following metastasis-directed therapy (i.e., complete resection, stereotactic ablative therapy or T-VEC/intralesional therapy) or systemic therapy followed by resection
  • Used as neoadjuvant therapy; AND
      • Used as a single agent or in combination with ipilimumab; AND
    • Patient has stage III disease; AND
  • Used as primary treatment for clinically positive, resectable nodal disease; OR
  • Used for limited resectable disease with clinical satellite/in-transit metastases; OR
    • Patient has limited resectable local satellite/in-transit recurrence; OR
    • Patient has resectable disease limited to nodal recurrence

*Metastatic disease includes stage III unresectable/borderline resectable disease with clinically positive node(s) or clinical satellite/in-transit metastases, or as well as unresectable local satellite/in-transit recurrence, unresectable nodal recurrence, and widely disseminated distant metastatic disease.

Uveal Melanoma ‡ 2,19,20,80

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

Merkel Cell Carcinoma 2,4,33,65,83

  • Used as neoadjuvant treatment; AND
    • Used as a single agent; AND
      • Patient is a surgical candidate with primary clinical N0 locally advanced disease where curative surgery and curative radiation therapy were originally deemed not feasibile; OR
      • Patient has primary clinical N+, M0 regional disease with biopsy positive draining nodal basin; OR
  • Used for M1 disseminated disease; AND
    • Used as a single agent; OR
    • Used in combination with ipilimumab; AND
      • Patient progressed on anti-PD-L1 or anti-PD-1 therapy OR anti-PD-L1 or anti-PD-1 therapy is contraindicated

Malignant Peritoneal Mesothelioma (MPeM)* ‡ 2,64,90

  • Used as a single agent or in combination with ipilimumab as subsequent therapy (if chemotherapy was administered first-line); OR
  • Used in combination with ipilimumab as first-line therapy; AND
    • Patient has unicavitary disease with epithelioid histology; AND
      • Used as adjuvant treatment for medically operable disease following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC); AND
        • Patient has surgical or pathologic high-risk features** and no neoadjuvant therapy was given; OR
  • Patient has medically inoperable disease and/or complete cytoreduction not achieved (including high-risk features**); OR
  • Patient has disease recurrence after prior CRS + HIPEC if no previous adjuvant systemic therapy was given; OR
    • Patient has biphasic/sarcomatoid histology; AND
      • Patient has bicavitary disease; OR
      • Patient has disease recurrence after prior CRS + HIPEC

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

** High-risk features include Ki-67 >9%, nodal metastasis, high tumor burden (Peritoneal Cancer Index [PCI] >17), completeness of cytoreduction (CC) score >1, biphasic disease, or bicavitary disease

Malignant Pleural Mesothelioma (MPM)* † ‡ Ф 1,2,37,38,47,64,81

  • Used as a single agent or in combination with ipilimumab as subsequent therapy (if chemotherapy was administered first-line); OR
  • Used in combination with ipilimumab as first-line therapy; AND
    • Patient has clinical stage IIIB or IV disease; OR
    • Patient has sarcomatoid or biphasic histology; OR
    • Disease is medically inoperable or unresectable; OR
    • Patient has clinical stage I-IIIA disease with epithelioid histology and did not receive induction chemotherapy

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

Non-Small Cell Lung Cancer (NSCLC) † ‡ 1,2,22,23,43,45,46

  • Used as neoadjuvant therapy for resectable (tumors ≥ 4 cm or node positive) disease; AND
  • Used in combination with platinum-doublet chemotherapy (e.g., cisplatin/carboplatin in combination with paclitaxel, pemetrexed, or gemcitabine); AND
  • Patient is negative for EGFR or ALK rearrangements; 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:
    • Patients with a performance status (PS) 0-1 who have tumors that are negative for actionable molecular biomarkers** ¥; and PD-L1 expression <1%
    • Patients with a PS 0-1 who are positive for one of the following molecular biomarkers: EGFR exon 20, KRAS G12C, BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, RET rearrangement, or ERBB2 (HER2)
    • PD-L1 expression-positive (PD-L1 ≥1%) tumors, as detected by an FDA or CLIA compliant testv, that are negative for actionable molecular biomarkers** ¥; 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 nonsquamous cell histology, or 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:
    • Patients with a PS 0-1 who are positive for one of the following molecular biomarkers and have received prior targeted therapy§: EGFR exon 19 deletion or exon 21 L858R tumors, EGFR S768I, L861Q, and/or G719X, ALK rearrangement, or ROS1 rearrangement
    • Patients with a PS 0-1 who are positive for one of the following molecular biomarkers: BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, or RET rearrangement; AND
  • Used in combination with ipilimumab; OR
  • Used in combination with ipilimumab, pemetrexed, and either carboplatin or cisplatin for nonsquamous cell histology; OR
  • Used in combination with ipilimumab, paclitaxel, and carboplatin for squamous cell histology; OR
    • Used as continuation maintenance therapy in combination with ipilimumab; AND
  • Patient has achieved a response or stable disease following first-line therapy with nivolumab and ipilimumab with or without chemotherapy

** Note: Actionable molecular genomic biomarkers include EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and ERBB2 (HER2). Complete genotyping for EGFR, KRAS, ALK, ROS1, BRAF, NTRK1/2/3, MET, RET, and ERBB2 (HER2) via biopsy and/or plasma testing. If a clinically actionable marker is found, it is reasonable to start therapy based on the identified marker. Treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes.

¥ May also be used for patients with KRAS G12C mutation positive tumors.

Pediatric Aggressive Mature B-Cell Lymphomas – Primary Mediastinal Large B-Cell Lymphoma (PMBCL) ‡ 2,74-76

  • Patient is ≤ 18 years of age*; AND
  • Used in combination with brentuximab vedotin; AND
    • Used as consolidation/additional therapy if a partial response was achieved after therapy for relapsed or refractory disease; OR
  • Used as a single agent for relapsed or refractory disease

* Pediatric Primary Mediastinal Large B-Cell Lymphoma may be applicable to adolescent and young adult (AYA) patients <39 years who are treated in a pediatric oncology setting.

Small Bowel Adenocarcinoma ‡ 2,31,39

  • Patient has advanced or metastatic disease that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used as a single agent or in combination with ipilimumab

Small Cell Lung Cancer (SCLC) ‡ Ф 2,24,61

  • Used as subsequent systemic therapy as a single agent; AND
  • There has been a chemotherapy-free interval of ≤6 months; AND
    • Patient has relapsed disease following a complete or partial response or stable disease after primary treatment; OR
    • Patient has primary progressive disease

Soft Tissue Sarcoma ‡ 2,72,84

  • Extremity/Body Wall, Head/Neck* or Retroperitoneal/Intra-Abdominal**
    • Used as a single agent or in combination with ipilimumab; AND
    • Used as subsequent therapy; AND
      • Patient has myxofibrosarcoma, undifferentiated pleomorphic sarcoma (UPS), dedifferentiated liposarcoma, cutaneous angiosarcoma, or undifferentiated sarcomas; OR
      • Patient has tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] disease as determined by an FDA-approved or CLIA-compliant testv; AND
  • Patient has no satisfactory alternative treatment options
  • Pleomorphic Rhabdomyosarcoma
    • Used as a single agent or in combination with ipilimumab; AND
    • Used as subsequent therapy; AND
    • Patient has tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] disease as determined by an FDA-approved or CLIA-compliant testv; AND
    • Patient has no satisfactory alternative treatment options
  • Angiosarcoma
    • Used in combination with ipilimumab

*For atypical lipomatous tumor/well-differentiated liposarcoma (ALT/WDLS) of the extremity, abdominal wall, trunk that was initially diagnosed as ALT and shows evidence of de-differentiation, treat as other soft tissue sarcomas.

**For well-differentiated liposarcoma (WDLS-retroperitoneum, paratesticular) with or without evidence of de-differentiation, treat as other soft tissue sarcomas; risk of WDLS progression without de-differentiation is low and therefore single-agent systemic therapy is recommended.

Extranodal NK/T-Cell Lymphomas ‡ 2,40

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

Endometrial Carcinoma (Uterine Neoplasms) ‡ 2,48

  • Used as a single agent; AND
  • Used as subsequent therapy for recurrent disease; AND
  • Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) disease as determined by an FDA-approved or CLIA-compliant testv

Vulvar Cancer 2,49

  • Used as a single agent; AND
  • Patient has adenocarcinoma or squamous cell carcinoma; AND
  • Used as subsequent therapy for HPV-related advanced, recurrent, or metastatic disease

Thyroid Carcinoma ‡ 2,94,95

  • Used as a single agent; AND
  • Used for stage IVC (metastatic) anaplastic carcinoma

v If confirmed using an FDA approved 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)

EGFR exon 19 deletion or exon 21 L858R tumors

EGFR S768I, L861Q, and/or G719X mutation positive tumors

EGFR exon 20 insertion mutation positive tumors

NTRK1/2/3 gene fusion positive tumors

  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib
  • Amivantamab
  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib
  • Amivantamab
  • Amivantamab
  • Larotrectinib
  • Entrectinib

ALK rearrangement-positive tumors

ROS1 rearrangement-positive tumors

BRAF V600E-mutation positive tumors

ERBB2 (HER2) mutation positive tumors

  • Alectinib
  • Brigatinib
  • Ceritinib
  • Crizotinib
  • Lorlatinib
  • Ceritinib
  • Crizotinib 
  • Entrectinib
  • Lorlatinib
  • Repotrectinib
  • Dabrafenib ± trametinib
  • Encorafenib + binimetinib
  • Vemurafenib
  • Fam-trastuzumab deruxtecan-nxki
  • Ado-trastuzumab emtansine

PD-L1 tumor

expression ≥ 1%

MET exon-14 skipping mutations

RET rearrangement-positive tumors

KRAS G12C mutation positive tumors

  • Pembrolizumab
  • Atezolizumab
  • Nivolumab + ipilimumab
  • Cemiplimab
  • Tremelimumab + durvalumab
  • Capmatinib
  • Crizotinib
  • Tepotinib
  • Selpercatinib
  • Cabozantinib
  • Pralsetinib
  • Sotorasib
  • Adagrasib
  1. Renewal Criteria 1,2,4-6,15-42,43,47,49,50,52-54,68,72,73,79,81,82,89

Coverage may be renewed based upon the following criteria:

  • Patient continues to meet the 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-related reactions, complications of allogeneic hematopoietic stem cell transplantation (HSCT), severe immune-mediated adverse reactions (i.e., pneumonitis, colitis, hepatitis/hepatotoxicity, endocrinopathies, nephritis/renal dysfunction, adverse skin reactions/rash, etc.), etc.; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • For the following indications, patient has not exceeded a maximum of two (2) years of therapy*:
    • Biliary Tract Cancer
    • Bone Cancer
    • Cervical Cancer
    • Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (first-line therapy)
    • MSI-H/dMMR Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancer (first-line and subsequent therapy)
    • Gastric Cancer (in combination with fluoropyrimidine- and platinum-containing chemotherapy OR ipilimumab)
    • Kaposi Sarcoma
    • Renal Cell Carcinoma (in combination with cabozantinib)
    • Malignant Pleural Mesothelioma (initial therapy in combination with ipilimumab)
    • Malignant Peritoneal Mesothelioma (initial therapy in combination with ipilimumab)
    • Non-Small Cell Lung Cancer (in combination with ipilimumab with or without platinum-doublet chemotherapy)
    • Vulvar Cancer
    • Urothelial Carcinoma (first line systemic therapy in combination with gemcitabine and cisplatin, followed by nivolumab maintenance therapy)

Urothelial Carcinoma (adjuvant therapy)*

  • Patient has not exceeded a maximum of one (1) year of therapy

Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (adjuvant therapy)*

  • Patient has not exceeded a maximum of one (1) year of therapy

MSI-H/dMMR Gastric, Esophageal, and Esophagogastric/Gastroesophageal Junction Cancer (neoadjuvant or perioperative therapy)

  • Patient has not exceeded a maximum of 12 weeks of pre-operative therapy (6 doses), followed by a maximum of 36 weeks (9 doses) of postoperative therapy after surgery

Classical Hodgkin Lymphoma (in combination with brentuximab vedotin)

  • Patient has not exceeded a maximum of 12 weeks of therapy (4 doses)

Classical Hodgkin Lymphoma (in combination with ICE)

  • Patient has not exceeded a maximum of 12 weeks of therapy (6 doses)

Cutaneous Melanoma (adjuvant therapy as a single agent)*

      • Patient has not exceeded a maximum of one (1) year of therapy

Cutaneous Melanoma (adjuvant therapy in combination with ipilimumab)

  • Patient has not exceeded a maximum of four (4) doses

Cutaneous Melanoma (re-induction therapy)

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

Cutaneous Melanoma (neoadjuvant therapy as a single agent)

  • Patient has not exceeded a maximum of four (4) doses

Cutaneous Melanoma (neoadjuvant therapy in combination with ipilimumab)

  • Patient has not exceeded a maximum of three (3) doses

Merkel Cell Carcinoma (neoadjuvant therapy)

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

Non-Small Cell Lung Cancer (neoadjuvant therapy in combination with platinum-doublet chemotherapy)

  • Patient has not exceeded a maximum of three (3) doses

Non-Small Cell Lung Cancer (maintenance therapy)

  • Refer to Section III for criteria

Δ Notes:

  • Patients responding to therapy who relapse ≥ 6 months after discontinuation due to duration (i.e., receipt of 24 months of therapy) are eligible to re-initiate PD-directed therapy.
  • Patients previously presenting with aggressive disease who are exhibiting stable disease on treatment as their best response (or if therapy improved performance status) may be eligible for continued therapy beyond the 24-month limit without interruption or discontinuation.
  • Patients who complete adjuvant therapy and progress ≥ 6 months after discontinuation are eligible to re-initiate PD-directed therapy for metastatic disease.
  • Patients whose tumors, upon re-biopsy, demonstrate a change in actionable mutation (e.g., MSS initial biopsy; MSI-H subsequent biopsy) may be eligible to re-initiate PD-directed therapy and will be evaluated on a case-by-case basis.
  • Patients diagnosed with Renal Cell Carcinoma with clear cell histology who have received previous immuno-oncology therapy may be eligible for treatment with nivolumab as subsequent therapy and will be evaluated on a case-by-case basis.
  1. Dosage/Administration 1,4-6,19,20,27,24,31-42,48-50,52-54,55,58,59,61,65,67,68,71-80-86,87,89,91,93,96

Indication

Dose

Ampullary Adenocarcinoma

Administer 3 mg/kg intravenously every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then 3 mg/kg 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

Biliary Tract Cancers

Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity for up to 24 months (2 years)

Urothelial Carcinoma (Bladder Cancer)

First-line therapy:

  • Administer 360 mg intravenously every 3 weeks for up to 6 cycles (given in combination with gemcitabine and cisplatin), followed by 480 mg intravenously every 4 weeks for a maximum of 2 years of treatment

Disease progression or second-line treatment:

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

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

Bone Cancer

Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity for up to 24 months (2 years)

Adult CNS Cancers

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 every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

Metastases from NSCLC

Single agent:

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

Pediatric CNS Cancers

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

Colorectal Cancer (CRC)

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

  • 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:

Neoadjuvant therapy

  • Administer 3 mg/kg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Primary/initial treatment

  • Administer 3 mg/kg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Subsequent therapy

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

Pediatric patients ≥ 12 years and < 40 kg:

  • Single agent: Administer 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity
  • In combination with ipilimumab:

Neoadjuvant therapy

  • Administer 3 mg/kg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Primary/initial treatment

  • Administer 3 mg/kg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Subsequent therapy

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

Appendiceal 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:

Primary/initial treatment

  • Administer 3 mg/kg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Subsequent therapy

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

Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer (Squamous Cell Carcinoma)

First-line therapy:

  • Administer 240 mg intravenously every 2 weeks or 360 mg intravenously every 3 weeks or 480 mg intravenously every 4 weeks (given in combination with fluoropyrimidine- and platinum-containing chemotherapy) until disease progression or unacceptable toxicity for up to 2 years
  • Administer 3 mg/kg intravenously every 2 weeks or 360 mg intravenously every 3 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity for up to 2 years

Subsequent therapy:

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

Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer (Adjuvant Therapy)

Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks for up to 1 year

MSI-H/dMMR Gastric, Esophageal, and Esophagogastric/ Gastroesophageal Junction Cancer

First-line therapy:

  • Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) for 16 weeks, followed by 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks for a maximum of 2 years of treatment
  • Administer 240 mg intravenously every 2 weeks or 360 mg intravenously every 3 weeks (give in combination with fluoropyrimidine- and platinum-containing chemotherapy) for a maximum of 2 years of treatment

Subsequent therapy:

  • Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) for 16 weeks, followed by 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks for a maximum of 2 years of treatment

Neoadjuvant/perioperative therapy (adenocarcinoma only):

  • Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) for 12 weeks, followed by surgery and then post-operative therapy (See below)

Post-operative therapy (adenocarcinoma only):

  • Administer 480 mg intravenously every 4 weeks for 36 weeks (9 cycles)

Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer (Adenocarcinoma)

First-line therapy:

Administer 240 mg intravenously every 2 weeks or 360 mg intravenously every 3 weeks (give in combination with fluoropyrimidine- and platinum-containing chemotherapy) until disease progression or unacceptable toxicity for up to 2 years

Gastric Cancer

Administer 240 mg intravenously every 2 weeks or 360 mg intravenously every 3 weeks until disease progression or unacceptable toxicity for up to 2 years

Gestational Trophoblastic Neoplasia (GTN)

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

SCCHN

Single agent OR in combination with cisplatin and gemcitabine:

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

In combination with cetuximab:

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

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 every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

Adult cHL

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 brentuximab vedotin

  • Administer 3 mg/kg intravenously every 3 weeks for up to 12 weeks (4 cycles)

In combination with ICE (ifosfamide, carboplatin, and etoposide)

  • Administer 240 mg intravenously every 2 weeks for up to 12 weeks (6 cycles)

Pediatric cHL

Single agent:

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

In combination with brentuximab vedotin

  • Administer 3 mg/kg intravenously every 3 weeks for up to 12 weeks (4 cycles)

Kaposi Sarcoma

Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity for up to 24 months (2 years)

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 every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then follow with the single agent regimen until disease progression or unacceptable toxicity

In combination with cabozantinib (Cabometyx):

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

Malignant Pleural Mesothelioma (MPM) & Malignant Peritoneal Mesothelioma (MPeM)

Single agent:

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

In combination with ipilimumab:

  • Initial Therapy
    • Administer 360 mg intravenously every 3 weeks or 3 mg/kg every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity for up to 2 years
  • Subsequent Therapy
    • Administer 3 mg/kg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity; OR
    • Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Cutaneous Melanoma

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

Single agent

  • Unresectable, limited resectable, or metastatic disease: Administer 240 mg intravenously every 2 weeks or 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity
  • 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
  • Neoadjuvant treatment: Administer 3 mg/kg intravenously every 14 days for 4 doses

In combination with ipilimumab

  • Unresectable or metastatic disease: Administer 1 mg/kg intravenously every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then follow with the single agent regimen
  • Adjuvant treatment: Administer 1 mg/kg intravenously every 3 weeks for 4 doses (given in combination with ipilimumab on the same day)
  • Neoadjuvant treatment: Administer 1 mg/kg intravenously every 3 weeks for up to 3 doses (given in combination with ipilimumab on the same day)

Pediatric patients ≥ 12 years and < 40 kg:

Single agent

  • Unresectable, limited resectable, or metastatic disease: Administer 3 mg/kg intravenously every 2 weeks or 6 mg/kg intravenously every 4 weeks until disease progression or unacceptable toxicity
  • Adjuvant treatment: Administer 3 mg/kg intravenously every 2 weeks or 6 mg/kg intravenously every 4 weeks until disease recurrence or unacceptable toxicity for up to 1 year

In combination with ipilimumab

  • Unresectable or metastatic disease: Administer 1 mg/kg intravenously every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then follow with the single agent regimen
  • Adjuvant treatment: Administer 1 mg/kg intravenously every 3 weeks for 4 doses (given in combination with ipilimumab on the same day)

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 every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity

Merkel Cell Carcinoma

Neoadjuvant treatment:

  • Administer 240 mg intravenously every 2 weeks (days 1 and 15) for a total of 2 doses

M1 disseminated disease:

Single agent:

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

In combination with ipilimumab:

  • Administer 1 mg/kg intravenously every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then follow with the single agent regimen
  • Administer 3 mg/kg intravenously or 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity

Non-Small Cell Lung Cancer (NSCLC)

Neoadjuvant treatment in combination with platinum-doublet chemotherapy:

  • Administer 360 mg intravenously with platinum-doublet chemotherapy every 3 weeks for 3 cycles

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 360 mg intravenously every 3 weeks (given in combination with ipilimumab every 6 weeks) until disease progression or unacceptable toxicity for up to 2 years

In combination with ipilimumab and platinum-doublet chemotherapy:

  • Administer 360 mg intravenously every 3 weeks (given in combination with ipilimumab 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

Pediatric Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

Single agent:

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

In combination with brentuximab vedotin:

  • Administer 3 mg/kg intravenously, with brentuximab vedotin on day 1, 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 every 3 weeks for 4 doses (given in combination with ipilimumab on the same day), then 3 mg/kg or 240 mg intravenously every 2 weeks until disease progression or unacceptable toxicity

SCLC

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

Soft Tissue Sarcoma

Single agent:

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

In combination with ipilimumab:

  • Administer 240 mg intravenously every 2 weeks (given in combination with ipilimumab every 6 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, then 480 mg intravenously every 4 weeks until disease progression or unacceptable toxicity

Vulvar Cancer & Cervical Cancer

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

Thyroid Carcinoma

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

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

Frequency (days)

Dosing (mg/kg)

Weight (kg)

Dose (mg)

14

3

<80

220

<73

200

<66

180

<58

160

<51

140

<44

120

21

4.5

<80

340

<78

320

<73

300

<68

280

<63

260

<58

240

<53

220

<48

200

<44

180

28

6

<80

440

<77

420

<73

400

<69

380

<66

360

<62

340

<58

320

<55

300

<51

280

<47

260

<44

240

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.

  1. Billing Code/Availability Information

HCPCS Code:

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

NDC(s):

  • Opdivo 40 mg/4 mL single-dose vial: 00003-3772-xx
  • Opdivo 100 mg/10 mL single-dose vial: 00003-3774-xx
  • Opdivo 120 mg/12 mL single-dose vial: 00003-3756-xx
  • Opdivo 240 mg/24 mL single-dose vial: 00003-3734-xx
  1. References
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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

C00.9

Malignant neoplasm of lip, unspecified

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

C05.8

Malignant neoplasm of overlapping sites of palate

C05.9

Malignant neoplasm of palate, unspecified

C06.0

Malignant neoplasm of cheek mucosa

C06.2

Malignant neoplasm of retromolar area

C06.80

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

C10.0

Malignant neoplasm of vallecula

C10.1

Malignant neoplasm of anterior surface of epiglottis

C10.2

Malignant neoplasm of lateral wall of oropharynx

C10.3

Malignant neoplasm of posterior wall of oropharynx

C10.4

Malignant neoplasm of branchial cleft

C10.8

Malignant neoplasm of overlapping sites of oropharynx

C10.9

Malignant neoplasm of oropharynx, unspecified

C11.0

Malignant neoplasm of superior wall of nasopharynx

C11.1

Malignant neoplasm of posterior wall of nasopharynx

C11.2

Malignant neoplasm of lateral wall of nasopharynx

C11.3

Malignant neoplasm of anterior wall of nasopharynx

C11.8

Malignant neoplasm of overlapping sites of nasopharynx

C11.9

Malignant neoplasm of nasopharynx, unspecified

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

C16.1

Malignant neoplasm of fundus of stomach

C16.2

Malignant neoplasm of body of stomach

C16.3

Malignant neoplasm of pyloric antrum

C16.4

Malignant neoplasm of pylorus

C16.5

Malignant neoplasm of lesser curvature of stomach, unspecified

C16.6

Malignant neoplasm of greater curvature of stomach, unspecified

C16.8

Malignant neoplasm of overlapping sites of stomach

C16.9

Malignant neoplasm of stomach, unspecified

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

C22.1

Intrahepatic bile duct carcinoma

C22.3

Angiosarcoma of liver

C22.8

Malignant neoplasm of liver, primary, unspecified as to type

C22.9

Malignant neoplasm of liver, not specified as primary or secondary

C23

Malignant neoplasm of gallbladder

C24.0

Malignant neoplasm of extrahepatic bile duct

C24.1

Malignant neoplasm of ampulla of Vater

C24.8

Malignant neoplasm of overlapping sites of biliary tract

C24.9

Malignant neoplasm of biliary tract, unspecified

C30.0

Malignant neoplasm of nasal cavity

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

C40.00

Malignant neoplasm of scapula and long bones of unspecified upper limb

C40.01

Malignant neoplasm of scapula and long bones of right upper limb

C40.02

Malignant neoplasm of scapula and long bones of left upper limb

C40.10

Malignant neoplasm of short bones of unspecified upper limb

C40.11

Malignant neoplasm of short bones of right upper limb

C40.12

Malignant neoplasm of short bones of left upper limb

C40.20

Malignant neoplasm of long bones of unspecified lower limb

C40.21

Malignant neoplasm of long bones of right lower limb

C40.22

Malignant neoplasm of long bones of left lower limb

C40.30

Malignant neoplasm of short bones of unspecified lower limb

C40.31

Malignant neoplasm of short bones of right lower limb

C40.32

Malignant neoplasm of short bones of left lower limb

C40.80

Malignant neoplasm of overlapping sites of bone and articular cartilage of unspecified limb

C40.81

Malignant neoplasm of overlapping sites of bone and articular cartilage of right limb

C40.82

Malignant neoplasm of overlapping sites of bone and articular cartilage of left limb

C40.90

Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb

C40.91

Malignant neoplasm of unspecified bones and articular cartilage of right limb

C40.92

Malignant neoplasm of unspecified bones and articular cartilage of left limb

C41.0

Malignant neoplasm of bones of skull and face

C41.1

Malignant neoplasm of  mandible

C41.2

Malignant neoplasm of vertebral column

C41.3

Malignant neoplasm of ribs, sternum and clavicle

C41.4

Malignant neoplasm of pelvic bones, sacrum and coccyx

C41.9

Malignant neoplasm of bone and articular cartilage, unspecified

C43.0

Malignant melanoma of lip

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

C45.1

Mesothelioma of peritoneum

C45.2

Mesothelioma of pericardium

C45.7

Mesothelioma of other sites

C45.9

Mesothelioma, unspecified

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

C46.0

Kaposi’s sarcoma of skin

C46.1

Kaposi’s sarcoma of soft tissue

C46.2

Kaposi’s sarcoma of palate

C46.3

Kaposi’s sarcoma of lymph nodes

C46.4

Kaposi’s sarcoma of gastrointestinal sites

C46.50

Kaposi’s sarcoma of unspecified lung

C46.51

Kaposi’s sarcoma of right lung

C46.52

Kaposi’s sarcoma of left lung

C46.7

Kaposi’s sarcoma of other sites

C46.9

Kaposi’s sarcoma, unspecified

C47.0

Malignant neoplasm of peripheral nerves of head, face and neck

C47.10

Malignant neoplasm of peripheral nerves of unspecified upper limb, including shoulder

C47.11

Malignant neoplasm of peripheral nerves of right upper limb, including shoulder

C47.12

Malignant neoplasm of peripheral nerves of left upper limb, including shoulder

C47.20

Malignant neoplasm of peripheral nerves of unspecified lower limb, including hip

C47.21

Malignant neoplasm of peripheral nerves of right lower limb, including hip

C47.22

Malignant neoplasm of peripheral nerves of left lower limb, including hip

C47.3

Malignant neoplasm of peripheral nerves of thorax

C47.4

Malignant neoplasm of peripheral nerves of abdomen

C47.5

Malignant neoplasm of peripheral nerves of pelvis

C47.6

Malignant neoplasm of peripheral nerves of trunk, unspecified

C47.8

Malignant neoplasm of overlapping sites of peripheral nerves and autonomic nervous system

C47.9

Malignant neoplasm of peripheral nerves and autonomic nervous system, unspecified

C48.0

Malignant neoplasm of retroperitoneum

C48.1

Malignant neoplasm of specified parts of peritoneum

C48.2

Malignant neoplasm of peritoneum, unspecified

C48.8

Malignant neoplasm of overlapping sites of retroperitoneum and peritoneum

C49.0

Malignant neoplasm of connective and soft tissue of head, face and neck

C49.10

Malignant neoplasm of connective and soft tissue of unspecified upper limb, including shoulder

C49.11

Malignant neoplasm of connective and soft tissue of right upper limb, including shoulder

C49.12

Malignant neoplasm of connective and soft tissue of left upper limb, including shoulder

C49.20

Malignant neoplasm of connective and soft tissue of unspecified lower limb, including hip

C49.21

Malignant neoplasm of connective and soft tissue of right lower limb, including hip

C49.22

Malignant neoplasm of connective and soft tissue of left lower limb, including hip

C49.3

Malignant neoplasm of connective and soft tissue of thorax

C49.4

Malignant neoplasm of connective and soft tissue of abdomen

C49.5

Malignant neoplasm of connective and soft tissue of pelvis

C49.6

Malignant neoplasm of connective and soft tissue of trunk, unspecified

C49.8

Malignant neoplasm of overlapping sites of connective and soft tissue

C49.9

Malignant neoplasm of connective and soft tissue, 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

C53.0

Malignant neoplasm of endocervix

C53.1

Malignant neoplasm of exocervix

C53.8

Malignant neoplasm of overlapping sites of cervix uteri

C53.9

Malignant neoplasm of cervix uteri, 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

C58

Malignant neoplasm of placenta

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

C71.0

Malignant neoplasm of cerebrum, except lobes and ventricles

C71.1

Malignant neoplasm of frontal lobe

C71.2

Malignant neoplasm of temporal lobe

C71.3

Malignant neoplasm of parietal lobe

C71.4

Malignant neoplasm of occipital lobe

C71.5

Malignant neoplasm of cerebral ventricle

C71.6

Malignant neoplasm of cerebellum

C71.7

Malignant neoplasm of brain stem

C71.8

Malignant neoplasm of overlapping sites of brain

C71.9

Malignant neoplasm of brain, unspecified

C72.0

Malignant neoplasm of spinal cord

C72.1

Malignant neoplasm of cauda equina

C72.9

Malignant neoplasm of central nervous system, unspecified

C73

Malignant neoplasm of thyroid gland

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

C79.31

Secondary malignant neoplasm of brain

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7B.1

Secondary Merkel cell carcinoma

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

C85.20

Mediastinal (thymic) large B-cell lymphoma, unspecified site

C85.21

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of head, face and neck

C85.22

Mediastinal (thymic) large B-cell lymphoma, intrathoracic lymph nodes

C85.23

Mediastinal (thymic) large B-cell lymphoma, intra-abdominal lymph nodes

C85.24

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of axilla and upper limb

C85.25

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of inguinal region and lower limb

C85.26

Mediastinal (thymic) large B-cell lymphoma, intrapelvic lymph nodes

C85.27

Mediastinal (thymic) large B-cell lymphoma, spleen

C85.28

Mediastinal (thymic) large B-cell lymphoma, lymph nodes of multiple sites

C85.29

Mediastinal (thymic) large B-cell lymphoma, 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

D37.1

Neoplasm of uncertain behavior of stomach

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

O01.9

Hydatidiform mole, unspecified

Z85.00

Personal history of malignant neoplasm of unspecified digestive organ

Z85.01

Personal history of malignant neoplasm of esophagus

Z85.028

Personal history of other malignant neoplasm of stomach

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.09

Personal history of malignant neoplasm of other digestive organs

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.42

Personal history of malignant neoplasm of other parts of uterus

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

Z85.72

Personal history of non-Hodgkin lymphomas

Z85.820

Personal history of malignant melanoma of skin                                                                     

Z85.821

Personal history of Merkel cell carcinoma

Z85.830

Personal history of malignant neoplasm of bone

Z85.831

Personal history of malignant neoplasm of soft tissue

Z85.841

Personal history of malignant neoplasm of brain                                                                     

Z85.848

848

Personal history of malignant neoplasm of other parts of nervous tissue

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

The preceding information is intended for non-Medicare coverage determinations. 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 Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents: https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

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

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

*Note: The maximum number of doses is dependent on the dosing frequency and duration of therapy. Refer to Section V for exact dosage.

Dosing Frequency

Maximum length of therapy

Maximum number of doses

2 weeks

1 year

26 doses

2 years

52 doses

3 weeks

2 years

35 doses

4 weeks

1 year

13 doses

2 years

26 doses

 

 

 

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