Asset Publisher
Opdivo® (nivolumab)
Policy Number: VP-0226
Intravenous
Last Review Date: 07/02/2024
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, 04/2024, 07/2024
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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. |
- 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 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 or Perioperative Therapy of Gastric 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 two (2) 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 or induction therapy for relieving dysphagia)
- MSI-H/dMMR Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (first-line therapy, subsequent therapy, or induction therapy for relieving dysphagia)
- Gastric Cancer (first-line therapy, subsequent therapy, or early-stage disease following endoscopic resection)
- Kaposi Sarcoma
- Renal Cell Carcinoma (in combination with cabozantinib)
- Pleural Mesothelioma (initial therapy in combination with ipilimumab)**
- Peritoneal Mesothelioma (initial therapy in combination with ipilimumab)**
- Non-Small Cell Lung Cancer (in combination with ipilimumab with or without platinum-doublet chemotherapy)
- Vaginal Cancer
- Vulvar Cancer
- Urothelial Carcinoma (first line therapy in combination with gemcitabine and cisplatin, followed by single-agent maintenance therapy)
** Including pericardial mesothelioma and tunica vaginalis testis mesothelioma
- Dosing Limits
- 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
- Max Units (per dose and over time) [HCPCS Unit]:
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Indication |
Billable Units (BU) |
Per unit time (days) |
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Extranodal NK/T-Cell Lymphoma |
80 billable units |
28 days |
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Biliary, Bone, cHL, Cutaneous Melanoma, Gastric, Gestational Trophoblastic Neoplasia (GTN), Head & Neck, HCC, Kaposi Sarcoma, RCC, Soft Tissue Sarcoma, Thyroid Carcinoma, Vulvar Cancer, Vaginal Cancer, & Cervical Cancer |
1440 billable units |
84 days |
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Anal, Appendiceal, CNS cancers, CRC, Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer, Merkel Cell, PM, PeM, Pericardial Mesothelioma, Tunica Vaginalis Testis Mesothelioma, PMBCL, NSCLC, SCLC, Small Bowel |
2040 billable units |
84 days |
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Uveal Melanoma |
6960 billable units |
84 days |
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Endometrial Carcinoma |
Initial 340 billable units |
14 days x 8 doses |
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Maintenance 480 billable units |
28 days |
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Ampullary Adenocarcinoma |
Initial 340 billable units |
21 days x 4 doses |
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Maintenance 680 billable units |
28 days |
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Urothelial Carcinoma (Bladder Cancer) |
Initial 360 billable units |
21 days x 6 doses |
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Maintenance 480 billable units |
28 days |
- Initial Approval Criteria 1
Coverage is provided for the following conditions:
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- 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, tislelizumab, 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 in combination with ipilimumab; AND
- Used as subsequent treatment for progression on or after systemic treatment for unresectable, resected gross residual (R2), or metastatic disease; AND
- Disease is refractory to standard therapies or there are no standard treatment options available; OR
- Used as subsequent treatment for progression on or after systemic treatment for unresectable, resected gross residual (R2), or metastatic disease; AND
- Used as neoadjuvant therapy for resectable locoregionally advanced disease (**NOTE: Only applies to Gallbladder Cancer); AND
- Patient has incidental finding of suspicious mass during surgery where hepatobiliary surgery expertise is unavailable; OR
- Patient has incidental finding on pathologic review (cystic duct node positive); OR
- Patient has mass on imaging
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:
- Used for disease that progressed during or following platinum-containing chemotherapy* OR as second-line treatment after chemotherapy other than a platinum; AND
- 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 as adjuvant therapy †; AND
- 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:
- Used as first-line systemic therapy in cisplatin eligible patients*; AND
- Locally advanced, unresectable, 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
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* Note: 10,51,60,70
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** Note: 1,62
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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 for isolated pelvic/anastomotic recurrence of rectal cancer; 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)
- Used as subsequent therapy; AND
* 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
- Patient has squamous cell carcinoma †; 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
- Patient is not a surgical candidate or has unresectable advanced, recurrent, or metastatic disease; AND
- Patient has adenocarcinoma; AND
- 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
- Patient has squamous cell carcinoma; 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; OR
- Used as induction systemic therapy for relieving dysphagia; AND
- Patient is medically fit and planned for esophagectomy with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3 cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N 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 in combination with oxaliplatin and capecitabine or fluorouracil; 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
- Tumor expresses PD-L1 (e.g., CPS ≥5) as determined by an FDA-approved or CLIA-compliant testv
- 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 in combination with ipilimumab; AND
- Patient is medically fit and planned for esophagectomy with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3 cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease; AND
*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
- Used in combination with fluoropyrimidine- and platinum-containing chemotherapy*; OR
- 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
- 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 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; OR
- Used as systemic therapy for early-stage disease; AND
- Patient has endoscopic features suggestive of deep submucosal invasion including converging folds, irregular surface pattern, and ulceration in a large gastric mass with favorable histology; AND
- Patient has completed an endoscopic resection; AND
- Used in combination with ipilimumab; OR
- 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 in combination with oxaliplatin and fluorouracil or capecitabine; 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
- Tumor expresses PD-L1 (e.g., CPS ≥5) as determined by an FDA-approved or CLIA-compliant testv
- 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 systemic therapy for early-stage disease; AND
- Used as postoperative management following R0 resection in patients who have received preoperative therapy with nivolumab and ipilimumab; OR
- Used as a single agent; AND
*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)
- Patient has intermediate placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT); AND
Squamous Cell Carcinoma of the Head and Neck (SCCHN) † ‡ 1,2,29,78
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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:
- Patient has nasopharyngeal cancer; AND
- 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 NON-nasopharyngeal cancer; 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:
- Used in combination with cetuximab for patients with performance status (PS) 0-1; AND
- 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 as subsequent therapy; AND
- Used as single agent or in combination with ipilimumab; AND
- Used for one of the following:
- Patient was previously treated with sorafenib (for use in combination with ipilimumab ONLY) †
- Patient has liver-confined, unresectable disease and deemed ineligible for transplant
- Patient has extrahepatic/metastatic disease and deemed ineligible for resection, transplant, or locoregional therapy
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; 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)
- Used as subsequent therapy (if not previously used); AND
* 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
- Patient has clear cell histology; AND
- 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
- Patient has clear cell histology; AND
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 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
- Patient is at least 12 years of age; 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
- Used as a single agent; 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
- 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
- Patient has oligometastatic disease and NED following metastasis-directed therapy (i.e., T-VEC/intralesional therapy, 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; OR
- Used in combination with ipilimumab; AND
- Used as neoadjuvant therapy; AND
- Used as a single agent or in combination with ipilimumab; AND
- Patient has stage III disease; AND
- Used as a single agent or in combination with ipilimumab; 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, as well as unresectable/borderline resectable 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 feasible; OR
- Patient has primary clinical N+, M0 regional disease with biopsy positive draining nodal basin; OR
- Used as a single agent; AND
- 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
Peritoneal Mesothelioma (PeM)* ‡ 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
- Used as adjuvant treatment for medically operable disease following cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC); AND
- Patient has unicavitary disease with epithelioid histology; AND
- 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 or bicavitary disease
*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
Pleural Mesothelioma (PM)* † ‡ 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) 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
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/WDLPS) of the extremity, abdominal wall, trunk that was initially diagnosed as ALT/WDLPS and shows evidence of de-differentiation, treat as other soft tissue sarcomas.
**For well-differentiated liposarcoma (WDLPS-retroperitoneum, paratesticular) with or without evidence of de-differentiation, treat as other soft tissue sarcomas.
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 ‡ 2,94,95,96
- Used as a single agent; AND
- Used for stage IVC (metastatic) anaplastic carcinoma
Vaginal Cancer ‡ 2,49,97
- Used as subsequent therapy as 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
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 |
|
|
|
|
|
ALK rearrangement-positive tumors |
ROS1 rearrangement-positive tumors |
BRAF V600E-mutation positive tumors |
ERBB2 (HER2) mutation positive tumors |
|
|
|
|
|
PD-L1 tumor |
MET exon-14 skipping mutations |
RET rearrangement-positive tumors |
KRAS G12C mutation positive tumors |
|
|
|
|
- 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 or induction therapy for relieving dysphagia)
- MSI-H/dMMR Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (first-line therapy, subsequent therapy, or induction therapy for relieving dysphagia)
- Gastric Cancer (first-line therapy, subsequent therapy, or early-stage disease following endoscopic resection)
- Kaposi Sarcoma
- Renal Cell Carcinoma (in combination with cabozantinib)
- Pleural Mesothelioma (initial therapy in combination with ipilimumab)**
- Peritoneal Mesothelioma (initial therapy in combination with ipilimumab)**
- Non-Small Cell Lung Cancer (in combination with ipilimumab with or without platinum-doublet chemotherapy)
- Vaginal Cancer
- Vulvar Cancer
- Urothelial Carcinoma (first line therapy in combination with gemcitabine and cisplatin, followed by single-agent maintenance therapy)
** Including pericardial mesothelioma and tunica vaginalis testis mesothelioma
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 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
Gastric 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 two (2) 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:
|
- Dosage/Administration ∆ 1,4-6,19,20,27,24,31-42,48-50,52-54,55,58,59,61,65,67,68,71-80-86,87,89,91,93,96,98-100
|
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:
Disease progression or second-line treatment:
Adjuvant treatment:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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:
In combination with ipilimumab:
Metastases from NSCLC Single agent:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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:
Neoadjuvant therapy
Primary/initial treatment
Subsequent therapy
Pediatric patients ≥ 12 years and < 40 kg:
Neoadjuvant therapy
Primary/initial treatment
Subsequent therapy
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Appendiceal Adenocarcinoma |
Primary/initial treatment
Subsequent therapy
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer |
First-line therapy (squamous cell carcinoma only):
First-line therapy (adenocarcinoma only):
Subsequent therapy (squamous cell carcinoma only):
Adjuvant therapy:
Induction therapy for relieving dysphagia
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
MSI-H/dMMR Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer |
First-line therapy:
Subsequent therapy:
Neoadjuvant/perioperative therapy:
Post-operative therapy:
Induction therapy for relieving dysphagia:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Gastric Cancer |
First-line therapy:
Subsequent therapy:
Neoadjuvant/perioperative therapy:
Post-operative therapy:
Early-stage disease following endoscopic resection:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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:
In combination with cetuximab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Hepatocellular Carcinoma (HCC) |
Single agent:
In combination with ipilimumab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adult cHL |
Single agent:
In combination with brentuximab vedotin
In combination with ICE (ifosfamide, carboplatin, and etoposide)
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Pediatric cHL |
Single agent:
In combination with brentuximab vedotin
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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:
In combination with ipilimumab:
In combination with cabozantinib (Cabometyx):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Pleural Mesothelioma (PM) & Peritoneal Mesothelioma (PeM) (including pericardial mesothelioma and tunica vaginalis testis mesothelioma) |
Single agent:
In combination with ipilimumab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Cutaneous Melanoma |
Adult patients and pediatric patients ≥ 12 years and ≥ 40 kg: Single agent
In combination with ipilimumab
Pediatric patients ≥ 12 years and < 40 kg: Single agent
In combination with ipilimumab
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Uveal Melanoma |
Single agent:
In combination with ipilimumab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Merkel Cell Carcinoma |
Neoadjuvant treatment:
M1 disseminated disease: Single agent:
In combination with ipilimumab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Non-Small Cell Lung Cancer (NSCLC) |
Neoadjuvant treatment in combination with platinum-doublet chemotherapy:
Single agent:
In combination with ipilimumab:
In combination with ipilimumab and platinum-doublet chemotherapy:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Pediatric Primary Mediastinal Large B-Cell Lymphoma (PMBCL) |
Single agent:
In combination with brentuximab vedotin:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Small Bowel Adenocarcinoma |
Single agent:
In combination with ipilimumab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
SCLC |
Administer 3 mg/kg intravenously every 2 weeks until disease progression or unacceptable toxicity |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Soft Tissue Sarcoma |
Single agent:
In combination with ipilimumab:
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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, Vaginal 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:
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. |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
- 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
- References
- Opdivo [package insert]. Princeton, NJ; Bristol-Myers Squibb Company; March 2024. Accessed June 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) nivolumab. National Comprehensive Cancer Network, 2024. 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 June 2024.
- 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.
- Walocko FM, Scheier BY, Harms PW, et al. Metastatic Merkel cell carcinoma response to nivolumab. J Immunother Cancer. 2016 Nov 15;4:79.
- 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.
- 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.
- 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.
- 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.
- 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.
- Gupta S, Bellmunt J, Plimack ER, et al. Defining “platinum-ineligible” patients with metastatic urothelial cancer (mUC). J Clin Oncol. 2022 June 1;40(16_suppl):4577.
- Hellmann MD, Ciuleanu TE, Pluzanski A, et al. Nivolumab plus ipilimumab in lung cancer with a high tumor mutational burden. N Engl J Med 2018; 378:2093-2104.
- Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
- Hematology/Oncology Pharmacy Association (2019). Intravenous Cancer Drug Waste Issue Brief. Retrieved from http://www.hoparx.org/images/hopa/advocacy/Issue-Briefs/Drug_Waste_2019.pdf
- Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
- Weber JS, D’Angelo SP, Minor D, et al. Nivolumab versus chemotherapy in patients with advanced melanoma who progressed after anti-CTLA-4 treatment (CheckMate 037): a randomised, controlled, open-label, phase 3 trial. Lancet Oncol. 2015 Apr;16(4):375-84. Doi: 10.1016/S1470-2045(15)70076-8. Epub 2015 Mar 18.
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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 |
|
C52 |
Malignant neoplasm of vagina |
|
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 |
|
Z85.820 |
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 |
|
M (11) |
NC, SC, WV, VA (excluding below) |
Palmetto GBA |
|
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 |