vp-0209
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Keytruda® (pembrolizumab) (Intravenous)

Policy Number: VP-0209

Last Review Date: 08/03/2021

Date of Origin: 09/30/2014

Dates Reviewed: 09/2014, 03/2015, 05/2015, 08/2015, 10/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 12/2016, 02/2017, 03/2017, 05/2017, 08/2017, 10/2017, 02/2018, 05/2018, 06/2018, 07/2018, 09/2018, 12/2018, 01/2019, 03/2019, 05/2019, 06/2019, 07/2019, 08/2019, 10/2019, 12/2019, 02/2020, 06/2020, 07/2020, 08/2020, 11/2020, 12/2020, 03/2021, 04/2021, 06/2021, 08/2021

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.

I. Length of Authorization 1-3,5,15-17,69

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

  • Anal, Bladder Cancer/Urothelial Carcinoma, Cervical, cHL, CNS metastases, Cutaneous Melanoma (in combination with ipilimumab), cSCC, Endometrial Carcinoma, Esophageal, GEJ, Gastric, HCC, MPM, MCC, MSI-H/dMMR Cancer, Mycosis Fungoides/Sezary Syndrome, NSCLC, PMBCL, RCC, SCCHN, Thymic Carcinoma, TMB-H Cancer, TNBC (recurrent unresectable or metastatic disease), Uveal Melanoma, and Vulvar can be authorized up to a maximum of twenty-four (24) months of therapy.
  • Adjuvant therapy in Cutaneous Melanoma can be authorized up to a maximum of twelve (12) months of therapy.
  • Neoadjuvant therapy in TNBC can be authorized up to a maximum of twenty-four (24) weeks of therapy.
  • Adjuvant therapy in TNBC can be authorized up to a maximum of twenty-seven (27) weeks of therapy.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Keytruda 100 mg/4 mL single use vial: 11 vials per 14 day supply
  1. Max Units (per dose and over time) [HCPCS Unit]:

Indication

Billable Units (BU)

Per unit time (days)

Adrenal Gland Tumors (that is not MSI-H/dMMR), Bladder/Urothelial, Cervical, cHL, cSCC, Cutaneous Melanoma, Endometrial Carcinoma (that is not MSI-H/dMMR), Esophageal, GEJ, Gastric, Gestational Trophoblastic Neoplasia, HCC, MCC, MSI-H/dMMR, NSCLC, PMBCL, RCC, SCCHN, Soft Tissue Sarcoma, Thymic, TMB-H Cancer, TNBC, & Vulvar

200 BU

21 days

CNS metastases & MPM

1150 BU

14 days

Anal Carcinoma, MF/SS, NK/T-Cell Lymphoma, & Uveal Melanoma

250 BU

21 days

III. Initial Approval Criteria 1,2

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

Coverage is provided in the following conditions:

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

Universal Criteria

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

Cutaneous Melanoma † ‡ Ф 1,2,22-24

  • Used as first-line therapy as a single agent for unresectable or metastatic* disease; OR
  • Used as subsequent therapy for unresectable or metastatic* disease after disease progression or maximum clinical benefit from BRAF targeted therapy (e.g., dabrafenib/trametinib, vemurafenib/cobimetinib, encorafenib/binimetinib, etc.); AND
    • Used as a single agent; AND
    • Anti-PD-1 immunotherapy was not previously used; OR
    • Used as re-induction therapy in patients who experienced disease control (i.e., complete response, partial response, or stable disease with no residual toxicity) from prior anti-PD-1 immunotherapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR
    • Used in combination with ipilimumab; AND
    • Used after progression on single-agent anti-PD-1 immunotherapy and combination ipilimumab/anti-PD-1 immunotherapy not previously used; OR
    • Used as re-induction therapy in patients who experienced disease control (i.e., complete response, partial response, or stable disease with no residual toxicity) from prior combination ipilimumab/anti-PD-1 immunotherapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR
  • Used as a single agent for adjuvant treatment; AND
    • Patient has lymph node involvement and has undergone complete resection, complete lymph node dissection (CLND), therapeutic lymph node dissection (TLND), or nodal basin ultrasound surveillance; OR
    • Patient has satellite/in-transit metastases or recurrence and has no evidence of disease after complete excision; OR
    • Patient has undergone TLND and/or complete resection of nodal recurrence; OR
    • Patient has undergone complete resection of distant metastatic disease

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

Uveal Melanoma ‡ 2,53,54

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

Gastric Cancer † ‡ Ф 1,2,39,67

  • Patient is not a surgical candidate or has unresectable, recurrent, locally advanced, or metastatic disease; AND
  • Patient has adenocarcinoma; AND
  • Used as a single agent; AND
    • Tumor expresses PD-L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA-approved or CLIA compliant testv; AND
    • Patient progressed on or after at least two prior systemic treatments; OR
  • Used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy; AND
    • Used as first-line therapy for HER2-positive disease

Esophageal or Gastroesophageal Junction Cancer † ‡ Ф 1,2,39,40,41,66,67

  • Patient is not a surgical candidate or has unresectable, recurrent, locally advanced, or metastatic disease; AND
    • Used in combination with platinum- and fluoropyrimidine-based chemotherapy ; AND
    • Used as first-line therapy; OR
    • Used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy (GEJ cancer only) ; AND
    • Used as first-line therapy for HER2-positive disease; AND
    • Patient has adenocarcinoma; OR
    • Used as a single agent; AND
    • Patient has squamous cell carcinoma ; AND
      • Tumor expresses PD-L1 (CPS ≥ 10) as determined by an FDA-approved or CLIA compliant testv; AND
      • Patient progressed on or after at least one prior systemic treatment; OR
    • Patient has adenocarcinoma; AND
      • Tumor expresses PD-L1 (CPS ≥ 1) as determined by an FDA-approved or CLIA compliant testv; AND
      • Patient progressed on or after at least two prior systemic treatments

Merkel Cell Carcinoma (MCC) † ‡ Ф 1,2,44

  • Patient is at least 6 months of age; AND
  • Used as a single agent; AND
    • Patient has recurrent disease AND both curative surgery and curative radiation therapy are not feasible ; OR
    • Patient has recurrent locally advanced or metastatic disease

Non-Small Cell Lung Cancer (NSCLC) † ‡ 1,2,25-29

  • Used for stage III disease; AND
    • Used as first-line therapy as a single-agent in patients who are not candidates for surgical resection or definitive chemoradiation with tumors that are expressing PD-L1 (TPS ≥1%) as determined by an FDA-approved or CLIA compliant testv and with no EGFR or ALK genomic tumor aberrations ; 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:
        • PD-L1 expression-positive (TPS ≥1%) tumors, as detected by an FDA or CLIA compliant testv, that are negative for actionable molecular markers*
        • Patients with performance status (PS) 0-1 who have tumor that are negative for actionable molecular markers* and PD-L1 expression <1%
        • Patients with PS 0-1 who are positive for one of the following molecular markers: BRAF V600E mutation, NTRK1/2/3 gene fusion, or MET exon 14 skipping mutation; AND
    • Used in combination with pemetrexed AND either carboplatin or cisplatin for non-squamous cell histology; OR
    • Used in combination with carboplatin AND either paclitaxel or albumin-bound paclitaxel for squamous cell histology; OR
    • Used as single agent therapy (for PD-L1 expression-positive tumors ONLY) ; OR
    • Used as subsequent therapy; AND
    • Used in patients with tumors expressing PD-L1 (TPS ≥1%) as determined by an FDA-approved or CLIA compliant testv; AND
      • Used as single agent therapy ; OR
    • Used for one of the following:
        • Patients with PS 0-1 who have ROS1 rearrangement-positive tumors and prior targeted therapy§
        • Patients with PS 0-1 who are positive for one of the following molecular markers: BRAF V600E mutations, NTRK1/2/3 gene fusions, or MET exon 14 skipping mutation; AND
      • Used in combination with carboplatin AND either paclitaxel or albumin-bound paclitaxel for squamous cell histology; OR
      • Used in combination with pemetrexed AND either carboplatin or cisplatin for non-squamous cell histology; OR
    • Used as continuation maintenance therapy in patients who have achieved tumor response or stable disease following initial therapy; AND
    • Used in combination with pemetrexed following a first-line pembrolizumab/pemetrexed/ (carboplatin or cisplatin) regimen for disease of non-squamous cell histology; OR
    • Used as a single agent following a first-line pembrolizumab/carboplatin/ (paclitaxel or albumin-bound paclitaxel) regimen for disease of squamous cell histology; OR
    • Used as a single agent following a first-line pembrolizumab monotherapy regimen

Note:  If there is insufficient tissue to allow for testing of EGFR and ALK and repeat tissue biopsy is contraindicated, circulating tumor DNA testing with a limited panel such as the Cobas EGFR Mutation Test may be undertaken. However, if EGFR and ALK status is unknown, patients may be treated as though they are EGFR and ALK negative.

* Note: Actionable molecular genomic biomarkers include EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET exon 14 skipping mutation, and RET rearrangement. If there is insufficient issue to allow testing for all of EGFR, ALK, ROS1, BRAF, NTRK1/2/3, MET and RET, repeat biopsy and/or plasma testing should be done. If these are not feasible, treatment is guided by available results and, if unknown, these patients are treated as though they do not have driver oncogenes.

 

Squamous Cell Carcinoma of the Head and Neck (SCCHN) † ‡ 1,2,31,32

  • Used as first-line therapy; AND
    • Patient is unfit for surgery or has locally advanced, unresectable, recurrent/persistent, or metastatic disease; AND
      • Used as a single-agent for tumors expressing PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; OR
      • Used in combination with fluorouracil and a platinum chemotherapy agent; OR
  • Used as subsequent therapy; AND
    • Patient has locally advanced, unresectable, recurrent/persistent, or metastatic disease; AND
      • Used as a single-agent therapy for disease that has progressed on or after platinum-containing chemotherapy; OR
      • Used in combination with fluorouracil and either carboplatin or cisplatin in patients with non-nasopharyngeal disease and performance status 0-1

Adult Classical Hodgkin Lymphoma (cHL) Ф 1,2,33,61

  • Used as a single agent for relapsed or refractory disease

Pediatric Classical Hodgkin Lymphoma † ‡ Ф 1,2,33,61

  • Patient is at least 6 months of age*; AND
  • Used as a single agent; AND
    • Patient has refractory disease ; OR
    • Patient has relapsed disease after two or more prior lines of therapy ; OR
    • Used in patients heavily pretreated with platinum or anthracycline-based chemotherapy; OR
    • Used as subsequent therapy in patients with an observed decrease in cardiac function

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

Primary Mediastinal Large B-Cell Lymphoma (PMBCL) † ‡ Ф 1,2,34

  • Patient is at least 6 months of age; AND
  • Used as single agent; AND
  • Patient has relapsed or refractory disease; AND
  • Patient does not require urgent cytoreductive therapy

Urothelial Carcinoma (Bladder Cancer) † 1,2,8,35-37

  • Used as a single agent; AND
    • Patient has Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) defined as one of the following:
        • Persistent disease despite adequate BCG therapy**; OR
        • Disease recurrence after an initial tumor free state following an adequate BCG course of therapy**; OR
        • T1 disease following a single induction course of BCG therapy; AND
      • Patient has carcinoma in situ (CIS); AND
      • Patient is ineligible for or has elected not to undergo cystectomy; OR
      • Patient has one of the following diagnoses:
        • Locally advanced or metastatic urothelial carcinoma; OR
        • Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder; OR
        • Metastatic or local bladder cancer recurrence post-cystectomy; OR
        • Primary carcinoma of the urethra; AND
        • Used for metastatic or recurrent disease (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes); OR
        • Used for clinical stage T3-4 cN1-2 disease or cN1-2 palpable inguinal lymph nodes (first-line therapy only); OR
        • Metastatic upper genitourinary (GU) tract tumors; OR
        • Metastatic urothelial carcinoma of the prostate; AND
      • Used for disease that progressed during or following platinum-containing chemotherapy*; OR
      • Used as second-line treatment after therapy other than a platinum or an immune checkpoint inhibitor; OR
      • Used as first-line therapy in cisplatin-ineligible patients*; AND
      • Patient is carboplatin-ineligible*; OR
      • Tumors express PD-L1 (CPS ≥10) as determined by an FDA-approved or CLIA-compliant testv

** Adequate BCG therapy is defined as administration of at least five of six doses of an initial induction course AND at least two of three doses of maintenance therapy or at least two of six doses of a second induction course.

* Note:10,18

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

Cervical Cancer † ‡ 1,2,42

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

Microsatellite Instability-High (MSI-H) Cancer † ‡ 1,2,4,38,51

  • Patient is at least 6 months of age; AND
  • Used as a single agent; AND
  • Patient’s disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND
  • Pediatric patients must not have a diagnosis of MSI-H central nervous system cancer; AND
  • Patient has one of the following cancers:
    • Colorectal Cancer
      • Used as primary treatment of unresectable or medically inoperable, locally advanced, or metastatic disease (excluding use as neoadjuvant therapy in rectal cancer); OR
      • Used for unresectable (or medically inoperable) metastases that remain unresectable after primary systemic therapy; OR
      • Used for unresectable, advanced, or metastatic disease that has progressed following treatment with one of the following:
        • Fluoropyrimidine, oxaliplatin, and/or irinotecan-based chemotherapy; OR
        • Non-intensive therapy
    • Pancreatic Adenocarcinoma
      • Used as subsequent therapy for locally advanced or metastatic disease after progression; OR
      • Used for recurrent or metastatic disease after resection; OR
      • Used as first-line therapy for metastatic disease in patients with poor performance status (i.e., ECOG ≥2)
    • Bone Cancer (Ewing Sarcoma, Chondrosarcoma [excluding dedifferentiated or mesenchymal subtypes], or Osteosarcoma [excluding high-grade undifferentiated pleomorphic sarcoma])
      • Used for unresectable or metastatic disease that has progressed following prior treatment; AND
      • Patient has no satisfactory alternative treatment options
    • Gastric Adenocarcinoma OR Esophageal/Gastroesophageal Junction Adenocarcinoma or Squamous Cell Carcinoma
      • Used as subsequent therapy for patients who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease
    • Ovarian Cancer (epithelial ovarian, fallopian tube, and primary peritoneal cancers)
      • Patient has carcinosarcoma (i.e., malignant mixed Müllerian tumor [MMMT]), clear cell, endometrioid, mucinous, or serous histology; AND
      • Used for patients with persistent or recurrent disease; AND
      • Patient is not experiencing an immediate biochemical relapse (i.e., rising CA-125 with no radiographic evidence of disease)
    • Uterine Cancer (endometrial carcinoma)
      • Used as second-line therapy for recurrent, metastatic, or high-risk disease that has progressed following prior treatment
    • Penile Cancer
      • Used as subsequent treatment for unresectable or metastatic disease that has progressed following prior treatment; AND
      • Patient has no satisfactory alternative treatment options
    • Testicular Cancer
      • Used as third-line therapy
    • Hepatobiliary Adenocarcinoma (gallbladder cancer, intra-/extra-hepatic cholangiocarcinoma)
      • Used as primary treatment for unresectable or metastatic disease; OR
      • Used for unresectable or metastatic disease that has progressed following prior treatment
    • Vulvar Squamous Cell Carcinoma
      • Used for advanced, recurrent, or metastatic disease as second-line therapy
    • Cervical Cancer
      • Used as second-line therapy for persistent, recurrent, or metastatic disease
    • Small Bowel Adenocarcinoma or Advanced Ampullary Cancer
      • Used for advanced or metastatic disease; AND
      • Used as initial therapy; OR
      • Used as subsequent therapy in patients without a contraindication to oxaliplatin
    • Breast Cancer
  • Used for recurrent unresectable or metastatic disease OR inflammatory breast cancer with no response to preoperative systemic therapy; AND
  • Patient has progressed following prior treatment; AND
  • Patient has no satisfactory alternative treatment options
    • Occult Primary/Cancer of Unknown Primary (CUP)
      • Used in symptomatic patients with PS 1-2 OR asymptomatic patients with PS 0 and aggressive disease; AND
      • Patient has adenocarcinoma or carcinoma not otherwise specified; AND
      • Patient has one of the following:
      • Axillary involvement in men if clinically indicated
      • Lung nodules or breast marker-negative pleural effusion
      • Resectable liver disease
      • Peritoneal mass or ascites with non-ovarian histology
      • Retroperitoneal mass of non-germ cell histology in selected patients
      • Unresectable liver disease or disseminated metastases
    • Very Advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN)
      • Patient has non-nasopharyngeal cancer; AND
      • Patient is unfit for surgery or has locally advanced, unresectable, recurrent/persistent, or metastatic disease
    • Prostate Cancer
      • Patient has castration-resistant metastatic disease; AND
      • Patient will continue androgen deprivation therapy (ADT); AND
      • Patient received prior docetaxel and no prior novel hormone therapy; OR
      • Patient received prior novel hormone therapy and no prior docetaxel; OR
      • Patient received prior docetaxel and prior novel hormone therapy (excluding patients with visceral metastases)
    • Neuroendocrine Tumors (Poorly differentiated neuroendocrine carcinoma, poorly differentiated unknown primary, or large or small cell carcinoma [other than lung])
      • Patient progressed following prior treatment and has no satisfactory alternative treatment options

Vulvar Squamous Cell Carcinoma 2

  • Used as a single agent; AND
  • Patient has advanced, recurrent, or metastatic disease; AND
  • Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used as second-line therapy for disease progression on or after chemotherapy

Thymic Carcinoma 2,16,17

  • Used as a single agent; AND
    • Used as first line therapy for unresectable, locally advanced, or metastatic disease in patients who are unable to tolerate first-line combination regimens; OR
    • Used as postoperative treatment in patients who are unable to tolerate first-line combination regimens; OR
    • Used as second-line therapy for unresectable or metastatic disease

Malignant Pleural Mesothelioma (MPM) ‡ 2,3

  • Used as subsequent therapy as a single agent

Central Nervous System (CNS) Cancer 2,47,50

  • Used as single agent therapy; AND
  • Primary tumor is due to melanoma or PD-L1 positive non-small cell lung cancer (NSCLC); AND
    • Used as initial treatment in patients with small asymptomatic brain metastases; OR
    • Used for relapsed disease in patients with limited brain metastases and stable systemic disease or reasonable treatment options; OR
    • Patient has recurrent limited brain metastases; OR
    • Used for recurrent disease in patients with extensive brain metastases and stable systemic disease or reasonable systemic treatment options

T-Cell Lymphoma/Extranodal NK 2,48

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

Anal Carcinoma ‡ 2,5,52

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

Gestational Trophoblastic Neoplasia ‡ 2,12

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

Hepatocellular Carcinoma (HCC) † Ф 1,43

  • Used as a single agent; AND
  • Patient was previously treated with sorafenib; AND
  • Patient has Child-Pugh Class A liver impairment (i.e., excluding Child-Pugh Class B and C)

Mycosis Fungoides/Sezary Syndrome ‡ 2,15

  • Used as primary therapy OR for relapsed or persistent disease; AND
    • Patient has stage III Mycosis Fungoides; OR
    • Patient has stage IV Sezary Syndrome; OR
  • Used for disease refractory to multiple previous therapies

Renal Cell Carcinoma (RCC) † ‡ 1,2,45

  • Patient has clear cell histology; AND
    • Used in combination with axitinib; AND
      • Used as first-line therapy for advanced, relapsed, or stage IV disease; OR
      • Used as subsequent therapy for relapsed or stage IV disease; OR
    • Used in combination with lenvatinib ; AND
      • Used for relapsed or stage IV disease; OR
  • Patient has non-clear cell histology; AND
    • Used as a single agent for relapsed or stage IV disease

Endometrial Carcinoma (Uterine Cancer) † ‡ 1,2,46

  • Patient has advanced or recurrent disease; AND
  • Disease has progressed following prior systemic therapy; AND
  • Patient is not a candidate for curative surgery or radiation; AND
  • Used in combination with lenvatinib

Soft Tissue Sarcoma ‡ 2

  • Used as a single agent; AND
      • Patient has alveolar soft part sarcoma (ASPS); OR
      • Patient has cutaneous angiosarcoma; OR
      • Patient has myxofibrosarcoma, undifferentiated pleomorphic sarcoma (UPS), or undifferentiated sarcoma (Retroperitoneal/Intra-Abdominal or Extremity/Body Wall, Head/Neck soft tissue sarcomas); AND
      • Used as subsequent therapy for advanced or metastatic disease

Tumor Mutational Burden-High (TMB-H) Cancer † ‡ 1,2

  • Patient is at least 6 months of age; AND
  • Patient has solid tumors that are tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] as determined by an FDA-approved or CLIA-compliant testv; AND
  • Used as a single agent; AND
  • Pediatric patients must not have a diagnosis of TMB-H central nervous system cancer; AND
  • Patient has one of the following cancers:
    • Bone Cancer (Ewing Sarcoma, Chordoma [chondroid or conventional histology], Chondrosarcoma [excluding dedifferentiated or mesenchymal subtypes], or Osteosarcoma [excluding undifferentiated pleomorphic sarcoma])
      • Patient has unresectable or metastatic disease that progressed following prior treatment; AND
      • Patient has no satisfactory alternative treatment options
    • Breast Cancer
      • Patient has recurrent unresectable or metastatic disease OR inflammatory breast cancer with no response to preoperative systemic therapy; AND
      • Patient has progressed following prior treatment; AND
      • Patient has no satisfactory alternative treatment options
    • Cervical Cancer
      • Used as second-line therapy for unresectable or metastatic disease; AND
      • Patient has no satisfactory alternative treatment options
    • Gastric Adenocarcinoma OR Esophageal/Gastroesophageal Junction Adenocarcinoma or Squamous Cell Carcinoma
      • Used as subsequent therapy for patients who are not surgical candidates or have unresectable locally advanced, recurrent, or metastatic disease
    • Hepatobiliary Adenocarcinoma (gallbladder cancer, intra-/extra-hepatic cholangiocarcinoma)
      • Used for unresectable or metastatic disease that has progressed following prior treatment
    • Salivary Gland Tumors
      • Used for recurrent metastatic disease in patients with a PS 0-3; OR
      • Used for unresectable locoregional recurrence or second primary with prior radiation therapy
    • Thyroid Carcinoma
      • Anaplastic Carcinoma
  • Used as first- or second-line therapy for metastatic disease
      • Follicular Carcinoma, Papillary Carcinoma, Hürthle Cell Carcinoma
  • Patient has unresectable locoregional recurrent/persistent or metastatic disease not amenable to radioactive iodine (RAI) therapy
      • Medullary Carcinoma
  • Patient has unresectable locoregional or recurrent/persistent metastatic disease
    • Uterine Cancer (uterine sarcoma [excluding low-grade endometrial stromal sarcoma], endometrial carcinoma)
      • Used as second-line therapy for unresectable or metastatic disease that progressed following prior treatment; AND
      • Patient has no satisfactory alternative treatment options
    • Vulvar Squamous Cell Carcinoma
      • Used for advanced, recurrent, or metastatic disease as second-line therapy; AND
      • Patient has no satisfactory alternative treatment options
    • Testicular Cancer
      • Used as third-line therapy
    • Occult Primary/Cancer of Unknown Primary (CUP)
      • Used in symptomatic patients with PS 1-2 OR asymptomatic patients with PS 0 and aggressive disease; AND
        • Patient has squamous cell carcinoma; AND
    • Patient has multiple lung nodules, pleural effusion, or disseminated metastases; OR
        • Patient has adenocarcinoma or carcinoma not otherwise specified; AND
    • Patient has one of the following:
          • Axillary involvement in men if clinically indicated
          • Lung nodules or breast marker-negative pleural effusion
          • Resectable liver disease
          • Peritoneal mass or ascites with non-ovarian histology
          • Retroperitoneal mass of non-germ cell histology in selected patients
          • Unresectable liver disease or disseminated metastases
    • Ovarian Cancer (epithelial ovarian, fallopian tube, and primary peritoneal cancers)
      • Patient has carcinosarcoma (i.e., malignant mixed Mullerian tumor [MMMT]), clear cell, endometrioid, mucinous, or serous histology; AND
      • Used for patients with persistent or recurrent disease; AND
      • Patient is not experiencing an immediate biochemical relapse (i.e., rising CA-125 with no radiographic evidence of disease); AND
      • Patient has no satisfactory alternative treatment options
    • Well-Differentiated Grade 3 Neuroendocrine Tumors
      • Patient has locally advanced or metastatic disease with unfavorable biology (e.g., relative high Ki-67 [≥55%], rapid growth rate, negative SSR-based PET imaging); AND
      • Patient progressed following prior treatment and has no satisfactory alternative treatment options
    • Neuroendocrine Tumors (Poorly differentiated neuroendocrine carcinoma, poorly differentiated unknown primary, or large or small cell carcinoma [other than lung])
      • Patient progressed following prior treatment and has no satisfactory alternative treatment options

Cutaneous Squamous Cell Carcinoma (cSCC) 1

  • Used as a single agent; AND
      • Patient has recurrent or metastatic disease; OR
      • Patient has locally advanced, high-risk, or very high-risk disease that is not curable by surgery or radiation; OR
      • Patient has inoperable or not fully resectable new regional disease that is not curable by radiation therapy

Adrenal Gland Tumors ‡ 2

  • Patient has locoregional unresectable or metastatic adrenocortical carcinoma (ACC); AND
  • Used with or without mitotane

Triple Negative Breast Cancer (TNBC) † ‡ 1,69

  • Patient has recurrent unresectable or metastatic disease OR inflammatory breast cancer with no response to preoperative systemic therapy; AND
      • Used in combination with chemotherapy; AND
      • Tumor expresses PD-L1 (CPS ≥10) as determined by an FDA-approved or CLIA-compliant testv; OR
  • Patient has high-risk early-stage disease; AND
      • Used as neoadjuvant therapy in combination with chemotherapy; OR
      • Used as adjuvant therapy as a single agent

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

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

Genomic Aberration/Mutational Driver Targeted Therapies

(Note: not all inclusive, refer to guidelines for appropriate use) §

Sensitizing EGFR mutation-positive tumors

ALK rearrangement-positive tumors

ROS1 rearrangement-positive tumors

BRAF V600E-mutation positive tumors

NTRK Gene Fusion positive tumors

  • Afatinib
  • Erlotinib
  • Dacomitinib
  • Gefitinib
  • Osimertinib
  • Amivantamab

(exon-20 insertion)

  • Alectinib
  • Brigatinib
  • Ceritinib
  • Crizotinib
  • Lorlatinib
  • Ceritinib
  • Crizotinib 
  • Entrectinib
  • Dabrafenib

± Trametinib

  • Vemurafenib
  • Larotrectinib
  • Entrectinib

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

MET Exon-14 skipping mutations

RET rearrangement-positive tumors

KRAS G12C mutations

  • Pembrolizumab
  • Atezolizumab
  • Nivolumab ± ipilimumab
  • Capmatinib
  • Crizotinib
  • Tepotinib
  • Selpercatinib
  • Cabozantinib
  • Vandetanib
  • Pralsetinib
  • Sotorasib

  1. Renewal Criteria 1-3,5,15-17

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet universal and other indication-specific relevant criteria identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: severe infusion reactions, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, dermatologic adverse reactions/rash, etc.), hepatotoxicity when used in combination with axitinib, etc.; AND
  • For the following indications, patient has not exceeded a maximum of twenty-four (24) months of therapy:
      • Anal Carcinoma
      • Bladder Cancer/Urothelial Carcinoma
      • Cervical Cancer
      • Classical Hodgkin Lymphoma (cHL)
      • CNS Metastases
      • Cutaneous Melanoma (in combination with ipilimumab only)
      • Cutaneous Squamous Cell Carcinoma (cSCC)
      • Endometrial Carcinoma
      • Esophageal/Gastroesophageal Cancer
      • Gastric Cancer
      • Hepatocellular Carcinoma (HCC)
      • Malignant Pleural Mesothelioma (MPM)
      • Merkel Cell Carcinoma (MCC)
      • MSI-H/dMMR Cancer
      • Mycosis Fungoides/Sezary Syndrome
      • Non-Small Cell Lung Cancer (NSCLC)
      • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
      • Renal Cell Carcinoma (RCC)
      • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
      • Thymic Carcinoma
      • Tumor Mutational Burden-High (TMB-H) Cancer
      • Triple Negative Breast Cancer (recurrent unresectable or metastatic disease)
      • Uveal Melanoma
      • Vulvar Squamous Cell Carcinoma

Cutaneous Melanoma (adjuvant treatment)

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

Triple Negative Breast Cancer (neoadjuvant treatment)

  • Patient has not exceeded a maximum of twenty-four (24) weeks of therapy

Triple Negative Breast Cancer (adjuvant treatment)

  • Patient has not exceeded a maximum of twenty-seven (27) weeks of therapy

Cutaneous Melanoma (subsequent treatment after prior anti-PD-1 immunotherapy) ‡

  • Refer to Section III for criteria

Continuation Maintenance Therapy for NSCLC

  • Refer to Section III for criteria
  1. Dosage/Administration 1-6,8,12,13,15-17,22-48,50-55

Indication

Dose

Bladder Cancer/Urothelial Carcinoma, Cervical, cSCC, Endometrial Carcinoma (that is NOT MSI-H/dMMR), Esophageal, GEJ, Gastric, HCC, NSCLC, RCC, SCCHN, & TNBC (recurrent unresectable or metastatic disease)

200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

*NMIBC treatment may continue up to a maximum of 24 months in patients without persistent or recurrent disease, disease progression, or unacceptable toxicity.

TNBC (neoadjuvant or adjuvant therapy)

Neoadjuvant therapy: 

200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks up to a maximum of 24 weeks in patients without disease progression or unacceptable toxicity (up to 8 doses of 200 mg every 3 weeks or 4 doses of 400 mg every 6 weeks)

Adjuvant therapy*:

200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks up to a maximum of 27 weeks in patients without disease progression or unacceptable toxicity (up to 9 doses of 200 mg every 3 weeks or 5 doses of 400 mg every 6 weeks)

* Patients who experience disease progression or unacceptable toxicity related to KEYTRUDA with neoadjuvant treatment in combination with chemotherapy should not receive adjuvant single agent KEYTRUDA.

Thymic Carcinoma & Vulvar Carcinoma

200 mg intravenously every 3 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

Cutaneous Melanoma

Single agent therapy (excluding adjuvant treatment):

200 mg intravenously every 3 weeks or 400 mg every 6 weeks until disease progression or unacceptable toxicity

In combination with ipilimumab:

200 mg intravenously every 3 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

Adjuvant treatment:

200 mg intravenously every 3 weeks or 400 mg every 6 weeks up to a maximum of 12 months in patients without disease recurrence or unacceptable toxicity

Uveal Melanoma

2 mg/kg intravenously every 3 weeks until up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

cHL, MCC, MSI-H/dMMR Cancer, PMBCL, & TMB-H Cancer

Adults*:

200 mg intravenously every 3 weeks or 400 mg every 6 weeks

Pediatrics*:

2 mg/kg (up to 200 mg) intravenously every 21 days

*Up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

CNS metastases & MPM

10 mg/kg intravenously every 2 weeks for up to 24 months or until confirmed progression or unacceptable toxicity

NK/T-Cell Lymphoma

2 mg/kg intravenously every 3 weeks

MF/SS

2 mg/kg intravenously every 3 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

Gestational Trophoblastic Neoplasia

200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks

Adrenal Gland Tumors (that is NOT MSI-H/dMMR) & Soft Tissue Sarcoma

200 mg intravenously every 3 weeks

Anal Carcinoma

200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks or 2 mg/kg intravenously every 3 weeks, up to a maximum of 24 months in patients without disease progression or unacceptable toxicity

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

  • Standard dose 200 mg IV every 3 weeks for patients > 50 kg
  • Use 100 mg IV every 3 weeks for patients ≤ 50 kg

-OR-

  • Standard dose 400 mg IV every 6 weeks for patients weighing > 82.5 kg
  • Use 300 mg IV every 6 weeks for patients weighing between 56 to 82.5 kg
  • Use 200 mg IV every 6 weeks for patients weighing ≤ 55 kg

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

VI. Billing Code/Availability Information

HCPCS Code:

  • J9271 – Injection, pembrolizumab, 1 mg; 1 billable unit = 1 mg

NDC:

  • Keytruda 100 mg/4 mL single use vial: 00006-3026-XX

VII. References

  1. Keytruda [package insert]. Whitehouse Station, NJ; Merck & Co, Inc; July 2021. Accessed July 2021.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pembrolizumab. National Comprehensive Cancer Network, 2021. 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 July 2021.
  3. Alley EW, Lopez J, Santoro A, et al. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. See comment in PubMed Commons belowLancet Oncol. 2017 May;18(5):623-630.
  4. Ott PA, Bang YJ, Berton-Rigaud D, et al. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. J Clin Oncol. 2017 Aug 1;35(22):2535-2541.
  5. Ott PA, Piha-Paul SA, Munster P, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. Doi: 10.1093/annonc/mdx029.
  6. Zinzani PL, Ribrag V, Moskowitz CH, et al. Safety and tolerability of pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270. Doi: 10.1182/blood-2016-12-758383. Epub 2017 May 10.
  7. U.S. Food and Drug Administrations (FDA). Division of Drug Information. Health Alert. http://s2027422842.t.en25.com/e/es?s=2027422842&e=88882&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=3f0714083e82421a8af346a664bedbfb&elqaid=3588&elqat=1. Accessed May 2018
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  9. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Merkel Cell Carcinoma. Version 1.2021. National Comprehensive Cancer Network, 2021. 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 July 2021.
  10. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 3.2021. National Comprehensive Cancer Network, 2021. 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 July 2021.
  11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 5.2021. National Comprehensive Cancer Network, 2021. 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 July 2021.
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  1. Andre T, Shiu KK, Kim TW, et al. Pembrolizumab versus chemotherapy for microsatellite instability-high/mismatch repair deficient metastatic colorectal cancer: The phase 3 KEYNOTE-177 Study. J Clin Oncol. 2020;38(18_suppl):LBA4-LBA4.
  2. Geoerger B, Kang HJ, Yalon-Oren M, et al. Pembrolizumab in paediatric patients with advanced melanoma or a PD-L1-positive, advanced, relapsed, or refractory solid tumour or lymphoma (KEYNOTE-051): interim analysis of an open-label, single-arm, phase 1-2 trial. Lancet Oncol. 2020;21(1):121-133. doi:10.1016/S1470-2045(19)30671-0.
  3. Pembrolizumab Improves Progression-Free Survival in Relapsed/Refractory Hodgkin Lymphoma. Oncologist. 2020;25 Suppl 1(Suppl 1):S18-S19. doi:10.1634/theoncologist.2020-0561.
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  7. Olson D, Luke JJ, Poklepovic AS, et al. Significant antitumor activity for low-dose ipilimumab (IPI) with pembrolizumab (PEMBRO) immediately following progression on PD1 Ab in melanoma (MEL) in a phase II trial. J Clin Oncol 2020;38(15_suppl): abstract 10004.
  8. Kato K, Shah MA, Enzinger P, et al. KEYNOTE-590: Phase III study of first-line chemotherapy with or without pembrolizumab for advanced esophageal cancer. Future Oncol. 2019 Apr;15(10):1057-1066. doi: 10.2217/fon-2018-0609.
  9. Chung HC, Bang YJ, S Fuchs C, et al. First-line pembrolizumab/placebo plus trastuzumab and chemotherapy in HER2-positive advanced gastric cancer: KEYNOTE-811. Future Oncol. 2021 Feb;17(5):491-501. doi: 10.2217/fon-2020-0737.
  10. Carlino MS, Menzies AM, Atkinson V, et al. Long-term Follow-up of Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Patients with Advanced Melanoma: KEYNOTE-029 Part 1B. Clin Cancer Res. 2020 Oct 1;26(19):5086-5091. doi: 10.1158/1078-0432.CCR-20-0177.
  11. Schmid P, Cortes J, Pusztai L, et al. Pembrolizumab for Early Triple-Negative Breast Cancer. N Engl J Med. 2020 Feb 27;382(9):810-821. doi: 10.1056/NEJMoa1910549.

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

C07

Malignant neoplasm of parotid gland

C08.0

Malignant neoplasm of submandibular gland

C08.1

Malignant neoplasm of sublingual gland

C08.9

Malignant neoplasm of major salivary gland, 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

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

C25.0

Malignant neoplasm of head of pancreas

C25.1

Malignant neoplasm of body of the pancreas

C25.2

Malignant neoplasm of tail of pancreas

C25.3

Malignant neoplasm of pancreatic duct

C25.7

Malignant neoplasm of other parts of pancreas

C25.8

Malignant neoplasm of overlapping sites of pancreas

C25.9

Malignant neoplasm of pancreas, unspecified

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

C37

Malignant neoplasm of thymus

C38.4

Malignant neoplasm of pleura

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

C43.10

Malignant melanoma of unspecified eyelid, including canthus

C43.111

Malignant melanoma of right upper eyelid, including canthus

C43.112

Malignant melanoma of right lower eyelid, including canthus

C43.121

Malignant melanoma of left upper eyelid, including canthus

C43.122

Malignant melanoma of left lower eyelid, including canthus

C43.20

Malignant melanoma of unspecified ear and external auricular canal

C43.21

Malignant melanoma of right ear and external auricular canal

C43.22

Malignant melanoma of left ear and external auricular canal

C43.30

Malignant melanoma of unspecified part of face

C43.31

Malignant melanoma of nose

C43.39

 Malignant melanoma of other parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.59

Malignant melanoma of other part of trunk

C43.60

Malignant melanoma of unspecified upper limb, including shoulder

C43.61

Malignant melanoma of right upper limb, including shoulder

C43.62

Malignant melanoma of left upper limb, including shoulder

C43.70

Malignant melanoma of unspecified lower limb, including hip

C43.71

Malignant melanoma of right lower limb, including hip

C43.72

Malignant melanoma of left lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

C44.00

Unspecified malignant neoplasm of skin of lip

C44.02

Squamous cell carcinoma of skin of lip

C44.09

Other specified malignant neoplasm of skin of lip

C44.121

Squamous cell carcinoma of skin of unspecified eyelid, including canthus

C44.1221

Squamous cell carcinoma of skin of right upper eyelid, including canthus

C44.1222

Squamous cell carcinoma of skin of right lower eyelid, including canthus

C44.1291

Squamous cell carcinoma of skin of left upper eyelid, including canthus

C44.1292

Squamous cell carcinoma of skin of left lower eyelid, including canthus

C44.221

Squamous cell carcinoma of skin of unspecified ear and external auricular canal

C44.222

Squamous cell carcinoma of skin of right ear and external auricular canal

C44.229

Squamous cell carcinoma of skin of left ear and external auricular canal

C44.320

Squamous cell carcinoma of skin of unspecified parts of face

C44.321

Squamous cell carcinoma of skin of nose

C44.329

Squamous cell carcinoma of skin of other parts of face

C44.42

Squamous cell carcinoma of skin of scalp and neck

C44.520

Squamous cell carcinoma of anal skin

C44.521

Squamous cell carcinoma of skin of breast

C44.529

Squamous cell carcinoma of skin of other part of trunk

C44.621

Squamous cell carcinoma of skin of unspecified upper limb, including shoulder

C44.622

Squamous cell carcinoma of skin of right upper limb, including shoulder

C44.629

Squamous cell carcinoma of skin of left upper limb, including shoulder

C44.721

Squamous cell carcinoma of skin of unspecified lower limb, including hip

C44.722

Squamous cell carcinoma of skin of right lower limb, including hip

C44.729

Squamous cell carcinoma of skin of left lower limb, including hip

C44.82

Squamous cell carcinoma of overlapping sites of skin

C44.92

Squamous cell carcinoma of skin, unspecified

C45.0

Mesothelioma of pleura

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

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

C50.011

Malignant neoplasm of nipple and areola, right female breast

C50.012

Malignant neoplasm of nipple and areola, left female breast

C50.019

Malignant neoplasm of nipple and areola, unspecified female breast

C50.021

Malignant neoplasm of nipple and areola, right male breast

C50.022

Malignant neoplasm of nipple and areola, left male breast

C50.029

Malignant neoplasm of nipple and areola, unspecified male breast

C50.111

Malignant neoplasm of central portion of right female breast

C50.112

Malignant neoplasm of central portion of left female breast

C50.119

Malignant neoplasm of central portion of unspecified female breast

C50.121

Malignant neoplasm of central portion of right male breast

C50.122

Malignant neoplasm of central portion of left male breast

C50.129

Malignant neoplasm of central portion of unspecified male breast

C50.211

Malignant neoplasm of upper-inner quadrant of right female breast

C50.212

Malignant neoplasm of upper-inner quadrant of left female breast

C50.219

Malignant neoplasm of upper-inner quadrant of unspecified female breast

C50.221

Malignant neoplasm of upper-inner quadrant of right male breast

C50.222

Malignant neoplasm of upper-inner quadrant of left male breast

C50.229

Malignant neoplasm of upper-inner quadrant of unspecified male breast

C50.311

Malignant neoplasm of lower-inner quadrant of right female breast

C50.312

Malignant neoplasm of lower-inner quadrant of left female breast

C50.319

Malignant neoplasm of lower-inner quadrant of unspecified female breast

C50.321

Malignant neoplasm of lower-inner quadrant of right male breast

C50.322

Malignant neoplasm of lower-inner quadrant of left male breast

C50.329

Malignant neoplasm of lower-inner quadrant of unspecified male breast

C50.411

Malignant neoplasm of upper-outer quadrant of right female breast

C50.412

Malignant neoplasm of upper-outer quadrant of left female breast

C50.419

Malignant neoplasm of upper-outer quadrant of unspecified female breast

C50.421

Malignant neoplasm of upper-outer quadrant of right male breast

C50.422

Malignant neoplasm of upper-outer quadrant of left male breast

C50.429

Malignant neoplasm of upper-outer quadrant of unspecified male breast

C50.511

Malignant neoplasm of lower-outer quadrant of right female breast

C50.512

Malignant neoplasm of lower-outer quadrant of left female breast

C50.519

Malignant neoplasm of lower-outer quadrant of unspecified female breast

C50.521

Malignant neoplasm of lower-outer quadrant of right male breast

C50.522

Malignant neoplasm of lower-outer quadrant of left male breast

C50.529

Malignant neoplasm of lower-outer quadrant of unspecified male breast

C50.611

Malignant neoplasm of axillary tail of right female breast

C50.612

Malignant neoplasm of axillary tail of left female breast

C50.619

Malignant neoplasm of axillary tail of unspecified female breast

C50.621

Malignant neoplasm of axillary tail of right male breast

C50.622

Malignant neoplasm of axillary tail of left male breast

C50.629

Malignant neoplasm of axillary tail of unspecified male breast

C50.811

Malignant neoplasm of overlapping sites of right female breast

C50.812

Malignant neoplasm of overlapping sites of left female breast

C50.819

Malignant neoplasm of overlapping sites of unspecified female breast

C50.821

Malignant neoplasm of overlapping sites of right male breast

C50.822

Malignant neoplasm of overlapping sites of left male breast

C50.829

Malignant neoplasm of overlapping sites of unspecified male breast

C50.911

Malignant neoplasm of unspecified site of right female breast

C50.912

Malignant neoplasm of unspecified site of left female breast

C50.919

Malignant neoplasm of unspecified site of unspecified female breast

C50.921

Malignant neoplasm of unspecified site of right male breast

C50.922

Malignant neoplasm of unspecified site of left male breast

C50.929

Malignant neoplasm of unspecified site of unspecified male breast

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

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

C58

Malignant neoplasm of placenta

C60.0

Malignant neoplasm of prepuce

C60.1

Malignant neoplasm of glans penis

C60.2

Malignant neoplasm of body of penis

C60.8

Malignant neoplasm of overlapping sites of penis

C60.9

Malignant neoplasm of penis, unspecified

C61

Malignant neoplasm of prostate

C62.00

Malignant neoplasm of unspecified undescended testis

C62.01

Malignant neoplasm of undescended right testis

C62.02

Malignant neoplasm of undescended left testis

C62.10

Malignant neoplasm of unspecified descended testis

C62.11

Malignant neoplasm of descended right testis

C62.12

Malignant neoplasm of descended left testis

C62.90

Malignant neoplasm of unspecified testis, unspecified whether descended or undescended

C62.91

Malignant neoplasm of right testis, unspecified whether descended or undescended

C62.92

Malignant neoplasm of left testis, unspecified whether descended or undescended

C63.2

Malignant neoplasm of scrotum

C63.7

Malignant neoplasm of other specified male genital organs

C63.8

Malignant neoplasm of overlapping sites of male genital organs

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

C72.0

Malignant neoplasm of spinal cord

C72.1

Malignant neoplasm of cauda equina

C73

Malignant neoplasm of thyroid gland

C74.00

Malignant neoplasm of cortex of unspecified adrenal gland

C74.01

Malignant neoplasm of cortex of right adrenal gland

C74.02

Malignant neoplasm of cortex of left adrenal gland

C74.90

Malignant neoplasm of unspecified part of unspecified adrenal gland

C74.91

Malignant neoplasm of unspecified part of right adrenal gland

C74.92

Malignant neoplasm of unspecified part of left adrenal 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

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7A.8

Other malignant neuroendocrine tumors

C7B.00

Secondary carcinoid tumors unspecified site

C7B.01

Secondary carcinoid tumors of distant lymph nodes

C7B.02

Secondary carcinoid tumors of liver

C7B.03

Secondary carcinoid tumors of bone

C7B.04

Secondary carcinoid tumors of peritoneum

C7B.1

Secondary Merkel cell carcinoma

C7B.8

Other secondary neuroendocrine tumors

C80.0

Disseminated malignant neoplasm, unspecified

C80.1

Malignant (primary) neoplasm, unspecified

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, 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

C84.00

Mycosis fungoides, unspecified site

C84.01

Mycosis fungoides, lymph nodes of head, face, and neck

C84.02

Mycosis fungoides, intrathoracic lymph nodes

C84.03

Mycosis fungoides, intra-abdominal lymph nodes

C84.04

Mycosis fungoides, lymph nodes of axilla and upper limb

C84.05

Mycosis fungoides, lymph nodes of inguinal region and lower limb

C84.06

Mycosis fungoides, intrapelvic lymph nodes

C84.07

Mycosis fungoides, spleen

C84.08

Mycosis fungoides, lymph nodes of multiple sites

C84.09

Mycosis fungoides, extranodal and solid organ sites

C84.10

Sézary disease, unspecified site

C84.11

Sézary disease, lymph nodes of head, face, and neck

C84.12

Sézary disease, intrathoracic lymph nodes

C84.13

Sézary disease, intra-abdominal lymph nodes

C84.14

Sézary disease, lymph nodes of axilla and upper limb

C84.15

Sézary disease, lymph nodes of inguinal region and lower limb

C84.16

Sézary disease, intrapelvic lymph nodes

C84.17

Sézary disease, spleen

C84.18

Sézary disease, lymph nodes of multiple sites

C84.19

Sézary disease, extranodal and solid organ sites

C84.90

Mature T/NK-cell lymphomas, unspecified site

C84.91

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

C84.92

Mature T/NK-cell lymphomas, intrathoracic lymph nodes

C84.93

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

C84.94

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

C84.95

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

C84.96

Mature T/NK-cell lymphomas, intrapelvic lymph nodes

C84.97

Mature T/NK-cell lymphomas, spleen

C84.98

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

C84.99

Mature T/NK-cell lymphomas, 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

Other specified types of T/NK-cell lymphoma

D09.0

Carcinoma in situ of bladder

D15.0

Benign neoplasm of other and unspecified intrathoracic organs

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

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

Z85.038

Personal history of other malignant neoplasm of large intestine

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.47

Personal history of malignant neoplasm of testis

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

Z85.830

Personal history of malignant neoplasm of bone

Z85.831

Personal history of malignant neoplasm of soft tissue

Z85.858

Personal history of malignant neoplasm of other endocrine glands

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

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

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