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Asset Publisher
Keytruda® (pembrolizumab)
Policy Number: VP-0209
Intravenous
Last Review Date: 07/02/2024
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, 11/2021, 12/2021, 01/2022, 03/2022, 04/2022, 06/2022, 09/2022, 12/2022, 02/2023, 03/2023, 05/2023, 08/2023, 09/2023, 11/2023, 12/2023, 01/2024, 02/2024, 03/2024, 07/2024
FOR PEEHIP Members Only -Coverage excludes the provider-administered medication(s) outlined in this drug policy from being accessed through a specialty pharmacy. It must be obtained through buy and bill. |
Table of Contents
- Anal Carcinoma
- Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- Biliary Tract Cancer (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma)
- Urothelial Carcinoma (Bladder Cancer)
- Triple Negative Breast Cancer (TNBC)
- Adult Central Nervous System (CNS) Cancer
- Pediatric Central Nervous System (CNS) Cancers
- Cervical Cancer
- Esophageal Cancer and Esophagogastric/Gastroesophageal Junction Cancer
- Gastric Cancer
- Gestational Trophoblastic Neoplasia
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Hepatocellular Carcinoma (HCC)
- Adult Classical Hodgkin Lymphoma (cHL)
- Pediatric Classical Hodgkin Lymphoma
- Kaposi Sarcoma
- Renal Cell Carcinoma (RCC)
- Cutaneous Melanoma
- Uveal Melanoma
- Merkel Cell Carcinoma (MCC)
- Adrenal Gland Tumors
- Non-Small Cell Lung Cancer (NSCLC)
- Ovarian, Fallopian Tube, and Primary Peritoneal Cancer
- Primary Cutaneous Lymphomas
- Small Cell Lung Cancer (SCLC)
- Soft Tissue Sarcoma
- Cutaneous Squamous Cell Carcinoma (cSCC)
- Extranodal NK/T-Cell Lymphomas
- Thymic Carcinoma
- Thyroid Carcinoma (Anaplastic Carcinoma)
- Endometrial Carcinoma (Uterine Neoplasms)
- Vaginal Cancer
- Vulvar Cancer
- Microsatellite Instability-High (MSI-H) Cancer
- Polymerase Epsilon/Delta (POLE/POLD1) Mutation Cancer
- Tumor Mutational Burden-High (TMB-H) Cancer
- Renewal Criteria
- Dosing/Administration
- Billing Code/Availability
- References
- Appendix I (ICD-10 Coding)
- Appendix II (Centers for Medicare and Medicaid Services – CMS)
- Appendix III (Internal Use Only)
- Length of Authorization ∆ 1-3,5,6,15-17,50,51,53,57,62,65,68,69,72,73,75-77,82,85-87,95,101,103
Coverage will be provided for 6 months and may be renewed (unless otherwise specified).
- Adrenal Gland Tumors, Anal Carcinoma, Biliary Tract Cancer (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma), Bladder Cancer/Urothelial Carcinoma, Cervical Cancer, cHL, CNS Cancer, Cutaneous Melanoma (in combination with ipilimumab, lenvatinib, OR trametinib and dabrafenib), cSCC, Endometrial Carcinoma (Uterine Neoplasms), Esophageal and Esophagogastric/Gastroesophageal Junction Cancer (first-line or subsequent therapy), Gastric Cancer (first-line therapy), HCC, MCC, MSI-H/dMMR Cancer**, NSCLC (first-line or subsequent therapy), PMBCL, POLE/POLD1 Mutation Cancer, Primary Cutaneous Lymphomas, RCC (first-line or subsequent therapy), SCCHN, SCLC, Thymic Carcinoma, Thyroid Carcinoma (Anaplastic), TMB-H Cancer, TNBC (recurrent unresectable or metastatic disease), Uveal Melanoma, Vaginal Cancer and Vulvar Cancer can be authorized up to a maximum of twenty-four (24) months of therapy.*
- Kaposi Sarcoma may not be renewed.
- Therapy for MSI-H/dMMR Esophageal, Esophagogastric/Gastroesophageal Junction, and Gastric Cancer can be authorized for a maximum of 48 weeks (16 doses) of postoperative therapy after surgery.
- Adjuvant therapy in NSCLC and RCC can be authorized up to a maximum of twelve (12) months of therapy.*
- Therapy for resectable NSCLC can be authorized for up to a maximum of twelve (12) weeks of neoadjuvant therapy and thirty-nine (39) weeks of adjuvant therapy.*
- Therapy for Cutaneous Melanoma can be authorized for up to a maximum of 8 weeks of neoadjuvant therapy (3 doses), followed by a maximum of 44 weeks (15 doses) of adjuvant therapy.
- Adjuvant therapy in Cutaneous Melanoma (if no previous neoadjuvant pembrolizumab was used) 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.*
**Excluding post-operative therapy for MSI-H/dMMR Esophageal, Esophagogastric/Gastroesophageal Junction, & Gastric Cancer
*Note: The maximum number of doses is dependent on the dosing frequency and duration of therapy. Refer to Section V for exact dosage. |
||
Dosing Frequency |
Maximum length of therapy |
Maximum number of doses |
2 weeks |
2 years |
52 doses |
3 weeks |
24 weeks |
8 doses |
27 weeks |
9 doses |
|
1 year |
18 doses |
|
2 years |
35 doses |
|
6 weeks |
24 weeks |
4 doses |
27 weeks |
5 doses |
|
1 year |
9 doses |
|
2 years |
18 doses |
- Dosing Limits
- Quantity Limit (max daily dose) [NDC Unit]:
- Keytruda 100 mg/4 mL single use vial: 12 vials per 14 day supply
- Max Units (per dose and over time) [HCPCS Unit]:
Indication |
Billable Units (BU) |
Per unit time (days) |
Biliary Tract Cancers, Bladder/Urothelial, Cervical, cHL, cSCC, Cutaneous Melanoma, Endometrial Carcinoma (Uterine Neoplasms), Esophageal, Esophagogastric/Gastroesophageal, Gastric, Gestational Trophoblastic Neoplasia, HCC, MCC, MSI-H/dMMR Cancer, PMBCL, RCC, SCCHN, TMB-H Cancer, TNBC, Thyroid Carcinoma (Anaplastic) & Vaginal Cancer |
400 BU |
42 days |
Adrenal Gland Tumors, Kaposi Sarcoma, Ovarian, Fallopian Tube, & Primary Peritoneal Cancer, Soft Tissue Sarcoma, Thymic, & Vulvar |
200 BU |
21 days |
CNS Cancer, NSCLC, & SCLC |
200 BU |
21 days |
1,200 BU |
14 days |
|
Anal Carcinoma & POLE/POLD1 Mutation Cancer |
600 BU |
42 days |
Primary Cutaneous Lymphomas, Extranodal NK/T-Cell Lymphomas, & Uveal Melanoma |
300 BU |
21 days |
- Initial Approval Criteria 1,2
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, nivolumab/relatlimab, retifanlimab, toripalimab, tislelizumab, etc.) unless otherwise specified ∆; AND
Anal Carcinoma ‡ 2,5,52,92
- Patient has metastatic squamous cell carcinoma; AND
- Used as a single agent as subsequent therapy
Primary Mediastinal Large B-Cell Lymphoma (PMBCL) † ‡ Ф 1,2,6,34,82
- Used as single agent; AND
- Patient is at least 6 months of age; AND
- Patient has relapsed or refractory disease; AND
- Patient does not require urgent cytoreductive therapy; OR
- Used in combination with brentuximab vedotin; AND
- Patient is at least 6 months to < 39 years of age*; AND
- Used as consolidation/additional therapy in patients who achieve a partial response after therapy for relapsed or refractory disease
* Pediatric Primary Mediastinal Large B-Cell Lymphoma may be applicable to adolescent and young adult (AYA) patients older than 18 years of age and less than 39 years of age, who are treated in the pediatric oncology setting.
Biliary Tract Cancers (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma) † ‡ Ф 1,2,94
- Used in combination with gemcitabine and cisplatin; AND
-
- Patient has unresectable, resected gross residual (R2), or metastatic disease; OR
- Patient has resectable locoregionally advanced disease (**NOTE: Only applies to Gallbladder Cancer); AND
- Used as neoadjuvant therapy; 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) † ‡ 1,2,8,10,35-37,88,93,99,111
- Used in combination with enfortumab vedotin; AND
-
-
- Used as first-line therapy; AND
-
- Patient has one of the following diagnoses:
-
-
- Locally advanced or metastatic urothelial carcinoma †;
- Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder treated with curative intent ‡
- Metastatic or local bladder cancer recurrence post-cystectomy treated with curative intent ‡
- Metastatic primary carcinoma of the urethra ‡
- Metastatic upper genitourinary (GU) tract tumors ‡
- Metastatic urothelial carcinoma of the prostate ‡; OR
-
-
-
- Used as a single agent; AND
- Patient has Bacillus Calmette-Guerin (BCG)-unresponsive**, high-risk, non-muscle invasive bladder cancer (NMIBC) †; AND
- Patient has carcinoma in situ (CIS); AND
- Patient is ineligible for or has elected not to undergo cystectomy; OR
- Patient has Bacillus Calmette-Guerin (BCG)-unresponsive**, high-risk, non-muscle invasive bladder cancer (NMIBC) †; AND
-
- Patient has one of the following diagnoses:
- Locally advanced or metastatic urothelial carcinoma †
- Muscle invasive bladder cancer with local recurrence or persistent disease in a preserved bladder treated with curative intent ‡
- Metastatic or local bladder cancer recurrence post-cystectomy treated with curative intent ‡
- Recurrent or metastatic primary carcinoma of the urethra (excluding recurrence of stage T3-4 disease or palpable inguinal lymph nodes) ‡
- Patient has one of the following diagnoses:
-
-
- Primary carcinoma of the urethra that is stage T3-4 cN1-2 OR cN1-2 with palpable inguinal lymph nodes (first-line therapy only) ‡
-
-
-
- Metastatic upper genitourinary (GU) tract tumors ‡
- 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 chemotherapy other than a platinum; OR
- Used as first-line therapy in cisplatin-ineligible patients*; AND
-
-
- Patient is not eligible for any platinum-containing chemotherapy (i.e., both cisplatin and carboplatin-ineligible)*
* Note: 10,71,79
|
** 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. |
Triple-Negative Breast Cancer (TNBC) † ‡ Ψ 1,2,69
- 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 (combined positive score [CPS] ≥10) as determined by an FDA-approved or CLIA-compliant testv; OR
- Patient has high-risk early-stage (i.e., stage II-III) disease; AND
- Used as neoadjuvant therapy in combination with chemotherapy; OR
- Used as adjuvant therapy as a single agent following use as neoadjuvant therapy in combination with chemotherapy
Adult Central Nervous System (CNS) Cancer ‡ 2,47,49,50
- Used as a single agent; AND
- Primary tumor is due to BRAF non-specific melanoma or PD-L1 positive (TPS ≥1%) non-small cell lung cancer (NSCLC); AND
- Used as initial treatment in patients with small asymptomatic brain metastases; OR
- Used for relapsed limited brain metastases with either stable systemic disease or reasonable systemic treatment options; OR
- Used for recurrent limited brain metastases; OR
- Used for recurrent extensive brain metastases with stable systemic disease or reasonable systemic treatment options
Pediatric Central Nervous System (CNS) Cancers ‡ 2,81
- Patient is ≤ 18 years of age; AND
- Patient has hypermutant 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 † ‡ 1,2,42,70,100
- Patient has FIGO 2014 Stage III-IVA disease; AND
- Used in combination with chemoradiotherapy (CRT); OR
- Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; AND
- Used as a single agent; AND
- Used as subsequent therapy for recurrent or metastatic disease; OR
- Used in combination with chemotherapy, with or without bevacizumab^; AND
- Patient has persistent, recurrent, or metastatic disease
- Used as a single agent; AND
^Pembrolizumab may be continued as maintenance therapy
Esophageal Cancer and Esophagogastric/Gastroesophageal Junction Cancer † ‡ Ф 1,2,39-41,66,67,95,98,101
- Patient is medically fit and planned for esophagectomy; AND
- Used as induction systemic therapy for relieving dysphagia; AND
- Patient has cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3 cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease; AND
- Tumor expresses PD-L1 (CPS ≥ 10) as determined by an FDA-approved or CLIA compliant testv; AND
-
- Used in combination with platinum- and fluoropyrimidine-based chemotherapy; OR
-
- Patient has HER2-positive adenocarcinoma; AND
-
- Used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy; AND
- Tumor expresses PD-L1 (CPS ≥ 1) as determined by an FDA-approved or CLIA compliant testv; OR
- Patient is not a surgical candidate or has unresectable locally advanced, recurrent, or metastatic disease; AND
- Used as first-line therapy; AND
- Patient has HER2-positive adenocarcinoma; AND
- Used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy; AND
- Tumor expresses PD-L1 (CPS ≥ 1) as determined by an FDA-approved or CLIA compliant testv; OR
- Patient has HER2-negative adenocarcinoma; AND
- Used in combination with platinum- and fluoropyrimidine-based chemotherapy; OR
- Patient has squamous cell carcinoma; AND
- Used in combination with platinum- and fluoropyrimidine-based chemotherapy; AND
- Tumor expresses PD-L1 (CPS ≥ 10) as determined by an FDA-approved or CLIA compliant testv; OR
- Used as subsequent therapy; AND
- 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
Gastric Cancer † ‡ Ф 1,2,39,67,95,98,103
- Patient is not a surgical candidate or has unresectable locally advanced, recurrent, or metastatic disease; AND
- Used as first-line therapy; AND
- Patient has HER2-positive adenocarcinoma; AND
- Used in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy; AND
- Tumor expresses PD-L1 (CPS ≥ 1) as determined by an FDA-approved or CLIA compliant testv; OR
- Patient has HER2-negative adenocarcinoma; AND
- Used in combination with fluoropyrimidine- and platinum-containing chemotherapy
Gestational Trophoblastic Neoplasia ‡ 2,12,55
- Used as a single agent for multiagent chemotherapy-resistant disease; AND
Squamous Cell Carcinoma of the Head and Neck (SCCHN) † ‡ 1,2,31,32,106
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; AND
- Used for oligometastatic or metastatic disease; OR
- Patient has Very Advanced Head and Neck Cancer*; AND
- Patient has nasopharyngeal cancer; AND
- Patient has a performance status 0-1; AND
- Used in combination with cisplatin and gemcitabine; AND
- Used for one of the following:
- Unresectable locoregional recurrence with prior radiation therapy (RT)
- Unresectable second primary with prior RT
- Unresectable persistent disease with prior RT
- Recurrent/persistent disease with distant metastases; OR
- Patient has NON-nasopharyngeal cancer; AND
- Patient is unfit for surgery or has T4b, N0-3, M0 disease; AND
- Used as a single agent as first-line therapy in patients with a performance status (PS) 3; AND
- Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; OR
- Patient has unresectable, recurrent, persistent, or metastatic disease; AND
- Used as a single agent; AND
-
-
- Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; OR
- Used as subsequent therapy for disease that has progressed on or after platinum-containing chemotherapy; OR
-
-
- Used in combination with cetuximab; AND
-
-
- Patient has a performance status 0-1; OR
-
-
- Used in combination with carboplatin or cisplatin AND either fluorouracil, docetaxel, paclitaxel; AND
-
-
- Patient has a performance status 0-1
-
-
* 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 1,2,43,107
- Used as a single agent; AND
- Disease is secondary to hepatitis B †; AND
- Patient has received prior systemic therapy other than a PD-1/PD-L1- containing regimen; OR
- Used as subsequent therapy for progressive disease ‡; AND
- Patient has liver-confined, unresectable disease and deemed ineligible for transplant; OR
- Patient has extrahepatic/metastatic disease and deemed ineligible for resection, transplant, or locoregional therapy
- Disease is secondary to hepatitis B †; AND
Adult Classical Hodgkin Lymphoma (cHL) † ‡ Ф 1,2,33,61,96,97
- Patient has relapsed or refractory disease; AND
- Used as a single agent; OR
- Used in combination with GVD (gemcitabine, vinorelbine, liposomal doxorubicin) or ICE (ifosfamide, carboplatin, etoposide); AND
- Patient is ≤ 60 years of age
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; AND
- Used after two (2) or more prior lines of therapy †; OR
- Used as subsequent therapy 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.
Kaposi Sarcoma ‡ 2,85,86
- Used as a single agent as subsequent therapy; AND
- Patient has endemic or classic disease; AND
- Used for relapsed/refractory advanced cutaneous, oral, visceral, or nodal disease; AND
- Disease has progressed on or has not responded to first-line systemic therapy; AND
- Disease has progressed on alternate first-line systemic therapy; AND
- Patient does not have multicentric Castleman disease (MCD) or KSHV–associated inflammatory cytokine syndrome (KICS)
Renal Cell Carcinoma (RCC) † ‡ 1,2,45,74-76
- Patient has clear cell histology; AND
- Used in combination with axitinib or lenvatinib; AND
- Used as first-line therapy for advanced, relapsed, or stage IV disease; OR
- Used in combination with axitinib or lenvatinib; AND
- Used as subsequent therapy for relapsed or stage IV disease ∆; OR
- Used as a single agent; AND
- Used as adjuvant therapy †; AND
- Patient has undergone a nephrectomy prior to receiving treatment; AND
-
-
- Patient has stage II disease with grade 4 tumors (with or without sarcomatoid features); OR
- Patient has stage III disease; OR
-
-
- Patient has undergone a metastasectomy with complete resection of disease within one year of nephrectomy 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 ‡
Cutaneous Melanoma † ‡ Ф 1,2,22-24,65,68,87,112
- Used as first-line therapy as a single agent for unresectable or metastatic* disease; OR
- Used as subsequent therapy; AND
- Used for metastatic or unresectable disease with progression following treatment with anti-PD-1/PD-L1-based therapy, including in combination with anti-CTLA-4 (e.g., ipilimumab) for ≥2 doses; AND
- Used in combination with lenvatinib; OR
- Used for metastatic or unresectable disease with disease progression or intolerance if BRAF/MEK and/or PD(L)-1 checkpoint inhibition not previously used; AND
- Patient has BRAF V600 activating mutation positive disease; AND
- Used in combination with trametinib and dabrafenib; OR
- Used for disease progression or relapse following treatment with BRAF/MEK + PD(L)-1 checkpoint inhibitor therapy; AND
- Patient has BRAF V600 activating mutation positive disease; AND
- Used in combination with trametinib and dabrafenib; AND
- Used as re-induction therapy in patients who experienced disease control (i.e., complete response, partial response, or stable disease) and no residual toxicity from prior combination BRAF/MEK + PD(L)-1 checkpoint inhibitor therapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR
- Used for metastatic* or unresectable disease with progression or relapse following treatment with anti-PD-1 therapy; AND
- Used as a single agent; AND
- Used as re-induction therapy in patients who experienced disease control (i.e., complete response, partial response, or stable disease) and no residual toxicity from prior anti-PD-1 therapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR
- Used for metastatic* or unresectable disease with 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; AND
- Anti-PD-1 therapy 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) and no residual toxicity from prior anti-PD-1 therapy, 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 therapy and combination ipilimumab/anti-PD-1 therapy 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) and no residual toxicity from prior combination ipilimumab/anti-PD-1 therapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR
- Used as a single agent; AND
- Used for metastatic or unresectable disease with progression following treatment with anti-PD-1/PD-L1-based therapy, including in combination with anti-CTLA-4 (e.g., ipilimumab) for ≥2 doses; AND
- Used as a single agent for neoadjuvant treatment; AND
-
- Patient has stage III disease; AND
- Used as primary treatment for clinically positive, resectable nodal disease; OR
- Used for limited resectable disease with clinical satellite/in-transit metastases; OR
- Patient has limited resectable local satellite/in-transit recurrence; OR
- Patient has resectable disease limited to nodal recurrence; OR
-
- Used as a single agent for adjuvant treatment; AND
- Patient has stage IIB or IIC melanoma following complete resection †; AND
- Patient is at least 12 years of age; OR
- Patient has stage III disease; AND
- Used following complete resection †; AND
- Patient has stage IIB or IIC melanoma following complete resection †; AND
- Patient is at least 12 years of age; OR
- Patient has resected sentinel node positive disease either during radiographic 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 to clear margins; OR
- Patient has local satellite/in-transit recurrence and has NED after complete excision to clear margins; OR
- Patient has resectable disease limited to nodal recurrence following excision and complete TLND; OR
- Patient has oligometastatic disease and NED after receiving metastasis-directed therapy (i.e., complete resection, stereotactic ablative therapy, or T-VEC/intralesional therapy) or systemic therapy followed by resection
*Metastatic disease includes stage III unresectable/borderline resectable disease with clinically positive node(s) or clinical satellite/in-transit metastases, as well as unresectable local satellite/in-transit recurrence, unresectable nodal recurrence, and widely disseminated distant metastatic disease.
Uveal Melanoma ‡ 2,53,54
- Used as a single agent; AND
- Patient has metastatic or unresectable disease
Merkel Cell Carcinoma (MCC) † ‡ Ф 1,2,9,44
- Patient is at least 6 months of age; AND
- Used as a single agent; AND
- Patient has primary locally advanced disease ‡; AND
- Both curative surgery and curative radiation therapy are not feasible; OR
- Patient has had disease progression on neoadjuvant nivolumab therapy; OR
- Patient has primary locally advanced disease ‡; AND
- Patient has recurrent locally advanced or metastatic disease †; OR
- Patient has recurrent regional disease ‡; AND
- Both curative surgery and curative radiation therapy are not feasible
Adrenal Gland Tumors ‡ 2,62,63,77
- Patient has locoregional unresectable or metastatic adrenocortical carcinoma (ACC); AND
- Used with or without mitotane
Non-Small Cell Lung Cancer (NSCLC) † ‡ 1,2,11,25-29,84
- 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; AND
- Used in patients with tumors 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 as neoadjuvant therapy †; AND
- Patient has resectable disease (tumors ≥4 cm or node positive); AND
- Used in combination with platinum-containing chemotherapy and then continued as a single agent as adjuvant treatment after surgery; OR
- Used as adjuvant therapy; AND
- Used as a single agent; AND
- Used following resection and previous adjuvant chemotherapy; AND
- Used as a single agent; AND
- Patient has stage IB (T2a ≥4 cm), II, or IIIA disease †; OR
- Patient has stage IIIB (T3, N2) disease; AND
-
- Disease is negative for EGFR exon 19 deletion or exon 21 L858R mutations, or ALK rearrangements; OR
- Used following previous neoadjuvant pembrolizumab plus chemotherapy and resection; 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-approved or CLIA compliant testv, that are negative for actionable molecular biomarkers*¥
- Patients with performance status (PS) 0-1 who have tumors that are negative for actionable molecular biomarkers*¥ and PD-L1 expression <1%
- Patients with PS 0-1 who are positive for one of the following molecular biomarkers: EGFR exon 20, BRAF V600E, NTRK1/2/3 gene fusion, MET exon 14 skipping, RET rearrangement, or ERBB2 (HER2); 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 a single agent (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 a single agent; OR
- Used for one of the following:
-
- Patients with PS 0-1 who are positive for one of the following molecular biomarkers* and have received prior targeted therapy§: EGFR exon 19 deletion or L858R tumors, EGFR S768I, L861Q and/or G719X, ALK rearrangement, or ROS1 rearrangement
- Patients with 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 for one of the following:
- 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 systemic therapy; AND
- Used in combination with pemetrexed following a first-line pembrolizumab/pemetrexed/(carboplatin or cisplatin) regimen for non-squamous cell histology; OR
- Used as a single agent following a first-line pembrolizumab/carboplatin/ (paclitaxel or albumin-bound paclitaxel) regimen for 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, 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. |
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer ‡ 2,104,105
- Patient has epithelial* ovarian, fallopian tube, or primary peritoneal cancer; AND
- Used in combination with oral cyclophosphamide and bevacizumab; AND
- Patient has platinum-resistant disease; AND
- Patient has persistent or recurrent disease; AND
- Patient is not experiencing an immediate biochemical relapse (i.e., rising CA-125 without radiographic evidence of disease); OR
- Patient has recurrent disease (low-grade serous carcinoma only)
- Patient has persistent or recurrent disease; AND
* Epithelial subtypes include serous, endometrioid, carcinosarcoma (malignant mixed Müllerian tumors [MMMTs] of the ovary), clear cell, mucinous, and borderline epithelial tumors (also known as low malignant potential [LMP] tumors).
Primary Cutaneous Lymphomas ‡ 2,15
- Used as a single agent systemic therapy; AND
- Patient has Mycosis Fungoides/Sezary Syndrome; AND
- Used as primary therapy OR as subsequent therapy for relapsed or persistent disease; AND
- Patient has stage IIB Mycosis Fungoides with generalized tumor lesions (for primary therapy ONLY); OR
- Patient has stage III Mycosis Fungoides; OR
- Patient has stage IV Sezary Syndrome; OR
- Patient has generalized cutaneous or extracutaneous lesions with large cell transformation (LCT); OR
- Used as subsequent therapy for disease refractory to multiple previous therapies (excluding use in patients with stage IA Mycosis Fungoides); OR
- Patient has primary cutaneous CD30+ T-Cell lymphoproliferative disorders; AND
- Used for relapsed or refractory disease; AND
- Used for primary cutaneous anaplastic large cell lymphoma (ALCL) with multifocal lesions, or cutaneous ALCL with regional node (N1) [excludes systemic ALCL]
Small Cell Lung Cancer (SCLC) ‡ Ф 2,72,73
- Used as subsequent therapy as a single agent; AND
- Patient has had a chemotherapy-free interval of ≤ 6 months; AND
- Patient has relapsed disease following a complete or partial response or stable disease with primary treatment; OR
- Patient has primary progressive disease
Soft Tissue Sarcoma ‡ 2,56,83,89.90
- Used in combination with axitinib; AND
- Patient has alveolar soft part sarcoma (ASPS); OR
- 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), dedifferentiated liposarcoma, or undifferentiated sarcomas; AND
- Used as subsequent therapy for advanced/metastatic disease with disseminated metastases (Note: only applies to Extremity/Body Wall, Head/Neck*); OR
- Used as alternative systemic therapy for unresectable or progressive disease after initial therapy for unresectable localized disease (Note: only applies to Retroperitoneal/Intra-Abdominal**); OR
- Used as subsequent therapy for stage IV disease with disseminated metastases (Note: only applies to Retroperitoneal/Intra-Abdominal**)
*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.
Cutaneous Squamous Cell Carcinoma (cSCC) † ‡ 1,2,58
- Used as a single agent; AND
- Patient has locally advanced, recurrent, or metastatic disease that is not curable by surgery or radiation
Extranodal NK/T-Cell Lymphomas ‡ 2,48
- Used as a single agent; AND
- Used for relapsed or refractory disease following additional therapy with an alternate asparaginase-based combination chemotherapy regimen not previously used; AND
- Participation in a clinical trial is unavailable
Thymic Carcinoma ‡ 2,16,17
- Used as a single agent; AND
- Patient is unable to tolerate first-line combination regimens; AND
- Used as preoperative systemic therapy for surgically resectable disease if R0 resection is considered uncertain; OR
- Used as postoperative treatment after R1 (microscopic residual tumor) or R2 (macroscopic residual tumor) resection; OR
- Used as first-line therapy for recurrent, advanced, or metastatic disease; OR
- Used as second-line therapy; AND
- Patient is unable to tolerate first-line combination regimens; AND
- Patient has unresectable or metastatic disease
Thyroid Carcinoma (Anaplastic Carcinoma) ‡ 2,108,109
- Used as a single agent or in combination with lenvatinib; AND
- Patient has stage IVC disease; AND
- Used as aggressive first-line therapy; OR
- Used as second-line therapy
Endometrial Carcinoma (Uterine Neoplasms) † ‡ 1,2,46,80,91
- Used in combination with lenvatinib; AND
- Disease is mismatch repair proficient (pMMR) as determined by an FDA-approved or CLIA-compliant testv or NOT microsatellite instability-high (MSI-H); AND
-
-
- Used as first-line therapy for recurrent disease after prior platinum-based therapy (excluding use in patients with isolated metastases); OR
- Used as subsequent therapy for advanced, recurrent, or metastatic disease; OR
-
-
- Disease is mismatch repair proficient (pMMR) as determined by an FDA-approved or CLIA-compliant testv or NOT microsatellite instability-high (MSI-H); AND
- Used in combination with carboplatin and paclitaxel, followed by single agent maintenance therapy; AND
- Used as adjuvant treatment; AND
-
-
- Patient has Stage III or IV endometrioid adenocarcinoma; OR
-
-
- Used as primary treatment (excluding use in patients with carcinosarcoma); AND
-
-
- Patient has Stage III or IV disease; OR
-
-
- Used for recurrent disease (excluding use in patients with carcinosarcoma); OR
- Used as adjuvant treatment; AND
- Used as a single agent as maintenance therapy following treatment with pembrolizumab in combination with carboplatin and paclitaxel
Vaginal Cancer ‡ 2,70
- Tumor expresses PD-L1 (CPS ≥1) as determined by an FDA-approved or CLIA-compliant testv; AND
- Patient has recurrent or metastatic disease; AND
- Used as a single agent as subsequent therapy; OR
- Used in combination with cisplatin or carboplatin, paclitaxel, and with or without bevacizumab; AND
- Used as first-line therapy; OR
- Used as subsequent therapy (if not previously used as first-line)
Vulvar Cancer ‡ 2,51,57
- Used as a single agent; AND
- Patient has adenocarcinoma or squamous cell carcinoma; 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 subsequent therapy for disease progression on or after chemotherapy
Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Cancer † ‡ 1,2,4,38,51,110,113-115
- Patient is at least 6 months of age; AND
- Patient has microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors, as determined by an FDA-approved or CLIA compliant testv; AND
- Patient has unresectable or medically inoperable, advanced, recurrent, persistent, or metastatic solid tumors; AND
- Used as a single agent; AND
- Used for disease progression following prior treatment †; OR
- Used as initial therapy † ‡; AND
- Patient has one of the following cancers:
- Ampullary Adenocarcinoma
- Biliary Tract Cancers (Gallbladder Cancer, Intra-/Extra-hepatic Cholangiocarcinoma)
- Appendiceal Adenocarcinoma – Colon Cancer
- Colorectal Cancer
- Esophageal Cancer or Esophagogastric/Gastroesophageal Junction Cancer
- Gastric Cancer
- Salivary Gland Tumors
- Very Advanced Squamous Cell Carcinoma of the Head and Neck (non-nasopharyngeal type)
- Occult Primary/Cancer of Unknown Primary (CUP)
- Pancreatic Adenocarcinoma
- Small Bowel Adenocarcinoma
- Endometrial Carcinoma (Uterine Neoplasms) (excluding patients with isolated metastases); OR
- Patient has one of the following cancers:
- Used as induction systemic therapy to relieve dysphagia ‡; AND
- Patient has Esophageal Cancer or Esophagogastric/Gastroesophageal Junction Cancer; AND
- Patient is medically fit and planned for esophagectomy with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease; OR
- Used as neoadjuvant therapy ‡; AND
- Patient has one of the following cancers:
- Colorectal Cancer
- Esophageal or Esophagogastric/Gastroesophageal Junction Adenocarcinoma
- Gastric Cancer
- Biliary Tract Cancers (Gallbladder Cancer only) (excluding patients with disease presenting as jaundice); OR
- Patient has one of the following cancers:
- Used as a single agent; AND
- Used as postoperative management ‡; AND
- Used following R0 resection in patients who have received preoperative therapy with pembrolizumab; AND
- Patient has one of the following cancers:
- Esophageal or Esophagogastric/Gastroesophageal Junction Adenocarcinoma
- Gastric Cancer; OR
- Used in combination with oxaliplatin AND either fluorouracil or capecitabine; AND
- Patient has Esophageal or Esophagogastric/Gastroesophageal Junction Cancer; AND
- Used as first-line therapy; OR
- Used as induction systemic therapy to relieve dysphagia; AND
- Patient is medically fit and planned for esophagectomy with cT2, N0 (high-risk lesions: lymphovascular invasion, ≥ 3cm, poorly differentiated), cT1b-cT2, N+ or cT3-cT4a, Any N disease; OR
- Patient has Gastric Cancer; AND
- Used as first-line therapy
- Patient has Esophageal or Esophagogastric/Gastroesophageal Junction Cancer; AND
Polymerase Epsilon/Delta (POLE/POLD1) Mutation Cancer ‡ 2,113-115
- Used as a single agent; AND
- Patient has advanced or metastatic Appendiceal Adenocarcinoma, Small Bowel Adenocarcinoma, Colon Cancer, or Rectal Cancer
Tumor Mutational Burden-High (TMB-H) Cancer † ‡ 1,2
- Patient is at least 6 months of age; AND
- Patient has tumor mutational burden-high (TMB-H) [≥ 10 mutations/megabase (mut/Mb)] solid tumors, 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 unresectable or medically inoperable, advanced, recurrent, persistent, or metastatic solid tumors; AND
- Used for disease progression following prior treatment †; OR
- Used as initial therapy ‡; AND
- Patient has one of the following cancers:
-
- Ampullary Adenocarcinoma
- Salivary Gland Tumors
- Very Advanced Squamous Cell Carcinoma of the Head and Neck (non-nasopharyngeal type)
- Occult Primary/Cancer of Unknown Primary (CUP)
- Pancreatic Adenocarcinoma
- Medullary Thyroid Carcinoma
- Follicular, Oncocytic, or Papillary Thyroid Carcinoma (only applicable to patients not amenable to radioactive iodine therapy)
- Endometrial Carcinoma (Uterine Neoplasms) (excluding patients with isolated metastases)
-
- Patient has one of the following cancers:
v If confirmed using an FDA-approved assay – http://www.fda.gov/companiondiagnostics
† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug
Ψ ER Scoring Interpretation (following ER testing by validated IHC assay) 116 |
|
Results |
Interpretation |
|
|
|
|
|
|
*Note: Invasive cancers with between 1%–10% ER positivity are considered ER-low–positive. However, this group is noted to be heterogeneous and the biologic behavior of ER-low–positive cancers may be more similar to ER-negative cancers. This should be considered in decision making for other adjuvant therapy and overall treatment pathway. |
§ Genomic Aberration/Mutational Driver Targeted Therapies 11 (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 expression ≥ 1% |
MET exon-14 skipping mutations |
RET rearrangement-positive tumors |
KRAS G12C mutation positive tumors |
|
|
|
|
- Renewal Criteria ∆ 1-3,5,6,15-17,50,51,53,57,62,65,68,69,70,72,73,75-77,82,85-87,95,101,103,109,112
Coverage may be renewed based upon the following criteria:
- Patient continues to meet the 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-related reactions, severe immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions/rash, etc.), hepatotoxicity when used in combination with axitinib, complications of allogeneic hematopoietic stem cell transplantation (HSCT), etc.; AND
- For the following indications, patient has not exceeded a maximum of twenty-four (24) months of therapy:
- Adrenal Gland Tumors
- Anal Carcinoma
- Biliary Tract Cancers
- Bladder Cancer/Urothelial Carcinoma
- Cervical Cancer
- Classical Hodgkin Lymphoma (cHL)
- CNS Cancer
- Cutaneous Melanoma (in combination with ipilimumab, lenvatinib, OR trametinib and dabrafenib only)
- Cutaneous Squamous Cell Carcinoma (cSCC)
- Endometrial Carcinoma (Uterine Neoplasm)
- Esophageal Cancer and Esophagogastric/Gastroesophageal Junction Cancer (first-line or subsequent therapy)
- Gastric Cancer (first-line therapy)
- Hepatocellular Carcinoma (HCC)
- Merkel Cell Carcinoma (MCC)
- MSI-H/dMMR Cancer (Excluding post-operative therapy for MSI-H/dMMR Esophageal, Esophagogastric/Gastroesophageal Junction, & Gastric Cancer)
- Non-Small Cell Lung Cancer (NSCLC) (first-line or subsequent therapy)
- POLE/POLD1 Mutation Cancer
- Primary Cutaneous Lymphomas
- Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
- Renal Cell Carcinoma (RCC) (first-line or subsequent therapy)
- Small Cell Lung Cancer (SCLC)
- Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Thymic Carcinoma
- Thyroid Carcinoma (Anaplastic Carcinoma)
- Tumor Mutational Burden-High (TMB-H) Cancer
- Triple Negative Breast Cancer (recurrent unresectable or metastatic disease)
- Uveal Melanoma
- Vaginal Cancer
- Vulvar Cancer
Kaposi Sarcoma
- Coverage may NOT be renewed
MSI-H/dMMR Esophageal, Esophagogastric/Gastroesophageal Junction, and Gastric Cancer (postoperative therapy)
- Patient has not exceeded a maximum of 48 weeks (16 doses) of postoperative therapy after surgery
NSCLC (adjuvant treatment)
- Patient has not exceeded a maximum of twelve (12) months of therapy
NSCLC (resectable disease)
- Patient has not exceeded a maximum of twelve (12) weeks of neoadjuvant therapy and thirty-nine (39) weeks of adjuvant therapy
NSCLC (continuous maintenance treatment)
- Refer to Section III for criteria
Renal Cell Carcinoma (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 or BRAF/MEK + anti-PD-1 immunotherapy) ‡
- Refer to Section III for criteria
Cutaneous Melanoma (neoadjuvant followed by adjuvant therapy)
- Patient has not exceeded a maximum of 8 weeks of neoadjuvant therapy (3 doses), followed by a maximum of 44 weeks (15 doses) of adjuvant therapy
Cutaneous Melanoma (adjuvant therapy, if no previous neoadjuvant pembrolizumab was used)
- Patient has not exceeded a maximum of twelve (12) months of therapy
Endometrial Carcinoma (continuous maintenance treatment)
- Refer to Section III for criteria
Cervical Cancer (continuous maintenance treatment)
- Refer to Section III for criteria
Δ Notes:
|
- Dosage/Administration ∆ 1-6,8,12,13,15-17,22-48,50-57,62,65,68,70,72,73,75-77,82,83,85-87,91,92,95,101,103-106,109,112
Indication |
Dose |
Biliary Tract Cancers, Bladder Cancer/Urothelial Carcinoma, Cervical, Vaginal, cSCC, Endometrial Carcinoma/Uterine Neoplasms (excluding MSI-H/dMMR), HCC, Thyroid Carcinoma (Anaplastic) & SCCHN |
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 high-risk disease, disease progression, or unacceptable toxicity. |
Esophageal and Esophagogastric/ Gastroesophageal Junction Cancer |
First-line or subsequent therapy: 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 Induction therapy to relieve dysphagia (MSI-H/dMMR disease ONLY): 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 Neoadjuvant therapy (MSI-H/dMMR disease ONLY): 200 mg intravenously every 3 weeks for at least 12 weeks, followed by surgery and then post-operative therapy (See below) Post-operative therapy(MSI-H/dMMR disease ONLY): 200 mg intravenously every 3 weeks for 48 weeks (16 cycles) |
Gastric Cancer |
First-line therapy: 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 Neoadjuvant therapy (MSI-H/dMMR disease ONLY): 200 mg intravenously every 3 weeks for at least 12 weeks, followed by surgery and then post-operative therapy (See below) Post-operative therapy(MSI-H/dMMR disease ONLY): 200 mg intravenously every 3 weeks for 48 weeks (16 cycles) |
NSCLC |
First-line, subsequent, or continuation maintenance therapy: 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 Adjuvant treatment of resected NSCLC: 200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks up to a maximum of 12 months in patients without disease recurrence or unacceptable toxicity Neoadjuvant and adjuvant treatment of resectable NSCLC:
|
RCC |
First-line or subsequent therapy: 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 Adjuvant therapy: 200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks up to a maximum of 12 months in patients without disease recurrence or unacceptable toxicity |
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 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 recurrence 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. |
Adrenal Gland Tumors, Thymic Carcinoma, & Vulvar Cancer |
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 neoadjuvant and adjuvant treatment): 200 mg intravenously every 3 weeks or 400 mg every 6 weeks until disease progression or unacceptable toxicity In combination with ipilimumab, lenvatinib, OR trametinib and dabrafenib: 200 mg intravenously every 3 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity Neoadjuvant and adjuvant treatment:
Adjuvant treatment (if no neoadjuvant pembrolizumab was used):
|
Uveal Melanoma |
2 mg/kg intravenously every 3 weeks 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
*Excluding MSI-H/dMMR neoadjuvant, induction, and post-operative therapy for Esophageal, Esophagogastric/Gastroesophageal Junction Cancer and neoadjuvant, and post-operative therapy for Gastric Cancer |
Adults: 200 mg intravenously every 3 weeks or 400 mg every 6 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity Pediatrics: 2 mg/kg (up to 200 mg) intravenously every 3 weeks up to a maximum of 24 months in patients without disease progression or unacceptable toxicity |
CNS Cancer |
Adults: 10 mg/kg intravenously every 2 weeks for up to 24 months in patients without disease progression or unacceptable toxicity Pediatrics: 2 mg/kg (up to 200 mg) intravenously every 3 weeks for up to 24 months in patients without disease progression or unacceptable toxicity |
Extranodal NK/T-Cell Lymphomas |
2 mg/kg intravenously every 3 weeks |
Primary Cutaneous Lymphomas |
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 |
Soft Tissue Sarcoma |
200 mg intravenously every 3 weeks |
Ovarian, Fallopian Tube, and Primary Peritoneal Cancer |
200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity |
Anal Carcinoma and POLE/POLD1 Mutation Cancer |
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 |
Small Cell Lung Cancer (SCLC) |
10 mg/kg intravenously every 2 weeks or 200 mg intravenously every 3 weeks, up to a maximum of 24 months in patients without disease progression or unacceptable toxicity |
Kaposi Sarcoma |
200 mg intravenously every 3 weeks, up to a maximum of 6 months in patients without unacceptable toxicity |
Dosing should be calculated using actual body weight and not flat dosing (as applicable) based on the following: Weight ≤ 55 kg:
Weight is ≤ 82.5 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. |
- Billing Code/Availability Information
HCPCS Code:
- J9271 – Injection, pembrolizumab, 1 mg; 1 billable unit = 1 mg
NDC:
- Keytruda 100 mg/4 mL single-dose vial: 00006-3026-xx
- References
- Keytruda [package insert]. Rahway, NJ; Merck & Co., Inc.; June 2024. Accessed June 2024.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pembrolizumab. 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.
- 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.
- 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.
- 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.
- 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.
- U.S. Food and Drug Administrations (FDA). Division of Drug Information. Health Alert. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-oncology-clinical-investigators-about-efficacy-issue. Accessed August 2018.
- Balar AV, Castellano D, O’Donnell PH, et al. First-line pembrolizumab in cisplatin-ineligible patients with locally advanced and unresectable or metastatic urothelial cancer (KEYNOTE-052): a multicenter, single-arm, phase 2 study. Lancet Oncol 2017; 18: 1483–92.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Merkel Cell Carcinoma. Version 1.2024. 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.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 4.2024. 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.
- Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 6.2024. 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.
- Ghorani E, Kaur B, Fisher RA, et al. Pembrolizumab is effective for drug-resistant gestational trophoblastic neoplasia. Lancet. 2017 Nov 25;390(10110):2343-2345.
- Chung HC, Lopez-Martin JA, Kao S, et al. Phase 2 study of pembrolizumab in advanced small-cell lung cancer (SCLC): KEYNOTE-158. J Clin Oncol 2018;36: Abstract 8506
- National Institutes of Health. Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/KEYNOTE-054). Available at: http://clinicaltrials.gov/show/NCT02362594.
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Appendix 1 – Covered Diagnosis Codes
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 |
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 |
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 |
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 |
C37 |
Malignant neoplasm of thymus |
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 |
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 |
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 |
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 |
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 |
C56.1 |
Malignant neoplasm of right ovary |
C56.2 |
Malignant neoplasm of left ovary |
C56.3 |
Malignant neoplasm of bilateral ovaries |
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 |
C63.7 |
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 |
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 |
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 |
C79.70 |
Secondary malignant neoplasm of unspecified adrenal gland |
C79.71 |
Secondary malignant neoplasm of right adrenal gland |
C79.72 |
Secondary malignant neoplasm of left adrenal gland |
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 |
C83.90 |
Non-follicular (diffuse) lymphoma, unspecified, unspecified site |
C83.91 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of head, face, and neck |
C83.92 |
Non-follicular (diffuse) lymphoma, unspecified, intrathoracic lymph nodes |
C83.93 |
Non-follicular (diffuse) lymphoma, unspecified, intra-abdominal lymph nodes |
C83.94 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of axilla and upper limb |
C83.95 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of inguinal region and lower limb |
C83.96 |
Non-follicular (diffuse) lymphoma, unspecified, intrapelvic lymph nodes |
C83.97 |
Non-follicular (diffuse) lymphoma, unspecified, spleen |
C83.98 |
Non-follicular (diffuse) lymphoma, unspecified, lymph nodes of multiple sites |
C83.99 |
Non-follicular (diffuse) 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 |
C86.6 |
Primary cutaneous CD30-positive T-cell proliferations |
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 |
D38.4 |
Neoplasm of uncertain behavior of thymus |
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 |
Z85.07 |
Personal history of malignant neoplasm of pancreas |
Z85.09 |
Personal history of malignant neoplasm of other digestive organs |
Z85.118 |
Personal history of other malignant neoplasm of bronchus and lung |
Z85.238 |
Personal history of other malignant neoplasm of thymus |
Z85.3 |
Personal history of malignant neoplasm of breast
|
Z85.42 |
Personal history of malignant neoplasm of other parts of uterus |
Z85.43 |
Personal history of malignant neoplasm of ovary |
Z85.46 |
Personal history of malignant neoplasm of prostate |
Z85.47 |
Personal history of malignant neoplasm of testis |
Z85.51 |
Personal history of malignant neoplasm of bladder |
Z85.528 |
Personal history of other malignant neoplasm of kidney |
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 |
Personal history of malignant neoplasm of other parts of nervous tissue |
Z85.850 |
Personal history of malignant neoplasm of thyroid |
Z85.858 |
Personal history of malignant neoplasm of other endocrine glands |
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 |
|
|