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Keytruda® (pembrolizumab)

Policy Number: VP-90209

(Intravenous)

 

Last Review Date: 03/05/2024

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

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

 
  1. 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, Primary Cutaneous Lymphomas, RCC (first-line or subsequent therapy), SCCHN, SCLC, Thymic Carcinoma, TMB-H Cancer, TNBC (recurrent unresectable or metastatic disease), Uveal Melanoma, 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 8 weeks of neoadjuvant therapy (3 doses), followed by a maximum of 48 weeks (16 doses) of postoperative therapy after surgery.
  • Adjuvant therapy in Cutaneous Melanoma, 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.*
  • 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 neoadjuvant and 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

  1. Dosing Limits
  1. Quantity Limit (max daily dose) [NDC Unit]:
  • Keytruda 100 mg/4 mL single use vial: 12 vials per 14 day supply
  1. Max Units (per dose and over time) [HCPCS Unit]:

Indication

Billable Units (BU)

Per unit time (days)

Biliary Tract Cancer (Gallbladder Cancer or Intra-/Extra-Hepatic Cholangiocarcinoma), Bladder/Urothelial, Cervical, cHL, cSCC, Cutaneous Melanoma, Endometrial Carcinoma (Uterine Neoplasms), Esophageal, Esophagogastric/Gastroesophageal, Gastric, Gestational Trophoblastic Neoplasia, HCC, MCC, MSI-H/dMMR Cancer, NSCLC, PMBCL, RCC, SCCHN, TMB-H Cancer, & TNBC

200 BU

21 days

400 BU

42 days

Adrenal Gland Tumors, Kaposi Sarcoma, Soft Tissue Sarcoma, Thymic, & Vulvar

200 BU

21 days

CNS Cancer & SCLC

200 BU

21 days

1,200 BU

14 days

Anal Carcinoma

200 BU

21 days

300 BU

21 days

400 BU

42 days

Primary Cutaneous Lymphomas, Extranodal NK/T-Cell Lymphomas, & Uveal Melanoma

300 BU

21 days

  1. Initial Approval Criteria 1,2

Coverage is provided in the following conditions:

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

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

Universal Criteria

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

Anal Carcinoma2,5,52,92

  • 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

  • Patient has unresectable, resected gross residual (R2), or metastatic disease; AND
  • Used in combination with gemcitabine and cisplatin

Urothelial Carcinoma (Bladder Cancer) † 1,2,8,10,35-37,88,93,99

  • Used in combination with enfortumab vedotin; AND
          • Patient has locally advanced or metastatic urothelial carcinoma ; AND
      • Used as first-line therapy; OR
    • Patient has one of the following diagnoses:
            • 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 ; AND
      • Used as first-line therapy in cisplatin ineligible patients*; 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 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)
        • 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

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

** 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

  • 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

Esophageal Cancer and Esophagogastric/Gastroesophageal Junction Cancer † ‡ Ф 1,2,39-41,66,67,95,98,101

  • 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; 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; 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
    • Patient has intermediate placental site trophoblastic tumor (PSTT) or epithelioid trophoblastic tumor (ETT); AND
      • Used for recurrent or progressive disease; OR
    • Patient has high risk disease (i.e., ≥7 prognostic score or stage IV disease)

Squamous Cell Carcinoma of the Head and Neck (SCCHN) † ‡ 1,2,31,32,106

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, or 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
  • Patient has Child-Pugh Class A liver impairment (i.e., excluding Child-Pugh Class B and C); 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 unresectable disease and is not a transplant candidate; OR
      • Patient has liver-confined disease that is inoperable by performance status, comorbidity, or with minimal or uncertain extrahepatic-disease; OR
      • Patient has metastatic disease or extensive liver tumor burden

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 Sarcoma2,85,86

  • 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 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

  • Used as first-line therapy as a single agent for unresectable or metastatic* disease; OR
  • Used as initial treatment of limited resectable disease; AND
    • Used as a single agent; AND
      • Patient has stage III disease with clinical satellite/in-transit metastases; OR
      • Patient has local satellite/in-transit recurrence; OR
  • Used as subsequent therapy; 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 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 is at least 12 years of age; OR
      • Patient has sentinel node positive disease either during observation without additional nodal surgery and with mandatory radiographic nodal surveillance OR after complete lymph node dissection (CLND); OR
      • Patient has clinically positive node(s) following wide excision of the primary tumor and therapeutic lymph node dissection (TLND) OR following neoadjuvant therapy; OR
      • Patient has clinical satellite/in-transit metastases and has no evidence of disease (NED) after complete excision 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 following neoadjuvant therapy; 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 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
  • 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 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)

* 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; 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, cutaneous angiosarcoma, 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 or stage IV disease (Note: only applies to Retroperitoneal/Intra-Abdominal**); OR
        • Used as subsequent therapy for recurrent unresectable or recurrent stage IV disease (Note: only applies to Retroperitoneal/Intra-Abdominal**)

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

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

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 has unresectable or metastatic disease

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
  • Used in combination with carboplatin and paclitaxel, followed by single agent maintenance therapy; AND
    • Patient has clear cell carcinoma, endometrioid adenocarcinoma, serous carcinoma, or undifferentiated/dedifferentiated carcinoma (excluding use in carcinosarcoma); AND
            • Used as primary or adjuvant therapy for patients with stage III-IV tumors; OR
            • Used as first-line or subsequent therapy for recurrent disease (excluding use as first-line therapy in patients with isolated metastases); OR
  • Used as a single agent as maintenance therapy following treatment with pembrolizumab in combination with carboplatin and paclitaxel

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

  • 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
      • Used as neoadjuvant therapy ; AND
        • Patient has one of the following cancers:
          • Colorectal Cancer
          • Esophageal or Esophagogastric/Gastroesophageal Junction Adenocarcinoma
          • Gastric Cancer; OR
      • 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
      • Used as first-line therapy; AND
      • Patient has one of the following cancers:
        • Esophageal or Esophagogastric/Gastroesophageal Junction Cancer
        • Gastric 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
            • Anaplastic or 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)

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)

Results

Interpretation

  • 0% – <1% of nuclei stain
  • ER-negative
  • 1%–10% of nuclei stain
  • ER-low–positive*
  • >10% of nuclei stain
  • ER-positive

*Note: Patients with cancers with ER-low–positive (1%–10%) results are a heterogeneous group with reported biologic behavior often similar to ER-negative cancers; thus, as such these cancers inherently behave aggressively and may be treated similar to triple-negative disease. Individualized consideration of risks versus benefits should be incorporated into decision-making.

§ Genomic Aberration/Mutational Driver Targeted Therapies

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

EGFR exon 19 deletion or exon 21 L858R tumors

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

EGFR exon 20 insertion mutation positive tumors

NTRK1/2/3 gene fusion positive tumors

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

ALK rearrangement-positive tumors

ROS1 rearrangement-positive tumors

BRAF V600E-mutation positive tumors

ERBB2 (HER2) mutation positive tumors

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

PD-L1 tumor

expression ≥ 1%

MET exon-14 skipping mutations

RET rearrangement-positive tumors

KRAS G12C mutation positive tumors

  • Pembrolizumab
  • Atezolizumab
  • Nivolumab + ipilimumab
  • Cemiplimab
  • Tremelimumab + durvalumab
  • Capmatinib
  • Crizotinib
  • Tepotinib
  • Selpercatinib
  • Cabozantinib
  • Pralsetinib
  • Sotorasib
  • Adagrasib
  1. Renewal Criteria 1-3,5,6,15-17,50,51,53,57,62,65,68,69,72,73,75-77,82,85-87,95,101,103

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 Cancer
      • 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 neoadjuvant and post-operative therapy for MSI-H/dMMR Esophageal, Esophagogastric/Gastroesophageal Junction, & Gastric Cancer)
      • Non-Small Cell Lung Cancer (NSCLC) (first-line or subsequent therapy)
      • 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
      • Tumor Mutational Burden-High (TMB-H) Cancer
      • Triple Negative Breast Cancer (recurrent unresectable or metastatic disease)
      • Uveal Melanoma
      • Vulvar Cancer

Kaposi Sarcoma

  • Coverage may NOT be renewed

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

  • Patient has not exceeded a maximum of 8 weeks of neoadjuvant therapy (3 doses), followed by 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

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 (adjuvant treatment)

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

NSCLC (continuous maintenance treatment)

  • Refer to Section III for criteria

Endometrial Carcinoma (continuous maintenance treatment)

  • Refer to Section III for criteria

Δ Notes:

  • Patients responding to therapy who relapse ≥ 6 months after discontinuation due to duration (i.e., receipt of 24 months of therapy) are eligible to re-initiate PD-directed therapy.
  • Patients previously presenting with aggressive disease who are exhibiting stable disease on treatment as their best response (or if therapy improved performance status) may be eligible for continued therapy beyond the 24-month limit without interruption or discontinuation.
  • Patients who complete adjuvant therapy and progress ≥ 6 months after discontinuation are eligible to re-initiate PD-directed therapy for metastatic disease.
  • Patients whose tumors, upon re-biopsy, demonstrate a change in actionable mutation (e.g., MSS initial biopsy; MSI-H subsequent biopsy) may be eligible to re-initiate PD-directed therapy and will be evaluated on a case-by-case basis.
  • Patients diagnosed with Renal Cell Carcinoma with clear cell histology who have received previous immuno-oncology therapy may be eligible for treatment with pembrolizumab as subsequent therapy and will be evaluated on a case-by-case basis.
  1. Dosage/Administration 1-6,8,12,13,15-17,22-48,50-57,62,65,68,72,73,75-77,82,83,85-87,91,92,95,101,103-106

Indication

Dose

Biliary Tract Cancers, Bladder Cancer/Urothelial Carcinoma, Cervical, cSCC, Endometrial Carcinoma/Uterine Neoplasms (excluding MSI-H/dMMR), HCC, & 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

Neoadjuvant therapy (MSI-H/dMMR disease ONLY):

200 mg intravenously every 3 weeks for 8 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 8 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:

  • Neoadjuvant therapy: 200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks in combination with chemotherapy for 12 weeks or until disease progression that precludes definitive surgery or unacceptable toxicity
  • Adjuvant therapy: 200 mg intravenously every 3 weeks or 400 mg intravenously every 6 weeks as a single agent after surgery for 39 weeks or until disease recurrence or unacceptable toxicity

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 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

Adjuvant treatment:

  • Adults: 200 mg intravenously every 3 weeks or 400 mg every 6 weeks up to a maximum of 12 months in patients without disease recurrence or unacceptable toxicity
  • Pediatrics: 2 mg/kg (up to 200 mg) intravenously every 3 weeks up to a maximum of 12 months in patients without disease recurrence or unacceptable toxicity

Uveal Melanoma

2 mg/kg intravenously every 3 weeks 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 neoadjuvant and post-operative therapy for MSI-H/dMMR Esophageal,  Esophagogastric/Gastroesophageal Junction, & 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

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:

  • Use 100 mg IV (2 mg/kg) every 21 days ; OR
  • Use 200 mg IV (4 mg/kg) every 42 days

Weight is ≤ 82.5 kg:

  • Use 300 mg IV (4 mg/kg) every 42 days

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

  1. Billing Code/Availability Information

HCPCS Code:

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

NDC:

  • Keytruda 100 mg/4 mL single-dose vial: 00006-3026-xx
  1. References
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  4. Ott PA, Bang YJ, Berton-Rigaud D, et al. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. J Clin Oncol. 2017 Aug 1;35(22):2535-2541.
  5. Ott PA, Piha-Paul SA, Munster P, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. Doi: 10.1093/annonc/mdx029.
  6. Zinzani PL, Ribrag V, Moskowitz CH, et al. Safety and tolerability of pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270. Doi: 10.1182/blood-2016-12-758383. Epub 2017 May 10.
  7. U.S. Food and Drug Administrations (FDA). Division of Drug Information. Health Alert. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-health-care-professionals-and-oncology-clinical-investigators-about-efficacy-issue. Accessed August 2018.
  8. 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.
  9. 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 January 2024.
  10. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 3.2023. 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 January 2024.
  11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. 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 January 2024.
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Appendix 1 – Covered Diagnosis Codes

ICD-10

ICD-10 Description

C00.0

Malignant neoplasm of external upper lip

C00.1

Malignant neoplasm of external lower lip

C00.2

Malignant neoplasm of external lip, unspecified

C00.3

Malignant neoplasm of upper lip, inner aspect

C00.4

Malignant neoplasm of lower lip, inner aspect

C00.5

Malignant neoplasm of lip, unspecified, inner aspect

C00.6

Malignant neoplasm of commissure of lip, unspecified

C00.8

Malignant neoplasm of overlapping sites of lip

C00.9

Malignant neoplasm of lip, unspecified

C01

Malignant neoplasm of base of tongue

C02.0

Malignant neoplasm of dorsal surface of tongue

C02.1

Malignant neoplasm of border of tongue

C02.2

Malignant neoplasm of ventral surface of tongue

C02.3

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

C02.4

Malignant neoplasm of lingual tonsil

C02.8

Malignant neoplasm of overlapping sites of tongue

C02.9

Malignant neoplasm of tongue, unspecified

C03.0

Malignant neoplasm of upper gum

C03.1

Malignant neoplasm of lower gum

C03.9

Malignant neoplasm of gum, unspecified

C04.0

Malignant neoplasm of anterior floor of mouth

C04.1

Malignant neoplasm of lateral floor of mouth

C04.8

Malignant neoplasm of overlapping sites of floor of mouth

C04.9

Malignant neoplasm of floor of mouth, unspecified

C05.0

Malignant neoplasm of hard palate

C05.1

Malignant neoplasm of soft palate

C05.8

Malignant neoplasm of overlapping sites of palate

C05.9

Malignant neoplasm of palate, unspecified

C06.0

Malignant neoplasm of cheek mucosa

C06.2

Malignant neoplasm of retromolar area

C06.80

Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89

Malignant neoplasm of overlapping sites of other parts of mouth

C06.9

Malignant neoplasm of mouth, unspecified

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

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

Z85.42

Personal history of malignant neoplasm of other parts of uterus

Z85.43

Personal history of malignant neoplasm of ovary

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

Z85.72

Personal history of non-Hodgkin lymphomas

Z85.820

Personal history of malignant melanoma of skin

Z85.821

Personal history of Merkel cell carcinoma

Z85.830

Personal history of malignant neoplasm of bone