vp-0209
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Keytruda® (pembrolizumab) (Intravenous)

Policy Number: VP-0209

Last Review Date: 10/01/2019

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

 

I. Length of Authorization

   Coverage will be provided for six months and may be renewed.

  • SCCHN, cHL, NSCLC, SCLC, HCC, Urothelial Carcinoma, MPM, MSI-H/dMMR, PMBCL, Cervical, Anal, Vulvar, MCC, Mycosis Fungoides/Sezary Syndrome, RCC, Thymic, Esophageal, Gastric Cancers, and Endometrial Carcinoma can be authorized up to a maximum of 24 months of therapy.
  • Adjuvant therapy in melanoma can be authorized up to a maximum of 12 months of therapy.

II. Dosing Limits

  1. Quantity Limit (max daily dose) [Pharmacy Benefit]:
  • Keytruda 50 mg single use vial: 1 vial per 14 day supply
  • Keytruda 100 mg/4 mL single use vial: 11 vials per 14 day supply
  1. Max Units (per dose and over time) [Medical Benefit]:

SCCHN, cHL, NSCLC, SCLC, Melanoma, Urothelial, Gastric, Esophageal, CNS metastases, PMBCL, Anal, Cervical, Vulvar, MSI-H/dMMR, MCC, RCC, Thymic, HCC Cancer, and Endometrial Carcinoma:

  • 200 billable units every 21 days

MPM & Uterine Cancer:

  • 1150 billable units every 14 days

NK/T-Cell Lymphoma & MF/SS:

  • 250 billable units every 21 days

Gestational Trophoblastic Tumor:

  • 300 billable units every 21 days

III. Initial Approval Criteria

Coverage is provided in the following conditions:

  • Patient must be 18 years of age or older (unless otherwise specified); AND
  • Patient has not received previous therapy with a programmed death (PD-1/PD-L1)-directed therapy (e.g., cemiplimab, avelumab, nivolumab, atezolizumab, durvalumab, etc.) unless otherwise specified; AND

Melanoma

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

      • Used as first-line therapy; OR

      • Used as subsequent therapy after disease progression or maximum clinical benefit from BRAF targeted therapy; OR

      • Used for retreatment of disease as re-induction in patients who experienced disease control (i.e., complete response, partial response, or stable disease with no residual toxicity) from prior checkpoint inhibitor therapy, but subsequently have disease progression/relapse > 3 months after treatment discontinuation; OR

      • Used as adjuvant treatment; OR

      • Patient has uveal melanoma with distant metastatic disease

Gastric Cancer

  • Used as a single agent: AND
  • Patient has gastric or gastro-esophageal junction adenocarcinoma; AND
  • Patient has recurrent, unresectable (or is not a candidate) locally advanced, or metastatic disease; AND
  • Tumor expresses PD-L1 (Combined Positive Score (CPS) ≥1) as determined by an FDA-approved testv; AND
  • Patient progressed on or after at least two prior systemic treatments which must have included a fluoropyrimidine and platinum-containing regimen; AND          
  • Patients with HER2 positive disease must have previously failed on HER2 directed therapy

Esophageal Cancer

  • Used as a single agent: AND
  • Patient has recurrent, locally-advanced, or metastatic disease; AND
  • Used for squamous cell histology disease; AND
  • Tumor expresses PD-L1 (CPS ≥ 10) as determined by an FDA-approved testv; AND
  • Patient progressed on or after at least one prior systemic treatment; AND
  • Patients with HER2 positive disease must have previously failed on HER2 directed therapy

Merkel Cell Carcinoma

  • Patients must be at least 2 years old; AND
  • Used as a single agent; AND
  • Patient has recurrent locally advanced or metastatic disease

     Non-Small Cell Lung Cancer (NSCLC)

  • Used for recurrent, advanced, or metastatic disease; AND

    • Used as initial therapy; AND

    • In combination with pemetrexed AND either carboplatin or cisplatin for non-squamous cell histology for tumors that are EGFR or ALK negative or unknown; OR

    • In combination with carboplatin or cisplatin AND either paclitaxel or albumin-bound paclitaxel for squamous cell histology; OR

    • As single agent therapy for tumors that are EGFR or ALK negative or unknown and expressing PD-L1 [(Tumor Proportion Score (TPS) ≥1%)] as determined by an FDA-approved testv; OR

  • Used for recurrent (excluding locoregional recurrence or symptomatic local disease without evidence of disseminated disease), advanced, or metastatic disease; AND

    • Used as first-line therapy in patients with PS ≤ 1 for genomic tumor aberration (e.g., EGFR, ALK, ROS1 and BRAF) negative or unknown**, and PD-L1 expression <1% or unknown OR as first-line therapy for BRAF V600E-mutation positive tumors; AND

    • Used with either carboplatin or cisplatin in combination with pemetrexed for non-squamous cell histology; OR

    • Used as subsequent therapy in patients with PS ≤ 1 for genomic tumor aberration (e.g., EGFR, ALK, and ROS1) positive and prior targeted therapy§ OR BRAF V600E mutation positive disease OR for PD-L1 expression-positive (≥1%) tumors and EGFR, ALK negative or unknown and no prior platinum-doublet chemotherapy; AND

    • Used with either carboplatin or cisplatin; AND

      • Used in combination with pemetrexed for non-squamous cell histology; OR

      • Used in combination with paclitaxel/nab-paclitaxel for squamous cell histology; OR

    • Used as subsequent therapy as a single agent in patients with a PS ≤ 2 and tumors expressing PD-L1 (TPS ≥1%) as determined by an FDA-approved testv with no prior progression on a PD-1/PD-L1 inhibitor therapy; OR

    • Used as continuation maintenance therapy in patients with a PS ≤ 2 who have achieved tumor response or stable disease following initial therapy; AND

    • Used in combination with pemetrexed if pembrolizumab was given first-line in combination with pemetrexed and either carboplatin or cisplatin for disease of non-squamous cell histology; OR

    • Used as a single agent if pembrolizumab was given first-line line in combination with carboplatin or cisplatin and paclitaxel/nab-paclitaxel for disease of squamous cell histology; OR

    • Used as a single agent if pembrolizumab monotherapy was given first-line for PD-L1 expression positive (TPS ≥1%) and EGFR, ALK negative or unknown; OR

    • Used as single-agent initial therapy in patients with stage III disease who aren’t candidates for surgical resection or definitive chemoradiation with tumors that are expressing PD-L1 (TPS 1%) and with no EGFR or ALK genomic tumor aberrations

  • **Every effort needs to be made to establish the genetic alteration status.

     Squamous Cell Carcinoma of the Head and Neck (SCCHN)

  • Patient has unresectable, recurrent, or metastatic disease; AND
    • Used as first-line therapy; AND
      • Used as a single-agent for tumors expressing PD-L1 [(CPS) ≥1] as determined by an FDA-approved testv; OR
      • Used in combination with fluorouracil and a platinum chemotherapy agent; OR
    • Used as subsequent therapy; AND
      • Used as a single-agent therapy for disease that has progressed on or after platinum-containing chemotherapy; OR
      • Used in combination with fluorouracil and a platinum chemotherapy agent for non-nasopharyngeal disease

     Classical Hodgkin Lymphoma (cHL)

  • Used as a single agent; AND
  • Patients must be at least 2 years old; AND
    • Patient relapsed after three or more prior lines of therapy; OR relapse after two lines of therapy in patients at least 18 years old; OR
    • Used for refractory disease

Primary Mediastinal Large B-Cell Lymphoma (PMBCL)

  • Used as single agent; AND
  • Patient has relapsed or refractory disease; AND
  • Patient must be at least 2 years old

Bladder Cancer/Urothelial Carcinoma †

  • Must be used as a single agent; AND
  • Patient has one of the following diagnoses:
    •  
    • Locally advanced or metastatic Urothelial Carcinoma; OR
    • Disease recurrence post-cystectomy; OR
    • Primary Carcinoma of the Urethra; AND
      • Used for recurrent or metastatic disease and the patient does not have recurrence of stage T3-4 disease or palpable inguinal lymph nodes; OR
      • Used as primary treatment for clinical stage T3-4, cN1-2 disease or cN1-2 palpable inguinal lymph nodes; OR
    •  
    • Metastatic Upper GU Tract Tumors; OR
    • Metastatic Urothelial Carcinoma of the Prostate; AND
  • Used as subsequent therapy after previous platinum treatment*; OR
  • Used as first-line therapy in cisplatin-ineligible patients; AND
    • Patient is carboplatin-ineligible; OR
    • Patient has a PD-L1 has a combined positive score (CPS) of ≥10v

*If platinum treatment occurred greater than 12 months ago, the patient should be re-treated with platinum-based therapy. Patients with comorbidities (e.g., hearing loss, neuropathy, poor PS, renal insufficiency, etc.) may not be eligible for cisplatin. Carboplatin may be substituted for cisplatin particularly in those patients with a GFR <60 mL/min or a PS of 2.

Cervical Cancer

  • Used as a single agent: AND
  • Patient has recurrent or metastatic disease; AND
  • Tumor expresses PD-L1 (combined positive score [CPS ≥1]) as determined by an FDA-approved testv; AND
  • Disease progressed on or after chemotherapy

Microsatellite Instability-High (MSI-H) Cancer

  • Patient must be at least 2 years old; AND
  • Used as a single agent; AND
  • Patient’s disease must be microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR); AND
  • Pediatric patients must not have a diagnosis of MSI-H central nervous system cancer; AND
  • Patient has one of the following cancers:
    • Colorectal Cancer
      • Initial therapy in patients with unresectable advanced or metastatic disease who are not candidates for intensive therapy; OR
      • Used as primary treatment in patients with unresectable or metastatic disease who failed adjuvant treatment with FOLFOX (fluorouracil, leucovorin and oxaliplatin) or CapeOX (capecitabine-oxaliplatin) in the previous 12 months; OR
      • Used for unresectable advanced or metastatic disease that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and/or irinotecan
    • Pancreatic Adenocarcinoma
      • Second-line therapy for locally advanced, recurrent,  or metastatic disease after progression for patients with good (ECOG 0-1) performance status
    • Bone Cancer (Ewing Sarcoma, Chondrosarcoma (excluding dedifferentiated or mesenchymal subtypes) or Osteosarcoma)
      • Used for unresectable or metastatic disease after progression following prior treatment and patient has no satisfactory alternative treatment options
    • Gastric adenocarcinoma OR esophageal/gastroesophageal junction adenocarcinoma or squamous cell carcinoma
      • Subsequent therapy for unresectable (or not a candidate for surgery) locally advanced, recurrent, or metastatic disease; AND
      • Patient has a performance score of ECOG ≤ 2 or Karnofsky ≥ 60%
    • Ovarian Cancer (epithelial ovarian, fallopian tube, and primary peritoneal cancers)
      • Used for patients with persistent or recurrent disease; AND
      • Patient is not experiencing an immediate biochemical relapse
    • Uterine Cancer (Endometrial Carcinoma)
      • Used for patients with high risk tumors, or recurrent or metastatic disease, that have progressed following prior cytotoxic chemotherapy
    • Penile Cancer
      • Used as subsequent treatment of unresectable or metastatic disease that is progressive and there are no other satisfactory treatment options
    • Testicular Cancer
      • Used as single-agent third-line therapy
    • Hepatobiliary Cancer (Gall bladder cancer; intra-/extra-hepatic cholangiocarcinoma)
      • Used as initial therapy for unresectable or metastatic disease; OR
      • Used for resected gross residual disease (R2)
    • Vulvar Squamous Cell Carcinoma
      • Used for advanced, recurrent or metastatic disease as second-line therapy
    • Cervical Cancer
      • Used second-line for recurrent or metastatic disease
    • Small Bowel Adenocarcinoma
      • Used as initial therapy for advanced or metastatic disease in patients with prior oxaliplatin therapy in the adjuvant setting (or contraindication); OR
      • Used as subsequent therapy for advanced or metastatic disease
    • Other Solid Tumor (e.g., adrenal gland tumors, poorly differentiated-high grade-neuroendocrine tumors [NET], large or small cell NET, etc.)
      • Used for unresectable or metastatic disease that progressed following prior treatment and there are no satisfactory alternative treatment options

Vulvar Squamous Cell Carcinoma ‡

  • Used as second-line therapy as a single agent; AND
  • Patient has progressive advanced, recurrent or metastatic disease; AND
  • Tumor expresses PD-L1 (CPS ≥1%) as determined by an FDA-approved testv

Thymic Carcinoma ‡

  • Used as second-line therapy as a single agent; AND
    • Patient has unresectable disease following first-line chemotherapy for potentially resectable locally advanced disease, solitary metastasis, or ipsilateral pleural metastasis; OR
    • Patient has extra-thoracic metastatic disease

Malignant Pleural Mesothelioma ‡

  • Used as subsequent therapy as a single agent

Central Nervous System Cancer ‡

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

T-Cell Lymphoma/Extranodal NK ‡

  • Patient has relapsed or refractory nasal type disease; AND
  • Disease progressed following additional treatment with an alternative asparaginase-based chemotherapy regimen, if not previously used; AND
  • Participation in a clinical trial is unavailable

     Anal Carcinoma ‡

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

    Gestational Trophoblastic Neoplasia ‡

  • Used as single-agent therapy; AND
    • Patient has recurrent or progressive intermediate placental or epitheloid trophoblastic tumor; AND
      • Patient was previously treated with a platinum/etoposide containing regimen; OR
    • Patient has methotrexate-resistant high risk disease

Small Cell Lung Cancer (SCLC) †

  • Used as subsequent single-agent therapy; AND
    • Patient has primary progressive disease; OR
    • Patient relapsed within 6 months following a complete or partial response or after stable disease after initial treatment

Hepatocellular Carcinoma (HCC) †

  • Used as a single agent; AND
  • Patient progressed on or was intolerant to sorafenib; AND
  • Patient has a laboratory confirmed diagnosis of hepatocellular carcinoma; AND
  • Patient has Child-Pugh Class A (excluding Child-Pugh Class B and C) liver impairment

Mycosis Fungoides/Sezary Syndrome ‡

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

Renal Cell Carcinoma (RCC) †

  • Patient has advanced, relapsed or metastatic disease; AND
  • Used in combination with axitinib; AND
    • Used as first-line treatment; OR
    • Used as subsequent therapy for clear-cell histology

Endometrial Carcinoma (Uterine Cancer) †

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

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

FDA Approved Indication(s); Compendia Approved Indication(s)

Genomic Aberration Targeted Therapies (not all inclusive) §

Sensitizing EGFR mutation-positive tumors

  • Erlotinib
  • Afatinib
  • Gefitinib
  • Osimertinib
  • Dacomitinib

ALK rearrangement-positive tumors

  • Crizotinib
  • Ceritinib
  • Brigatinib
  • Alectinib
  • Lorlatinib

ROS1 rearrangement-positive tumors

  • Crizotinib 
  • Ceritinib

BRAF V600E-mutation positive tumors

  • Dabrafenib/Trametinib

NTRK Gene Fusion positive tumors

  • Larotrectinib

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

  • Pembrolizumab
  • Atezolizumab

 

IV. Renewal Criteria

Coverage can be renewed based upon the following criteria:

  • Patient continues to meet the criteria identified in section III; AND
  • Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
  • Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include severe infusion reactions, immune-mediated adverse reactions (e.g., pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction, skin, etc), etc.).; AND
  • For the follow indications, patient has not exceeded a maximum of twenty-four (24) months of therapy:
      • Squamous Cell Carcinoma of the Head and Neck (SCCHN)
      • Non-Small Cell Lung Cancer (NSCLC)
      • Classical Hodgkin Lymphoma (cHL)
      • Primary Mediastinal Large B-Cell Lymphoma (PMBCL)
      • Urothelial Carcinoma
      • MSI-H Cancer (including the following cancers: colorectal, pancreatic, bone, gastric/gastroesophageal, ovarian, uterine, penile, testicular, hepatobiliary and other solid tumors)
      • Anal Cancer
      • Malignant Pleural Mesothelioma
      • Gastric/GEJ Adenocarcinoma
      • Esophageal Cancer
      • Cervical Cancer
      • Vulvar Squamous Cell Carcinoma
      • Merkel Cell Carcinoma
      • Mycosis Fungoides/Sezary Syndrome
      • Renal Cell Carcinoma
      • Squamous Cell Lung Cancer (SCLC)
      • Hepatocellular Carcinoma (HCC)
      • Endometrial Carcinoma

     Melanoma (metastatic or unresectable disease) ‡

  • Refer to Section III for criteria

Continuation Maintenance Therapy for NSCLC

  • Refer to Section III for criteria

V. Dosage/Administration

Indication

Dose

NSCLC, SCLC, HCC, SCCHN, Gastric/GEJ Carcinoma, Esophageal, Anal, Cervical, Vulvar and  Urothelial Carcinoma, RCC, Thymic, Endometrial Carcinoma

200 mg every 21 days until disease progression, unacceptable toxicity, or up to a maximum of 24 months in patients without disease progression

Melanoma

200 mg every 21 days (adjuvant therapy for up to 1 year of treatment)

CNS metastases

200 mg every 21 days

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

Adults*:

200 mg every 21 days

Pediatrics*:

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

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

MPM & Uterine Cancer

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

NK/T-Cell Lymphoma & MF/SS

2 mg/kg every 21 days

Gestational Trophoblastic Tumor

3 mg/kg every 21 days

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

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

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

 

VI. Billing Code/Availability Information

Jcode:

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

      NDC:

  • Keytruda 50 mg single use vial: 00006-3029-XX (Discontinued)
  • Keytruda 100 mg/4 mL single use vial: 00006-3026-XX

VII. References

  1. Keytruda [package insert]. Whitehouse Station, NJ; Merck & Co, Inc; July 2019. Accessed September 2019.
  2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) pembrolizumab. National Comprehensive Cancer Network, 2019. 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 September 2019.
  3. Alley EW, Lopez J, Santoro A, et al. Clinical safety and activity of pembrolizumab in patients with malignant pleural mesothelioma (KEYNOTE-028): preliminary results from a non-randomised, open-label, phase 1b trial. See comment in PubMed Commons belowLancet Oncol. 2017 May;18(5):623-630.
  4. Ott PA, Bang YJ, Berton-Rigaud D, et al. Safety and Antitumor Activity of Pembrolizumab in Advanced Programmed Death Ligand 1-Positive Endometrial Cancer: Results From the KEYNOTE-028 Study. J Clin Oncol. 2017 Aug 1;35(22):2535-2541.
  5. Ott PA, Piha-Paul SA, Munster P, et al. Safety and antitumor activity of the anti-PD-1 antibody pembrolizumab in patients with recurrent carcinoma of the anal canal. Ann Oncol. 2017 May 1;28(5):1036-1041. doi: 10.1093/annonc/mdx029.
  6. Zinzani PL, Ribrag V, Moskowitz CH, et al. Safety and tolerability of pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270. doi: 10.1182/blood-2016-12-758383. Epub 2017 May 10.
  7. U.S. Food and Drug Administrations (FDA). Division of Drug Information. Health Alert. http://s2027422842.t.en25.com/e/es?s=2027422842&e=88882&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=3f0714083e82421a8af346a664bedbfb&elqaid=3588&elqat=1. Accessed May 2018
  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 multicentre, 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 2.201 National Comprehensive Cancer Network, 2019. 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 Septmeber 2019
  10. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Bladder Cancer. Version 4.2019. National Comprehensive Cancer Network, 2019. 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 September 2019.
  11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) Non-Small Cell Lung Cancer. Version 7.2019. National Comprehensive Cancer Network, 2019. 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 September 2019.
  12. Ghorani E, Kaur B, Fisher RA, et al. Pembrolizumab is effective for drug-resistant gestational trophoblastic neoplasia. Lancet. 2017 Nov 25;390(10110):2343-2345.
  13. Chung HC, Lopez-Martin JA, Kao S, et al. Phase 2 study of pembrolizumab in advanced small-cell lung cancer (SCLC): KEYNOTE-158. J Clin Oncol 2018;36: Abstract 8506
  14. National Institutes of Health. Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/KEYNOTE-054). Available at: http://clinicaltrials.gov/show/NCT02362594.
  15. Khodadoust M, Rook AH, Porcu P, et al. Pembrolizumab for Treatment of Relapsed/Refractory Mycosis Fungoides and Sezary Syndrome: Clinical Efficacy in a Citn Multicenter Phase 2 Study. Blood 2016 128:181
  16. Giaccone, G, Kim C, Thompson J, et al. Pembrolizumab in patients with thymic carcinoma: a single-arm, single-centre, phase 2 study. Lancet. Volume 19, ISSUE 3, P347-355, March 01, 2018
  17. Cho J, Kim HS, Ku BM, et al. Pembrolizumab for Patients With Refractory or Relapsed Thymic Epithelial Tumor: An Open-Label Phase II Trial. J Clin Oncol. 2018 Jun 15:JCO2017773184. doi: 10.1200/JCO.2077.3184. [Epub ahead of print]

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

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

C06.0

Malignant neoplasm of cheek mucosa

C06.2

Malignant neoplasm of retromolar area

C06.80

Malignant neoplasm of overlapping sites of unspecified parts of mouth

C06.89

Malignant neoplasm of overlapping sites of other parts of mouth

C06.9

Malignant neoplasm of mouth, unspecified

C09.0

Malignant neoplasm of tonsillar fossa

C09.1

Malignant neoplasm of tonsillar pillar (anterior) (posterior)

C09.8

Malignant neoplasm of overlapping sites of tonsil

C09.9

Malignant neoplasm of tonsil, unspecified

C10.3

Malignant neoplasm of posterior wall of oropharynx

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

C22.9

Malignant neoplasm of liver, not specified as primary or secondary

C23

Malignant neoplasm of gallbladder

C24.0

Malignant neoplasm of extrahepatic bile duct

C24.8

Malignant neoplasm of overlapping sites of biliary tract

C24.9

Malignant neoplasm of biliary tract, unspecified

C25.0

Malignant neoplasm of head of pancreas

C25.1

Malignant neoplasm of body of the pancreas

C25.2

Malignant neoplasm of tail of pancreas

C25.3

Malignant neoplasm of pancreatic duct

C25.7

Malignant neoplasm of other parts of pancreas

C25.8

Malignant neoplasm of overlapping sites of pancreas

C25.9

Malignant neoplasm of pancreas, unspecified

C31.0

Malignant neoplasm of maxillary sinus

C31.1

Malignant neoplasm of ethmoidal sinus

C32.0

Malignant neoplasm of glottis

C32.1

Malignant neoplasm of supraglottis

C32.2

Malignant neoplasm of subglottis

C32.3

Malignant neoplasm of laryngeal cartilage

C32.8

Malignant neoplasm of overlapping sites of larynx

C32.9

Malignant neoplasm of larynx, unspecified

C33

Malignant neoplasm of trachea

C34.00

Malignant neoplasm of unspecified main bronchus

C34.01

Malignant neoplasm of right main bronchus

C34.02

Malignant neoplasm of left main bronchus

C34.10

Malignant neoplasm of upper lobe, unspecified bronchus or lung

C34.11

Malignant neoplasm of upper lobe, right bronchus or lung

C34.12

Malignant neoplasm of upper lobe, left bronchus or lung

C34.2

Malignant neoplasm of middle lobe, bronchus or lung

C34.30

Malignant neoplasm of lower lobe, unspecified bronchus or lung

C34.31

Malignant neoplasm of lower lobe, right bronchus or lung

C34.32

Malignant neoplasm of lower lobe, left bronchus or lung

C34.80

Malignant neoplasm of overlapping sites of unspecified bronchus and lung

C34.81

Malignant neoplasm of overlapping sites of right bronchus and lung

C34.82

Malignant neoplasm of overlapping sites of left bronchus and lung

C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

C37

Malignant neoplasm of thymus

C38.4

Malignant neoplasm of pleura

C40.00

Malignant neoplasm of scapula and long bones of unspecified upper limb

C40.01

Malignant neoplasm of scapula and long bones of right upper limb

C40.02

Malignant neoplasm of scapula and long bones of left upper limb

C40.10

Malignant neoplasm of short bones of unspecified upper limb

C40.11

Malignant neoplasm of short bones of right upper limb

C40.12

Malignant neoplasm of short bones of left upper limb

C40.20

Malignant neoplasm of long bones of unspecified lower limb

C40.21

Malignant neoplasm of long bones of right lower limb

C40.22

Malignant neoplasm of long bones of left lower limb

C40.30

Malignant neoplasm of short bones of unspecified lower limb

C40.31

Malignant neoplasm of short bones of right lower limb

C40.32

Malignant neoplasm of short bones of left lower limb

C40.80

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

C40.81

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

C40.82

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

C40.90

Malignant neoplasm of unspecified bones and articular cartilage of unspecified limb

C40.91

Malignant neoplasm of unspecified bones and articular cartilage of right limb

C40.92

Malignant neoplasm of unspecified bones and articular cartilage of left limb

C41.0

Malignant neoplasm of bones of skull and face

C41.1

Malignant neoplasm of  mandible

C41.2

Malignant neoplasm of vertebral column

C41.3

Malignant neoplasm of ribs, sternum and clavicle

C41.4

Malignant neoplasm of pelvic bones, sacrum and coccyx

C41.9

Malignant neoplasm of bone and articular cartilage, unspecified

C43.0

Malignant melanoma of lip

C43.10

Malignant melanoma of unspecified eyelid, including canthus

C43.11

Malignant melanoma of right eyelid, including canthus

C43.12

Malignant melanoma of left eyelid, including canthus

C43.20

Malignant melanoma of unspecified ear and external auricular canal

C43.21

Malignant melanoma of right ear and external auricular canal

C43.22

Malignant melanoma of left ear and external auricular canal

C43.30

Malignant melanoma of unspecified part of face

C43.31

Malignant melanoma of nose

C43.39

 Malignant melanoma of other parts of face

C43.4

Malignant melanoma of scalp and neck

C43.51

Malignant melanoma of anal skin

C43.52

Malignant melanoma of skin of breast

C43.59

Malignant melanoma of other part of trunk

C43.60

Malignant melanoma of unspecified upper limb, including shoulder

C43.61

Malignant melanoma of right upper limb, including shoulder

C43.62

Malignant melanoma of left upper limb, including shoulder

C43.70

Malignant melanoma of unspecified lower limb, including hip

C43.71

Malignant melanoma of right lower limb, including hip

C43.72

Malignant melanoma of left lower limb, including hip

C43.8

Malignant melanoma of overlapping sites of skin

C43.9

Malignant melanoma of skin, unspecified

C44.00

Unspecified malignant neoplasm of skin of lip

C44.02

Squamous cell carcinoma of skin of lip

C44.09

Other specified malignant neoplasm of skin of lip

C45.0

Mesothelioma of pleura

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

C4A.0

Merkel cell carcinoma of lip

C4A.10

Merkel cell carcinoma of eyelid, including canthus

C4A.11

Merkel cell carcinoma of right eyelid, including canthus

C4A.12

Merkel cell carcinoma of left 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

C51.0

Malignant neoplasm of labium majus

C51.1

Malignant neoplasm of labium minus

C51.2

Malignant neoplasm of clitoris

C51.8

Malignant neoplasm of overlapping sites of vulva

C51.9

Malignant neoplasm of vulva, unspecified

C53.0

Malignant neoplasm of endocervix

C53.1

Malignant neoplasm of exocervix

C53.8

Malignant neoplasm of overlapping sites of cervix uteri

C53.9

Malignant neoplasm of cervix uteri, unspecified

C54.0

Malignant neoplasm of isthmus uteri

C54.1

Malignant neoplasm of endometrium

C54.2

Malignant neoplasm of myometrium

C54.3

Malignant neoplasm of fundus uteri

C54.8

Malignant neoplasm of overlapping sites of corpus uteri

C54.9

Malignant neoplasm of corpus uteri, unspecified

C55

Malignant neoplasm of uterus, part unspecified

C56.1

Malignant neoplasm of right ovary

C56.2

Malignant neoplasm of left ovary

C56.9

Malignant neoplasm of unspecified ovary

C57.00

Malignant neoplasm of unspecified fallopian tube

C57.01

Malignant neoplasm of right fallopian tube

C57.02

Malignant neoplasm of left fallopian tube

C57.10

Malignant neoplasm of unspecified broad ligament

C57.11

Malignant neoplasm of right broad ligament

C57.12

Malignant neoplasm of left broad ligament

C57.20

Malignant neoplasm of unspecified round ligament

C57.21

Malignant neoplasm of right round ligament

C57.22

Malignant neoplasm of left round ligament

C57.3

Malignant neoplasm of parametrium

C57.4

Malignant neoplasm of uterine adnexa, unspecified

C57.7

Malignant neoplasm of other specified female genital organs

C57.8

Malignant neoplasm of overlapping sites of female genital organs

C57.9

Malignant neoplasm of female genital organ, unspecified

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

C69.90

Malignant neoplasm of unspecified site of unspecified eye

C69.91

Malignant neoplasm of unspecified site of right eye

C69.92

Malignant neoplasm of unspecified site of left eye

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

C78.89

Secondary malignant neoplasm of other digestive organs

C79.31

Secondary malignant neoplasm of brain

C79.51

Secondary malignant neoplasm of bone

C79.52

Secondary malignant neoplasm of bone marrow

C79.82

Secondary malignant neoplasm of genital organs

C79.89

Secondary malignant neoplasm of other specified sites

C79.9

Secondary malignant neoplasm of unspecified site

C7A.1

Malignant poorly differentiated neuroendocrine tumors

C7A.8

Other malignant neuroendocrine tumors

C7B.8

Other secondary 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

C81.10

Nodular sclerosis Hodgkin lymphoma, unspecified site

C81.11

Nodular sclerosis Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.12

Nodular sclerosis Hodgkin lymphoma, intrathoracic lymph nodes

C81.13

Nodular sclerosis Hodgkin lymphoma, intra-abdominal lymph nodes

C81.14

Nodular sclerosis Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.15

Nodular sclerosis Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.16

Nodular sclerosis Hodgkin lymphoma, intrapelvic lymph nodes

C81.17

Nodular sclerosis Hodgkin lymphoma, spleen

C81.18

Nodular sclerosis Hodgkin lymphoma, lymph nodes of multiple sites

C81.19

Nodular sclerosis Hodgkin lymphoma, extranodal and solid organ sites

C81.20

Mixed cellularity Hodgkin lymphoma, unspecified site

C81.21

Mixed cellularity Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.22

Mixed cellularity Hodgkin lymphoma, intrathoracic lymph nodes

C81.23

Mixed cellularity Hodgkin lymphoma, intra-abdominal lymph nodes

C81.24

Mixed cellularity Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.25

Mixed cellularity Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.26

Mixed cellularity Hodgkin lymphoma, intrapelvic lymph nodes

C81.27

Mixed cellularity Hodgkin lymphoma, spleen

C81.28

Mixed cellularity Hodgkin lymphoma, lymph nodes of multiple sites

C81.29

Mixed cellularity Hodgkin lymphoma, extranodal and solid organ sites

C81.30

Lymphocyte depleted Hodgkin lymphoma, unspecified site

C81.31

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.32

Lymphocyte depleted Hodgkin lymphoma, intrathoracic lymph nodes

C81.33

Lymphocyte depleted Hodgkin lymphoma, intra-abdominal lymph nodes

C81.34

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.35

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.36

Lymphocyte depleted Hodgkin lymphoma, intrapelvic lymph nodes

C81.37

Lymphocyte depleted Hodgkin lymphoma, spleen

C81.38

Lymphocyte depleted Hodgkin lymphoma, lymph nodes of multiple sites

C81.39

Lymphocyte depleted Hodgkin lymphoma, extranodal and solid organ sites

C81.40

Lymphocyte-rich Hodgkin lymphoma, unspecified site

C81.41

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of head, face, and neck

C81.42

Lymphocyte-rich Hodgkin lymphoma, intrathoracic lymph nodes

C81.43

Lymphocyte-rich Hodgkin lymphoma, intra-abdominal lymph nodes

C81.44

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of axilla and upper limb

C81.45

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of inguinal region and lower limb

C81.46

Lymphocyte-rich Hodgkin lymphoma, intrapelvic lymph nodes

C81.47

Lymphocyte-rich Hodgkin lymphoma, spleen

C81.48

Lymphocyte-rich Hodgkin lymphoma, lymph nodes of multiple sites

C81.49

Lymphocyte-rich Hodgkin lymphoma, extranodal and solid organ sites

C81.70

Other Hodgkin lymphoma unspecified site

C81.71

Other Hodgkin lymphoma lymph nodes of head, face, and neck

C81.72

Other Hodgkin lymphoma intrathoracic lymph nodes

C81.73

Other Hodgkin lymphoma intra-abdominal lymph nodes

C81.74

Other Hodgkin lymphoma lymph nodes of axilla and upper limb

C81.75

Other Hodgkin lymphoma lymph nodes of inguinal region and lower limb

C81.76

Other Hodgkin lymphoma intrapelvic lymph nodes

C81.77

Other Hodgkin lymphoma spleen

C81.78

Other Hodgkin lymphoma lymph nodes of multiple sites

C81.79

Other Hodgkin lymphoma extranodal and solid organ sites

C81.90

Hodgkin lymphoma, unspecified, unspecified site

C81.91

Hodgkin lymphoma, unspecified, lymph nodes of head, face, and neck

C81.92

Hodgkin lymphoma, unspecified, intrathoracic lymph nodes

C81.93

Hodgkin lymphoma, unspecified, intra-abdominal lymph nodes

C81.94

Hodgkin lymphoma, unspecified, lymph nodes of axilla and upper limb

C81.95

Hodgkin lymphoma, unspecified, lymph nodes of inguinal region and lower limb

C81.96

Hodgkin lymphoma, unspecified, intrapelvic lymph nodes

C81.97

Hodgkin lymphoma, unspecified, spleen

C81.98

Hodgkin lymphoma, unspecified, lymph nodes of multiple sites

C81.99

Hodgkin lymphoma, unspecified, extranodal and solid organ sites

C84.00

Mycosis fungoides, unspecified site

C84.01

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

C84.02

Mycosis fungoides, intrathoracic lymph nodes

C84.03

Mycosis fungoides, intra-abdominal lymph nodes

C84.04

Mycosis fungoides, lymph nodes of axilla and upper limb

C84.05

Mycosis fungoides, lymph nodes of inguinal region and lower limb

C84.06

Mycosis fungoides, intrapelvic lymph nodes

C84.07

Mycosis fungoides, spleen

C84.08

Mycosis fungoides, lymph nodes of multiple sites

C84.09

Mycosis fungoides, extranodal and solid organ sites

C84.10

Sézary disease, unspecified site

C84.11

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

C84.12

Sézary disease, intrathoracic lymph nodes

C84.13

Sézary disease, intra-abdominal lymph nodes

C84.14

Sézary disease, lymph nodes of axilla and upper limb

C84.15

Sézary disease, lymph nodes of inguinal region and lower limb

C84.16

Sézary disease, intrapelvic lymph nodes

C84.17

Sézary disease, spleen

C84.18

Sézary disease, lymph nodes of multiple sites

C84.19

Sézary disease, extranodal and solid organ sites

C84.90

Mature T/NK-cell lymphomas, unspecified site

C84.91

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

C84.92

Mature T/NK-cell lymphomas, intrathoracic lymph nodes

C84.93

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

C84.94

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

C84.95

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

C84.96

Mature T/NK-cell lymphomas, intrapelvic lymph nodes

C84.97

Mature T/NK-cell lymphomas, spleen

C84.98

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

C84.99

Mature T/NK-cell lymphomas, extranodal and solid organ sites

C84.Z0

Other mature T/NK-cell lymphomas, Unspecified site

C84.Z1

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

C84.Z2

Other mature T/NK-cell lymphomas, intrathoracic lymph nodes

C84.Z3

Other mature T/NK-cell lymphomas, intra-abdominal lymph nodes

C84.Z4

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

C84.Z5

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

C84.Z6

Other mature T/NK-cell lymphomas, intrapelvic lymph nodes

C84.Z7

Other mature T/NK-cell lymphomas, spleen

C84.Z8

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

C84.Z9

Other mature T/NK-cell lymphomas, extranodal and solid organ sites

C85.20

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

C85.21

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

C85.22

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

C85.23

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

C85.24

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

C85.25

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

C85.26

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

C85.27

Mediastinal (thymic) large B-cell lymphoma, spleen

C85.28

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

C85.29

Mediastinal (thymic) large B-cell lymphoma, extranodal and solid organ sites

C86.0

Other specified types of T/NK-cell lymphoma

D09.0

Carcinoma in situ of bladder

D15.0

Benign neoplasm of other and unspecified intrathoracic organs

D37.01

Neoplasm of uncertain behavior of lip

D37.02

Neoplasm of uncertain behavior of tongue

D37.05

Neoplasm of uncertain behavior of pharynx

D37.09

Neoplasm of uncertain behavior of other specified sites of the oral cavity

D37.1

Neoplasm of uncertain behavior of stomach

D37.8

Neoplasm of uncertain behavior of other specified digestive organs

D37.9

Neoplasm of uncertain behavior of digestive organ, unspecified

D38.0

Neoplasm of uncertain behavior of larynx

D38.5

Neoplasm of uncertain behavior of other respiratory organs

D38.6

Neoplasm of uncertain behavior of respiratory organ, unspecified

D39.2

Neoplasm of uncertain behavior of placenta

D39.8

Neoplasm of uncertain behavior of other specified female genital organs

D39.9

Neoplasm of uncertain behavior of female genital organ, 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

Z85.038

Personal history of other malignant neoplasm of large intestine

Z85.068

Personal history of other malignant neoplasm of small intestine

Z85.07

Personal history of malignant neoplasm of pancreas

Z85.118

Personal history of other malignant neoplasm of bronchus and lung

Z85.21

Personal history of malignant neoplasm of larynx

Z85.22

Personal history of malignant neoplasm of nasal cavities, middle ear, and accessory sinuses

Z85.43

Personal history of malignant neoplasm of ovary

Z85.46

Personal history of malignant neoplasm of prostate

Z85.47

Personal history of malignant neoplasm of testis

Z85.49

Personal history of malignant neoplasm of other male genital organs

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

Z85.810

Personal history of malignant neoplasm of tongue

Z85.818

Personal history of malignant neoplasm of other sites of lip, oral cavity and pharynx

Z85.819

Personal history of malignant neoplasm of unspecified site of lip, oral cavity and pharynx

Z85.820

Personal history of malignant melanoma of skin

Z85.821

Personal history of Merkel cell carcinoma

Z85.830

Personal history of malignant neoplasm of bone

Z85.858

Personal history of malignant neoplasm of other endocrine glands

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

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

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

Medicare Part B Administrative Contractor (MAC) Jurisdictions

Jurisdiction

Applicable State/US Territory

Contractor

E (1)

CA, HI, NV, AS, GU, CNMI

Noridian Healthcare Solutions, LLC

F (2 & 3)

AK, WA, OR, ID, ND, SD, MT, WY, UT, AZ

Noridian Healthcare Solutions, LLC

5

KS, NE, IA, MO

Wisconsin Physicians Service Insurance Corp (WPS)

6

MN, WI, IL

National Government Services, Inc. (NGS)

H (4 & 7)

LA, AR, MS, TX, OK, CO, NM

Novitas Solutions, Inc.

8

MI, IN

Wisconsin Physicians Service Insurance Corp (WPS)

N (9)

FL, PR, VI

First Coast Service Options, Inc.

J (10)

TN, GA, AL

Palmetto GBA, LLC

M (11)

NC, SC, WV, VA (excluding below)

Palmetto GBA, LLC

L (12)

DE, MD, PA, NJ, DC (includes Arlington & Fairfax counties and the city of Alexandria in VA)

Novitas Solutions, Inc.

K (13 & 14)

NY, CT, MA, RI, VT, ME, NH

National Government Services, Inc. (NGS)

15

KY, OH

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