Last Review Date: 11/05/2024

Date of Origin: 02/28/2012

Dates Reviewed: 06/2012, 09/2012, 09/2012, 12/2012, 03/2013, 06/2013, 09/2013, 12/2013, 03/2014, 06/2014, 09/2014, 12/2014, 03/2015, 05/2015, 08/2015, 11/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 04/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020, 12/2020, 03/2021, 06/2021, 09/2021, 12/2021, 03/2022, 06/2022, 09/2022, 12/2022, 03/2023, 06/2023, 09/2023, 12/2023, 03/2024, 05/2024, 8/2024, 11/2024

1. Length of Authorization ^{1,5,7,15,18,21}

Coverage will be provided for 6 months and may be renewed (unless otherwise specified).

• Treatment of previously untreated Pediatric Classical Hodgkin Lymphoma (cHL) as a component of Bv-AVE-PC (brentuximab vedotin, doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide) has a maximum of 5 doses.
• Pediatric cHL as a component of AEPA (brentuximab vedotin, etoposide, prednisone, doxorubicin) has a maximum of 2 cycles (6 doses).
• Pediatric cHL as a component of CAPDAC (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine) has a maximum of 4 cycles (8 doses).
• Adult cHL in combination with nivolumab has a maximum of 8 doses.
• Pediatric cHL in combination with nivolumab has a maximum of 4 doses.
• Pediatric and Adult cHL in combination with bendamustine has a maximum of 6 doses.
• Adult cHL in combination with ifosfamide, carboplatin, and etoposide (ICE) has a maximum of 4 doses.
• Adult cHL in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD) has a maximum of 6 doses.
• Adult cHL post-auto HSCT, Primary Cutaneous Lymphomas (excluding use with bendamustine or CHP), single agent use for T-Cell Lymphomas (excluding Systemic ALCL), and Pediatric cHL (excluding use with Bv-AVE-PC, AEPA, CAPDAC, nivolumab, or bendamustine) has a maximum of 16 doses.
• Treatment of previously untreated Adult Stage III or IV cHL in combination with AVD (doxorubicin, vinblastine, and dacarbazine) has a maximum of 12 doses.
• Treatment of T-cell lymphomas in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) has a maximum of 8 doses.
• Primary Cutaneous Lymphomas in combination with CHP for Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders has a maximum of 8 doses.

2. Dosing Limits

1. Quantity Limit (max daily dose) [NDC Unit]:

• Adcetris 50 mg single-dose vial: 9 vials every 28 days

2. Max Units (per dose and over time) [HCPCS Unit]:

Classical Hodgkin Lymphoma:

• 1350 billable units every 84 days

All other indications:

2. • 200 billable units every 21 days
3. Initial Approval Criteria ¹

Coverage is provided in the following conditions:

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

Universal Criteria ¹

• • Patient must not be receiving concomitant bleomycin; AND
  • Patient does not have severe renal impairment (i.e., CrCl <30 mL/min); AND
  • Patient does not have moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment; AND
• Patient has CD30-positive disease; AND

Adult Classic Hodgkin Lymphoma (cHL) † ‡ Ф ^1,2,4,12-14

• • Used as single agent therapy; AND
    • Used as consolidation/maintenance therapy post-autologous hematopoietic stem cell transplant (auto-HSCT) in patients at high risk* for relapse or progression † ‡; OR
    • Patient has relapsed disease after failure of auto-HSCT or after failure of at least 2 (two) prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates †; OR
    • Used as subsequent systemic therapy (if not previously used) for relapsed or refractory disease ‡; OR
    • Used as palliative therapy for relapsed or refractory disease ‡; AND

• • • • Patient is > 60 years of age; OR
      • Patient has poor performance status; OR
      • Patient has substantial comorbidities; OR
  • Used in combination with bendamustine; AND
    • Used as subsequent systemic therapy (if not previously used) for relapsed or refractory disease ‡; OR
• Used in combination with nivolumab; AND

• Used as subsequent systemic therapy (if not previously used) for relapsed or refractory disease ‡; OR
  • Used in combination with dacarbazine; AND
    • Used as primary treatment in patients with low ejection fraction ‡; AND
      • Patient is > 60 years of age; OR
      • Patient has poor performance status; OR
      • Patient has substantial comorbidities; OR
  • Used in combination with ifosfamide, carboplatin, and etoposide (ICE); AND
    • Used as subsequent systemic therapy (if not previously used) for relapsed or refractory disease ‡; OR
  • Used in combination with doxorubicin, vinblastine, and dacarbazine (AVD); AND
    • Used as initial therapy for previously untreated stage III or IV disease †; OR
    • Used as primary treatment for stage I-II unfavorable disease with no neuropathy ‡; AND

• • • • Patient is > 60 years of age; OR
      • Patient has poor performance status; OR
      • Patient has substantial comorbidities; OR
  • Used in combination with etoposide, cyclophosphamide, doxorubicin, dacarbazine, dexamethasone (BrECADD); AND
    • Used as primary treatment for stage III-IV disease; AND
    • Patient is 18-61 years of age

Pediatric Classic Hodgkin Lymphoma (cHL) † ‡ Ф ^1,2,24

• Patient is ≤ 18 years of age*; AND
  • • Used as re-induction or subsequent therapy (if not previously used); AND

• • • Patient has relapsed or refractory disease; AND

• • • Used in combination with bendamustine, nivolumab, or gemcitabine; AND
      • Used in patients heavily pretreated with platinum or anthracycline-based chemotherapy; OR
      • Used if a decrease in cardiac function is observed; OR
  • Used as maintenance therapy following high-dose therapy and autologous stem cell rescue (HDT/ASCR); AND
    • Used as a single agent for relapsed or refractory high-risk disease (i.e., progressive disease, refractory disease, or relapse within 1 year of original diagnosis); OR
  • Used as primary therapy in patients with high risk disease**; AND
• Used as a component of AEPA (brentuximab vedotin, etoposide, prednisone, doxorubicin) regimen; OR
• Used as a component of Bv-AVE-PC (brentuximab vedotin, doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide) †; AND
  • • • Patient is at least 2 years of age; OR
  • Used as additional treatment following primary treatment with AEPA regimen in patients with high risk disease**; AND
• Used as a component of CAPDAC (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine) regimen

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

**High risk disease may be defined as: Stage IIB with bulk or E-lesions (involvement of extra-lymphatic tissue), Stage IIIA with E-lesions, or Stage IIIB or IV disease.

Pediatric Aggressive Mature B-Cell Lymphomas (Primary Mediastinal Large B-Cell Lymphoma) ‡ ^2,21

• Patient is ≤ 18 years of age*; AND
• Used in combination with nivolumab or pembrolizumab; AND
• Used as consolidation/additional therapy if a partial response was achieved after therapy for relapsed or refractory disease

*Pediatric Aggressive Mature 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.

T-Cell Lymphomas ^1-3,15,16

• • Peripheral T-Cell Lymphomas (PTCL)

• • Used as a single agent for relapsed or refractory disease as subsequent OR as initial palliative intent therapy for one of the following:
    • • • • • Systemic Anaplastic Large Cell Lymphoma (sALCL) † Ф
            • Peripheral T-Cell Lymphoma not otherwise specified (PTCL-NOS) ‡ Ф
            • Angioimmunoblastic T-cell Lymphoma (AITL) ‡ Ф; OR
  • Used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) as initial therapy for previously untreated:
    • • • • Systemic Anaplastic Large Cell Lymphoma (sALCL) † Ф
          • Peripheral T-Cell Lymphoma not otherwise specified (PTCL-NOS) † Ф
          • Angioimmunoblastic T-cell Lymphoma (AITL) † Ф
          • Enteropathy-Associated T-cell Lymphoma (EATL) ‡ Ф
          • Monomorphic Epitheliotropic Intestinal T-cell Lymphoma (MEITL) ‡
          • Nodal Peripheral T-cell Lymphoma with TFH phenotype (PTCL, TFH) ‡
          • Follicular T-cell Lymphoma (FTCL) ‡

• • Breast-Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) ‡
    • Used as adjuvant therapy as a single agent or in combination with cyclophosphamide, doxorubicin, and prednisone (CHP); AND
• Patient has localized disease to the capsule, implant, or breast with residual disease following an incomplete excision or partial capsulectomy, if either node positive or radiation therapy is not feasible; OR
• Patient has extended disease (stage II-IV); OR
  • • Used as subsequent therapy for relapsed or refractory disease as a single agent
  • Adult T-Cell Leukemia/Lymphoma ‡ Ф
    • Used as a single agent; AND

• • • Used as subsequent therapy for nonresponders to first-line therapy for chronic high risk, acute, or lymphoma subtypes; OR

• • Used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP); AND
    • Used as first-line therapy for chronic high risk, acute or lymphoma subtypes; OR
    • Used as continued treatment in responders to first-line therapy for acute or lymphoma subtypes; OR
    • Used as additional therapy for nonresponders to first-line therapy for chronic low risk or smoldering symptomatic subtype; OR
    • Used as additional therapy for nonresponders to first-line therapy with zidovudine and interferon for chronic high risk subtype; OR

• • • Used as additional therapy (if not previously used) for nonresponders to first-line therapy for acute subtype
  • Extranodal NK/T-Cell Lymphoma ‡ Ф
    • Used as a single agent for relapsed or refractory disease; AND
    • Used following additional therapy with an alternate combination chemotherapy regimen (asparaginase-based) not previously used
  • Hepatosplenic T-Cell Lymphoma ‡
    • Used as single-agent therapy; AND
    • Used for refractory disease as subsequent therapy after 2 (two) first-line therapy regimens

Primary Cutaneous Lymphomas ^1,2,17

• • Mycosis Fungoides (MF) † Ф/Sezary Syndrome (SS) ‡
    • Used as single agent systemic therapy; AND

• • • Used as primary therapy (excluding use in patients with stage IA disease); OR
    • Used as subsequent therapy; OR

• • • Used in combination with bendamustine; AND

• • • Used as primary treatment; AND
      • Patient has stage IVA2 non-Sezary or stage IVB visceral disease (solid organ); OR
      • Patient has generalized cutaneous or extracutaneous lesions with large cell transformation (LCT); AND
        • Used in combination with skin-directed therapy; OR
    • Used as subsequent treatment; AND
      • Used for disease refractory to multiple previous therapies; AND
        • Used in combination with skin-directed therapy; AND
          5. Patient has stage IIB Mycosis Fungoides with generalized tumor lesions; OR
          5. Patient has stage III Mycosis Fungoides; OR
          5. Patient has limited cutaneous lesions with large cell transformation (LCT); OR
      • Used for relapsed or persistent disease; AND
        • Patient has stage IVA2 non-Sezary or stage IVB visceral disease (solid organ); OR
        • Patient has LCT with generalized cutaneous or extracutaneous lesions; AND
          5. Used in combination with skin-directed therapy

• • Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders ‡ Ф
    • Used as a single agent; AND

• • • Patient has primary cutaneous anaplastic large cell lymphoma (pcALCL) † Ф; OR
    • Patient has cutaneous ALCL with regional node (N1) (excludes systemic ALCL); OR
    • Patient has lymphomatoid papulosis (LyP) with extensive lesions that is relapsed or refractory to treatment options (e.g., clinical trial, observation, retreatment with primary treatment, or treatment with alternative regimen not used for primary treatment); OR

• • Used in combination with cyclophosphamide, doxorubicin, and prednisone (CHP); AND
    • Patient has cutaneous ALCL with regional node (N1) (excludes systemic ALCL)

B-Cell Lymphomas ‡ ^2,11

• • Diffuse Large B-Cell Lymphoma (DLBCL), HIV-Related B-Cell Lymphomas (i.e., DLBCL, primary effusion lymphoma, or HHV8-positive DLBCL, not otherwise specified), or High Grade B-Cell Lymphomas

• • • Used as a single agent as subsequent therapy if no intention to proceed to transplant; AND

• • • Used for relapsed disease >12 months after completion of first-line therapy; OR
    • Used for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of first-line therapy*; OR 

• • • Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease*

• • Monomorphic Post-Transplant Lymphoproliferative Disorders (PTLD)

• • • Used as a single agent as subsequent therapy for B-cell type disease if no intention to proceed to transplant; AND

• • • Used for relapsed disease >12 months after completion of initial treatment with chemoimmunotherapy; OR
    • Used for primary refractory disease (partial response, no response, or progression) or relapsed disease <12 months after completion of initial treatment with chemoimmunotherapy*; OR
    • Used as alternative systemic therapy (if not previously used) for relapsed/refractory disease*

*Note: Only applies to patients who are non-candidates for CAR T-cell therapy.

† FDA Approved Indication(s); ‡ Compendia Recommended Indication(s); Ф Orphan Drug

4. Renewal Criteria ¹

Coverage may be renewed based upon the following criteria:

• • Patient continues to meet the universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
  • Disease response with treatment 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: peripheral neuropathy, anaphylaxis and infusion reactions, hematologic toxicities (thrombocytopenia, neutropenia, and anemia), serious infections, opportunistic infections, tumor lysis syndrome, hepatotoxicity, pulmonary toxicity, serious dermatologic reactions, gastrointestinal complications, uncontrolled hyperglycemia, etc.; AND
  • Patient has been evaluated for the presence of progressive multifocal leukoencephalopathy (PML) and has been found to be negative; AND

Pediatric cHL (in combination with Bv-AVE-PC, AEPA, CAPDAC, nivolumab, or bendamustine)

• • Coverage may not be renewed.

Pediatric cHL (all other treatment settings/regimens)

• • Patient has not exceeded a maximum of 16 (sixteen) doses.

Adult cHL (in combination with nivolumab, bendamustine, ICE, BrECADD)

• • Coverage may not be renewed.

Adult cHL (post-auto HSCT consolidation/maintenance)

• • Patient has not exceeded a maximum of 16 (sixteen) doses.

Adult cHL (previously untreated stage III or IV in combination with AVD)

• • Patient has not exceeded a maximum of 12 (twelve) doses.

Primary Cutaneous Lymphomas (excluding in combination with bendamustine or CHP)

• • Patient has not exceeded a maximum of 16 (sixteen) doses.

Primary Cutaneous Lymphomas (in combination with CHP for Primary Cutaneous CD30+ T-Cell Lymphoproliferative Disorders)

• • Coverage may not be renewed.

Single Agent Treatment of T-cell Lymphomas (excluding Systemic ALCL)

• • Patient has not exceeded a maximum of 16 (sixteen) doses.

T-Cell Lymphomas (in combination with CHP)

• • Coverage may not be renewed.

5. Dosage/Administration ^{1,5,7,15,18-21,23,25-31,35-38}

6. Billing Code/Availability Information

HCPCS Code:

• J9042 – Injection, brentuximab vedotin, 1 mg; 1 billable unit = 1 mg

NDC:

• Adcetris 50 mg powder for injection in a single-dose vial: 51144-0050-xx

7. References

1. Adcetris [package insert]. Bothell, WA; Seagen, Inc; June 2023. Accessed October 2024.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for brentuximab vedotin. 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 October 2024.
3. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) T-Cell Lymphomas. Version 4.2024.  National Comprehensive Cancer Network, 2024. The NCCN Compendium^® is a derivative work of the NCCN Guidelines^®. NATIONAL COMPREHENSIVE CANCER NETWORK^®, NCCN^®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed October 2024.
4. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Hodgkin Lymphoma. Version 3.2024.  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 October 2024.
5. Duvic M, Tetzlaff MT, Gangar P, et al. Results of a Phase II trial of brentuximab vedotin for CD30+ cutaneous T-cell lymphoma and lymphomatoid papulosis. J Clin Oncol 2015; 33:3759-65.
6. Horwitz SM, Advani RH, Bartlett NL, et al. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood 2014;123:3095-3100.
7. Alderuccio, JP., Desai, A., Yepes, M.M., et al. Frontline brentuximab vedotin in breast implant-associated anaplastic large-cell lymphoma. Clin Case Rep 2018; 6(4): 634-637. Doi:10.1002/ccr3.1382.
8. Fahrenbruch R, Kintzel P, Bott AM, et al. Dose Rounding of Biologic and Cytotoxic Anticancer Agents: A Position Statement of the Hematology/Oncology Pharmacy Association. J Oncol Pract. 2018 Mar;14(3):e130-e136.
9. Hematology/Oncology Pharmacy Association (Updated January 2022). Intravenous Cancer Drug Waste Issue Brief. Retrieved from https://www.hoparx.org/documents/65/HOPA_Drug_Waste_Issue_Brief_-_Updated_01.19.22_FINAL.pdf
10. Bach PB, Conti RM, Muller RJ, et al. Overspending driven by oversized single dose vials of cancer drugs. BMJ. 2016 Feb 29;352:i788.
11. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) B-Cell Lymphomas. Version 3.2024.  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 October 2024.
12. Connors JM, Jurczak W, Straus DJ, et al. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin’s Lymphoma [published correction appears in N Engl J Med. 2018 Mar 1;378(9):878]. N Engl J Med. 2018;378(4):331-344.
13. Moskowitz CH, Nademanee A, Masszi T, et al. Brentuximab vedotin as consolidation therapy after autologous stem-cell transplantation in patients with Hodgkin’s lymphoma at risk of relapse or progression (AETHERA): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015;385(9980):1853-1862.
14. Younes A, Gopal AK, Smith SE, et al. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin’s lymphoma. J Clin Oncol. 2012;30(18):2183-2189.
15. Horwitz S, O’Connor OA, Pro B, et al. Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomized, phase 3 trial. Lancet. 2019;393(10168):229-240.
16. Pro B, Advani R, Brice P, et al. Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study. J Clin Oncol. 2012;30(18):2190-2196.
17. Prince HM, Kim YH, Horwitz SM, et al. Brentuximab vedotin or physician’s choice in CD30-positive cutaneous T-cell lymphoma (ALCANZA): an international, open-label, randomized, phase 3, multicentre trial. Lancet. 2017;390(10094):555-566.

18. Cole PD, McCarten KM, Pei Q, et al. Brentuximab vedotin with gemcitabine for paediatric and young adult patients with relapsed or refractory Hodgkin’s lymphoma (AHOD1221): a Children’s Oncology Group, multicentre single-arm, phase 1-2 trial. Lancet Oncol. 2018 Sep;19(9):1229-1238. Doi: 10.1016/S1470-2045(18)30426-1. Epub 2018 Aug 16.
19. Jacobsen ED, Sharman JP, Oki Y, et al. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. Blood. 2015 Feb 26;125(9):1394-402. Doi: 10.1182/blood-2014-09-598763. Epub 2015 Jan 8.
20. Chang VA, Wang HY, Reid EG. Activity of brentuximab vedotin in AIDS-related primary effusion lymphoma. Blood Adv. 2019 Mar 12;3(5):766-768. Doi: 10.1182/bloodadvances.2018026351.
21. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium^®) Pediatric Aggressive Mature B-Cell Lymphomas. Version 2.2024.  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 October 2024.
22. Zinzani PL, Pellegrini C, Chiappella A, et al. Brentuximab vedotin in relapsed primary mediastinal large B-cell lymphoma: results from a phase 2 clinical trial. Blood. 2017 Apr 20;129(16):2328-2330. doi: 10.1182/blood-2017-01-764258.
23. Zinzani PL, Santoro A, Gritti G, et al. Nivolumab Combined With Brentuximab Vedotin for Relapsed/Refractory Primary Mediastinal Large B-Cell Lymphoma: Efficacy and Safety From the Phase II CheckMate 436 Study. J Clin Oncol. 2019 Nov 20;37(33):3081-3089. doi: 10.1200/JCO.19.01492.
24. Castellino SM, Pei Q, Parsons SK, et al. Brentuximab Vedotin with Chemotherapy in Pediatric High-Risk Hodgkin's Lymphoma. N Engl J Med. 2022 Nov 3;387(18):1649-1660. doi: 10.1056/NEJMoa2206660.
25. Cole PD, Mauz-Körholz C, Mascarin M, et al. Nivolumab and brentuximab vedotin (BV)-based, response‐adapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis. J Clin Oncol 2020;38:8013.
26. Harker-Murray P, Mauz-Körholz C, Leblanc T, et al. Nivolumab and brentuximab vedotin with or without bendamustine for R/R Hodgkin lymphoma in children, adolescents, and young adults. Blood. 2023 Apr 27;141(17):2075-2084. doi: 10.1182/blood.2022017118. PMID: 36564047.
27. O’Connor OA, Lue JK, Sawas A, et al. Brentuximab vedotin plus bendamustine in relapsed or refractory Hodgkin’s lymphoma: an international, multicenter, single-arm, phase 1-2 trial. Lancet Oncol 2018;19:257-266.
28. Lynch RC, Cassaday RD, Smith SD, et al. Dose-dense brentuximab vedotin plus ifosfamide, carboplatin, and etoposide for second-line treatment of relapsed or refractory classical Hodgkin lymphoma: a single centre, phase 1/2 study. Lancet Haematol 2021;8:e562-e571.
29. Friedberg JW, Forero-Torres A, Bordoni RE, et al. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged ≥60 years with HL. Blood 2017;130:2829-2837.
30. Friedberg JW, Forero-Torres A, Holkova B, et al. Long-term follow-up of brentuximab vedotin ± dacarbazine as first line therapy in elderly patients with Hodgkin lymphoma [abstract]. J Clin Oncol 2018;36 (Suppl 15):Abstract 7542.
31. Advani RH, Moskowitz AJ, Bartlett NL, et al. Brentuximab vedotin in combination with nivolumab in relapsed or refractory Hodgkin lymphoma: 3-year study results. Blood 2021;138:427-438
32. Borchmann P, Moccia AA, Greil R, et al. BrECADD Is non-inferior to eBEACOPP in patients with advanced stage classical Hodgkin Lymphoma: Efficacy results of the GHSG Phase III HD21 trial. Hematological Oncology 2023;41:881-882.
33. Eichenauer DA, Plütschow A, Kreissl S, et al. Incorporation of brentuximab vedotin into first-line treatment of advanced classical Hodgkin's lymphoma: final analysis of a phase 2 randomised trial by the German Hodgkin Study Group. Lancet Oncol. 2017 Dec; 18(12): 1680-1687. doi: 10.1016/S1470-2045(17)30696-4. Epub 2017 Nov 10. PMID: 29133014.
34. Evens AM, Advani RH, Helenowski IB, et al. Multicenter Phase II Study of Sequential Brentuximab Vedotin and Doxorubicin, Vinblastine, and Dacarbazine Chemotherapy for Older Patients With Untreated Classical Hodgkin Lymphoma. J Clin Oncol. 2018 Oct 20;36(30):3015-3022. doi: 10.1200/JCO.2018.79.0139. Epub 2018 Sep 4.
35. Aubrais R, Bouabdallah K, Chartier L, et al. Salvage therapy with brentuximab-vedotin and bendamustine for patients with R/R PTCL: a retrospective study from the LYSA group. Blood Adv. 2023 Oct 10; 7(19): 5733–5742. Published online 2022 Dec 10. doi: 10.1182/bloodadvances.2022008524
36. Metzger ML, Link MP, Billett AL, et al. Excellent Outcome for Pediatric Patients With High-Risk Hodgkin Lymphoma Treated With Brentuximab Vedotin and Risk-Adapted Residual Node Radiation. J Clin Oncol. 2021 Jul 10;39(20):2276-2283. doi: 10.1200/JCO.20.03286. Epub 2021 Apr 7. PMID: 33826362; PMCID: PMC8260923.
37. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Brentuximab vedotin: T-Cell Lymphomas Chemotherapy Order Template, TCL23. National Comprehensive Cancer Network, 2024. 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 Guidelines, go online to NCCN.org. Accessed October 2024.
38. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Brentuximab vedotin: T-Cell Lymphomas Chemotherapy Order Template, TCL12. National Comprehensive Cancer Network, 2024. 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 Guidelines, go online to NCCN.org. Accessed October 2024.

Appendix 1 – Covered Diagnosis Codes

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

The preceding information is intended for non-Medicare coverage determinations. Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determinations (NCDs) and/or Local Coverage Determinations (LCDs) may exist and compliance with these policies is required where applicable. Local Coverage Articles (LCAs) may also exist for claims payment purposes or to clarify benefit eligibility under Part B for drugs which may be self-administered. The following link may be used to search for NCD, LCD, or LCA documents https://www.cms.gov/medicare-coverage-database/search.aspx. Additional indications, including any preceding information, may be applied at the discretion of the health plan.

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