Medical Policy



Subject: Brentuximab Vedotin (Adcetris®)
Document #: DRUG.00047 Current Effective Date:    05/18/2017
Status: Revised Last Review Date:    05/04/2017

Description/Scope

This document addresses indications and criteria for use of brentuximab vedotin (Adcetris, Seattle Genetics, Bothell, WA), an antibody-drug conjugate (ADC) that combines a small molecule chemotherapeutic agent (monomethyl auristatin E [MMAE]) with a chimeric IgG1 antibody that binds to the CD30-positive cells (CD30+).

Position Statement

Medically Necessary:  

  1. Brentuximab vedotin is considered medically necessary for the treatment of individuals with Hodgkin lymphoma with any of the following indications:
    1. After failure of autologous hematopoietic stem cell transplant; or
    2. After failure of at least two prior multi-agent chemotherapy regimens in individuals who are not autologous hematopoietic stem cell transplant candidates; or
    3. As cytoreduction prior to either autologous or allogeneic stem cell transplantation for relapsed or refractory Hodgkin lymphoma; or
    4. As consolidation therapy after an autologous stem cell transplantation for individuals at high risk of relapse or progression, that is, individuals with any of the following:
      1. Primary refractory Hodgkin lymphoma; or
      2. Relapsed Hodgkin lymphoma with an initial remission duration of less than 12 months; or
      3. Extranodal involvement at the start of pre-transplantation salvage chemotherapy; or
    5. As maintenance therapy for 1 year following high-dose therapy and autologous stem cell rescue for relapsed or refractory disease in those who are brentuximab vedotin naïve and have a Deauville score of less than 5; or
    6. As a single-agent, palliative treatment option for relapsed or refractory disease in older adults (age > 60).
  2. Brentuximab vedotin is considered medically necessary for the treatment of individuals diagnosed with CD30+ non-Hodgkin lymphoma with any of the following indications:
    1. Cutaneous anaplastic large cell lymphoma; or
    2. Cutaneous T-cell lymphoma, including mycosis fungoides/Sézary syndrome which is relapsed, refractory or as first-line therapy for advanced disease presentation (for example, folliculotropic, large-cell transformation or extracutaneous disease); or
    3. Relapsed or refractory disease after at least one prior multi-agent chemotherapy regimen for treatment of any of the following:
      1. Systemic anaplastic large cell lymphoma; or
      2. T-cell lymphoma (excluding cutaneous T-cell lymphoma); or
      3. Lymphomatoid papulosis that is symptomatic or characterized by extensive cutaneous lesions; or
    4. As a single-agent for adult T-cell leukemia/lymphoma after high dose therapy and autologous stem cell rescue; or
    5. As an adjuvant systemic therapy for breast implant-associated anaplastic large cell lymphoma for either of the following:
      1. Residual, localized disease (confined to capsule/implant/breast) following partial excision or capsulectomy; or
      2. Extended disease (stage II–IV).

Investigational and Not Medically Necessary:

Brentuximab vedotin is considered investigational and not medically necessary when the above criteria are not met and for all other indications.

Rationale

The United States (U.S.) Food and Drug Administration (FDA) granted accelerated drug approval for brentuximab vedotin (Adcetris) on August 19, 2011.  The labeled indications included brentuximab as monotherapy for relapsed or refractory Hodgkin lymphoma (HL) after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens when individuals were ineligible for transplant.  Additionally, brentuximab was approved as a treatment for systemic anaplastic large cell lymphoma (ALCL) after failure of at least one prior multi-agent regimen.  In 2015 the label was expanded to include treatment as a consolidation therapy for classical HL at high risk of relapse or progression after auto-HSCT (PI Label, 2016; Younes, 2012).  

Hodgkin Lymphoma

There are two main classifications of HL: lymphocyte-predominant Hodgkin lymphoma (LPHL) and classical Hodgkin lymphoma (CHL) (American Cancer Society [ACS], 2016; National Comprehensive Cancer Network® [NCCN], 2017).  CHL is distinguished by the presence of abnormal Reed-Sternberg cells which express CD15 and CD30 in a majority of the cases, with CD20 expression occurring at a lower rate.  Approximately 30% to 40% of individuals with advanced HL are refractory to initial therapy or will relapse despite advances in front-line treatment (Deutsch, 2011).

A multi-national, open label, single-arm clinical trial included 102 individuals with relapsed or refractory HL after an auto-HSCT.  Treatment included brentuximab 1.8 mg/kg intravenous (IV) infusions given every 3 weeks with a median duration of treatment of 27 weeks (range, 3 to 56 weeks).  Efficacy evaluations were performed by an independent review facility.  The primary endpoint was overall response rate (ORR) which was 73% with a median duration of response of 6.7 months (range, 1.3 to 21.9 months).  Complete response (CR) was 32% with a median duration of response of 20.5 months (range, 1.4 to 21.9+ months).  Partial response (PR) was 40% with a median duration of 3.5 months (range 1.3 to 18.7 months) (PI Label, 2016; Younes, 2012).  The safety and efficacy of brentuximab vedotin after a failed auto-HSCT or after at least two prior multi-agent chemotherapy regimens in individuals who are not AHSCT candidates, have been demonstrated and are included as FDA approved labeled indications.

The NCCN Hodgkin Lymphoma Clinical Practice Guideline ([CPG] 2017) notes for those individuals with progressive disease after high-dose therapy and autologous stem cell rescue (HDT/ASCR) or at least two prior chemotherapy regimens, brentuximab vedotin is a treatment option regardless of the individual's eligibility for HDT/ASCR.  This recommendation was based on a 2A category of evidence and uniform consensus.

There are phase I and II clinical trials that are investigating the use of brentuximab vedotin after allogeneic stem cell transplantation.  There are a few case reports involving the use of brentuximab vedotin with and without donor lymphocyte infusions (DLI) after allogeneic hematopoietic stem cell transplant as a treatment for relapsed Hodgkin disease.  At this time, there is no published data from prospective studies regarding the safety and efficacy of brentuximab vedotin after an allogeneic stem cell transplant or as prophylaxis to recurrence or relapse after a prior hematopoietic stem cell transplant.

There are retrospective case series that reported limited data on the use of brentuximab vedotin to treat individuals with refractory or relapsed Hodgkin disease prior to autologous and allogeneic hematopoietic stem cell transplantation (Chen, 2012; Sasse, 2013).  Additionally, specialty consensus opinion suggests that brentuximab vedotin may be used for cytoreduction prior to an auto-HSCT.

The use of brentuximab vedotin as consolidation therapy for individuals with unfavorable risk of relapse or progression of Hodgkin lymphoma after auto-HSCT was studied in a phase III double-blind, randomized controlled trial (RCT) called AETHERA (Moskowitz, 2015).  Inclusion criteria required the participants to have one of the following risk factors: "Primary refractory Hodgkin lymphoma (failure to achieve complete remission, as determined by investigator), relapsed Hodgkin lymphoma with an initial remission duration of less than 12 months, or extranodal involvement at the start of pre-transplantation salvage chemotherapy."  Individuals were randomized at 78 North American and European centers to receive 16 cycles of brentuximab vedotin every 3 weeks beginning 30-45 days after AHSCT.  The primary endpoint was progression-free survival (PFS) assessed by independent reviewers.  A total of 329 individuals were enrolled and 165 participants were randomized to brentuximab vedotin treatment and 164 individuals were assigned to the placebo group.  Computerized tomography (CT) scans were performed at baseline and repeated after the first dose of study drug at 3, 6, 9, 12, 18 and 24 months.  The median follow-up was 30 months (range, 0-50 months).  Median PFS was significantly improved in those treated with brentuximab vedotin; 42.9 months (95% confidence interval [CI]; 30.4-42.9 months) compared to those who received placebo 24.1 months (95% CI; 11.5 –not estimable months).  In August of 2015, the FDA expanded the label based on the AETHERA trial to include treatment for CHL when the risk of relapsed or refractory disease is high following an auto-HSCT.

The NCCN published updated CPGs for HL (2017) with an NCCN 2A recommendation for use of brentuximab as maintenance therapy for 1 year following high-dose therapy and auto-HSCT for relapsed or refractory disease in those who are brentuximab naïve. This recommendation was based on the previously discussed AETHERA trial, which investigated 48 weeks of consolidation therapy in this population (Moskowitz, 2015).  An additional NCCN 2A recommendation was added to the HL CPGs for use of brentuximab as palliative therapy for relapsed or refractory disease in older adults, 60 years of age or older. This recommendation is based on a 2014 abstract of 36 individuals who were an average age of 34 years (Chen, 2014).

Non-Hodgkin Lymphoma

Anaplastic Large Cell Lymphoma (ALCL)

ALCL is a subtype of mature peripheral T-cell (PTCL) non-Hodgkin lymphoma (NHL) that involves less than 5% of all NHL cases.  There are three subtypes of ALCL: anaplastic lymphoma kinase (ALK)-positive ALCL, ALK-negative ALCL, and primary cutaneous ALCL.  CD30 is a strong diffuse expression in those with ALCL (NCCN, 2016).

A phase II, single-arm, multicenter, open label clinical trial studied 58 individuals with relapsed systemic ALCL treated with brentuximab 1.8 mg/kg administered IV every 3 weeks.  Participants had a median of two prior therapies and 26% had received prior AHSCT.  The majority (72%) of the participants were ALK-negative.  Of the 58 study participants, 50% had relapsed disease and 50% were refractory to recent therapy.  Median duration of treatment was 24 weeks (range, 3 to 56 weeks).  ORR was 86% with a median duration of response of 12.6 months (range, 0.1 to 15.9+ months).  CR was 57% with a median duration of response of 13.2 months (range, 0.7 to 15.9+ months).  With a median duration of 2.1 months (range, 0.1, to 15.8 months), PR was 29% (PI Label, 2016).  The most commonly reported adverse events (grade 3-4) included neutropenia (21%), thrombocytopenia (14%) and peripheral sensory neuropathy (10%) (Pro, 2012; Shustov, 2011).

The NCCN CPG for T-Cell Lymphomas (2017) recommends brentuximab vedotin as a treatment for individuals with relapsed or refractory systemic ALCL (excluding cutaneous ALCL) as second-line or subsequent therapy based on three phase II clinical trials that included this population (Horwitz 2014; Pro 2012; Pro 2013).  There is also a 2A recommendation for breast-implant associated large cell lymphoma as adjuvant therapy for localized disease following incomplete excision or partial capsulectomy with residual disease, or for extended disease (stage II-IV).  No rationale or clinical trial data in support of this NCCN recommendation was provided.

Cutaneous ALCL

According to the National Institutes of Health (NIH) database of clinical trials, there are ongoing phase II and phase III clinical trials investigating brentuximab vedotin as a treatment for cutaneous ALCL.  The NCCN CPG for NHL (2016) includes a 2A off-label indication for brentuximab to treat cutaneous ALCL.  This recommendation is supported by a recently published phase II study by Duvic and colleagues (2015).  A total of 48 individuals with heavily pretreated CD30+ lymphoproliferative disorders or mycosis fungoides (MF) were enrolled and administered brentuximab vedotin every 21 days.  Although only 4 of the 48 individuals enrolled had cutaneous ALCL, the CR rate in this subset was 100%.  The most frequently reported adverse event was peripheral neuropathy (n=31) and 2 deaths occurred amongst the 48 evaluable enrollees from untreated sepsis (one originated from ulceration of a cutaneous ALCL tumor).  The most frequently reported grade 3 and 4 adverse event was neutropenia (n=5).  In this rare, difficult to treat disease, brentuximab vedotin appears to be active with a tolerable safety profile.  Results from phase III clinical trials underway will further elucidate the efficacy and safety of this agent in the treatment of cutaneous ALCL.

Other T-Cell Lymphomas and Lymphoproliferative Disorders

There is an NCCN 2A recommendation for the second-line treatment of systemic CD30+ PTCL subtypes.  The recommendation is based on Phase II open-label trials which included angioimmunoblastic T-cell lymphoma (AITL), PTCL-not otherwise specified (PTCL-NOS), and ALCL subtypes (Horwtiz, 2014; Pro, 2012; Shustov, 2011).

Until recently, there were only case reports and small case series reporting outcomes of brentuximab vedotin to treat MF/Sezary syndrome (SS) and lymphomatoid papulosis (LyP).  The NCCN guidelines for T-Cell Lymphomas (2017) include 2A off-label indications for brentuximab to treat MF/SS and LyP.  These recommendations are supported by the previously described study by Duvic (2015).  In the study, 28 of the 48 evaluable study participants had MF/SS with an ORR of 54% (n=13 PR; n=2 CR) and 9 had LyP with an ORR of 100% (n=5 CR; n=4 PR).  Another Phase II clinical trial conducted by Kim and colleagues (2015) evaluated brentuximab in 30 individuals with MF/SS.  In this heavily pre-treated cohort with a wide range of CD30 expression levels and advanced disease states, high response rates were achieved.  The primary study endpoint, overall global response rate, was 70% (n=21; 90% CI, 53-83%).  CD30 expression level in cutaneous lesions (from negligible to 100% expression) was significantly associated with the likelihood of global response (p<0.005).  Similar to Duvic's (2015) findings, the most commonly reported adverse event was peripheral neuropathy; 1 case was so severe it resulted in pneumonia and ultimately death.  In this rare, difficult to treat disease, brentuximab vedotin has demonstrated efficacy with a tolerable safety profile.

Other Uses

There are ongoing clinical trials investigating the use of brentuximab vedotin in the treatment of diffuse large B cell lymphoma (DLBCL [NCCN 2B off-label indication]), graft-versus-host disease, germ cell tumors and in various lines of treatments. However, the data has not yet been published to support the long-term safety and efficacy in these novel indications.

Background/Overview

A monoclonal antibody is a protein developed in the laboratory that can locate and bind to a targeted substance in the body and on the surface of cancer cells.  These antibodies can carry drugs, toxins, or radioactive substances to the targeted cancer cells (National Cancer Institute [NCI], 2016).  This novel ADC combines a monoclonal antibody which targets CD30+ cells with MMAE, a cytotoxic antimicrotubule.  Once the ADC is attached to CD30+ cells, the MMAE disrupts the microtubule network resulting in death of the cell.

Hodgkin Lymphoma

HL is a type of malignancy which starts in the lymphocytes, a type of white blood cell that fights infection.  HL most commonly affects people between the ages of 15 and 40 and people older than age 55.  According to recent estimates 8500 new cases of Hodgkin lymphoma are diagnosed annually in the US and 1120 will succumb to the disease (NCI, 2017).  In HL, cells in the lymphatic system grow abnormally and may spread beyond the lymphatic system.  As the disease progresses, it compromises the body's ability to fight infection.  Many initial signs and symptoms may be similar to those of influenza, such as fever, fatigue and night sweats.  Eventually, tumors develop.  HL is distinguished by the presence of abnormal Reed-Sternberg cells with a majority of cases expressing CD15 and CD30 on immunohistochemistry testing of tissue.  In developed countries, classical HL accounts for approximately 95% of all Hodgkin disease (ACS, 2014).  Lymphocyte-predominant Hodgkin lymphoma (LPHL) accounts for approximately 5% of all HL cases, usually expressing CD45 and CD20.  In LPHL, lymphocyte predominant cells, also called "popcorn cells" are present in the lymphoma tissue instead of the Reed-Sternberg cells (NCCN, 2017).

The NCI (2017) and NCCN (2017) report chemotherapy and radiation therapy may cure more than 75% to 80% of all newly diagnosed Hodgkin disease cases.  Autologous or allogeneic hematopoietic stem cell transplantation is recognized as the best option for refractory or relapsed Hodgkin disease in individuals who meet the criteria for transplantation.  Advances in diagnosis, staging and treatment of Hodgkin disease have helped to make this once uniformly fatal disease highly treatable with the potential for full recovery.  The national mortality rate for adult Hodgkin lymphoma has fallen more rapidly than for any other malignancy.

Non-Hodgkin Lymphoma 

NHLs are a group of malignancies with varying patterns of disease course and treatment responses.  Similar to HL, NHL usually originates in lymphatic tissue and spreads to other organs. However, unlike HL, NHL is less predictable and therefore less treatable.  Prognosis is based on a number of factors including histology and stage.  In 2017 an estimated 73,000 new cases of NHL will be diagnosed in the U.S. and 20,150 will die from the disease (NCI, 2017).  NHLs are divided into two prognostic groups, indolent and aggressive lymphomas.

Peripheral T-cell lymphoma (PTCL) is a subtype of NHL that develops from mature T-cells of post-thymic origin and constitutes a mixed group of lymphoproliferative disorders (LPDs).  Subtypes of PTCL include PTCL-NOS, the most common subtype, and less frequently, AITL and ALCL which expresses CD30 (NCCN, 2017).

Primary cutaneous ALCL has an indolent course with frequent relapses typically limited to the skin and very good long-term survival.  Combination therapy is rarely indicated for primary cutaneous ALCL.  Standard induction therapy for ALK-positive ALCL is cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) chemotherapy and radiation therapy (RT).  There is no standard therapy for the other subtypes.  NCCN clinical practice guidelines (2017) note it is "critical to distinguish CD30+ T-cell LPDs [such as MF/SS] from other CD30+ processes involving the skin that includes: systemic lymphomas (e.g., systemic ALCL, adult T-cell leukemia/lymphoma [ATLL], PTCL)."  

Adverse Events and Warnings

The PI Label (2016) for brentuximab vedotin includes the following Black Box Warnings:

John Cunningham (JC) virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in individuals receiving brentuximab vedotin.

Additional warnings from the PI Label (2016) include the following:

Adverse Reactions:
The most common adverse reactions (greater than or equal to 20%) are neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough, and vomiting.

Additional Warnings and Precautions:

Definitions

Antibodies: Proteins that are made by the immune system to help fight infection. Antibodies may also be cloned or developed in a laboratory (see monoclonal antibody).

Chemotherapy: Medical treatment of a disease, particularly cancer, with drugs or other chemicals.

CHOP: A regimen which includes cyclophosphamide, doxorubicin, vincristine, and prednisone.

Complete response (CR): The disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured; also called a complete remission.

Hematopoietic stem cells: Primitive cells capable of replication and formation into mature blood cells in order to repopulate the bone marrow.

High-dose or myeloablative chemotherapy (HDC): The administration of cytotoxic agents using doses several times greater than the standard therapeutic dose.

Monoclonal antibody: A protein developed in the laboratory that can locate and bind to a specific target in the body.

Monotherapy: A single therapy; a single drug.

Partial response: A decrease in the size of a tumor or in the extent of cancer in the body, in response to treatment; also called a partial remission.

Primary refractory disease: Cancer that does not respond at the beginning of treatment; may also be called resistant disease.

Relapse: After a period of improvement, the signs and symptoms of cancer return.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.  

When services may be Medically Necessary when criteria are met:

HCPCS  
J9042 Injection, brentuximab vedotin, 1 mg
   
ICD-10 Diagnosis  
C81.00-C81.99 Hodgkin lymphoma
C84.00-C84.19 Mycosis fungoides, Sézary disease
C84.40-C84.49 Peripheral T-cell lymphoma, not classified
C84.60-C84.69 Anaplastic large cell lymphoma, ALK-positive
C84.70-C84.79 Anaplastic large cell lymphoma, ALK-negative
C84.A0-C84.A9 Cutaneous T-cell lymphoma, unspecified
C86.1 Hepatosplenic T-cell lymphoma
C86.2 Enteropathy-type (intestinal) T-cell lymphoma
C86.5 Angioimmunoblastic T-cell lymphoma
C86.6 Primary cutaneous CD30-positive T-cell proliferations
C91.50-C91.52 Adult T-cell lymphoma/leukemia (HTLV-1-associated)
Z85.71 Personal history of Hodgkin lymphoma
Z85.72 Personal history of non-Hodgkin lymphomas

When services are Investigational and Not Medically Necessary:
For the codes listed above when criteria are not met or for all other diagnoses not listed; or when the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

References

Peer Reviewed Publications: 

  1. Berger GK, McBride A, Lawson S, et al. Brentuximab vedotin for treatment of non-Hodgkin lymphomas: A systematic review. Crit Rev Oncol Hematol. 2017; 109:42-50.
  2. Chen R, Palmer J, Martin P, et al. Results of a phase II trial of brentuximab vedotin as first line salvage therapy in relapsed/refractory HL prior to AHCT. Blood. 2014; 124; Abstract 501. Available at: http://www.bloodjournal.org/content/124/21/501?sso-checked=true. Accessed on May 09, 2017.
  3. Chen R, Palmer JM, Thomas SH, et al. Brentuximab vedotin enables successful reduced-intensity allogeneic hematopoietic cell transplantation in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2012; 119(26):6379-6381.
  4. Dada R, Zekri, Al Saadi R. Brentuximab vedotin in pretreated Hodgkin lymphoma patients: a systematic review and meta-analysis. Expert Opin Biol Ther. 2016; 16(6):739-745.
  5. Deutsch YE, Tadmor T, Podack ER, Rosenblatt JD. CD30: an important new target in hematologic malignancies. Leuk Lymphoma. 2011; 52(9):1641-1654.
  6. 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; 10; 33(32):3759-3765.
  7. Forero-Torres A, Holkova B, Goldschmidt J, et al. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015; 126(26):2798-2804.
  8. Foyil KV, Bartlett NL. Brentuximab vedotin for the treatment of CD30+ lymphomas. Immunotherapy. 2011; 3(4):475-485.
  9. Gopal AK, Chen R, Smith SE, et al. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015; 125(8):1236-1243.
  10. Horwitz SM, Advani RH, Bartlett NL, et al. Objective responses in relapsed T-cell lymphomas with single-agent brentuximab vedotin. Blood. 2014; 123(20):3095-3100.
  11. Jacobsen ED, Sharman JP, Oki Y, et al. Blood. Brentuximab vedotin demonstrates objective responses in a phase 2 study of relapsed/refractory DLBCL with variable CD30 expression. 2015. 26; 125(9):1394-1402.
  12. Kim YH, Tavallaee M, Sundram U, et al. Phase II investigator-initiated study of brentuximab vedotin in mycosis fungoides and sézary syndrome with variable CD30 expression level: a multi-institution collaborative project. J Clin Oncol. 2015; 10; 33(32):3750-3758.
  13. Kim YH, Tavallee M, Sundram U, et al. Available at: Brentuximab Vedotin Demonstrates Significantly Superior Clinical Outcomes in Patients with CD30-Expressing Cutaneous T Cell Lymphoma Versus Physician's Choice (Methotrexate or Bexarotene): The Phase 3 Alcanza Study. American Society of Hematology.  Abstract 182. https://ash.confex.com/ash/2016/webprogram/Paper91517.html .  Accessed on April 07, 2017.
  14. 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 randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 385(9980):1853-1862.
  15. 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.
  16. Pro B, Advani R, Brice P. et al. Three-year survival results from an ongoing phase 2 study of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma. Blood. 2013; 122: 1809.
  17. Sasse S, Rothe A, Goergen H, et al. Brentuximab vedotin (SGN-35) in patients with transplant-naive relapsed/refractory Hodgkin lymphoma. Leuk Lymphoma. 2013; 54(10):2144-2148.
  18. Shustov A, Advani R, Brice P, et al. Durable remissions with SGN-35 (brentuximab vedotin): updated results of a phase 2 study in patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) [abstract]. Ann Oncol. 2011; 22(Supple 4): Abstract 125. Available at: http://annonc.oxfordjournals.org/content/22/suppl_4/iv125.full.pdf+html. Accessed on April 08, 2017.
  19. Taverna JA, Yun S, Jonnadula J, et al. Role of maintenance therapy after high-dose chemotherapy and autologous hematopoietic cell transplantation in aggressive lymphomas: A systematic review. Biol Blood Marrow Transplant. 2016;22(7):1182-1196.
  20. Younes A, Bartlett NL, Leonard JP, et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N Engl J Med. 2010; 363(19):1812-1821.
  21. Younes A, Connors JM, Park SI, et al. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013; 14(13):1348-1356.
  22. 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.

Government Agency, Medical Society, and Other Authoritative Publications: 

  1. Brentuximab Vedotin Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS® ) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised March 9, 2015. Accessed on April 08, 2017.
  2. Brentuximab vedotin [Product Information]. Seattle Genetics, Inc., Bothell, WA; March 04, 2016. Available at: http://www.accessdata.fda.gov/spl/data/e97d3806-3585-9a45-1b83-a3a6636d9539/e97d3806-3585-9a45-1b83-a3a6636d9539.xml. Accessed on April 08, 2017.
  3. Brentuximab vedotin. In: DrugPoints® System (electronic version). Truven Health Analytics. Greenwood Village, CO. Updated February 23, 2017. Available at: http://www.micromedexsolutions.com. Accessed on April 08, 2017.
  4. National Comprehensive Cancer Network® . NCCN Drugs & Biologic Compendium® (electronic version). For additional information visit the NCCN website: http://www.nccn.org. Accessed on April 08, 2017.
  5. NCCN Clinical Practice Guidelines in Oncology®. © 2017 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website at: http://www.nccn.org/index.asp. Accessed on April 08, 2017.
    • Hodgkin Lymphoma. V.1.2017. Updated March 01, 2017.
    • T-Cell Lymphomas V.2.2017. Updated February 02, 2017.
Websites for Additional Information
  1. American Cancer Society (ACS). Available at: http://www.cancer.org/cancer/index. Accessed on April 08, 2017.
  2. American College of Nuclear Medicine (ACNM).  Deuville Criteria. 2014. Available at: http://www.snmmi.org/ACNM/Residents/Content.aspx?ItemNumber=12279. Accessed on April 8, 2017.
  3. National Cancer Institute (NCI). Bone Marrow Transplantation and Peripheral Blood Stem Cell Transplantation: Questions and Answers. Reviewed on August 12, 2013. Available at: http://www.cancer.gov/cancertopics/factsheet/Therapy/bone-marrow-transplant. Accessed on April 08, 2017.
  4. National Cancer Institute (NCI). PDQ® Adult Hodgkin Lymphoma Treatment. Last modified January 27, 2017. Available at: http://www.cancer.gov/types/lymphoma/hp/adult-hodgkin-treatment-pdq. Accessed on April 08, 2017.
  5. National Cancer Institute (NCI). PDQ® Adult Non-Hodgkin Lymphoma Treatment. Last modified January 26, 2017. Available at: http://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq. Accessed on April 08, 2017.
  6. National Cancer Institute (NCI). PDQ® Mycosis Fungoides and the Sézary Syndrome. Last modified March 03, 2016. Available at: http://www.cancer.gov/types/lymphoma/hp/mycosis-fungoides-treatment-pdq. Accessed on April 08, 2017.
  7. National Institutes of Health (NIH). ClinicalTrials.gov. Available at: http://clinicaltrials.gov/. Accessed on April 08, 2017.
Index

SGN-35
Anti-CD30

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Revised 05/04/2017 Medical Policy & Technology Assessment Committee (MPTAC) review.
Revised 05/03/2017 Hematology/Oncology Subcommittee review.  Reformatted MN criteria and expanded criteria with additional Hodgkin lymphoma and Non-Hodgkin lymphoma criteria. Updated Rationale, Background/Overview, Coding, References and Websites sections.
Revised 05/05/2016 MPTAC review
Revised 05/04/2016 Hematology/Oncology Subcommittee review.  Updated criteria with MN indications for mycosis fungoides, sézary syndrome and lymphomatoid papulosis.  Updated Rationale, Background/Overview, Coding, References and Websites sections.
Revised 11/05/2015 MPTAC review.
Revised 11/04/2015 Hematology/Oncology Subcommittee review. Updated MN criteria for Hodgkin lymphoma and added indication for CD30+ T-cell lymphoma. Updated Rationale, Background/Overview, Coding, References and Websites sections. Removed ICD-9 codes from Coding section.
Revised 05/07/2015 MPTAC review.
Revised 05/06/2015 Hematology/Oncology Subcommittee review. Removed trademark from title and replaced with registered mark. Added MN indication for cutaneous ALCL. Updated Background, Rationale, Coding, References and Websites sections. 
Reviewed 05/15/2014 MPTAC review.
Reviewed 05/14/2014 Hematology/Oncology Subcommittee review. Updated Background, Rationale, References and Websites sections. 
Revised 11/14/2013 MPTAC review.
Revised 11/13/2013 Hematology/Oncology Subcommittee review. Added MN indication for cytoreduction. Updated Background, Rationale, References and Web Site sections. 
Reviewed 11/08/2012 MPTAC review.
Reviewed 11/07/2012 Hematology/Oncology Subcommittee review. Updated Black Box Warnings, Background, Rationale, Reference and Web Site sections.  Updated Coding section with 01/01/2013 HCPCS changes; removed C9287 deleted 12/31/2012.
New 11/17/2011 MPTAC review.
New 11/16/2011 Hematology/Oncology Subcommittee review. Initial document development.