Medical Policy

 

Subject: Ofatumumab (Arzerra®)
Document #: DRUG.00063 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

 

This document addresses the indications for the use of ofatumumab. Ofatumumab (Arzerra, Novartis Pharmaceuticals, East Hanover, NJ) is a humanized, cytolytic monoclonal antibody directed against the surface antigen CD20, which is expressed on more than 90% of B-cell lymphocytes from pre-B-cell stage to maturity.

 

Position Statement

Medically Necessary:

  1. Ofatumumab is considered medically necessary when either of the following criteria are met:
    1. As first-line therapy for chronic lymphocytic leukemia/small lymphocytic lymphoma in combination with chlorambucil; or
    2. For the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma as a single agent and only in one line of therapy.
  2. Ofatumumab is considered medically necessary as maintenance treatment for up to 24 months for relapsed or progressive chronic lymphocytic leukemia/small lymphocytic lymphoma when all of the following criteria are met:
    1. A complete or partial response has been achieved; and
    2. Treatment is following at least two lines of therapy.

Investigational and Not Medically Necessary:

Ofatumumab is considered investigational and not medically necessary when the criteria above are not met and for all other indications, including, but not limited to, Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma.

Rationale

Newly Diagnosed Chronic Lymphocytic leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

On April 17, 2014, the United States (U.S.) Food and Drug Administration (FDA) approved ofatumumab in combination with chlorambucil, for the treatment of previously untreated individuals with CLL, for whom fludarabine-based therapy is considered inappropriate (FDA Product Information [PI] Label). This FDA approval was based, in part, on the results of the COMPLEMENT 1 randomized study that compared chlorambucil with and without ofatumumab in 447 subjects with comorbidities that resulted in intolerances to fludarabine. Treatment duration was a minimum of 3 cycles, until best response to a maximum of 12 cycles. The primary outcome was progression-free survival (PFS), which was significantly longer in the ofatumumab arm (22.4 months) compared to the chlorambucil arm (13.1 months, p<0.001). Complete remission (or response; CR) was also significantly higher in the ofatumumab arm (12% vs. 1%). The authors concluded that intravenous (IV) ofatumumab added to chlorambucil demonstrated clinically important improvements with a manageable side effect profile in those with CLL who are considered inappropriate candidates for fludarabine-based therapy (Hillmen, 2015).

Refractory or Relapsed CLL

On October 26, 2009, ofatumumab was approved by the FDA with a breakthrough therapy designation for the treatment of CLL refractory to alemtuzumab and fludarabine. The pivotal trial consisted of a single-arm clinical study (n=138; mean age, 64 years, range 41-86) enrolling adults with relapsed or refractory CLL (fludarabine-refractory disease and alemtuzumab-refractory disease [n=59] or fludarabine-refractory CLL with bulky lymphadenopathy [n=79]) (Wierda, 2010). Ofatumumab as a single agent was administered IV for a total of 8 weekly infusions, followed by 4 monthly infusions over a 24-week period (300 mg for dose 1; 2000 mg for doses 2-12). Individuals were considered drug refractory if they failed to achieve partial or full response to the last dose of fludarabine or alemtuzumab, or experienced disease progression within 6 months of the last dose of fludarabine or alemtuzumab. The primary outcome measure of a planned interim analysis was the overall response rate (ORR), reported in 58% and 47% in the fludarabine- and alemtuzumab-refractory and bulky lymphadenopathy groups, respectively. The median PFS ranged from 5.7 to 5.9 months in these 2 groups. The most common adverse events were grade 1 or 2 infusion-related reactions in 64% of individuals with refractory disease. A total of 4 deaths (7%) occurred in the fludarabine-refractory group and 2 (3%) in the lymphadenopathy group. This interim analysis focused on the more limited outcome of ORR, rather than the more mature outcome of PFS. However, based on the ORR, the authors concluded that ofatumumab provided meaningful improvements in heavily pretreated subjects refractory to both fludarabine and alemtuzumab, or in subjects with bulky lymphadenopathy considered poor candidates for alemtuzumab. For example, the drug was associated with resolution of constitutional symptoms and improvements in performance standards.

A randomized, open-label, phase III clinical trial was conducted by Byrd and colleagues, assessing the efficacy and safety of ofatumumab versus ibrutinib in 391 individuals with relapsed or refractory CLL/SLL (2014). The primary outcome of interest was the duration of PFS, while overall survival and ORR were secondary endpoints. At a median follow-up of 9.4 months, ibrutinib arm (n=195) had not yet achieved median duration of survival. Therefore, ibrutinib was found to significantly improve PFS compared to the ofatumumab arm’s (n=196) median PFS which was 8.1 months (hazard ration [HR] for PFS with ibrutinib was 0.22; 95% confidence interval [CI], 0.15-0.32; p<0.001). The ORR was significantly higher in the ibrutinib arm (42.6% vs. 4.1%, p<0.001). The efficacy of ibrutinib was not affected by baseline characteristics or molecular variations in disease. The safety profile of ibrutinib was acceptable, especially considering the duration of treatment, on average, exceeded that of the ofatumumab arm.

On August 31, 2016, the FDA expanded the PI label for ofatumumab to include treatment of relapsed CLL in combination with fludarabine and cyclophosphamide. Approval was based on the Phase III COMPLEMENT 2 clinical trial in which 365 individuals diagnosed with relapsed CLL were randomized 1:1 to receive either ofatumumab, fludarabine and cyclophosphamide (OFC) or fludarabine and cyclophosphamide (FC) alone. The primary endpoint was PFS and secondary outcomes included ORR and overall survival (OS). The median duration of treatment for both study arms was six cycles. At study-end, PFS was assessed by independent-review and determined to be significantly longer in the OFC arm versus the FC arm (28.9 months vs 18.8 months; HR=0.67 [95% CI, 0.51-0.89]; p=0.0036). Similarly, the ORR was 84% for the OFC arm and 68% for the FC arm (p=0.0004). Median OS (follow-up at 34 months) however, was not significantly different between the two arms (Robak, 2017). Furthermore, the comparator group for this trial was not the ideal choice for demonstration of superiority over best available treatments (i.e., ibrutinib [Byrd, 2014]).

According to the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines (CPG) for CLL/SLL (2017), ofatumumab is a category 2A recommended single-agent treatment for individuals with relapsed/refractory chronic CLL/SLL, with and without a del(17p)/TP53 mutation and in combination with fludarabine and cyclophosphamide in individuals without a del(17p)/TP53 mutation.

Maintenance Therapy for CLL/SLL

On January 19, 2016, the FDA approved ofatumumab for the extended treatment of individuals with recurrent or progressive CLL who have achieved a complete or partial response (PR) following at least two lines of therapy. This label expansion was based on the open-label, phase III PROLONG trial in which 474 individuals who had achieved either a PR or complete remission, after either second- or third-line therapy, were randomized to receive ofatumumab (n=238) or observation (n=236) across 24 countries (van Oers, 2015). Eligible participants had a performance status of 2 or better, did not have refractory disease (per a response assessment within the 3 months previous to enrollment), and had never received maintenance therapy or a stem cell transplant. Once enrolled, study participants in the treatment arm received ofatumumab every 8 weeks for up to 2 years or until withdrawal from the study for a variety of reasons (for example, withdrawn consent, disease progression or intolerable side-effects). The study arms were well matched demographically and with respect to prior therapies and disease severity. At the time of study end, the median duration of follow-up was 19.1 months. PFS, the primary outcome, was significantly longer in the ofatumumab group (29.4 months) compared with those assigned to the observation arm (15.2 months; HR=0.50; 95% CI, 0.38-0.66, p<0.0001). There was no difference in overall survival between the two study groups (HR=0.85, p=0.4877). The most frequently reported grade 3 and 4 adverse events were related to neutropenia and infection and were significantly higher in the ofatumumab group. A total of two treatment related deaths occurred in the ofatumumab arm and five deaths occurred in the observation arm; no deaths were attributable to the study drug. Limitations of this study include the open-label design, lack of effect on overall survival, and study funding and data analyses were administered by the drug manufacturer. The NCCN has given ofatumumab a category 2B recommendation for use of ofatumumab as a maintenance therapy for CLL (NCCN, 2017).

Other Uses

Ofatumumab as a Component of a Chemoimmunotherapy Regimen

Ofatumumab has also been investigated as a component of a chemoimmunotherapy regimen, specifically as an alternative to rituximab. Wierda (2011) investigated ofatumumab combined with fludarabine and cyclophosphamide in previously untreated individuals. A total of 61 participants were randomized to receive either 500 mg (n=31) or 1000 mg (n=30) of ofatumumab combined with fludarabine and cyclophosphamide (O-FC) administered every 4 weeks for a total of 6 courses of treatment. CR rate was 32% in the 500 mg group compared to 50% in the 1000 mg group. The authors concluded that a chemoimmunotherapy regimen incorporating ofatumumab is active in individuals with newly diagnosed CLL.

Shanafelt (2013) conducted an uncontrolled study to evaluate ofatumumab combined with pentostatin and cyclophosphamide in 48 previously untreated individuals with CLL. A total of 13 individuals (27%) had grade 3+ hematologic toxicity and 23% had grade 3+ nonhematologic activity. The ORR was 96% (46/48) and the CR rate was 46% (22/48). After a median follow-up of 24 months, 21% experienced disease progression and 17% required additional treatment. When compared with historical controls, time to retreatment appeared to be longer for ofatumumab-based chemoimmunotherapy. Study investigators suggested that well-designed randomized controlled trials are needed to compare ofatumumab-based chemoimmunotherapy with other standard treatments.

Cortelezzi and colleagues (2014) conducted a non-comparative, phase II trial investigating the safety and efficacy of ofatumumab in combination with bendamustine in 47 relapsed/refractory CLL subjects. Most of the study population had failed treatment with fludarabine (75%) or previously received rituximab (55%), and over one-third were 70 years of age or older. The median follow-up was 23.6 months (range, 1.3-33.3 months), and the primary outcome of the study, ORR, was 72.3% (95% CI, 57-84%), with 17% achieving a CR. The most common toxicity was myelosuppression. Grade 3 or higher neutropenia was observed in 61.7% of participants, and grade 3 or higher infections occurred in 6%. Authors concluded that ofatumumab in combination with bendamustine may be a feasible treatment option for relapsed/refractory CLL in a high-risk population. Larger randomized controlled trials are warranted.

Similarly, Flinn (2016) and colleagues conducted a non-comparative, slightly larger phase II trial (n=97) investigating the safety and efficacy of ofatumumab and bendamustine in treatment naïve (n=44) and relapsed individuals (n=53) with CLL. After 29 months of follow-up, the ORR was 95% (43% CR for the previously untreated, and 74% (11% CR) for the relapsed population). Grade 3 and grade 4 events occurred in 57% of previously untreated, and 72% of relapsed patients. An additional study conducted in this setting was stopped early due to toxicities (Ujani, 2015). Although the NCCN has given a 2A recommendation for the treatment of relapsed CLL in the first-line setting a rationale is not provided; additional study is warranted.

Waldenström's Macroglobulinemia/Lymphoplasmacytic Lymphoma

There is sparse evidence regarding the safety and efficacy of ofatumumab for the treatment of Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma. Treon (2011) conducted a small case series of individuals with relapsed/refractory Waldenström's macroglobulinemia (n=30) to primarily evaluate treatment with bendamustine therapy. The majority of individuals underwent treatment with bendamustine and rituximab, while 6 rituximab-intolerant participants received bendamustine alone (n=4) or combined with ofatumumab (n=2). The 2 participants treated with the combination of ofatumumab and bendamustine experienced a partial response without infusion-related or other complications. No other outcomes were stratified by treatment type. Preliminary evidence from this very small case series (n=2) and one abstract (Furman, 2011) suggest that ofatumumab may be active in individuals with prior exposure to rituximab and may be a consideration for individuals who are intolerant to rituximab. However, clinical trials with sufficient numbers of participants, published in the peer-reviewed literature, are needed to assess its safety and clinical efficacy. One phase II clinical trial is currently underway to investigate the safety and efficacy of ofatumumab for Waldenström's macroglobulinemia/lymphoplasmacytic lymphoma.

According to the NCCN CPG (2017) for Waldenström’s macroglobulinemia/lymphoplasmacytic lymphoma, ofatumumab may be considered as treatment in individuals who are intolerant to rituximab, either as a single agent, or as combination salvage therapy for disease that does not respond to primary therapy or for progressive or relapsed disease (NCCN, 2017). However, the evidence to support their 2A recommendation is a small case series (n=2; previously described) providing indirect evidence and a study abstract that has not been published to date.

There are additional ongoing trials investigating the use of ofatumumab as a single, first-line agent and in combination with other agents to treat other types of cancer, such as follicular lymphoma, diffuse large B-cell lymphoma and mantle-cell lymphoma. However, at this time, the published data on these indications consists of early results from phase I and phase II trials that are primarily dose-finding studies. 

Background/Overview

SLL and CLL are related types of indolent, non-Hodgkin lymphoma characterized by a clonal proliferation of mature B lymphocytes. SLL is dominated by nodal involvement while CLL is characterized by blood and bone marrow involvement. 

CLL is often characterized by infectious or autoimmune complications, enlarged lymph nodes, liver, and spleen, increased lymphocyte count, and impaired hematopoiesis (Bauer, 2012). The clinical course and prognosis of CLL is highly variable, with some individuals experiencing no to minimal symptoms for many years with normal life expectancy, while others are immediately symptomatic at diagnosis or soon thereafter (Wierda, 2010).

There are no standard and well-defined treatments for refractory or relapsed disease. Currently available salvage treatments include purine analogs, such as fludarabine or pentostatin; alkylating agents, such as chlorambucil, cyclophosphamide, or bendamustine; and chemoimmunotherapy, such as fludarabine, cyclophosphamide, and rituximab. However, these treatments, alone or in combination, often have low response rates, short time to treatment failure (median, 2-3 months) and poor survival outcomes (median, 6 months) (Wierda, 2010; Wierda, 2011). As a result, new effective treatments are needed for refractory or relapsed disease.

Adverse Events and Warnings

An open-label phase I-II, dose-escalating study evaluated the safety and efficacy of ofatumumab in 33 subjects with relapsed or refractory chronic CLL (Coiffer, 2008). A total of 32 subjects received a total of 4 escalating dose infusions administered once each week. A maximum tolerated dose (MTD) was not reached. Approximately 92% of all subjects experienced adverse events, determined to be grade 1 or 2, during or immediately following the first infusion. These adverse events were not wholly prevented by concomitant treatment regimens, such as paracetamol, antihistamines, and glucocorticoids. The most common adverse events attributed to the ofatumumab infusions were transient rigors, pyrexia, fatigue, rash, and increased sweating. The total number and severity of adverse events decreased at each subsequent infusion. At least one infection (grade 1 or 2) was observed in more than half of all individuals (17/33; 51%), the most common of which was nasopharyngitis. One subject died due to infectious interstitial pneumonia and study investigators warned that severe infection due to immunosuppression may occur due to the depletion of normal B-Cells. Ofatumumab appears to be generally well tolerated up to doses of 2000 mg, although additional well-designed clinical trials are still necessary to evaluate the safety and efficacy of ofatumumab in relapsed or refractory chronic CLL.

Several black box warnings have been described on the FDA Product Information Label. Hepatitis B Virus (HBV) reactivation can occur in individuals receiving CD20-directed cytolytic antibodies, including Arzerra, and in some cases such reactivation could result in fulminant hepatitis, liver failure, and death. Progressive Multifocal Leukoencephalopathy (PML) that results in death can occur in individuals receiving CD20-directed cytolytic antibodies.

Animal data suggests that fetal harm could occur so use of these therapies in pregnant or nursing mothers is cautioned.

Close monitoring and premedication with intravenous corticosteroid, oral acetaminophen, and an oral or IV antihistamine is recommended to lessen infusion reactions associated with CD20-directed cytolytic antibodies. In cases of tumor lysis syndrome, aggressive administration of IV hydration and anti-hyperuricemic agents has been recommended.

According to the manufacturer, the common adverse events (≥ 10%) associated with Arzerra include cough, diarrhea, fatigue, nausea, pneumonia, rash, fever, decreased white blood cell (WBC) and red blood cell (RBC) counts, in addition to bronchitis and upper respiratory infections (URIs). Serious complications of Arzerra include the increased likelihood of infections, such as progressive multifocal leukoencephalopathy. In addition, individuals at high risk of contracting hepatitis B should be carefully screened before receiving treatment. Furthermore, individuals who exhibit inactive hepatitis should be routinely monitored for active infection during and following treatment with Arzerra (Product Information Label, 2016).

Definitions

Complete response (CR): The disappearance of all signs of cancer as a result of treatment; also called complete remission; does not indicate the cancer has been cured.

Line of Therapy:

Monoclonal antibody: A protein developed in the laboratory that can locate and bind to specific substances in the body and on the surface of cancer cells.

One line of therapy: Single line of therapy.

Partial response (PR): A decrease in the size of a tumor, or in the amount of cancer in the body, resulting from treatment; also called partial remission.

Progression free survival (PFS): The time from random assignment in a clinical trial to disease progression.

Progressive disease (PD): Cancer that is growing, spreading, or getting worse; also called disease progression.

Refractory disease: Illness or disease that does not respond to treatment.

Relapse: After a period of improvement, the return of signs and symptoms of illness or disease.

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

 

J9302

Injection, ofatumumab, 10 mg

 

 

ICD-10 Diagnosis

 

 

C83.00-C83.09

Small cell B-cell lymphoma [specified as small lymphocytic lymphoma]

 

C91.10-C91.12

Chronic lymphocytic leukemia of B-cell type

 

When services are Investigational and Not Medically Necessary:
For the procedure and diagnosis 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. Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med. 2014; 371(3):213-223.
  2. Coiffier B, Lepretre S, Pedersen LM, et al. Safety and efficacy of ofatumumab, a fully human monoclonal anti-CD20 antibody, in patients with relapsed or refractory B-cell chronic lymphocytic leukemia: a phase 1-2 study. Blood. 2008; 111(3):1094-1100.
  3. Cortelezzi A, Sciumè M, Liberati AM, et al. Bendamustine in combination with ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial. Leukemia. 2014; 28(3):642-648.
  4. Czuczman MS, Kahanic S, Forero A, et al. Results of a phase II study of bendamustine and ofatumumab in untreated indolent B cell non-Hodgkin's lymphoma. Ann Hematol. 2015; 94(4):633-641.
  5. Flinn IW, Panayiotidis P, Afanasyev B, et al. A phase 2, multicenter study investigating ofatumumab and bendamustine combination in patients with untreated or relapsed CLL. Am J Hematol. 2016; 91(9):900-906.
  6. Flinn IW, Ruppert AS, Harwin W et al. A phase II study of two dose levels of ofatumumab induction followed by maintenance therapy in symptomatic, previously untreated chronic lymphocytic leukemia. Am J Hematol. 2016; 91(10):1020-1025.
  7. Furman RR, Eradat H, DiRienzo CG, et al. A phase II trial of ofatumumab in subjects with Waldenstrom's macroglobulinemia. Blood. 2011; 118(21):3701. Available at: http://www.bloodjournal.org/content/118/21/3701?sso-checked=true.  Accessed on September 28, 2017.
  8. Hillmen P, Robak T, Janssens A, et al. Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Lancet. 2015; 385(9980):1873-1883.
  9. Ladyzynski P, Molik M, Foltynski P. A network meta-analysis of progression free survival and overall survival in first-line treatment of chronic lymphocytic leukemia. Cancer Treat Rev. 2015; 41(2):77-93.
  10. Martínez C, Díaz-López A, Rodriguez-Calvillo M, et al. Phase II trial of ofatumumab plus ESHAP (O-ESHAP) as salvage treatment for patients with relapsed or refractory classical Hodgkin lymphoma after first-line chemotherapy. Br J Haematol. 2016; 174(6):859-867.
  11. Moreno C, Montillo M, Panayiotidis P, et al. Ofatumumab in poor-prognosis chronic lymphocytic leukemia: a Phase IV, non-interventional, observational study from the European Research Initiative on Chronic Lymphocytic Leukemia. Haematologica. 2015; 100(4):511-516.
  12. Robak T, Warzocha K, Govind Babu K. et al. Ofatumumab plus fludarabine and cyclophosphamide in relapsed chronic lymphocytic leukemia: results from the COMPLEMENT 2 trial. Leuk Lymphoma. 2017; 58(5):1084-1093.
  13. Shanafelt T, Lanasa MC, Call TG, et al. Ofatumumab-based chemoimmunotherapy is effective and well tolerated in patients with previously untreated chronic lymphocytic leukemia (CLL). Cancer. 2013; 119(21):3788-3796.
  14. Sorensen PS, Lisby S, Grove R, et al. Safety and efficacy of ofatumumab in relapsing-remitting multiple sclerosis: a phase 2 study. Neurology. 2014; 82(7):573-581.
  15. Treon SP, Hanzis C, Tripsas C, et al. Bendamustine therapy in patients with relapsed or refractory Waldenström’s macroglobulinemia. Clin Lymphoma Myeloma Leuk. 2011; 11(1):133-135.
  16. Ujjani C, Ramzi P, Gehan E, et al. Ofatumumab and bendamustine in previously treated chronic lymphocytic leukemia and small lymphocytic lymphoma. Leuk Lymphoma. 2015; 56(4):915-920.
  17. van Oers MH, Kuliczkowski K, Smolej L, et al. Ofatumumab maintenance versus observation in relapsed chronic lymphocytic leukaemia (PROLONG): an open-label, multicentre, randomised phase 3 study. Lancet Oncol. 2015; 16(13):1370-1379.
  18. Wierda WG, Kipps TJ, Durig J, et al. Chemoimmunotherapy with O-FC in previously untreated patients with chronic lymphocytic leukemia. Blood. 2011; 117(24):6450-6458.
  19. Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol. 2010; 28(10):1749-1755.
  20. Wierda WG, Padmanabhan S, Chan GW, et al. Ofatumumab is active in patients with fludarabine-refractory CLL irrespective of prior rituximab: results from the phase 2 international study. Blood. 2011; 118(19):5126-5129.
  21. Wu Y, Wang Y, Gu Y, et al. Safety and efficacy of Ofatumumab in chronic lymphocytic leukemia: a systematic review and meta-analysis. Hematology. 2017 Jun. [Epub ahead of print].

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Arzerra [Product Information]. Research Triangle Park, NC. GlaxoSmithKline; Revised August 30, 2016. Available at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125326s063lbl.pdf. Accessed on September 26, 2017.
  2. Bauer K, Rancea M, Roloff V, et al. Rituximab, ofatumumab and other monoclonal anti-CD20 antibodies for chronic lymphocytic leukaemia. Cochrane Database Syst Rev. 2012: (11):CD008079.
  3. National Comprehensive Cancer Network®. NCCN® Drugs & Biologic Compendium™ (electronic version). For additional information visit the NCCN website: http://www.nccn.org/index/asp. Accessed on September 26, 2017.
  4. NCCN Clinical Practice Guidelines in Oncology®. © 2017 National Comprehensive Cancer Network, Inc. For additional information visit the NCCN website: http://www.nccn.org/index.asp. Accessed on September 26, 2017.
    • Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia (V.1.2018). August, 21, 2017.
    • Waldenström’s Macroglobulinemia/Lymphoplasmacytic Lymphoma (V.1 2017). January 31, 2017.
  5. Ofatumumab: DrugPoints® System (electronic version). Truven Health Analytics, Greenwood Village, CO. Updated August 11, 2017. Available at: http://www.micromedexsolutions.com. Accessed on September 26, 2017.
  6. Ofatumumab Monograph. Lexicomp® Online, American Hospital Formulary Service® (AHFS®) Online, Hudson, Ohio, Lexi-Comp., Inc. Last revised April 6, 2016. Accessed on September 26, 2017.

    Websites for Additional Information

 
  1. National Cancer Institute (NCI). Available at: http://www.ncbi.nlm.nih.gov/pubmedhealth/. Accessed on September 25, 2017.
Index

Arzerra

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

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review.

Reviewed

11/01/2017

Hematology/Oncology Subcommittee review. Updated header language from “Current Effective Date” to “Publish Date.” Updated Rationale, Background/Overview and References sections.

Reviewed

11/03/2016

MPTAC review.

Reviewed

11/02/2016

Hematology/Oncology Subcommittee review. Updated formatting in Position Statement section. Updated Rationale, Background/Overview and References sections.

Revised

05/05/2016

MPTAC review.

Revised

05/04/2016

Hematology/Oncology Subcommittee review. Reformatted criteria and added MN criteria for maintenance treatment for CLL/SLL. Updated Title with registered trademark symbol. Updated Rationale, Background/Overview and References sections. Removed ICD-9 codes from Coding section.

Revised

05/07/2015

MPTAC review.

Revised

05/06/2015

Hematology/Oncology Subcommittee review. Clarified MN statement. Updated Description/Scope, Rationale, Background/Overview and References sections.

Revised

11/13/2014

MPTAC review.

Revised

11/12/2014

Hematology/Oncology Subcommittee review. Addition of INV & NMN statement to Position Statement. Updated Rationale and References sections.

New

05/15/2014

MPTAC review.

New

05/14/2014

Hematology/Oncology Subcommittee review. Initial document development.