Notification

Blinatumomab (Blincyto®)


Notification Issue Date: 07/10/2018



Medical Policy Bulletin


Title:Blinatumomab (Blincyto®)

Policy #:08.01.21c

This policy is applicable to the Company’s commercial products only. Policies that are applicable to the Company’s Medicare Advantage products are accessible via a separate Medicare Advantage policy database.


The Company makes decisions on coverage based on Policy Bulletins, benefit plan documents, and the member’s medical history and condition. Benefits may vary based on contract, and individual member benefits must be verified. The Company determines medical necessity only if the benefit exists and no contract exclusions are applicable.

When services can be administered in various settings, the Company reserves the right to reimburse only those services that are furnished in the most appropriate and cost-effective setting that is appropriate to the member’s medical needs and condition. This decision is based on the member’s current medical condition and any required monitoring or additional services that may coincide with the delivery of this service.

This Medical Policy Bulletin document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy Bulletin will be reviewed regularly and be updated as scientific and medical literature becomes available. For more information on how Medical Policy Bulletins are developed, go to the About This Site section of this Medical Policy Web site.



Policy

MEDICALLY NECESSARY

Coverage is subject to the terms, conditions, and limitations of the member's contract.

Blinatumomab (Blincyto®) administered as a single agent is considered medically necessary and, therefore, covered for individuals who meet all of the following criteria, including Dosing and Frequency Requirements:

MINIMAL RESIDUAL DISEASE POSITIVE (MRD+) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL)
  • B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%
  • Consolidation therapy for Philadelphia chromosome-negative B-ALL in adolescents and young adults (ages 15 to 39 years at initial cancer diagnosis) who are minimal residual disease positive (MRD+) following a complete response to induction therapy
  • Consolidation therapy for Philadelphia chromosome-negative B-ALL in adults under 65 years of age without substantial comorbidities who are MRD+ following a complete response to induction therapy

RELAPSED OR REFRACTORY B-CELL ALL
  • Relapsed or refractory Philadelphia chromosome-negative B-cell acute lymphoblastic leukemia (B-ALL)
  • Relapsed or refractory Philadelphia chromosome-positive B-ALL in individuals who are intolerant to or refractory to tyrosine kinase inhibitor therapies (e.g., dasatinib [Sprycel®], imatinib [Gleevec®], ponatinib [Iclusig®])

DOSING AND FREQUENCY REQUIREMENTS

The Company reserves the right to modify the Dosing and Frequency Requirements listed in this policy to ensure consistency with the most recently published recommendations for the use of blinatumomab (Blincyto®). Changes to these guidelines are based on a consensus of information obtained from resources such as, but not limited to: the US Food and Drug Administration (FDA); Company-recognized authoritative pharmacology compendia; or published peer-reviewed clinical research. The professional provider must supply supporting documentation (i.e., published peer-reviewed literature) in order to request coverage for an amount of blinatumomab (Blincyto®) outside of the Dosing and Frequency Requirements listed in this policy. For a list of Company-recognized pharmacology compendia, view our policy on off-label coverage for prescription drugs and biologics.

Accurate member information is necessary for the Company to approve the requested dose and frequency of this drug. If the member’s dose, frequency, or regimen changes (based on factors such as changes in member weight or incomplete therapeutic response), the provider must submit those changes to the Company for a new approval based on those changes as part of the precertification process. The Company reserves the right to conduct post-payment review and audit procedures for any claims submitted for blinatumomab (Blincyto®).

MINIMAL RESIDUAL DISEASE POSITIVE (MRD+) B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL)
For MRD+ B-Cell ALL, a treatment course consists of 1 cycle of blinatumomab (Blincyto®) for induction (Cycle 1), followed by up to 3 additional cycles for consolidation treatment (Cycles 2-4). Each cycle consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval (total 42 days). Do not exceed a maximum of 875 mcg, or 25 vials, per month.
        Induction Cycle 1 and Consolidation Cycles 2-4
        • Days 1-28
          • Weight ≥ 45 kg: 28 mcg/day
          • Weight < 45 kg: 15 mcg/m2/day, not to exceed 28 mcg/day
        • Days 29-42: 14-day treatment-free interval

RELAPSED OR REFRACTORY B-CELL ALL
For Relapsed or Refractory B-Cell ALL, a treatment course consists of up to 2 cycles of blinatumomab (Blincyto®) for induction (Cycles 1-2), followed by 3 additional cycles for consolidation treatment (Cycles 3-5) and up to 4 additional cycles of continued therapy (Cycles 6-9). Each induction or consolidation therapy cycle consists of 4 weeks of continuous intravenous infusion followed by a 2-week treatment-free interval (total 42 days). Each continued therapy cycle consists of 4 weeks of continuous intravenous infusion followed by an 8-week treatment-free interval (total 84 days). Do not exceed a maximum of 875 mcg, or 25 vials, per month.
        Induction Cycle 1, Days 1-7
        • Weight ≥ 45 kg: 9 mcg/day
        • Weight < 45 kg: 5 mcg/m2/day, not to exceed 9 mcg/day

        Induction Cycle 1, Days 8-28
        • Weight ≥ 45 kg: 28 mcg/day
        • Weight < 45 kg: 15 mcg/m2/day, not to exceed 28 mcg/day

        Induction Cycle 1, Days 29-42: 14-day treatment-free interval

        Induction Cycle 2 and Consolidation Cycles 3-5
        • Days 1-28
          • Weight ≥ 45 kg: 28 mcg/day
          • Weight < 45 kg: 15 mcg/m2/day, not to exceed 28 mcg/day
        • Days 29-42: 14-day treatment-free interval

        Consolidation Cycles 6-9
        • Days 1-28
          • Weight ≥ 45 kg: 28 mcg/day
          • Weight < 45 kg: 15 mcg/m2/day, not to exceed 28 mcg/day
        • Days 29-84: 56-day treatment-free interval

INPATIENT ADMISSION

When the medical necessity criteria has been met, the inpatient admission for administration of blinatumomab (Blincyto®), as recommended by the US Food and Drug Administration (FDA), is covered in accordance with the following time-frames*:
  • First Cycle: Days 1-3 of therapy (MRD+ B-Cell ALL) or Days 1-9 of therapy (Relapsed or Refractory B-Cell ALL)
  • Second Cycle: Days 1-2 of therapy
*Consideration will be given for individuals receiving therapy in subsequent cycle starts and for reinitiation of therapy (e.g., if treatment is interrupted for 4 or more hours). Inpatient hospital stays that are longer than the preceding timeframes must be re-evaluated for medical necessity. Home infusion therapy is an option for subsequent therapy.

NOT MEDICALLY NECESSARY

Utilization of more than 875 units of service (UOS) equivalent to 25 vials of blinatumomab (Blincyto®) per month is considered not medically necessary and, therefore, not covered.
  • One unit of service (UOS) equals one microgram (mcg), and thus, 1 vial equals 35 UOS.
  • Reconstituted blinatumomab (Blincyto®) must be prepared using the combination of vials that result in the least amount of wastage for the dosage amount being administered.
    • Per the manufacturer's two-day infusion protocol, five vials (or 175 UOS) should be used to reconstitute six days of drug.
    • Per the manufacturer's seven-day infusion protocol, six vials (or 210 UOS) should be used to reconstitute seven days of drug.

EXPERIMENTAL/INVESTIGATIONAL

All other uses of blinatumomab (Blincyto®) are considered experimental/investigational and, therefore, not covered unless the indication is supported as an accepted off-label use, as defined in the medical policy on off-label coverage for prescription drugs and biologics.

REQUIRED DOCUMENTATION

The individual's medical record must reflect the medical necessity for the drug. These medical records may include, but are not limited to: records from the professional provider's office, hospital, nursing home, home health agencies, therapies, and test reports.

The company may conduct reviews and audits of services to our members, regardless of the participation status of the provider. All documentation is to be available to the Company upon request. Failure to produce the requested information may result in a denial of the drug.

When coverage of blinatumomab (Blincyto®) is requested outside of the Dosing and Frequency Requirements listed in this policy, the prescribing professional provider must supply documentation (i.e., published peer-reviewed literature) to the Company that supports this request.
Guidelines

BLACK BOX WARNINGS

Refer to the specific manufacturer's prescribing information for any applicable Black Box Warnings.

BENEFIT APPLICATION

Subject to the terms and conditions of the applicable benefit contract, blinatumomab (Blincyto®) is covered under the medical benefits of the Company’s products when the medical necessity criteria and Dosing and Frequency Requirements listed in this medical policy are met.

US FOOD AND DRUG ADMINISTRATION (FDA) STATUS

Blinatumomab (Blincyto®) was approved by the FDA on December 3, 2014 for the treatment of Philadelphia chromosome--negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BALL). Supplemental approvals for blinatumomab (Blincyto®) have since been issued by the FDA.

The safety and effectiveness of blinatumomab (Blincyto®) have been established in the pediatric population.

Description

ACUTE LYMPHOBLASTIC LEUKEMIA (ALL)

The American Cancer Society estimates that, in the year 2018, there will be approximately 5,960 individuals in the United States newly diagnosed with acute lymphoblastic leukemia (ALL) (i.e., acute lymphocytic leukemia). Only about one-third of all cases will be in adults: the majority of cases occur in children. The 5-year overall survival rate for ALL in children is higher than 85%, but is only 40% to 60% in adults (although these rates vary depending on the subtype of ALL and other prognostic factors).

The goal of therapy is to achieve complete remission, obtain an undetectable minimal residual disease (MRD) result, and to then undergo a hematopoietic stem cell transplant (HSCT). About 70% to 90% of adults will achieve complete remission from ALL after induction therapy; however, approximately half of these individuals will experience relapse due to chemoresistant disease. One indicator of clinical relapse is the MRD result: the lower the MRD measurement, the better the chance of overall survival. It has been reported that up to 80% of individuals who fail to clear MRD experience a clinical relapse despite continued chemotherapy. The role of MRD testing is less understood in adults compared with children due to paucity of data in adults.

Treatment of ALL is dependent on the particular subtype of the disease. Although most adults are Philadelphia chromosome--negative, approximately 20% to 30% of adults with ALL have a genetic mutation referred to as Philadelphia chromosome--positive. Treatment of ALL subtypes may consist of chemotherapy (induction, consolidation, and maintenance), tyrosine kinase inhibitors [e.g., dasatinib (Sprycel), imatinib [Gleevec®], ponatinib (Iclusig)], monoclonal antibodies [e.g., blinatumomab (Blincyto®)].

BLINATUMOMAB (BLINCYTO®)

A T-cell (immune cell) is activated when its receptors bind to the antigens on a cancer cell. The T-cell releases cytotoxic components that form pores in the tumor cell's structure and causes cell death. However, cancer cells have found many ways to evade T-cell recognition (e.g., mutation, blocking T-cell signaling, etc.). Blinatumomab (Blincyto®), a monoclonal antibody, was created to combat this evasion. Blinatumomab (Blincyto®) is the first bispecific T-cell engager (BiTE®) immunotherapy product to be approved by the FDA. It creates a bridge between the T-cell and the cancer cell, by binding to two different proteins at the same time (CD19 located on malignant B-cells and CD3 located on T-cells); this triggers the activation of the T-cells which ultimately will cause the death of the malignant cells.

Blinatumomab (Blincyto®) obtained accelerated approval by the US Food and Drug Administration (FDA) on December 3, 2014 for the treatment of Philadelphia chromosome--negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (BALL). Subsequent approvals were established for those with Philadelphia chromosome--positive relapsed or refractory BALL and in those with BALL in first or second complete remission with minimal residual disease.

CYTOKINE RELEASE SYNDROME
Cytokines are proteins that communicate with cells about the need for immune assistance. Cytokines are secreted by both healthy and cancerous cells. When blinatumomab (Blincyto®) infusion is initiated, a transient release (increase) of cytokines occurs in response to the T-cell activation, called cytokine release syndrome (CRS). CRS is common during the initial infusions of monoclonal antibodies and typically subsides with subsequent doses. Symptoms may range from mild in severity to life-threatening or fatal reactions, and include flu-like reactions, hypotension, tachycardia, gastrointestinal disturbances, dyspnea, shock, disseminated intravascular coagulation (DIC), capillary leak syndrome (CLS), and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS). For relapsed or refractory B-Cell ALL, it has been reported that the highest risk of CRS occurs during the first 9 days of the first cycle and during the first 2 days of the second cycle of blinatumomab (Blincyto®). For MRD+ B-Cell ALL, it has been reported that the highest risk of CRS occurs during the first 3 days of the first cycle and during the first 2 days of the second cycle of blinatumomab (Blincyto®). For these reasons, hospitalization is recommended during these days of therapy. Also per FDA labeling, "For all subsequent cycle starts and reinitiation (e.g., if treatment is interrupted for 4 or more hours), supervision by a healthcare professional or hospitalization is recommended."

PEER-REVIEWED LITERATURE

SUMMARY
The safety and efficacy of blinatumomab (Blincyto®) was evaluated in an open-label, multicenter, single-arm, Phase II study of 185 adults with Philadelphia chromosome--negative relapsed or refractory B-precursor ALL. Blinatumomab (Blincyto®) was administered as a continuous intravenous (IV) infusion. In the first cycle, the initial dose was 9 mcg/day for week 1, then 28 mcg/day for the remaining 3 weeks. In the second and subsequent cycles, 28 mcg/day was administered starting on day 1 of each cycle. The median number of treatment cycles administered was 2 (range: 1 to 5). A reported 77 out of 185 (41.6%) patients achieved complete remission or complete remission with partial hematologic recovery (CR/CRh) within the first 2 treatment cycles, which was the primary endpoint of the study; the majority of responses (81%, 62 out of 77 patients) occurred within the first cycle of treatment. Among those who achieved CR/CRh, 39% (30 out of 77 individuals) proceeded to hematopoietic stem cell transplant (HSCT). There was also a 75% (58 out of 77 individuals) achievement of minimal residual disease (MRD) response. The study also reported that 32% of individuals in the study experienced complete remission for approximately 6.7 months after at least 4 weeks of infusion treatment. 

A Phase III, randomized, open-label, multicenter, confirmatory study demonstrating an increase in overall survival was performed by Kantarjian, et al 2017. Adult participants (N=405) with relapsed or refractory B-cell precursor ALL were randomized 2:1 to receive blinatumomab (Blincyto®) or standard of care chemotherapy. The median number of blinatumomab (Blincyto®) cycles received was two (range one to nine cycles). The median overall survival was statistically significantly longer in the blinatumomab (Blincyto®) group (7.7 months) compared with the chemotherapy group (4 months).

Martinelli, et al 2017 performed an open label, Phase II study of adults with Philadelphia chromosome--positive relapsed or refractory B-precursor ALL who had prior treatment with at least one second-generation or later tyrosine kinase inhibitor (TKI) or were intolerant to second-generation or later TKIs and intolerant or refractory to imatinib. The primary endpoint of complete remission (CR) or CR with partial hematologic recovery (CRh) during the first two cycles of blinatumomab (Blincyto®) was obtained by 16 out of 45 participants (36%). Additionally, 88% of those who obtained CRh achieved a complete minimal residual disease (MRD) response. The median relapse-free survival and overall survival were 6.7 and 7.1 months, respectively.

The safety and effectiveness of blinatumomab (Blincyto®) was studied in the pediatric population (N=70) with relapsed or refractory B-precursor ALL in an open-label, multicenter, single arm trial. The median number of blinatumomab (Blincyto®) cycles received was one (range one to five cycles). Twenty-three out of 70 (32.9%) participants achieved complete remission or complete remission with partial hematologic recovery (CR/CRh) within the first 2 treatment cycles with 17 out of 23 (73.9%) occurring within Cycle 1 of treatment.

Gökbuget, et al 2018 performed an open label, multicenter, single-arm study of 86 adults with B-cell precursor ALL who had received at least 3 chemotherapy blocks of standard ALL therapy, were in first or second hematologic complete remission (CR1 and CR2), and had minimal residual disease (MRD) at a level of ≥ 0.1%. Blinatumomab (Blincyto®) 15 mcg/m2/day up to a maximum dosage of 28 mcg/day IV was administered for up to four cycles. The primary endpoint was complete MRD response status after 1 cycle of blinatumomab. Results showed there 73.8% of patients in CR1 and 50% of patients in CR2 obtained complete MRD response. The median hematological relapse-free survival was 35.2 months in patients in CR1 and 12.3 months in patients in CR2.

RISK EVALUATION AND MITIGATION STRATEGY (REMS)

Blinatumomab (Blincyto®) was approved by the FDA with a risk evaluation and mitigation strategy (REMS). The goal of this communication is to inform healthcare professionals about the serious risks associated with taking this drug, including the risks of CRS, which may be life-threatening or fatal; neurological toxicities, which may be severe, life-threatening, or fatal; and errors that may occur during preparation or administration of blinatumomab (Blincyto®).

OFF-LABEL INDICATIONS

There may be additional indications contained in the Policy section of this document due to evaluation of criteria highlighted in the Company’s off-label policy, and/or review of clinical guidelines issued by leading professional organizations and government entities.
References


American Cancer Society. About acute ALL. Available at: https://www.cancer.org/cancer/acute-lymphocytic-leukemia.html . Accessed April 30, 2018.

American Cancer Society. Leukemia in children. Available at: https://www.cancer.org/cancer/leukemia-in-children.html . Accessed April 30, 2018.

American Hospital Formulary Service (AHFS). Drug Information 2018. Blinatumomab. [Lexicomp Online Web site]. 02/22/16. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed April 30, 2018.

American Society of Clinical Oncology (ASCO). Leukemia - Acute Lymphocytic - ALL: Overview. Updated 05/2017. Available at: http://www.cancer.net/cancer-types/leukemia-acute-lymphocytic-all/overview . Accessed April 30, 2018.

BiTE® Immunotherapy. Amgen Oncology. 2014. Available at: http://www.biteantibodies.com/ . Accessed April 30, 2018.

Blinatumomab (Blincyto) Prescribing Information. Thousand Oaks, CA: Amgen Inc.; 03/2018. Available at: http://www.blincyto.com/ . Accessed April 27, 2018.

Breslin S. Cytokine-release syndrome: overview and nursing implications. Clin J Oncol Nurs. 2007;11(1 Suppl):37-42.

Elsevier’s Clinical Pharmacology Compendium. Blinatumomab. [ClinicalKey Web site]. 03/30/18. Available at: https://www.clinicalkey.com/pharmacology/ [via subscription only]. Accessed April 30, 2018.

Gökbuget N, Dombret H, Bonifacio M, et al. Blinatumomab for minimal residual disease in adults with B-cell precursor acute lymphoblastic leukemia. Blood. 2018;131(14):1522-1531.

Horton TM, Steuber CP. Overview of the treatment of acute lymphoblastic leukemia in children and adolescents. [UpToDate Web Site]. 03/21/18. Available at:http://www.uptodate.com/contents/overview-of-the-treatment-of-acute-lymphoblastic-leukemia-in-children-and-adolescents?source=search_result&search=blincyto&selectedTitle=9~9 . Accessed April 30, 2018.

Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. N Engl J Med. 2017;376(9):836-847.

Larson RA. Treatment of relapsed or refractory acute lymphoblastic leukemia in adults. [UpToDate Web Site]. 02/05/18. Available at: http://www.uptodate.com/contents/treatment-of-relapsed-or-refractory-acute-lymphoblastic-leukemia-in-adults?source=search_result&search=blincyto&selectedTitle=4~9. Accessed April 30, 2018.

Lexi-Drugs Compendium. Blinatumomab. 04/24/18. [Lexicomp Online Web site]. Available at: http://online.lexi.com/lco/action/home [via subscription only]. Accessed April 30, 2018.

Martinelli G, Boissel N, Chevallier P, et al. Complete hematologic and molecular response in adult patients with relapsed/refractory Philadelphia chromosome-positive B-precursor acute lymphoblastic leukemia following treatment with blinatumomab: results from a phase II, single-arm, multicenter study. J Clin Oncol. 2017;35(16):1795-1802.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). ALL. Version 1.2018. [NCCN Website]. Available at: http://www.nccn.org/professionals/physician_gls/pdf/all.pdf [via free subscription]. Accessed April 30, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Adolescent and Young Adult (AYA) Oncology. Version 2.2018. [NCCN Website]. Available at: https://www.nccn.org/professionals/physician_gls/pdf/aya.pdf [via free subscription]. Accessed May 24, 2018.

National Comprehensive Cancer Network (NCCN). NCCN Drugs & Biologics Compendium. Blinatumomab. [NCCN Web site]. 2018. Available at: http://www.nccn.org/professionals/drug_compendium/content/contents.asp [via subscription only]. Accessed April 26, 2018.

Seiter K. Acute lymphoblastic leukemia. Updated 01/17/18. Available at: http://emedicine.medscape.com/article/207631-overview#showall . Accessed April 30, 2018.

Stock W, Estrov Z. Clinical use of minimal residual disease detection in acute lymphoblastic leukemia. [UpToDate Web Site]. 09/14/17. Available at: http://www.uptodate.com/contents/clinical-use-of-minimal-residual-disease-detection-in-acute-lymphoblastic-leukemia?source=search_result&search=acute+lymphoblastic+leukemia+adult&selectedTitle=7~150 . Accessed April 30, 2018.

Topp MS, Goekbuget N, Stein AS, et al. Confirmatory open-label, single-arm, multicenter phase 2 study of the BiTE antibody blinatumomab in patients (pts) with relapsed/refractory B-precursor acute lymphoblastic leukemia (r/r ALL). 2014 ASCO Annual Meeting - Abstract Number: 7005. J Clin Oncol 2014;32:5s (suppl; abstr 7005).

Topp MS, Gökbuget N, Zugmaier G, et al. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012;120(26):5185-7.

Topp MS, Kufer P, Gökbuget N, et al. Targeted therapy with the T-cell-engaging antibody blinatumomab of chemotherapy-refractory minimal residual disease in B-lineage acute lymphoblastic leukemia patients results in high response rate and prolonged leukemia-free survival. J Clin Oncol. 2011;29(18):2493-8.

Truven Health Analytics, Inc. Micromedex® 2.0 Healthcare Series. DrugDex®. Blinatumomab (Blincyto). [Micromedex® Web site]. Updated 04/25/18. Available at: http://www.micromedexsolutions.com/micromedex2/librarian [via subscription only]. Accessed April 30, 2018.

US Food and Drug Administration (FDA). Center for Drug Evaluation and Research. Drugs @FDA. Blinatumomab (Blincyto) approval letter and prescribing information. [FDA Web site]. 03/29/2018. Available at:
https://www.accessdata.fda.gov/scripts/cder/daf/#labelinfo . Accessed April 27, 2018.

US Food and Drug Administration (FDA). RISK EVALUATION AND MITIGATION STRATEGY (REMS). Original 12/2014. Updated 04/2018. Available at: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=341. Accessed May 7, 2018.





Coding

Inclusion of a code in this table does not imply reimbursement. Eligibility, benefits, limitations, exclusions, precertification/referral requirements, provider contracts, and Company policies apply.

The codes listed below are updated on a regular basis, in accordance with nationally accepted coding guidelines. Therefore, this policy applies to any and all future applicable coding changes, revisions, or updates.

In order to ensure optimal reimbursement, all health care services, devices, and pharmaceuticals should be reported using the billing codes and modifiers that most accurately represent the services rendered, unless otherwise directed by the Company.

The Coding Table lists any CPT, ICD-9, ICD-10, and HCPCS billing codes related only to the specific policy in which they appear.

CPT Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD - 10 Procedure Code Number(s)

N/A


Professional and outpatient claims with a date of service on or before September 30, 2015, must be billed using ICD-9 codes. Professional and outpatient claims with a date of service on or after October 1, 2015, must be billed using ICD-10 codes.

Facility/Institutional inpatient claims with a date of discharge on or before September 30, 2015, must be billed with ICD-9 codes. Facility/Institutional inpatient claims with a date of discharge on or after October 1, 2015, must be billed with ICD-10 codes.


ICD -10 Diagnosis Code Number(s)

C91.00 Acute lymphoblastic leukemia not having achieved remission

C91.02 Acute lymphoblastic leukemia, in relapse



HCPCS Level II Code Number(s)

J9039 Injection, blinatumomab, 1 microgram


Revenue Code Number(s)

N/A

Coding and Billing Requirements


Cross References


Policy History

Revisions to 08.01.21c
10/08/2018This version of the policy will become effective 10/08/2018.

This policy has been updated in consideration of revisions within the US Food and Drug Administration (FDA) labeling and National Comprehensive Cancer Network (NCCN) compendia.

Dosing and Frequency Requirements have been added for all indications.

A position of Not Medically Necessary has been added for doses above 875 units of service (UOS) or 25 vials of blinatumomab (Blincyto®) per month.

Revisions to 08.01.21b
12/27/2017The policy has undergone a routine review, and the medical necessity criteria have been revised to reflect the updated US Food and Drug Administration (FDA) and National Comprehensive Cancer Network (NCCN) criteria.

Effective 10/05/2017 this policy has been updated to the new policy template format.


Version Effective Date: 10/08/2018
Version Issued Date: 10/08/2018
Version Reissued Date: N/A

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