BLINCYTO (blinatumomab)

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1 BLINCYTO (blinatumomab) Non-Discrimination Statement and Multi-Language Interpreter Services information are located at the end of this document. Coverage for services, procedures, medical devices and drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only and does not imply that a service or treatment is clinically appropriate or inappropriate. The provider and the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug and is in no way intended as a statement of medical necessity and/or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mandates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food and Drug Administration (FDA) may not be considered experimental or investigational and thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" and "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD and the Cross and Shield Symbols are registered service marks of the Blue Cross and Blue Shield Association, an association of independent Blue Cross and Blue Shield Plans. All other trademarks and service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. O1042.docx Page 1 of 7

2 Description: Blincyto (blinatumomab) is a bispecific T-cell engager (BiTE) which binds to CD19 expressed on B-cells and CD3 expressed on T-cells. Blincyto is indicated for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children. Definitions: Adult: Age 18 years and older Refractory Acute Lymphoblastic Leukemia (ALL): Refractory (resistant) ALL disease is defined as those individuals who fail to obtain complete response with induction therapy, i.e., failure to eradicate all detectable leukemia cells (<5% blasts) from the bone marrow and blood with subsequent restoration of normal hematopoiesis (>25% marrow cellularity and normal peripheral blood counts). Relapsed Acute Lymphoblastic Leukemia (ALL): Relapsed ALL disease describes the reappearance of leukemia cells in the bone marrow or peripheral blood after the attainment of a complete remission with chemotherapy and/or allogeneic cell transplant. Risk Evaluation and Mitigation Strategies (REMS): Use of Blincyto (blinatumomab) is subject to a Risk Evaluation and Mitigation Strategies (REMS) program that requires provider, patient, and dispensing pharmacy be enrolled into the program. Only providers and Pharmacies enrolled into the REMS may prescribe and dispense the drug, respectively, to individuals who are also in the program. A REMS program attempts to manage known or potentially serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) for some drugs to ensure that the benefits of a drug outweigh its risks. O1042.docx Page 2 of 7

3 Criteria: See Resources section for FDA-approved dosage. For off-label use of an FDA-approved prescription drug prescribed for the treatment of cancer, refer to BCBSAZ Medical Coverage Guideline #O603, Prescription Medications for the Treatment of Cancer. BLINCYTO IS AVAILABLE ONLY THROUGH A RESTRICTED PROGRAM UNDER A RISK EVALUATION AND MITIGATION STRATEGY (REMS) CALLED THE BLINCYTO REMS PROGRAM. Blincyto for the treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) is considered medically necessary with documentation of ALL of the following: 1. ONE of the following: Philadelphia chromosome (Ph)-negative ALL Philadelphia chromosome (Ph)-positive ALL and failure of, contraindication to or intolerance to TWO tyrosine kinase inhibitors (TKIs) (e.g., Gleevec [imitinib], Iclusig [ponatinib], Sprycel [dasatinib], Tasigna [nilotinib]) 2. No known hypersensitivity to blinatumomab or to any component of the product formulation Blincyto for all other indications not previously listed or if above criteria not met is considered experimental or investigational based upon: 1. Lack of final approval from the Food and Drug Administration, and 2. Insufficient scientific evidence to permit conclusions concerning the effect on health outcomes, and 3. Insufficient evidence to support improvement of the net health outcome, and 4. Insufficient evidence to support improvement of the net health outcome as much as, or more than, established alternatives, and 5. Insufficient evidence to support improvement outside the investigational setting. These indications include, but are not limited to: Treatment with dosing or frequency outside the FDA-approved dosing and frequency O1042.docx Page 3 of 7

4 Resources: Literature reviewed 01/23/18. We do not include marketing materials, poster boards and nonpublished literature in our review. Blincyto Package Insert: - FDA-approved indication and dosage: Indication Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children Recommended Dose A treatment course consists of up to 2 cycles of Blincyto for induction followed by 3 additional cycles for consolidation and up to 4 additional cycles of continued therapy. Cycle Induction Cycle 1 Days 1-7 Days 8-28 Days Induction Cycle 2 Days 1-28 Days Consolidation Cycles 3-5 Days 1-28 Days Greater than or equal to 45 kg (fixed dose) 9 mcg/day Less than 45 kg (BSA-based dose) 5mcg/m 2 /day (not to exceed 9 mcg.day) O1042.docx Page 4 of 7

5 Resources: (cont.) Blincyto Package Insert: (cont.) - FDA-approved indication and dosage: (cont.) Indication Relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children (cont.) Cycle Continued Therapy Cycles 6-9 Recommended Dose Greater than or equal to 45 kg (fixed dose) Less than 45 kg (BSA-based dose) Days 1-28 Days day treatmentfree 56-day treatmentfree A single cycle of treatment of Blincyto induction or consolidation consists of 28 days of continuous intravenous infusion followed by a 14-day treatment-free (total 42 days). A single cycle of treatment of Blincyto continued therapy consists of 28 days of continuous intravenous infusion followed by a 56-day treatment-free (total 84 days). Approval Duration: 9 cycles with initial fills of 14 days per fill for first 2 cycles O1042.docx Page 5 of 7

6 Non-Discrimination Statement: Blue Cross Blue Shield of Arizona (BCBSAZ) complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. BCBSAZ provides appropriate free aids and services, such as qualified interpreters and written information in other formats, to people with disabilities to communicate effectively with us. BCBSAZ also provides free language services to people whose primary language is not English, such as qualified interpreters and information written in other languages. If you need these services, call (602) for Spanish and (877) for all other languages and other aids and services. If you believe that BCBSAZ has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file a grievance with: BCBSAZ s Civil Rights Coordinator, Attn: Civil Rights Coordinator, Blue Cross Blue Shield of Arizona, P.O. Box 13466, Phoenix, AZ , (602) , TTY/TDD (602) , crc@azblue.com. You can file a grievance in person or by mail or . If you need help filing a grievance BCBSAZ s Civil Rights Coordinator is available to help you. You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services, 200 Independence Avenue SW., Room 509F, HHH Building, Washington, DC 20201, , (TDD). Complaint forms are available at Multi-Language Interpreter Services: O1042.docx Page 6 of 7

7 Multi-Language Interpreter Services: (cont.) O1042.docx Page 7 of 7

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