Last Review Date: 09/01/2020

Date of Origin: 12/16/2014

Dates Reviewed: 12/2014, 09/2015, 02/2016, 05/2016, 08/2016, 11/2016, 02/2017, 05/2017, 08/2017, 11/2017, 02/2018, 04/2018, 09/2018, 12/2018, 03/2019, 06/2019, 09/2019, 12/2019, 03/2020, 06/2020, 09/2020

I. Length of Authorization

• Relapsed or Refractory B-Cell Precursor Acute Lymphocytic Leukemia (ALL)

• Initial coverage will be provided for 30 weeks for a total of five cycles (2 cycles of induction followed by 3 cycles of consolidation)
• Continued coverage will be provided every 24 weeks for a maximum of two additional authorizations (4 cycles of continued therapy)

• MRD+ B-Cell Precursor Acute Lymphocytic Leukemia (ALL)

• Initial coverage will be provided for 24 weeks for a total of four cycles (1 cycle of induction followed by 3 cycles of consolidation)
• Continued coverage may not be renewed

II. Dosing Limits

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

• Blincyto 35 mcg powder for injection: 28 vials per 42 day supply

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

• Relapsed or Refractory B-Cell Precursor Acute Lymphocytic Leukemia (ALL)

Cycle 1 – 5 (Induction/Consolidation)

• 980 billable units per 42 days

Cycle 6 – 9 (Continued Therapy)

• 980 billable units per 84 days

• MRD+ B-Cell Precursor Acute Lymphocytic Leukemia (ALL)

Cycle 1 – 4 (Induction/Consolidation)

• 980 billable units per 42 days

III. Initial Approval Criteria 

Coverage is provided in the following conditions:

• Patient is at least 1 month old; AND

Universal Criteria 

• Used as single agent therapy; AND
• Patient has not received a live vaccine within 2 weeks prior to initiating therapy and will not receive concurrent treatment with lives vaccine while on therapy; AND

B-Cell Precursor Acute Lymphocytic Leukemia (ALL) † Ф 

• Patient has relapsed or refractory disease (Philadelphia chromosome [Ph]-positive patients must be TKI intolerant/refractory); OR
• Used as consolidation therapy in patients with minimal residual disease positive (MRD+) following a complete response/remission to induction therapy; OR
• Used in patients that are MRD+ after consolidation therapy ‡; OR
• Used in patients that are Ph-positive with less than complete response or high-risk genetics (e.g., KMT2Ar, low hypodiploidy, TCF3-PBX1, IKZF1 deletion, etc.) ‡

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

IV. Renewal Criteria 

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and other indication-specific relevant criteria such as concomitant therapy requirements (not including prerequisite therapy), performance status, etc. identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: Cytokine Release Syndrome (CRS), neurological toxicities, serious infections, pancreatitis, tumor lysis syndrome, neutropenia/febrile neutropenia, elevated liver enzymes, leukoencephalopathy, etc.; AND
• Treatment response or stabilization of disease as indicated by CBC, bone marrow cytogenic analysis, QPCR, or FISH; AND
  • Patient has not exceeded 4 cycles of continued therapy or 9 total cycles of therapy for the treatment of relapsed or refractory disease; OR
  • Continued therapy for use in the treatment of MRD+ ALL may not be renewed.

V. Dosage/Administration 

VI. Billing Code/Availability Information

HCPCS Code:

• J9039 - Injection, blinatumomab, 1 microgram; 1 billable unit = 1 microgram

NDC:

• Blincyto 35 mcg single-use powder for injection: 55513-0160-xx

VII. References

1. Blincyto [package insert]. Thousand Oaks, CA; Amgen, March 2020. Accessed August 2020.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) blinatumomab. National Comprehensive Cancer Network, 2020.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2020.
3. Jen EY, Xu Q, Schetter A, Przepiorka D, et al. FDA Approval: Blinatumomab for Patients with B-cell Precursor Acute Lymphoblastic Leukemia in Morphologic Remission with Minimal Residual Disease. Clin Cancer Res. 2019 Jan 15;25(2):473-477. doi: 10.1158/1078-0432.CCR-18-2337. Epub 2018 Sep 25.
4. Kantarjian H, Stein A, Gökbuget N, et al. Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia. N Engl J Med. 2017 Mar 2;376(9):836-847. doi: 10.1056/NEJMoa1609783.
5. 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 Jun 1;35(16):1795-1802. doi: 10.1200/JCO.2016.69.3531. Epub 2017 Mar 29. Erratum in: J Clin Oncol. 2017 Aug 10;35(23):2722. J Clin Oncol. 2017 Aug 20;35(24):2856.
6. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for Pediatric Acute Lymphoblastic Leukemia 2.2020. National Comprehensive Cancer Network, 2020.  The NCCN Compendium® is a derivative work of the NCCN Guidelines®. NATIONAL COMPREHENSIVE CANCER NETWORK®, NCCN®, and NCCN GUIDELINES® are trademarks owned by the National Comprehensive Cancer Network, Inc. To view the most recent and complete version of the Compendium, go online to NCCN.org. Accessed August 2020.
7. Topp MS, Gökbuget N, Stein AS, et al. Safety and activity of blinatumomab for adult patients with relapsed or refractory B-precursor acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 study. Lancet Oncol. 2015;16(1):57-66.
8. von Stackelberg A, Locatelli F, Zugmaier G, et al. Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia. J Clin Oncol. 2016;34(36):4381-4389.
9. Palmetto GBA. Local Coverage Article (LCA): Billing and Coding for Chemotherapy (A56141). Centers for Medicare & Medicaid Services, Inc. Updated on 05/26/2020 with effective date 04/30/2020. Accessed August 2020.

Appendix 1 – Covered Diagnosis Codes

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

Medicare coverage for outpatient (Part B) drugs is outlined in the Medicare Benefit Policy Manual (Pub. 100-2), Chapter 15, §50 Drugs and Biologicals. In addition, National Coverage Determination (NCD), Local Coverage Determinations (LCDs), Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: http://www.cms.gov/medicare-coverage-database/search/advanced-search.aspx. Additional indications may be covered at the discretion of the health plan.

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