Document Number: IC-0425

Last Review Date: 10/24/2022

Date of Origin: 02/04/2019

Dates Reviewed: 02/2019, 11/2019, 11/2020, 11/2021, 04/2022, 11/2022

1. Length of Authorization

Coverage will be provided for 6 months and may be renewed.

2. Dosing Limits

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

• Asparlas 3,750 units per 5 mL single-dose vial: 2 vials every 21 days

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

• 750 billable units (2 vials) per 21 days

3. Initial Approval Criteria ^1,2

Coverage is provided in the following conditions:

• Patient is at least 1 month up to 21 years of age; AND
• Patient must not have a history of serious hypersensitivity reactions § with pegylated L-asparaginase therapy; AND
• Patient must not have a history of serious pancreatitis, severe hepatic impairment, thrombosis, or hemorrhagic events with prior L-asparaginase therapy; AND

Universal Criteria ¹

• Used as a component of a multi-agent chemotherapy regimen; AND
• Patient will receive premedication prior to administration of Asparlas to decrease the risk and severity of both infusion and hypersensitivity reactions§ (e.g., acetaminophen, an H-1 receptor blocker [such as diphenhydramine], and an H-2 receptor blocker [such as famotidine]); AND

Acute Lymphoblastic Leukemia (ALL) † Ф ^1,2

† FDA Approved Indication(s); ‡ Compendia recommended indication(s); Ф Orphan Drug

4. Renewal Criteria ^1,2

Coverage can be renewed based upon the following criteria:

• Patient continues to meet universal and indication-specific criteria as identified in section III; AND
• Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: hypersensitivity reactions (including anaphylaxis), serious thrombotic events, hemorrhage, severe hepatotoxicity, pancreatitis, etc.; AND
• Disease stabilization or improvement as evidenced by a complete response [CR] (i.e., morphologic, cytogenetic or molecular complete response CR), complete hematologic response or a partial response by CBC, bone marrow cytogenic analysis, QPCR, or FISH

5. Dosage/Administration ¹

6. Billing Code/Availability Information

HCPCS Code:

• J9118 – Injection, calaspargase pegol-mknl, 10 units: 1 billable unit = 10 units

NDC(s):

• Asparlas 3,750 units/5 mL single-dose vial: 72694-0515-xx

7. References

1. Asparlas [package insert]. Boston, MA; Servier Pharmaceuticals Inc.; December 2021. Accessed October 2022.
2. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN Compendium®) for calaspargase pegol-mknl. National Comprehensive Cancer Network, 2022. 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 October 2022.
3. Silverman LB, Blonquist TM, Hunt SK, et al. Randomized Study of Pegasparagase (SS-PEG) and Calaspargase Pegol (SC-PEG) in Pediatric Patients with Newly Diagnosed Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma: Results of DFCI ALL Consortium Protocol 11-001. Blood 2016;128:175.
4. Stock W, Douer D, DeAngelo DJ, et al. Prevention and management of asparaginase/pegasparaginase-associated toxicities in adults and older adolescents: recommendations of an expert panel. Leuk Lymphoma 2011:52;2237-2253.
5. Common Terminology Criteria for Adverse Events (CTCAE) v5.0. NIH National Cancer Institute: Division of Cancer Treatment & Diagnosis – Cancer Therapy Evaluation Program. Available at: https://ctep.cancer.gov/protocoldevelopment/electronic_applications/ctc.htm#ctc_50
6. Angiolillo AL, Schore RJ, Devidas M, et al. Pharmacokinetic and pharmacodynamic properties of calaspargase pegol Escherichia coli L-asparaginase in the treatment of patients with acute lymphoblastic leukemia: results from Children’s Oncology Group study AALL07P4. J Clin Oncol. 2014;32(34):3874-3882.

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), and Local Coverage Articles (LCAs) may exist and compliance with these policies is required where applicable. They can be found at: https://www.cms.gov/medicare-coverage-database/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): N/A