BlueCross BlueShield of Tennessee Medical Policy Manual

Aldesleukin (Proleukin®)


65483-0116-XX PROLEUKIN 22000000UNIT Solution Reconstituted (CLINIGEN GROUP PLC)


Aldesleukin is a human recombinant interleukin-2 product classified as a biological response modifier.  It is a highly purified protein manufactured by recombinant DNA technology to encode a modified human IL-2 gene.  The resulting agent possesses the same biological activities of native IL-2, including the inhibition of tumor growth; however side effects can be life threatening, including capillary leak syndrome (CLS).  CLS is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. It results in hypotension and reduced organ perfusion which may be severe and can result in death




Universal Criteria 

Renal Cell Carcinoma 


Hematopoietic Cell Transplantation





Melanoma & Renal Cell Carcinoma

600,000 IU/kg (0.037 mg/kg) administered intravenously IV every 8 hours for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated. Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.

Hematopoietic Cell Transplantation/GVHD

1 million IU/m2 subcutaneously daily for 12 weeks, followed by a 4 week treatment break after the initial treatment period. Thereafter, patients showing improvement can continue treatment at the same dose (1 million IU/m2 subcutaneously daily) indefinitely.



Max Units (per dose and over time) [HCPC Unit]:



All other indications



BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.


We develop Medical Policies to provide guidance to Members and Providers.  This Medical Policy relates only to the services or supplies described in it.  The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy.  For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed.  If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.


For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).


1.     Proleukin [package insert]. Yardley, PA; Clinigen, Inc.; September 2019. Accessed November 2020.

2.     Referenced with permission from the NCCN Drugs and Biologics Compendium (NCCN Compendium®) aldesleukin; Interleukin-2, recombinant. 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 Accessed November 2020.

3.     Fyfe G, Fisher RI, Rosenberg SA, et al. Results of treatment of 255 patients with metastatic renal cell carcinoma who received high-dose recombinant interleukin-2 therapy. J Clin Oncol. 1995 Mar; 13(3):688-96.

4.     Atkins MB, Lotze MT, Dutcher JP, et al. High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993. J Clin Oncol. 1999 Jul; 17(7):2105-16.

5.     Koreth J, Kim HT, Jones KT, et al. Efficacy, durability, and response predictors of low dose interleukin-2 therapy for chronic graft-versus-host disease. Blood. 2016 Jul 7;128(1):130-7. doi: 10.1182/blood-2016-02-702852. Epub 2016 Apr 12.

6.     Lexicomp Online. (2020, March). AHFS DI. Aldesleukin. Retrieved December 29, 2020 from Lexicomp Online with AHFS.

7.     MICROMEDEX Healthcare Series. Drugdex Evaluations. (2020, November). Aldesleukin. Retrieved December 29, 2020 from MICROMEDEX Healthcare Series. 




Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.

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