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
Aldesleukin for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Hematopoietic Cell Transplantation/ GVHD
Renal cell carcinoma (kidney cancer
Aldesleukin for the treatment of other conditions/diseases is considered investigational.
Patient is at least 18 years of age; AND
Patient must have normal cardiac function (i.e., normal ejection fraction and unimpaired wall motion) as determined by thallium stress testing prior to initiating therapy; AND
Patient must have normal pulmonary function determined by formal pulmonary function testing (i.e., FEV1 >2 liters or ≥75% of predicted for height and age) prior to initiating therapy; AND
Patient must have a baseline serum creatinine of ≤1.5 mg/dL prior to initiating therapy; AND
Pre-existing bacterial infections should be adequately treated prior to initiation of therapy; AND
Patient has an ECOG performance status of 0-1; AND
Proleukin will be administered in a hospital setting under close supervision of a qualified physician; AND
Patient must not have an organ allograft; AND
Patient must not have untreated or active CNS metastases; AND
Renal Cell Carcinoma
Patient has relapsed or metastatic disease; AND
Used as a single agent; AND
Used as first-line therapy; AND
Patient has predominant clear cell histology
Patient has unresectable or metastatic disease; AND
Used as a single agent: AND
Used as first line therapy; OR
Used as subsequent therapy; AND
Patient has disease progression or used after maximum clinical benefit from BRAF targeted therapy; AND
Patient does not have inadequate organ reserves
Hematopoietic Cell Transplantation
Used for chronic graft-versus-host disease (GVHD) as additional therapy in conjunction with systemic corticosteroids following no response (steroid-refractory disease) to first-line therapy options
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 initial approval criteria; AND
Disease response with treatment as defined by stabilization of disease or decrease in size of tumor or tumor spread; AND
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include: capillary leak syndrome (CLS), sustained ventricular tachycardia (≥5 beats), cardiac arrhythmias not controlled or unresponsive to management; chest pain with ECG changes, consistent with angina or myocardial infarction; cardiac tamponade, intubation for >72 hours, renal failure requiring dialysis >72 hours, coma or toxic psychosis lasting >48 hours, repetitive or difficult to control seizures; bowel ischemia/perforation, GI bleeding requiring surgery, serious manifestations of eosinophilia, etc..; AND
Patient must not have developed moderate to severe lethargy or somnolence
Melanoma & Renal Cell Carcinoma
IU/kg (0.037 mg/kg) administered
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.
LENGTH OF AUTHORIZATION
Coverage for RCC and melanoma is provided for 2 months and may be renewed.
Coverage for HSCT is provided for 4 months and may be renewed.
Max Units (per dose and over time) [HCPC Unit]:
Initially 84 billable units per 112 days, maintenance is 1 billable unit per day
All other indications
88 billable units per 68 days
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
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 NCCN.org. 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.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 6/2/2021
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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