65483-0116-XX Proleukin 22000000 UNIT SOLR (PROMETHEUS)
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.)
Renal cell carcinoma (kidney cancer)
Aldesleukin for the treatment of other conditions/diseases is considered investigational.
Aldesleukin is considered medically appropriate if ALL of the following criteria are met:
Administration in a hospital setting under qualified physician with close supervision
Individual has documentation of ALL of the following:
18 years of age or older
Normal results from ALL of the following:
Thallium stress test for cardiac function
Formal pulmonary function testing
Pre-existing bacterial infections adequately treated prior to initiation of therapy
Absence of organ allograft
Individual has a performance status (ECOG of 0-1)
Diagnosis of ANY ONE of the following
Renal cell carcinoma (kidney cancer) if ALL of the following:
Single agent treatment
Relapsed or metastatic disease
Predominantly clear cell histology
Melanoma if ALL of the following:
Metastatic or unresectable disease
Treatment is ANY ONE of the following:
Used as first-line therapy
Used as second-line or subsequent therapy if ALL of the following:
used for disease progression OR the individual has achieved maximum clinical benefit from BRAF targeted therapy
Absence of active or untreated brain metastases or inadequate organ reserves
Aldesleukin is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet the medical appropriateness criteria above
Disease response with treatment is indicated by stabilization of disease or decrease in tumor size or spread
Absence of unacceptable toxicity from the drug, including, but not limited to, ANY ONE of the following:
Sustained ventricular tachycardia (≥5 beats)
Cardiac arrhythmias not controlled or unresponsive to management
Chest pain with ECG changes, consistent with angina or myocardial infarction
Intubation for >72 hours
Renal failure requiring dialysis >72 hours
Coma or toxic psychosis lasting >48 hours
Repetitive or difficult to control seizures
GI bleeding requiring surgery
Individual must not have developed moderate to severe lethargy or somnolence
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|All indications||600,000 IU/kg administered every 8 hours IV 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.|
LENGTH OF AUTHORIZATION
Coverage is provided for two months and may be renewed.
Refer to DOSAGE LIMITS below
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).
Lexicomp Online. (2018). AHFS DI. Aldesleukin. Retrieved January 25, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, January). Aldesleukin. Retrieved January 25, 2019 from MICROMEDEX Healthcare Series.
National Comprehensive Cancer Network. (2019). NCCN Drugs & Biologics Compendium®. Aldesleukin. Retrieved January 25, 2019 from the National Comprehensive Cancer Network.
U. S. Food and Drug Administration. (2012, July). Center for Drug Evaluation and Research. Proleukin® (aldesleukin) for injection, for intravenous infusion. Retrieved January 25, 2019 from
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 5/31/2019
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit