BlueCross BlueShield of Tennessee Medical Policy Manual

Aldesleukin

NDC CODE(S)

65483-0116-07 Proleukin 22000000 UNIT SOLR (PROMETHEUS)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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.

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

No controlled studies were found in the published literature that validate the use of aldesleukin for the treatment of other conditions or diseases

SOURCES

Lexicomp Online. (2017). AHFS DI. Aldesleukin. Retrieved February 17, 2017 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, November). Aldesleukin. Retrieved February 17, 2017 from MICROMEDEX Healthcare Series. 

National Comprehensive Cancer Network. (2017). NCCN Drugs & Biologics Compendium®. Aldesleukin. Retrieved February 17, 2017 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 February 28, 2017 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/103293s5130lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  5/9/2017

ID_MRx

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.

Pharmaceutical Decision Support Tree

Aldesleukin (Proleukin ®)

  1. Is this the initial request for this agent for this individual?

If yes, go to questions #2

If no, go to question #8

  1. Does the individual have documentation of ALL of the following?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual have a diagnosis of renal cell carcinoma (kidney cancer) with ALL of the following?

If yes, go to question #5

If no, go to question #4

  1. Does the individual have a diagnosis of melanoma with ALL of the following?

If yes, go to question #5

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested coverage for two months or less?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for 88 billable units per 68 days or less?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the requested dosage 600,000 IU/kg administered every 8 hours IV for a maximum of 2 courses of 14 doses with 9 days of rest in between (28 doses total)? 

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the initial criteria in questions 2 through 7?

If yes, go to question #9

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Has there been a rest period of at least 7 weeks from the date of hospital discharge between the last treatment course (i.e., schedule series of maximum of two 14 dose series separated by 9 days of rest)?

If yes, go to question #10

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is disease response indicated by stabilization of disease or decrease in tumor size or spread?

If yes, go to question #11

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the agent, including, but not limited to, ANY ONE of the following?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.