L28758

 

ALDESLEUKIN (PROLEUKIN®, INTERLEUKIN-2, RECOMBINANT, AND RIL-2)

 

02/02/2009

 

Indications and Limitations of Coverage and/or Medical Necessity

 

ALDESLEUKIN (PROLEUKIN, INTERLEUKIN-2, RECOMBINANT, AND RIL-2) - J9015

 

Medicare will consider the use of aldesleukin as medically reasonable and necessary for the FDA approved uses, as well as for the following off-labeled indications:

• Acute myeloid leukemia.

• Chronic myeloid leukemia.

Dosage:

• Aldesleukin comes in a single-use vial containing 22 million IU (1.3 mg) of Proleukin.

o When reconstituted as directed, each ml contains 18 million IU (1.1 mg) of Proleukin.

o Any unused portion should be discarded.

• The usual adult dose for aldesleukin for injection for metastatic renal cell carcinoma or metastatic melanoma carcinoma is:

o High dose therapy:

 Intravenous infusion (over fifteen minutes), 600,000 International Units (IU) per kg of body weight (0.037 mg per kg of body weight) every eight hours for a total of fourteen doses.

 Following nine days of rest, the schedule is repeated for another fourteen doses, for a maximum of twenty-eight doses per course.

 If a provider departs from the recommended high dose label recommendations for the hospital setting and gives a reduced dosage (off-label) and/or different route of administration in an alternate setting, the rationale for such administration should be documented in the medical record.

Warnings on the FDA drug label for Aldesleukin (Proleukin®) for Injection include:

• Proleukin should be administered in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents.

o An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.

• Proleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space.

o CLS results in hypotension and reduced organ perfusion which may be severe and can result in death.

o CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.

• Proleukin administration should be withheld in patients developing

o Moderate to severe lethargy.

Or

o Somnolence. (Continued administration may result in coma.).

FDA label contraindications for aldesleukin (Proleukin®) include:

• Proleukin is contraindicated in patients with a known history of hypersensitivity to interkeukin-2 or any component of the Proleukin formulation.

• Proleukin is contraindicated in patients with an abnormal thalium stress test or abnormal pulmonary function tests and those with organ allografts.

(See product label for additional information).

Coding Information

 

Bill Type Codes

• Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service.

• Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type.

• Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

 

13x Hospital Outpatient

21x Skilled Nursing - Inpatient (Including Medicare Part A)

23x Skilled Nursing - Outpatient

85x Critical Access Hospital

 

Revenue Codes

• Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service.

• In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination.

• Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

 

0636 Pharmacy - Drugs Requiring Detailed Coding

 

 

CPT/HCPCS Codes

 

J9015 INJECTION, ALDESLEUKIN, PER SINGLE USE VIAL

 

 

ICD-9 Codes that Support Medical Necessity

 

172.0 MALIGNANT MELANOMA OF SKIN OF LIP

172.1 MALIGNANT MELANOMA OF SKIN OF EYELID INCLUDING CANTHUS

172.2 MALIGNANT MELANOMA OF SKIN OF EAR AND EXTERNAL AUDITORY CANAL

172.3 MALIGNANT MELANOMA OF SKIN OF OTHER AND UNSPECIFIED PARTS OF FACE

172.4 MALIGNANT MELANOMA OF SKIN OF SCALP AND NECK

172.5 MALIGNANT MELANOMA OF SKIN OF TRUNK EXCEPT SCROTUM

172.6 MALIGNANT MELANOMA OF SKIN OF UPPER LIMB INCLUDING SHOULDER

172.7 MALIGNANT MELANOMA OF SKIN OF LOWER LIMB INCLUDING HIP

172.8 MALIGNANT MELANOMA OF OTHER SPECIFIED SITES OF SKIN

172.9 MELANOMA OF SKIN SITE UNSPECIFIED

189.0 MALIGNANT NEOPLASM OF KIDNEY EXCEPT PELVIS

189.1 MALIGNANT NEOPLASM OF RENAL PELVIS

190.6 MALIGNANT NEOPLASM OF CHOROID

205.00 ACUTE MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.01 MYELOID LEUKEMIA ACUTE IN REMISSION

205.02 ACUTE MYELOID LEUKEMIA, IN RELAPSE

205.10 CHRONIC MYELOID LEUKEMIA, WITHOUT MENTION OF HAVING ACHIEVED REMISSION

205.11 MYELOID LEUKEMIA CHRONIC IN REMISSION

205.12 CHRONIC MYELOID LEUKEMIA, IN RELAPSE

 

 

Documentation Requirements

• Medical record documentation maintained by the ordering/referring physician must substantiate the medical need for the use of these chemotherapy drugs by clearly indicating the condition for which these drugs are being used.

o This might include the type of cancer, staging, if applicable, prior therapy and the patient’s response to that therapy.

o This documentation is usually found in the history and physical or in the office/progress notes.

• If the provider of the service is other than the ordering/referring physician, that provider must maintain copies of the ordering/referring physician’s order for the chemotherapy drug.

• The physician must state the clinical indication/medical need for using the chemotherapy drug in the order.

• The FDA label recognizes the higher dosages of Aldesleukin for an inpatient facility.

• Input from the provider community shows this drug is being given at lower dosages in the office or other outpatient setting with appropriate precautions.

• If a provider departs from the recommended high dose label recommendations and gives a reduced dosage (off-label) and/or different route of administration in an alternate setting, the rationale for such administration should be documented in the medical record.

Treatment Logic:

• Aldesleukin is classified as a biological response modifier.

• It increases cellular immunity and inhibits tumor growth.

• Because of its potential life-threatening toxicities, it is recommended that this medication be given only after careful consideration of the risks and benefits.

• Aldesleukin is FDA approved for the following indications:

o Treatment of adults with metastatic renal cell carcinoma.

o Treatment of adults with metastatic melanoma.

 

Sources of Information and Basis for Decision

 

Compendia-Based Drug Bulletin. (November 2006). The Association of Community Cancer Centers. [On-Line]. Available: http://www.accc-cancer.org/.

 

FCSO L29053 Aldesleukin (Proleukin®, Interleukin-2, Recombinant, and RIL-2) 02/02/2009. The official local coverage determination (LCD) is the version on the Medicare coverage database at www.cms.gov/medicare-coverage-database/.

 

Hamilton, S. (2005). Chemotherapy Drugs, Aldesleukin [Electronic version]. Cleveland Clinic Cancer Center. Retrieved January 18, 2006, from http://www.Chemocare.com.

 

Proleukin® (Aldesleukin) for Injection package insert (2000). Chiron Corporation, Emeryville, CA.

 

Thomson Micromedex (2007). USP DI Drug Information for the Health Care Professional. [On-Line]. Available: http://www.thomsonhc.com/home/dispatch

 

U.S. Food and Drug Administration, Department of Health and Human Services, CDER web site updates, February 2007.

 

 

AMA CPT Copyright Statement

CPT codes, descriptions and other data only are copyright 2012 American Medical Association (or such other date of publication of CPT). All Rights Reserved. Applicable FARS/DFARS Clauses Apply.

 

© Automated Clinical Guidelines, LLC 2009-2013

 

CMS LCD ALDESLEUKIN (PROLEUKIN®, INTERLEUKIN-2, RECOMBINANT, AND RIL-2)