DESCRIPTION
Oprelvekin is a biosynthetic version of interleukin 11 (IL-11) produced by recombinant DNA technology. It differs from that produced in the body in having only 177 amino acids while native IL-11 has 178. It lacks the amino-terminal proline residue but there have been no measurable differences in bioactivity due to this difference.
IL-11 is a member of a group of human growth factors which includes human growth hormone, granulocyte colony-stimulating factor (G-CSF) and others. IL-11has multiple systemic effects, but it directly stimulates hematopoiesis and megakaryocytopoiesis resulting in increased platelet production. As with native IL-11, oprelvekin has been shown to promote improved platelet nadirs and accelerated platelet recoveries.
An example of a preparation of oprelvekin is Neumega®.
REFER TO DECISION SUPPORT TREE
POLICY
Oprelvekin for the prevention of thrombocytopenia is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Oprelvekin for the treatment of other conditions/diseases, including, but not limited to, the following is considered investigational:
Individual receiving myeloablative chemotherapy
Thrombocytopenia secondary to Wiskott - Aldrich syndrome
MEDICAL APPROPRIATENESS
Oprelvekin for the prevention of thrombocytopenia is medically appropriate if the individual meets ALL of the following criteria:
18 years of age or older
Diagnosis of non-myeloid malignancy
Has received myelosuppressive chemotherapy
At high risk for severe thrombocytopenia (e.g., platelet count less than 20,000 / µL)
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
No controlled studies were found in the published literature that validate the use of oprelvekin for other conditions/diseases.
SOURCES
Lexi-Comp Online. (2009). AHFS DI. Oprelvekin. Retrieved September 3, 2009 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Oprelvekin. Retrieved September 3, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2009, September). Center for Drug Evaluation and Research. Neumega® (Oprelvekin) label. Retrieved September 3, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/103694s1008lbl.pdf.
ORIGINAL EFFECTIVE DATE: 11/1/2004
MOST RECENT REVIEW DATE: 12/16/2009
ID_BT
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
Oprelvekin (Neumega®)
Is the requested medication being used to treat ANY ONE of the following?
Individual who received myeloablative chemotherapy
Thrombocytopenia secondary to Wiskott - Aldrich syndrome
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual need to prevent thrombocytopenia with evidence of ALL of the following?
Age of 18 years or older
Diagnosis of a non-myeloid malignancy
Received myelosuppressive chemotherapy
At high risk for severe thrombocytopenia (e.g., platelet count less than 20,000 / µL)
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.