Natalizumab
DESCRIPTION
Natalizumab is a recombinant humanized IgG4κ monoclonal antibody produced in murine myeloma cells. It was the first member of a class of monoclonal antibodies referred to as selective adhesion molecule inhibitors. Natalizumab binds to the surface alpha-4 integrin receptor sites of all leukocytes except neutrophils, inhibiting the adhesion of leukocytes to their counter-receptors found on activated vascular endothelium cells and vascular endothelial cells of the gastrointestinal tract. This prevents leukocytes from migrating across the endothelium into inflamed parenchymal tissue where they exacerbate the inflammatory process.
Additionally, natalizumab interferes with movement of potentially damaging immune cells across the blood-brain-barrier and into the brain and spinal cord. It also likely inhibits further recruitment and inflammatory activity of activated immune cells.
An example of a preparation of natalizumab is Tysabri®.
REFER TO DECISION SUPPORT TREE
POLICY
Natalizumab for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Multiple sclerosis
Crohn's disease
Natalizumab for the treatment of other conditions/diseases, including, but not limited to, chronic progressive multiple sclerosis is considered investigational.
See also: General Policy for Multiple Sclerosis
MEDICAL APPROPRIATENESS
Natalizumab for the treatment of ANY ONE of the following is considered medically appropriate if the following criteria are met:
Multiple sclerosis if ALL the following:
Disease is a relapsing form
The agent is used as monotherapy
The individual has tried alternate multiple sclerosis therapies (e.g., glatiramer acetate [Copaxone®], interferon beta-1a [Avonex® or Rebif®], interferon beta-1b [Betaseron®], mitoxantrone hydrochloride [Novantrone®]) with lack of response/inability to tolerate
Crohn’s disease if ALL the following:
The individual is 18 years of age or older
Disease is moderately- to severely-active
Disease shows evidence of inflammation
The individual has tried ALL of the following with lack of response/inability to tolerate:
Conventional therapies (e.g., corticosteroids, antibiotics)
A TNF-alpha inhibitor (e.g., infliximab [Remicade®], adalimumab [Humira®], etanercept [Enbrel®])
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.
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 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 natalizumab for the treatment or prevention of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2011, May). AHFS DI. Natalizumab. Retrieved July 19, 2011 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2011, May). Natalizumab. Retrieved July19, 2011 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2008, October). Center for Drug Evaluation and Research. Tysabri® (natalizumab). Retrieved July 19, 2011 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125104s0438s0475lbl.pdf.
ORIGINAL EFFECTIVE DATE: 1/13/2007
MOST RECENT REVIEW DATE: 9/6/2011
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
Natalizumab (Tysabri®)
Is the requested medication being used to treat chronic progressive multiple sclerosis?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of multiple sclerosis with ALL of the following criteria?
Disease is a relapsing form
Agent is to be used as monotherapy
The individual has tried alternate multiple sclerosis therapies (e.g., glatiramer acetate [Copaxone®], interferon beta-1a [Avonex® or Rebif®], interferon beta-1b [Betaseron®], mitoxantrone hydrochloride [Novantrone®]) with lack of response/inability to tolerate
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, go to question #3
Does the individual have a diagnosis of Crohn’s disease with ALL of the following criteria?
The individual is 18 years of age or older
Disease is moderately- to severely-active
Disease shows evidence of inflammation
The individual has tried conventional therapies (e.g., corticosteroids, antibiotics) AND a TNF-alpha inhibitor (e.g., infliximab [Remicade®], adalimumab [Humira®], etanercept [Enbrel®]) with a lack of response or an inability to tolerate the treatment(s)
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.