Rilonacept
DESCRIPTION
Rilonacept, a recombinant dimeric fusion protein, is an interleukin-1 beta (IL-1β) receptor antagonist (IL-1βRa). IL-1β is a key proinflammatory cytokine. It mediates local and systemic responses to infection and tissue injury. When activated, it induces multiple effects that include fever, sensitization to pain, and destruction of bone and cartilage.
IL-1β is activated by the cryopyrin inflammasome, a multi-protein cellular complex which normally responds to stimuli from microbes and dead cells to convert pro-IL-1β to its immunologically active form. Cryopyrin is encoded by the NLRP-3 gene. Cryopyrin-associated periodic syndrome (CAPS) is a spectrum of rare inherited inflammatory disorders or cryopyrinopathies caused by mutations in the NLRP-3 gene. This results in excessive activity of the cryopyrin inflammasome, overproduction of activated IL-1β and increased inflammation. Rilonacept binds to activated IL-1β and blocks signals to increase inflammation.
An example of a preparation of rilonacept is Arcalyst®.
REFER TO DECISION SUPPORT TREE
POLICY
Rilonacept for the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS) spectrum of disease [e.g., Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS)] is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rilonacept for the treatment of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Rilonacept for the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS) spectrum of disease [e.g., Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS)] is considered medically appropriate if the individual is 12 years of age or older.
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 rilonacept in the treatment or prevention of any other condition/disease.
SOURCES
Lexi-Comp Online. (2010). AHFS DI. Rilonacept. Retrieved January 26, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010). Rilonacept. Retrieved January 26, 2010 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. Center for Drug Evaluation and Research. (2008, February). Arcalyst™ (rilonacept). Retrieved January 26, 2010 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/125249lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/13/2008
MOST RECENT REVIEW DATE: 7/6/2010
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
Rilonacept (Arcalyst®)
Does the individual have a diagnosis of Cryopyrin-Associated Periodic Syndrome (CAPS) spectrum of disease [e.g., Familial Cold Autoinflammatory Syndrome (FCAS), Muckle-Wells Syndrome (MWS)]?
If yes, go to question #2
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the individual 12 years of age or older?
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.