Cidofovir
DESCRIPTION
Cidofovir, an antiviral agent, is converted via cellular enzymes to the pharmacologically active diphosphate metabolite, which inhibits activity against certain viruses. Cidofovir diphosphate exerts its antiviral effect by interfering with DNA synthesis and inhibiting viral replication.
An example of a preparation of cidofovir is Vistide®.
REFER TO DECISION SUPPORT TREE
POLICY
Cidofovir for the treatment of cytomegalovirus (CMV) retinitis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Cidofovir for the treatment of other conditions/diseases, including, but not limited to, the following: respiratory papillomas, cowpox virus, acyclovir resistant herpes simplex type one and two, and treatment of anogenital condylomata acuminate is considered investigational.
MEDICAL APPROPRIATENESS
Cidofovir for the treatment of CMV retinitis is considered medically appropriate if ALL of the following criteria are met:
The individual has AIDS-related CMV retinitis
Is not pregnant or breast-feeding
Has normal renal function
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).
The evidence in the literature is insufficient to permit conclusions on the health outcomes and effects of cidofovir for any of the other conditions/diseases.
SOURCES
Drugs for non-HIV viral infections. (2007, July). Treatment Guidelines from The Medical Letter, 5 (Issue 59), 59-70.
Lexi-Comp Online. (2009). AHFS DI. Cidofovir. Retrieved May 25, 2009 from Lexi-Comp Online with AHFS.
National Comprehensive Cancer Network. (2009). NCCN Drugs & Biologics Compendium™. Cidofovir. Retrieved May 25, 2009 from http://www.nccn.org/professionals/drug_compendium/mainpage.aspx.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Cidofovir. Retrieved May 25, 2009 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2000, September). Center for Drug Evaluation and Research. Vistide. Retrieved May 25, 2009 from http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/020638s003lbl.pdf.
ORIGINAL EFFECTIVE DATE: 5/1/2004
MOST RECENT REVIEW DATE: 9/23/2009
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
Cidofovir (Vistide®)
Is the requested medication being used to treat respiratory papillomas, cowpox virus, acyclovir resistant herpes simplex type one and two, or treatment of anogenital condylomata acuminate?
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 cytomegalovirus (CMV) retinitis and evidence of ALL the following?
The individual has AIDS-related CMV retinitis
Is not pregnant or breast-feeding
Has normal renal function
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.