Rotavirus Vaccine
DESCRIPTION
Rotavirus vaccine is a live, oral vaccine for the prevention of rotavirus gastroenteritis in infants and children. This live attenuated human rotavirus replicates in the small intestine and induces immunity.
Rotavirus vaccine (i.e., RotaTeq®) is a 3-dose series for infants between the ages of 6 to 32 weeks. It is indicated for the prevention of G1, G2, G3, and G4 serotypes of rotavirus gastroenteritis.
Rotavirus vaccine (i.e., Rotarix®) is a 2-dose series for infants between the ages of 6 to 24 weeks. It is indicated for the prevention of G1 and non-G1 types (G3, G4, and G9) of rotavirus gastroenteritis.
REFER TO DECISION SUPPORT TREE
POLICY
Rotavirus vaccine for the prevention of rotavirus gastroenteritis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Rotavirus vaccine for other ages or the prevention of any other conditions/diseases is considered investigational.
The use of a pharmaceutical agent that has not been approved for any indication by the U. S. Food and Drug Administration is considered investigational.
MEDICAL APPROPRIATENESS
Rotavirus vaccine for the prevention of rotavirus gastroenteritis is considered medically appropriate if ANY ONE of the following criteria are met:
RotaTeq® is being used for infants between the ages of 6 to 32 weeks
Rotarix® is being used for infants between the ages of 6 to 24 weeks
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).
The evidence in the literature is insufficient to permit conclusions on health outcomes or the effects of rotavirus vaccine for other ages or in the prevention and/or treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2009). AHFS DI. Rotavirus vaccine live oral. Retrieved March 18, 2008 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2009). Rotavirus vaccine, live. Retrieved October 15, 2009 from MICROMEDEX Healthcare Series.
RotaTeq®: A New Oral Rotavirus Vaccine. (2006, July). The Medical Letter On Drugs and Therapeutics, 48 (issue 1240), 61-62.
U. S. Food and Drug Administration. (2008, July). Center for Biologics Evaluation and Research. Label information. Rotavirus vaccine, live, oral, pentavalent (RotaTeq®). Retrieved October 30, 2009 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142288.pdf.
U. S. Food and Drug Administration. (2009, May). Center for Biologics Evaluation and Research. Rotarix® (rotavirus vaccine, live, oral) label information. Retrieved October 30, 2009 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM133539.pdf.
ORIGINAL EFFECTIVE DATE: 10/14/2006
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
Rotavirus Vaccine (RotaTeq®, Rotarix®)
Is the agent requested to prevent rotavirus gastroenteritis?
If yes, go to question #2
If no, this does not meet medical necessity and medical appropriateness criteria
Is the agent being requested rotavirus vaccine (i.e., RotaTeq®)?
If yes, go to question #3
If no, go to question #4
Is the infant between the ages of 6 to 32 weeks?
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the agent being requested rotavirus vaccine (i.e., Rotarix®)?
If yes, go to question #5
If no, this does not meet medical necessity and/or medical appropriateness criteria
Is the infant between the ages of 6 to 24 weeks?
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.