TrendsRx® Rx-to-OTC Alert December
What’s new.What’s next.What to do now
Zyrtec®(cetirizine) and Zyrtec-D 12 Hour®(cetirizine/pseudoephedrine)*
• Prescription Zyrtec (Pfizer Inc) is approved by the U.S. Food and Drug Administration (FDA) for the treatment
of seasonal and perennial al ergic rhinitis, as wel as chronic urticaria.
• Recently, McNeil Consumer Healthcare received approval by the FDA for an over-the-counter (OTC)
version of Zyrtec 5 mg and 10 mg oral tablets, 5 mg and 10 mg chewable tablets, and 1 mg/mL syrup.
The OTC version of Zyrtec is indicated for the temporary relief of symptoms due to hay fever or otherrespiratory al ergies (sneezing; runny nose; itchy, watery eyes; itchy throat or nose) in adults and childrentwo years of age and older. The OTC version of Zyrtec products is also indicated for the relief of itchingdue to hives in people six years of age and older, including adults.
• Prescription Zyrtec-D 12 Hour (Pfizer Inc) was approved by the FDA for the relief of nasal and non-nasal
symptoms associated with seasonal or perennial al ergic rhinitis in adults and children 12 years of ageand older. Zyrtec-D should be used when both the antihistaminic properties of cetirizine and the nasaldecongestant properties of pseudoephedrine are desired.
• Recently, McNeil Consumer Healthcare received approval by the FDA for OTC version of Zyrtec-D in
adults and children 12 years of age and older. The OTC version of Zyrtec-D is indicated for the relief ofsymptoms due to hay fever or other upper respiratory al ergies such as, runny nose; sneezing; itchy,watery eyes; itching of the nose or throat; and nasal congestion. The OTC version of Zyrtec-D is alsoindicated for reducing swel ing of nasal passages, for relief of sinus congestion and pressure, and forrestoring freer breathing through the nose.
• Zyrtec chewable tablet(s); 5 mg and 10 mg
• Zyrtec-D tablet(s), extended-release; 5 mg/120 mg
• OTC forms of Zyrtec and Zyrtec-D wil be available in late January 2008
• Later in 2007, there may be more information regarding the availability of generic forms of prescription
• Generic prescription Zyrtec may be available after December 25, 2007.
• Generics (various generic manufacturers): fexofenadine, loratadine (OTC), loratadine/pseudoephedrine (OTC)
• Brands: Al egra® (fexofenadine, sanofi-aventis U.S. LLC), Al egra-D® 12 Hour (fexofenadine/pseudoephedrine,
sanofi-aventis U.S. LLC), Al egra-D® 24 Hour (fexofenadine/pseudoephedrine, sanofi-aventis U.S. LLC),
Clarinex® (desloratadine, Schering Corporation), Clarinex-D® (desloratadine/pseudoephedrine, Schering
Corporation), Claritin® (loratadine [OTC], Schering-Plough HealthCare Products, Inc.), Claritin-D® 24 Hour
(loratadine/pseudoephedrine [OTC], Schering-Plough HealthCare Products, Inc.), Xyzal® (levocetirizine,UCB, Inc. and sanofi-aventis U.S. LLC)
• Caremark estimates that OTC availability of Zyrtec and Zyrtec-D wil offer clients Per Member Per Month
(PMPM) cost savings of $0.07 to $0.12, which equates to Per Member Per Year (PMPY) cost savings of$0.82 to $1.48.
• This is a preliminary
budget impact estimate, which may be altered by a number of market factors,
including the availability of generic cetirizine. This budget impact estimate does not include anyassumptions regarding the availability of generic forms of Zyrtec or impact of potential increasedutilization of generic fexofenadine or other available brand NSAs.
• Caremark wil continue to monitor the long-term budget effects of Zyrtec’s patent expiration and OTC
• Potential availability of generic cetirizine wil have an impact on any future benefit modeling in this class.
Contact your Caremark account representative for modeling and rebate impact information. Modelingwil be available that looks at multiple potential plan design options such as promoting prescriptionsgenerics or changing the level of coverage of the NSA class.‡
• Caremark recognizes the unique needs of plan participants with al ergic rhinitis.
• To better assist you and your participants with the transition from prescription-to-OTC products, Caremark
offers an OTC Program which includes letters sent directly to participants educating them regarding thestatus change from prescription to OTC, when product wil be available on the shelf, and which dosageforms wil be available. Even if you are not enrol ed in the complete Caremark OTC Program, you can stiltake advantage of the communication offering for OTC Zyrtec and Zyrtec-D.
• In the event that a generic version of prescription Zyrtec becomes available, Caremark has robust
generics offerings that successful y contain drug spend. Caremark is committed to increasing genericdispensing rates by leveraging innovative programs and services that engage physicians, pharmacists,plan participants and clients. We consistently highlight opportunities to use generics, both within atherapeutic class and across therapeutic classes, when clinical y appropriate.
• Caremark is committed to assisting clients in the development of an appropriate management
strategy for OTCs and generics.
• For more information, contact your Caremark account representative.
Please Note: This document provides a brief overview of the subject. This review is provided as a referenceonly, and is based in part on information derived from third parties.
* This information is current as of December 3, 2007. The information presented is subject to change and is represented to the best of our knowledge at the time
of this publication.
† This Launch Date may not reflect the date of availability for this medication. Due to circumstances beyond the control of Caremark, information related to prospective
medication launch dates is subject to change without notice. This information should not be solely relied upon for decision-making purposes. This medication isexpected to be available for purchase within a few days of this date.
‡ Changes in coverage of the NSA class may have potential rebate impacts. Please consult your Caremark account representative to determine what rebate impacts a
change in coverage of the NSA class may have for you.
• Caremark Generic Contracting Team.
• Caremark Internal Pharmacy Budget Impact, Research and Development.
• Drugs@FDA. Rockvil e, MD: Food and Drug Administration, Center for Drug Evaluation and Research. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.
• Facts & Comparisons. Facts & Comparisons Web site. http://www.factsandcomparisons.com/. Accessed November 19, 2007.
• FDA approves the al ergy treatment Zyrtec® for use without a prescription [press release]. Fort Washington, PA: McNeil Consumer Healthcare; November 16, 2007.
http://www.zyrtecprofessional.com/zyrtecprofessional/assets/pdf/Zyrtec_Ful _Approval_press_release_FINAL.pdf. Accessed November 19, 2007.
• FDA News. FDA approves nonprescription Zyrtec-D for al ergies
. Food and Drug Administration. Food and Drug Administration Web site. http://www.fda.gov/bbs/topics/
NEWS/2007/NEW01742.html. Accessed November 9, 2007.
• Zyrtec [package insert]. New York, NY: Pfizer Inc; May 2006.
• Zyrtec-D 12 Hour [package insert]. New York, NY: Pfizer Inc; August 2003.
2007 Caremark Inc. All rights reserved.
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