Pharmacoeconomic simulations

Is anyone aware of any papers or abstracts using computer-assisted trial design that incorporates a pharmacoeconomic component to the simulation? Or any pop pharmacokinetic-pharmacodynamic papers that include the same? Thanks Pete bonate Peter L. Bonate, PhD, FCP Genzyme Corporation Senior Director Clinical Pharmacology and Pharmacokinetics 4545 Horizon Hill Blvd San Antonio, TX 78229 USA [email protected] phone: 210-949-8662 fax: 210-949-8219 crackberry: 210-315-2713 "Beware of geeks bearing formulas". Written by Warren Buffet as part of Berkshire Hathaway's 2009 Annual Report to Stockholders.

Pete, The best paper I know is by Hughes et al - see below with abstract Hughes DA, Walley T. Economic evaluations during early (phase II) drug development: a role for clinical trial simulations? Pharmacoeconomics. 2001;19(11):1069-77. Abstract Faced with increasing demands on demonstrating cost effectiveness, pharmaceutical companies are required to conduct pharmacoeconomic evaluations throughout the drug development programme. At present, there is particular emphasis in the literature on burden-of-illness studies and on economic evaluations conducted alongside phase III clinical trials but not on those conducted during phase II clinical trials. This article describes modelling techniques, namely clinical trial simulations (CTS), which are gaining popularity in the clinical research community, but which might also prove to be beneficial during the conduct of these early pharmacoeconomic evaluations. The basic concepts and structure of CTS are described by using published examples of simulations of antipsychotic and anticancer drugs. With the use of an illustrative example of a hypothetical cholinesterase inhibitor for Alzheimer's disease, an integrated CTS-based pharmacoeconomic evaluation is presented. The results demonstrate how the modelling may be of value in 'go/no-go' decisions during the drug development programme. Regards, Jeff Jeffrey S. Barrett, Ph.D. Research Associate Professor, Pediatrics Director, Pediatric Pharmacology Research Unit, Laboratory for Applied PK/PD Clinical Pharmacology & Therapeutics Abramson Research Center, Rm 916H The Children's Hospital of Philadelphia 3615 Civic Center Blvd. Philadelphia, PA 19104 KMAS (Kinetic Modeling & Simulation) Institute for Translational Medicine University of Pennsylvania email: [email protected] Ph: (267) 426-5479 >>> "Bonate, Peter" <[email protected]> 4/23/2009 10:37 AM >>> Is anyone aware of any papers or abstracts using computer-assisted trial design that incorporates a pharmacoeconomic component to the simulation? Or any pop pharmacokinetic-pharmacodynamic papers that include the same? Thanks Pete bonate Peter L. Bonate, PhD, FCP Genzyme Corporation Senior Director Clinical Pharmacology and Pharmacokinetics 4545 Horizon Hill Blvd San Antonio, TX 78229 USA [email protected] phone: 210-949-8662 fax: 210-949-8219 crackberry: 210-315-2713 "Beware of geeks bearing formulas". Written by Warren Buffet as part of Berkshire Hathaway's 2009 Annual Report to Stockholders. BEGIN:VCARD VERSION:2.1 X-GWTYPE:USER FN:Barrett, Jeffrey ORG:;Clinical Pharmacology EMAIL;WORK;PREF;NGW:[email protected] N:Barrett;Jeffrey END:VCARD

A clinical utility index (CUI), as described recently by Ouellet et al. Clinical Pharmacology & Therapeutics (2009); 85, 3, 277?282 as well as by others elsewhere, is amenable to being used as a pharmacoeconomic vehicle. Typically the CUI is derived in terms of patient benefit:risk, but could easily be adapted to other tangible measures of value. Jeff "Bonate, Peter" <Peter.Bonate Sent by: owner-nmusers 23-Apr-2009 10:37 To nmusers cc Subject [NMusers] Pharmacoeconomic simulations Is anyone aware of any papers or abstracts using computer-assisted trial design that incorporates a pharmacoeconomic component to the simulation? Or any pop pharmacokinetic-pharmacodynamic papers that include the same? Thanks Pete bonate Peter L. Bonate, PhD, FCP Genzyme Corporation Senior Director Clinical Pharmacology and Pharmacokinetics 4545 Horizon Hill Blvd San Antonio, TX 78229 USA peter.bonate phone: 210-949-8662 fax: 210-949-8219 crackberry: 210-315-2713 "Beware of geeks bearing formulas". Written by Warren Buffet as part of Berkshire Hathaway's 2009 Annual Report to Stockholders. (image/gif attachment: 01-part)

A clinical utility index (CUI), as described recently by Ouellet et al. Clinical Pharmacology & Therapeutics (2009); 85, 3, 277?282 as well as by others elsewhere, is amenable to being used as a pharmacoeconomic vehicle. Typically the CUI is derived in terms of patient benefit:risk, but could easily be adapted to other tangible measures of value. Jeff "Bonate, Peter" <[email protected]> Sent by: [email protected] 23-Apr-2009 10:37 To [email protected] cc Subject [NMusers] Pharmacoeconomic simulations Is anyone aware of any papers or abstracts using computer-assisted trial design that incorporates a pharmacoeconomic component to the simulation? Or any pop pharmacokinetic-pharmacodynamic papers that include the same? Thanks Pete bonate Peter L. Bonate, PhD, FCP Genzyme Corporation Senior Director Clinical Pharmacology and Pharmacokinetics 4545 Horizon Hill Blvd San Antonio, TX 78229 USA [email protected] phone: 210-949-8662 fax: 210-949-8219 crackberry: 210-315-2713 "Beware of geeks bearing formulas". Written by Warren Buffet as part of Berkshire Hathaway's 2009 Annual Report to Stockholders. <<image/gif>>

Peter, Pharmacoeconomic means different things to different people, and the following references should cover a useful spectrum Poland B, Wada R. Combining drug-disease and economic modelling to inform drug development decisions Drug Discovery Today. November 2001;6(22):1165-1170. Korsan B, Dykstra K, Pullman W. Transparent Trade-Offs: A Clinical Utility Index (CUI) Openly Evaluates a Product's Attributes - and Chance of Success Pharmaceutical Executive. March 2005. Poland B, Hodge F, Khan A, Clemen R, Dykstra K, Krishna R. The Clinical Utility Index as a Practical Multiattribute Approach to Drug Development Decisions (Accepted 2009) Dykstra K, Hodge F, Carrothers TJ, Korsan B. Linking Modeling & Simulation, Decision Analysis, and the Technology of Drug Formulation American Conference on Pharmacometrics (ACoP); March 9-12, 2008; Tucson, Arizona Hodge F, Using the Clinical Utility Index (CUI) to Inform Dose Selection Decisions; Webinar February 2009; http://www.pharsight.com/events/eventsonline_archive.php#replay_028 Korsan B, Modeling and Decision Analysis to Support Formulation Selection and Trial Sequencing, Webinar April 2006 http://www.pharsight.com/events/eventsonline_archive.php#replay_003 Cheers -Jon