Guidance Document: Global Pharmacoeconomic Model Adaption Strategies

C Daniel Mullins; Nneka C Onwudiwe; Gabriela Tannus Branco de Araújo; Wen Chen; Jianwei Xuan; Aleš Tichopád; Shanlian Hu

doi:10.1016/j.vhri.2014.02.006

Guidance Document: Global Pharmacoeconomic Model Adaption Strategies

Value Health Reg Issues. 2014 Dec:5:7-13. doi: 10.1016/j.vhri.2014.02.006. Epub 2014 May 16.

Authors

C Daniel Mullins¹, Nneka C Onwudiwe², Gabriela Tannus Branco de Araújo³, Wen Chen⁴, Jianwei Xuan⁵, Aleš Tichopád⁶, Shanlian Hu⁷

Affiliations

¹ Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, MD, USA. Electronic address: dmullins@rx.umaryland.edu.
² Department of Pharmaceutical Health Services Research, School of Pharmacy, University of Maryland, Baltimore, MD, USA.
³ Axia. Bio Consulting, São Paulo, Brazil.
⁴ Center for Pharmacoeconomics Evaluation and Research, School of Public Health, Fudan University, Shanghai, China.
⁵ Medical Development Group, Emerging Markets, Pfizer, New York, NY, USA Inc.
⁶ CEEOR - Central and Eastern European Outcomes Research, Prague, Czech Republic.
⁷ Shanghai Health Development and Research Center, School of Public Health, Fudan University, Shanghai, China.

PMID: 29702790
DOI: 10.1016/j.vhri.2014.02.006

Abstract

Objective: The purpose of this guidance was to assist in the adaptation of pharmacoeconomic models originally developed in one country and intended for use in another. The intent was to produce user-friendly recommendations and a checklist for adapting a global model to treat a specific disease state. This guidance will allow model developers to tailor existing models so that they are "locally applicable," while maintaining the scientific integrity of the original pharmacoeconomic model and will benefit formulary decision makers and other stakeholders involved in evaluating pharmacoeconomic studies.

Methods: A working group of experts from various countries participated in the Global Pharmacoeconomic Model Guidance development to discuss the adaptation of pharmacoeconomic models. A systematic review of studies adapting pharmacoeconomic models and translation across countries was conducted and recommendations were made for adaptation. The working group interviewed internal and external stakeholders to solicit best practices for model adaptation and developed a draft set of key principles and general recommendations for global adaptation.

Results: The working group provided a set of 16 recommendations for adapting pharmacoeconomic models for local decision makers. The recommendations span various aspects of estimating or modeling both the costs and effectiveness of pharmacoeconomic models as well as guidance for ensuring local acceptability.

Conclusions: These recommendations and the related principles not only will provide pharmacoeconomic models that are meaningful to local decision makers but also will improve the consistency and credibility of pharmacoeconomic model adaptations. The guidance may also help those who will build the original models to design them with the flexibility to allow pharmacoeconomic model adaptations as described in this document.

Keywords: cost-effectiveness analysis; health technology assessment; pharmacoeconomic model.