Pharmacoeconomic Guidelines Around The World

Introduction

Pharmacoeconomic evaluation is an analytical tool used with increasing frequency to assist decision making in the financing and management of pharmaceutical products in the health care system or national health insurance programs of an individual country. Pharmacoeconomic (PE) guidelines can be used as a standard for preparation of studies to be included in application for reimbursement, a guide for designing and conducting a study, or a template for evaluating the economic study reports.

This section of the ISPOR website, “Pharmacoeconomic Guidelines Around the World” provides the following:

• A comparative table of 33 guideline key features. The key features of the guidelines are: 1) type, 2) title and year of the document, 3) affiliation of authors, 4) main policy objective, 5) standard reporting format included, 6) disclosure of funding/ author’s interests, 7) target audience, 8) perspective, 9) indication, 10) target population, 11) subgroup analysis, 12) choice of comparator, 13) time horizon, 14) assumptions required, 15) preferred analytical technique, 16) costs to be included, 17) source of costs, 18) modeling, 19) systematic review of evidences, 20) preference for effectiveness over efficacy, 21) preferred outcome measure, 22) preferred method to derive utility, 23) Equity issue stated, 24) discounting costs, 25) discounting outcomes, 26) sensitivity analysis- parameters and range, 27) sensitivity analysis- methods, 28) presenting results, 29) incremental analysis, 30) total C/E, 31) portability of results (generalizability), 32) financial impact analysis, and 33) Mandatory or recommended or voluntary
   
• Country-specific guidelines’ key features (33) as well as hyperlinks or full text of the guideline (as copyright permission allows) or publication reference including a map of the country

The information presented below is derived from an article, “Pharmacoeconomic Guidelines Around the World” by Tony YH Tarn, MS, PhD, ISPOR Visiting Scholar and Associate Professor, School of Pharmacy, National Defense Medical Center, Taipei 114, Taiwan, and Marilyn Dix Smith PhD, ISPOR Executive Director, published in ISPOR CONNECTIONS, Vol. 10, No. 4 (August 2004).

Guidelines listed are dated based on the publication date of the document and categorized as follows:

		Published PE Recommendations: they are country-specific economic evaluation guidelines or recommendations published by experts in the field but are not “officially” recognized or required by the healthcare decision making bodies/entities in this country/region for reimbursement.
		PE Guidelines:  they are country-specific “official” guidelines or policies concerning economic evaluation that are recognized or required by the healthcare decision making bodies/entities in this country/region for reimbursement.
		Submission Guidelines: they are country-specific “official” guidelines or policies concerning drug submission requirements with an economic evaluation part/section and are required by the healthcare decision making bodies/entities in this country/region for reimbursement.

COUNTRY-SPECIFIC PHARMACOECONOMIC GUIDELINES

	Published PE Recommendations	PE Guidelines	Submission Guidelines
Africa	South Africa 2010
America-Latin		Brazil 2009 Cuba 2003 México 2008
America-North	United States 2009	Canada 2006
Asia	China Mainland 2011	Taiwan 2006 South Korea 2006	Israel 2010 Thailand 2008
Europe	Austria 2006 Denmark 1997 Hungary 2002 Italy 2001 Russian Federation 2010  Spain 2010	Baltic (Latvia, Lithuania, Estonia) 2002 Belgium 2008 France 2004 Germany 2009 Ireland 2010 The Netherlands 2006Norway 2005 Portugal 1998 Slovak Republic 2008 Sweden 2003	England & Wales 2008 Finland 2009 Poland 2009Scotland 2007
Oceania		New Zealand 2007	Australia 2008

If you would like your country’s pharmacoeconomics guidelines at the ISPOR website or have comments concerning this section of the ISPOR website, email your request to PEguidelines@ispor.org.