1. INTRODUCTION

1.1.   Definitions

Economic Evaluations Studies (EES) are the “comparative analysis of alternative courses of action in terms of both their costs and their consequences”, with a view for decision making on their added value to the current standard of practice in the healthcare system.

There are two main types of Economic Evaluations Studies used for resource allocation decisions:

A.  Partial Economic Studies is a sub-discipline of economic evaluation where an analysis of cost or consequence occurred independently e.g.:

     o  Budget Impact Analysis (BIA): an economic evaluation that assess the financial impact of the adoption of new intervention that can aid in setting and allocating resources relative to its affordability.

B.  Full Economic Studies or Pharmacoeconomics Evaluation Studies (PES) is a sub-discipline of economic evaluation where an analysis of different intervention compared in terms of both their costs and their added value for an outcomes. There are four main types of PESs:

     o  Cost Effectiveness Analysis (CEA): is a comparative economic evaluation of two or more alternatives intervention in terms of their relative costs and outcomes, where the later are measured in a natural unit.

     o  Cost Minimization Analysis (CMA): is a comparative economic evaluation in which the outcomes of the two or more comparators are assumed to have equivalent health effects.

     o  Cost Utility Analysis (CUA): is a comparative economic evaluation where the outcomes are expressed by a using either generic preference-based measure or condition specific-based measure that considers both the effect on mortality and morbidity.

     o  Cost Benefit Analysis (CBA): is a comparative economic evaluation, where both the costs and outcomes are expressed in monetary terms.

1.2.  Objective 

This guidance helps manufacturers, marketing authorization holders, or agents in describing a standard method for performing, submitting, or publishing an EES. These will be evaluated at the Saudi Food and Drug Authority (SFDA) to determine the added value and premiums deserved over the current standard of practice utilized in Saudi Arabia’s healthcare system.

1.3.  Scope

This guidance applied to all Human pharmaceutical products submitted for registration and renewal in SFDA. It is mandatory to provide at least one of the best-suited EES based on product type: