Masterarbeit

Pharmaceutical pricing and reimbursement in Latin America - Implications for Regulatory Strategy ***

Pablo Gabriel Amaya Rodriguez (2015)

Summary
Language: English
Pharmaceutical pricing and reimbursement processes worldwide have gained strong relevance in the last years since they are, after regulatory approval, an essential milestone for a new medicinal product to timely access the market and become available to the patients. Due to the constant increment of pharmaceutical expenditure above average country economic growth in the last decades, increase of ageing population and change in the epidemiological patterns from acute / infectious to chronic diseases, policy-makers are now more concerned about the future sustainability of the healthcare system. Thus, measures to control the price or rationalise coverage of new medicines are being established not only in high-income but also mid- and low-income countries, like those in Latin America.
This Master Thesis is divided into 5 main sections. The first section describes the improvements on health indicators worldwide occurring in the last decades and their impact on standard of life, epidemiological patterns and healthcare and pharmaceutical expenditure. Secondly, the characteristics of the pharmaceutical market and price formation are analysed in comparison to an ideally competitive market. This section outlines the possible background behind increasing costs of new medicinal products, economic methods used by payers to assess added value (CEA, CUA) of new medicines and the incremental costs added along the supply chain. The third and fourth sections contain a description of the policies implemented worldwide and also in the biggest Latin American countries to control pharmaceutical expenditure, putting major emphasis on those policies aiming pricing control and reimbursement.
The fifth section provides strategic considerations for market access in Latin America from a global perspective, which aim to integrate local requirements in the worldwide clinical development program, global regulatory strategy and regional / local pricing and reimbursement negotiations.
Pages: 53