Impact of the economic crisis in the approval of new oncological drugs:the Portuguese paradigm

• Main Author: Fernandes, I.
• Publication Date: 2015
• Other Authors: Rueff, M. C., Portela, S., Mansinho, A.
• Format: Article
• Language: eng
• Source: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Download full: http://hdl.handle.net/10071/10783
• topic: Innovation; Economic crisis; Healthcare

Background: The European crisis lead to funding restrains in healthcare, already under pressure due to the ageing of the population and the increase of demands from innovation. Portugal is the paradigm of the European crisis since has both an economic and demographic crisis. The researchers aimed to evaluate the impact of economic restrains in Portugal for access and reimbursement of new oncological drugs. Methodology: A qualitative approach was used, supported by 27 formal, tape recorded, semi-structured interviews to representatives of the different healthcare stakeholders and policymakers. The content analysis with semantic associations through co-occurrence analysis were done with the support of Tropes® software. Results: The results of the content analysis showed that economic restrains are leading to a policy of cost control with lower prices and reduced access to innovation; an excessive delay in the approval of new drugs; lack of transparency; serious limitations and inequity between hospitals. Contractual boundaries to national prescription was established and agreements with pharmaceuticals were made. Changes in the reimbursement process are being implemented with an increase of risk sharing mechanisms and implementation of a new system of health technological evaluation (SINATS). Treatment protocols are also being revised and public hospitals are trying to increase the number of clinical trials but there is still much bureaucracy. In this qualitative approach, the following factors with impact on survival were identified: Innovation and technological development, government funding, the price of drugs and type of oncological diseases. Conclusions: The economic crisis is leading to a very serious problem of inequity. However, it is also an opportunity for a structural reform. In Portugal, an attempt of reform is being made with the implementation of SINATS since it is important to distinguish molecules that effectively bring added value. In order to consider the strategic vision in which the patient is the center of all efforts, the process of reimbursement approval for new medicines should be faster, more transparent and interdisciplinary. Moreover, the decisions must be done triangulating evidence based medicine, economics, health policy and ethical and legal issues. For National Health Service sustainability, efficiency and efficacy, clinical and economic reassessments must be done after market introduction of new medicines, with subsequent renegotiations.