Destaques da 5ª Conferência Latino-americana da ISPOR – Dispositivos Médicos

Highlights of the 5th Latin American Conference of ISPOR – MCDA

28 October, 2015

“The value of health is not the end of life”

December 8, 2015

Another highlight of the 5th Latin American Conference of the International Society for Pharmaeconomics and Outcomes Research (ISPOR) is medical devices and their implications in decision making.
According to its definition, a medical device is understood as any instrument, machine, software, biomedical equipment, whether used alone or in conjunction with other components and accessories that allow its full activity. These, in turn, should not present a substitute character for the role of health professionals, but rather guarantee better quality of care and promote value in care.
An important aspect that refers to the devices is the characteristic of accelerated cycle of updating and renewal of technologies, as the process of paradigm shift in health, or that promotes an economic impact in the deterioration of products that become obsolete or not optimized alvo public year. In addition to making it challenging to quickly incorporate these at the same speed as they are created.
Comparatively like drugs, medical devices have greater access to treatment, however, the skill of the operator and the different learning curves linked to the process can compromise the expected results, unfortunately, presenting significant variability. Not only does this factor trap its endorsement in studies, as it also reduces the size of the population to be committed to technology and the difficulty of power in a controlled and masked group.
Based on these limitations, most regulatory agencies base the registration of two devices based on their risk category:

Class I (low cliff): technology subject to generic control, given that it does not present any potential for harm to the patient.

Class IIa (moderate risk): device subject to special control in the manufacturing phase to demonstrate its effectiveness and safety.

Class IIb (high risk): device subject to special control not designed and manufactured to demonstrate its effectiveness and safety.

Class III (very high risk): technology subject to special control in all its development processes, seen or potential to cause harm to the patient.
Despite this alternative, the economic analysis is vulnerable to the vieses, given the lower quality of the information and the fact that the sensitivity analyzes will be more complex to interpret, reflecting a lower robustness. This is due to the absence of a standard value consensus for discount rates as they are made with medicines.
A European study conducted by Reinhard Busse and colleagues attempted to address these challenges in order to create a new taxonomic model for medical devices, minimizing the implications of the step that brings them together in relation to their risk and different criteria for selection and prioritization in the evaluation of health technologies. , with the data obtained from stories that present the highest quality and experience possible and through interviews in 16 different European institutions.
Allied to the previously described classification for additions to classes IV (implanted devices, such as cochlear) and V (in-vitro diagnostic methods).
Identified that devices in the low-risk categories present less importance in safety and economic aspects. Implants, in turn, are described as being of greater relevance to social, ethical and legal issues.
Despite these two facts, the referendum still lacks greater evidence, with more robust data, to more precisely evaluate the impact of the devices and how to proceed with their evaluation and a decision has been made.
More news about the 5th Latin American Conference of ISPOR:
Multicriteria Decision Analysis (MCDA)
Payment Limit