Gesetzliche Krankenversicherung
Benefit Analysis Will Gain Importance for Medtech
28.03.2012|Cologne|
Medtech companies will have to increasingly address the „benefit analysis“ topic in connection with new examination and treatment methods. The industry should develop a reimbursement scheme for innovations early on in the game, and pursue it strategically. The topic of „benefit analysis“ will at first be restricted to class IIb and III medical devices with higher risk, which make up barely 10 percent of all medical devices. This was the upshot of the „Innovation Access for Medical Technologies“ conference held in Cologne in March 2012.When speaking on the level of evidence required for a benefit analysis, Dr. Matthias Perleth of the Joint Federal Committee (JFC) emphasized that the JFC had also approved submissions without randomized controlled trials (RCTs). The JFC regards benefit as „a greater than slight patient-relevant positive effect of a medical measure in consideration of the risk“. The costs of the method apparently do not play a role in the JFC decisions. An assessment of benefit would not be indicated if the product is a part of a method whose benefit has already been proven, for instance a new hemodialysis device, if the submission concerns a lower risk class or product modification that does not have a relevant impact on the performance.
According to Dr. Stefan Sauerland of the Institute for Quality and Economic Efficiency in Healthcare (IQWiG), new medical technological methods will involve more benefit analyses in the future. This particularly applies to medical devices of class IIb and III. The IQWiG regards evidence levels in light of the best possible evidence: whenever possible, randomized controlled trials (RCTs) should be conducted, and they should use concealed randomization and compare data with the best available common conventional treatment method. It makes no difference, who sponsors the trial, says Sauerland. Only the method matters.
BVMed Analysis: Differentiated approach for medtech companies
The great diversity of medical devices requires a differentiation with regard to the applicable assessment methods. It is clear that in the future an innovation must represent a medical and economical advance, for instance when the increase in benefit is higher than the increase in cost. Innovative medical technologies will be successful when they provide a greater medical benefit compared to existing methods, and this benefit can be achieved at the same or lower cost, or the increase in benefit is greater than the increase in cost.
