Summary
A distinction between "Breakthrough-drug" and "Me-too-drug" within one therapeutic class of medication is usually not clinically relevant. The concept of a class effect, which would mean, that one "Me-too drug" could be substituted with another one from the same therapeutic class, is only proven for very few drug classes. Usually an individual risk/benefit assessment has to be performed for each specific drug. Even if a class effect has been established, doctors should not be forced to switch their patients to the cheapest drug within the same class. Patient specific factors such as compliance have to be considered first. However at the onset of a new therapy regimen, the drug with the lowest price should be used.
Zusammenfassung
Die Unterscheidung zwischen Innovator und "Me-too"-Präparaten in einer therapeutischen Klasse ist klinisch meist nicht relevant. Das Konzept eines Klasseneffekts, der Analogpräparate untereinander austauschbar macht, ist nur für wenige Substanzklassen als gesichert anzusehen. Im Allgemeinen muss für jedes Präparat ein Nutzen/Risikoprofilerstellt werden. Selbst bei Vorliegen eines Klasseneffekts sollte eine Umstellung auf das jeweilig billigste Präparat einer Klasse nicht erzwungen werden, da auch patientenrelevante Faktoren wie Compliance zu berücksichtigen sind. Bei Neueinstellungen ist aber dem günstigsten Präparat der Vorzug zu geben.
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Blöchl-Daum, B. "Me-too drugs" und das Konzept des Klasseneffekts. Wien Med Wochenschr 156, 494–497 (2006). https://doi.org/10.1007/s10354-006-0333-2
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DOI: https://doi.org/10.1007/s10354-006-0333-2
Keywords
- Me-too drugs
- Follow-on drugs
- Breakthrough drug
- Class effect
- Risk/benefit assessment
- Compliance
- Drug price
- Medication