|Grüner P, Pichler M|
Bluthochdrucktherapie 2018: Generika oder Originalsubstanzen – Quo vadis? // Modern Antihypertensive therapy: Generics or original substances. Quo vadis?
Journal für Hypertonie - Austrian Journal of Hypertension 2019; 23 (1): 4-7
Volltext (PDF) Summary Praxisrelevanz
Keywords: Hypertonie, Kostenallokation, Medikamentenherstellung, Qualitätskontrolle, Therapie, Valsartanrückruf, cost allocation, drug production, quality control, recall of valsartan
All present antihypertensive drugs are available as generic formulations, at much lower prizes than their branded predecessors which were blockbusters in their beginnings.
Generic drug manufacturers must demonstrate that their product is bioequivalent to the innovator drug product. Bioequivalency is demonstrated by measuring the drug’s plasma concentration vs time curve (AUC) in 24–36 healthy volunteers.
Metaanalysis and large RCT (CONVINCE, INVEST) which evaluated both innovator and generic formulations provide compelling evidence that blood pressure lowering and cardiovascular outcome are similar regardless of drug status.
Patients’ adherence to and persistence with therapy may be negatively influenced by switching generic drugs for cost containment purposes.
The discussion about the quality and similarity of generic antihypertensive drugs to brand name drugs has to be differentiated from the recent scandal involving the recall of valsartan medications manufactured in China. The recall was due to an impurity – N-nitrosodimethylamine (NDMA) – which is classified as probable human carcinogen. In 2012 the chinese manufacturer had notified the EMA about a change in its manufacturing processes of valsartan that are believed to have produced NDMA as a side product. However it lasted six years until the impurity was detected! In assessing the situation of manufacturing pharmaceutical companies in Asia the problem is not a lack of regulation but rather a lack of adequate and rigorous control of quality.
The recent ESH/ESC guidelines on hypertension open a new market place for fixed combination antihypertensive pills of generic pharmacy industry. New galenic patterns and better prizes are the advantages of these drugs. In addition to the economic perspective of cost containment with generic drugs produced in Asia great attention has to be drawn by the regulators to a rigorous quality control in the manufacturing process.
Furthermore the ongoing prize dumping of generic antihypertensive drugs without setting of a lower limit has to be critized. It has to be questioned if this kind of lowest prize policy allows an adequate quality in the production process and a reliable patient’s safety of the formulation. In Austria recently the lowest prized valsartan was actually manufactured in Ireland (free of NDMA) while the most expensive valsartan product came from China. This may one lead to the assumption that for some drug companies their principle priority is just to maximize their profit.
Kurzfassung: Alle heute am Markt befindlichen Antihypertensiva waren nach ihrer Markteinführung „Blockbuster“. Die Entwicklung wie auch der „market access“ neuer Präparate ist u.a. auch finanziell aufwendig. Während des Patentschutzes kann das investierte Geld exklusiv in Gewinn umgesetzt werden. Nach dem Patentablauf können weitere pharmazeutische Unternehmen in Herstellung und Vertrieb einsteigen; sofern die Arzneimittel auf Kosten der Sozialversicherung erstattet werden, kommen dann die im ASVG geregelten Preisabschläge zur Anwendung.