Abstracts by keywords: blood sugar control
When discussing surrogates and endpoints, one quickly comes to the question of which treatment results and characteristics are actually relevant for the patient. The appropriate expression “patient-relevant endpoint” is anchored in the legal basis for early benefit assessment according to Section 35a SGB V.1 While in other places there is explicit talk of a “therapy-relevant higher benefit” or “therapy-relevant side effects” (cf. e.g. § 35 Para. 1b SGB V), is clearly aimed at the patient. In the associated dossier specifications for Section 35a SGB V, module 3.3.6 mentions patient preferences as a data source to be taken into account.2 Thus, the importance of patient-relevant endpoints and patient preferences has increased with the AMNOG (Law on the Reorganization of the Medicines Market), but what role they play in concrete terms plays is still to be clarified. Nevertheless, the IQWiG (Institute for Quality and Efficiency) commissioned pre-AMNOG for two pilot studies on preference measurement (Conjoint Analysis, Analytical Hierarchy Process), one of which has already been published. IQWiG also focuses on patient preferences in its current method paper (see IQWIG (2013); IQWIG (2010b); IQWIG (2011)).