The systematic literature search – an indispensable tool in the context of benefit assessment

This blogpost addresses the relevance of a systematic literature search in the context of the AMNOG according to § 35a SGB V.

The aim of a systematic literature search (SLR) is the focused acquisition of information on a previously defined question, which in the context of the benefit assessment according to Section 35a of the German Social Code Book V (SGB V), for example, aims to identify relevant evidence for the drug to be assessed. The SLR is performed based on previously defined search criteria such as the active ingredient name and the relevant indication in various relevant databases. The sources identified in this way are subjected to a content assessment with regard to their relevance to the research question based on predefined criteria. This ensures that only the sources relevant to the research question are used for information extraction after the SLR has been performed.

Conduct SLR to identify relevant evidence for the drug being evaluated

In the context of the preparation of the dossier for the benefit assessment according to § 35a SGB V, an SLR for the identification of relevant studies is mandatory. The template of the Federal Joint Committee (G-BA) for Module 4 (“Medical benefit and additional medical benefit, patient groups with therapeutically significant additional benefit”) provides the corresponding framework for this. Thus, a search for randomized controlled trials (RCT) with the drug to be evaluated is mandatory. The extent to which an SLR for other types of studies, such as non-comparative studies or studies for an indirect comparison, is necessary depends on the respective situation regarding the drug to be evaluated.

An extended SLR can be particularly useful if no RCT is available for the drug to be evaluated or if the RCT identified does not represent an adequate comparison with the appropriate comparator therapy (APT) determined by the G-BA. In these constellations, taking into account strategic key points such as the available evidence , the strategic orientation for the benefit assessment and the subsequent price negotiation, as well as the positioning of the drug to be assessed in the overall therapeutic context of the relevant indication, an adequate and targeted search strategy is the decisive starting point for being able to use all potentially relevant evidence in the final decision regarding the presentation in the dossier for the benefit assessment and thus for deriving the added benefit.  Only a properly conducted SLR enables the exploration of all strategic options while avoiding non-acceptance of the SLR due to methodological deficiencies or studies subsequently identified by the Institute for Quality and Efficiency in Health Care (IQWiG) or the G-BA.

Other possible SLRs in the benefit assessment and related processes 

Also, for module 3 (“Purposeful comparative therapy, number of patients with a therapeutically significant additional benefit, costs of the therapy for the SHI, requirements for a quality-assured application”) SLRs are optionally possible and in many cases recommendable to give the presented contents a higher validity. The topics of epidemiology and costs are particularly emphasized in the corresponding template of the G-BA. Thus, for epidemiology, SLR can be performed to identify data on the frequency of the disease in Germany and then, depending on the results obtained, expanded in Europe and/or worldwide. For this purpose, the SLR provides a quick overview of the available sources in order to efficiently sift through them and decide on a strategy for deriving the patient numbers as well as to ensure the valid determination of the patient numbers. In the context of a purely unsystematic hand search, there is always the risk of overlooking relevant sources. For the costs, an SLR is suitable, for example, if the ZVT identified by the G-BA represents a symptom-oriented patient-specific therapy and available measures/therapy options are to be addressed here in a concrete and targeted manner in order to be able to represent corresponding costs for these therapies. In this case, an SLR can be particularly helpful in the price negotiation that follows the benefit assessment.

Other possible uses of an SLR are, for example, in the context of consultations with the G-BA (e.g. to identify the ZVT or for a preliminary search for possible studies) or for the strategic preparation of price negotiations in order to systematically identify relevant competitor drugs and their study (data). The possibilities offered by SLR are extremely diverse and can be used to address a wide range of issues.

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