Abbreviated resolutions of early benefit assessments in the new doctor information system? – An ordinance expected in June 2018 should provide clarity
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Dipl.-Kauffrau Heike Kielhorn-Schönermark
Founder and Managing Director
Founder and Managing Director
Fon: +49 511 64 68 14 – 0
Fax: +49 511 64 68 14 18
Fax: +49 511 64 68 14 18
Critical voices are currently raising both in terms of the objective and the design of the doctor information system. The National Association of Statutory Health Insurance Physicians (Kassenärztliche Bundesvereinigung, KBV) fears, for example, a prescription control by reason of a higher risk of regress. If it should be regulated that the G-BA would provide information on the cost-effectiveness of new drugs, this would in fact lead to prescription exclusions in practice. Although Michael Henning, drug expert of the CDU, and Sabine Richard from the Federal Association of the AOK (AOK Bundesverband) emphasize that the new AIS is not about prescription control, but about informing physicians about drugs to which the Federal Joint Committee (G-BA) has given an added benefit compared to standard therapy, the outlook on the information system currently seems to cause more confusion and concern than to arouse positive expectations.
What's more, the KBV sees physicians heading for dilemmas between established guidelines and the newly-prepared information of the early benefit assessments. For example, how is a physician to decide when to choose between a drug with a hint of significant added benefit, which has recently undergone the early benefit assessment and whose evaluation is based on some clinical trials with a highly selected study population and often a low reference to daily care, and another drug with evidence of a minor added benefit that, as part of the evidence-based therapeutic guideline, adequately reflects the medical-therapeutic reality?
Dr. Marc Oppermann, drug expert at the G-BA, also points out that the decision of the G-BA cannot be shortened without further ado. According to Oppermann, the G-BA resolutions are political decisions which must be preserved in the wording and cannot be prepared as "slim information" (wording of Jörg Berling, vice chairman of the Association of Statutory Health Insurance Physician of Lower Saxony; Kassenärztliche Vereinigung Niedersachsen).
In June 2018, the publication of the ordinance on the doctor information system and thus a clarification of the situation for regulators and service providers is expected. As a consulting firm with expertise in both strategic consulting and writing of value dossiers for early benefit assessments as well as addressing strategic and operational challenges of the Market Access of Digital Health applications, SKC is excitedly awaiting future developments.
BY Prof. Matthias P. Schönermark, M.D., Ph.D., managing director and Beate Kasper, M.A. sociology
Sources (German only):
Ärzteblatt: Rechtsverordnung zum Arztinformationssystem soll im Juni kommen
Ärzteblatt: Arztinformationssystem: Spagat zwischen Nutzen- und Wirtschaftlichkeitsbewertung
Positionspapier der KBV zum Arztinformationssystem und Erstattungsbetrag
Ärzteblatt: Arztinformationssystem: „G-BA-Beschlüsse können nicht verkürzt werden“