The medical information system - Do the concerns and challenges outweigh the goal of a higher quality drug supply in Germany?
About the author
Prof. Matthias P. Schönermark, M.D., Ph.D.
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
To provide patients with the most effective contemporary pharmaceutical products, one of those measures is to inform physicians about the early benefit assessment of new drugs, by means of a suitable medical information system integrated in the physicians practice software. Thereby, physicians will be provided with information about questions of the additional benefit and should be supported in therapy decisions. As part of the benefit assessment, the Federal Joint Committee (“Gemeinsame Bundesausschuss” - G-BA) decides on the additional benefit of a newly launched drug within the German market in comparison to an appropriate comparative therapy (in German: “zweckmäßige Vergleichstherapie”). This evaluation is a key basis for the price negotiations between the pharmaceutical company and the umbrella organization of SHIs to determine a reasonable price for the drug.
Thus, the medical information system is valuable such as innovative medicines will find faster use in patient care and patients would further benefit from the extended information available for physicians. However, there is a risk of uncertainty among physicians in dealing with additional benefit categories of new drugs and their prescription in relation to different patient sub-populations, which might show different benefits of the pharmaceutical product.
It is important to note that the defined additional benefit category could have a significant influence on the prescription frequency of certain medicinal products compared with others and therefore, could impact the exclusion of certain prescriptions. Critics also note that the regulation of certain drugs according to their additional benefit could be considered as an uneconomic behavior and thus, increases the regressive pressure on the prescribing physicians.
Therefore, processing of information within the medical information system plays a decisive role in counteracting a potential "drug prescription control". Approximating the goal of improving the quality of supply of medicinal products would require equipping physicians with information on the active substances, particularly the area of application, the assessment of the additional benefit, and requirements for a quality assured application of the medicinal product. In addition, existing information should only be regarded as an add-on material and should not be considered as a substitute for evidence-based treatment guidelines and does not aim to reduce drug expenditure. It remains to be seen which effects the medical information system will have in the future and whether it will be beneficial for patients.
Our SKC expertise in the area of AMNOG enables us to recognize the impact of the early benefit assessment and the appointed additional benefit of innovative medicines and to develop purposeful and optimized solutions as a strategic consultancy to support our clients.
BY Prof. Matthias P. Schönermark, M.D., Ph.D., Founder and Managing Director of SKC Beratungsgesellschaft mbH and Dr. rer. nat. Alexandra Kuhn, SKC Beratungsgesellschaft mbH
Sources:
Bundesgesundheitsministerium: Entwurf eines Gesetzes zur Stärkung der Arzneimittelversorgung in der GKV (German only)
Bundesgesundheitsministerium: Bundestag verabschiedet Gesetz zur Stärkung der Arzneimittelversorgung (German only)
Ärzteblatt: Geplantes Arztinformationssystem darf nicht zur Verordnungskontrolle führen (German only)