GKV-Routinedatenanalysen zur Unterstützung des Market Access von Arzneimitteln, Impfstoffen und Medizintechnik

Empirische Beispiele zur Machbarkeit

authored by

Christian Jacob

supervised by

Johann-Matthias Graf von der Schulenburg

Abstract

As part of the market access process, manufacturers of drugs, vaccines and medical technology are confronted with a variety of research questions. These include, for example, questions about unmet medical needs, the epidemiology of diseases and the care situation of patients. They concern medical costs, the effectiveness and safety of products in the real-life healthcare situation, and the positioning of the company’s own products compared to competitors. Studies based on statutory health insurance (SHI) claims data have had a firm place in national and international health services research for many years. They provide an important contribution to the understanding of the healthcare situation of patients in a wide variety of indications, from common diseases affecting large parts of the population to rare diseases with small sample size. This cumulative dissertation examines the potential of SHI claims data based health service research studies to support the market access of drugs, vaccines and medical technology from the perspective of the respective manufacturers. Six modules answer research questions regarding the market access of drugs. Three of these modules examine aspects of the rare diseases non-cystic fibrosis bronchiectasis (NCFB) and phenylketonuria (PKU). In addition to epidemiological data, they collect data on the costs of illness and the burden of concomitant diseases, drug therapies and hospitalizations. Two further modules concern the indication asthma. They thematize the identification of disease severity and analyze the cost of the disease in terms of age and sex differences. A next module examines the effects and costs of iron deficiency in patients with heart failure and compares different treatment alternatives in terms of cost of illness and effectiveness. Four modules present studies from the field of vaccine market access. Three studies examine the effects of updated recommendations of the Standing Committee on Vaccination (STIKO), using pneumococcal vaccination as an example. One study analyzes pneumonia rates in different risk populations. Two studies compare the vaccination rate and vaccination adherence of "mature" and "preterm" infants before and after the change in vaccination recommendation. Another module describes the disease burden of HPV-associated anogenital disease in young women. Finally, one module analyzes the costs and resource utilization of instrumental spinal surgeries and potential reoperations - a study to support the market access of medical technology. On the basis of eleven empirical examples this cumulative dissertation showed that SHI claims data based health services research studies can represent a meaningful instrument for manufacturers of drugs, vaccines and medical technology to support the market access of their products.

Organisation(s)

Faculty of Economics and Management

Type

Doctoral thesis

No. of pages

153

Publication date

2023

Publication status

Published

Sustainable Development Goals

SDG 3 - Good Health and Well-being

Electronic version(s)

https://doi.org/10.15488/13551 (Access: Open)