Abstracts by keywords: Pharmaceuticals
Ensuring the continuous availability of medicines is crucial in healthcare, and supply shortages are a growing problem [1]. These are caused by global supply chain disruptions, production problems, and increasing demand [2], which can lead to significant supply problems and jeopardize patient care. Established inventory management and forecasting methods often reach their limits. According to the German Federal Institute for Drugs and Medical Devices (BfArM), a supply shortage is defined as "an interruption of delivery at the usual level lasting longer than two weeks or a significantly increased demand that cannot be adequately met" [1]. For patients, this becomes relevant when the prescribed medicine or an alternative medicine is not in stock and cannot be ordered from wholesalers in a timely manner. This would constitute a supply shortage. Legislation already addresses this problem in the Pharmacy Operations Ordinance, which stipulates: „[E]very pharmacy must keep in stock medicinal products and pharmacy-only medical devices sufficient to meet at least the average demand for one week“ (§ 15 ApBetrO). Furthermore, § 52b (1) of the German Medicines Act (AMG) states: „Pharmaceutical companies and operators of pharmaceutical wholesalers [...] shall ensure an adequate and continuous supply of the medicinal product so that the needs of patients within the scope of this Act are met.“
05.10.2025
The aim of the study is to precisely examine the population-normalized treatment costs of orphan drugs. For this purpose, a study examining the treatment costs of orphan drugs for the years 2005 to 2021 was already conducted in 2022. The calculations have now been validated as part of a study update using the identical population. The update enabled inflation adjustment based on the 2022 price index as well as seamless treatment costs after AMNOG assessment and price negotiations for all orphan drugs. The analysis shows that AMNOG fulfills its function as a price regulation instrument for orphan drugs as well. Since the introduction of AMNOG, the inflation-adjusted normalized treatment costs for orphan drugs have decreased both in terms of the introductory price (minus 25% of the total) and the reimbursement amount (minus 6% of the total).
03.06.2024
The abolition of the supplementary federal subsidy in 2023, which will provide an additional 14 billion euros in the coffers of statutory health insurance (GKV) in 2022 (Bundestag 2021), thus increasing the total amount to 28.5 billion euros, gave rise to a debate about the impending funding gap for statutory health insurance in 2023. The question therefore arises as to which measures are suitable to enable targeted expenditure control in the statutory health insurance. The federal government's draft law for the financial stabilization of statutory health insurance (Federal Ministry of Health 2022) lists a number of measures that are intended to realize efficiency reserves without benefit cuts amounting to around 3 billion euros for 2023. For example, the sales threshold for drugs to treat a rare disease (orphan drugs) for the benefit assessment is to be reduced to 20 million euros.
21.09.2022
The concept of needs-based justice follows the idea of a balanced distribution of goods and services within a society according to objective criteria. Needs-based health care means that - viewed objectively - all citizens receive the care services that are necessary for them from a qualitative and quantitative perspective. Aspects such as effectiveness, quality and cost-effectiveness of and equal access to care services are of particular importance. Where needs are not met, under-supply, over-supply and incorrect supply can result. In its current 2014 report on needs-based care, the Council of Experts examines the question of how the requirement of needs-based care can be further developed in individual service areas. The focus is on current performance and future development opportunities in the supply of pharmaceuticals, the supply of medical devices and medical rehabilitation. The availability of evidence-based knowledge bases is seen as an essential prerequisite for targeted control measures in all three areas.