Abstracts by key term: drug
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
This article examines the practical implementation of the interface between the price regulation instruments AMNOG and the fixed price in the German pharmaceutical market from 2011 to July 2024. It examines three typical case scenarios of the linking of the price regulation instruments and analyzes the procedural practices of self-administration based on previous application.
03.12.2024
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
With the Pharmaceutical Market Reorganization Act (AMNOG) in 2011, the German legislature enshrined the principle of benefit-based pricing in law. Since then, price negotiations have been largely based on the additional benefits of a medicine, in addition to the annual therapy costs of comparable medicines and retail prices in other EU countries. The aim of the law was to negotiate the price for new drugs with patent protection or new document protection following an additional benefit assessment. The benefit assessment is carried out compared to the appropriate comparator therapy (zVT). This determined additional benefit, together with the previously mentioned criteria, forms the basis for the reimbursement price negotiation, which is carried out between the pharmaceutical company and the umbrella association of health insurance companies (GKV-SV) on the basis of the resolution of the Federal Joint Committee (G-BA). The resulting price discount on the introductory price is the basis for calculating the AMNOG savings in accordance with Section 130b SGB V. These are calculated using the sales difference between the real sales considered (price corresponding to reimbursement amount negotiation x quantity) and a “fictitious” sales (price without Reimbursement amount negotiation x quantity) which would have been reimbursed without the AMNOG price negotiations.
14.10.2023
For drugs for the treatment of rare diseases (orphan drugs), the requirements of early benefit assessment according to Section 35a SGB V represent a particular challenge. The Institute for Quality and Efficiency in Health Care (IQWiG) concludes in working paper GA21-01 on orphan drugs, which are in the As part of a re-evaluation of a regular benefit assessment, the additional benefit of the initial benefit assessment for market access was fictitious.
02.04.2023
Discount contracts have played a prominent role in the pharmaceutical supply of statutory health insurance (GKV). This competitive field has undergone dramatic change in many respects. Not only contract design, implementation, but also legal assessment and public perception have changed. Implementation problems from the beginning have largely been resolved. The savings from the contracts are essential for the GKV - every statutory health insurance company has reported numerous contracts. The article provides an overview of the experiences of the German BKK.
01.06.2010
The instrument of drug discount contracts was implemented in the statutory health insurance (GKV) system in order to curb drug spending in the outpatient sector. The GKV Competition Strengthening Act (GKV-WSG), which came into force on April 1, 2007, paved the way for health insurance companies to be able to conclude discount agreements with pharmaceutical manufacturers more effectively than before. Since then, pharmacists have had to give preference to discounted medications. Ideally, both manufacturers and health insurance companies can benefit from such discount agreements.
01.06.2010
The past and presumably also the current reforms of politics in the pharmaceutical sector strengthen the service providers working in the field of discount agreements according to §130a SGB V for the GKV. The reason for this lies essentially in the complexity of the materials as well as in the bundling of demand volumes. Despite the merger of several health insurance companies, however, they wish to see their individual interests reflected in the contract. Service providers like GWQ ServicePlus AG are measured by whether they enable individual contract strategies in the pharmaceuticals sector on the one hand and whether they successfully achieve high discounts on the other. This is accompanied by the complex task of the technical implementation of the contracts and also a far-reaching consulting service on drug contracts. This concerns pharmaceutical, procurement law, data technology and financial aspects.
01.06.2010
With the founding of the IQWiG 5 years ago, the legislator pursued the purpose of being able to further postpone rationing in the health care system by using funds more rationally. In order to have a decision-making basis that is independent of industry in particular, IQWiG should evaluate therapies independently from a specialist perspective. Meanwhile, the drug assessment of the Institute itself is in the public criticism, it tendentious. A not medical, but legal assessment of IQWiG's drug assessment practice actually shows discrepancies between the legal requirements and assessment practice, particularly with regard to the definition of the order and the choice of method.