Abstracts by keywords: AMNOG
Deutschland zählt zu den bedeutendsten Arzneimittelmärkten Europas und zeichnet sich durch eine unmittelbare Erstattungsfähigkeit neu zugelassener Arzneimittel zum Zeitpunkt der Markteinführung aus. Seit Inkrafttreten des Arzneimittelmarktneuordnungsgesetzes (AMNOG) im Jahr 2011 unterliegen neue Arzneimittel einer Nutzenbewertung durch den Gemeinsamen Bundesausschuss (G-BA), welche die Grundlage für die anschließenden Preisverhandlungen bildet. Ziel dieses Systems ist es, Preisaufschläge ausschließlich […]
05.10.2026
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
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
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
In order to determine the so-called EU reference price, the pharmaceutical company must “report the amount of the actual selling price in other European countries (see Appendix 2, RV) (…) to the extent that the drug in question is offered there” (framework agreement according to Section 130b Paragraph 9 SGB, §3 paragraph (2) SGB V). According to Annex 4 to the RV, in order to “determine the actual sales price weighted according to purchasing power and sales, the company’s actual country-specific sales price must be corrected according to purchasing power and weighted with the sales share of this country in the total sales of the countries to be taken into account. The prices weighted in this way are added together for the comparison countries (framework agreement according to §130b SBG V, Annex 4) and result in the European reference price. However, the arbitration award on the RV of June 21, 2016 (§6 (3) RV) expressly included a regulation in the RV according to which, in justified cases, the turnover weighting can be deviated from and the turnover weighting can instead be carried out approximately using the number of inhabitants. Furthermore, a regulation was included in the RV according to which the contractual partners can deviate from the requirements of Annex 4 No. 2 and No. 3 of the RV, provided that both contractual partners agree or the special features of the specific reimbursement amount agreement or special problems in obtaining data give rise to this. Which methodology appears suitable in which cases and what limitations there are, particularly when it comes to sales weighting, will be discussed below.
04.04.2019
There has been a clear volume dynamic on the German pharmaceutical market for several years [1]. In addition, factors such as demographic change, medical-technical progress and the increase in outpatient therapy options lead to increasing pharmaceutical expenditure [2]. The legislature took up this progressive development by introducing the Medicines Market Reorganization Act (AMNOG) in 2011. Since then, new medications have been evaluated for their additional benefits. It turns out that a large number of new pharmaceutical products continue to come onto the German market, the additional benefit of which often cannot be proven or for which only a small additional benefit has been identified [3]. In addition, in the period from 2013 to the beginning of 2014, drugs that had already been approved were assessed as part of the AMNOG with regard to their additional benefit (so-called existing market call).1 The only group of active ingredients whose process was completed include the DPP-4 inhibitors (also gliptins).
06.12.2017
The Medicines Market Reorganization Act (AMNOG) has been in force since January 1, 2011. The introduction of this legal system represents a paradigm shift, comparable to the fixed price regulation introduced in 1989. The background to the AMNOG was the legislature's desire to counteract the “cost explosion” in the health system while at the same time ensuring an adequate supply of medicines. The implementation of the AMNOG regulations primarily means the implementation of the early benefit assessment in accordance with Section 35a SGB V. This system is based in particular on comparable models from the Scottish Medicine Consortium (SMC) and the English National Institute for Clinical Research (NICE).
24.01.2013
We are in the 4th year of AMNOG. After 38 months, 68 benefit assessments were available. Their results have been and continue to be widely discussed. The topic of price negotiations and the resulting savings potential are also regularly the focus of interest. But what about the effects of the AMNOG processes on everyday care? How have new active ingredients become established on the market depending on their benefit assessment? This article aims to provide the first (cautious) highlights of this – from the perspective of a data service provider.
24.01.2013
On January 1, 2011, the law to reorganize the pharmaceutical market (AMNOG) came into force. Since the AMNOG came into force, pharmaceutical companies (companies) have had to submit evidence of the additional benefit of the new active ingredient for all drugs with new active ingredients as of the date of market launch. According to the draft bill for AMNOG, one of the objectives of this law was to create “reliable framework conditions for innovation, care for insured persons and job security” (1). The research-based pharmaceutical drug manufacturers have faced the extremely high administrative effort associated with dossier creation. In public statements, IQWiG certifies that the pharmaceutical companies' dossiers are of good quality. After three years of experience with early benefit assessment, the question now arises as to whether AMNOG is an obstacle or an accelerator for innovation.