The Pharmaceuticals Market Reorganisation Act (Arzneimittelmarkt- Neuordnungsgesetz – AMNOG) of 22 December aims to limit the cost. The early benefit assessment, the core of AMNOG, brought new challenges for . an analysis of the dossier assessments completed up to the end of June The Act on the Reform of the Market for Medicinal Products (AMNOG) and the Regulation on the Benefit Assessment of Drugs (AM-NutzenV) form the legal basis.

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In contrast, a G-BA decision of less benefit as occurred in one of the subgroups in the assessment of eribulin implies a negative benefit-risk balance. The upper limit of the CI for such an endpoint needs to be 0. Who benefits from the refund rate negotiations?

If a surrogate endpoint is used, its surrogacy for the clinical endpoint needs to be validated. For eribulin, only some of the data presented by the manufacturer were deemed relevant by IQWiG and G-BA for the specified subgroups, leading to a decrease in the level of evidence for additional benefit [ 7 0212. In the dossiers for abiraterone acetate, cabazitaxel, eribulin, ipilimumab and vemurafenib, an additional benefit in overall survival was reported [ 7 ].

Abstract Objectives Since the introduction of the German health care reform in Januaryan early benefit assessment EBA is required for all new medicines.

AMNOG since 2011

Results Twenty-seven EBAs were analysed. We believe this is one area where we especially need our academic colleagues to join in and conduct research to provide more insight into the choice of the comparative measure, thresholds to define benefit categories, one study against two studies, and how decisions on these issues will impact the design and analysis of registration trials.

The manufacturer may request an advice meeting with the G-BA in order to determine the appropriate comparative therapy ACT and address any other relevant questions. The 201 of the studies and data included in the Benefit Dossier needs to be described. The pharmaceutical company reports both it and the refund rate to the price reporting amng. This criterion applies to price negotiations only.

The pharmaceutical companies are obliged by law to inform the National Association of Statutory Health Insurance Funds of the actual sales prices retail prices not including value-added tax, minus the discounts that have been or which must be granted. This is however only amnoog at the earliest one year after publication of the resolution on the early additional benefit evaluation.

The Federal Ministry of Health: Here, the benefit in comparison to other medicinal products of a fixed-rate group takes on a major role in proving a therapeutic improvement. This means that the additional benefit is portrayed not in differentiated grades and probabilities, but exclusively as a yes-no decision regarding whether or not a therapeutic improvement is proven within the meaning of the fixed-rate arrangement. Nevertheless, a considerable amount smnog experience has been gained in the EBA procedures.


Insofar as a nonmedicinal treatment is considered as the comparator, this must be deliverable within amng framework of the statutory health insurance. Prophylaxis of venous thromboembolism after athroplasty hip or knee replacement.

Inflammation in the eye following operation to remove cataract. On the rare occasions when a component of a composite endpoint is removed, we propose in Section 2. zmnog

Skin and soft-tissue infections, community-acquired pneumonia. The fixed rate is a maximum refund up to which the statutory health funds assume the costs of specific medicinal products prescribed by physicians. Institute for Quality and Efficiency in Health Care and G-BA decisions regarding adverse events, as well as the weighting applied when deriving a total score, were analysed.

If the new product is deemed to have no additional benefit, it will go into a fixed reference price group.

It also remains unclear under what circumstances a manufacturer may deviate from the assessment methodologies of IQWiG and G-BA, and to what extent benefit assessment will be penalised for such deviations.

– Legal foundations of IQWiG

Additional benefits were categorised according to the three dimensions stated within the relevant social law, i. In practice, primary endpoints for registration trials are selected in agreement with regulators and supported by medical experts. For high correlation, IQWiG requires the lower bound of the confidence interval for the correlation coefficient to be greater than 0. Both statutory and private health insurers can presume in future that high refund rates are indeed countered by a corresponding additional benefit for patient care, and aamnog they do not have to finance spurious innovations which all too frequently are excessively expensive, as they used to have to.

It issues directives for the benefit catalog of the statutory health insurance funds and specifies measures for quality assurance in inpatient and outpatient areas of the healthcare system. Assessment of actual benefits of new drugs by the Transparency Committee. In February the legislator stopped all planned assessments of the established market by changing the law 14th Social Code Book V Amendment Act. Verfahrensordnung des Gemeinsamen Bundesausschusses; 5. Flow chart covering benefit assessment and price negotiation according to the new German regulations since January What is the difference between an additional benefit and a therapeutic improvement?

This applies to every newly approved drug from 1 January Study populations were divided into subgroups more frequently by IQWiG than by the manufacturers. In accordance with the principles applied by the Federal Joint 2102, the expedient comparative therapy must comply with the wmnog standard of evidence-based medicine and be licensed in Germany.


The refund rate that was negotiated applies annog persons with both statutory and private insurance, and to self-paying patients in Germany. Conflict of interest F. The conclusions of IQWiG and G-BA on adverse events were sometimes related to subgroup analyses belatacept, boceprevir, fingolimod and telaprevir [ 7 ].

In three of the 16 cases abiraterone acetate, fampridine and fingolimod ammog, data for the suggested comparators e.

The public is able to read here about all active ingredients for which the Federal Joint Committee is carrying out or has already completed an early additional benefit evaluation. Negotiation of reimbursement rates led to savings in amount of Mio.

Implementation of AMNOG: An industry perspective

Those deemed to bring an incremental therapeutic benefit score ranging from 1 to 4 qualify for price negotiations, and may obtain a price premium over the appropriate therapeutic comparator. While these endpoints have become established and recognised by the regulatory bodies, they are not necessarily accepted by HTA bodies.

Accessed 4 Sep It should be mentioned that G-BA has not assigned the category of major additional benefit to any single drug evaluated so far, and it is therefore unclear what impact a drug would need to have in order for G-BA to consider it as having a major additional benefit. These statutory stipulations are complied with by the Federal Joint Committee by submitting a separate dossier for medicinal products that are comparable with fixed-rate medicinal products in pharmacological and therapeutic terms Annex VI to the 5th Chapter of the Rules of Procedure of the Federal Joint Committee.

For the first time, the AMNOG is seriously tackling the price monopoly of the pharmaceuticals industry in Germany with this central arrangement. Regulators do not necessarily restrict approval to the subgroup of PS 0—2 even though the registration studies were conducted only in these patients as long as there is no biological reason to believe that the new product may not benefit more advanced patients.

Journal of Clinical Epidemiology It may be assumed that G-BA would not consider a transient decrease in white blood cell count as patient relevant, whereas it would consider a symptomatic myocardial infarction to be patient relevant.