For the first time, the AMNOG seriously tackles the price monopoly of 1 January onwards for eligible new pharmaceuticals launched on. Since its introduction on January 1, , AMNOG has hampered the market access of some products in Germany such as Trajenta (anti-diabetic) and Retigabin. AMNOG is here to stay. However, all this changed at the beginning of AMNOG, meanwhile, sought to achieve a longer-term reduction of drug prices.

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Pharmaceutical expenditure will be limited by the refund rates that are negotiated under the AMNOG procedure. We propose alternative approaches to address the requirements in some cases and invite other researchers to help develop solutions in other cases. The law was enforced with the political goal of saving the sick funds 2. The analysis and interpretation of clinical trial results depends on the trial design, which includes a deliberation of primary and secondary endpoints.

Lower 22011 on medicinal products with no additional benefit means that the probability of additional contributions and contribution increases falls. It is only for those medicinal products that pharmaceutical companies can expect to receive an adequate refund rate in future. The Federal Joint Committee defines the expedient comparative therapy according to transparent procedural criteria.

There needs to be an explanation of the roles of secondary endpoints in interpreting trial results. We highlight three key changes in the proposal that all pharmaceutical manufacturers should be monitoring to prepare for successful launches in Germany: It is not an exception for a funding organisation to carry out remuneration negotiations on the object of the evaluations subsequently to the evaluation by the Federal Joint Committee, such as the National Association of Statutory Health Insurance Funds with the pharmaceutical company on medicinal products in the case of new active ingredients.

The methods, based on the work of Buyse and Piedbois, Lassereand Buyse et al. The refund rate for such medicinal products may not be higher than the cost of the expedient amnlg group with which the new medicinal product was compared.

The further procedure depends on this decision and can, in simple terms, take two directions. Suitable, in other words fair, means for us that the prices of the new medicinal products are orientated towards the additional benefit for patients, and not towards the wishes of the companies.


For the first time, pharmaceutical companies are obliged to submit a dossier on product benefit when a new product is launched on the German market or authorized for new indications. Questions and answers What is meant by AMNOG, and how is it to help improve the regulation of medicinal product prices?

By submitting our proposals, we are also inviting other statisticians who design and analyze clinical trials to join us in developing solutions to minimize the impact of the identified differences. Do the refund rate negotiations constitute negotiations on price? The negotiated price becomes effective 12 months after the Benefit Dossier submission or product launch.

When presented with the same data, IQWiG may conclude that additional benefit could not be proven. Here you will find: PDF accessed 3 June For example, the benefit of cabazitaxel on mortality in patients with advanced prostate cancer was initially judged to be considerable.

AMNOG since 2011

Instead of using ICER, the German and French decision makers for pharmaceutical product reimbursement place their primary focus on determining the clinical benefit from clinical studies. Indications or notes by themselves are therefore fundamentally unsuited to prove a therapeutic improvement. The approach has been criticized by some researchers e. This resolution is published without delay, and includes the G-BA’s decision on the pricing procedure for the new medicine.

All resolutions that are adopted, including the summary scientific and legal evaluation, the discussions, as well as the debate with the arguments put forward in the statement procedure, are retrievable on the Internet site of the Federal Joint Committee.

This change will influence the treatment choices available to the physician and patient.

Implementation of AMNOG: An industry perspective

The sales prices communicated in the 15 countries are weighted according to their respective turnover and purchasing power using purchasing power parity.

Focusing on the first phase, this paper investigates requirements of benefit assessment of a new product under this law with special attention on the methods applied by the German authorities on issues such as the choice of the comparator, patient relevant endpoints, subgroup analyses, extent of benefit, 201 of net benefit, primary and secondary endpoints, and uncertainty of the additional benefit.

A cost-benefit evaluation can be carried out section 35b of Book V of the Social Code. For companies in Germany, planning for extensive subgroup analysis will become essential to be prepared for contingencies with amnoy reimbursement.


Biometrical Journal this issue. 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. If turnover is higher, the pharmaceutical companies need to prove an additional benefit for such orphan drugs too.

Guide to methods of technology appraisal This criterion applies to price negotiations only. Verfahrensordnung des Gemeinsamen Bundesausschusses; 5. The maximum period is three years.

– AMNOG since

The fixed rate is a maximum refund up to which the statutory health funds assume the costs of specific medicinal products prescribed by physicians. Please send any general questions regarding benefit ajnog to the following email address. A consultation before the start of phase 3 authorization studies must involve the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute. If there are several indications, several comparative therapies may also be defined.

Support Center Support Center. Different questions are relevant within the framework of early benefit assessment. For high correlation, IQWiG requires the lower bound of the confidence interval for the correlation coefficient to be greater than 0. This resolution of the Federal Joint Committee is published.

Lack of data could also result in downgrading. Prior to this, the companies in question may make a statement in a written and oral statement procedure. When conducting benefit assessments, we prefer following prespecified rules to protect the integrity of the statistical inference. There is no obligation for the pharmaceutical companies to reduce their price to the fixed rate. The G-BA is responsible for the overall procedure of early benefit assessment and the pharmaceutical companies submit their dossiers to the G-BA.

Patient representatives take part in the amngo in an advisory capacity. AMNOG – evaluation of new pharmaceutical.

Validity of surrogate endpoints in oncology Version 1. 211 in most European countries, amnig health insurance previously had to accept any price that was demanded for new products, regardless of whether or not the active ingredient was a gain for patients.