Translation of "Nutzenbewertung" in English

How does the early assessment of pharmaceuticals work under the AMNOG law?

This is the decision-making body in the field of early benefit assessment.

In addition, a junior symposium and a symposium will be held on the benefit evaluation of drugs.

The studies listed in the following table were included in the benefit assessment.

The medicinal products subcommittee deals with the early benefit assessment.

Table 3 and Table 4 describe the studies used for the benefit assessment.

2The benefit assessment is conducted on the basis of the dossier.

One aspect of the Act is the early benefit assessment, which will be explained in greater detail below.

In Germany every medicinal product that newly comes onto the market goes through a so-called benefit assessment procedure.

The early benefit assessment in the context of AMNOG has consequences for all stakeholders within the healthcare system.

The benefit evaluation is based on verifications by the pharmaceutical companies which then forward these data to the G-BA.

However, the CHMP considered that the particular context of anthrax (i. e. bioterrorism) required deviation from the usual requirement of clinical data and the benefit assessment.

It should be noted that it is not necessary to include the least certain elements of the benefit evaluation – in particular those related to mortality – in order to justify the costs of the proposed amendment for the same ten-year period (ECU 800 million for boilers and ECU 1 200 million for gas turbines).

A more robust benefit assessment would require more analysis and data on the extent and severity of health effects of CO.

On the other hand it draws up a cost-benefit assessment in the event of an unsuccessful arbitration award (the complete early benefit assessment procedure is discussed in detail in section 2.6).

Reinhard Rychlik of the Institut für empirische Gesundheitsökonomie (Institute for Empiric Health Economy), Burscheid, lectured about benefit assessment of pharmaceuticals in Germany and the EC.

To ease understanding, the two bodies involved - the G-BA and the IQWiG – will first be presented and the structure and content of the dossier underlying an early benefit assessment clarified.

The benefit assessments cover a broad range of parameters organized around five central themes: air, waste, water, nature and biodiversity, as well as climate change as a cross-cutting theme.

In the future, manufacturers of drugs can no longer necessarily choose the cheapest comparative therapy for the benefit assessment of their candidates, but can also use other comparative therapies that are possibly more expensive but scientifically more suitable. This also assumes that the Federal Joint Committee (G-BA) agrees in principle to multiple comparison therapies.

Do you need help with the preparation of drug approval documents or the translation of medical documents such as early benefit assessments?

His research areas are computational operations research, economic value of information systems and economics of information security.

The Cologne researchers examined whether the total statement in March 2006 of the locked use evaluation changes, if one includes additionally recent clinical comparisons.

Rising expenditure, the search for synergies in benefit assessments and the development of treatments for rare diseases are recurrent challenges for the social security systems when it comes to pharmaceuticals.

3The benefit assessment also includes a summary of the main information as an assessment of the information in the dossier according to s. 9 para.

Under the AMNOG, the IQWiG is assigned two new tasks: on the one hand, it assesses the dossier of the pharmaceutical manufacturer and draws up a benefit assessment on this basis.

That being said, "the Federal Joint Committee can order a benefit assessment even for medicinal products already authorised before the 1st of January 2011 and placed on the market (so-called existing market)" (German Parliament, 2013).

The larger and smaller Member States are at odds over fundamentally crucial political provisions, such as the question of the binding nature of a Europe-wide benefit assessment.

Thus, for our scientific papers, we face the opportunity to become connected with governmental representatives whom we can ask about our scientific questions regarding the required added value or other uncertainties before we hand in the final paper.