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 companies can send any questions they may have regarding the G-BA consultation procedure to the following email address:. We will continue to monitor and analyze the upcoming developments and discussions in particular with a focus on the impact on small biotech- companies and orphan drug manufacturers. Lack of data could also result in downgrading.

AMNOG since 2011

Subgroup analyses are conducted to explore, rather than confirm, the uniformity of an observed overall treatment effect. Is it really better than the treatments already on the market? An advantage of Table 3 is its transparency in that a manufacturer knows what to expect. The Federal Joint Committee defines the expedient comparative therapy according to transparent procedural criteria.

In the case of drugs for rare diseases orphan drugsthe approval of the drug is at the same time deemed to be proof of added benefit. In accordance with the principles applied by the Federal Joint Committee, the expedient comparative therapy must comply with the international standard of evidence-based medicine and be licensed in Germany.

AMNOG and the German Reforms: What Will Change? | eyeforpharma

For this purpose, the company submits a dossier to the G-BA based on the authorization documents and all studies carried out on this pharmaceutical. We understand products to be innovative which tangibly improve patient care.

The proposed legislation gives the GBA the opportunity to exclude patient sub-groups from reimbursement if the Added Benefit is not evident. In practice, primary endpoints for registration trials are selected in agreement with regulators and supported by medical experts. Involvement of patients As in all IQWiG reports, the patient perspective also plays a key role in early benefit assessments.


At federal level, the negotiated refund rate may be followed by selective contracts between individual health insurance funds or their associations, and the pharmaceutical companies.

On the rare occasions when a component of a composite endpoint is removed, we propose in Section 2. We focus on seven areas: Under the revised rules, a manufacturer could choose the comparator if several comparators are allowed. 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.

First, regulatory approvals for conditions with unmet medical needs may be based solely on single arm studies. Major criteria are improving the state of health, shortening the period qmnog illness, extending survival, reducing side-effects or improving quality of life.

For medicinal products which cannot be directly included in the fixed-rate arrangement, the National Association of Statutory Amnogg Insurance Funds then negotiates with the pharmaceutical company on a refund rate.

The implementation of AMNOG in sought to reduce drug prices and relieve the healthcare budget, yet financial pressure remains, particularly from high-priced novel agents in Hepatitis C, and Oncology.

The cost of the substantiating studies is to be met by the pharmaceutical company. If there is no manog comparative therapy with medicinal products, non-drug therapies can also be considered if they are eligible as benefits under statutory health insurance.

– AMNOG since

AMNOG itself is vague on the quantitative definition of an additional benefit. The early additional benefit evaluation is completed and published at the latest three months after the market launch of the medicinal product. Questions and answers What is meant by AMNOG, and how is it to help improve the regulation of medicinal product prices? If the upper confidence limit is greater than 0. Products are repeatedly launched with a considerable amount of marketing activity which however do not in fact deliver in everyday care what they promised.


Composite endpoints that have been traditionally used as the primary endpoints in many large registration trials can now be questioned by IQWiG. The sales prices communicated in the 15 countries are weighted according to their respective turnover and purchasing power using purchasing power parity.

In both cases, the decisions did not seem to weigh adverse reaction data in a quantitative analysis. The latter is the case if no suitable reference price group exists.

If you would like to have more information, please do not hesitate to contact us at cposchen partners4access. Since it is the standard with which a new medicinal product is compared as to its additional benefit, it is of central importance. If it is not possible for an additional benefit to be proven as a therapeutic improvement for active ingredients which are eligible for the fixed rate, the active ingredients are directly assigned to the existing fixed-rate group.

Other countries are already doing this.

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.

The decision could also depend on a patient’s disease state prior to initiating a new treatment. This applies to primary and secondary endpoints, analysis methods, and the analysis sets. New medicinal products which are comparable in pharmacological and therapeutic terms with fixed-rate medicinal products are directly evaluated here in the context of a fixed rate. After another three months, the G-BA passes a resolution based on the benefit assessment and the hearings.

New address from 1 January on: