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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For the cost-benefit evaluation, the Federal Joint Committee may agree with manog pharmaceutical company on a period for submission of substantiating studies, which should preferably be carried out in Germany. The pharmaceutical company must send these documents, including all clinical trials it has commissioned or carried out, to the G-BA in electronic form no later than the day the pharmaceutical is first brought into circulation.

Amnogg English translations are courtesy translations only. European Journal of Cancer 45— The fixed rate is a maximum refund up to which the statutory health funds assume the costs of specific medicinal products prescribed by physicians.

If the G-BA decides that the new pharmaceutical does not have any additional benefit over the appropriate comparator preferably a therapy for which endpoint studies are available and which has proved beneficial in practical useit will be included in the reference price system within six months of market launch. Until the AMNOG procedure has been completed, that is in the first twelve months, the price set by the pharmaceutical company itself applies to the medicinal product, if it is the first time that an active ingredient has been placed on the market.

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.

For the first time, the AMNOG seriously tackles the price monopoly of the pharmaceutical industry in Germany with this central arrangement. 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.

Implementation of AMNOG: An industry perspective

However, due to the brief processing period of 3 months, the involvement of patients is not easy. In the third year of early benefit assessments IQWiG determined the highest category of benefit for the first time, and in several cases. 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.

The quality of the studies and amngo included in the Benefit Dossier needs to be described. General Methods Version 4. It would be an exaggeration to portray this withdrawal of the pharmaceutical companies as a risk that Germany might no longer be supplied with modern medicinal products. When it comes to approval, however, only amnkg, quality and safety are examined and the market launch is regulated by weighing up benefits and risks.


If the cost of treatment exceeds a yearly turnover limit of 50 million euros in statutory health insurance, then the orphan drug is subject to the regular procedure of early benefit amhog.

Here you will find:. However, the latter is typically amngo in the context of the disease population and the overall evidence instead of applying a prespecified set of thresholds to all situations. Composite endpoints that have been traditionally used as the primary endpoints in many large registration trials can now be questioned by IQWiG.

Until the AMNOG procedure has been completed, the price set by the pharmaceutical company itself applies to the new pharmaceutical for one year. Within this period, firstly, the Federal Joint Committee adopts a resolution on the additional benefit of a new medicinal product, having carried out its evaluation.

Ammog criterion applies to price negotiations only.

AMNOG since 2011

The pharmaceutical company reports both it and the refund rate to the price reporting agency. If the additional benefit is less than that of the expedient comparative therapy, the National Association of Statutory Health Insurance Funds stipulates a deduction. Consultation fees in accordance with SGB V, section 35a back to top Questions and answers on the procedure Questions on the scope of application Questions on the special case of orphan drugs Questions on appropriate comparators Questions on compiling dossiers Questions on documents in module 5 of the dossier Questions on submitting dossiers Questions on hearing procedures Questions on the handling of confidential documents Questions on the revisability of G-BA decisions Questions on price negotiations with statutory health insurance providers back to top.

With the Fourteenth Act Amending Book Five of the Social Code, the legislature provided that in addition to the Association of Private Health Insurance, which in accordance with section b of Book Five of the Social Code is involved in the negotiations on the refund rate as a guest, a representative of each health insurance fund attends the negotiations. After publication of the report, the G-BA conducts a commenting procedure.

This resolution of the Federal Joint Committee is published. Subgroup analyses are conducted to explore, rather than confirm, the uniformity of an observed overall treatment effect.

We have proposed some possible alternatives in Section 2. If the new product is deemed to have no additional 22011, it will go into a fixed reference price group. This applies to every newly approved drug from 1 January This will be taken into consideration during price negotiations. The new medicinal product must take this as its benchmark.


For example, the benefit of cabazitaxel on mortality in patients with advanced prostate cancer was initially judged to amnoy considerable. The methods, based on the work of Buyse and Piedbois, Lassereand Buyse et al.

Please use two envelopes and note the following on the inside envelope containing the cover letter and CD or DVD: The arbitration body is composed of three non-partisan representatives and two representatives each of both negotiation partners. For electronic transmission, the dossier must be sent to the Federal Joint Committee as a CD or DVD, and include a cover letter signed by an authorized person including authorization, if applicable.

Each step of the benefit assessment is described in the chapter 5 of the G-BA rules of procedure in detail.

IQWiG has been dealing with this question since In particular it contains statements on the extent of additional benefit, patient groups eligible for treatment, requirements for quality-assured administration, and the cost of treatment with the pharmaceutical.

In Octoberone year after publication of the first early benefit assessment, IQWiG staff members published an analysis of the dossier assessments completed up to the end of June Patients and contributors of the statutory and private health insurance ajnog certainly benefit. The AMNOG provides for the benefit assessment of reimbursable pharmaceuticals with new active ingredients based on proof provided by the pharmaceutical company.

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Implementation of AMNOG: An industry perspective

After the resolution of the Federal Joint Committee, negotiations on a refund rate for medicinal products with an additional benefit for patient care are taken up between the National Association of Statutory Health Insurance Funds and the pharmaceutical company negotiations in accordance with section b of Book Five of the German Social Code [SGB V]. Aamnog advantage of this approach is that, even with a lower confidence level, the point estimate for the additional benefit still needs to be of a certain magnitude for the confidence interval to meet the efficacy requirements.

If a treatment effect is found to be statistically amngo at the prespecified significance level, the treatment is said to be efficacious. 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, determination of net benefit, primary and secondary endpoints, and uncertainty of the additional benefit.

The staff office is closed from 24 December to 1 January The process consists of two phases.