The benefit assessment of medicinal products in accordance with the German Social Code, Book Five (SGB V), section 35a

This page compiles information on the benefit assessment of medicinal products in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG).

The benefit assessment of medicinal products in accordance with the German Social Code, Book Five (SGB V), section 35a

The German parliament passed the Act on the Reform of the Market for Medicinal Products (AMNOG) on 11 November 2010. It completely revises pricing regulations for newly authorized medicinal products and their reimbursement by statutory health insurance providers.

It also assigns a key responsibility to the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Health Care (IQWiG): that of conducting benefit assessments of newly authorized medicinal products in accordance with SGB V, section 35a. Since 2011, their findings form the basis of decisions on the prices statutory health insurance providers pay for new medicinal products with new active ingredients.

This law went into effect on 1 January 2011. 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.

The responsibilities of the G-BA following AMNOG

Within three months of market authorization of a new medicinal product, the G-BA assesses recognition of any additional benefit claimed over the appropriate comparator. For this purpose, the company submits a dossier to the G-BA based on the authorization documents and all studies carried out on this medicinal product. The dossier must prove an additional benefit of the medicinal product over the appropriate comparator specified by the G-BA. The G-BA can delegate the benefit assessment to the Institute for Quality and Efficiency in Health Care (IQWiG) or third parties.

The result of the benefit assessment is published on the internet, and pharmaceutical companies, federations, and experts are given the opportunity to submit written and verbal statements on the result.

After another three months, the G-BA passes a resolution based on the benefit assessment and the hearings. 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 medicinal product. This resolution is published without delay, and includes the G-BA's decision on the pricing procedure for the new medicine. Within six months, if additional benefit is proved, the Central Federal Association of Health Insurance Funds and the pharmaceutical company negotiate the reimbursement price paid by the statutory health insurance funds. This takes the form of a rebate on the retail price originally set by the company. If no agreement is reached, an arbitration board determines the reimbursement price using European pricing levels as its standard.

If the G-BA decides that the new medicinal product 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 use), it will be included in the reference price system within six months of market launch. If a medicinal product without additional benefit cannot be allocated to a reference price group, a reimbursement price will also be agreed on. The annual treatment costs must not exceed those of the appropriate comparator.

The Ordinance on the Benefit Assessment of Medicinal Products (AM-NutzenV)

Lawmakers have regulated details on the benefit assessment in the Ordinance for the Benefit Assessment of Medicinal Products (AM-NutzenV), which also went into effect on 1 January 2011. Based on this ordinance, the G-BA has supplemented its rules of procedure to set forth the details on the benefit assessment procedure in accordance with SGB V, section 35a.

Supplement to the G-BA rules of procedure

A supplementary chapter was added to the G-BA rules of procedure in the G-BA resolution dated 20 January 2011. It supplements the various AMNOG stipulations and its accompanying legal regulations, and summarizes them into a uniform set of rules.

A new fifth chapter was added to the rules of procedure. In four sections, it defines in detail the steps of the benefit assessment. It includes three appendices: a consultation request form (Appendix I) , specifications on the format and structure of dossiers and documents submitted (Appendix II), and a submission form for a written hearing on the benefit assessment (Appendix III). This supplement to the rules of procedure went into effect on 22 January 2011.

Further information for pharmaceutical companies

Dossier submission in accordance with SGB V, section 35a

The AMNOG provides for the benefit assessment of reimbursable medicinal products with new active ingredients based on proof provided by the pharmaceutical company. This also applies to newly authorized indications of these medicinal products.

Each step of the benefit assessment is described in the chapter 5 of the G-BA rules of procedure in detail. Appendix II is of particular importance to pharmaceutical companies. It describes clearly the standards for proof of additional benefit, for determining the appropriate comparator, and for the dossier submitted by the pharmaceutical company. Pharmaceutical companies may submit the dossier to the G-BA in advance for the purpose of a check for formal completeness without regard todata contents. Where necessary, the G-BA will then give comments in writing to the company which additional documents or information is required.

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 medicinal product is first brought into circulation.

For electronic transmission, the dossier must be preferentially submitted via AMNOG portal.

Please always ensure to use the latest version of the dossier templates for each module. For the latest templates, please refer to: Formulare und Vorgaben zum Download – Anlagen zum 5. Kapitel der Verfahrensordnung. A dossier must be accompanied by a cover letter signed by an authorized person (including authorization, if applicable).

The submission should ideally be accompanied by a cover letter electronically signed by an authorized person using a qualified electronic signature. Once the documents have been successfully uploaded and transferred, you will receive a confirmation of receipt (upload protocol).

Alternatively documents can be submitted as a CD or DVD, and include a cover letter signed by an authorized person (including authorization, if applicable). In this alternative case, please use two envelopes and note the following on the inside envelope containing the cover letter and CD or DVD:
Note: Dossier submission. Do not open.

Please use the following address on the outside envelope:

Gemeinsamer Bundesausschuss
The Federal Joint Committee
Gutenbergstraße 13
10587 Berlin

Email for further questions

Please send any general questions regarding benefit assessments to the following email address. You will receive a prompt reply:

nutzenbewertung35a@g-ba.de

Request for consultation in accordance with SGB V, section 35a

Pharmaceutical companies can request consultation by the G-BA on documents and studies to be submitted and on the appropriate comparator (SGB V, section 35a, paragraph 7). A consultation prior to the start of phase 3 authorization studies should involve the Federal Institute for Drugs and Medical Devices or the Paul Ehrlich Institute. Further information on the involvement of the Federal Institute for Drugs and Medical Devices and the Paul Ehrlich Institute in the consultation is summarized in a guideline Leitfaden(pdf 433,74 kB). The pharmaceutical company must pay the costs of the consultation in accordance with the schedule of fees effective 22 January 2011.

Current information related to the risk assessment on COVID-19 by Robert-Koch-Institute:

Due to the urgent need for infection control measures, the capacities of The Federal Joint Committee´s office are unfortunately limited at present.
The office is making every effort to process requests for consultation in a timely manner and to keep the agreed consultation appointments. However, until further notice, consultations will take place exclusively via video conference. We kindly ask for your understanding.

Pharmaceutical companies that would like to request a consultation on documents and studies to be submitted and on the appropriate comparator are asked to submit their request using the form provided (VerfO, chapter 5, appendix I). The forms including the documents to be attached should preferentially be submitted to the G-BA electronically using the AMNOG portal platform for upload.  The documents must be accompanied by a cover letter signed by an authorized person (including authorization, if applicable). The submission cover letter should ideally be accompanied by a cover letter electronically signed by an authorized person using a qualified electronic signature. Once the documents have been successfully uploaded and transferred, you will receive a confirmation of receipt (upload protocol).

Alternatively documents can be submitted as a CD or DVD, along with a cover letter signed by an authorized person (including authorization, if applicable) and addressed to the Federal Joint Committee:

In this alternative case, please use two envelopes and note the following on the inside envelope containing the cover letter and CD or DVD:
Note: Request for consultation. Do not open.

Please use the following address on the outside envelope:

Gemeinsamer Bundesausschuss
The Federal Joint Committee
Gutenbergstraße 13
10587 Berlin

Pharmaceutical companies can send any questions they may have regarding the G-BA consultation procedure to the following email address:

beratung35a@g-ba.de

For a reliable planning of a consultation, you can find a table below showing the timeline for consultations. After the application documents have been received by the G-BA either via the AMNOG portal or by mail, the documents will be reviewed. In case of missing documents, the pharmaceutical company will be notified so that the missing documents can be submitted subsequently. Once the submission is complete, the consultation procedure will be started. The start of the procedure as well as the calendar week (KW) in which the consultation will take place is shown in the timeline table below.

Furthermore, pharmaceutical companies are asked to pre-register for selected consultation appointments by providing information on the active ingredient itself as well as the planned indication (including details such as therapy line). For a pre-announcement of consultations, the following e-mail address is to be used: beratung35a@g-ba.de .

timeline table

The costs of a consultation by the G-BA have to be paid by the pharmaceutical company. A corresponding fee schedule entered into force on 22 January 2011.

For a consultation request the Federal Joint Committee provides a form(doc 49,92 kB) to be used; please note that this form is available in German only. For consultations dealing with study design an additional form comprising a study synopsis has to be submitted using the provided template(doc 21,64 kB) either in German or English.