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:
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 9 December 2021. Currently, consultations take place via video conference until further notice.
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:
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 .
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 9 December 2021.
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.
European consultations: G-BA acts as coordination contact for parallel consultations by EMA and HTA agencies in Europe in the interim period until the full implementation of the EU HTA Regulation
With the help of Health Technology Assessment (HTA), the added value of new health technologies for patients can be evaluated in comparison to the current standard therapy. The EU HTA Regulation regulates the future assessment of the clinical study situation of new medicinal products and medical devices at European level. This is published in so-called EU-HTA reports (Joint Clinical Assessments, JCA) and is to be given due consideration by the EU Member States in their country-specific decisions on additional benefits and reimbursement. The application of the EU HTA Regulation will start in January 2025 with EU HTA reports on new cancer medicines and advanced therapies (ATMPs).
A prerequisite for a meaningful EU HTA report is the generation of robust data within the framework of the pivotal studies, which are supposed to answer questions from both the marketing authorisation and the HTA side. One possibility for an early exchange between manufacturers, the European Medicines Agency (EMA) and HTA authorities is offered by the European consultations (Joint Scientific Consultations, JSC). From September 2023, up to and including the end of 2024 (before the full application of the EU HTA Regulation), health technology developers can obtain scientific advice from the national HTA agencies and the EMA in a parallel procedure. The G-BA acts as the central HTA coordination contact: it coordinates all incoming requests for parallel scientific advice and facilitates the procedure with the national HTA agencies. This parallel scientific advice (so-called "Parallel EMA/HTA body (HTAb) Scientific Advice") can be requested by the manufacturers via the G-BA as a transitional model until the application of the EU HTA Regulation.
Go directly to the application documents
From September 2023: Transition phase from EUnetHTA 21 to the EU HTA Regulation
The EU HTA Regulation is the basis for the future cooperation of the national HTA agencies of the EU Member States and the European Economic Area (EEA). The implementation is being prepared by the EUnetHTA 21 consortium until September 2023: 13 EUnetHTA 21 member organisations are developing the methodological and procedural basis and documents for joint work under the EU HTA Regulation. The G-BA and the Institute for Quality and Efficiency in Health Care (IQWiG) are represented for Germany.
The implementation and shaping of the EU HTA Regulation is the responsibility of the Member state coordination group on HTA (HTACG) and its four subgroups with the support of the European Commission, which acts as the secretariat. The four subgroups, which deal with the topics of methodology and procedures, JCA (Joint Clinical Assessments), JSC (Joint Scientific Consultations) and Emerging Health Technologies, have already been installed. In the EUnetHTA 21 consortium, the G-BA is in charge of the European consultations and provides the EUnetHTA 21 JSC Secretariat. The G-BA now also chairs the newly installed JSC subgroup under the EU HTA Regulation. This reflects the commitment of the G-BA to European consultations beyond the EUnetHTA 21 project phase. IQWiG provides another German chair position within the EU HTA Regulation governance structure with the chair for the subgroup on the development of methodological and procedural guidance.
The parallel EMA/EUnetHTA 21 Joint Scientific Consultations (JSCs) under the EUnetHTA 21 service contract must be completed by the end of the contract in September 2023. In the transition period between the termination of EUnetHTA 21 and the application of the EU HTA Regulation in January 2025, the EMA and the national HTA agencies will offer an interim approach to parallel scientific consultation.
Offer of parallel scientific advice from EMA and HTA agencies ("Parallel EMA/HTA body (HTAb) Scientific Advice") in the interim period until the Application of the EU HTA Regulation
HTA agencies in Europe can participate in parallel scientific advice on a voluntary and individual basis from September 2023. The selection criteria of the EU HTA Regulation apply. The acceptance of a consultation depends on the currently available resources of the HTA agencies. At least two HTA agencies must be involved per procedure. If less than two HTA agencies are available, the scientific advice will only be provided by the EMA.
As a result of the parallel scientific advice provided by the EMA and the HTA agencies, the manufacturer receives:
an advisory document from EMA (EMA Scientific Advice Letter) and
the individual advice documents (non-consolidated) of the participating national HTA agencies.
HTA organisations also have the option to participate in the procedures as observers. HTA agencies with observer status will not provide written comments or feedback.
Health technology developers can flag their interest in a parallel scientific consultation by submitting the corresponding form to the G-BA as the central HTA coordination contact, copying EMA.
The following documents are available for the consultation procedures:
Contact email address G-BA: interimadvice.hta@g-ba.de
Contact email address EMA: scientificadvice@ema.europa.eu
Outlook: Integration of EU HTA reports into the German AMNOG procedure
Since 1 January 2011, the G-BA has had the legal task of carrying out an (additional) benefit assessment for all newly authorised medicinal products with new active substances immediately after market entry (§ 35a SGB V). The assessment examines whether the new medicinal product has advantages over the previous standard therapy (the so-called appropriate comparative therapy). The G-BA received the mandate to assess the additional benefit through the Act on the Reorganisation of the Pharmaceutical Market (AMNOG), therefore the benefit assessments are also referred to as AMNOG procedures. The result of the benefit assessment is the basis for deciding how much the statutory health insurance funds in Germany will pay for a new medicinal product with a new active substance. The reimbursement amount applies retroactively (since the GKV Financial Stabilisation Act came into force in November 2022) from the seventh month after market entry. In the first six months after market entry of a medicinal product, the price set by the manufacturer applies.
Once the EU HTA reports are available, these joint clinical evaluations at the European level must be included in the early benefit assessment procedure of the G-BA. The exact structuring of the national process is to be discussed and agreed in the near future, as soon as the details of the European procedure are clearly defined.
From 2025, in accordance with the EU HTA Regulation, the first EU HTA reports on cancer drugs and ATMPs will be prepared in parallel with the marketing authorisation application for these new medicinal products, followed by EU HTA reports on orphan drugs in 2028 and all other new medicinal products from 2030. The regulation does not specify any deadlines for the evaluation of medical devices.