{"id":7098,"date":"2025-06-02T21:13:05","date_gmt":"2025-06-02T19:13:05","guid":{"rendered":"https:\/\/value-dossier.com\/german-benefit-assessment-amnog\/"},"modified":"2026-04-14T13:52:21","modified_gmt":"2026-04-14T11:52:21","slug":"german-benefit-assessment-amnog","status":"publish","type":"page","link":"https:\/\/value-dossier.com\/en\/german-benefit-assessment-amnog\/","title":{"rendered":"German Benefit Assessment (AMNOG)"},"content":{"rendered":"\n<section class=\"wrap_outer intro-alternative no-spacing\">\n    <div class=\"wrap_inner\">\n\n        <div class=\"intro__text\">\n            <div class=\"okd-text\">\n                                    <div class=\"badge\">AMNOG<\/div>\n                                <h1>Early Benefit Assessment of Pharmaceuticals (AMNOG)<\/h1>\n                                    <div class=\"usps\">\n                        <ul>\n                                                            <li>Strategic consulting on benefit assessment <\/li>\n                                                            <li>Expert dossier preparation, including medical writing and statistics<\/li>\n                                                            <li>Written submissions, oral hearings, and negotiation training<\/li>\n                                                            <li>G-BA consultation requests<\/li>\n                                                    <\/ul>\n                    <\/div>\n                                                    <a class=\"button\" href=\"https:\/\/value-dossier.com\/en\/contact\/\" target=\"_self\">Get in touch<\/a>\n                            <\/div>\n        <\/div>\n\n    <\/div>\n    <div class=\"intro__visual\">\n        <div class=\"wrap_inner\">\n\n                                            <video class=\"video-js vjs-fluid\" controls preload=\"auto\" data-setup=\"{}\" poster=\"https:\/\/value-dossier.com\/wp-content\/uploads\/2025\/07\/amnog-erklaervideo-en_thumb.jpg\">\n                    <source src=\"https:\/\/value-dossier.com\/wp-content\/uploads\/2025\/07\/amnog-erklaervideo-en.mp4\" type=\"video\/mp4\">\n                    Sorry, your browser doesn&#8217;t support embedded videos.\n                <\/video>\n\n            \n        <\/div>\n    <\/div>\n<\/section>\n\n\n\n\n<section class=\"wrap_outer textblock\">\n    <div class=\"wrap_inner\">\n\n        <div class=\"okd-text\">\n            <h2>The AMNOG process<\/h2>\n<div id=\"attachment_7928\" style=\"width: 220px\" class=\"wp-caption alignnone\"><a href=\"https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/04\/amnog_process_EN.svg\"><img loading=\"lazy\" decoding=\"async\" aria-describedby=\"caption-attachment-7928\" class=\"wp-image-7928 size-full\" src=\"https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/04\/amnog_process_EN.svg\" alt=\"\" width=\"210\" height=\"150\" \/><\/a><p id=\"caption-attachment-7928\" class=\"wp-caption-text\">Figure 1: Phases and Milestones of the AMNOG Process<\/p><\/div>\n        <\/div>\n\n    <\/div>\n<\/section>\n\n\n<section class=\"wrap_outer textblock\">\n    <div class=\"wrap_inner\">\n\n        <div class=\"okd-text\">\n            <h2>AMNOG: Benefit Assessment and Strategic Support<\/h2>\n<p>In Germany, innovative pharmaceuticals can be marketed at a freely determined manufacturer price for a period of six months after market entry. The early benefit assessment under the Pharmaceutical Market Restructuring Act (AMNOG, Section 35a SGB V) and the subsequent price negotiations for reimbursement amounts under Section 130b SGB V are the key mechanisms for pricing innovative pharmaceuticals in Germany.<br \/>\nIf additional indications are approved for an innovative drug, separate benefit assessments and price negotiations must also be conducted for these indications.<\/p>\n<p>Pharmaceutical companies are required to submit a benefit dossier to the Joint Federal Committee (G-BA) on the day of market entry in Germany. Based on this dossier, the G-BA determines whether there is an additional benefit compared to the appropriate comparator therapy (ACT).<br \/>\nThe determination of the ACT by the G-BA is a critical component in preparing the benefit dossier. Therefore,<a href=\"https:\/\/value-dossier.com\/en\/hearing-and-negotiation-training\/\"> early consultation with the G-BA<\/a> is an essential step in the strategic preparation of the dossier.<\/p>\n<p>The early benefit assessment is conducted by the Institute for Quality and Efficiency in Health Care (IQWiG) on behalf of the G-BA. Benefit and additional benefit are evaluated based on patient-relevant endpoints in accordance with Section 2(3) of the AM-NutzenV, covering the dimensions mortality, morbidity, quality of life, and adverse events, and based on the principles of evidence-based medicine.<\/p>\n<p>Randomized controlled trials (evidence level 1b) are generally required. A particular challenge arises when the ACT is not reflected in the available studies. In such cases, <a href=\"https:\/\/value-dossier.com\/en\/statistical-services\/\">indirect comparisons<\/a> may be used to enable quantification of medical benefit and additional benefit.<br \/>\nThe benefit assessment is published three months after dossier submission. Following publication, the pharmaceutical company and other eligible stakeholders have three weeks to submit written comments. In addition, an oral hearing takes place at the G-BA prior to the final decision on added benefit. The <a href=\"https:\/\/value-dossier.com\/en\/hearing-and-negotiation-training\/\">oral hearing<\/a> plays a crucial role in the outcome of the assessment.<\/p>\n<p>The final decision on the extent and probability of additional benefit is published six months after market entry\/dossier submission. The G-BA also determines the number of patients in the indication or subpopulation in Germany (prevalence and incidence), the annual treatment costs of the innovative drug compared to the ACT and specifies drugs that may be used in combination therapies.<\/p>\n<div class='ays-chart-container-google ays-chart-container-9' id='ays-chart-container69e79fb206911' data-id='69e79fb206911'><div class='ays-chart-header-container'><div class='ays-chart-charts-title ays-chart-charts-title69e79fb206911'>Benefit assessments of new drugs since 2011<\/div><div class='ays-chart-charts-description ays-chart-charts-description69e79fb206911'><\/div><\/div><div class='ays-chart-charts-main-container ays-chart-charts-main-container69e79fb206911' id=ays-chart-donut_chart69e79fb206911 data-type='donut_chart'><\/div><div class='ays-chart-actions-container'><div class='ays-chart-export-buttons' data-id='9'><button class='ays-chart-export-button-69e79fb206911' title='Download as a PNG' data-type='image' value='image'>Image<\/button><div style='display:none'><iframe src='' style='width:100%;height:600px;'><\/iframe><\/div><\/div><\/div><\/div>\n<p>Figure 2: Benefit assessments of new drugs by the G-BA since the start of the AMNOG, as of March 27, 2026.<\/p>\n<p>&nbsp;<\/p>\n<p>The outcome of the benefit assessment is a key factor in the subsequent <a href=\"https:\/\/value-dossier.com\/en\/hearing-and-negotiation-training\/\">negotiations<\/a> of the reimbursement amount with the National Association of Statutory Health Insurance Funds (GKV-SV).<br \/>\nFor more information on the early benefit assessment process and dossier preparation in Germany, please feel free to contact us directly.<\/p>\n<h3>EU-HTA (Joint Clinical Assessment)<\/h3>\n<p>With the introduction of <a href=\"https:\/\/value-dossier.com\/en\/european-health-technology-assessment-eu-hta\/\">EU-HTA<\/a> (Health Technology Assessment), also known as Joint Clinical Assessment (JCA), the evaluation of pharmaceuticals with new active substances and certain medical devices is shifting from the national to the EU level. This currently applies to new oncology products and ATMPs.<br \/>\nIn the JCA process, clinical data are assessed at the European level and then incorporated into national benefit assessments. However, decisions on the extent of added benefit and price negotiations remain under national authority.<br \/>\nTherefore, a well-aligned evidence strategy is becoming increasingly important to avoid discrepancies between European and national assessment frameworks.<br \/>\nFor more information on the EU-HTA process, please contact us directly.<\/p>\n<h2>Impact of Additional Benefit on Pricing<\/h2>\n<p>The objective of early benefit assessment under AMNOG is to negotiate a reimbursement amount for innovative pharmaceuticals and subsequent indications.<br \/>\nWhile the benefit assessment is conducted by IQWiG and the decision on additional benefit is made by the G-BA, price negotiations are the responsibility of the GKV-SV. Pricing is regulated under Section 130b SGB V.<br \/>\nIn principle, the reimbursement amount is based on the extent and probability of added benefit determined during the assessment. In addition to the level of added benefit, factors such as prices of the ACT and comparable pharmaceuticals also play a role.<br \/>\nSince the GKV Financial Stabilization Act (GKV-FinStG), additional factors &#8211; such as patent protection, previous benefit assessments of comparator therapies and comparable drugs, and the implementation of medical research in Germany &#8211; also have influence on pricing.<br \/>\nTo provide an initial assessment on how these complex regulations may impact reimbursement and pricing for your product, we have developed a practical guide to help navigate various AMNOG scenarios. Feel free to try it free of charge and without obligation:<\/p>\n        <\/div>\n\n    <\/div>\n<\/section>\n\n\n<section class=\"wrap_outer cta-break\">\n    <div class=\"wrap_inner\">\n\n        <div class=\"cta-break__wrapper\">\n\n                            <div class=\"badge\">AMNOG<\/div>\n            \n            <div class=\"okd-text\">\n                <h2>AMNOG negotiation guide<\/h2>\n                                    <p>Our AMNOG tool gives you a compact overview of the possible price range for your product.<\/p>\n                                                    <p>\n                        <a href=\"https:\/\/value-dossier.com\/en\/amnog-negotiation-guide\/\" target=\"_self\" class=\"button button-secondary button-calc\">Calculate<\/a>\n                    <\/p>\n                            <\/div>\n\n        <\/div>\n\n    <\/div>\n<\/section>\n\n\n<section class=\"wrap_outer textblock textblock-faq\">\n    <div class=\"wrap_inner\">\n\n        <div class=\"okd-text\">\n            <p>Special Product Groups in the AMNOG Process<\/p>\n                <details>\n                    <summary>Benefit Assessment of Orphan Drugs<\/summary>\n                    <div><p>Medicinal products for rare diseases (orphan drugs) benefit from certain privileges in benefit assessment and price negotiations:<br \/>\n\u2022 Approval alone is generally considered sufficient to demonstrate additional benefit; the assessment focuses on the extent and probability of the additional benefit<br \/>\n\u2022 No ACT is defined by the G-BA<br \/>\n\u2022 The assessment is based on clinical data submitted for marketing authorization (MAA)<br \/>\nHowever, a reassessment may be initiated if annual sales exceed \u20ac30 million within 12 calendar months. In this case, a comparison with an ACT is required, and reimbursement negotiations are revisited based on the new assessment.<\/p>\n<\/div>\n                <\/details>\n                                <details>\n                    <summary>Inpatient Sector<\/summary>\n                    <div><p>The AMNOG benefit assessment also applies to pharmaceuticals used in inpatient settings.<\/p>\n<p>While uniform pricing applies in the outpatient sector, prices in hospitals can be negotiated between pharmaceutical companies and hospitals. The launch price and subsequent reimbursement amount serve as an upper price limit due to legal regulations.<\/p>\n<p>Reimbursement in the inpatient sector follows the hospital payment system. Pharmaceuticals are reimbursed either via diagnosis-related groups (DRGs) or as a fee for new diagnostic and treatment methods (NUB).<\/p>\n<p>Hospitals must submit <a href=\"https:\/\/value-dossier.com\/en\/reimbursement-of-medical-devices\/\">NUB applications<\/a> annually (deadline: October 31) to the Institute for the Hospital Remuneration System (InEK). If approved, the new drug is reimbursed in addition to DRG payments. Decisions are typically issued by the end of January of the following year.<\/p>\n<\/div>\n                <\/details>\n                                <details>\n                    <summary>ATMPs (Advances Therapy Medicinal Products)<\/summary>\n                    <div><p>ATMPs include innovative therapies such as gene therapies, cell therapies, and tissue-engineered products. These products undergo both the European JCA process and subsequent national assessment.<\/p>\n<p>Gene and cell therapies are evaluated like other new pharmaceuticals and are subject to the same criteria. In contrast, tissue-engineered products &#8211; despite being authorized as medicinal products &#8211; are classified in Germany (for outpatient use) as new diagnostic and treatment methods under Section 135 SGB V.<\/p>\n<p>As a result, they are only reimbursable once the benefit assessment as a new method has been successfully completed. In the inpatient sector, however, they are reimbursable immediately after market entry, and NUB funding may also be applied for.<\/p>\n<p>This creates specific challenges for market access and reimbursement.<\/p>\n<p>Gene and cell therapies are particularly interesting from a market access perspective because they are often one-time treatments. This creates a temporal gap between costs and patient benefit. To address this, various models have been developed, including real-world evidence collection, installment payment models, and risk-pooling mechanisms.<\/p>\n<\/div>\n                <\/details>\n                        <\/div>\n\n    <\/div>\n<\/section>\n\n\n\n\n\n\n<section class=\"wrap_outer trust background-shift\">\n    <div class=\"wrap_inner\">\n\n                    <div class=\"tile tile-image\">\n                <img loading=\"lazy\" decoding=\"async\" width=\"2560\" height=\"1572\" src=\"https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1.jpg\" class=\"attachment-full size-full\" alt=\"\" srcset=\"https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1.jpg 2560w, https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1-300x184.jpg 300w, https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1-1024x629.jpg 1024w, https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1-768x472.jpg 768w, https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1-1536x943.jpg 1536w, https:\/\/value-dossier.com\/wp-content\/uploads\/2026\/02\/vd-team-1-2048x1258.jpg 2048w\" sizes=\"auto, (max-width: 2560px) 100vw, 2560px\" \/>            <\/div>\n        \n        \n                <div class=\"tile tile-linkedin\">\n            <span><\/span>\n            <div class=\"h3\">WS Value &#038; Dossier GmbH<\/div>\n            <a href=\"https:\/\/de.linkedin.com\/company\/value-dossier\" target=\"_blank\" rel=\"noopener nofollow\" class=\"read-more\">Follow us on LinkedIn<\/a>\n        <\/div>\n        \n        \n                    <div class=\"tile tile-quote\">\n                <p>After more than 25 years of experience in market access, we are still fascinated by the unique strategic and substantive challenges that each individual project brings. Our clients\u2019 success is what drives us and fuels our ambition. We approach every project with passion and provide high-quality analyses and customized solutions that best serve our clients\u2019 interests.<\/p>\n                <div class=\"quote-author\">\n                    <p>\n                        <strong>Dr. Willi Schnorpfeil<\/strong><br>\n                        WS Value &amp; Dossier GmbH                    <\/p>\n                <\/div>\n            <\/div>\n        \n        \n    <\/div>\n<\/section>\n\n\n<section class=\"wrap_outer outro no-spacing background-default\">\n    <div class=\"wrap_inner\">\n\n        <div class=\"outro__text\">\n            <div class=\"okd-text\">\n                <h2>Successfully navigating <strong>AMNOG<\/strong> \u2013 with clear expertise by your side<\/h2>\n<p>The AMNOG process is complex and crucial to the market success of your product. We guide you safely and purposefully through the entire process. Start the AMNOG process with us now \u2014 contact us for a no-obligation consultation!<\/p>\n            <\/div>\n            <div class=\"outro__contact\">\n                                    <a class=\"button\" href=\"https:\/\/value-dossier.com\/en\/contact\/\" target=\"_self\">Get in touch<\/a>\n                                                    <a href=\"tel:+49 6173 \/ 39 41 0 16\" class=\"button button-tertiary button-phone\">+49 6173 \/ 39 41 0 16<\/a>\n                            <\/div>\n        <\/div>\n\n    <\/div>\n<\/section>","protected":false},"excerpt":{"rendered":"","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-7098","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages\/7098","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/comments?post=7098"}],"version-history":[{"count":23,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages\/7098\/revisions"}],"predecessor-version":[{"id":7931,"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/pages\/7098\/revisions\/7931"}],"wp:attachment":[{"href":"https:\/\/value-dossier.com\/en\/wp-json\/wp\/v2\/media?parent=7098"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}