Source: http://journal.emwa.org/health-economics-and-market-access/early-benefit-assessment-of-new-drugs-in-germany-framework-for-submission-of-dossiers-by-pharmaceutical-companies/
Timestamp: 2017-11-22 04:01:32+00:00

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Medical Writing | Health Economics and Market Access | Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies
Medical Writing Health Economics and Market Access Early benefit assessment of new drugs in Germany: Framework for submission of dossiers by pharmaceutical companies
Authors: Natalie McGauran, Michael Köhler
For the early benefit assessment of new drugs in Germany, medical writers are involved in the preparation of dossiers submitted by pharmaceutical companies to the main decision-making body of the German statutory healthcare system, the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). These dossiers are generally assessed by the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). The present article summarises the documents that are publicly available to guide dossier preparation and to ensure transparency. These documents detail the requirements for the structure and content of the dossier, procedures for dossier submission, assessment by IQWiG, and decision-making by the G-BA. Medical writers should adhere closely to the available guidance to help ensure that the submitted dossiers fulfil the formal and content requirements.
Keywords: Medical writing, new drugs, early benefit assessment, Dossier assessment, (German) Act on the Reform of the Market for Medicinal Products
Kleijnen S, Goettsch W, D'Andon A, Vitre P, George E, Goulden S, et al. EUnetHTA JA WP5: relative effectiveness assessment (REA) of pharmaceuticals. [Updated 2011 Jul; cited 2013 May 15]. Available from: http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Final%20version%20of%20Background%20Review%20on%20Relative%20Effectiveness%20Assessment+appendix.pdf
Henschke C, Sundmacher L, Busse R. Structural changes in the German pharmaceutical market: price setting mechanisms based on the early benefit evaluation. Health Policy 2013;109(3):263–9.
Bundesministerium für Gesundheit [Federal Ministry of Health]. The Act on the Reform of the Market for Medicinal Products (Gesetz zur Neuordnung des Arzneimittelmarktes – AMNOG). [Updated 2012 Aug 29; cited 2013 May 15]. Available from: http://www.bmg.bund.de/ministerium/english-version/amnog.html
SGB V Sozialgesetzbuch: gesetzliche Krankenversicherung; § 35a SGB V; Bewertung des Nutzens von Arzneimitteln mit neuen Wirkstoffen [SGB V Social Code Book: statutory health insurance; § 35a SGB V; assessment of the benefit of pharmaceuticals with new active ingredients]. [Updated 2013 Feb 20; cited 2013 May 15]. Available from: http://www.sozialgesetzbuch-sgb.de/sgbv/35a.html
Bundesministerium für Gesundheit [Federal Ministry of Health]. Verordnung über die Nutzenbewertung von Arzneimitteln nach § 35a Absatz 1 SGB V für Erstattungsvereinbarungen nach § 130b SGB V (Arzneimittel-Nutzenbewertungsverordnung – AM-NutzenV), [Ordinance on the Benefit Assessment of Pharmaceuticals acc. to § 35a (1) Social Code Book V for reimbursement agreements acc. to § 130b Social Code Book V]. Bundesgesetzblatt [Federal Law Gazette]. Teil 2010; 1(68):2324–8.
Gemeinsamer Bundesausschuss [Federal Joint Committee]. The Federal Joint Committee. [Cited 2013 May 15] Available from: http://www.english.g-ba.de/
Institute for Quality and Efficiency in Health Care. Responsibilities and objectives of IQWiG. [Cited 2013 Apr 25]. Available from: https://www.iqwig.de/en/about_us/responsibilities_and_objectives_of_iqwig.2946.html
Rüdig C, Staeck K, Reken S, Minarzyk A, Köhler M, Wieseler B. Verfügbarkeit und Transparenz von Ergebnissen früher HTA-Bewertungen von Arzneimitteln [Availability and transparency of results of early HTA assessments of drugs]. In: Entscheiden trotz Unsicherheit: 14. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin; 15.-16.03.2013; Berlin Deutschland [In: Decision-making despite uncertainty: 14. Annual Meeting of the German Network for Evidence-based Medicine]. [Updated 2013 Mar 11; cited 2013 May 25] Available from: http://www.egms.de/static/de/meetings/ebm2013/13ebm071.shtml
Gemeinsamer Bundesausschuss [Federal Joint Committee]. The benefit assessment of pharmaceuticals in accordance with the German Social Code, Book Five (SGB V), section 35a. [Cited 2013 May 15]. Available from: http://www.english.g-ba.de/benefitassessment/information/
Gemeinsamer Bundesausschuss [Federal Joint Committee]. Questions and answers about the procedure: the special case of orphan drugs; are orphan drugs exempt from early assessment? [Cited 2013 May 15] Available from: http://www.english.g-ba.de/benefitassessment/information/faq/#3
Gemeinsamer Bundesausschuss [Federal Joint Committee]. Verfahrensordnung des Gemeinsamen Bundesausschusses [Rules of Procedure of the Federal Joint Committee]. [Updated 2012 Dec 06; cited 2013 May 15]. Available from: http://www.g-ba.de/downloads/62%E2%80%93492-667/VerfO_2012-12-06.pdf
Institute for Quality and Efficiency in Health Care. General methods: version 4.0. [Updated 2011 Sep 23; cited 2013 May 15]. Available from: https://www.iqwig.de/download/General_Methods_4-0.pdf
Institute for Quality and Efficiency in Health Care. Ticagrelor: benefit assessment according to § 35a Social Code Book V; extract. [Updated 2011 Sep 29; cited 2013 May 15]. Available from: https://www.iqwig.de/download/A11-02_Extract_of_dossier_assessment_Ticagrelor.pdf
Biomarkers Definitions Working Group. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Clin Pharmacol Ther 2001;69(3):89–95.
Gemeinsamer Bundesausschuss [Federal Joint Committee]. Erstellung und Einreichung eines Dossiers zur Nutzenbewertung gemäß § 35a SGB V: Format und Gliederung des Dossiers, einzureichende Unterlagen, Vorgaben für technische Standards [Preparation and submission of a dossier for benefit assessment pursuant to §35a Social Code Book V: format and structure of the dossier, documents to be submitted, requirements for technical standards]. [Updated 2011 Nov 20; cited 2013 May 15]. Available from: http://www.g-ba.de/downloads/17-98-2988/II-1_Erstellung-Einreichung-Dossier.pdf
Gemeinsamer Bundesausschuss [Federal Joint Committee]. Anlagen zum 5. Kapitel der Verfahrensordnung: Formulare und Vorgaben zum Download [Appendices for Chapter 5 of the Rules of Procedure: forms and requirements for downloading]. [Updated 2012 Apr 26; cited 2013 May 05] Available from: http://www.g-ba.de/institution/themenschwerpunkte/arzneimittel/nutzenbewertung35a/anlagen/
Gemeinsamer Bundesausschuss [Federal Joint Committee]. Dossier zur Nutzenbewertung gemäß § 35a SGB V: Modul 1 Anhang; Checkliste zur Prüfung der formalen Vollständigkeit des Dossiers; Dokumentvorlage; Version vom 20.01.2011 [Dossier for benefit assessment pursuant to § 35a Social Code Book V: Module 1 Addendum; Checklist for assessment of formal completeness of dossier; document template; Version of 20.01.2011]. [Updated 2011 Jan 20; cited 2013 May 15]. Available from: http://www.g-ba.de/downloads/17-98-2992/II-3_Dossier_Anhang-Modul1_Checkliste.pdf
Nink K, Hörn H, Pieper K, YB B. Ein Jahr frühe Nutzenbewertung: das IQWiG zieht Bilanz [One year of early benefit assessment: IQWIG takes stock]. GGW 2012;12(4):18–24.
Gemeinsamer Bundesausschuss [Federal Joint Committee]. G-BA veranlasst Nutzenbewertung von Arzneimitteln aus dem Bestandsmarkt [G-BA initiates benefit assessment of pharmaceuticals from the existing market]. [Updated 2012 Jun 07; cited 2013 May 15] Available from: http://www.g-ba.de/institution/presse/pressemitteilungen/439/#footer
Institute for Quality and Efficiency in Health Care. First assessment of the established drug market: advantage for sitagliptin. [Updated 2013 July 01; cited 2013 July 22]. Available from: https://www.iqwig.de/en/press/press_releases/press_releases/first_assessment_of_the_established_drug_market_advantage_for_sitagliptin.3671.html
Gemeinsamer Bundesausschuss [Federal Joint Committee]. G-BA legt Kriterien für Bestandsmarktaufruf fest und bestimmt erste Wirkstoffgruppen für die Nutzenbewertung [G-BA specifies criteria for call-up for existing market and specifies groups of drugs for benefit assessment]. [Updated 2013 May 10; cited 2013 May 15]. Available from: http://www.g-ba.de/institution/presse/pressemitteilungen/485/

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