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GENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aSEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
HTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure.ALLGEMEINE METHODEN
Allgemeine Methoden Version 6.0 vom 05.11.2020 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - ii - Präambel Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen(IQWiG) ist eine
CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice. Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs. In order to show the clinical relevance of a difference between two treatmentIQWIG IM DIALOG
Die Referate und Diskussionen beim diesjährigen IQWiG im Dialog befasste sich mit der Frage, inwieweit HTA-Entscheidungen einen konfirmatorischen Charakter haben können und inwieweit eine solche Forderung überhaupt sinnvoll sein kann. Vorträge, Abstracts und Programm. 2014: Nutzenbewertung bei Studien mit erlaubtemBehandlungswechsel.
ARZNEIMITTELBEWERTUNG: AUFGABEN DES RESSORTS Arzneimittelbewertung: Aufgaben des Ressorts. Das Ressort bewertet hauptsächlich den und Schaden von in Deutschland zugelassenen Arzneimitteln. Es vergleicht dazu Arzneimittel mit anderen medikamentösen, aber auch mit nichtmedikamentösen Maßnahmen. Diese Vergleiche sollen feststellen, welche Behandlungsalternative welcheVor- und Nachteile
RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aSEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
HTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure.ALLGEMEINE METHODEN
Allgemeine Methoden Version 6.0 vom 05.11.2020 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - ii - Präambel Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen(IQWiG) ist eine
CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice. Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs. In order to show the clinical relevance of a difference between two treatmentIQWIG IM DIALOG
Die Referate und Diskussionen beim diesjährigen IQWiG im Dialog befasste sich mit der Frage, inwieweit HTA-Entscheidungen einen konfirmatorischen Charakter haben können und inwieweit eine solche Forderung überhaupt sinnvoll sein kann. Vorträge, Abstracts und Programm. 2014: Nutzenbewertung bei Studien mit erlaubtemBehandlungswechsel.
ARZNEIMITTELBEWERTUNG: AUFGABEN DES RESSORTS Arzneimittelbewertung: Aufgaben des Ressorts. Das Ressort bewertet hauptsächlich den und Schaden von in Deutschland zugelassenen Arzneimitteln. Es vergleicht dazu Arzneimittel mit anderen medikamentösen, aber auch mit nichtmedikamentösen Maßnahmen. Diese Vergleiche sollen feststellen, welche Behandlungsalternative welcheVor- und Nachteile
JOBS | IQWIG.DE
Let us know in which of IQWiG’s departments or units you would like to work – we will provide feedback as soon as possible. Please send your application (by e-mail only) to: bewerbung@iqwig.de. As a rule, applicants are expected to have a good command of the German language. Therefore, job postings are usually available only in German. DRUG ASSESSMENT: RESPONSIBILITIES OF THE DEPARTMENT Since 2004: Head of IQWiG 's Drug Assessment Department. Responsibilities. Further development of methodological principles to evaluate the effects of pharmaceuticals. Further development of the methods of evidence-based medicine, including systematic literature searches. Publication of the results of the Institute's methodologicaland other
BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personalDOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. LAROTRECTINIB IN TUMOURS WITH NTRK GENE FUSION: DATA ARE In the summer of 2019, larotrectinib was approved as the first drug in Europe to be used in numerous different solid tumours if the tumour tissue displays a so-called NTRK gene fusion. Since such a fusion of a Neurotrophic Tyrosine Receptor Kinase gene with another gene leads to increased proliferation of the tumour cells, the aim is to selectively block the corresponding signal pathway. GALCANEZUMAB (MIGRAINE) Indication: Prophylaxis of migraine in adults who have at least 4 migraine days per month. Result of dossier assessment: Added benefit not proven for 2 of 3 research questions due to lack of study data. Adults with episodic or chronic migraine for whom otherwise best supportive care is the only option: indication of major added benefit. IQWIG PRESENTS A METHOD FOR EVALUATING THE RELATION IQWiG presents a method for evaluating the relation between cost and benefit. Method guarantees medically necessary services to all patients and can slow down costs. After nearly two years of development and extensive discussion in the scientific community, the Institute for Quality and Efficiency in Health Care (IQWiG) presentsits methods for
MULTIPLE SCLEROSIS: NEW STANDARDS REQUIRED FOR PLANNING Multiple sclerosis is the most common autoimmune disease of the central nervous system, affecting more than 200,000 people in Germany. They suffer from impaired vision and sensation as well as restrictions in coordination and even paralysis. The diagnosis is usually made between the ages of 20 and 40 - women are affected more frequentlythan men.
PALBOCICLIB IN ADVANCED BREAST CANCER: DISADVANTAGES Palbociclib in advanced breast cancer: Disadvantages predominate in certain patients. Severe side effects in first-line treatment after menopause more frequent / no data for other patients. Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breastcancer who
INDICATION OF CONSIDERABLE ADDED BENEFIT OF VEMURAFENIB IN Indication of considerable added benefit of vemurafenib in advanced melanoma. Advantages for overall survival, but also disadvantages in the form of side effects. The drug vemurafenib (trade name Zelboraf®) has been approved since February 2012 for the treatment of advanced melanoma (cancer of the skin cells that produce the dark pigment RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure.JOBS | IQWIG.DE
Let us know in which of IQWiG’s departments or units you would like to work – we will provide feedback as soon as possible. Please send your application (by e-mail only) to: bewerbung@iqwig.de. As a rule, applicants are expected to have a good command of the German language. Therefore, job postings are usually available only in German.SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
ALLGEMEINE METHODEN
Allgemeine Methoden Version 6.0 vom 05.11.2020 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - ii - Präambel Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen(IQWiG) ist eine
BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personalDOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. EVIDENCE ON ORPHAN DRUGS Evidence on orphan drugs. Subscribe to daily updated information on projects, calls for tender, and events as well as our press releases. ARZNEIMITTELBEWERTUNG: AUFGABEN DES RESSORTS Arzneimittelbewertung: Aufgaben des Ressorts. Das Ressort bewertet hauptsächlich den und Schaden von in Deutschland zugelassenen Arzneimitteln. Es vergleicht dazu Arzneimittel mit anderen medikamentösen, aber auch mit nichtmedikamentösen Maßnahmen. Diese Vergleiche sollen feststellen, welche Behandlungsalternative welcheVor- und Nachteile
PALBOCICLIB IN ADVANCED BREAST CANCER: DISADVANTAGES Palbociclib in advanced breast cancer: Disadvantages predominate in certain patients. Severe side effects in first-line treatment after menopause more frequent / no data for other patients. Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breastcancer who
FRIKTIONSKOSTENANSATZ Der Friktionskostenansatz berücksichtigt bei der Bestimmung der Produktivitätsverluste durch Krankheit die Zeitdauer bis zur Neubesetzung der frei gewordenen Arbeitsstelle. Dieser Zeitraum wird als Friktionsperiode bezeichnet. IQWIG: ERSTE KOSTEN-NUTZEN-BEWERTUNG …TRANSLATE THIS PAGE Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) hat seine erste Kosten-Nutzen-Bewertung (KNB) abgeschlossen.Der am 30. Oktober 2013 publizierte Bericht zu Antidepressiva zeigt, dass die Methode der „ Effizienzgrenze “ funktioniert und aufschlussreiche Ergebnisse liefern kann: Einige Medikamente haben im Verhältnis zu ihrem Nutzen deutlich höhere RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personal RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personalJOBS | IQWIG.DE
Let us know in which of IQWiG’s departments or units you would like to work – we will provide feedback as soon as possible. Please send your application (by e-mail only) to: bewerbung@iqwig.de. As a rule, applicants are expected to have a good command of the German language. Therefore, job postings are usually available only in German.SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
ALLGEMEINE METHODEN
Allgemeine Methoden Version 6.0 vom 05.11.2020 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - ii - Präambel Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen(IQWiG) ist eine
BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personalDOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. EVIDENCE ON ORPHAN DRUGS Evidence on orphan drugs. Subscribe to daily updated information on projects, calls for tender, and events as well as our press releases. ARZNEIMITTELBEWERTUNG: AUFGABEN DES RESSORTS Arzneimittelbewertung: Aufgaben des Ressorts. Das Ressort bewertet hauptsächlich den und Schaden von in Deutschland zugelassenen Arzneimitteln. Es vergleicht dazu Arzneimittel mit anderen medikamentösen, aber auch mit nichtmedikamentösen Maßnahmen. Diese Vergleiche sollen feststellen, welche Behandlungsalternative welcheVor- und Nachteile
PALBOCICLIB IN ADVANCED BREAST CANCER: DISADVANTAGES Palbociclib in advanced breast cancer: Disadvantages predominate in certain patients. Severe side effects in first-line treatment after menopause more frequent / no data for other patients. Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breastcancer who
FRIKTIONSKOSTENANSATZ Der Friktionskostenansatz berücksichtigt bei der Bestimmung der Produktivitätsverluste durch Krankheit die Zeitdauer bis zur Neubesetzung der frei gewordenen Arbeitsstelle. Dieser Zeitraum wird als Friktionsperiode bezeichnet. IQWIG: ERSTE KOSTEN-NUTZEN-BEWERTUNG …TRANSLATE THIS PAGE Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) hat seine erste Kosten-Nutzen-Bewertung (KNB) abgeschlossen.Der am 30. Oktober 2013 publizierte Bericht zu Antidepressiva zeigt, dass die Methode der „ Effizienzgrenze “ funktioniert und aufschlussreiche Ergebnisse liefern kann: Einige Medikamente haben im Verhältnis zu ihrem Nutzen deutlich höhere RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aGENERAL METHODS
The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results arepublished.
BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German Federal RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aGENERAL METHODS
The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results arepublished.
SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
DOSSIER ASSESSMENTS
Transfer of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the transfer of the dossier.; Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier.The database of the assessment is the manufacturer's dossier.SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
JOBS | IQWIG.DE
You have not found a position among our current vacancies that matches your interests? Then feel free to send an unsolicited application: Due to our growing tasks, we sometimes have interesting job offers also at short notice, particularly in Research – including in the Drug Assessment Department. Let us know in which of IQWiG’s departments or units you would like to work – we willALLGEMEINE METHODEN
Allgemeine Methoden Version 6.0 vom 05.11.2020 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - ii - Präambel Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen(IQWiG) ist eine
EVIDENCE ON ORPHAN DRUGS Evidence on orphan drugs. Subscribe to daily updated information on projects, calls for tender, and events as well as our press releases. MEDICAL BIOMETRY: RESPONSIBILITIES OF THE DEPARTMENT Dr. Guido Skipka, Dipl.-Stat. Professional profile. Statistician and biometrician. 1998 - 2002 Research Associate at the Department of Medical Informatics, Biometry and Epidemiology, Ruhr University, Bochum. 2003 - February 2005 Research Associate at the Institute for Mathematical Stochastics, University of Göttingen (2003: Certificate in Applied Statistics, Centre for Statistics, University ARZNEIMITTELBEWERTUNG: AUFGABEN DES RESSORTS Dr. med. Thomas Kaiser. Berufsprofil. 1990 Abschluss Systementwickler; 1999 Abschluss Studium der Humanmedizin; 2002 Mitbegründer des DIeM - Institut für evidenzbasierte Medizin, Köln; 2002 bis 2004 Benannter Experte in Arbeitsgruppen für Disease Management Programme im Koordinierungsausschuss und im Gemeinsamen Bundesausschuss; 2005 Promotion zum Dr. med.; 2008 Preisträger Bill PALBOCICLIB IN ADVANCED BREAST CANCER: DISADVANTAGES Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breast cancer who are not eligible for chemotherapy, radiotherapy or further surgery. FRIKTIONSKOSTENANSATZ Der Friktionskostenansatz berücksichtigt bei der Bestimmung der Produktivitätsverluste durch Krankheit die Zeitdauer bis zur Neubesetzung der frei gewordenen Arbeitsstelle. Dieser Zeitraum wird als Friktionsperiode bezeichnet. IQWIG: ERSTE KOSTEN-NUTZEN-BEWERTUNG …TRANSLATE THIS PAGE Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) hat seine erste Kosten-Nutzen-Bewertung (KNB) abgeschlossen.Der am 30. Oktober 2013 publizierte Bericht zu Antidepressiva zeigt, dass die Methode der „ Effizienzgrenze “ funktioniert und aufschlussreiche Ergebnisse liefern kann: Einige Medikamente haben im Verhältnis zu ihrem Nutzen deutlich höhere RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aGENERAL METHODS
The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results arepublished.
BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German Federal RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aGENERAL METHODS
The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results arepublished.
BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German FederalDOSSIER ASSESSMENTS
Transfer of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the transfer of the dossier.; Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier.The database of the assessment is the manufacturer's dossier.SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
JOBS | IQWIG.DE
You have not found a position among our current vacancies that matches your interests? Then feel free to send an unsolicited application: Due to our growing tasks, we sometimes have interesting job offers also at short notice, particularly in Research – including in the Drug Assessment Department. Let us know in which of IQWiG’s departments or units you would like to work – we willALLGEMEINE METHODEN
Allgemeine Methoden Version 6.0 vom 05.11.2020 Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) - ii - Präambel Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen(IQWiG) ist eine
EVIDENCE ON ORPHAN DRUGS Evidence on orphan drugs. Subscribe to daily updated information on projects, calls for tender, and events as well as our press releases. MEDICAL BIOMETRY: RESPONSIBILITIES OF THE DEPARTMENT Dr. Guido Skipka, Dipl.-Stat. Professional profile. Statistician and biometrician. 1998 - 2002 Research Associate at the Department of Medical Informatics, Biometry and Epidemiology, Ruhr University, Bochum. 2003 - February 2005 Research Associate at the Institute for Mathematical Stochastics, University of Göttingen (2003: Certificate in Applied Statistics, Centre for Statistics, University ARZNEIMITTELBEWERTUNG: AUFGABEN DES RESSORTS Dr. med. Thomas Kaiser. Berufsprofil. 1990 Abschluss Systementwickler; 1999 Abschluss Studium der Humanmedizin; 2002 Mitbegründer des DIeM - Institut für evidenzbasierte Medizin, Köln; 2002 bis 2004 Benannter Experte in Arbeitsgruppen für Disease Management Programme im Koordinierungsausschuss und im Gemeinsamen Bundesausschuss; 2005 Promotion zum Dr. med.; 2008 Preisträger Bill PALBOCICLIB IN ADVANCED BREAST CANCER: DISADVANTAGES Palbociclib (trade name: Ibrance) has been approved since November 2016 for the treatment of women with advanced hormone receptor-positive breast cancer who are not eligible for chemotherapy, radiotherapy or further surgery. FRIKTIONSKOSTENANSATZ Der Friktionskostenansatz berücksichtigt bei der Bestimmung der Produktivitätsverluste durch Krankheit die Zeitdauer bis zur Neubesetzung der frei gewordenen Arbeitsstelle. Dieser Zeitraum wird als Friktionsperiode bezeichnet. IQWIG: ERSTE KOSTEN-NUTZEN-BEWERTUNG …TRANSLATE THIS PAGE Das Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) hat seine erste Kosten-Nutzen-Bewertung (KNB) abgeschlossen.Der am 30. Oktober 2013 publizierte Bericht zu Antidepressiva zeigt, dass die Methode der „ Effizienzgrenze “ funktioniert und aufschlussreiche Ergebnisse liefern kann: Einige Medikamente haben im Verhältnis zu ihrem Nutzen deutlich höhere RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable healthGENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German Federal BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personal CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice. Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs. In order to show the clinical relevance of a difference between two treatment GALCANEZUMAB (MIGRAINE) Head and nerves. Indication: Prophylaxis of migraine in adults who have at least 4 migraine days per month. Result of dossier assessment: Added benefit not proven for 2 of 3 research questions due to lack of study data. Adults with episodic or chronic migraine for whom otherwise best supportive care is the only option: indication of majoradded
VALIDITY OF SURROGATE ENDPOINTS IN ONCOLOGY Scientific methods for assessing surrogate endpoints are ready to be tested in practice / Appeal to researchers to analyse available studies. to the press release. Report documents. Executive summary of the rapid report version 1.1: Validity of surrogate endpoints in oncology (Rapid report) EN, PDF, 419 kB, PDF. published on Nov 24,2011.
RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable healthGENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German Federal BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personal CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice. Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs. In order to show the clinical relevance of a difference between two treatment GALCANEZUMAB (MIGRAINE) Head and nerves. Indication: Prophylaxis of migraine in adults who have at least 4 migraine days per month. Result of dossier assessment: Added benefit not proven for 2 of 3 research questions due to lack of study data. Adults with episodic or chronic migraine for whom otherwise best supportive care is the only option: indication of majoradded
VALIDITY OF SURROGATE ENDPOINTS IN ONCOLOGY Scientific methods for assessing surrogate endpoints are ready to be tested in practice / Appeal to researchers to analyse available studies. to the press release. Report documents. Executive summary of the rapid report version 1.1: Validity of surrogate endpoints in oncology (Rapid report) EN, PDF, 419 kB, PDF. published on Nov 24,2011.
INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen. BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personalSEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
DOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. EARLY BENEFIT ASSESSMENT Early benefit assessment - the whole range. IQWiG assessed a total of 24 manufacturer dossiers on time for the deadlines of 1 March and 15 March. As examples, the indications and results reflect the complexity of the AMNOG procedure. "The AMNOG procedure has passed its MEDICAL BIOMETRY: RESPONSIBILITIES OF THE DEPARTMENT Dr. Guido Skipka, Dipl.-Stat. Professional profile. Statistician and biometrician. 1998 - 2002 Research Associate at the Department of Medical Informatics, Biometry and Epidemiology, Ruhr University, Bochum. 2003 - February 2005 Research Associate at the Institute for Mathematical Stochastics, University of Göttingen (2003: Certificate in Applied Statistics, Centre for Statistics, University DAROLUTAMIDE (PROSTATE CANCER) Project no.:A20-43. Commission awarded on 30.04.2020 by the Federal Joint Committee (G-BA). Adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease. After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commentingprocedure.
PATIENT-RELEVANT ENDPOINTS Patient-relevant endpoints fall into the categories of mortality, morbidity, side effects and health-related quality of life. We explain the questions behind the categories and the aspects IQWiG considers in its benefit assessments. LAROTRECTINIB IN TUMOURS WITH NTRK GENE FUSION: DATA ARE In the summer of 2019, larotrectinib was approved as the first drug in Europe to be used in numerous different solid tumours if the tumour tissue displays a so-called NTRK gene fusion. Since such a fusion of a Neurotrophic Tyrosine Receptor Kinase gene with another gene leads to increased proliferation of the tumour cells, the aim is to selectively block the corresponding signal pathway. DULAGLUTIDE (TYPE 2 DIABETES MELLITUS) Indication: Adults with type 2 diabetes mellitus; monotherapy for patients in whom diet and exercise alone do not provide sufficient glycaemic control and for whom metformin is considered inappropriate due to intolerance or contraindications; combination therapy for patients in whom diet and exercise and the treatment with other blood-glucose lowering drugs do not provide sufficient RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable healthGENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.HTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as a BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German Federal BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personal CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice. Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs. In order to show the clinical relevance of a difference between two treatmentDOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. GALCANEZUMAB (MIGRAINE) Head and nerves. Indication: Prophylaxis of migraine in adults who have at least 4 migraine days per month. Result of dossier assessment: Added benefit not proven for 2 of 3 research questions due to lack of study data. Adults with episodic or chronic migraine for whom otherwise best supportive care is the only option: indication of majoradded
RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable healthGENERAL METHODS
General Methods. The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results
INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IMTRANSLATE THIS PAGE Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.HTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as a BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German Federal BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personal CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW Clinical relevance of patient-reported outcomes: new threshold proven feasible in practice. Current examples prove the feasibility of the 15 percent threshold newly defined by IQWiG for the acceptance of responder analyses in early benefit assessments of drugs. In order to show the clinical relevance of a difference between two treatmentDOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. GALCANEZUMAB (MIGRAINE) Head and nerves. Indication: Prophylaxis of migraine in adults who have at least 4 migraine days per month. Result of dossier assessment: Added benefit not proven for 2 of 3 research questions due to lack of study data. Adults with episodic or chronic migraine for whom otherwise best supportive care is the only option: indication of majoradded
JOBS | IQWIG.DE
Let us know in which of IQWiG’s departments or units you would like to work – we will provide feedback as soon as possible. Please send your application (by e-mail only) to: bewerbung@iqwig.de. As a rule, applicants are expected to have a good command of the German language. Therefore, job postings are usually available only in German.SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
BACKGROUND: WHAT ARE PATIENT PREFERENCES? The first step is the search for information. For example, patients might first ask a doctor what options there are and what advantages and disadvantages they have. The second step is weighing the options as to what is more "important" or "preferable" from a personal point of view. The result of weighing the pros and cons is the personalDOSSIER ASSESSMENTS
Dossier assessments are conducted within the framework of the early benefit assessment of drugs (according to AMNOG ). The law stipulates that new drugs must be tested at market entry as to whether they provide an added benefit versus the current standard therapy. The manufacturer must submit a dossier in order to prove this. DAROLUTAMIDE (PROSTATE CANCER) Project no.:A20-43. Commission awarded on 30.04.2020 by the Federal Joint Committee (G-BA). Adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease. After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commentingprocedure.
AUFGABEN UND ZIELE DES IQWIG Das IQWiG hat unter anderem den gesetzlichen Auftrag, Vor- und Nachteile von medizinischen Verfahren zu bewerten, also zum Beispiel verschiedene Arzneimittel oder Operationsverfahren untereinander zu vergleichen. Dafür suchen die Mitarbeiterinnen und Mitarbeiter des Instituts in der internationalen Fachliteratur systematisch nach Studien, in denen die gefragten Vergleiche beschrieben sind. VALIDITY OF SURROGATE ENDPOINTS IN ONCOLOGY Scientific methods for assessing surrogate endpoints are ready to be tested in practice / Appeal to researchers to analyse available studies. to the press release. Report documents. Executive summary of the rapid report version 1.1: Validity of surrogate endpoints in oncology (Rapid report) EN, PDF, 419 kB, PDF. published on Nov 24,2011.
INDICATION OF CONSIDERABLE ADDED BENEFIT OF VEMURAFENIB IN Indication of considerable added benefit of vemurafenib in advanced melanoma. Advantages for overall survival, but also disadvantages in the form of side effects. The drug vemurafenib (trade name Zelboraf®) has been approved since February 2012 for the treatment of advanced melanoma (cancer of the skin cells that produce the dark pigmentIQWIG-BERICHTE
Rapid Report Auftrag: Version: Stand: V16-01A 1.0 23.06.2017 Definitionen der Geburtsphasen IQWiG-Berichte – Nr. 517 FRIKTIONSKOSTENANSATZ Der Friktionskostenansatz berücksichtigt bei der Bestimmung der Produktivitätsverluste durch Krankheit die Zeitdauer bis zur Neubesetzung der frei gewordenen Arbeitsstelle. Dieser Zeitraum wird als Friktionsperiode bezeichnet. RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IM Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results arepublished.
DOSSIER ASSESSMENTS
Transfer of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the transfer of the dossier.; Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier.The database of the assessment is the manufacturer's dossier.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German FederalSEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW In order to show the clinical relevance of a difference between two treatment alternatives, in recent years, the manufacturer dossiers submitted in early benefit assessments of new drugs have increasingly contained responder analyses for patient-relevant outcomes. GALCANEZUMAB (MIGRAINE) Galcanezumab (migraine) - Benefit assessment according to 35a Social Code Book V. Last updated 01.07.2019 RESPONSIBILITIES AND OBJECTIVES OF IQWIG The independent Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG) examines the benefits and harms of medical interventions for patients.We provide information about the advantages and disadvantages of examination and treatment methods in the form of scientific reports and easily understandable health INSTITUT FÜR QUALITÄT UND WIRTSCHAFTLICHKEIT IM Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten.Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen.GENERAL METHODS
The General Methods describe the basic work procedures of the Institute. They describe in detail, among other things, the scientific principles followed by IQWiG, the sequence of the individual steps followed in the production of the work results, the procedure of the collaboration with external experts and how IQWiG's results arepublished.
DOSSIER ASSESSMENTS
Transfer of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the transfer of the dossier.; Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier.The database of the assessment is the manufacturer's dossier.GENERAL METHODS
a. This translation is . based on the German document . Allgemeine Methoden (Version 6.0) of 5 November 2020. Please note: The translation is provided as aHTA REPORTS
HTA reports are based on suggestions submitted on the website “ ThemenCheck Medizin ” (Topic check medicine) by statutory health insurance members and other interested people. The legislator has initiated this tool to provide a possibility for people to get involved in the promotion of evidence-based medicine. These reports always assess benefit and harm of a medical procedure. BODIES AND COMMITTEES The Foundation Council represents the sponsoring organizations: The twelve members are divided equally between representatives of the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) and the service providers, in other words, the doctors and hospitals.They are represented by the Federal Association for Statutory Health Insurance Physicians (KBV), the German FederalSEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
CLINICAL RELEVANCE OF PATIENT-REPORTED OUTCOMES: NEW In order to show the clinical relevance of a difference between two treatment alternatives, in recent years, the manufacturer dossiers submitted in early benefit assessments of new drugs have increasingly contained responder analyses for patient-relevant outcomes. GALCANEZUMAB (MIGRAINE) Galcanezumab (migraine) - Benefit assessment according to 35a Social Code Book V. Last updated 01.07.2019DOSSIER ASSESSMENTS
Transfer of the dossier by the G-BA: A dossier assessment is always initiated by a commission from the G-BA and the transfer of the dossier.; Information retrieval and scientific evaluation: On receipt of the dossier at IQWiG, the Institute will start the assessment with regard to the contents of the dossier.The database of the assessment is the manufacturer's dossier.SEARCH | IQWIG.DE
This is a search page. Easily understandable information for thegeneral public
JOBS | IQWIG.DE
You have not found a position among our current vacancies that matches your interests? Then feel free to send an unsolicited application: Due to our growing tasks, we sometimes have interesting job offers also at short notice, particularly in Research – including in the Drug Assessment Department. Let us know in which of IQWiG’s departments or units you would like to work – we will BACKGROUND: WHAT ARE PATIENT PREFERENCES? People who are constantly sick have to make both small and big decisions: Am I feeling so bad that I should go and see a doctor? Should I have surgery or rathe AUFGABEN UND ZIELE DES IQWIG Das IQWiG hat unter anderem den gesetzlichen Auftrag, Vor- und Nachteile von medizinischen Verfahren zu bewerten, also zum Beispiel verschiedene Arzneimittel oder Operationsverfahren untereinander zu vergleichen. Dafür suchen die Mitarbeiterinnen und Mitarbeiter des Instituts in der internationalen Fachliteratur systematisch nach Studien, in denen die gefragten Vergleiche beschrieben sind. DAROLUTAMIDE (PROSTATE CANCER) Darolutamide (prostate cancer) - Benefit assessment according to §35a Social Code Book V. Last updated 03.08.2020 VALIDITY OF SURROGATE ENDPOINTS IN ONCOLOGY Validity of surrogate endpoints in oncology (Rapid report) Project no.: A10-05. Commission: Commission awarded on 19.08.2010 by the Federal Joint Committee (G-BA). INDICATION OF CONSIDERABLE ADDED BENEFIT OF VEMURAFENIB IN The drug vemurafenib (trade name Zelboraf®) has been approved since February 2012 for the treatment of advanced melanoma (cancer of the skin cells that produce the dark pigment, melanin).IQWIG-BERICHTE
Rapid Report Auftrag: Version: Stand: V16-01A 1.0 23.06.2017 Definitionen der Geburtsphasen IQWiG-Berichte – Nr. 517 FRIKTIONSKOSTENANSATZ Der Friktionskostenansatz berücksichtigt bei der Bestimmung der Produktivitätsverluste durch Krankheit die Zeitdauer bis zur Neubesetzung der frei gewordenen Arbeitsstelle. Dieser Zeitraum wird als Friktionsperiode bezeichnet. * accessibility.to-content ACCESSIBILITY.NAVIGATION.META* IQWiG
* ThemenCheck Medizin * GesundheitsinformationEnglisch
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* Infodienst abonnieren * Als Sachverständiger registrieren ------------------------- MEDIZIN AUF DEM PRÜFSTAND Das unabhängige Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG) untersucht den Nutzen und den Schaden von medizinischen Maßnahmen für Patientinnen und Patienten. Über die Vorteile und Nachteile von Untersuchungs- und Behandlungsverfahren informieren wir in Form von wissenschaftlichen Berichten und allgemein verständlichen Gesundheitsinformationen. LETZTE AKTUALISIERUNGEN * Pressemitteilungen * Stellungnahmeverfahren* Ausschreibungen
PRESSEMITTEILUNGEN
PRESSEMITTEILUNGEN
BELIMUMAB BEI AKTIVEM SYSTEMISCHEM LUPUS ERYTHEMATODES: ZUSATZNUTZEN FÜR KINDER UND JUGENDLICHE 14.05.2020 Nachgereichte Informationen ermöglichten im Addendum eine Einschätzung der Vorteile bei den Nebenwirkungen. Die Datenlage erlaubt aber keine Quantifizierung des Zusatznutzens. mehr erfahren Link zu „%headline%“ ALLE KLINISCHEN STUDIENDATEN ZU COVID-19-ARZNEIMITTELN UND -IMPFSTOFFEN SOLLTEN MIT DEM TAG DER MARKTZULASSUNG VERÖFFENTLICHTWERDEN!
14.05.2020 Offener Brief an die Europäische Arzneimittel-Agentur mehr erfahren Link zu „%headline%“ OBSTRUKTIVE SCHLAFAPNOE: UNTERKIEFERPROTRUSIONSSCHIENE HILFT GEGENTAGESSCHLÄFRIGKEIT
12.05.2020 Nachts eine Kunststoffschiene im Mund zu tragen, um die Atemwege mechanisch offenzuhalten, hilft bei obstruktiver Schlafapnoe ähnlich gut wie eine Positivdruckbehandlung per Schlafmaske. mehr erfahren Link zu „%headline%“ DMP COPD: LEITLINIEN-SYNOPSE ZEIGT AKTUALISIERUNGSBEDARF BEI MEHRERENVERSORGUNGSASPEKTEN
06.05.2020 Internationale Leitlinien liefern neue Ansätze bei mehreren Versorgungsaspekten, u. a. bei Langzeit-Sauerstofftherapie, Patienten-Monitoring und medikamentöser Behandlung. mehr erfahren Link zu „%headline%“ GEBÄRMUTTERHALSKREBS-FRÜHERKENNUNG: FRAUEN KÖNNEN INFORMIERTENTSCHEIDEN
27.04.2020 Vom IQWiG entwickelte Entscheidungshilfe erweist sich in Nutzertests als hilfreich und informativ. mehr erfahren Link zu „%headline%“ SPINALE MUSKELATROPHIE (SMA): NEUGEBORENENSCREENING VERSPRICHT EINENNUTZEN
27.03.2020 Eine frühestmögliche Diagnose und Therapie der infantilen SMA durch ein Screening der Neugeborenen führt zu einer besseren motorischen Entwicklung und zu weniger Dauerbeatmung undTodesfällen.
mehr erfahren Link zu „%headline%“ VERSICHERTENINFORMATION ZUR PRÄNATALDIAGNOSTIK: STELLUNGNAHMEFRISTVERLÄNGERT
24.03.2020 Stellungnahmen können nun bis zum 29. Mai 2020eingereicht werden.
mehr erfahren Link zu „%headline%“ BÜRGERINNEN UND BÜRGER FRAGEN – DIE WISSENSCHAFT ANTWORTET 13.03.2020 Neue HTA-Aufträge klären Fragen zu Blasenentzündung, Herzerkrankung bei Kindern, sozialer Isolation im Alter, Vitamin B12 / Vitamin D bei Senioren und Feldenkrais bei Störungen derBeweglichkeit.
mehr erfahren Link zu „%headline%“ NICHT INVASIVE PRÄNATALTESTS: VERSTÄNDLICHE INFORMATIONEN FÜR DIE SELBSTBESTIMMTE ENTSCHEIDUNG 06.03.2020 Zweiteilige Versicherteninformation des IQWiG unterstützt Schwangere bei der Entscheidung, welche vorgeburtlichen Untersuchungen sie in Anspruch nehmen wollen mehr erfahren Link zu „%headline%“ DUPILUMAB BEI CHRONISCHER RHINOSINUSITIS MIT NASENPOLYPEN: BELEG FÜREINEN ZUSATZNUTZEN
02.03.2020 Das Ausmaß ist nicht quantifizierbar, aber mindestens beträchtlich. Positiven Effekten bei mehreren Symptom-Endpunkten stehen keine negativen Effekte gegenüber. mehr erfahren Link zu „%headline%“ weitere Pressemitteilungen ------------------------- {{ 'accessibility.scroll_more'|trans }} {{ 'accessibility.scroll_back'|trans }} STELLUNGNAHMEVERFAHREN STELLUNGNAHMEVERFAHRENNR.
TITEL
TYP
FRISTENDE
P17-01
Versicherteninformation zur Pränataldiagnostikzum Vorbericht
29.05.2020
-------------------------AUSSCHREIBUNGEN
AUSSCHREIBUNGEN
Derzeit gibt es keine Ausschreibungen. ------------------------- ALLGEMEINVERSTÄNDLICHE GESUNDHEITSINFORMATIONEN FÜR BÜRGERINNEN UNDBÜRGER
GESUNDHEITSVERSORGUNG IN DEUTSCHLAND Wer krank wird, hat es in Deutschland normalerweise nicht schwer, medizinische Hilfe zu finden. Es gibt ein dichtes Netz von leicht zugänglichen Behandlungsangeboten. Sich im deutschen Gesundheitssystem zurechtzufinden, ist trotzdem nicht immer einfach. Wir möchten deshalb einen Überblick und gleichzeitig eine praktische Orientierungshilfe geben. mehr erfahren RAMUCIRUMAB (CYRAMZA) BEI METASTASIERTEM LUNGENKREBS Ramucirumab (Handelsname Cyramza) ist seit Januar 2020 zur Therapie von Erwachsenen mit metastasiertem nicht kleinzelligen Lungenkrebs zugelassen. mehr erfahren (Link zu „%headline%“ ‚Äì öffnet in einem neuen Fenster) ------------------------- -------------------------SUCHE
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------------------------- WEITERE INFORMATIONEN DER IQWIG-INFODIENST Tagesaktuelle Informationen zu Projekten, Veranstaltungen und Ausschreibungen abonnieren.Abonnieren
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