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Galcanezumab (Migraine) – Benefit Assessment According to §35A Social Code Book V1

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Galcanezumab (Migraine) – Benefit Assessment According to §35A Social Code Book V1 IQWiG Reports – Commission No. A19-28 Galcanezumab (migraine) – Benefit assessment according to §35a Social Code Book V1 Extract 1 Translation of Sections 2.1 to 2.7 of the dossier assessment Galcanezumab (Migräne) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 27 June 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. Extract of dossier assessment A19-28 Version 1.0 Galcanezumab (migraine) 27 June 2019 Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Galcanezumab (migraine) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 29 March 2019 Internal Commission No.: A19-28 Address of publisher: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen Im Mediapark 8 50670 Köln Germany Phone: +49 221 35685-0 Fax: +49 221 35685-1 E-mail: [email protected] Internet: www.iqwig.de Institute for Quality and Efficiency in Health Care (IQWiG) - i - Extract of dossier assessment A19-28 Version 1.0 Galcanezumab (migraine) 27 June 2019 Medical and scientific advice: . Thomas Henze, practice for neurology Dr. Blersch, Regensburg, Germany IQWiG thanks the medical and scientific advisor for his contribution to the dossier assessment. However, the advisor was not involved in the actual preparation of the dossier assessment. The responsibility for the contents of the dossier assessment lies solely with IQWiG. IQWiG employees involved in the dossier assessment: . Lisa Junge . Katharina Biester . Judith Gibbert . Charlotte Guddat . Michaela Florina Kerekes . Stefan Kobza . Cornelia Rüdig . Dorothea Sow Keywords: galcanezumab, migraine disorders, benefit assessment, NCT02614183, NCT02614196, NCT02614261 Institute for Quality and Efficiency in Health Care (IQWiG) - ii - Extract of dossier assessment A19-28 Version 1.0 Galcanezumab (migraine) 27 June 2019 Table of contents Page List of tables ............................................................................................................................. iv List of abbreviations ................................................................................................................. v 2 Benefit assessment ............................................................................................................. 1 2.1 Executive summary of the benefit assessment .......................................................... 1 2.2 Research question ....................................................................................................... 8 2.3 Information retrieval and study pool ...................................................................... 10 2.3.1 Studies included ................................................................................................... 10 2.4 Research question 1: adult patients for whom treatment with metoprolol or propranolol or flunarizine or topiramate or amitriptyline is an option .............. 11 2.4.1 Results on added benefit (research question 1) .................................................... 11 2.4.2 Probability and extent of added benefit (research question 1) ............................. 11 2.4.3 List of included studies (research question 1) ...................................................... 11 2.5 Research question 2: adult patients for whom treatment with valproic acid or clostridium botulinum toxin type A is an option ............................................... 11 2.5.1 Results on added benefit (research question 2) .................................................... 11 2.5.2 Probability and extent of added benefit (research question 2) ............................. 12 2.5.3 List of included studies (research question 2) ...................................................... 12 2.6 Research question 3: adult patients for whom BSC is the only treatment option .......................................................................................................................... 12 2.6.1 Study characteristics ............................................................................................. 12 2.6.2 Results on added benefit ....................................................................................... 24 2.6.2.1 Outcomes included ......................................................................................... 24 2.6.2.2 Risk of bias ..................................................................................................... 25 2.6.2.3 Results ............................................................................................................. 27 2.6.2.4 Subgroups and other effect modifiers ............................................................. 34 2.6.3 Probability and extent of added benefit ................................................................ 35 2.6.3.1 Assessment of the added benefit at outcome level ......................................... 35 2.6.3.2 Overall conclusion on added benefit .............................................................. 38 2.6.4 List of included studies (research question 3) ...................................................... 39 2.7 Probability and extent of added benefit – summary .............................................. 42 References for English extract .............................................................................................. 43 Institute for Quality and Efficiency in Health Care (IQWiG) - iii - Extract of dossier assessment A19-28 Version 1.0 Galcanezumab (migraine) 27 June 2019 List of tables2 Page Table 2: Research questions of the benefit assessment of galcanezumab .................................. 1 Table 3: Galcanezumab – probability and extent of added benefit ............................................ 8 Table 4: Research questions of the benefit assessment of galcanezumab .................................. 9 Table 5: Study pool – RCT, direct comparison: galcanezumab vs. ACT ................................ 10 Table 6: Characteristics of the studies included – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC ........................................................................................................ 13 Table 7: Characteristics of the interventions – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC............................................................................................................ 15 Table 8: Characteristics of the study populations – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC ................................................................................ 21 Table 9: Risk of bias across outcomes (study level) – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC ................................................................................ 24 Table 10: Matrix of outcomes – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC .......................................................................................................................... 25 Table 11: Risk of bias across outcomes and outcome-specific risk of bias – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC ............................................................ 26 Table 12: Results (mortality, side effects) – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC............................................................................................................ 28 Table 13: Results (morbidity, dichotomous) – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC............................................................................................................ 29 Table 14: Results (morbidity, health-related quality of life, continuous) – RCT, direct comparison: galcanezumab + BSC vs. placebo + BSC ............................................................ 30 Table 15: Extent of added benefit at outcome level: galcanezumab + BSC vs. placebo + BSC .......................................................................................................................................... 37 Table 16: Positive and negative effects from the assessment of galcanezumab + BSC compared with placebo + BSC ................................................................................................. 38 Table 17: Galcanezumab – probability and extent of added benefit ........................................ 42 2 Table numbers start with “2” as numbering follows that of the full dossier assessment. Institute for Quality and Efficiency in Health Care (IQWiG) - iv - Extract of dossier assessment A19-28 Version 1.0 Galcanezumab (migraine) 27 June 2019 List of abbreviations Abbreviation Meaning ACT appropriate comparator therapy AE adverse event BSC best supportive care CI confidence interval EF Emotional Function G-BA Gemeinsamer Bundesausschuss (Federal Joint Committee) ICHD-3 International Classification of Headache Disorders, 3rd edition IPD individual patient data IQWiG Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (Institute for Quality and Efficiency in Health Care) LOCF last observation carried forward MMRM mixed-effects model repeated measures MSQ Migraine-Specific Quality of Life Questionnaire PGI-I Patient Global Impression of Improvement PGI-S Patient Global Impression of Severity RCT randomized controlled trial RFR Role Function-Restrictive SAE serious adverse event SGB Sozialgesetzbuch
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