Real-World Clinical Effectiveness and Migraine-Related Healthcare Resource Utilization in Patients Initiating Fremanezumab in Germany and the United Kingdom

Axel Heinze,1 Shazia K Afridi,2 Todor I Totev,3 Lynda J Krasenbaum,4 Emi Terasawa,5 Hasan Akcicek,6 Joachim Hipp,7 Dalbir Dhiraj,8 Rochelle Sun,3 Erica Yim,5 Binyam Yilma,5 Maurice T Driessen9 1Migraine and Headache Center, Pain Clinic Kiel, Kiel, Germany; 2Department of Neurology, Guy’s and St Thomas’ NHS Foundation Trust, London, UK; 3Analysis Group, Inc., Boston, MA, USA; 4Global Medical Affairs, Teva Branded Pharmaceutical Products R&D, Inc., West Chester, PA, USA; 5Analysis Group, Inc., New York, NY, USA; 6Medical Affairs, Teva Pharmaceuticals B.V., Haarlem, Netherlands; 7Teva GmbH, Ulm, Germany; 8Global Medical Affairs, Teva UK Ltd, Castleford, UK; 9Global Health Economics, Value and Outcomes, Teva Pharmaceuticals B.V., Haarlem, NetherlandsCorrespondence: Maurice T Driessen, Global Health Economics, Value and Outcomes, Teva Pharmaceuticals B.V., Haarlem, Netherlands, Email Maurice.Driessen@Tevaeu.comPurpose: Fremanezumab, a humanized monoclonal antibody targeting calcitonin gene-related peptide, is approved in Germany and the United Kingdom (UK) for patients experiencing migraine ≥ 4 days per month, and it is reimbursed for patients where ≥ 4– 5 (Germany) or ≥ 3 (UK) prior migraine preventive treatments have failed. We evaluated real-world clinical effectiveness and healthcare resource utilization (HCRU) in patients initiating fremanezumab in Germany and the UK.Methods: This non-interventional, retrospective, physician panel-based, online, multicenter chart review study included adult patients with chronic migraine (CM) or episodic migraine (EM) with first fremanezumab treatment initiation (index date) from June 2019 or later (Germany), and from June 2020 or later (UK). Changes in monthly migraine days (MMD), monthly headache days (MHD), and disability outcomes (Migraine Disability Assessment [MIDAS] and Headache Impact Test-6 [HIT-6]) were evaluated from baseline (pre-index) to 3 months post-index, and changes in HCRU were evaluated from 6 months pre-index to 6 months post-index.Results: The study population included 207 German and 183 UK patients (CM, 48.3% and 95.1%; monthly dosing, 59.4% and 51.9%, respectively). Reductions in MMD and MHD were observed in the German cohort (percent reductions: 60.2% and 55.1%, respectively) and the UK cohort (51.9% and 47.3%, respectively; all p < 0.001 vs baseline). Reductions in mean MIDAS and HIT-6 scores (all p < 0.01 vs baseline), outpatient office visits, urgent care/emergency room visits, and inpatient admissions were also observed (all p < 0.05 vs baseline) for both countries.Conclusion: Fremanezumab demonstrated real-world clinical effectiveness in German and UK cohorts and may decrease the burden of migraine for patients and providers.Plain Language Summary: Why was this study conducted?Fremanezumab is a migraine preventive treatment approved in Germany and the UK for patients experiencing ≥ 4 days with migraine symptoms per month, and is reimbursed for patients where ≥ 4– 5 (Germany) or ≥ 3 (UK) prior preventive treatments have been ineffective or were not well-tolerated.There is a need for real-world data on the impact of fremanezumab treatment on migraine and the use of migraine-related healthcare services, and these data can inform healthcare decisions makers.What did this study do?This study looked at the impact of fremanezumab treatment in adults with chronic or episodic migraine in Germany and the UK.Researchers recruited German and UK physicians who could provide patient records without patient names or personal details, to collect data on the number of days per month that a patient experienced migraine, migraine-related disability questionnaire scores, outpatient visits, inpatient admissions, and urgent care/ER visits from before and during treatment with fremanezumab.What does this study find?After 3 months of fremanezumab treatment, patients reported that the number of days per month that they experienced migraine had been reduced by more than half compared with before they started treatment, and that the level of disability caused by their migraine had also decreased.After 6 months of fremanezumab treatment, outpatient visits, urgent care/ER visits, and inpatient admissions were all significantly reduced compared with before patients started treatment.InterpretationTreatment with fremanezumab was effective in German and UK patients with migraine in real-world clinical practice.Fremanezumab treatment also reduced the need to seek additional healthcare, relieving the burden of migraine on patients and healthcare providers.Keywords: burden of migraine, calcitonin gene-related peptide, migraine-related disability, cost effectiveness