What is the comparative clinical and cost-effectiveness of pharmacological treatments for adults with episodic migraine? A systematic review, network meta-analysis, and economic model

Research Question: To review and compare the clinical and cost-effectiveness of prophylactic drug treatments for adults with episodic migraine. Background: Migraine, the second most frequent disabling condition globally, affects approximately 15% of UK adults, resulting in substantial economic costs due to absenteeism and presenteeism. Episodic migraine is defined as headaches on fewer than 14 days per month. While oral medications have traditionally been used for migraine prevention, the introduction of expensive calcitonin gene-related peptide (CGRP) monoclonal antibodies (MAbs) and more recently, gepants offer promising alternatives. However, the comparative effectiveness and cost-effectiveness of these treatments in preventing episodic migraine are yet to be determined. Aims and Objectives: We aim to generate rigorous evidence to help individuals with episodic migraines. their doctors and policy makers to make more informed decisions about prophylactic treatment option for episodic migraine. Our research objectives are to determine: What is the comparative effectiveness of prophylactic medications for episodic migraine? What is known about the cost-effectiveness of prophylactic medications for episodic migraine? Which prophylactic medications for the management of episodic migraine are the most cost-effective? Methods: We propose three work packages (WP), which build on our previous NIHR-funded study for chronic migraine and we will incorporate patient and public involvement throughout each WP. WP1: A systematic review and network meta-analysis (NMA) of randomised controlled trials to assess the clinical effectiveness of prophylactic medications for episodic migraine. Outcomes of interest will include reductions in headache/migraine days and improvements in headache-related quality of life. Included studies will be assessed using the Cochrane risk of bias tool. The NMA will integrate direct and indirect evidence to rank treatments based on effectiveness. WP2: A systematic review of cost-effectiveness studies of prophylactic medications for episodic migraine. The quality of these studies will be assessed using appropriate tools developed by Husereau et al. and Phillips et al., and the findings will be synthesised to highlight the most cost-effective treatments. WP3: An economic model using data from WP1 and WP2 will be developed to compare the long-term cost-effectiveness of the different prophylactic treatments for episodic migraine. The model will incorporate healthcare costs, clinical outcomes and quality-adjusted life years (QALYs). Patient and Public Involvement: Working closely with two patient representatives who have experience of migraine, we will discuss our results with them at regular intervals via teleconference or face-to-face meetings, where appropriate and feasible. Their involvement will be throughout the whole project, in particular in the interpretation of the results of each WP, reviewing model inputs and assumptions, the translation to research recommendations and, also dissemination of findings. Timelines for Delivery: We will complete the project within 12 months. Anticipated Impact and Dissemination: The results will offer valuable insights into the most effective and cost-effective preventive medications for episodic migraine, benefiting patients, clinicians, and policymakers and will feed directly into policy recommendations. Findings will be published in open-access peer-reviewed journals and presented at conferences.