Patient Perspectives and Experiences of Preventive Treatments and Self-Injectable Devices for Migraine: A Focus Group Study

Abstract

Background Although several self-injectable preventive treatments for migraine have become available, they are not yet widely used. Thus, understanding patients' perceptions towards them is limited. Objective This study aimed to inform the design of a preference-elicitation instrument, which is being developed to quantify preventive treatment preferences of people with migraine. Methods We conducted a qualitative study involving nine in-person focus groups (three per country) in the United States, the United Kingdom, and Germany. Participants were adults (n = 47) with episodic or chronic migraine who were currently using or had used a prescription preventive treatment for migraine within the previous 5 years. During the focus groups, participants described their experiences of migraine and preventive treatments; handled and simulated self-injection using five different unbranded, fired demonstration auto-injectors and prefilled syringes; and ranked different aspects of preventive treatments by importance. Focus groups were analyzed with a focus on themes that would be feasible or meaningful to include in a subsequent preference-elicitation instrument. Results Reducing the frequency and severity of migraine attacks was consistently ranked as the most important aspect of preventive treatment. Participants expressed dissatisfaction with available daily oral preventive treatments for migraine they had previously used because they were ineffective or caused intolerable adverse events. Many participants were willing to selfinject a treatment that was effective and tolerable. When presented with devices for self-injecting a preventive treatment for migraine, participants generally preferred autoinjectors over prefilled syringes. Participants especially valued safety features such as the unlocking step and automated needle insertion, and audible and visual dose confirmation increased confidence in autoinjector use. Autoinjector needle protection mechanisms were also appreciated, especially by participants averse to needles, as the needles are not visible. Conclusions This study highlights the fact that many people with migraine still lack access to a preventive treatment that is effective and tolerable. In addition to efficacy and safety considerations, treatment decisions may be guided by the mode of administration. In the case of self-injectable preventive treatments, key device characteristics affecting these decisions may be ease of use, comfort, and confidence in self-injection. Insights gained from this study were used to help develop a preliminary set of attributes and levels for a preference-elicitation instrument.

Discrete Choice Experiment to Understand Japanese Patients’ and Physicians’ Preferences for Preventive Treatments for Migraine

“…This study benefitted from a best-practice mixed methods design [56][57][58]. The attributes in the DCE were identified through a targeted literature review and nine in-person focus groups conducted in the US, UK, and Germany, during which patients simulated using unbranded auto-injectors and prefilled syringes [27]. The DCE was also qualitatively and quantitatively pilot-tested before surveying Japanese patients and physicians.…”

“…The DCE was also qualitatively and quantitatively pilot-tested before surveying Japanese patients and physicians. In addition, in order to address possible challenges in communicating auto-injector attribute levels to participants, the patient information leaflets for CGRP mAbs and the findings of the focus group study [ 27 ] were used to develop a short video to help participants to understand the attributes and to distinguish their levels. This was especially important for attributes describing different parts of the devices, such as the base and dose confirmation window, which would not be familiar to participants who have not used such devices.…”

“…The attributes and levels included in the DCE were initially identified through a targeted literature review, and were explored in nine in-person focus groups conducted in the US, the UK, and Germany (three per country) between October and November 2019 [ 27 ]. During the focus groups, participants handled and simulated self-injection using five unbranded, deactivated injection devices, and were asked about which device characteristics were important to them and why those characteristics were important.…”

Treatment Patterns for Calcitonin Gene-Related Peptide Monoclonal Antibodies Including Galcanezumab versus Conventional Preventive Treatments for Migraine: A Retrospective US Claims Study

“… 10 Further, the focus group study conducted in 2019 in the US, UK, and Germany, in patients using or who had used preventive treatments for migraine showed that the top priority for patients was to reduce migraine attack severity and frequency. 34 Patients also reported dissatisfaction with oral preventive treatments due to intolerance or adverse events and were willing to self-inject efficacious and tolerable preventive treatments via syringes or autoinjectors. 34 However, most of the patients in the study group lacked access to efficacious preventive treatments for migraine.…”

“… 34 Patients also reported dissatisfaction with oral preventive treatments due to intolerance or adverse events and were willing to self-inject efficacious and tolerable preventive treatments via syringes or autoinjectors. 34 However, most of the patients in the study group lacked access to efficacious preventive treatments for migraine. The AHS 2021 consensus statement suggests preventive treatments in patients severely affected due to migraine for two or more days in a month, with any level A/B drugs categories as first- and second-line treatment, followed by CGRP mAb as third line treatment.…”