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

DOI: https://doi.org/10.1007/s40271-021-00525-z

Abstract-Summary Although several self-injectable preventive treatments for migraine have become available, they are not yet widely used.

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.

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.

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 treat- ments for migraine they had previously used because they were ineffective or caused intolerable adverse events.

Many participants were willing to self-inject a treatment that was effective and

tolerable.

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When presented with devices for self-injecting a preventive treatment for

migraine, participants generally preferred autoinjectors over prefilled syringes.

This study highlights the fact that many people with migraine still lack access to

a preventive treatment that is effective and tolerable.

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.

Extended: During the focus group discussions, participants were given the oppor- tunity to handle and simulate self-injection using several devices and were queried about which characteristics mattered to them.

We plan to leverage the focus group findings to develop visual aids such as illus- trations and videos to help participants make informed choice decisions in the pref- erence study.

This study will serve as a foundation for future preference studies that aim to quantify the trade-offs that people with migraine are willing to make when choosing between different preventive treatments for migraine, including self-injectables.

Introduction Individuals who experience at least four migraine headache days per month should be considered for preventive treatment [213].

Monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) that bind either CGRP itself or the CGRP receptor provide a novel alternative for people with migraine, especially for those in whom standard (non-CGRP-targeting) oral agents have failed.

Erenumab, galcanezumab, and fremanezumab are self-injectable CGRP-

targeting mAbs indicated for migraine prevention [214].

Understanding the experiences and perspectives of people with migraine pertain- ing to preventive treatment characteristics, including delivery mechanisms (e.g., injection devices), is needed to help guide decision-making about preventive treat- ments and, for injectable treatments, the devices for administering them [215, 216]. 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 [217].

We explored what people with episodic or chronic migraine value as key charac- teristics of preventive treatments, including attributes of devices for subcutaneously administering self-injectable treatments.

Methods An in-person focus group study was conducted to identify patient-relevant treat- ment aspects.

The focus groups used a discussion guide, whose design was informed by a tar- geted literature review (Online Resource 1, see the electronic supplementary material). Development of the focus group discussion guide was also based on concepts covered in the Subcutaneous Administration Assessment Questionnaire, a self- administered instrument that evaluates patient experiences of using devices such as a prefilled syringe or autoinjector [218].

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Before the focus groups, there had been no contact between the moderators/co-

moderators and the participants.

Participants were encouraged to share their expectations and concerns about pre- ventive treatments for migraine, to help inform development of benefit and risk attributes for the planned preference study.

The analysis focused on identifying the themes that explain patients’ valuation of key characteristics of preventive treatments for migraine, as well as their percep- tions of differences between treatments and the medical devices for administering them [219–222].

Results Participants in five of the nine focus groups indicated that they would like a preven- tive treatment that allows them to have “normal functions” and live a “normal life,” enabling them to work, leave the house, and perform daily activities that they were otherwise unable to do during a migraine attack.

The most frequently discussed physical adverse event associated with preventive treatment (emerging in six focus groups) was weight change, with which partici- pants from all three countries expressed their dissatisfaction.

After simulating self-injection with the five different medical devices, partici- pants generally preferred autoinjectors over prefilled syringes, describing them with words such as “robust,” “stable,” and “easy to use.”

Device characteristics often judged to contribute to a stable grip included size, material, and shape, with participants across five focus groups expressing concern that they may experience an accident (i.e., the devices might “slip”) during administration.

Discussion This focus group study examined which characteristics of preventive treatments for migraine matter to people with migraine and why, with a focus on gaining insight on preferences for devices used to inject CGRP-targeting mAbs indicated for migraine prevention.

The focus group study also identified a number of adverse events of concern that are linked to oral and self-injectable preventive migraine treatments, including weight change, cognitive problems, and psychological problems; these were antici- pated based on the results of the targeted literature review.

Although the study included people with both episodic and chronic migraine spanning a wide age range (20–69 years) across different countries, the sample may not have been large or diverse enough to fully understand the treatment preferences of people with migraine or to explore any potential differences based on participant characteristics [216].

Conclusion This study will serve as a foundation for future preference studies that aim to quan- tify the trade-offs that people with migraine are willing to make when choosing between different preventive treatments for migraine, including self-injectables.

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Acknowledgement A machine generated summary based on the work of Seo, Jaein; Smith, Charlie A.; Thomas, Caitlin; Tervonen, Tommi; Hareendran, Asha; Ford, Janet H.; Stauffer, Virginia L.; Nicholson, Robert A.; Duffy, Kevin Harrison; Tockhorn-Heidenreich, Antje. 2021 in The Patient - Patient-Centered Outcomes Research.

Real world preventative drug management of migraine among Spanish neurologists