Mapping Migraine-Specific Quality of Life to Health State Utilities in Patients Receiving Rimegepant

DOI: https://doi.org/10.1007/s12325-021-01897-2

Abstract-Summary The objective of this study was to characterize migraine-specific quality of life ver- sion 2.1 (MSQv2) scores and corresponding mapped EuroQol-5 Dimensions-3 Level (EQ-5D-3L) utility values.

Study participants were randomized into two treatment regimens: individuals with 2–14 MMD received rimegepant 75 mg as needed (PRN), and those with 4–14 MMD at baseline who received rimegepant on a fixed every- other- day schedule plus an as needed dose on days they did not treat (QOD + PRN).

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MSQv2 data were available for 1,800 patients: 1,033 with 2–8 MMD in the PRN group, 481 with 9–14 MMD in the PRN group, and 286 with 4–14 MMD in the QOD + PRN group.

For all MSQv2 domains as well as mapped utility values, outcomes improved

over each study visit.

EQ-5D-3L utilities were 0.66, 0.63, and 0.65 for the 2–8 MMD PRN, 9–14

MMD PRN, and 4–14 MMD QOD + PRN groups, respectively.

Rimegepant 75 mg, which has been shown to be associated with reduced MMD, is associated with improvement in MSQv2 domains over time, leading to estimated improvement in EQ-5D-3L utilities.

While this improvement was observed in all patient-groups, it was most pro-

nounced in those with higher MMD and those taking rimegepant QOD + PRN.

Extended: The objective of Study 201 was to evaluate the long-term safety of rimegepant 75  mg and to assess the effects of repeated dosing of rimegepant on MSQv2, and MMD, amongst other endpoints [112–114].

To facilitate future economic analyses of rimegepant 75 mg, the objectives of the current study were to (1) map long-term MSQv2 outcomes from Study 201 to EQ-5D-3L health state utilities using the validated mapping algorithm by Gillard et al. [115], and (2) compare health state utilities across rimegepant 75 mg dosing regimens (PRN or QOD + PRN) and by observed reduction in MMD.

Introduction There is no single gold-standard method to measure the patient experience of migraine and its impact on HRQoL. Generic preference-based measures such as the EuroQol five-dimension (EQ-5D) or Health Utility Index (HUI) have been used to quantify HRQoL, but may not fully characterize the clinical features or burden of migraine [116].

Disease-specific measures such as the Migraine-Specific Quality of Life version 2.1 (MSQv2) and Headache Impact Test (HIT-6) are thought to have better ability to detect change associated with treatment, and are recommended for use in clinical trials for migraine therapies, particularly those with preventive effects [117, 118].

In migraine trials that did not directly measure health-state utilities, mapping algorithms can be used to estimate EuroQol 5-Dimensions 3-Level (EQ-5D-3L) scores from MSQv2 disease-specific HRQoL scores, using mapping by statistical association, as described by Gillard et al. [115].

Methods The MSQv2 is a validated 14-question disease-specific patient-reported outcome (PRO) measure that is frequently used to measure the impact of migraine and mul- tidimensional aspects of preventive treatments’ effectiveness on HRQoL in a mean- ingful way [119, 120].

The United Kingdom (UK) value set was applied by Gillard et al. to a dataset sourced from the International Burden of Migraine Study, which included partici- pants from five Western European countries, as well as from Australia, Brazil, Canada, Taiwan, and the United States (US) [115].

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Using patient-level data from Study 201, MSQv2 values were mapped to EQ-5D-3L utilities using a validated mapping by statistical association algorithm using the method described by Gillard et al. [115].

The model defined for episodic migraine was used and followed the form: This validated algorithm produced statistically significant correlation coefficients between EQ-5D-3L utility scores and MSQv2 scores [115].

MSQv2 has been validated for use in patients with migraine [120], and several

MSQv2 and EQ-5D-3L dimensions overlap with regards to content [115].

Results MSQv2 data were available for 1800 patients: 1033 with 2–8 MMD in the PRN group, 481 with 9–14 MMD in the PRN group, and 286 with 4–14 MMD in the QOD + PRN group [113].

MMD (SD) at baseline was 7.02 (3.74 for the PRN 2–8 group, 12.2 (4.64) for the

PRN 9–14 group, and 9.0 (3.90) for the QOD + PRN 4–14 group.

When the MSQv2 was mapped to EQ-5D-3L utilities, baseline utility values were 0.66, 0.63, and 0.65 for the 2–8 MMD PRN, 9–14 MMD PRN, and 4–14 MMD QOD + PRN groups, respectively.

Discussion This study provides new information about the effects of different rimegepant dos- ing regimens on MMD, MSQv2, and EQ-5D-3L utility scores which may be useful for economic evaluations and decision-making.

EQ-5D-3L utility scores at baseline were 0.66, 0.63, and 0.65 for the 2–8 MMD

PRN, 9–14 MMD PRN, and 4–14 MMD QOD + PRN groups, respectively.

At the end of Study 201, as MMD decreased with rimegepant treatment, MSQv2 increased and EQ-5D-3L utilities increased to 0.75, 0.73, and 0.77 for the three enrollment groups, resulting in change scores from baseline of +0.09, +0.10, and +0.12, respectively.

When comparing the difference in baseline to end-of-study MMD frequency in the present analysis, and corresponding mapped EQ-5D-3L change scores, and comparing them to the difference by MMD in the erenumab/onabotulinumtoxinA analysis, the differences are more pronounced for rimegepant than for erenumab.

Conclusions Rimegepant 75 mg, which has been shown to be associated with reduced MMD in addition to acute treatment effects, is associated with improvement in MSQv2 domains over time, leading to estimated improvement in EQ-5D-3L utilities.

While this improvement was observed in all patient-groups, it was most pro- nounced in those with higher MMD and those taking rimegepant on a fixed QOD plus as-needed dosing schedule.

Acknowledgement A machine generated summary based on the work of Johnston, Karissa M.; L’Italien, Gilbert; Popoff, Evan; Powell, Lauren; Croop, Robert; Thiry, Alexandra; Harris, Linda; Coric, Vladimir; Lipton, Richard B. 2021 in Advances in Therapy.

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