Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society

Diener, Hans-Christoph; Ashina, Messoud; Durand‐Zaleski, Isabelle; Kurth, Tobias; Lantéri-Minet, Michel; Lipton, Richard B.; Ollendorf, Daniel A.; Pozo‐Rosich, Patricia; Tassorelli, Cristina; Terwindt, Gisela M.

doi:10.1177/0333102421989247

Cited by 28 publications

(30 citation statements)

References 68 publications

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“…Since its questions are not disease or occupation-specific, the instrument can be adapted and generalized across different diseases and occupations with ease 33 . Thus, the WPAI is a recommended instrument for use in assessing migraine-specific productivity losses at workplace 34,35 .…”

Section: Impact On Work Productivitymentioning

confidence: 99%

Healthcare resource use and indirect costs associated with migraine in Italy: results from theMy Migraine Voicesurvey

Martelletti

Schwedt

et al. 2021

Journal of Medical Economics

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Aims: To evaluate the healthcare resource use (HRU) and cost of lost productivity due to migraine among Italians with !4 monthly migraine days (MMDs), with a focus on those with !2 prior preventive treatment failures (TFs). Materials and methods: Data from Italian participants from the My Migraine Voice survey were used to assess migraine-related HRU and migraine's impact on work productivity and daily activities using the Work Productivity and Activity Impairment questionnaire. The mean, annualized cost of lost productivity was estimated using the Human Capital Approach and extrapolated to employed Italian population with !4 MMDs to calculate the overall migraine-related indirect cost burden in Italy. Results: Data of 420 participants, enrolled between September 2017 and February 2018, were analyzed (mean age: 38.5 years, 81.2% women, 37.8% with !2 TF). During a 6-month period, 57.6% of participants visited general practitioners (mean visits: 4.5), 31.9% neurologists (mean visits: 2.6), and 26.4% headache specialists (mean visits: 2.8). Overall, 32.0% of participants had !1 emergency room visit (mean visits: 2.8) and 15.0% had !1 hospitalization (mean visits: 2.9) because of migraine in the past 12 months. Participants who were employed (N ¼ 215) reported 15.5% absenteeism, 45.3% presenteeism, 53.8% overall work impairment, and 52.6% activity impairment. The mean annualized indirect cost was estimated to be e14,368. The annual indirect cost burden was estimated to be e7.6 billion for the employed Italian population with !4 MMDs. The impact of migraine was particularly high among the !2 TF subgroups on all parameters. The indirect cost was estimated to be e15,881 (e5,007 attributed to absenteeism). Conclusion: Migraine-related HRU and indirect costs are high among individuals with !4 MMDs (particularly those with !2 TF). There is a need for more effective treatments and better management of migraines to reduce the functional and economic burden among this difficult-to-treat population.

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Section: Impact On Work Productivitymentioning

confidence: 99%

Healthcare resource use and indirect costs associated with migraine in Italy: results from theMy Migraine Voicesurvey

Martelletti

Schwedt

et al. 2021

Journal of Medical Economics

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“…Published findings support the importance of pain freedom at 2 h post dose in determining acute treatment efficacy; this endpoint aligns with patients' wishes for rapid onset and complete relief from pain. In a recent position statement, the IHS recommended criteria for defining failure of a triptan, including an inadequate response at 2 h post dose for pain freedom in at least three migraine attacks (18). The mTOQ is a validated, self-administered questionnaire used to assess the efficacy of current acute migraine treatment (10).…”

Section: Triptan Insufficient Responder Subgroupsmentioning

confidence: 99%

Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study

et al. 2021

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Background A significant proportion of triptan users exhibit an insufficient response or inadequate tolerability to a triptan, and some may develop a contraindication. Lasmiditan, a selective 5-HT1F receptor agonist, may be an option for these individuals. We assessed lasmiditan efficacy in a subgroup of patients in CENTURION (Phase 3 migraine consistency study) who exhibited an insufficient response to triptans, including a subgroup with insufficient response due to efficacy only. Methods Patients were randomized to lasmiditan 200 mg for four attacks, lasmiditan 100 mg for four attacks, or placebo for three and lasmiditan 50 mg for one attack. Triptan insufficient responders were pre-defined as patients with insufficient efficacy or tolerability, or who developed a contraindication. Results In triptan insufficient responders, lasmiditan was superior to placebo ( p < 0.05) for pain freedom beginning at 1 h (both doses); pain relief beginning at 0.5 (200 mg) or 1 h (100 mg); migraine-related disability freedom, much/very much better on the Patient Global Impression of Change, and most bothersome symptom freedom at 2 h; sustained pain freedom; and need for rescue medication. Lasmiditan showed benefit for consistency of effect across attacks for 2-h pain freedom and pain relief. Findings were similar in triptan responders and triptan naïve patients and when the triptan insufficient response definition was based on efficacy only. Conclusions Lasmiditan was efficacious across multiple clinically relevant endpoints in the acute treatment of migraine independent of prior response to triptans. Trial Registration: CENTURION (NCT03670810); SAMURAI (NCT02439320); SPARTAN (NCT02605174)

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“…Health technology assessments can be performed by transnational agencies, but they are often delegated to national or local agencies that use different process and protocols (25,26). The IHS recently published an official position statement intended to facilitate and standardize the conduct of health technology assessments of medications and neuromodulation devices approved and/or cleared for the acute and preventive treatment of migraine (27).…”

Section: Rescue Medication Amentioning

confidence: 99%

Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

Tassorelli

Diener²,

Silberstein

et al. 2021

Cephalalgia

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Background Although the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine. Methods An international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine. Results Key terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created. Conclusions Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.

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Health technology assessment for the acute and preventive treatment of migraine: A position statement of the International Headache Society

Cited by 28 publications

References 68 publications

Healthcare resource use and indirect costs associated with migraine in Italy: results from theMy Migraine Voicesurvey

Healthcare resource use and indirect costs associated with migraine in Italy: results from theMy Migraine Voicesurvey

Lasmiditan efficacy in the acute treatment of migraine was independent of prior response to triptans: Findings from the CENTURION study

Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

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