Cost-effectiveness of rimegepant oral lyophilisate compared to best supportive care for the acute treatment of migraine in the UK

References

• Headache Classification Committee of the International Headache Society (IHS). The international classification of headache disorders. Cephalalgia. 2018;38(1):1–211. doi: 10.1177/0333102417738202.
   PubMed Web of Science ®Google Scholar
• Mayans L, Walling A. Acute migraine headache: treatment strategies. Am Fam Physician. 2018;97(4):243–251.
   PubMed Web of Science ®Google Scholar
• Ailani J, Burch R, Robbins M. The American headache society consensus statement: update on integrating new migraine treatments into clinical practice. Headache. 2021;61(7):1021–1039. doi: 10.1111/head.14153.
   PubMed Web of Science ®Google Scholar
• Safiri S, Pourfathi H, Eagan A, et al. Global, regional, and national burden of migraine in 204 countries and territories, 1990 to 2019. Pain. 2022;163(2):e293–e309. doi: 10.1097/j.pain.0000000000002275.
   PubMed Web of Science ®Google Scholar
• Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the global burden of disease study 2016. Lancet. 2017;390(10100):1211–1259. doi: 10.1016/S0140-6736(17)32154-2.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Bigal ME, Diamond M, et al. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007;68(5):343–349. doi: 10.1212/01.wnl.0000252808.97649.21.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Rm, Munjal S. One-year incidence of migraine in the US population: results from the migraine in America symptoms and treatment (MAST) study (abstract OR08). Headache. 2019;59:9–10.
   Google Scholar
• National Health Service. Improved NHS migraine care to save thousands of hospital stays. London: NHS; 2020 [cited April 2022]. https://www.england.nhs.uk/2020/01/improved-nhs-migraine-care/
   Google Scholar
• The Work Foundation. Society’s headache: The socioeconomic impact of migraine: The Work Foundation; 2018 [cited April 2022]. https://www.lancaster.ac.uk/media/lancaster-university/content-assets/documents/lums/work-foundation/SocietysHeadacheTheSocioeconomicimpactofmigraine.pdf.
   Google Scholar
• Shapiro RE, Martin AA, Bhardwaj S, et al. Relationships between headache frequency, disability, and disability-related unemployment among adults with migraine. J Manag Care Spec Pharm. 2023;29(2):197–209. doi: 10.18553/jmcp.2023.29.2.197.
   PubMed Web of Science ®Google Scholar
• Fischer M, Frank F, Wille G, et al. Triptans for acute migraine headache: current experience with triptan use and prescription habits in a tertiary care headache outpatient clinic: an observational study. Headache. 2016;56(6):952–960. doi: 10.1111/head.12820.
   PubMed Web of Science ®Google Scholar
• Wells RE, Markowitz SY, Baron EP, et al. Identifying the factors underlying discontinuation of triptans. Headache. 2014;54(2):278–289. doi: 10.1111/head.12198.
   PubMed Web of Science ®Google Scholar
• Holland S, Fanning KM, Serrano D, et al. Rates and reasons for discontinuation of triptans and opioids in episodic migraine: results from the American migraine prevalence and prevention (AMPP) study. J Neurol Sci. 2013;326(1-2):10–17. doi: 10.1016/j.jns.2012.12.020.
   PubMed Web of Science ®Google Scholar
• Hirata K, Ueda K, Komori M, et al. Unmet needs in Japanese patients who report insufficient efficacy with triptans for acute treatment of migraine: retrospective analysis of real-world data. Pain Ther. 2021;10(1):415–432. doi: 10.1007/s40122-020-00223-y.
   PubMed Web of Science ®Google Scholar
• Lombard L, Farrar M, Ye W, et al. A global real-world assessment of the impact on health-related quality of life and work productivity of migraine in patients with insufficient vs good response to triptan medication. J Headache Pain. 2020;21(1):41. doi: 10.1186/s10194-020-01110-9.
   PubMed Web of Science ®Google Scholar
• Marcus SC, Shewale AR, Silberstein SD, et al. Comparison of healthcare resource utilization and costs among patients with migraine with potentially adequate and insufficient triptan response. Cephalalgia. 2020;40(7):639–649. doi: 10.1177/0333102420915167.
   PubMed Web of Science ®Google Scholar
• Korolainen M, Kurki S, Lassenius M, et al. Burden of migraine in Finland: health care resource use, sick-leaves and comorbidities in occupational health care. J Headache Pain. 2019;20(1):13. doi: 10.1186/s10194-019-0964-5.
   PubMedGoogle Scholar
• British Association for the Study of Headache. National headache management system for adults. 2019 [2024 Apr 11]. Available from: https://headache.org.uk/wp-content/uploads/2023/02/bash-guideline-2019.pdf
   Google Scholar
• Harris L, L'Italien G, O'Connell T, et al. A framework for estimating the eligible patient population for new migraine acute therapies in the United States. Adv Ther. 2021;38(10):5087–5097. doi: 10.1007/s12325-021-01781-z.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Reed ML, Kurth T, et al. Framingham‐based cardiovascular risk estimates among people with episodic migraine in the US population: results from the American migraine prevalence and prevention (AMPP) study. Headache. 2017;57(10):1507–1521. doi: 10.1111/head.13179.
   PubMed Web of Science ®Google Scholar
• Buse DC, Reed ML, Fanning KM, et al. Cardiovascular events, conditions, and procedures among people with episodic migraine in the US population: results from the American migraine prevalence and prevention (AMPP) study. Headache. 2017;57(1):31–44. doi: 10.1111/head.12962.
   PubMed Web of Science ®Google Scholar
• Lipton RB, Buse DC, Serrano D, et al. Examination of unmet treatment needs among persons with episodic migraine: results of the American migraine prevalence and prevention (AMPP) study. Headache. 2013;53(8):1300–1311. doi: 10.1111/head.12154.
   PubMed Web of Science ®Google Scholar
• Limmroth V, Katsarava Z, Fritsche G, et al. Features of medication overuse headache following overuse of different acute headache drugs. Neurology. 2002;59(7):1011–1014. doi: 10.1212/wnl.59.7.1011.
   PubMed Web of Science ®Google Scholar
• Dodick DW, Doty EG, Aurora SK, et al. Medication overuse in a subgroup analysis of phase 3 placebo-controlled studies of galcanezumab in the prevention of episodic and chronic migraine. Cephalalgia. 2021;41(3):340–352. doi: 10.1177/0333102420966658.
   PubMed Web of Science ®Google Scholar
• Schwedt TJ, Alam A, Reed ML, et al. Factors associated with acute medication overuse in people with migraine: results from the 2017 migraine in America symptoms and treatment (MAST) study. J Headache Pain. 2018;19(1):38. doi: 10.1186/s10194-018-0865-z.
   PubMed Web of Science ®Google Scholar
• Schwedt TJ, Hentz JG, Sahai-Srivastava S, et al. Headache characteristics and burden from chronic migraine with medication overuse headache: cross-sectional observations from the medication overuse treatment strategy trial. Headache. 2021;61(2):351–362. doi: 10.1111/head.14056.
   PubMed Web of Science ®Google Scholar
• May A, Schulte LH. Chronic migraine: risk factors, mechanisms and treatment. Nat Rev Neurol. 2016;12(8):455–464. doi: 10.1038/nrneurol.2016.93.
   PubMed Web of Science ®Google Scholar
• Mungoven TJ, Henderson LA, Meylakh N. Chronic migraine pathophysiology and treatment: a review of current perspectives. Front Pain Res. 2021;2:705276. doi: 10.3389/fpain.2021.705276.
   Google Scholar
• Rothrock JF. Chronic migraine: medication overuse headache. Headache. 2007;47(3):467–468. doi: 10.1111/j.1526-4610.2007.00748.x.
   PubMed Web of Science ®Google Scholar
• Torres-Ferrús M, Ursitti F, Alpuente A, et al. From transformation to chronification of migraine: pathophysiological and clinical aspects. J Headache Pain. 2020;21(1):42. doi: 10.1186/s10194-020-01111-8.
   PubMed Web of Science ®Google Scholar
• Deighton AM, Harris LA, Johnston K, et al. The burden of medication overuse headache and patterns of switching and discontinuation among triptan users: a systematic literature review. BMC Neurol. 2021;21(1):425. doi: 10.1186/s12883-021-02451-x.
   PubMed Web of Science ®Google Scholar
• Silberstein SD. Practice parameter: evidence-based guidelines for migraine headache (an evidence-based review): report of the quality standards subcommittee of the American academy of neurology. Neurology. 2000;55(6):754–762. doi: 10.1212/wnl.55.6.754.
   PubMed Web of Science ®Google Scholar
• Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the a merican H eadache S ociety evidence assessment of migraine pharmacotherapies. Headache. 2015;55(1):3–20. doi: 10.1111/head.12499.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Excellence. Headaches in over 12s: diagnosis and management: clinical guideline (CG150). Manchester: NICE; 2012 [cited May 2021]. https://www.nice.org.uk/guidance/cg150/chapter/Key-priorities-for-implementation#tensiontype-headache-migraine-and-cluster-headache
   Google Scholar
• Gendolla A, Rauer N, Kraemer S, et al. Epidemiology, demographics, triptan contraindications, and prescription patterns of patients with migraine: a German claims database study. Neurol Ther. 2022;11(1):167–183. doi: 10.1007/s40120-021-00304-w.
   PubMed Web of Science ®Google Scholar
• Piccinni C, Cevoli S, Ronconi G, et al. A real-world study on unmet medical needs in triptan-treated migraine: prevalence, preventive therapies and triptan use modification from a large Italian population along two years. J Headache Pain. 2019;20(1):74. doi: 10.1186/s10194-019-1027-7.
   PubMed Web of Science ®Google Scholar
• European Medicines Agency. Summary of product characteristics: VYDURA 75 mg oral lyophilisate 2023 [cited 2023 Nov 24]. https://www.ema.europa.eu/en/documents/product-information/vydura-epar-product-information_en.pdf.
   Google Scholar
• National Institute for Health and Care Excellence. Rimegepant for treating migraine (TA919) 2023 [cited 2023 Oct 23]. https://www.nice.org.uk/guidance/TA919.
   Google Scholar
• National Institute for Health and Care Excellence. Rimegepant for preventing migraine (TA906). 2023. https://www.nice.org.uk/guidance/TA906.
   Google Scholar
• Scottish Medicines Consortium. Rimegepant (Vydrua®) is accepted for restricted use within NHS Scotland. 2023 [cited 2023 Nov 23]. https://www.scottishmedicines.org.uk/medicines-advice/rimegepant-vydura-resub-smc2603/.
   Google Scholar
• Lipton RB, Blumenfeld A, Jensen CM, et al. Efficacy of rimegepant for the acute treatment of migraine based on triptan treatment experience: pooled results from three phase 3 randomized clinical trials. Cephalalgia. 2023;43(2):3331024221141686. doi: 10.1177/03331024221141686.
   Web of Science ®Google Scholar
• Lipton RB, Berman G, Kudrow D, et al. Long-term, open-label safety study of rimegepant 75 mg for the treatment of migraine (study 201): interim analysis of safety and exploratory efficacy (poster P235LB). Headache. 2019;59(S1):1–208.
   Google Scholar
• L’Italien G, Popoff E, Johnston K, et al. Rimegepant 75 mg for acute treatment of migraine is associated with significant reduction in monthly migraine days: results from a long-term, open-label study. Cephalalgia Rep. 2022;5:251581632210755. doi: 10.1177/25158163221075596.
   Google Scholar
• Atlas S, Touchette D, Agboola F, et al. Acute treatments for migraine: effectiveness and value. 2020 [cited 2022 Jan 18]. http://icer-review.org/material/acute-migraine-evidence-report/.
   Google Scholar
• Biohaven Pharmaceuticals Inc. Data on file: clinical study report BHV3000-303: a Phase 3, Double-blind, Randomized, Placebo-controlled, Safety and Efficacy Trial of BHV-3000 (rimegepant) Orally Disintegrating Tablet (ODT) for the Acute Treatment of Migraine. 2019.
   Google Scholar
• National Institute for Health and Clinical Excellence. Guide to the methods of technology appraisal 2013. Manchester: NICE; 2013. https://www.nice.org.uk/process/pmg9/resources/guide-to-the-methods-of-technology-appraisal-2013-pdf-2007975843781
   Google Scholar
• Touchette D, Atlas S, Agboola F, et al. Pnd15 long-term cost-effectiveness of lasmiditan, ubrogepant and rimegepant for treatment of acute migraine. Value Health. 2020;23: S261. doi: 10.1016/j.jval.2020.04.908.
   Web of Science ®Google Scholar
• Diener H, Holle-Lee D, Nagel S, et al. Treatment of migraine attacks and prevention of migraine: guidelines by the German migraine and headache society and the German society of neurology. Clin Transl Neurosci. 2019;3:1–40. doi: 10.1177/2514183X18823377.
   Google Scholar
• National Institute for Health and Clinical Excellence. Erenumab for preventing migraine: Technology appraisal guidance (TA682). Manchester: NICE; 2021 [cited Apr 2022]. https://www.nice.org.uk/guidance/ta682/resources/erenumab-for-preventing-migraine-pdf-82609376694469.
   Google Scholar
• National Institute for Health and Clinical Excellence. Fremanezumab for preventing migraine technology appraisal guidance (TA764). Manchester: NICE; 2022 [cited Apr 2022]. https://www.nice.org.uk/guidance/ta764
   Google Scholar
• Croop R, Goadsby PJ, Stock DA, et al. Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial. Lancet. 2019;394(10200):737–745. doi: 10.1016/S0140-6736(19)31606-X.
   PubMed Web of Science ®Google Scholar
• Croop R, Lipton RB, Kudrow D, et al. Oral rimegepant for preventive treatment of migraine: a phase 2/3, randomised, double-blind, placebo-controlled trial. Lancet. 2021;397(10268):51–60. doi: 10.1016/S0140-6736(20)32544-7.
   PubMed Web of Science ®Google Scholar
• Office for National Statistics. National life tables, United Kingdom 2018-2020. 2021 [cited 2022 Jan 2022]. https://www.ons.gov.uk/peoplepopulationandcommunity/birthsdeathsandmarriages/lifeexpectancies/bulletins/nationallifetablesunitedkingdom/2018to2020.
   Google Scholar
• Vetvik KG, MacGregor EA. Sex differences in the epidemiology, clinical features, and pathophysiology of migraine. Lancet Neurol. 2017;16(1):76–87. doi: 10.1016/s1474-4422(16)30293-9.
   PubMed Web of Science ®Google Scholar
• Faubion SS, Batur P, Calhoun AH. Migraine throughout the female reproductive life cycle. Mayo Clin Proc. 2018;93(5):639–645. doi: 10.1016/j.mayocp.2017.11.027.
   PubMed Web of Science ®Google Scholar
• Vos T, Allen C, Arora M, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries; 2015: a systematic analysis for the global burden of disease study 2015. Lancet. 2016;388(10053):1545–1602. doi: 10.1016/S0140-6736(16)31678-6.
   PubMed Web of Science ®Google Scholar
• Martelletti P, Schwedt TJ, Lanteri-Minet M, et al. My migraine voice survey: a global study of disease burden among individuals with migraine for whom preventive treatments have failed. J Headache Pain. 2018;19(1):115. doi: 10.1186/s10194-018-0946-z.
   PubMed Web of Science ®Google Scholar
• Lipton RBC, Stock EG, Stock D. et al. Efficacy, safety, and tolerability of rimegepant 75 Mg, an oral CGRP receptor antagonist, for the acute treatment of migraine: results from a double-blind, randomized, placebo-controlled trial, study, 301. Headache. 2018;58(8):1336–1337. doi: 10.1111/head.13411
   Google Scholar
• Lipton RB, Cr Stock EG, Stock DA, et al. Rimegepant, an oral calcitonin gene-related peptide receptor antagonist, for migraine. N Engl J Med. 2019;381(2):142–149.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Care Excellence. Committee papers – Rimegepant for treating acute migraine [ID1539]. 2023 [cited 2023 Oct 23]. https://www.nice.org.uk/guidance/ta919/documents/committee-papers-3.
   Google Scholar
• Yu S, Ma L, Zhong Q, et al. Interim results of a long-term safety study of 75 mg rimegepant administered as needed in acute treatment of migraine among Chinese adults. Seoul, Republic of Korea: International Headache Congress; 2023.
   Google Scholar
• Gillard PJ, Devine B, Varon SF, et al. Mapping from disease-specific measures to health-state utility values in individuals with migraine. Value Health. 2012;15(3):485–494. doi: 10.1016/j.jval.2011.12.007.
   PubMed Web of Science ®Google Scholar
• National Institute for Health and Clinical Excellence. Galcanezumab for preventing migraine: Technology appraisal guidance (TA659). Manchester: NICE; 2020 [cited April 2022]. https://www.nice.org.uk/guidance/ta659.
   Google Scholar
• Stafford M, Hareendran A, Ng-Mak D, et al. EQ-5D™-derived utility values for different levels of migraine severity from a UK sample of migraineurs. Health Qual Life Outcomes. 2012;10(1):65. doi: 10.1186/1477-7525-10-65.
   PubMedGoogle Scholar
• Vo P, Fang J, Bilitou A, et al. Patients’ perspective on the burden of migraine in Europe: a cross-sectional analysis of survey data in France, Germany, Italy, Spain, and the United Kingdom. J Headache Pain. 2018;19(1):82. doi: 10.1186/s10194-018-0907-6.
   PubMed Web of Science ®Google Scholar
• British National Formulary. Drug acquisition cost for rimegepant 8-pack. 2022 [cited 2022 May 1]. https://bnf.nice.org.uk/drug/.
   Google Scholar
• Lipton R, Berman G, Kudrow D, et al. Long-term, open-label safety study of rimegepant 75 mg for the treatment of migraine (study 201): interim analysis of safety and exploratory efficacy (abstract P235LB). Headache. 2019;59(S1):175.
   Google Scholar
• Jones K, Burns A. Unit costs of health and social care Canterbury (kent). Personal Social Services Research Unit, University of Kent; 2021. https://kar.kent.ac.uk/92342/
   Google Scholar
• NHS Improvement. National schedule of NHS costs – Year 2019–2020. 2022. https://www.england.nhs.uk/national-cost-collection/.
   Google Scholar
• Schürks M, Rist P, Shapiro R, et al. Migraine and mortality: a systematic review and meta-analysis. Cephalalgia. 2011;31(12):1301–1314. doi: 10.1177/0333102411415879.
   PubMed Web of Science ®Google Scholar
• Johnston K, Harris L, Powell L, et al. Monthly migraine days, tablet utilization, and quality of life associated with rimegepant – post hoc results from an open label safety study (BHV3000–201). J Headache Pain. 2022;23(1):10. doi: 10.1186/s10194-021-01378-5.
   PubMed Web of Science ®Google Scholar
• Hubig LT, Smith T, Williams E, et al. Measuring interictal burden among people affected by migraine: a descriptive survey study. J Headache Pain. 2022;23(1):97. doi: 10.1186/s10194-022-01467-z.
   PubMed Web of Science ®Google Scholar
• Lo SH, Gallop K, Smith T, et al. Real-World experience of interictal burden and treatment in migraine: a qualitative interview study. J Headache Pain. 202 2;23(1):65. doi: 10.1186/s10194-022-01429-5.
   PubMed Web of Science ®Google Scholar
• Xu R, Insinga RP, Golden W, et al. EuroQol (EQ-5D) health utility scores for patients with migraine. Qual Life Res. 2011;20(4):601–608. doi: 10.1007/s11136-010-9783-5.
   PubMed Web of Science ®Google Scholar
• Drummond MF, Sculpher MJ, Claxton K, et al. Methods for the economic evaluation of health care programmes. Oxford: Oxford university press; 2015.
   Google Scholar
• Biohaven Pharmaceuticals Inc. Data on File: clinical study report BHV3000-201: a multicenter, open-label long-term safety study of BHV-3000 in the acute treatment of migraine. 2020.
   Google Scholar
• L’Italien G, Harris LA, Mohajer A, et al. Reduction in point prevalence of medication overuse headache following initiation of Nurtec ODT treatment– A real world administrative claims study. American Academy of Neurology 2022 Annual Meeting; April 2-7; Seattle, WA2022. doi: 10.1212/WNL.98.18_supplement.3698.
   Google Scholar
• Sacco S, Lampl C, Amin FM, et al. European headache federation (EHF) consensus on the definition of effective treatment of a migraine attack and of triptan failure. J Headache Pain. 2022 2022;23(1):133. doi: 10.1186/s10194-022-01502-z.
   PubMed Web of Science ®Google Scholar
• Steiner TJ, Jensen R, Katsarava Z, et al. Aids to management of headache disorders in primary care (2nd edition): on behalf of the european headache federation and lifting the burden: the global campaign against headache. J Headache Pain. 2019;20(1):57. doi: 10.1186/s10194-018-0899-2.
   PubMed Web of Science ®Google Scholar
• Turner IM, Pavlovic JM, B L R, et al. P0275: Patient preference, satisfaction, and improved clinical global impression of change with rimegepant 75 mg for the acute treatment of migraine: results from a long-term Open-Label safety study. The International Headache Congress – IHS and EHF Joint Congress 2021. J Headache Pain. 2021;22(1):103. doi: 10.1186/s10194-021-01293-9.
   PubMed Web of Science ®Google Scholar