Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany

Abstract Background Monoclonal antibodies (mAbs) targeting the Calcitonin Gene-Related Peptide (CGRP) pathway are safe and effective treatments for migraine prevention. However, the high cost of these novel therapies has led to reimbursement policies requiring patients to try multiple traditional pr...

Full description

Bibliographic Details
Main Authors: Ja Bin Hong, Kristin Sophie Lange, Mira Fitzek, Lucas Hendrik Overeem, Paul Triller, Anke Siebert, Uwe Reuter, Bianca Raffaelli
Format: Article
Language:English
Published: BMC 2023-10-01
Series:The Journal of Headache and Pain
Subjects:
Online Access:https://doi.org/10.1186/s10194-023-01682-2
_version_ 1797636740055302144
author Ja Bin Hong
Kristin Sophie Lange
Mira Fitzek
Lucas Hendrik Overeem
Paul Triller
Anke Siebert
Uwe Reuter
Bianca Raffaelli
author_facet Ja Bin Hong
Kristin Sophie Lange
Mira Fitzek
Lucas Hendrik Overeem
Paul Triller
Anke Siebert
Uwe Reuter
Bianca Raffaelli
author_sort Ja Bin Hong
collection DOAJ
description Abstract Background Monoclonal antibodies (mAbs) targeting the Calcitonin Gene-Related Peptide (CGRP) pathway are safe and effective treatments for migraine prevention. However, the high cost of these novel therapies has led to reimbursement policies requiring patients to try multiple traditional preventives before access. In Germany, a recent change in insurance policy significantly expanded coverage for the CGRP receptor mAb erenumab, enabling migraine patients who failed just one prior prophylactic medication to receive this mAb. Here, we compare the clinical response to treatment with erenumab in migraine patients treated using the old and new coverage policy. Methods In this retrospective cohort study, we included CGRP-mAb naïve patients with episodic or chronic migraine, who started erenumab at our headache center according to either the old or the new insurance policy and received at least 3 consecutive injections. Headache diaries and electronic documentation were used to evaluate reductions in monthly headache and migraine days (MHD and MMD) and ≥ 50% and ≥ 30% responder rates at month 3 (weeks 9–12) of treatment. Results We included 146 patients who received erenumab according to the old policy and 63 patients that were treated using the new policy. At weeks 9–12 of treatment, 37.7% of the old policy group had a 50% or greater reduction in MHD, compared to 63.5% of the new policy group (P < 0.001). Mean reduction in MHD was 5.02 days (SD = 5.46) and 6.67 days (SD = 5.32, P = 0.045) in the old and new policy cohort, respectively. After propensity score matching, the marginal effect of the new policy on treatment outcome was 2.29 days (standard error, SE: 0.715, P = 0.001) more reduction in MHD, and 30.1% (SE: 10.6%, P = 0.005) increase in ≥ 50% response rate for MHD. Conclusions Starting erenumab earlier in the course of migraine progression in a real-world setting may lead to a better response than starting after multiple failed prophylactic attempts. Continually gathering real-world evidence may help policymakers in deciding how readily to cover CGRP-targeted therapies in migraine prevention.
first_indexed 2024-03-11T12:38:26Z
format Article
id doaj.art-2b3af9fda92b4d4494c9c4f5fded28b5
institution Directory Open Access Journal
issn 1129-2377
language English
last_indexed 2024-03-11T12:38:26Z
publishDate 2023-10-01
publisher BMC
record_format Article
series The Journal of Headache and Pain
spelling doaj.art-2b3af9fda92b4d4494c9c4f5fded28b52023-11-05T12:25:14ZengBMCThe Journal of Headache and Pain1129-23772023-10-0124111010.1186/s10194-023-01682-2Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from GermanyJa Bin Hong0Kristin Sophie Lange1Mira Fitzek2Lucas Hendrik Overeem3Paul Triller4Anke Siebert5Uwe Reuter6Bianca Raffaelli7Department of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinDepartment of Neurology, Charité-Universitätsmedizin BerlinAbstract Background Monoclonal antibodies (mAbs) targeting the Calcitonin Gene-Related Peptide (CGRP) pathway are safe and effective treatments for migraine prevention. However, the high cost of these novel therapies has led to reimbursement policies requiring patients to try multiple traditional preventives before access. In Germany, a recent change in insurance policy significantly expanded coverage for the CGRP receptor mAb erenumab, enabling migraine patients who failed just one prior prophylactic medication to receive this mAb. Here, we compare the clinical response to treatment with erenumab in migraine patients treated using the old and new coverage policy. Methods In this retrospective cohort study, we included CGRP-mAb naïve patients with episodic or chronic migraine, who started erenumab at our headache center according to either the old or the new insurance policy and received at least 3 consecutive injections. Headache diaries and electronic documentation were used to evaluate reductions in monthly headache and migraine days (MHD and MMD) and ≥ 50% and ≥ 30% responder rates at month 3 (weeks 9–12) of treatment. Results We included 146 patients who received erenumab according to the old policy and 63 patients that were treated using the new policy. At weeks 9–12 of treatment, 37.7% of the old policy group had a 50% or greater reduction in MHD, compared to 63.5% of the new policy group (P < 0.001). Mean reduction in MHD was 5.02 days (SD = 5.46) and 6.67 days (SD = 5.32, P = 0.045) in the old and new policy cohort, respectively. After propensity score matching, the marginal effect of the new policy on treatment outcome was 2.29 days (standard error, SE: 0.715, P = 0.001) more reduction in MHD, and 30.1% (SE: 10.6%, P = 0.005) increase in ≥ 50% response rate for MHD. Conclusions Starting erenumab earlier in the course of migraine progression in a real-world setting may lead to a better response than starting after multiple failed prophylactic attempts. Continually gathering real-world evidence may help policymakers in deciding how readily to cover CGRP-targeted therapies in migraine prevention.https://doi.org/10.1186/s10194-023-01682-2MigrainePreventive treatmentMonoclonal antibodiesCalcitonin gene-related peptideErenumabInsurance coverage
spellingShingle Ja Bin Hong
Kristin Sophie Lange
Mira Fitzek
Lucas Hendrik Overeem
Paul Triller
Anke Siebert
Uwe Reuter
Bianca Raffaelli
Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany
The Journal of Headache and Pain
Migraine
Preventive treatment
Monoclonal antibodies
Calcitonin gene-related peptide
Erenumab
Insurance coverage
title Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany
title_full Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany
title_fullStr Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany
title_full_unstemmed Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany
title_short Impact of a reimbursement policy change on treatment with erenumab in migraine – a real-world experience from Germany
title_sort impact of a reimbursement policy change on treatment with erenumab in migraine a real world experience from germany
topic Migraine
Preventive treatment
Monoclonal antibodies
Calcitonin gene-related peptide
Erenumab
Insurance coverage
url https://doi.org/10.1186/s10194-023-01682-2
work_keys_str_mv AT jabinhong impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT kristinsophielange impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT mirafitzek impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT lucashendrikovereem impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT paultriller impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT ankesiebert impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT uwereuter impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany
AT biancaraffaelli impactofareimbursementpolicychangeontreatmentwitherenumabinmigrainearealworldexperiencefromgermany