A Managed Access Protocol for Liraglutide for Weight Management: A Retrospective, Observational Study in Ireland.

Barrett R, Smith A, Gorry C, Doran S, Barry M, McCullagh L

Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research15 Apr 2025

PMID40246067DOI10.1016/j.jval.2025.03.017PepBankPUB-40246067

Publisher page PubMedAsk about this study

Summary

ObjectivesPivotal trial data highlight that liraglutide (Saxenda) is effective for weight management, versus placebo. However, cost-effectiveness in Ireland, is not proven. Here, we demonstrate how a Managed Access Protocol (MAP) in Ireland's healthcare service facilitates access to this high-budget-impact drug in a real-world subpopulation (of the fully licensed population), in whom the intervention is expected to be the most cost-effective, as determined by health technology assessment, while containing overall expenditure.MethodsTwo key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database. Key characteristics of the applications approved for reimbursement under the MAP were compared with (1) those of an identified pivotal trial subgroup and (2) those not approved for reimbursement under the MAP. Utilization and expenditure were compared with those predicted in the absence of the MAP.ResultsOf the 7927 applications submitted in the first year of the MAP by physicians for individual patients, 52.2% were approved. Differences were noted in most of the key characteristics (including mean age, mean HbA1c, and mean body mass index) in the groups compared. Expenditure on liraglutide was approximately €3.1 million in 2023. Had all applications submitted under the MAP had been approved, expenditure of up to €5.5 million would have been expected.ConclusionsThe MAP facilitates access for a subpopulation in whom liraglutide is effective and also expected to be most cost-effective, according to health technology assessment.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone6

In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Liraglutide.

01HumanNot a test of Liraglutide aloneObservational studyOther
In the Irish liraglutide managed-access program, 52.2% of 7927 physician applications submitted in its first year were approved; applications are administrative units, not a clinical analyzed N.
In plain wordsIn Ireland’s liraglutide access program, 52.2% of 7927 first-year applications were approved.
Peptide
Liraglutide
Outcome
Not applicableApproved managed-access applications
Study
n: not reported in source
Outcome group
Healthcare costs and utilization · Whole body
Measurements
applications
7927
first year
approval rate
52.2%
first year
Source sentences
Summary
Of the 7927 applications submitted in the first year of the MAP by physicians for individual patients, 52.2% were approved.
2 context sentences(design, population, supporting numbers)
Summary · context
Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database.
Summary · context
Key characteristics of the applications approved for reimbursement under the MAP were compared with (1) those of an identified pivotal trial subgroup and (2) those not approved for reimbursement under the MAP.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-4024606701
02HumanNot a test of Liraglutide aloneObservational studyOther
In Ireland’s liraglutide managed-access program, actual liraglutide expenditure was approximately €3.1 million in 2023.
In plain wordsIn Ireland’s liraglutide access program, actual spending was about €3.1 million in 2023.
Peptide
Liraglutide
Outcome
Not applicableLiraglutide expenditure
Study
n: not reported in source
Outcome group
Healthcare costs and utilization · Whole body
Measurements
Actual expenditure
≈ 3.1 million euros
Ireland, 2023
Source sentences
Summary
Expenditure on liraglutide was approximately €3.1 million in 2023.
2 context sentences(design, population, supporting numbers)
Summary · context
Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database.
Summary · context
Utilization and expenditure were compared with those predicted in the absence of the MAP.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-4024606702
03HumanNot a test of Liraglutide aloneObservational studyOther
In Ireland’s liraglutide managed-access study, approving every submitted application was projected to produce expenditure of up to €5.5 million; this was a counterfactual administrative forecast.
In plain wordsIn Ireland’s liraglutide access study, approving every submitted application was expected to cost up to €5.5 million.
Peptide
Liraglutide
Outcome
Not applicableExpected expenditure if all submitted applications were approved
Study
n: not reported in source
Outcome group
Healthcare costs and utilization · Whole body
Measurements
Expected expenditure
≤ 5.5 million euros
counterfactual: every submitted MAP application approved
Source sentences
Summary
Had all applications submitted under the MAP had been approved, expenditure of up to €5.5 million would have been expected.
2 context sentences(design, population, supporting numbers)
Summary · context
Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database.
Summary · context
Utilization and expenditure were compared with those predicted in the absence of the MAP.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-4024606703
04HumanNot a test of Liraglutide aloneObservational studyOther
In Ireland’s liraglutide managed-access study, mean age differed among compared applicant/trial groups; the difference direction, coefficient and exact pairwise reference were unstated.
In plain wordsIn Ireland’s liraglutide access study, compared applicant/trial groups differed in age; direction and exact pairwise estimates were unstated.
Peptide
Liraglutide
Outcome
Direction not reportedApplication-group mean age difference
Study
n: not reported in source
Comparator
Pivotal-trial subgroup and applications not approved under MAP; exact pairwise estimate unstated
Outcome group
Overall treatment effect · Whole body
Source sentences
Summary
Differences were noted in most of the key characteristics (including mean age, mean HbA1c, and mean body mass index) in the groups compared.
2 context sentences(design, population, supporting numbers)
Summary · context
Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database.
Summary · context
Key characteristics of the applications approved for reimbursement under the MAP were compared with (1) those of an identified pivotal trial subgroup and (2) those not approved for reimbursement under the MAP.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-4024606704
05HumanNot a test of Liraglutide aloneObservational studyOther
In Ireland’s liraglutide managed-access study, mean HbA1c differed among compared applicant/trial groups; the difference direction, coefficient and exact pairwise reference were unstated.
In plain wordsIn Ireland’s liraglutide access study, compared applicant/trial groups differed in HbA1c; direction and exact pairwise estimates were unstated.
Peptide
Liraglutide
Outcome
Direction not reportedApplication-group mean HbA1c difference
Study
n: not reported in source
Comparator
Pivotal-trial subgroup and applications not approved under MAP; exact pairwise estimate unstated
Outcome group
Overall treatment effect · Whole body
Source sentences
Summary
Differences were noted in most of the key characteristics (including mean age, mean HbA1c, and mean body mass index) in the groups compared.
2 context sentences(design, population, supporting numbers)
Summary · context
Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database.
Summary · context
Key characteristics of the applications approved for reimbursement under the MAP were compared with (1) those of an identified pivotal trial subgroup and (2) those not approved for reimbursement under the MAP.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-4024606705
06HumanNot a test of Liraglutide aloneObservational studyOther
In Ireland’s liraglutide managed-access study, mean body mass index differed among compared applicant/trial groups; the difference direction, coefficient and exact pairwise reference were unstated.
In plain wordsIn Ireland’s liraglutide access study, compared applicant/trial groups differed in BMI; direction and exact pairwise estimates were unstated.
Peptide
Liraglutide
Outcome
Direction not reportedApplication-group mean body mass index difference
Study
n: not reported in source
Comparator
Pivotal-trial subgroup and applications not approved under MAP; exact pairwise estimate unstated
Outcome group
Overall treatment effect · Whole body
Source sentences
Summary
Differences were noted in most of the key characteristics (including mean age, mean HbA1c, and mean body mass index) in the groups compared.
2 context sentences(design, population, supporting numbers)
Summary · context
Two key data sources were analyzed; (1) national anonymized MAP database of liraglutide applications and (2) national reimbursed pharmacy claims database.
Summary · context
Key characteristics of the applications approved for reimbursement under the MAP were compared with (1) those of an identified pivotal trial subgroup and (2) those not approved for reimbursement under the MAP.
In this study, Liraglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Liraglutide.
Show in the study text Report a problemFND-4024606706

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Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
12 Oct 2026, 11:11 UTC
Study results updated
Version 1
9 Oct 2026, 03:04 UTC
First added · source update from Europe PMC

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