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Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis

Dyfrig A Hughes, Konstantinos Skiadas, Deborah Fitzsimmons Orcid Logo, Pippa Anderson, Adrian Heald

BMJ Open, Volume: 11, Issue: 12, Start page: e051702

Swansea University Authors: Konstantinos Skiadas, Deborah Fitzsimmons Orcid Logo, Pippa Anderson

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DOI (Published version): 10.1136/bmjopen-2021-051702

Abstract

Objective Medicines with limited evidence of effectiveness are prime candidates for disinvestment. However, investment in further research may be preferable to deimplementation, given that the absence of evidence is not evidence of absence, and research can inform formulary decisions. A case in poin...

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Published in: BMJ Open
ISSN: 2044-6055 2044-6055
Published: BMJ 2021
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A value of information analysis</title><swanseaauthors><author><sid>d12c5c1b38899d247cc40f232ccf31c8</sid><firstname>Konstantinos</firstname><surname>Skiadas</surname><name>Konstantinos Skiadas</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>e900d99a0977beccf607233b10c66b43</sid><ORCID>0000-0002-7286-8410</ORCID><firstname>Deborah</firstname><surname>Fitzsimmons</surname><name>Deborah Fitzsimmons</name><active>true</active><ethesisStudent>false</ethesisStudent></author><author><sid>128cdedfba6e5e6374fdc85d5c78c428</sid><firstname>Pippa</firstname><surname>Anderson</surname><name>Pippa Anderson</name><active>true</active><ethesisStudent>false</ethesisStudent></author></swanseaauthors><date>2021-11-09</date><deptcode>HHE</deptcode><abstract>Objective Medicines with limited evidence of effectiveness are prime candidates for disinvestment. However, investment in further research may be preferable to deimplementation, given that the absence of evidence is not evidence of absence, and research can inform formulary decisions. A case in point is liothyronine, which is sometimes prescribed to levothyroxine-treated patients who continue to experience hypothyroid symptoms. It is a putative low value medicine, associated with uncertainties in both clinical and cost-effectiveness. The aim was to assess the cost-effectiveness of liothyronine in this context, and estimate the value of conducting further research.Design Cost utility and value of information analyses.Setting Primary care within the National Health Service in the UK.Participants Fifty-four levothyroxine-treated patients with persistent symptoms of hypothyroidism.Interventions Liothyronine plus levothyroxine versus levothyroxine alone.Primary and secondary outcome measures Incremental cost per quality-adjusted life year (QALY) gained, and the expected monetary value of sample information.Results 20/54 (37%) of patients who responded to the survey reported severe problems in carrying out usual activities of everyday living and 12/54 (22%) reported severe anxiety or depression symptoms. Mean (SD) utility was 0.53 (0.23). The differences in expected total, 10-year costs and QALYs between a treatment strategy of liothyronine/levothyroxine combination therapy, and levothyroxine alone, was &#xA3;12&#x2009;053 and 1.014, respectively. The incremental cost-effectiveness ratio of &#xA3;11&#x2009;881 per QALY gained was sensitive to the price of liothyronine. The probability of liothyronine/levothyroxine combination therapy being cost effective at a threshold of &#xA3;20&#x2009;000 per QALY was 0.56. The value of reducing uncertainty in the efficacy of treatment was &#xA3;3.64&#x2009;m per year in the UK.Conclusions A definitive clinical trial to confirm clinical effectiveness may be preferable to immediate disinvestment, and would be justified given the value of the information gained far exceeds the cost.</abstract><type>Journal Article</type><journal>BMJ Open</journal><volume>11</volume><journalNumber>12</journalNumber><paginationStart>e051702</paginationStart><paginationEnd/><publisher>BMJ</publisher><placeOfPublication/><isbnPrint/><isbnElectronic/><issnPrint>2044-6055</issnPrint><issnElectronic>2044-6055</issnElectronic><keywords/><publishedDay>3</publishedDay><publishedMonth>12</publishedMonth><publishedYear>2021</publishedYear><publishedDate>2021-12-03</publishedDate><doi>10.1136/bmjopen-2021-051702</doi><url/><notes>Data are available upon reasonable request.</notes><college>COLLEGE NANME</college><department>Swansea Centre for Health Economics</department><CollegeCode>COLLEGE CODE</CollegeCode><DepartmentCode>HHE</DepartmentCode><institution>Swansea University</institution><apcterm>Other</apcterm><funders>Funding for the model development was supported by the All Wales Therapeutics and Toxicology Centre. DAH is recipient of a senior research leader award by Health and Care Research Wales.</funders><lastEdited>2022-07-05T16:27:35.8912312</lastEdited><Created>2021-11-09T09:41:26.2289880</Created><path><level id="1">Faculty of Medicine, Health and Life Sciences</level><level id="2">School of Health and Social Care</level></path><authors><author><firstname>Dyfrig A</firstname><surname>Hughes</surname><order>1</order></author><author><firstname>Konstantinos</firstname><surname>Skiadas</surname><order>2</order></author><author><firstname>Deborah</firstname><surname>Fitzsimmons</surname><orcid>0000-0002-7286-8410</orcid><order>3</order></author><author><firstname>Pippa</firstname><surname>Anderson</surname><order>4</order></author><author><firstname>Adrian</firstname><surname>Heald</surname><order>5</order></author></authors><documents><document><filename>58585__21908__0942e91bd4e748998372ddeb0b32d693.pdf</filename><originalFilename>58585.pdf</originalFilename><uploaded>2021-12-17T16:40:57.4110640</uploaded><type>Output</type><contentLength>672420</contentLength><contentType>application/pdf</contentType><version>Version of Record</version><cronfaStatus>true</cronfaStatus><documentNotes>&#xA9; Author(s) (or their employer(s)) 2021. 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spelling 2022-07-05T16:27:35.8912312 v2 58585 2021-11-09 Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis d12c5c1b38899d247cc40f232ccf31c8 Konstantinos Skiadas Konstantinos Skiadas true false e900d99a0977beccf607233b10c66b43 0000-0002-7286-8410 Deborah Fitzsimmons Deborah Fitzsimmons true false 128cdedfba6e5e6374fdc85d5c78c428 Pippa Anderson Pippa Anderson true false 2021-11-09 HHE Objective Medicines with limited evidence of effectiveness are prime candidates for disinvestment. However, investment in further research may be preferable to deimplementation, given that the absence of evidence is not evidence of absence, and research can inform formulary decisions. A case in point is liothyronine, which is sometimes prescribed to levothyroxine-treated patients who continue to experience hypothyroid symptoms. It is a putative low value medicine, associated with uncertainties in both clinical and cost-effectiveness. The aim was to assess the cost-effectiveness of liothyronine in this context, and estimate the value of conducting further research.Design Cost utility and value of information analyses.Setting Primary care within the National Health Service in the UK.Participants Fifty-four levothyroxine-treated patients with persistent symptoms of hypothyroidism.Interventions Liothyronine plus levothyroxine versus levothyroxine alone.Primary and secondary outcome measures Incremental cost per quality-adjusted life year (QALY) gained, and the expected monetary value of sample information.Results 20/54 (37%) of patients who responded to the survey reported severe problems in carrying out usual activities of everyday living and 12/54 (22%) reported severe anxiety or depression symptoms. Mean (SD) utility was 0.53 (0.23). The differences in expected total, 10-year costs and QALYs between a treatment strategy of liothyronine/levothyroxine combination therapy, and levothyroxine alone, was £12 053 and 1.014, respectively. The incremental cost-effectiveness ratio of £11 881 per QALY gained was sensitive to the price of liothyronine. The probability of liothyronine/levothyroxine combination therapy being cost effective at a threshold of £20 000 per QALY was 0.56. The value of reducing uncertainty in the efficacy of treatment was £3.64 m per year in the UK.Conclusions A definitive clinical trial to confirm clinical effectiveness may be preferable to immediate disinvestment, and would be justified given the value of the information gained far exceeds the cost. Journal Article BMJ Open 11 12 e051702 BMJ 2044-6055 2044-6055 3 12 2021 2021-12-03 10.1136/bmjopen-2021-051702 Data are available upon reasonable request. COLLEGE NANME Swansea Centre for Health Economics COLLEGE CODE HHE Swansea University Other Funding for the model development was supported by the All Wales Therapeutics and Toxicology Centre. DAH is recipient of a senior research leader award by Health and Care Research Wales. 2022-07-05T16:27:35.8912312 2021-11-09T09:41:26.2289880 Faculty of Medicine, Health and Life Sciences School of Health and Social Care Dyfrig A Hughes 1 Konstantinos Skiadas 2 Deborah Fitzsimmons 0000-0002-7286-8410 3 Pippa Anderson 4 Adrian Heald 5 58585__21908__0942e91bd4e748998372ddeb0b32d693.pdf 58585.pdf 2021-12-17T16:40:57.4110640 Output 672420 application/pdf Version of Record true © Author(s) (or their employer(s)) 2021. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license true eng http://creativecommons.org/licenses/by-nc/4.0/
title Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
spellingShingle Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
Konstantinos Skiadas
Deborah Fitzsimmons
Pippa Anderson
title_short Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
title_full Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
title_fullStr Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
title_full_unstemmed Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
title_sort Liothyronine for hypothyroidism: a candidate for disinvestment or in need of further research? A value of information analysis
author_id_str_mv d12c5c1b38899d247cc40f232ccf31c8
e900d99a0977beccf607233b10c66b43
128cdedfba6e5e6374fdc85d5c78c428
author_id_fullname_str_mv d12c5c1b38899d247cc40f232ccf31c8_***_Konstantinos Skiadas
e900d99a0977beccf607233b10c66b43_***_Deborah Fitzsimmons
128cdedfba6e5e6374fdc85d5c78c428_***_Pippa Anderson
author Konstantinos Skiadas
Deborah Fitzsimmons
Pippa Anderson
author2 Dyfrig A Hughes
Konstantinos Skiadas
Deborah Fitzsimmons
Pippa Anderson
Adrian Heald
format Journal article
container_title BMJ Open
container_volume 11
container_issue 12
container_start_page e051702
publishDate 2021
institution Swansea University
issn 2044-6055
2044-6055
doi_str_mv 10.1136/bmjopen-2021-051702
publisher BMJ
college_str Faculty of Medicine, Health and Life Sciences
hierarchytype
hierarchy_top_id facultyofmedicinehealthandlifesciences
hierarchy_top_title Faculty of Medicine, Health and Life Sciences
hierarchy_parent_id facultyofmedicinehealthandlifesciences
hierarchy_parent_title Faculty of Medicine, Health and Life Sciences
department_str School of Health and Social Care{{{_:::_}}}Faculty of Medicine, Health and Life Sciences{{{_:::_}}}School of Health and Social Care
document_store_str 1
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description Objective Medicines with limited evidence of effectiveness are prime candidates for disinvestment. However, investment in further research may be preferable to deimplementation, given that the absence of evidence is not evidence of absence, and research can inform formulary decisions. A case in point is liothyronine, which is sometimes prescribed to levothyroxine-treated patients who continue to experience hypothyroid symptoms. It is a putative low value medicine, associated with uncertainties in both clinical and cost-effectiveness. The aim was to assess the cost-effectiveness of liothyronine in this context, and estimate the value of conducting further research.Design Cost utility and value of information analyses.Setting Primary care within the National Health Service in the UK.Participants Fifty-four levothyroxine-treated patients with persistent symptoms of hypothyroidism.Interventions Liothyronine plus levothyroxine versus levothyroxine alone.Primary and secondary outcome measures Incremental cost per quality-adjusted life year (QALY) gained, and the expected monetary value of sample information.Results 20/54 (37%) of patients who responded to the survey reported severe problems in carrying out usual activities of everyday living and 12/54 (22%) reported severe anxiety or depression symptoms. Mean (SD) utility was 0.53 (0.23). The differences in expected total, 10-year costs and QALYs between a treatment strategy of liothyronine/levothyroxine combination therapy, and levothyroxine alone, was £12 053 and 1.014, respectively. The incremental cost-effectiveness ratio of £11 881 per QALY gained was sensitive to the price of liothyronine. The probability of liothyronine/levothyroxine combination therapy being cost effective at a threshold of £20 000 per QALY was 0.56. The value of reducing uncertainty in the efficacy of treatment was £3.64 m per year in the UK.Conclusions A definitive clinical trial to confirm clinical effectiveness may be preferable to immediate disinvestment, and would be justified given the value of the information gained far exceeds the cost.
published_date 2021-12-03T04:15:13Z
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