More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report

On 20 February 2020, the Institute for Clinical and Economic Review (ICER) released its draft evidence report to establish the value of innovative therapies in the treatment of cystic fibrosis. Following its usual practice, ICER contracted with an outside group to construct a value assessment framew...

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Main Author: Paul Langley
Format: Article
Language:English
Published: University of Minnesota Libraries Publishing 2020-03-01
Series:INNOVATIONS in Pharmacy
Subjects:
Online Access:https://pubs.lib.umn.edu/index.php/innovations/article/view/3056
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author Paul Langley
author_facet Paul Langley
author_sort Paul Langley
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description On 20 February 2020, the Institute for Clinical and Economic Review (ICER) released its draft evidence report to establish the value of innovative therapies in the treatment of cystic fibrosis. Following its usual practice, ICER contracted with an outside group to construct a value assessment framework, in this case a microsimulation model, to generate value claims.  The primary outcomes for value claims were incremental cost-per-QALY simulations for four target cystic fibrosis populations. The value assessment, in common with the same model applied earlier by ICER in cystic fibrosis, recommended substantial price discounts based on arbitrary threshold cost-per-QALY values. Unfortunately, the entire exercise, as detailed in previous commentaries in INNOVATIONS in Pharmacy is essentially a waste of time. Not only is the reference case model presented by ICER only one of a multiverse of other models, all driven by a selective application of model structure and assumptions, but the fact that the utilities that are applied to hypothetical time spent in different disease stages to modeled QALYs and lifetime cost-per-QALY claims fail to meet fundamental measurement axioms: they are ordinal manifest scores. Applied to target cystic fibrosis target patient groups, the modeled claims are meaningless. From the manufacturer’s perspective, in this case Vertex Pharmaceuticals who have developed all the cystic fibrosis therapies ‘modeled’ by the ICER contractor, their response to ICER claims should be to reject them out of hand; the constructs are imaginary and the outcome claims nonsense.   Article Type: Commentary
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spelling doaj.art-9e9f8e6b1ada4a72bdde0cdb9c0a42812022-12-21T18:21:09ZengUniversity of Minnesota Libraries PublishingINNOVATIONS in Pharmacy2155-04172020-03-0111110.24926/iip.v11i1.3056More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence ReportPaul Langley0University of MinnesotaOn 20 February 2020, the Institute for Clinical and Economic Review (ICER) released its draft evidence report to establish the value of innovative therapies in the treatment of cystic fibrosis. Following its usual practice, ICER contracted with an outside group to construct a value assessment framework, in this case a microsimulation model, to generate value claims.  The primary outcomes for value claims were incremental cost-per-QALY simulations for four target cystic fibrosis populations. The value assessment, in common with the same model applied earlier by ICER in cystic fibrosis, recommended substantial price discounts based on arbitrary threshold cost-per-QALY values. Unfortunately, the entire exercise, as detailed in previous commentaries in INNOVATIONS in Pharmacy is essentially a waste of time. Not only is the reference case model presented by ICER only one of a multiverse of other models, all driven by a selective application of model structure and assumptions, but the fact that the utilities that are applied to hypothetical time spent in different disease stages to modeled QALYs and lifetime cost-per-QALY claims fail to meet fundamental measurement axioms: they are ordinal manifest scores. Applied to target cystic fibrosis target patient groups, the modeled claims are meaningless. From the manufacturer’s perspective, in this case Vertex Pharmaceuticals who have developed all the cystic fibrosis therapies ‘modeled’ by the ICER contractor, their response to ICER claims should be to reject them out of hand; the constructs are imaginary and the outcome claims nonsense.   Article Type: Commentaryhttps://pubs.lib.umn.edu/index.php/innovations/article/view/3056imaginary worlds, cystic fibrosis, ICER, pseudoscience, nonsense claims, nonsense recommendations
spellingShingle Paul Langley
More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
INNOVATIONS in Pharmacy
imaginary worlds, cystic fibrosis, ICER, pseudoscience, nonsense claims, nonsense recommendations
title More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
title_full More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
title_fullStr More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
title_full_unstemmed More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
title_short More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
title_sort more unnecessary imaginary worlds part 3 cystic fibrosis and the institute for clinical and economic review s draft evidence report
topic imaginary worlds, cystic fibrosis, ICER, pseudoscience, nonsense claims, nonsense recommendations
url https://pubs.lib.umn.edu/index.php/innovations/article/view/3056
work_keys_str_mv AT paullangley moreunnecessaryimaginaryworldspart3cysticfibrosisandtheinstituteforclinicalandeconomicreviewsdraftevidencereport