Paul C. Langley
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View article: Rejecting False Claims from Markov Simulations in Alzheimer's Disease
Rejecting False Claims from Markov Simulations in Alzheimer's Disease Open
There is no abstract as this is a letter
View article: After The QALY: Training for a New Start Paradigm in Health Technology Assessment
After The QALY: Training for a New Start Paradigm in Health Technology Assessment Open
INTRODUCTION There is a need for a new paradigm to support health technology assessment (HTA). A recent evaluation of the status of the standards for therapy assessment in HTA concluded that practitioners were locked into a meme, rather th…
View article: Post-Menopausal Quality of Life Claims: Overlooking the Requirements of Normal Science and Fundamental Measurement in ICER’S Cost-Effectiveness Assessment of Fezolinetant for Moderate to Severe Vasomotor Symptoms
Post-Menopausal Quality of Life Claims: Overlooking the Requirements of Normal Science and Fundamental Measurement in ICER’S Cost-Effectiveness Assessment of Fezolinetant for Moderate to Severe Vasomotor Symptoms Open
One of the signal failures in health technology assessment is the absence of consideration given, not only to the standards of normal science, but to those of fundamental measurement. A recent evidence report by the Institute for Clinical …
View article: Rasch Measurement and Patient Reported Value Claims: A Primer for Hemophilia
Rasch Measurement and Patient Reported Value Claims: A Primer for Hemophilia Open
This commentary proposes that Rasch Measurement Theory (RMT) is an innovative method for assessments of patient-centric therapy response in hemophilia A and B, as they are in other disease states or target patient populations. RMT is a nec…
View article: Evidentiary Standards for Patient-Centered Core Impact (PC-CIS) Value Claims
Evidentiary Standards for Patient-Centered Core Impact (PC-CIS) Value Claims Open
Proposals for a patient centered core impact set (PC-CIS) are of little relevance to formulary and health system decisions, let alone patients and providers, unless the elements included in the data set meet the standards of normal science…
View article: Formulary Submissions: Value Claims, Protocols and Outcomes Based Contracting in Rare Disease
Formulary Submissions: Value Claims, Protocols and Outcomes Based Contracting in Rare Disease Open
Outcomes based payments contracting is in its infancy. The increased attention being given to rare disease place a premium on the ability to engage with payers to ensure that there is an analytical framework relevant to value claims contra…
View article: Facilitating bias in cost-effectiveness analysis: CHEERS 2022 and the creation of assumption-driven imaginary value claims in health technology assessment
Facilitating bias in cost-effectiveness analysis: CHEERS 2022 and the creation of assumption-driven imaginary value claims in health technology assessment Open
The current standards for health technology cost-effectiveness assessment rest on the creation of lifetime assumption-driven modeled simulations for imaginary pricing and consequent patient access recommendations. A recent BMJ paper report…
View article: Concerns with Patient Reported Outcome Measurement and Value Claims for Therapy Response: The Case of Mavacamten and Symptomatic Hypertrophic Cardiomyopathy (SHCM)
Concerns with Patient Reported Outcome Measurement and Value Claims for Therapy Response: The Case of Mavacamten and Symptomatic Hypertrophic Cardiomyopathy (SHCM) Open
Fundamental measurement is the basis for a rational assessment of patient reported outcome (PRO) value claims; both as response to therapy and the submission of credible and evaluable value claims to formulary committees and other health s…
View article: Mapping Impossible Utilities: The ICER Report on Tezepelumab for Severe Asthma
Mapping Impossible Utilities: The ICER Report on Tezepelumab for Severe Asthma Open
The focus of this commentary is on the attempt to create EQ-5D-3L ordinal preferences from a disease specific asthma questionnaire, the Asthma Quality of Life Questionnaire (AQLQ). The question is whether it is possible from the perspectiv…
View article: Nothing to Cheer About: Endorsing Imaginary Economic Evaluations and Value Claims with CHEERS 22
Nothing to Cheer About: Endorsing Imaginary Economic Evaluations and Value Claims with CHEERS 22 Open
One of the more unfortunate features of health technology assessment is the tenacity with which leaders in the field and organizations such as the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the Institute …
View article: A Critical Examination for the Pricing of Eculizumab and Efgartigimod in Myasthenia Gravis
A Critical Examination for the Pricing of Eculizumab and Efgartigimod in Myasthenia Gravis Open
The purpose of this commentary is to focus on the downside of assumption-driven simulation modeling, the potential creation of a multitude of competing models, the mathematically impossible quality adjusted life year (QALY) and the failure…
View article: A Critical Examination of Simulation Pricing and Access Recommendations for Atopic Dermatitis
A Critical Examination of Simulation Pricing and Access Recommendations for Atopic Dermatitis Open
It has been demonstrated conclusively that value and utility preference scores have only ordinal properties. This means, as has been pointed out on numerous occasions, that the quality adjusted life year (QALY) is a mathematically impossib…
View article: Abandoning Eugenics and the QALY
Abandoning Eugenics and the QALY Open
Should decision making in health care, notably in respect of the allocation of resources between individuals and disease states, rest on notions of the burden of disease and denial of care as assessed by societal evaluations or on the exte…
View article: Supping with the Devil: Belief and the Imaginary World of Multiple Myeloma Therapies Invented by the Institute for Clinical and Economic Review
Supping with the Devil: Belief and the Imaginary World of Multiple Myeloma Therapies Invented by the Institute for Clinical and Economic Review Open
Previous commentaries in Innovations in Pharmacy and other peer reviewed journals have made the case that the analytical framework, if that is not too strong a term, to support pricing and access recommendations endorsed by the Institute f…
View article: Peter Rabbit is a Badger in Disguise: Deconstructing the Belief System of the Institute for Clinical and Economic Review in Health Technology Assessment
Peter Rabbit is a Badger in Disguise: Deconstructing the Belief System of the Institute for Clinical and Economic Review in Health Technology Assessment Open
The Institute for Clinical and Economic Review (ICER), a Boston-based consulting group, has seen itself as the lead organization in the US for evaluating pharmaceuticals and, at product launch, making recommendations for pricing and access…
View article: Fundamental Outcome Measurement: Selecting Patient Reported Outcome Instruments and Interpreting the Data they Produce
Fundamental Outcome Measurement: Selecting Patient Reported Outcome Instruments and Interpreting the Data they Produce Open
Over the past 40 years literally thousands of generic and disease specific patient reported outcome (PRO) instruments have been developed. While most were developed for a specific study and were never used again, there is still the questio…
View article: Fundamental Measurement: The Need Fulfilment Quality of Life (N-QOL) Measure
Fundamental Measurement: The Need Fulfilment Quality of Life (N-QOL) Measure Open
The quality adjusted life year (QALY) has serious problems related to its failure to adhere to measurement theory. If a QALY is to be meaningful, the utility score that translates time spent to an equivalent time spent in so-called perfect…
View article: Medicaid Formulary Decisions and the Institute for Clinical and Economic Review: Abandoning Pseudoscience in Imaginary Pharmaceutical Pricing Claims
Medicaid Formulary Decisions and the Institute for Clinical and Economic Review: Abandoning Pseudoscience in Imaginary Pharmaceutical Pricing Claims Open
Medicaid formulary committees and other gatekeepers face a difficult task. On the one hand they can utilize technical expertise in evaluating the real world evidence for clinical, quality of life and resource utilization claims for competi…
View article: Let a Thousand Models Bloom: ICER Analytics Opens the Floodgates to Cloud Pseudoscience
Let a Thousand Models Bloom: ICER Analytics Opens the Floodgates to Cloud Pseudoscience Open
It has been noted on numerous occasions that modeled claims for cost-effectiveness, if driven by assumption for the lifetime of a hypothetical patient population, can be easily ‘gamed’ to create a required claim. These marketing exercises …
View article: To Dream the Impossible Dream: The Commitment by the Institute for Clinical and Economic Review to Rewrite the Axioms of Fundamental Measurement for Hemophilia A and Bladder Cancer Value Claims
To Dream the Impossible Dream: The Commitment by the Institute for Clinical and Economic Review to Rewrite the Axioms of Fundamental Measurement for Hemophilia A and Bladder Cancer Value Claims Open
Understandably, after 30 years of ignoring the axioms of fundamental measurement, advocates of creating approximate information through the construction of lifetime cost-per-QALY worlds are somewhat unnerved by the realization that their m…
View article: Value Assessment, Real World Evidence and Fundamental Measurement: Version 3.0 of the Minnesota Formulary Submission Guidelines
Value Assessment, Real World Evidence and Fundamental Measurement: Version 3.0 of the Minnesota Formulary Submission Guidelines Open
This latest version of the Minnesota guidelines is intended to reassert the application of the standards of normal science in formulary submissions for new and existing pharmaceutical products and devices. This represents a paradigm shift …
View article: The Impossible QALY and the Denial of Fundamental Measurement: Rejecting the University of Washington Value Assessment of Targeted Immune Modulators (TIMS) in Ulcerative Colitis for the Institute for Clinical and Economic Review (ICER)
The Impossible QALY and the Denial of Fundamental Measurement: Rejecting the University of Washington Value Assessment of Targeted Immune Modulators (TIMS) in Ulcerative Colitis for the Institute for Clinical and Economic Review (ICER) Open
All too often organizations embrace standards for health technology assessment that fail to meet the standards of normal science. A continuing puzzle is why the axioms of fundamental measurement are ignored by researchers such as the Unive…
View article: Measurement, modeling and QALYs
Measurement, modeling and QALYs Open
Over the past 30 years, a mainstay of health technology assessment has been the creation of modeled incremental cost-per-quality adjusted life year (QALY) claims. These are intended to inform resource allocation decisions. Unfortunately, t…
View article: The Great I-QALY Disaster
The Great I-QALY Disaster Open
The QALY is an impossible construct; it defies common sense. It fails completely once we consider the axioms of fundamental measurement. Utilities as ordinal scales cannot be used to create QALYS. The QALY should never have been introduced…
View article: The National Pharmaceutical Council: Endorsing the Construction of Imaginary Worlds in Health Technology Assessment
The National Pharmaceutical Council: Endorsing the Construction of Imaginary Worlds in Health Technology Assessment Open
All too often, organizations embrace standards for health technology assessment that fail to meet those of normal science. A value assessment framework has been endorsed that is patently in the realm of pseudoscience. If a value assessment…
View article: Post QALY: Scientific Approaches to Real World Formulary Decision Making
Post QALY: Scientific Approaches to Real World Formulary Decision Making Open
The purpose of this anniversary supplement for Innovations in Pharmacy is to consider and / or propose modern, scientific methods for determining the evidence base for the fair pricing and accessibility of pharmaceutical products and medic…
View article: Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers
Pharmacoeconomic Evaluations: Guidelines for Drug Purchasers Open
The guidelines provide MCOs with a new systematic approach for identifying the overall cost and clinical outcomes impact of drug therapies. The guidelines are designed to take into account the characteristics of the patient population bein…
View article: Value Assessment in Cystic Fibrosis: ICER’s Rejection of the Axioms of Fundamental Measurement
Value Assessment in Cystic Fibrosis: ICER’s Rejection of the Axioms of Fundamental Measurement Open
One of the features of the ICER stakeholder involvement in the development of ICER evidence reports is the ability for public comment. Unfortunately, and this may just a miscommunication, the replies from ICER to public comments frequently…
View article: More Unnecessary Imaginary Worlds – Part 4: The ICER Evidence Report for Crizanlizumab, Voxelotor and L-Glutamine for Sickle Cell Disease
More Unnecessary Imaginary Worlds – Part 4: The ICER Evidence Report for Crizanlizumab, Voxelotor and L-Glutamine for Sickle Cell Disease Open
A number of commentaries have been published over the past 4 years by the present author on the manifest flaws in the reference case value assessment framework of the Institute for Economic and Clinical Review. The recent release of the ev…
View article: More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report
More Unnecessary Imaginary Worlds – Part 3: Cystic Fibrosis and the Institute for Clinical and Economic Review’s Draft Evidence Report Open
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…