scholarly journals Transparency, Imaginary Worlds and ICER Value Assessments

2017 ◽  
Vol 8 (4) ◽  
pp. 11
Author(s):  
Paul C. Langley
Keyword(s):  
Lifetime Cost ◽  
Pharmaceutical Products ◽  
Decision Makers ◽  
Assessment Process ◽  
Value Assessment ◽  
Assessment Framework ◽  
Modeling Framework ◽  
Price Discounts ◽  
A Value ◽  
Independent Assessment

The Institute for Clinical and Economic Review (ICER) is seen as offering a credible platform for evaluating the pricing policies for pharmaceutical products and devices. Over the past few years ICER has presented a stream of reports, many of which have recommended substantial price discounts where the results of a lifetime cost-per-QALY modeling suggests they are out of line with notional willingness to pay thresholds and arbitrary budget constraints. At the same time, there have been growing concerns over the lack of transparency in the ICER value assessment process, focusing in particular on the refusal by ICER to allow access to its value assessment modeling framework. The purpose of this brief commentary is to point out that the position taken by ICER over model access is not defensible; the arguments given are specious. This ongoing refusal undercuts the ICER claim to be independent and the credibility of ICER recommendations for price discounting. The solution is for ICER to commit to a transparent process of value assessment, allowing in particular access to its models and for the ICER model to be subject to an independent assessment. At the same time, manufacturers and other stakeholders should have access to the model with the opportunity to challenge the model through developing model frameworks which they feel better represent product value. This advocacy, it should be noted, does not reflect acceptance of the ICER lifetime cost-per-QALY value assessment framework. Health care decision makers would be better served by a value assessment framework that provided short-term credible, evaluable and replicable claims, facilitating meaningful feedback to decision makers, and not on the construction of simulated imaginary worlds. Conflict of Interest: None   Type: Commentary

scholarly journals Imaginary Worlds and the Institute for Clinical and Economic Review (ICER) Evidence Report: Targeted Immune Modulators for Rheumatoid Arthritis

2017 ◽  
Vol 8 (2) ◽  
Author(s):  
Paul C Langley
Keyword(s):  
Rheumatoid Arthritis ◽  
Decision Makers ◽  
Unit Price ◽  
Value Assessment ◽  
Assessment Framework ◽  
Immune Modulators ◽  
Price Discounts ◽  
Comparative Cost ◽  
The Us ◽  
Care Decision

In April 2017, the Institute for Clinical and Economic Review (ICER) issued its evidence report on the value of targeted immune modulators (TIMs) in rheumatoid arthritis. The report made the case that for the TIMs to be accepted for formulary placement in the US, where notional willingness-to-pay thresholds are the ICER gateway criteria, manufacturers should be prepared to offer substantial unit price discounts. The purpose of this commentary is to make the case that the methodology underpinning the ICER claims for value assessment does not meet the required standards of normal science. None of the claims made for clinical and comparative cost-effectiveness are credible, evaluable and replicable. As such, formulary committees have no idea whether ICER recommendations are right or even if they are wrong. They are, in fact, immune to failure and should be rejected. Utilizing ICER claims generated by simulated projections, this review points out that it is entirely possible to justify the current WAC or net pricing structure of TIMS. The review concludes that if ICER is to contribute to the successful formulary placement of drugs and devices the methodology for pricing recommendation should be re-assessed. As it stands, questions must be raised regarding recommendations for, possibly unnecessary, price discounts. ICER needs to develop an assessment framework that focuses on developing claims for competing therapies that are robust, evaluable and replicable together with recommendations on how these claims are to be evaluated in a timeframe meaningful to health care decision makers.   Type: Commentary

OP83 Value Assessment Framework: Evidence-Informed Deliberative Processes

2017 ◽  
Vol 33 (S1) ◽  
pp. 38-38
Author(s):  
Marcia Tummers ◽  
Rob Baltussen ◽  
Maarten Jansen ◽  
Leon Bijlmakers ◽  
Janneke Grutters ◽  
...  
Keyword(s):  
Decision Making ◽  
Priority Setting ◽  
Stakeholder Involvement ◽  
Value Assessment ◽  
Assessment Framework ◽  
Accountability For Reasonableness ◽  
A Value ◽  
Public Scrutiny ◽  
The One ◽  
Deliberative Processes

INTRODUCTION:Priority setting in health care has been long recognized as an intrinsically complex and value-laden process. Yet, Health Technology Assessment (HTA) agencies presently employ value assessment frameworks that are ill-fitted to capture the range and diversity of stakeholder values, and thereby risk to compromise the legitimacy of their recommendations. We propose ‘evidence-informed deliberative processes’ as an alternative framework with the aim to enhance this legitimacy.METHODS:The framework is based on an integration of two increasingly popular and complementary frameworks for priority setting: multi-criteria decision analysis (MCDA) and accountability for reasonableness (A4R), Evidence-informed deliberative processes are, on the one hand, based on early, continued stakeholder deliberation to learn about the importance of relevant social values. On the other hand, they are based on rational decision-making – through evidence-informed evaluation of the identified values.RESULTS:The framework has important implications for how HTA agencies should ideally organize their processes. Firstly, HTA agencies should take the responsibility to organize stakeholder involvement. Second, agencies are advised to integrate their assessment and appraisal phase, allowing for the timely collection of evidence on values that are considered relevant. Third, HTA agencies should subject their specification of decision-making criteria to public scrutiny. Fourth, agencies are advised to use a checklist of potentially relevant criteria, and to provide argumentation how each criterion affected the recommendation. Fifth, HTA agencies must publish their argumentation and install options for appeal.CONCLUSIONS:Adopting ‘evidence-informed deliberative processes’ as a value assessment framework could be an important step forward for HTA agencies to optimize the legitimacy of their priority setting decisions. Agencies can incorporate elements according to their needs and affordances.

scholarly journals Nonsense on Stilts – Part 1: The ICER 2020-2023 Value Assessment Framework for Constructing Imaginary Worlds

2020 ◽  
Vol 11 (1) ◽  
pp. 12 ◽  
Author(s):  
Paul Langley
Keyword(s):  
Health Care ◽  
Care Delivery ◽  
Measurement Theory ◽  
Lifetime Cost ◽  
Health Technology ◽  
Disease Stage ◽  
Value Assessment ◽  
Assessment Framework ◽  
Reference Case ◽  
Utility Scores

Previous commentaries in the Formulary Evaluation section of INNOVATIONS in Pharmacy have pointed to the lack of credibility in modeled claims for cost-effectiveness and associated recommendations for pricing and access by the Institute for Clinical and Economic Review (ICER). The principal objection to ICER reports has been that their modeled claims fail the standards of normal science: they are best seen as pseudoscience. The purpose of this latest commentary is to provide a critique of the recently released ICER 2020 Value Assessment Framework (VAF). Although ICER has taken upon itself the pole position in health technology assessments and recommendations for product pricing in the US health care system, the incremental, lifetime cost-per-QALY modeling methodology should not be taken seriously. The creation of imaginary modeled worlds, built entirely from assumption, fails the demarcation test between science and pseudoscience. The ICER evidence reports are best seen as the health technology assessment equivalent of ‘intelligent design’ in counterpoint to ‘natural selection’. It is surprising, therefore, that health care decision makers should take ICER’s recommendations seriously as providing ‘approximate information’ for formulary decision making. What is not appreciated is that the claims made by ICER lack credibility, are impossible to evaluate and lack the ability to be replicated across treatment settings. Indeed, the models presented under the guise of a ‘state of the art’ value assessment were never intended to support evaluable claims. We have no idea and will never know if they are right or if they are wrong. ICER’s position becomes even more untenable once the models presented are assessed in detail. Without in any way supporting the ICER methodology, it is worth noting that all too often ICER’s claims for incremental QALYs in specific models are based upon what appears to be, from the limited evidence presented, a casual and ad hoc assemblage of utility scores from diverse constructs. This is a critical weakness given the role attributed by ICER to the modeled cost-per-QALY claims as central to ICERs imaginary value assessment. ICER also overlooks the fact that the utility scores it captures from the literature to populate its imaginary reference case world lack objectivity. They are ordinal rather than interval measures. To apply these manifest scores to time spent in a disease stage and then aggregate these over different disease stages is nonsensical. The critical issue is one of instrument development. The case made here is for the application of Rasch Measurement Theory (RMT) to construct a unidimensional instrument with interval properties, in this case from the needs fulfillment construct of quality of life (QoL). Unless an instrument meets RMT standards in its development, the logic of Rasch modeling to achieve fundamental measurement standards means that other scales are, by definition, ordinal. It is absurd to ‘assume’ they are interval. RMT is designed to create instruments to evaluate change and test hypotheses. In the absence of instruments that have RMT properties, the cost-per-QALY reference case modelling meme collapses. It is an analytical dead end. If we are to support a meaningful scientific program to discover new facts to support health care delivery and improve the lives of patients, caregivers and their families, then ICER should be put to one side.   Article Type: Commentary

scholarly journals The Great I-QALY Disaster

2020 ◽  
Vol 11 (3) ◽  
pp. 7
Author(s):  
Paul Langley
Keyword(s):  
Cost Effectiveness ◽  
Common Sense ◽  
Pharmaceutical Products ◽  
Value Assessment ◽  
Assessment Framework ◽  
Look Ahead ◽  
Ordinal Scales

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 to support the value assessment of pharmaceutical products and devices. The result is 30 years of QALY based assessments of pharmaceutical products and devices which are conceptually and technically wrong. They are a charade and will have contributed mistakenly to thousands of formulary decisions. In the search for a common metric to evaluate cost-effectiveness the impossibility of a QALY was overlooked. The result is a disaster, unfolding over decades. Our next steps must be to abandon the QALY paradigm and look ahead to a new value assessment framework.   Commentary

Assessing impacts of implementing low-carbon tourism program for sustainable tourism in a world heritage city

2019 ◽  
Vol 74 (2) ◽  
pp. 216-234 ◽  
Author(s):  
Machima Thongdejsri ◽  
Vilas Nitivattananon
Keyword(s):  
Impact Assessment ◽  
Carbon Emission ◽  
Sustainable Tourism ◽  
World Heritage ◽  
Decision Makers ◽  
Assessment Process ◽  
Low Carbon ◽  
Assessment Framework ◽  
Content Type ◽  
The Impact

Purpose This study aims to illustrate the impact-assessment procedure of low-carbon tourism (LCT) program implemented in a world heritage city and to develop specific indicators toward sustainability. Design/methodology/approach The impact-assessment framework was indicator-based and designed for creating sustainable tourism (ST) in a case study. A set of indicators in various dimensions was developed and applied, referring to the UNWTO guideline. A mixed method of primary and secondary data collected from different sources included document review, site observation, key informant interview, questionnaire survey and focus-group discussions. Assessment of actual/observed impacts was proceeded based on the data collected from tourists and stakeholders, especially on tourist behaviors and resource consumptions. Findings The implementation of LCT program in a world heritage city provided impacts in different dimensions and characters. The observed activities were majorly tourism activities in accommodations and recreational places. The indicator initiation is the first development toward sustainability in a case of tourism study in a city destination. Indicators were developed with participation from key stakeholders and covered sustainability and carbon-emission dimensions. Impact-assessment results show a positive theme in less carbon emission, enhanced local income distribution and community capacity. However, the negative impacts include increased amounts of resource consumption and waste generation in visiting sites. The impact matrix works as the map for decision-makers to maximize benefits and manage the cons of the LCT program toward ST principles. Research limitations/implications Research methodology, procedure and results on impact assessment with holistic perspectives imply academic contribution and practical benefits for decision-makers regarding ST development. The number of samples and enterprises was limited because of the program implementation period. Originality/value The research illustrates the impact-assessment process for an implemented city-based LCT program toward ST, where stakeholder participation was also functioning. A list of indicators was specially designed and can be practically applied for other LCT programs in city destinations. Applying a sustainability impact-assessment framework to the program can provide a clear presentation on how to develop ST.

scholarly journals Value Assessment in Cystic Fibrosis: ICER’s Rejection of the Axioms of Fundamental Measurement

2020 ◽  
Vol 11 (2) ◽  
pp. 8
Author(s):  
Paul Langley
Keyword(s):  
Cystic Fibrosis ◽  
Stakeholder Involvement ◽  
Normal Science ◽  
Value Assessment ◽  
Assessment Framework ◽  
Multiattribute Utility ◽  
Public Comment ◽  
A Value ◽  
Article Type ◽  
Utility Scores

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 miss the point or fail to provide backup for their claims. The purpose of this commentary is to review ICER’s responses to public comments by the author on the just released final evidence report on cystic fibrosis. The message is quite simple: the ICER value assessment framework lacks credibility. It fails to meet the standards of normal science. This is seen in ICERs apparent ignorance or rejection of the axioms of fundamental measurement which point quite clearly to the mathematical impossibility of creating QALYs from generic multiattribute utility scores. The ICER report also fails standards by creating a model from prior assumptions; there is no logical basis for constructing a value assessment claim. Either ICER should withdraw its value claims or admit the dubious basis on which the model is built, as a duty to its readership.   Article Type: Commentary    

scholarly journals 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

2020 ◽  
Vol 11 (4) ◽  
pp. 22
Author(s):  
Paul Langley
Keyword(s):  
Lifetime Cost ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Pharmaceutical Products ◽  
Normal Science ◽  
Value Assessment ◽  
New Paradigm ◽  
Dead End ◽  
Patient Reported ◽  
New Vision

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 methodology is incompatible with those axioms. This is made all the more unnerving when it is pointed out that this incompatibility was pointed out over 30 years ago, following the formalization of those axioms almost 80 years ago. Why this was overlooked is a mystery. The result was a commitment to the application of ordinal utility and other patient reported outcome measures to support claims for response to competing therapies; most egregiously, the advocacy of cost-per-QALY lifetime models and willingness to pay thresholds to support recommendations for pricing and access to pharmaceutical products and devices. Although this incompatibility has been pointed out in respect of simulation modeling, to groups such as the Institute for Clinical and Economic Review (ICER) they press on, producing evidence reports and recommendations for emerging products that fail the standards of normal science.  While these are an analytical dead end, ICER has nowhere else to go. This is their business model; to admit otherwise would mean withdrawing their many evidence reports and admit they were wrong. ICER has rejected this; rather it has decided, together with its academic consultants, to challenge the axioms of fundamental measurement, to produce a parallel measurement universe that can sustain QALYs and the imaginary simulation lifetime models. The purpose here is to make clear that ICER is manifestly wrong and that there is no way it can maintain its credibility in pursuing this path. This is achieved by a deconstruction of the arguments put forward by ICER to defend its new vision of the axioms of fundamental measurement, a vision which provides a case study in the distinction between justified belief and opinion.  Fortunately, we have the framework for a new paradigm in value assessment; a paradigm that recognizes the standards of normal science and rejects belief in an alternative reality consistent with fundamental measurement axioms.

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

2020 ◽  
Vol 11 (1) ◽  
pp. 15
Author(s):  
Paul Langley
Keyword(s):  
Cystic Fibrosis ◽  
Lifetime Cost ◽  
Value Assessment ◽  
Reference Case ◽  
Usual Practice ◽  
A Value ◽  
Article Type ◽  
Innovative Therapies ◽  
Patient Groups ◽  
Disease Stages

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

scholarly journals More Unnecessary Imaginary Worlds – Part 4: The ICER Evidence Report for Crizanlizumab, Voxelotor and L-Glutamine for Sickle Cell Disease

2020 ◽  
Vol 11 (2) ◽  
pp. 4
Author(s):  
Paul Langley
Keyword(s):  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Lifetime Cost ◽  
Value Assessment ◽  
Assessment Framework ◽  
Cell Disease ◽  
Reference Case ◽  
The Past ◽  
Article Type ◽  
Utility Scale

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 evidence report on sickle cell disease continues ICER’s commitment to what has been described as the creation of imaginary worlds to support value assessment. The purpose of the present commentary is to continue the critiques that have been presented for earlier evidence reports. This is important because of the apparent willingness to take ICER’s recommendations at face value rather than a critical review of the value assessment framework. The case presented here points to a  number of weaknesses in the ICER framework: (i) the fabrication of imaginary constructs with a lifetime cost-per-incremental QALY framework; (ii) the consequent failure to meet the standards of normal science; (iii) the illogical reliance of assumptions drawn from the literature to create future scenarios; (iv) the rejection of hypothesis testing in favor of  ‘approximate information’ and (v) a belief that in the construction of QALYS that the EQ-5D-3L utility scale has ratio properties. This last point is demonstrably false which means that the ICER value assessment framework collapses. It is impossible mathematically, a failure to meet the axioms of fundamental measurement, for an ordinal utility scale to be combined with time spent in a disease state. The result is that the pricing and access recommendations for Crizanlizumab, Voxelotor and L-glutamine in sickle cell disease (SCD) are complete nonsense and should be rejected.   Article Type: Commentary

scholarly journals The National Pharmaceutical Council: Endorsing the Construction of Imaginary Worlds in Health Technology Assessment

Pharmacy ◽  
2020 ◽  
Vol 8 (3) ◽  
pp. 119
Author(s):  
Paul C Langley
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology ◽  
Quality Adjusted Life Year ◽  
Normal Science ◽  
Value Assessment ◽  
Assessment Framework ◽  
Professional Groups ◽  
A Value ◽  
Quality Adjusted Life

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 framework is to be accepted, then claims for the value of competing products must be credible, evaluable and replicable. If not, for example, when the assessment relies on the construction of an imaginary lifetime incremental cost-per-quality-adjusted-life-year (QALY) world, then that assessment should be rejected. Such an assessment would fail one of the central roles of normal science: the discovery of new facts through an ongoing process of conjecture and refutation where provisional claims can be continually challenged. It is no good defending an endorsement of a value framework that fails expected standards on the grounds that it has been endorsed by professional groups and reflects decades of development. This is intellectually lazy. If this is the case, then the scientific revolution of the 17th century need not have happened. The purpose of this commentary is to consider the recommended standards for health technology assessment of the National Pharmaceutical Council (NPC), with particular reference to proposed methodological standards in value assessment and the commitment to mathematically impossible QALYs.

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