The Path Forward

2021 ◽  
pp. 240-246
Author(s):  
Neumann Peter J. ◽  
Cohen Joshua T. ◽  
Ollendorf Daniel A
Keyword(s):  
Societal Perspective ◽  
Late Stage ◽  
Drug Price ◽  
Quality Adjusted Life Year ◽  
Value Assessment ◽  
Drug Prices ◽  
Leading Role ◽  
Starting Point ◽  
Length Of Life ◽  
Quality Adjusted Life

Factors interfering with market-based alignment of drug prices and value make explicit value assessment necessary. The widely used quality-adjusted life year serves as a starting point because it accounts for both quality and length of life. Cost estimates could improve by accounting for drug price changes accompanying the loss of market exclusivity. Consistent use of a societal perspective when relevant would also improve value assessments. Prices should sometimes reflect government contributions to development, although such adjustments make the most sense when government facilitates late-stage research. The Institute for Clinical and Economic Review, a private group with a leading role in US value assessment, should make its analyses transparent and defer to payers regarding judgements about value. Finally, payers should embrace value-based pricing. They may not always get the lowest prices, but aligning price and value will mean society expends its resources efficiently and improves the population’s overall health.

Costs and the cost-effectiveness threshold

2017 ◽  
Author(s):  
Jan Abel Olsen
Keyword(s):  
Societal Perspective ◽  
Threshold Value ◽  
Quality Adjusted Life Year ◽  
Healthcare Sector ◽  
The Difference ◽  
The Cost ◽  
Qaly Threshold ◽  
Cost Effectiveness Threshold ◽  
Effectiveness Threshold ◽  
Quality Adjusted Life

Chapter 19 starts by distinguishing between the two contrasting perspectives that an economic evaluation would take: the healthcare sector perspective versus the societal perspective. The former is considered a ‘narrow analysis’ which includes only the costs accruing within the healthcare sector, while the latter represents a ‘broad analysis’ that accounts for all resource implications in all sectors of the economy. After an investigation into various types of costs, a ‘limited societal perspective’ is suggested to be more appropriate than either of the two ‘extreme perspectives’. The chapter continues with a discussion of the cost per quality-adjusted life year (QALY) threshold and explains the difference between a demand side- versus a supply-side approach to determining a threshold value for a QALY.

scholarly journals Measurement, modeling and QALYs

F1000Research ◽  
2020 ◽  
Vol 9 ◽  
pp. 1048
Author(s):  
Paul C. Langley ◽  
Stephen P. McKenna
Keyword(s):  
Quality Adjusted Life Year ◽  
Response To Therapy ◽  
Value Assessment ◽  
Scaling Properties ◽  
Ratio Scales ◽  
Utility Scale ◽  
Allocation Decisions ◽  
Inform Resource Allocation ◽  
Quality Adjusted Life ◽  
Utility Measures

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, the reliance on the construction of QALYs from generic utility scales is misplaced. Those advocating QALY-based lifetime modeled claims fail to appreciate the limitations placed on these constructs by the axioms of fundamental measurement. Utility scales, such as those created by the EQ-5D-3L instrument, are nothing more than multidimensional, ordinal scales. Such scales cannot support basic arithmetic operations. Interval scales can support addition and subtraction; ratio scales the further operations of multiplication and division. Those who advocate the construction of QALYs fail to appreciate that such an operation is only possible if the utility scale is unidimensional and has ratio properties with a true zero. The utility measures available do not meet these requirements. As we cannot produce meaningful utility values, the QALY is an invalid construct. Consequently, cost-per-incremental QALY claims are impossible to sustain and the application of cost-per QALY thresholds meaningless. As utility is a latent, unidimensional variable, the best a measure of utility could achieve would be unidimensionality and interval scaling properties. Where such measures are available, they could support claims for response to therapy. Consequently, there would be no need to continue constructing imaginary lifetime value assessment frameworks. Admitting that the QALY is a fatally flawed construct means rejecting 30 years of cost-per-QALY models.

Institute for Clinical and Economic Review

2021 ◽  
pp. 112-141
Author(s):  
Neumann Peter J. ◽  
Cohen Joshua T. ◽  
Ollendorf Daniel A
Keyword(s):  
Impact Analysis ◽  
The United States ◽  
Quality Adjusted Life Year ◽  
Value Assessment ◽  
Private Organization ◽  
Wide Range ◽  
Powerful Approach ◽  
Assessment Approach ◽  
Contextual Elements ◽  
Quality Adjusted Life

Although its origins date to 2006, the Institute for Clinical and Economic Review (ICER) gained prominence around 2015 when it focused its health technology assessment (HTA) efforts on a new highly effective, though expensive, treatment for hepatitis C. ICER, a small, private organization, seemed to fill a void in the United States because it offered a systematic value assessment approach and made its analyses publicly accessible. Drawing inspiration from England and Wales’ HTA body, ICER has used the quality-adjusted life year (QALY) and cost-effectiveness analysis. That decision gives ICER a powerful approach applicable to a wide range of technologies, but it has also spurred controversy. The organization has responded to criticisms by revising its “value framework.” Changes include separation of budget impact analysis from value determinations, introduction of other value measures beyond the QALY, increasing consideration of contextual elements, and adoption of a “societal perspective” where data support it.

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.

Quality of Life and Resource Allocation

1988 ◽  
Vol 23 ◽  
pp. 33-55 ◽  
Author(s):  
Michael Lockwood
Keyword(s):  
Quality Of Life ◽  
Resource Allocation ◽  
Quality Adjusted Life Year ◽  
Medical Resources ◽  
Medical Vocabulary ◽  
Quality Adjusted Life

A new word has recently entered the British medical vocabulary. What it stands for is neither a disease nor a cure. At least, it is not a cure for a disease in the medical sense. But it could, perhaps, be thought of as an intended cure for a medicosociological disease: namely that of haphazard or otherwise ethically inappropriate allocation of scarce medical resources. What I have in mind is the term ‘QALY’, which is an acronym standing for quality adjusted life year. Just what this means and what it is intended to do I shall explain in due course. Let me first, however, set the scene.

Cost–effectiveness analysis of ribociclib plus fulvestrant for hormone receptor-positive/human EGF receptor 2-negative breast cancer

Immunotherapy ◽  
2021 ◽  
Author(s):  
Wei Jiang ◽  
Zhichao He ◽  
Tiantian Zhang ◽  
Chongchong Guo ◽  
Jianli Zhao ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cost Effectiveness ◽  
Hormone Receptor ◽  
Egf Receptor ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Cost Effectiveness Ratio ◽  
Hormone Receptor Positive ◽  
The Cost ◽  
Quality Adjusted Life

Aim: To evaluate the cost–effectiveness of ribociclib plus fulvestrant versus fulvestrant in hormone receptor-positive/human EGF receptor 2-negative advanced breast cancer. Materials & methods: A three-state Markov model was developed to evaluate the costs and effectiveness over 10 years. Direct costs and utility values were obtained from previously published studies. We calculated incremental cost–effectiveness ratio to evaluate the cost–effectiveness at a willingness-to-pay threshold of $150,000 per additional quality-adjusted life year. Results: The incremental cost–effectiveness ratio was $1,073,526 per quality-adjusted life year of ribociclib plus fulvestrant versus fulvestrant. Conclusions: Ribociclib plus fulvestrant is not cost-effective versus fulvestrant in the treatment of advanced hormone receptor-positive/human EGF receptor 2-negative breast cancer. When ribociclib is at 10% of the full price, ribociclib plus fulvestrant could be cost-effective.

scholarly journals A one-year cost–utility analysis of REBOA versus RTACC for non-compressible torso haemorrhage

Trauma ◽  
2017 ◽  
Vol 21 (1) ◽  
pp. 45-54 ◽  
Author(s):  
Maxwell S Renna ◽  
Cristiano van Zeller ◽  
Farah Abu-Hijleh ◽  
Cherlyn Tong ◽  
Jasmine Gambini ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Cost Effective ◽  
Quality Adjusted Life Year ◽  
Cost Utility ◽  
Incremental Cost Effectiveness Ratio ◽  
Cost Utility Analysis ◽  
Utility Analysis ◽  
Cost Effectiveness Ratio ◽  
One Year ◽  
Quality Adjusted Life

Introduction Major trauma is a leading cause of death and disability in young adults, especially from massive non-compressible torso haemorrhage. The standard technique to control distal haemorrhage and maximise central perfusion is resuscitative thoracotomy with aortic cross-clamping (RTACC). More recently, the minimally invasive technique of resuscitative endovascular balloon occlusion of the aorta (REBOA) has been developed to similarly limit distal haemorrhage without the morbidity of thoracotomy; cost–utility studies on this intervention, however, are still lacking. The aim of this study was to perform a one-year cost–utility analysis of REBOA as an intervention for patients with major traumatic non-compressible abdominal haemorrhage, compared to RTACC within the U.K.’s National Health Service. Methods A retrospective analysis of the outcomes following REBOA and RTACC was conducted based on the published literature of survival and complication rates after intervention. Utility was obtained from studies that used the EQ-5D index and from self-conducted surveys. Costs were calculated using 2016/2017 National Health Service tariff data and supplemented from further literature. A cost–utility analysis was then conducted. Results A total of 12 studies for REBOA and 20 studies for RTACC were included. The mean injury severity scores for RTACC and REBOA were 34 and 39, and mean probability of death was 9.7 and 54%, respectively. The incremental cost-effectiveness ratio of REBOA when compared to RTACC was £44,617.44 per quality-adjusted life year. The incremental cost-effectiveness ratio, by exceeding the National Institute for Health and Clinical Effectiveness’s willingness-to-pay threshold of £30,000/quality-adjusted life year, suggests that this intervention is not cost-effective in comparison to RTACC. However, REBOA yielded a 157% improvement in utility with a comparatively small cost increase of 31.5%. Conclusion Although REBOA has not been found to be cost-effective when compared to RTACC, ultimately, clinical experience and expertise should be the main factor in driving the decision over which intervention to prioritise in the emergency context.

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