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

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

Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective

2020 ◽  
pp. 1-7
Author(s):  
Nadine T. Hillock ◽  
Tracy L. Merlin ◽  
Jonathan Karnon ◽  
John Turnidge ◽  
Jaklin Eliott
Keyword(s):  
Cost Effectiveness ◽  
Healthcare Resource ◽  
Economic Evaluations ◽  
Value Assessment ◽  
Antimicrobial Drugs ◽  
Policy Makers ◽  
Stakeholder Perspective ◽  
Definition Of ◽  
The Impact ◽  
Potential Use

Abstract Background The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. Objectives To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. Methods Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. Results Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. Conclusions Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

scholarly journals Post QALY: Scientific Approaches to Real World Formulary Decision Making

2020 ◽  
Vol 11 (2) ◽  
pp. 19
Author(s):  
Paul Langley ◽  
Stephen McKenna
Keyword(s):  
Decision Making ◽  
Medical Devices ◽  
Evidence Base ◽  
Pharmaceutical Products ◽  
Normal Science ◽  
Value Assessment ◽  
Scientific Methods ◽  
Article Type ◽  
The Us ◽  
The Uk

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 medical devices. At present, such decisions are based on the construction of imaginary value assessment models that fail to meet the standards of normal science. Such a business model has been adopted by the Institute for Clinical and Economic Review (ICER) in the US, NICE in the UK and in a number of other countries.   Article Type: Call for Papers

scholarly journals Bariatric surgery, lifestyle interventions and orlistat for severe obesity: the REBALANCE mixed-methods systematic review and economic evaluation

2018 ◽  
Vol 22 (68) ◽  
pp. 1-246 ◽  
Author(s):  
Alison Avenell ◽  
Clare Robertson ◽  
Zoë Skea ◽  
Elisabet Jacobsen ◽  
Dwayne Boyers ◽  
...  
Keyword(s):  
Weight Loss ◽  
Cost Effectiveness ◽  
Weight Regain ◽  
Severe Obesity ◽  
Clinical Effectiveness ◽  
Cost Effective ◽  
Research Unit ◽  
Look Ahead ◽  
Obesity Trends

Background Adults with severe obesity [body mass index (BMI) of ≥ 35 kg/m2] have an increased risk of comorbidities and psychological, social and economic consequences. Objectives Systematically review bariatric surgery, weight-management programmes (WMPs) and orlistat pharmacotherapy for adults with severe obesity, and evaluate the feasibility, acceptability, clinical effectiveness and cost-effectiveness of treatment. Data sources Electronic databases including MEDLINE, EMBASE, PsycINFO, the Cochrane Central Register of Controlled Trials and the NHS Economic Evaluation Database were searched (last searched in May 2017). Review methods Four systematic reviews evaluated clinical effectiveness, cost-effectiveness and qualitative evidence for adults with a BMI of ≥ 35 kg/m2. Data from meta-analyses populated a microsimulation model predicting costs, outcomes and cost-effectiveness of Roux-en-Y gastric bypass (RYGB) surgery and the most effective lifestyle WMPs over a 30-year time horizon from a NHS perspective, compared with current UK population obesity trends. Interventions were cost-effective if the additional cost of achieving a quality-adjusted life-year is < £20,000–30,000. Results A total of 131 randomised controlled trials (RCTs), 26 UK studies, 33 qualitative studies and 46 cost-effectiveness studies were included. From RCTs, RYGB produced the greatest long-term weight change [–20.23 kg, 95% confidence interval (CI) –23.75 to –16.71 kg, at 60 months]. WMPs with very low-calorie diets (VLCDs) produced the greatest weight loss at 12 months compared with no WMPs. Adding a VLCD to a WMP gave an additional mean weight change of –4.41 kg (95% CI –5.93 to –2.88 kg) at 12 months. The intensive Look AHEAD WMP produced mean long-term weight loss of 6% in people with type 2 diabetes mellitus (at a median of 9.6 years). The microsimulation model found that WMPs were generally cost-effective compared with population obesity trends. Long-term WMP weight regain was very uncertain, apart from Look AHEAD. The addition of a VLCD to a WMP was not cost-effective compared with a WMP alone. RYGB was cost-effective compared with no surgery and WMPs, but the model did not replicate long-term cost savings found in previous studies. Qualitative data suggested that participants could be attracted to take part in WMPs through endorsement by their health-care provider or through perceiving innovative activities, with WMPs being delivered to groups. Features improving long-term weight loss included having group support, additional behavioural support, a physical activity programme to attend, a prescribed calorie diet or a calorie deficit. Limitations Reviewed studies often lacked generalisability to UK settings in terms of participants and resources for implementation, and usually lacked long-term follow-up (particularly for complications for surgery), leading to unrealistic weight regain assumptions. The views of potential and actual users of services were rarely reported to contribute to service design. This study may have failed to identify unpublished UK evaluations. Dual, blinded numerical data extraction was not undertaken. Conclusions Roux-en-Y gastric bypass was costly to deliver, but it was the most cost-effective intervention. Adding a VLCD to a WMP was not cost-effective compared with a WMP alone. Most WMPs were cost-effective compared with current population obesity trends. Future work Improved reporting of WMPs is needed to allow replication, translation and further research. Qualitative research is needed with adults who are potential users of, or who fail to engage with or drop out from, WMPs. RCTs and economic evaluations in UK settings (e.g. Tier 3, commercial programmes or primary care) should evaluate VLCDs with long-term follow-up (≥ 5 years). Decision models should incorporate relevant costs, disease states and evidence-based weight regain assumptions. Study registration This study is registered as PROSPERO CRD42016040190. Funding The National Institute for Health Research Health Technology Assessment programme. The Health Services Research Unit and Health Economics Research Unit are core funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorate.

Moving the Ball Down the Field

2014 ◽  
pp. 172-187
Author(s):  
Mark Reid ◽  
Dan Ashcraft
Keyword(s):  
Air Force ◽  
Common Sense ◽  
Best Practice ◽  
Assessment Framework ◽  
Standard Assessment ◽  
Corporate Memory ◽  
Us Air Force ◽  
The Us ◽  
Positive Experiences

The US Air Force's (USAF) Pacific Air Forces (PACAF) has an effective approach to turning observations of problems into accomplished actions and mission improvements. This common-sense approach relies on 1) motivated buy-in and participation from the Chief Stakeholder (i.e., CEO, Commander, the Boss); 2) a standard assessment framework; 3) experienced, enduring, corporate memory-equipped assessors; 4) Chief Stakeholder's confidence in his assessors; 5) mid-managers empowered to fix their own problems; 6) access for the assessors to the Chief Stakeholder; and 7) an empowered ramrod to enforce the process and ensure follow-through. This chapter relates the steps of PACAF's process, which Headquarters (HQ) US Air Force called in 2012 “the Air Force's Best Practice at turning observations into progress” and illustrates these steps with PACAF's very positive experiences.

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.

Is FDA-Approved Bevacizumab Cost-Effective When Included in the Treatment of Platinum-Resistant Recurrent Ovarian Cancer?

2016 ◽  
Vol 12 (7) ◽  
pp. e775-e783 ◽  
Author(s):  
Nicole P. Chappell ◽  
Caela R. Miller ◽  
Aaron D. Fielden ◽  
Jason C. Barnett
Keyword(s):  
Ovarian Cancer ◽  
Cost Effectiveness ◽  
Willingness To Pay ◽  
Progression Free Survival ◽  
Recurrent Ovarian Cancer ◽  
Phase Iii ◽  
Value Assessment ◽  
Free Survival ◽  
Platinum Resistant ◽  
The Cost

Purpose: Although the Food and Drug Administration has approved incorporation of bevacizumab (BEV) into the treatment of platinum-resistant ovarian cancer (PROC), cost-value measures are an essential consideration, as evidenced by the recent ASCO Value Framework initiative. We assessed the cost-effectiveness and reviewed the net health benefit (NHB) of this expensive treatment. Methods: A cost-effectiveness decision model was constructed using results from a phase III trial comparing BEV plus cytotoxic chemotherapy with chemotherapy alone in patients with PROC. The Avastin Use in Platinum-Resistant Epithelial Ovarian Cancer (AURELIA) trial demonstrated improvement in progression-free survival and quality of life in patients receiving BEV. Costs, paracentesis rates, and adverse events were incorporated, including subgroup analysis of different partner chemotherapy agents. Results: Inclusion of BEV in the treatment of platinum-resistant recurrent ovarian cancer meets the common willingness-to-pay incremental cost-effectiveness ratio (ICER) threshold of $100,000 per progression-free life-year saved (LYS) for 15-mg/kg dosing and approaches this threshold for 10-mg/kg dosing, with an ICER of $160,000. In sensitivity analysis, reducing the cost of BEV by 13% (from $9,338 to $8,100 per cycle) allows 10-mg/kg dosing to reach a $100,000 ICER. Exploratory analysis of different BEV chemotherapy partners showed an ICER of $76,000 per progression-free LYS (6.5-month progression-free survival improvement) and $54,000 per LYS (9.1-month overall survival improvement) for the addition of BEV to paclitaxel once per week. Using the ASCO framework for value assessment, the NHB score for BEV plus paclitaxel once per week is 48. Conclusion: Using a willingness-to-pay threshold of $100,000 ICER, the addition of BEV to chemotherapy either demonstrates or approaches cost-effectiveness and NHB when added to the treatment of patients with PROC.

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