Louis P. Garrison

Linking payment to health outcomes: A taxonomy and examination of performance-based reimbursement schemes between healthcare payers and manufacturers

OBJECTIVE To identify, categorize and examine performance-based health outcomes reimbursement schemes for medical technology. METHODS We performed a review of performance-based health outcomes reimbursement schemes over the past 10 years (7/98-010/09) using publicly available databases, web and grey literature searches, and input from healthcare reimbursement experts. We developed a taxonomy of scheme types by inductively organizing the schemes identified according to the timing, execution, and health outcomes measured in the schemes. RESULTS Our search yielded 34 coverage with evidence development schemes, 10 conditional treatment continuation schemes, and 14 performance-linked reimbursement schemes. The majority of schemes are in Europe and Australia, with an increasing number in Canada and the U.S. CONCLUSION These schemes have the potential to alter the reimbursement and pricing landscape for medical technology, but significant challenges, including high transaction costs and insufficient information systems, may limit their long-term impact. Future studies regarding experiences and outcomes of implemented schemes are necessary.

Economic evaluation of influenza pandemic mitigation strategies in the United States using a stochastic microsimulation transmission model.

OBJECTIVES To project the potential economic impact of pandemic influenza mitigation strategies from a societal perspective in the United States. METHODS We use a stochastic agent-based model to simulate pandemic influenza in the community. We compare 17 strategies: targeted antiviral prophylaxis (TAP) alone and in combination with school closure as well as prevaccination. RESULTS In the absence of intervention, we predict a 50% attack rate with an economic impact of

Can't Get No Satisfaction? Will Pay for Performance Help?: Toward an Economic Framework for Understanding Performance-Based Risk-Sharing Agreements for Innovative Medical Products

187 per capita as loss to society. Full TAP (FTAP) is the most effective single strategy, reducing number of cases by 54% at the lowest cost to society (

The Potential Clinical and Economic Outcomes of Pharmacogenomic Approaches to EGFR-Tyrosine Kinase Inhibitor Therapy in Non–Small-Cell Lung Cancer

127 per capita). Prevaccination reduces number of cases by 48% and is the second least costly alternative (

Cost-effectiveness analysis of trastuzumab in the adjuvant setting for treatment of HER2-positive breast cancer.

140 per capita). Adding school closure to FTAP or prevaccination further improves health outcomes but increases total cost to society by approximately

Global Eradication of Measles: An Epidemiologic and Economic Evaluation

2700 per capita. CONCLUSION FTAP is an effective and cost-saving measure for mitigating pandemic influenza.

A Formal Risk-Benefit Framework for Genomic Tests: Facilitating the Appropriate Translation of Genomics Into Clinical Practice

This article examines performance-based risk-sharing agreements for pharmaceuticals from a theoretical economic perspective. We position these agreements as a form of coverage with evidence development. New performance-based risk sharing could produce a more efficient market equilibrium, achieved by adjustment of the price post-launch to reflect outcomes combined with a new approach to the post-launch costs of evidence collection. For this to happen, the party best able to manage or to bear specific risks must do so. Willingness to bear risk will depend not only on ability to manage it, but on the degree of risk aversion. We identify three related frameworks that provide relevant insights: value of information, real option theory and money-back guarantees. We identify four categories of risk sharing: budget impact, price discounting, outcomes uncertainty and subgroup uncertainty.We conclude that a value of information/real option framework is likely to be the most helpful approach for understanding the costs and benefits of risk sharing. There are a number of factors that are likely to be crucial in determining if performance-based or risk-sharing agreements are efficient and likely to become more important in the future: (i) the cost and practicality of post-launch evidence collection relative to pre-launch; (ii) the feasibility of coverage with evidence development without a pre-agreed contract as to how the evidence will be used to adjust price, revenues or use, in which uncertainty around the pay-off to additional research will reduce the incentive for the manufacturer to collect the information; (iii) the difficulty of writing and policing risk-sharing agreements; (iv) the degree of risk aversion (and therefore opportunity to trade) on the part of payers and manufacturers; and (v) the extent of transferability of data from one country setting to another to support coverage with evidence development in a risk-sharing framework.There is no doubt that — in principle — risk sharing can provide manufacturers and payers additional real options that increase overall efficiency. Given the lack of empirical evidence on the success of schemes already agreed and on the issues we set out above, it is too early to tell if the recent surge of interest in these arrangements is likely to be a trend or only a fad.

Estimating the Effect of Changes in Body Mass Index on Health State Preferences

OBJECTIVES Pharmacogenomic applications in oncology offer significant promise, but the clinical and economic implications remain unclear. The objective of this study was to evaluate the potential cost-utility of implementing epidermal growth factor receptor (EGFR) testing before initiating second-line therapy for advanced refractory non-small-cell lung cancer (NSCLC). METHODS We developed a decision analytic model to evaluate the cost-utility of EGFR protein expression or gene copy number testing compared to standard care with erlotinib in refractory advanced NSCLC patients. Costs and utilities were obtained from publicly available sources. We performed sensitivity analyses to evaluate uncertainty in the results. RESULTS The quality-adjusted life expectancies for erlotinib, EGFR protein expression testing, and gene copy number testing were: 0.44, 0.48, and 0.50 quality-adjusted life years (QALYs); and the costs were:

Weight-Related Quality of Life, Health Utility, Psychological Well-Being, and Satisfaction With Exenatide Once Weekly Compared With Sitagliptin or Pioglitazone After 26 Weeks of Treatment

57,238,

Potential impact of task-shifting on costs of antiretroviral therapy and physician supply in Uganda.

63,512, and