Showing papers by "Louis P. Garrison published in 2018"
TL;DR: The third section of the Special Task Force report identifies and defines a series of elements that warrant consideration in value assessments of medical technologies and aims to broaden the view of what constitutes value in health care and to spur new research on incorporating additional elements of value into cost-effectiveness analysis (CEA).
279 citations
TL;DR: In this article, the authors define a health economics approach to the concept of value in health care systems, and discuss the relationship of value to perspective and decision context, that is, how recently proposed value frameworks vary by the types of decisions being made and by the stakeholders involved; describing the patient perspective on value because the patient is a key stakeholder, but one also wearing the hat of a health insurance purchaser.
113 citations
TL;DR: A more comprehensive economic evaluation is called for that could include novel elements of value (e.g., insurance value and equity) as part of either an "augmented" cost-effectiveness analysis or a multicriteria decision analysis.
108 citations
TL;DR: The task force recommends that those designing economic analyses for new vaccination programs take into account the decision maker's policy objectives and country-specific decision context when estimating: uptake rate in the target population; vaccination program's impact on disease cases in the population over time using a dynamic transmission epidemiologic model; and the changes in costs and health outcomes of the target disease(s).
89 citations
TL;DR: The objectives were to describe the conceptual bases for value and its use in decision making, critically examine existing value frameworks, discuss the importance of sound conceptual underpinning, identify key elements of value relevant to specific decision contexts, and recommend good practice in value definition and implementation.
83 citations
TL;DR: The sixth section of the STF report reviews and comments on recent US-oriented value assessment frameworks, specifically those published by the American College of Cardiology/American Heart Association, the Institute for Clinical and Economic Research, the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the Memorial Sloan Kettering Cancer Center.
53 citations
TL;DR: Results suggest that a partially effective HIV vaccine will have substantial impact on the HIV epidemic in South Africa and offer good value if priced less than $105 for a five-dose series.
Abstract: Promising multi-dose HIV vaccine regimens are being tested in trials in South Africa. We estimated the potential epidemiological and economic impact of HIV vaccine campaigns compared to continuous vaccination, assuming that vaccine efficacy is transient and dependent on immune response. We used a dynamic economic mathematical model of HIV transmission calibrated to 2012 epidemiological data to simulate vaccination with anticipated antiretroviral treatment scale-up in South Africa. We estimate that biennial vaccination with a 70% efficacious vaccine reaching 20% of the sexually active population could prevent 480,000-650,000 HIV infections (13.8-15.3% of all infections) over 10 years. Assuming a launch price of $15 per dose, vaccination was found to be cost-effective, with an incremental cost-effectiveness ratio of $13,746 per quality-adjusted life-year as compared to no vaccination. Increasing vaccination coverage to 50% will prevent more infections but is less likely to achieve cost-effectiveness. Campaign vaccination is consistently more effective and costs less than continuous vaccination across scenarios. Results suggest that a partially effective HIV vaccine will have substantial impact on the HIV epidemic in South Africa and offer good value if priced less than $105 for a five-dose series. Vaccination campaigns every two years may offer greater value for money than continuous vaccination reaching the same coverage level.
20 citations
TL;DR: On 16 March, the Centers for Medicare and Medicaid Services announced that Medicare will cover Food and Drug Administration–approved or cleared genomic tests that encompass broad gene panels for advanced cancer patients, and the final policy does not include the initial draft's wide gene panels.
Abstract: On 16 March, the Centers for Medicare and Medicaid Services (CMS) announced that Medicare will cover Food and Drug Administration (FDA)–approved or cleared genomic tests that encompass broad gene panels for advanced cancer patients ([ 1 ][1]). The final policy does not include the initial draft's
16 citations
TL;DR: External price referencing cannot be directly associated with narrow European price corridor, and lower income countries still have slightly lower list prices, but findings indicate small price variation for pharmaceuticals that points towards the occurrence of price-convergence.
Abstract: External price referencing (EPR) is a frequently applied cost-containment measure to control pharmaceutical prices. This study aims to determine the implications of EPR on ex-factory pharmaceutical prices in European countries. Prices of 21 pharmaceuticals and 17 non-pharmaceutical services were collected with a survey and price corridors were defined in 7 countries. To increase the sample size for further analysis, pharmaceutical prices were retrieved from EURIPID database for 8 additional countries. Regression analyses were applied to evaluate explanatory variables on pharmaceutical list prices including EPR components, GDP per capita, and population size in 15 European countries. Price corridor was narrower for pharmaceuticals compared to non-pharmaceutical services. In univariate regression analysis, higher GDP per capita and population size were associated with higher prices, and taking lowest price from referenced basket of countries was associated with lower prices. In multiple regression analysis, GDP per capita, population size and number of countries referencing a country had modest, but significant association with prices. Findings indicate small price variation for pharmaceuticals that points towards the occurrence of price-convergence. The relatively minor association of EPR with pharmaceutical list prices could be explained by manufacturers’ compensatory mechanisms including confidential price reductions and discounts while maintaining high list prices in countries with strong price-control measures or delayed product launch in countries with traditionally lower prices. Consequently, EPR cannot be directly associated with narrow European price corridor, and lower income countries still have slightly lower list prices.
15 citations
TL;DR: This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.
Abstract: In February and September of 2017, the International Society for Pharmacoeconomics and Outcomes Research Health Technology Assessment Council held roundtables focused on Latin America to discuss health technology assessment best practices, collaboration opportunities, and regional experiences regarding health policies to improve the affordability of and access to healthcare technologies. The access to high-cost technologies, increased social pressure to achieve universal coverage, population aging, and the limits of traditional mechanisms to control costs create political pressure to begin considering other pricing alternatives, including value-based pricing, in Latin America. This article attempts to conceptualize key stakeholders' perceptions of their experiences, opportunities, and barriers to implementing value-based pricing in Latin America.
6 citations
TL;DR: The Cap-Score is a potentially valuable clinical tool for management of unexplained infertility because it is projected to improve clinical pregnancy rates, save money, and, depending on the price of the test, increase access to treatment for infertility.
Abstract: The Cap-Score™ was developed to assess the capacitation status of men, thereby enabling personalized management of unexplained infertility by choosing timed intrauterine insemination (IUI), versus immediate in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) in individuals with a low Cap-Score™. The objective of this study was to estimate the differences in outcomes and costs comparing the use of the Cap-Score™ with timed IUI (CS-TI) and the standard of care (SOC), which was assumed to be three IUI cycles followed by three IVF-ICSI cycles. We developed and parameterized a decision-analytic model of management of unexplained infertility for women based on data from the published literature. We calculated the clinical pregnancy rates, live birth rates, and medical costs comparing CS-TI and SOC. We used Monte Carlo simulation to quantify uncertainty in projected estimates and performed univariate sensitivity analysis. Compared to SOC, CS-TI was projected to increase the pregnancy rate by 1–26%, marginally reduce live birth rates by 1–3% in couples with women below 40 years, increase live birth rates by 3–7% in couples with women over 40 years, reduce mean medical costs by $4000–$19,200, reduce IUI costs by $600–$1370, and reduce IVF costs by $3400–$17,800, depending on the woman’s age. The Cap-Score™ is a potentially valuable clinical tool for management of unexplained infertility because it is projected to improve clinical pregnancy rates, save money, and, depending on the price of the test, increase access to treatment for infertility.
TL;DR: The potential economic impact of introducing HRV testing and ANS optimization into RA treatment appears substantial and cost-effective based on the exploratory analysis.
Abstract: BACKGROUND Autonomic nervous system (ANS) testing with heart rate variability (HRV) has been shown in early research to predict 52-week outcomes in rheumatoid arthritis (RA). HRV testing could be combined with putative ANS biologic pathways to improve treatment response for RA patients. This study explored potential costs and health outcomes of introducing HRV testing into RA treatment, without and with ANS optimization. METHODS A decision tree exploratory economic model compared HRV testing to standard care in moderate-to-severe biologic-eligible patients over a 10-year time horizon. HRV data was derived from an observational study of RA patients (n = 33). Patients were stratified into treatment groups based on HRV test scores indicating "low probability of response" and "moderate to high probability of response". This study explored adding ANS optimization based on HRV score followed by clinically-appropriate treatment. Costs and quality-adjusted life-years (QALYs) for the US population were estimated. RESULTS HRV testing in biologic-eligible patients decreased non-effective biologic use, reducing US healthcare costs by $34.6 billion over 10 years with QALYs unchanged. When combined with ANS optimization in biologic-eligible patients, HRV testing could increase costs by $3.6 billion over 10 years but save over 350,000 QALYs. Among all RA patients, HRV testing with ANS optimization could save over $8 billion and over 100,000 QALYs over 10 years, depending on the positive predictive value (PPV) of the HRV test. CONCLUSIONS The potential economic impact of introducing HRV testing and ANS optimization into RA treatment appears substantial and cost-effective based on the exploratory analysis. Additional rigorous studies are warranted in larger patient samples to better inform decision-making.
TL;DR: The Patient Centred Outcomes Research (PCOR) as mentioned in this paper initiative is an initiative of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Foundation to train the scientific workforce capable of conducting and using comparative effectiveness research (CER).
Abstract: The term comparative effectiveness research (CER) took center stage with passage of the American Recovery and Reinvestment Act (2009). The companion US$1.1 billion in funding prompted the launch of initiatives to train the scientific workforce capable of conducting and using CER. Passage of the Patient Protection and Affordable Care Act (2010) focused these initiatives on patients, coining the term 'patient-centered outcomes research' (PCOR). Educational and training initiatives were soon launched. This report describes the initiative of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Foundation. Through provision of grant funding to six academic Centers of Excellence, to spearheading and sponsoring three national conferences, the PhRMA Foundation has made significant contributions to creation of the scientific workforce that conducts and uses CER/PCOR.
01 Feb 2018
TL;DR: Through provision of grant funding to six academic Centers of Excellence, to spearheading and sponsoring three national conferences, the PhRMA Foundation has made significant contributions to creation of the scientific workforce that conducts and uses CER/PCOR.
Abstract: The term comparative effectiveness research (CER) took center stage with passage of the American Recovery and Reinvestment Act (2009). The companion US$1.1 billion in funding prompted the launch of initiatives to train the scientific workforce capable of conducting and using CER. Passage of the Patient Protection and Affordable Care Act (2010) focused these initiatives on patients, coining the term 'patient-centered outcomes research' (PCOR). Educational and training initiatives were soon launched. This report describes the initiative of the Pharmaceutical Research and Manufacturers Association of America (PhRMA) Foundation. Through provision of grant funding to six academic Centers of Excellence, to spearheading and sponsoring three national conferences, the PhRMA Foundation has made significant contributions to creation of the scientific workforce that conducts and uses CER/PCOR.