Showing papers by "Louis P. Garrison published in 2014"

Cost-effectiveness of bariatric surgical procedures for the treatment of severe obesity

Abstract: One-third of Americans are obese and an increasing number opt for bariatric surgery. This study estimates the cost-effectiveness of common bariatric surgical procedures from a healthcare system perspective. We evaluated the three most common bariatric surgical procedures in the US: laparoscopic gastric bypass (LRYGB), conventional (open) Roux-en-Y gastric bypass (ORYGB), and laparoscopic adjustable gastric banding (LAGB) compared to no surgery. The reference case was defined as a 53-year old female with body mass index (BMI) of 44 kg/m2. We developed a two-part model using a deterministic approach for the first 5-year period post-surgery and separate empirical forecasts for the natural history of BMI, costs and outcomes in the remaining years. We used a combination of datasets including Medicare and MarketScan® together with estimates from the literature to populate the model. Bariatric surgery produced additional life expectancy (80–81 years) compared to no surgery (78 years). The incremental cost-effectiveness ratios (ICERs) of the surgical procedures were US $6,600 per quality-adjusted life expectancy (QALY) gained for LRYGB, US $6,200 for LAGB, and US $17,300 for ORYGB (3 % discount rate for cost and QALYs). ICERs varied according to choice of BMI forecasting method and clinically plausible variation in parameter estimates. In most scenarios, the ICER did not exceed a threshold of US $50,000 per QALY gained.

Current status and trends in performance-based risk-sharing arrangements between healthcare payers and medical product manufacturers.

Abstract: Our objective was to identify and characterize publicly available cases and related trends for performance-based risk-sharing arrangements (PBRSAs). We performed a review of PBRSAs over the past 20 years (1993–2013) using available databases and reports from colleagues and healthcare experts. These were categorized according to a previously published taxonomy of scheme types and assessed in terms of the underlying product and market attributes for each scheme. Macro-level trends were identified related to the timing of scheme adoption, countries involved, types of arrangements, and product and market factors. Our search yielded 148 arrangements. From this set, 65 arrangements included a coverage with an evidence development component, 20 included a conditional treatment continuation component, 54 included a performance-linked reimbursement component, and 42 included a financial utilization component. Each type of scheme addresses fundamental uncertainties that exist when products enter the market. The pace of adoption appears to be slowing, but new countries continue to implement PBRSAs. Over this 20-year period, there has been a consistent movement toward arrangements that minimize administrative burden. In conclusion, the pace of PBRSA adoption appears to be slowing but still has traction in many health systems. These remain a viable coverage and reimbursement mechanism for a wide range of medical products. The long-term viability and growth of these arrangements will rest in the ability of the parties to develop mutually beneficial arrangements that entail minimal administrative burden in their development and implementation.

A Framework for Assessing the Economic Value of Pharmacovigilance in Low- and Middle-Income Countries

Abstract: Pharmacovigilance (PV) programs are an essential component of national healthcare systems. Well-functioning PV programs can improve population health by identifying and reducing medicines-related problems (MRPs). Many low- and middle-income countries lack functional PV systems, but this deficiency has not been described in terms of the potential economic value of strengthening PV systems. The assessment of economic value for PV can support rational decision making at the country level. We propose a framework for assessing the economic value of PV. We divide national PV systems into four levels: (1) no PV, (2) basic PV, (3) semi-functional PV, and (4) functional PV. These categories represent increasing levels of investment in PV capacity at the national or health facility level for all available medicines, including vaccines. The proposed framework can be used to estimate the costs of PV (including the value of investments to increase PV capacity and the costs of managing MRPs) and outcomes associated with PV (including improvements in morbidity, mortality, and quality of life as a result of the reduction in MRPs). The quantitative approach proposed for assessing costs and benefits uses a decision-analytic modeling framework that would estimate the value of the consequences of MRPs adjusted for their probability of occurrence. This allows the quantification of value using monetary outcomes (cost–benefit analysis), natural units (cost-effectiveness analysis), or mortality adjusted for quality of life or disability (cost–utility analysis). Evidence generated using this framework could assist policy makers, program managers, and donors in evaluating investments that aim to increase the capacity and efficiency of national and facility-level PV programs in low- and middle-income countries.

The Expanding Value Footprint of Oncology Treatments

Abstract: This publication examines the importance and history of HTA evaluations for additional uses for cancer drugs after their initial approval. The cohort of cancer drugs included are the ten approved by the EMA during 2003–2005. This time period was chosen based on the assumption that cancer drugs on the market for eight years or more are likely to have been approved for additional indications. New indications, for example, may be for use in a different cancer, disease stage, treatment stage, treatment regimen, or patient population or subpopulation. The decisions of three entities were included in the study - the Haute Autorite de Sante (HAS) in France, NICE in England and Wales, and Aetna, a private health insurance company in the US. These three were selected to suggest how assessment approaches might differ in interpreting value. The value of a particular medicine, as this study illustrates well, may not be evident at the time of first approval and value can vary both over time and by indication. This may result in pricing and reimbursement decisions that fail to adequately reward important innovation and so discourage future innovation, to the detriment of society. Public policy options for addressing this challenge include, for example, pricing that varies by indication, and consideration of potential expanded use as part of the initial deliberations, and decisions about pricing and reimbursement.

Projecting the cost-effectiveness of pertuzumab with trastuzumab and docetaxel in the neoadjuvant treatment of HER2-positive, locally advanced, inflammatory or early breast cancer.

Abstract: 642 Background: The NeoSphere trial (Gianni et al. [2012]) compared the following regimens for neoadjuvant treatment in HER2+, locally advanced, inflammatory or early breast cancer: 1) trastuzumab ...

Estimating the incremental net health benefit of requirements for cardiovascular risk evaluation for diabetes therapies

Abstract: Purpose To evaluate the advantages and disadvantages of pre-approval requirements for safety data to detect cardiovascular (CV) risk contained in the December 2008 U.S. Food and Drug Administration (FDA) guidance for developing type 2 diabetes drugs compared with the February 2008 FDA draft guidance from the perspective of diabetes population health. Methods We applied the incremental net health benefit (INHB) framework to quantify the benefits and risks of investigational diabetes drugs using a common survival metric (life-years [LYs]). We constructed a decision analytic model for clinical program development consistent with the requirements of each guidance and simulated diabetes drugs, some of which had elevated CV risk. Assuming constant research budgets, we estimate the impact of increased trial size on drugs investigated. We aggregate treatment benefit and CV risks for each approved drug over a 35-year horizon under each guidance. Results The quantitative analysis suggests that the December 2008 guidance adversely impacts diabetes population health. INHB was −1.80 million LYs, attributable to delayed access to diabetes therapies (−0.18 million LYs) and fewer drugs (−1.64 million LYs), but partially offset by reduced CV risk exposure (0.02 million LYs). Results were robust in sensitivity analyses. Conclusion The health outcomes impact of all potential benefits and risks should be evaluated in a common survival measure, including health gain from avoided adverse events, lost health benefits from delayed or forgone efficacious products, and impact of alternative policy approaches. Quantitative analysis of the December 2008 FDA guidance for diabetes therapies indicates that negative impact on patient health will result. © 2014 The Authors. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons, Ltd.

Authors’ Reply to Curto and Garattini: “Current Status and Trends in Performance-Based Risk-Sharing Arrangements Between Healthcare Payers and Medical Product Manufacturers”

Abstract: We thank Dr. Garattini and Mr. Curto for their comments and will gladly provide further clarification [1]. The original article from which the taxonomy used in our current article was taken focused on health outcomes arrangements and excluded non-outcomes-based schemes [2, 3]. Therefore, the original article includes definitions for coverage with evidence development (CED), conditional treatment continuation (CTC), and performance-linked reimbursement (PLR) categories but not financial/utilization (FU). The FU category is represented by the non-outcomes schemes, which are included in the taxonomy figure, but not explicitly defined in the figure or in the text. We apologize if this caused some confusion. We define the FU category as arrangements where the reimbursement is tied to the measure of financial or utilization outcomes as opposed to explicit clinical outcomes. Subsequent to our original article and taxonomy publication, there have been both derivative and independently created taxonomies. One example—the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Task Force taxonomy—is similar to the original taxonomy, though it differs somewhat, as you have noted [4]. We did not choose to use the ISPOR Task Force taxonomy for our most recent work, opting to stay with our original. Regarding the CTC for Alzheimer’s drugs in Italy, the arrangement would not need to be officially listed as a management entry agreement (MEA) by AIFA, the Italian Medicines Agency, to be included in our review if it meets our criterion, i.e., continuation of coverage for individual patients is conditional upon meeting short-term treatment goals. Our information about this article came from a previously published news article [5]. To the extent this reference is accurate, the Alzheimer’s arrangement meets our criteria. Finally, we classified the arrangements in the UK and Italy according to the aforementioned taxonomy. The current paper provides the relevant numbers according to each of the taxonomic components. Most of the arrangements in Italy contained multiple components. For example, a common arrangement for a cancer therapy in Italy entails a treatment initiation period (often with a financial component with free product or a discounted price, i.e., an FU component), followed by evaluation of short-term response (CTC) with a refund for those not responding according to the predetermined response criteria (PLR). The UK has utilized multiple types of arrangements, but the last 25 Patient Access Schemes have been confidential discounts, suggesting a movement away from performance-based risk-sharing arrangements.