Kim DD, Basu A.
Value in Health. 2016;19(5):602-613.BACKGROUND
The prevalence of adult obesity exceeds 30% in the United States, posing a significant public health concern as well as a substantial financial burden. Although the impact of obesity on medical spending is undeniably significant, the estimated magnitude of the cost of obesity has varied considerably, perhaps driven by different study methodologies.
To document variations in study design and methodology in existing literature and to understand the impact of those variations on the estimated costs of obesity.
We conducted a systematic review of the twelve recently published articles that reported costs of obesity and performed a meta-analysis to generate a pooled estimate across those studies. Also, we performed an original analysis to understand the impact of different age groups, statistical models, and confounder adjustment on the magnitude of estimated costs using the nationally representative Medical Expenditure Panel Surveys from 2008-2010.
We found significant variations among cost estimates in the existing literature. The meta-analysis found that the annual medical spending attributable to an obese individual was $1901 ($1239-$2582) in 2014 USD, accounting for $149.4 billion at the national level. The two most significant drivers of variability in the cost estimates were age groups and adjustment for obesity-related comorbid conditions.
It would be important to acknowledge variations in the magnitude of the medical cost of obesity driven by different study design and methodology. Researchers and policy-makers need to be cautious on determining appropriate cost estimates according to their scientific and political questions.
Ciani O, Buyse M, Drummond M, Rasi G, Saad ED, Taylor RS.
Value in Health. 2017;20(3):487-495.
The efficacy of medicines, medical devices, and other health technologies should be proved in trials that assess final patient-relevant outcomes such as survival or morbidity. Market access and coverage decisions are, however, often based on surrogate end points, biomarkers, or intermediate end points, which aim to substitute and predict patient-relevant outcomes that are unavailable because of methodological, financial, or practical constraints. We provide a summary of the present use of surrogate end points in health care policy, discussing the case for and against their adoption and reviewing validation methods. We introduce a three-step framework for policymakers to handle surrogates, which involves establishing the level of evidence, assessing the strength of the association, and quantifying relations between surrogates and final outcomes. Although the use of surrogates can be problematic, they can, when selected and validated appropriately, offer important opportunities for more efficient clinical trials and faster access to new health technologies that benefit patients and health care systems.
Chidi AP, Bryce CL, Donohue JM, Fine MJ, Landsittel DP, Myaskovsky L, Rogal SS, Switzer GE, Tsung A, Smith KJ.
Value in Health. 2016;19(4):326-334.
Interferon-free hepatitis C treatment regimens are effective but very costly. The cost-effectiveness, budget, and public health impacts of current Medicaid treatment policies restricting treatment to patients with advanced disease remain unknown.
To evaluate the cost-effectiveness of current Medicaid policies restricting hepatitis C treatment to patients with advanced disease compared with a strategy providing unrestricted access to hepatitis C treatment, assess the budget and public health impact of each strategy, and estimate the feasibility and long-term effects of increased access to treatment for patients with hepatitis C.
Using a Markov model, we compared two strategies for 45- to 55-year-old Medicaid beneficiaries: 1) Current Practice—only advanced disease is treated before Medicare eligibility and 2) Full Access—both early-stage and advanced disease are treated before Medicare eligibility. Patients could develop progressive fibrosis, cirrhosis, or hepatocellular carcinoma, undergo transplantation, or die each year. Morbidity was reduced after successful treatment. We calculated the incremental cost-effectiveness ratio and compared the costs and public health effects of each strategy from the perspective of Medicare alone as well as the Centers for Medicare & Medicaid Services perspective. We varied model inputs in one-way and probabilistic sensitivity analyses.
Full Access was less costly and more effective than Current Practice for all cohorts and perspectives, with differences in cost ranging from 5,369 to 11,960 and in effectiveness from 0.82 to 3.01 quality-adjusted life-years. In a probabilistic sensitivity analysis, Full Access was cost saving in 93% of model iterations. Compared with Current Practice, Full Access averted 5,994 hepatocellular carcinoma cases and 121 liver transplants per 100,000 patients.
Current Medicaid policies restricting hepatitis C treatment to patients with advanced disease are more costly and less effective than unrestricted, full-access strategies. Collaboration between state and federal payers may be needed to realize the full public health impact of recent innovations in hepatitis C treatment.
Mühlbacher AC, Juhnke C, Beyer AR, Garner S.
Value in Health. 2016;19(6):734-740.
Regulatory decisions are often based on multiple clinical end points, but the perspectives used to judge the relative importance of those end points are predominantly those of expert decision makers rather than of the patient. However, there is a growing awareness that active patient and public participation can improve decision making, increase acceptance of decisions, and improve adherence to treatments. The assessment of risk versus benefit requires not only information on clinical outcomes but also value judgments about which outcomes are important and whether the potential benefits outweigh the harms. There are a number of mechanisms for capturing the input of patients, and regulatory bodies within the European Union are participating in several initiatives. These can include patients directly participating in the regulatory decision-making process or using information derived from patients in empirical studies as part of the evidence considered. One promising method that is being explored is the elicitation of “patient preferences.” Preferences, in this context, refer to the individual's evaluation of health outcomes and can be understood as statements regarding the relative desirability of a range of treatment options, treatment characteristics, and health states. Several methods for preference measurement have been proposed, and pilot studies have been undertaken to use patient preference information in regulatory decision making. This article describes how preferences are currently being considered in the benefit-risk assessment context, and shows how different methods of preference elicitation are used to support decision making within the European context.
Kircher SM, Meeker CR, Nimeiri H, Geynisman DM, Zafar SY, Shankaran V, De Souza J, Wong Y-N.
Value in Health. 2016;19(1):88-98.
Over the last decade, there has been increased development and use of oral anticancer medications, which sometimes leads to high cost sharing for patients. Drug parity laws require insurance plans to cover oral anticancer medications with the same cost sharing as intravenous/injected chemotherapy or have a capped limit on out-of-pocket costs. There are currently 36 enacted state laws (plus the District of Columbia) addressing drug parity, but no federal laws. In this policy perspective piece, we discuss the history, opportunities, and limitations of drug parity laws in oncology. We also discuss the implications of provisions of the Affordable Care Act and other proposed policy reforms on financing oral chemotherapy.
Leung MYM, Carlsson NP, Colditz GA, Chang S-H.
Value in Health. 2017;20(1):77-84.
Diabetes is one of the most prevalent and costly chronic diseases in the United States.
To analyze the risk of developing diabetes and the annual cost of diabetes for a US general population.
Data from the Medical Expenditure Panel Survey, 2008 to 2012, were used to analyze 1) probabilities of developing diabetes and 2) annual total health care expenditures for diabetics. The age-, sex-, race-, and body mass index (BMI)-specific risks of developing diabetes were estimated by fitting an exponential survival function to age at first diabetes diagnosis. Annual health care expenditures were estimated using a generalized linear model with log-link and gamma variance function. Complex sampling designs in the Medical Expenditure Panel Survey were adjusted for. All dollar values are presented in 2012 US dollars.
We observed a more than 6 times increase in diabetes risks for class III obese (BMI ≥ 40 kg/m2) individuals compared with normal-weight individuals. Using age 50 years as an example, we found a more than 3 times increase in annual health care expenditures for those with diabetes ($13,581) compared with those without diabetes ($3,954). Compared with normal-weight (18.5 ≤ BMI < 25 kg/m2) individuals, class II obese (35 ≤ BMI < 40 kg/m2) and class III obese (BMI ≥ 40 kg/m2) individuals incurred an annual marginal cost of $628 and $756, respectively. The annual health care expenditure differentials between those with and without diabetes of age 50 years were the highest for individuals with class II ($12,907) and class III ($9,703) obesity.
This article highlights the importance of obesity on diabetes burden. Our results suggested that obesity, in particular, class II and class III (i.e., BMI ≥ 35 kg/m2) obesity, is associated with a substantial increase in the risk of developing diabetes and imposes a large economic burden.