Cost-Effectiveness and Value-Based Pricing of Aducanumab for Patients With Early Alzheimer Disease

Introduction:Aducanumab was granted accelerated approval with a conflicting evidence base, near-unanimous FDA Advisory Committee vote to reject approval, and a widely criticized launch price of $56,000 per year. The objective of this analysis was to estimate its cost-effectiveness.Methods:We developed a Markov model to compare aducanumab in addition to supportive care to supportive care alone over a lifetime horizon. Results were presented from both the health system and modified societal perspective. The model tracked the severity of disease and the care setting. Incremental cost-effectiveness ratios were calculated, and a threshold analysis was conducted to estimate at what price aducanumab would meet commonly used cost-effectiveness thresholds.Results:Using estimates of effectiveness based on pooling of data from both pivotal trials, patients treated with aducanumab spent four more months in earlier stages of AD. Over the lifetime time horizon, treating a patient with aducanumab results in 0.154 more QALYs gained per patient and 0.201 evLYGs per patient from the health care system perspective, with additional costs of approximately $204,000 per patient. The incremental outcomes were similar for the modified societal perspective. At the list price of $56,000 per year, the cost-effectiveness ranged from $1.02 million per evLYG to $1.33 million per QALY gained from the health care system perspective; and from $938,000 per evLYG to $1.27 million per QALY gained in the modified societal perspective. The annual price to meet commonly used cost-effectiveness thresholds ranged from $2,950 to $8,360, which represents a discount of 85-95% off from the annual launch price set by the manufacturer. Using estimates of effectiveness based only on the trial that suggested a benefit, the mean incremental cost was greater than $400,000 per QALY gained.Discussion:Patients treated with aducanumab received minimal improvements in health outcomes at considerable cost. This resulted in incremental cost-effectiveness ratios that far exceeded commonly used value thresholds, even under optimistic treatment effectiveness assumptions. These findings are subject to the substantial uncertainty regarding whether aducanumab provides any true net health benefit, but evidence available currently suggests that an annual price of aducanumab of $56,000 is not in reasonable alignment with its clinical benefits.

Toward a broader concept of societal value: family spillovers in Alzheimer's disease

Recognizing that the “healthcare sector perspective” can be too limited in some situations, the National Institute of Health and Care Excellence (NICE), Institute for Clinical and Economic Review (ICER), and the U.S. Second Panel on Cost-Effectiveness in Health and Medicine all recommend a “societal” perspective in “reference case” cost-effectiveness analyses (CEAs). Although costs of informal caregiving are sometimes included in the CEAs of Alzheimer's Disease (AD) drugs, the benefits and disutility to family members, referred to as “family spillovers” by the U.S. Second Panel, are usually omitted. We estimate that the aggregate cost of family spillovers could be substantial in the USA—on the order of USD 57 billion or over 10 percent of the total economic burden of AD in 2020. Incorporation of family spillovers in AD value frameworks and HTAs is important for comprehensively defining, rewarding, and providing high-value care in AD.

Have City Dwellers Lost Touch with Modern Agriculture? In Quest of Differences between Urban and Rural Population

Frequently, urbanization and loss of an urban population’s connection to agriculture are given as the main reasons for decreasing societal acceptance of modern-day agriculture. An online survey of the German population in 2018 provided two selective subsamples of rural (n = 337) and urban residents (n = 560). Comparing group differences with regard to (a) the general societal perspective on agriculture and (b) positions on the use of digital farming technologies shows only little evidence of significant contributions of the used predictor items. Thus, no generalized tendency can be found that city dwellers are more opposed to agricultural developments based on different attitudes and perceptions.

Cost-effectiveness analysis of a large-scale crèche intervention to prevent child drowning in rural Bangladesh

Background Drowning is the leading cause of death among children 12–59 months old in rural Bangladesh. This study evaluated the cost-effectiveness of a large-scale crèche (daycare) intervention in preventing child drowning. Methods The cost of the crèches intervention was evaluated using an ingredients-based approach and monthly expenditure data collected prospectively throughout the study period from two agencies implementing the intervention in different study areas. The estimate of the effectiveness of the crèches intervention was based on a previous study. The study evaluated the cost-effectiveness from both a program and societal perspective. Results From the program perspective the annual operating cost of a crèche was $416.35 (95% CI: $221 to $576), the annual cost per child was $16 (95% CI: $8 to $23), and the incremental-cost-effectiveness ratio (ICER) per life saved with the crèches was $17,008 (95% CI: $8817 to $24,619). From the societal perspective (including parents time valued) the ICER per life saved was − $166,833 (95% CI: − $197,421 to − $141,341)—meaning crèches generated net economic benefits per child enrolled. Based on the ICER per disability-adjusted-life years averted from the societal perspective (excluding parents time), $1978, the crèche intervention was cost-effective even when the societal economic benefits were ignored. Conclusions Based on the evidence, the crèche intervention has great potential for generating net societal economic gains by reducing child drowning at a program cost that is reasonable.

The cost effectiveness of personalized dietary advice to increase protein intake in older adults with lower habitual protein intake: a randomized controlled trial

Purpose To examine the cost effectiveness of dietary advice to increase protein intake on 6-month change in physical functioning among older adults. Methods In this multicenter randomized controlled trial, 276 community-dwelling older adults with a habitual protein intake < 1.0 g/kg adjusted body weight (aBW)/d were randomly assigned to either Intervention 1; advice to increase protein intake to ≥ 1.2 g/kg aBW/d (PROT, n = 96), Intervention 2; similar advice and in addition advice to consume protein (en)rich(ed) foods within half an hour after usual physical activity (PROT + TIMING, n = 89), or continue the habitual diet with no advice (CON, n = 91). Primary outcome was 6-month change in 400-m walk time. Secondary outcomes were 6-month change in physical performance, leg extension strength, grip strength, body composition, self-reported mobility limitations and quality of life. We evaluated cost effectiveness from a societal perspective. Results Compared to CON, a positive effect on walk time was observed for PROT; – 12.4 s (95%CI, – 21.8 to – 2.9), and for PROT + TIMING; – 4.9 s (95%CI, – 14.5 to 4.7). Leg extension strength significantly increased in PROT (+ 32.6 N (95%CI, 10.6–54.5)) and PROT + TIMING (+ 24.3 N (95%CI, 0.2–48.5)) compared to CON. No significant intervention effects were observed for the other secondary outcomes. From a societal perspective, PROT was cost effective compared to CON. Conclusion Dietary advice to increase protein intake to ≥ 1.2 g/kg aBW/d improved 400-m walk time and leg strength among older adults with a lower habitual protein intake. From a societal perspective, PROT was considered cost-effective compared to CON. These findings support the need for re-evaluating the protein RDA of 0.8 g/kg BW/d for older adults. Trial registration The trial has been registered at ClinicalTrials.gov (NCT03712306). Date of registration: October 2018. Registry name: The (Cost) Effectiveness of Increasing Protein Intake on Physical Functioning in Older Adults. Trial Identifier: NCT03712306.

Cost burden and cost-effective analysis of the nationwide implementation of the Quality in Acute Stroke Care protocol in Australia

Background The Quality in Acute Stroke Care (QASC) protocol is a multidisciplinary approach to implement evidence-based treatment after acute stroke that reduces death and disability. Aim This study sought to evaluate the cost-effectiveness of implementing the QASC protocol across Australia, from a healthcare and a societal perspective. Methods A decision-analytic model was constructed to reflect one-year outcomes post-stroke, aligned with the stroke severity categories of the modified Rankin scale (mRS). Decision analysis compared outcomes following implementation of the QASC protocol versus no implementation. Population data were extracted from Australian databases and data inputs regarding stroke incidence, costs, and utilities were drawn from published sources. The analysis assumed a progressive uptake and efficacy of the QASC protocol over five years. Health benefits and costs were discounted by 5% annually. The cost of each year lived by an Australian, from a societal perspective, was based on the Australian Government's “value of statistical life year” (AUD 213,000). Results Over five years, the model predicted 263,722 strokes among the Australian population. The implementation of the QASC protocol was predicted to prevent 1,154 deaths and yield a gain of 876 years of life (0.003 per stroke), and 3,180 quality-adjusted life years (QALYs) (0.012 per stroke). There was an estimated net saving of AUD 65.2 million in healthcare costs (AUD 247 per stroke) and AUD 251.7 million in societal costs (AUD 955 per stroke). Conclusions Implementation of the QASC protocol in Australia represents both a dominant (cost-saving) strategy, from a healthcare and a societal perspective. FUNDunding Acknowledgement Type of funding sources: None. Decision tree PSA