This study aimed to evaluate the influence of drug price dynamics in cost-effectiveness analyses.
We evaluated scenarios involving typical US drug price increases during the exclusivity period and ...price decreases after the loss of exclusivity (LOE). Worked examples are presented using the Institute for Clinical and Economic Review’s assessments of tezepelumab for the treatment of severe asthma and targeted immune modulators for rheumatoid arthritis.
Tezepelumab case: yearly 2% price increases during the period of exclusivity and a post-LOE price decrease of 25% yielded an incremental cost per quality-adjusted life-year (QALY) gained that increased over the base case from $430 300 to $444 600 (+3.2%). Yearly 2% price increases followed by a steeper post-LOE price reduction of 40% resulted in a cost per QALY gained of $401 400 (6.8% reduction vs the base case). Rheumatoid arthritis case: incorporating post-LOE price reductions for etanercept (intervention) and adalimumab (comparator) ranging from 25% to 40% yielded an incremental cost per QALY of $121 000 and $122 300, respectively (< 3% increase from the base case of $119 200/QALY). Including a 2% yearly price increase during the projected exclusivity periods of both intervention and comparator increased the cost per QALY gained by > 60%.
Two biologic treatment cases incorporating price dynamics in cost-effectiveness analyses had varied impacts on the cost-effectiveness ratio depending on the magnitude of pre-LOE price increase and post-LOE price decrease and whether the LOE also affected the comparator. Yearly price increase magnitude during the period of exclusivity, among other factors, may counterbalance the effects of lower post-LOE intervention prices.
•Previous studies have revealed that accounting for a chronic drug’s future loss of market exclusivity can improve the results of cost-effectiveness analyses. Nevertheless, no studies have examined the extent to which US price increases during the period of exclusivity may counterbalance this effect.•Using frameworks from previous Institute for Clinical and Economic Review biologic treatment assessments, we found that yearly price increases of 3% or higher in the years before a drug’s loss of exclusivity more than counterbalanced the effect of post–loss of exclusivity price reductions, resulting in an overall increase in the cost per quality-adjusted life-year gained.
We investigated the relationship between neurochemical and hemodynamic responses as a function of image contrast in the human primary visual cortex (V1). Simultaneously acquired BOLD-fMRI and single ...voxel proton MR spectroscopy signals were measured in V1 of 24 healthy human participants of either sex at 7 tesla field strength, in response to presentations (64 s blocks) of different levels of image contrast (3%, 12.5%, 50%, 100%). Our results suggest that complementary measures of neurotransmission and energy metabolism are in partial agreement: BOLD and glutamate signals were linear with image contrast; however, a significant increase in glutamate concentration was evident only at the highest intensity level. In contrast, GABA signals were steady across all intensity levels. These results suggest that neurochemical concentrations are maintained at lower ranges of contrast levels, which match the statistics of natural vision, and that high stimulus intensity may be critical to increase sensitivity to visually modulated glutamate signals in the early visual cortex using MR spectroscopy.
Glutamate and GABA are the major excitatory and inhibitory neurotransmitters of the brain. To better understand the relationship between MRS-visible neurochemicals, the BOLD signal change, and stimulus intensity, we measured combined neurochemical and BOLD signals (combined fMRI-MRS) to different image contrasts in human V1 at 7 tesla. While a linear change to contrast was present for both signals, the increase in glutamate was significant only at the highest stimulus intensity. These results suggest that hemodynamic and neurochemical signals reflect common metabolic markers of neural activity, whereas the mismatch at lower contrast levels may indicate a sensitivity threshold for detecting neurochemical changes during visual processing. Our results highlight the challenge and importance of reconciling cellular and metabolic measures of neural activity in the human brain.
The cost-effectiveness of community health worker (CHW)-based cardiovascular disease (CVD) risk-reduction interventions is not well established. Colorado Heart Healthy Solutions is a CHW-based ...intervention designed to reduce modifiable CVD risk factors. This program has previously demonstrated success, but the cost-effectiveness is unknown. CHW-based interventions are potentially attractive complements to healthcare delivery because laypersons implement the intervention at a lower cost relative to medical care and may be attractive in rural settings with limited clinical resources.
CHWs performed screenings and provided ongoing participant support within predominantly rural communities. A point-of-service software tool was used to generate 10-year Framingham CVD risk scores and assist CHWs to make medical referrals and provide ongoing individualized support for lifestyle changes. A sample of program participants returned for reassessment of risk factors. We calculated quality-adjusted life years (QALYs) gained and program costs using a Markov model. Transition probabilities were calculated using Framingham risk equations or derived from the literature using the observed mean reduction in 10-year CVD risk score over of 37- months follow-up. Program cost-effectiveness was calculated for both at-risk (abnormal baseline CVD risk factors) and overall program populations.
The base-case scenario evaluating a 52-year-old male participant revealed an incremental cost savings of $3576 and a gain of 0.16 QALYs associated with the intervention. Cost savings were greater in at-risk populations. The economic dominance of the model was robust in multiple sensitivity analyses.
A community-based CVD intervention demonstrated to reduce CVD risk is cost-effective. This suggests that population-based public health programs may have the potential to complement primary care preventative services to improve health and reduce the burden of traditional medical care.
Health technology assessment (HTA) agencies are considering adopting a lifecycle approach to assessments to address uncertainties in the evidence base at launch and to revisit the clinical and ...economic value of therapies in a dynamic clinical landscape. For reassessments of therapies post launch, HTA agencies are looking to real-world evidence (RWE) to enhance the clinical and economic evidence base, though challenges and concerns in using RWE in decision-making exists. Stakeholders are embarking on demonstration projects to address the challenges and concerns and to further define when and how RWE can be used in HTA decision making. The Institute for Clinical and Economic Review piloted a 24-month observational RWE reassessment. Key learnings from this pilot include identifying the benefits and challenges with using RWE in reassessments and considerations on prioritizing and selecting topics relevant for RWE updates.
In humans, motor learning is underpinned by changes in sensorimotor network functional connectivity (FC). Unilateral contractions increase FC in the ipsilateral primary motor cortex (M1) and ...supplementary motor area (SMA); areas involved in motor planning and execution of the contralateral hand. Therefore, unilateral contractions are a promising approach to augment motor performance in the contralateral hand. In a within-participant, randomized, cross-over design, 15 right-handed adults had two magnetic resonance imaging (MRI) sessions, where functional-MRI and MR-Spectroscopic Imaging were acquired before and after repeated right-hand contractions at either 5% or 50% maximum voluntary contraction (MVC). Before and after scanning, response times (RTs) were determined in both hands. Nine minutes of 50% MVC contractions resulted in decreased handgrip force in the contracting hand, and decreased RTs and increased handgrip force in the contralateral hand. This improved motor performance in the contralateral hand was supported by significant neural changes: increased FC between SMA-SMA and increased FC between right M1 and right Orbitofrontal Cortex. At a neurochemical level, the degree of GABA decline in left M1, left and right SMA correlated with subsequent behavioural improvements in the left-hand. These results support the use of repeated handgrip contractions as a potential modality for improving motor performance in the contralateral hand.
Drs Rind, Campbell, Pearson, Ms Herce-Hagiwara, Ms Fluetsch, and Ms Herron-Smith report grants from Arnold Ventures; Kaiser Foundation Health Plan, Inc; The Patrick and Catherine Donaghue Medical ...Research Foundation; Blue Cross Blue Shield of Massachusetts; and California Healthcare Foundation during the course of this study.
Patients discharged from the hospital to a skilled nursing facility (SNF) are not typically part of a heart failure disease management program (HF-DMP). The objective of this study is to determine if ...an HF-DMP in SNF improves outcomes for patients with HF.
Cluster-randomized controlled trial.
The trial was conducted in 47 SNFs, and 671 patients were enrolled (329 HF-DMP; 342 to usual care).
The HF-DMP included documentation of ejection fraction, symptoms, weights, diet, medication optimization, education, and 7-day visit post SNF discharge. The composite outcome was all-cause hospitalization, emergency department visits, or mortality at 60 days. Secondary outcomes included the composite endpoint at 30 days, change in the Kansas City Cardiomyopathy Questionnaire and the Self-care of HF Index at 60 days. Rehospitalization and mortality rates were calculated as an exploratory outcome.
Mean age of the patients was 79 ± 10 years, 58% were women, and the mean ejection fraction was 51% ± 16%. At 30 and 60 days post SNF admission, the composite endpoint was not significant between DMP (29%) and usual care (32%) at 30 days and 60 days (43% vs 47%, respectively). The Kansas City Cardiomyopathy Questionnaire significantly improved in the HF-DMP vs usual care for the Physical Limitation (11.3 ± 2.9 vs 20.8 ± 3.6; P = .039) and Social Limitation subscales (6.0 ± 3.1 vs 17.9 ± 3.8; P = .016). Self-care of HF Index was not significant. The total number of events (composite endpoint) totaled 517 (231 in HF-DMP and 286 in usual care). Differences in the 60-day hospitalization rate mean HF-DMP rate 0.43 (SE 0.03) vs usual care 0.54 (SE 0.05), P = .04 and mortality rate (HF-DMP 5.2% vs usual care 10.8%, P < .001) were significant.
The composite endpoint was high for patients with HF in SNF regardless of group. Rehospitalization and mortality rates were reduced by the HF-DMP. HF-DMPs in SNFs may be beneficial to the outcomes of patients with HF. SNFs should consider structured HF-DMPs for their patients.
PDF
