Valuing the Societal Impact of Medicines and Other Health Technologies: A User Guide to Current Best Practices.

This study argues that value assessment conducted from a societal perspective should rely on the Generalized Cost-Effectiveness Analysis (GCEA) framework proposed herein. Recently developed value assessment inventories - such as the Second Panel on Cost-Effectiveness's "impact inventory" and International Society of Pharmacoeconomics Outcomes Research (ISPOR) "value flower" - aimed to more comprehensively capture the benefits and costs of new health technologies from a societal perspective. Nevertheless, application of broader value elements in practice has been limited in part because quantifying these elements can be complex, but also because there have been numerous methodological advances since these value inventories have been released (e.

An Alternative Measure of Health for Value Assessment: The Equal Value Life-Year.

The quality-adjusted life-year (QALY) is an international standard in cost-effectiveness analysis. A known concern arises from the relatively lower QALY gains attributed to treatments that extend the life of individuals with chronic disability. We analyze here the advantages and disadvantages of the equal value life-year (evLY) as an alternative or a complementary measure to the QALY, and share learned experiences from using this measure in health technology assessments.

Cost-effectiveness of : an adaptation of the diabetes prevention programme for delivery by community health workers in urban South Africa.

Background: is an adapted version of the Diabetes Prevention Program designed for delivery by community health workers to socioeconomically disadvantaged populations in low- and middle-income countries (LMICs). Results from the trial conducted in an under-resourced community in South Africa indicated that the programme had a significant effect on reducing haemoglobin A1c (HbA1c).

Objective: To estimate the cost of implementation and the cost-effectiveness (in cost per point reduction in HbA1c) of the programme to inform decision-makers of the resources required and the value of this intervention.

Living Health Technology Assessment: Issues, Challenges and Opportunities.

Health technology assessments (HTAs) are typically performed as one-off evaluations and can potentially become out-of-date due to the availability of new data, new comparators, or other factors. Recently, living approaches have been applied to systematic reviews and network meta-analyses to enable evidence syntheses to be updated more easily. In this paper, we provide a definition for 'Living HTA' where such a living approach could be applied to the entire HTA process.

Differences in cardiac testing resource utilization using two different risk stratification schemes.

Objective: Assess whether changing an emergency department (ED) chest pain pathway from utilizing the Thrombolysis in Myocardial Infarction (TIMI) score for risk stratification to an approach utilizing the History, EKG, Age, Risk, Troponin (HEART) score was associated with reductions in healthcare resource utilization.

Methods: A retrospective, quasi-experimental study using difference-in-differences and interrupted time series specifications evaluated all ED patients with a chest pain encounter from 8/2015 to 7/2019 at a large academic medical center. We included patients age ≥ 18 with negative troponin testing discharged from the ED.

The Influence of the Rural Transitions Nurse Program for Veterans on Healthcare Utilization Costs.

Background: The Veterans Affairs (VA) Healthcare System Rural Transitions Nurse Program (TNP) addresses barriers veterans face when transitioning from urban tertiary VA hospitals to home. Previous clinical evaluations of TNP have shown that enrolled veterans were more likely to follow up with their primary care provider within 14 days of discharge and experience a significant reduction in mortality within 30 days compared to propensity-score matched controls.

Objective: Examine changes from pre- to post-hospitalization in total, inpatient, and outpatient 30-day healthcare utilization costs for TNP enrollees compared to controls.

Oral treatments for outpatient COVID-19: Effectiveness and value.

Ms Beinfeld and Nahn and Drs Whittington, Mohammed, and Pearson report grants from Arnold Ventures, Kaiser Foundation Health Plan Inc., The Patrick and Catherine Weldon Donaghue Medical Research Foundation, Blue Cross Blue Shield of Massachusetts, and The Commonwealth Foundation, during the conduct of the study; and other from America's Health Insurance Plans, Anthem, AbbVie, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Cambia Health Services, CVS, Editas, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, Health Partners, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Premera, Prime Therapeutics, Regeneron, Sanofi, United Healthcare, HealthFirst, Pfizer, Boehringer-Ingelheim, uniQure, Humana, Sun Life, and Envolve Pharmacy Solutions, outside the submitted work. Dr Yeung received a contract from ICER to be an evidence author for COVID-19 outpatient treatments.

Cost-Effectiveness Analysis: Personal Systems Approach in Improving Medication Adherence in Adult Kidney Transplant Patients.

Interventions to improve medication nonadherence in transplantation have recently moved from a focus on motivation and intention, to a focus on person-level quality improvement strategies. These strategies link adherence to established daily routines, environmental cues, and supportive people. The objective of this evaluation was to estimate the cost of implementation and the cost-effectiveness of a person-level intervention shown to increase medication adherence.

The Cost-Effectiveness of Remdesivir for Hospitalized Patients With COVID-19.

Objectives: This study aimed to estimate the cost-effectiveness of remdesivir, the first novel therapeutic to receive Emergency Use Authorization for the treatment of hospitalized patients with COVID-19, and identify key drivers of value to guide future pricing and reimbursement efforts.

Methods: A Markov model evaluated the cost-effectiveness of remdesivir in patients hospitalized with COVID-19 from a US healthcare sector perspective. A lifetime time horizon captured potential long-term costs and outcomes.

Common Ground: Primary Care and Specialty Clinicians' Perceptions of E-Consults in the Veterans Health Administration.

Objective: The US Department of Veterans Affairs (VA) introduced electronic consultation (e-consult) to increase access to specialty care. The objective of this study was to understand perceptions of e-consults that may be relevant to increasing adoption in the VA.

Methods: Deductive and inductive content analysis of semistructured qualitative telephone interviews with VA primary care practitioners (PCPs), specialists, and specialty division chiefs was performed.

Performing Cost-Effectiveness Analyses to Support Policy Making: Key Lessons From the Assessment of Aducanumab.

The purpose of this article is to describe the process and the methods of cost-effectiveness analysis for clinicians interested in joining or leading aspects of this branch of evidence-based research. Cost-effectiveness is a useful tool for policymakers and is considered a starting point for discussions of fair pricing. Clinicians are important members of teams conducting cost-effectiveness analyses, particularly as it relates to integrating their clinical expertise into the decisions around the design and conduct of the analysis.

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

Background And Objectives: Aducanumab was granted accelerated approval with a conflicting evidence base, near-unanimous Food and Drug Administration 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.

A Systems-Based Morbidity and Mortality Conference Was Associated With a Transient Reduction in ECG Completion Times.

Background And Objectives: During its monthly morbidity and mortality conference (MMC), the University of Colorado Division of Cardiology reviewed a "near-miss" patient safety event involving the delayed completion of a Stat-priority (ie, statim, meaning high priority) electrocardiogram (ECG). Because critical and interprofessional stakeholders participated in the conference, we hypothesized that the MMC would be associated with reduced ECG completion times.

Methods: Data were collected for in-hospital ECGs performed at the University of Colorado Hospital between January 1, 2017, and June 30, 2018.

The effectiveness and value of aducanumab for Alzheimer's disease.

Funding for this summary was contributed by Arnold Ventures, The Donaghue Foundation, Harvard Pilgrim Health Care, and Kaiser Foundation Health Plan to the Institute for Clinical and Economic Review (ICER), an independent organization that evaluates the evidence on the value of health care interventions. ICER's annual policy summit is supported by dues from AbbVie, America's Health Insurance Plans, Anthem, Alnylam, AstraZeneca, Biogen, Blue Shield of CA, Boehringer-Ingelheim, Cambia Health Services, CVS, Editas, Evolve Pharmacy, Express Scripts, Genentech/Roche, GlaxoSmithKline, Harvard Pilgrim, Health Care Service Corporation, HealthFirst, Health Partners, Humana, Johnson & Johnson (Janssen), Kaiser Permanente, LEO Pharma, Mallinckrodt, Merck, Novartis, National Pharmaceutical Council, Pfizer, Premera, Prime Therapeutics, Regeneron, Sanofi, Sun Life Financial, uniQure, and United Healthcare. Whittington, Rind, and Pearson are employed by ICER.

Health costs of women with chronic overlapping pain conditions by opioid and complementary and integrative health use.

Objective: To estimate differences in average annual health care expenditures of adult women with chronic overlapping pain conditions (COPCs) by pain treatment modality as follows: (1) no long-term opioid or complementary and integrative health (CIH) use; (2) CIH only use; (3) long-term opioid only use; and (4) long-term opioid and CIH use.

Data Source: Cross-sectional Medical Expenditure Panel Survey data (2012-2016).

Study Design: We estimated differences between average annual expenditures of adult women with COPCs by their use of long-term opioids and CIH modalities.

The influence of a Sprint optimization and training intervention on time spent in the electronic health record (EHR).

Objective: We report the influence of Sprint electronic health record (EHR) training and optimization on clinician time spent in the EHR.

Materials And Methods: We studied the Sprint process in one academic internal medicine practice with 26 providers. Program offerings included individualized training sessions, and the ability to clean up, fix, or build new EHR tools during the 2-week intervention.

Patient and Payer Preferences for Additional Value Criteria.

Defining the value of healthcare is an elusive target, and depends heavily on the decision context and stakeholders involved. Cost-utility analysis and the quality-adjusted life year (QALY) have become the method and value definition of choice for traditional value judgements in coverage and pricing decisions. Other criteria that may influence value are often not measured and therefore omitted from value assessments, or are only used to qualitatively contextualize assessments.

Economic and clinical burden of comorbidities among patients with acromegaly.

Objective: Acromegaly is a rare, pituitary hormonal disorder that requires improved awareness worldwide. The objective of this analysis was to quantify the clinical and economic burden of comorbidities for patients with acromegaly and examine the influence of biochemical control on these outcomes.

Study Design: Markov cohort decision analytic model consisting of two states, including alive (with and without comorbidity) and dead.

Does Cost-Effectiveness Analysis Overvalue Potential Cures? Exploring Alternative Methods for Applying a "Shared Savings" Approach to Cost Offsets.

Objectives: To evaluate alternative methods to calculate and/or attribute economic surplus in the cost-effectiveness analysis of single or short-term therapies.

Methods: We performed a systematic literature review of articles describing alternative methods for cost-effectiveness analysis of potentially curative therapies whose assessment using traditional methods may suggest unaffordable valuations owing to the magnitude of estimated long-term quality-adjusted life-year (QALY) gains or cost offsets. Through internal deliberation and discussion with staff at the Health Technology Assessment bodies in England and Canada, we developed the following 3 alternative methods for further evaluation: (1) capping annual costs in the comparator arm at $150 000 per year; (2) "sharing" the economic surplus with the health sector by apportioning only 50% of cost offsets or 50% of cost offsets and QALY gains to the value of the therapy; and (3) crediting the therapy with only 12 years of the average annual cost offsets or cost offsets and QALY gains over the lifetime horizon.