Experiences and Interest in Value-Based Payment Arrangements for Medical Products Among Medicaid Agencies: An Exploratory Analysis.

Unlabelled: Policy Points State Medicaid experience with value-based payment (VBP) arrangements for medical products is still relatively limited, and states face a number of challenges in designing and implementing such arrangements, particularly because of the resource-intensive nature of arrangements and data needed to support measurement of desired outcomes. A number of success factors and opportunities to support VBP arrangement efforts were identified through this study, including leveraging established venues or processes for collaboration with manufacturers, engaging external and internal partners in VBP efforts to bolster capabilities, acquiring access to new data sources, and utilizing annual renegotiation of contracts to allow for adjustments.

Context: To date, uptake of value-based payment (VBP) arrangements for medical products and knowledge of their design and impact have been mainly concentrated among private payers.

Beta amyloid PET scans for dementia diagnoses: Practice and research implications from CARE-IDEAS.

Beta amyloid PET scans are a minimally invasive biomarker that may inform Alzheimer's disease (AD) diagnosis. The Caregiver's Reactions and Experience (CARE) study, an IDEAS supplement, aimed to understand experiences of PET scan recipients and their care partners regarding motivations for scans, reporting and interpreting results, and impact of results. Patients with mild cognitive impairment or dementia who agreed to join the CARE-IDEAS study and their care partners participated in a baseline survey and follow-up survey approximately 18 months later, supplemented by in-depth qualitative interviews with subsets of participants.

Elevated Amyloid-β PET Scan and Cognitive and Functional Decline in Mild Cognitive Impairment and Dementia of Uncertain Etiology.

Background: Elevated amyloid-β (Aβ) on positron emission tomography (PET) scan is used to aid diagnosis of Alzheimer's disease (AD), but many prior studies have focused on patients with a typical AD phenotype such as amnestic mild cognitive impairment (MCI). Little is known about whether elevated Aβ on PET scan predicts rate of cognitive and functional decline among those with MCI or dementia that is clinically less typical of early AD, thus leading to etiologic uncertainty.

Objective: We aimed to investigate whether elevated Aβ on PET scan predicts cognitive and functional decline over an 18-month period in those with MCI or dementia of uncertain etiology.

Continuity of care (COC) and amyloid-β PET scan: the CARE-IDEAS study.

Background: High continuity of care (COC) is associated with better clinical outcomes among older adults. The impact of amyloid-β PET scan on COC among adults with mild cognitive impairment (MCI) or dementia of uncertain etiology is unknown.

Methods: We linked data from the CARE-IDEAS study, which assessed the impact of amyloid-β PET scans on outcomes in Medicare beneficiaries with MCI or dementia of uncertain etiology and their care partners, to Medicare claims (2015-2018).

Amyloid-β PET Scan Results Disclosure and Care-Partner Emotional Well-Being Over Time.

Background: Diagnostic tests, such as amyloid-β positron emission tomography (PET) scans, can increase appropriate therapeutic management for the underlying causes of cognitive decline. To evaluate the full utility of this diagnostic tool, information is needed on whether results from amyloid-β PET scans influence care-partner outcomes.

Objective: This study examines the extent to which previous disclosure of elevated amyloid (suggestive of Alzheimer's disease (AD) etiology) versus not-elevated amyloid (not suggestive of AD etiology) is associated with changes in care-partner wellbeing.

Navigating the high costs of cancer care: opportunities for patient engagement.

Over the past decade, the financial burden of cancer care on patients and their families has garnered increased attention. Many of the potential solutions have focused on system-level interventions such as adopting value-based payment models and negotiating drug prices; less consideration has been given to actions at the patient level to address cancer care costs. We argue that it is imperative to develop and support patient-level strategies that engage patients and consider their preferences, values and individual circumstances.

Value-based arrangements may be more prevalent than assumed.

Objectives: To better understand the prevalence of US value-based payment arrangements (VBAs), their characteristics, and the factors that facilitate their success or act as barriers to their implementation.

Study Design: Surveys were administered to a convenience sample of subject matter experts who were senior representatives from payer organizations and biopharmaceutical manufacturers. These data were supplemented with qualitative interviews in a subsample of survey respondents.

Advancing Value Assessment in the United States: A Multistakeholder Perspective.

Rising costs without perceived proportional improvements in quality and outcomes have motivated fundamental shifts in health care delivery and payment to achieve better value. Aligned with these efforts, several value assessment frameworks have been introduced recently to help providers, patients, and payers better understand the potential value of drugs and other interventions and make informed decisions about their use. Given their early stage of development, it is imperative to evaluate these efforts on an ongoing basis to identify how best to support and improve them moving forward.

The role of hospital payments in the adoption of new medical technologies: an international survey of current practice.

This study examined the role of prospective payment systems in the adoption of new medical technologies across different countries. A literature review was conducted to provide background for the study and guide development of a survey instrument. The survey was disseminated to hospital payment systems experts in 15 jurisdictions.

Improving medical device regulation: the United States and Europe in perspective.

Context: Recent debates and events have brought into question the effectiveness of existing regulatory frameworks for medical devices in the United States and Europe to ensure their performance, safety, and quality. This article provides a comparative analysis of medical device regulation in the two jurisdictions, explores current reforms to improve the existing systems, and discusses additional actions that should be considered to fully meet this aim. Medical device regulation must be improved to safeguard public health and ensure that high-quality and effective technologies reach patients.

The politics of comparative effectiveness research: lessons from recent history.

Efforts to support and use comparative effectiveness research (CER), some more successful than others, have been promulgated at various times over the last forty years. Following a resurgence of interest in CER, recent health care reforms provided substantial support to strengthen its role in US health care. While CER has generally captured bipartisan support, detractors have raised concerns that it will be used to ration services and heighten government control over health care.

Medical technology as a key driver of rising health expenditure: disentangling the relationship.

Health care spending has risen steadily in most countries, becoming a concern for decision-makers worldwide. Commentators often point to new medical technology as the key driver for burgeoning expenditures. This paper critically appraises this conjecture, based on an analysis of the existing literature, with the aim of offering a more detailed and considered analysis of this relationship.

Evolving reimbursement and pricing policies for devices in Europe and the United States should encourage greater value.

Rising health care costs are an international concern, particularly in the United States, where spending on health care outpaces that of other industrialized countries. Consequently, there is growing desire in the United States and Europe to take a more value-based approach to health care, particularly with respect to the adoption and use of new health technology. This article examines medical device reimbursement and pricing policies in the United States and Europe, with a particular focus on value.

Valuing end-of-life care in the United States: the case of new cancer drugs.

New cancer therapies offer the hope of improved diagnosis to patients with life-threatening disease. Over the past 5-10 years, a number of specialty drugs have entered clinical practice to provide better systemic therapy for advanced cancers that respond to few therapeutic alternatives. To date, however, such advances have been only modestly effective in extending life and come with a high price tag, raising questions about their value for money, patient access and implications for health care costs.

Comparative effectiveness research: the experience of the National Institute for Health and Clinical Excellence.

Purpose: To assess the relevance of the experience of the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom to the comparative effectiveness research (CER) initiative in the United States.

Methods: The activities of NICE were reviewed to assess its experience in analytic methods, engagement with stakeholders, communication of findings, and implementation of recommendations.

Results: The main lessons for the United States from the experience of NICE relate to how the institute has gathered, synthesized, and used information on the clinical and cost effectiveness of health care interventions.

Reflections on the evolution of health technology assessment in Europe.

Health technology assessment (HTA) has assumed an increasing role in health systems in recent years, with many countries establishing agencies or programmes to evaluate health technology and other interventions to inform policy decisions and clinical practice. This paper reflects upon its development and evolution in Europe over the last decade, with a focus on England, France, Germany and Sweden. In particular, we explore how HTA has evolved over time as well as its impact on policy and practice.

Applying health economics for policy decision making: do devices differ from drugs?

Medical devices pose unique challenges for economic evaluation and associated decision-making processes that differ from pharmaceuticals. We highlight and discuss these challenges in the context of cardiac device therapy, based on a systematic review of relevant economic evaluations. Key challenges include practical difficulties in conducting randomized clinical trials, allowing for a 'learning curve' and user characteristics, accounting for the wider organizational impacts of introducing new devices, and allowing for variations in product characteristics and prices over time.

Infectious disease surveillance in the United States and the United Kingdom: from public goods to the challenges of new technologies.

Infectious diseases are a long-standing and continuing threat to health and welfare, with their containment dependent on national disease surveillance and response capacities. This article discusses infectious disease surveillance in the United States and the United Kingdom, examining historical national traditions for identifying and controlling infectious disease risks and how globalization and technical advances have influenced the evolution of their respective approaches. The two systems developed in different but parallel ways.

Medical technology procurement in Europe: a cross-country comparison of current practice and policy.

Procurement policy can influence the diffusion of medical devices into national health systems, but limited comparative evidence exists on how countries procure such technologies. This paper discusses the procurement of select medical devices across five countries (England, France, Germany, Italy, and Spain) based on a review of published and grey literature and policy documents, as well as expert interviews. All countries have introduced various regulatory or policy measures that implicitly or explicitly influence device procurement, from lists of devices for purchase to changes in financing mechanisms.

Use of comparative effectiveness research in drug coverage and pricing decisions: a six-country comparison.

Comparative effectiveness research (CER) has assumed an increasing role in drug coverage and, in some cases, pricing decisions in Europe, as decision-makers seek to obtain better value for money. This issue brief comparatively examines the use of CER across six countries--Denmark, England, France, Germany, the Netherlands, and Sweden. With CER gaining traction in the United States, these international experiences offer insights and potential lessons.