Time to Care: The Importance of Caregiver Voice in Healthcare, Drug Development, and Value Assessment
Nesrin Vurgun, PhD, Purple Squirrel Economics, a Cytel Company, Montréal, QC, Canada; Elizabeth Hubscher, PhD, and Karen Sandman, PhD, Purple Squirrel Economics, a Cytel Company, New York, NY, USA
Our global population is aging dramatically. According to the United Nations World Population Ageing report, in 2019, 703 million people aged 65 years or older were living worldwide—a number that is expected to double by 2050.1 Older adults have traditionally received assistance from family members or other unpaid caregivers (hereafter referred to as family caregivers) with day-to-day activities as well as healthcare needs. Shifting demographics have wide-reaching implications: not only will more people need care, but caregivers themselves are getting older.
From a societal viewpoint, the value of informal care provided by family caregivers is immense. In addition to assisting older adults with activities of daily living, family caregivers are intimately involved with carrying out complex and wide-ranging healthcare activities. These include coordinating medical care, managing medications, monitoring symptoms, and performing direct patient care tasks. The AARP Public Policy Institute estimated that family caregivers provided 34 billion hours of unpaid care across the United States in 2017, which equated to an economic value of $470 billion.2
The demands of caregiving, combined with limited formal training or external supports, can adversely impact the health and well-being of family caregivers. “Caregiver strain” is a concept that has been used to describe the spectrum of physical, psychological, social, and financial impacts experienced by family caregivers.3–5 Dependence on family caregivers and high caregiver strain are most prominent in conditions that impose both physical and cognitive limitations, such as stroke, Alzheimer’s disease, and dementia, which predominantly afflict older individuals.
C. Grace Whiting, JD, the president and CEO of the National Alliance for Caregiving, stressed that, “Family caregivers are caring for multiple people ... [and] need care themselves to maintain their own health and wellness and to be the best care provider for a patient. When caregivers don’t have the support they need, it becomes more difficult for them to be a partner in care to the patient.”
Given the inherent societal value and costs associated with informal caregiving, there may be benefits associated with medical products that diminish severity of symptoms, slow disease progression, or lower treatment burden, thereby reducing caregiver strain. At present, there is a critical need for medical product manufacturers, value assessment agencies, and payers to improve engagement with family caregivers.
Giving a Voice to Family Caregivers in Medical Product Development
Caregiving activities and caregiver strain evolve over the course of the care recipient’s illness and depend on the care plan. As a result, family caregivers have unique perspectives into the burden of diseases, impact of existing treatments, and any unmet needs that could be fulfilled by novel therapies. In situations of medical complexity, cognitive impairment, or functional limitation, family caregivers can be essential participants during all stages of clinical development. They can facilitate engagement and participation in clinical trials and act as patient representatives. For example, in clinical trials of Alzheimer’s disease or dementia interventions, family caregivers typically provide reports on the patient’s cognition, behavior, global health, and functional status.6
Beyond the role of representative or advocate for the care recipient, family caregivers can also provide distinct information on their own well-being, strain, and health-related quality of life (HRQoL). These “caregiver-reported outcomes” can complement the patient’s voice as well as other efficacy and safety evidence. During clinical development, caregiver-reported outcomes data can be collected with validated general or disease-specific assessments.7 One such assessment, the Zarit Burden Interview , evaluates caregiver strain in terms of physical, psychological, social, and financial well-being and has been validated in several languages for use in dementia. Caregiver HRQoL (eg, utilities) can be assessed with instruments such as the EQ-5D. These data can be incorporated as evidence in economic models to assess the cost-effectiveness of new medical products and ultimately employed by healthcare decision makers and payers.
Family caregivers provided 34 billion hours of unpaid care across the United States in 2017, which equated to an economic value of $470 billion.
Informal Caregiving and Value Assessments
Inclusion of caregiver outcomes and costs of informal caregiving is essential to estimate the true impact of new medical products from the societal perspective, particularly for conditions with a greater demand for caregiving, such as Alzheimer’s disease or dementia. Many high-income countries (with the notable exception of the United States) have established national health technology assessment (HTA) agencies to assess the value of new medical products to patients, caregivers, and society. Evidence considered in HTA evaluations can include the so-called “spillover effect” of a condition, such as the family caregiver’s lost wages, productivity, or change in caregiver HRQoL.8 The UK’s National Institute for Health and Care Excellence (NICE) recommends, but does not require, the inclusion of data related to the direct health of family caregivers (eg, EQ-5D data).9 Nevertheless, a recent review of over 400 NICE technology appraisals found that family caregiver HRQoL was only considered in 3% of analyses; half of these involved pediatric patient populations and one examined Alzheimer’s disease.10
Economic benefits of new medical products may be underestimated in analyses that fail to encapsulate cost offsets arising from the alleviation of caregiver strain, such as reduced productivity losses or decreased healthcare spending for the informal caregiver. In a review that examined cost-utility analyses published in Alzheimer’s disease or dementia, incorporation of caregiver-specific evidence (eg, HRQoL, time costs) generally led to better cost-effectiveness results than when these data were not considered.11 The implications of omitting or inadequately capturing family caregiver-relevant outcomes in economic analyses and HTA submissions are serious and far-reaching, as they may influence access to new therapies and reimbursement decisions.
One potential barrier to conducting analyses is the lack of published evidence on the economic burden of informal caregiving and disease- or population-specific family caregiver HRQoL or utilities data.10 There are also limitations due to the oversimplification of what informal caregiving entails in analyses, such as the assumption that informal care is provided by a sole family caregiver.
According to Whiting, “Health assessors should think about social and behavioral determinants of health that can impact a family unit, such as financial costs (both long-term and short-term), emotional and physical strain due to care, and lack of support like other care providers.”
While HTA agencies such as NICE consider issues related to the equitable access of new therapies, equity in the context of informal caregiving may not be captured in value assessments. Risk factors for high caregiver strain include socioeconomic factors such as social isolation, financial stress, longer hours of caregiving, and caregiving without a feeling of choice.3,5 These risks are amplified for family caregivers from marginalized communities who face health disparities. For example, older adults from racial and ethnic minorities may rely on informal caregiving due to a variety of institutional, structural, and cultural factors, such as distrust, language barriers, limited resources, or lack of access to paid care.12 In part due to these barriers, patients from these communities are also underrepresented in clinical trials or other health and economic studies, thus exacerbating family caregiver data gaps.
Inclusion of caregiver outcomes and costs of informal caregiving is essential to estimate the true impact of new medical products from the societal perspective, particularly for conditions with a greater demand for caregiving, such as Alzheimer’s disease or dementia.
Whiting stressed that, “Medical product manufacturers must continue to include marginalized communities in the development of products that ultimately will be used by members of these communities. Medical product innovators should also ask what other social, economic, and environmental factors play a role in the participation of families from the communities they seek to include such as whether insurance will continue to provide healthcare if someone enrolls in a clinical trial; transportation to the trial site if necessary; expense of trial participation; cost of trial participation (and potential missed work); and cultural and language barriers that may make it difficult to participate without accommodation.”
The tremendous value informal caregiving brings to communities and societies often comes at a price for individual family caregivers. This price can only be expected to rise as the demand for informal caregiving increases along with a growing global population of older people. The complex reality of informal caregiving must be appreciated by medical product developers, healthcare decision makers, and other stakeholders. Engagement with family caregivers and collection of caregiver-reported outcomes with validated assessments should therefore be prioritized during medical product development as well as value assessment. Family caregivers are active participants within the healthcare system and have a breadth of lived experiences. The distinct voice of caregivers must be recognized to appreciate fully the potential value of new medical products for individuals, families, and societies.
Whiting emphasized that, “Formalizing roles for family caregivers in medical product development allows us to better understand and collect meaningful data about the roles caregivers play in providing individual care, improving population health, and reducing healthcare costs. As medicine and healthcare continues to trend towards ‘whole person’ and ‘whole family’ approaches, medical innovators have an opportunity to build assessments that include what we know about family caregiving, leading to a more comprehensive understanding of the value of their products to families and the healthcare system.”
We would like to thank C. Grace Whiting and Lauren Rachel St. Pierre from the National Alliance for Caregiving (NAC) for illuminating discussions on caregiving in the United States. NAC is a nonprofit organization, which is dedicated to improving the lives of family caregivers through advocacy, innovation, research, and building partnerships with stakeholders. For further information, the reader is directed to the following research reports available from NAC:
• Caregiving in the US 2020 (May 2020)
1. United Nations. Department of Economic and Social Affairs, Population Division. World Population Ageing 2019.Published 2019. Accessed July 8, 2021. https://www.un.org/en/development/desa/population/publications/pdf/ageing/WorldPopulationAgeing2019-Highlights.pdf.
2. Reinhard SC, Friss Feinberg L, Houser A, Choula R, Evans M. Valuing the Invaluable: 2019 Update: Charting a Path Forward. AARP Public Policy Institute. Published November 2019. Accessed July 8, 2021. https://www.aarp.org/content/dam/aarp/ppi/2019/11/valuing-the-invaluable-2019-update-charting-a-path-forward.doi.10.26419-2Fppi.00082.001.pdf.
3. AARP, National Alliance for Caregiving. Caregiving in the United States 2020. Published May 14, 2020. Accessed July 8, 2021. https://doi.org/10.26419/ppi.00103.001.
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9. National Institute for Health and Care Excellence. Guide to the methods of technology appraisal 2013. Published April 4, 2013. Accessed July 7, 2021. https://www.nice.org.uk/process/pmg9.
10. Pennington BM. Inclusion of carer health-related quality of life in National Institute for Health and Care Excellence appraisals. Value Health. 2020;23(10):1349-1357. doi:10.1016/j.jval.2020.05.017.
11. Lin P-J, D’Cruz B, Leech AA, et al. Family and caregiver spillover effects in cost-utility analyses of Alzheimer’s disease interventions. Pharmacoeconomics. 2019;37(4):597-608. doi:10.1007/s40273-019-00788-3.
12. Dilworth-Anderson P, Moon H, Aranda MP. Dementia caregiving research: expanding and reframing the lens of diversity, inclusivity, and intersectionality. Gerontologist. 2020;60(5):797-805. doi:10.1093/geront/gnaa050.