Health Sector Management : Publications since January 2023

%% Ridley, David B.   
@article{fds375866,
   Author = {Ridley, DB and Lasanta, AM and Storer Jones and F and Ridley,
             SK},
   Title = {European priority review vouchers for neglected disease
             product development.},
   Journal = {BMJ global health},
   Volume = {9},
   Number = {1},
   Pages = {e013686},
   Publisher = {BMJ},
   Year = {2024},
   Month = {January},
   url = {http://dx.doi.org/10.1136/bmjgh-2023-013686},
   Abstract = {<h4>Introduction</h4>Neglected diseases are a significant
             global health challenge. Encouraging the development of
             therapeutics and vaccines for these diseases would address
             an important unmet medical need. We propose a priority
             review voucher programme for the European Union (EU). The
             developer of a drug or vaccine for a neglected disease would
             receive a voucher for accelerated assessment of a different
             product at the European Medicines Agency
             (EMA).<h4>Methods</h4>This study uses retrospective
             observational data to estimate the potential commercial
             value of the proposed voucher programme using a five-step
             approach: (1) estimating the time saved in the EMA
             accelerated regulatory review; (2) gauging time reductions
             in accelerated pricing and reimbursement decisions by EU
             member states; (3) selecting 10 high-revenue products
             launched between 2015 and 2020 representing typical voucher
             users; (4) analysing IQVIA MIDAS sales data for the selected
             products and (5) calculating the net present value (NPV) of
             the voucher based on the 10 products.<h4>Results</h4>The
             accelerated EMA review would reduce regulatory time by an
             average of 182 days. Additionally, products could save more
             than a year in many member states through an expedited
             120-day pricing and reimbursement review. The estimated NPV
             of regulatory acceleration by two quarters would be
             €100 million. In addition, if France, Italy and Spain
             reviewed pricing and reimbursement in only 120 days, then
             the value would double.<h4>Conclusion</h4>An EU voucher
             estimated at more than €100 million, coupled with a
             US$100 million counterpart, offers a meaningful incentive
             for novel product development. However, the voucher
             programme should be part of a comprehensive strategy for
             tackling neglected diseases, rather than a standalone
             solution.},
   Doi = {10.1136/bmjgh-2023-013686},
   Key = {fds375866}
}

@article{fds372991,
   Author = {Liebman, E and Lawler, EC and Dunn, A and Ridley,
             DB},
   Title = {Consequences of a shortage and rationing: Evidence from a
             pediatric vaccine.},
   Journal = {Journal of health economics},
   Volume = {92},
   Pages = {102819},
   Publisher = {Elsevier BV},
   Year = {2023},
   Month = {December},
   url = {http://dx.doi.org/10.1016/j.jhealeco.2023.102819},
   Abstract = {Shortages and rationing are common in health care, yet we
             know little about the consequences. We examine an 18-month
             shortage of the pediatric Haemophilus Influenzae Type B
             (Hib) vaccine. Using insurance claims data and variation in
             shortage exposure across birth cohorts, we find that the
             shortage reduced uptake of high-value primary doses by 4
             percentage points and low-value booster doses by 26
             percentage points. This suggests providers largely complied
             with rationing recommendations. In the long-run, catch-up
             vaccination occurred but was incomplete: shortage-exposed
             cohorts were 4 percentage points less likely to have
             received the ir booster dose years later. We also find that
             the shortage and rationing caused provider switches, extra
             provider visits, and negative spillovers to other
             care.},
   Doi = {10.1016/j.jhealeco.2023.102819},
   Key = {fds372991}
}

@article{fds374357,
   Author = {Cuddy, E and Lu, YP and Ridley, DB},
   Title = {FDA Global Drug Inspections: Surveillance Of Manufacturing
             Establishments Remains Well Below Pre-COVID-19
             Levels.},
   Journal = {Health affairs (Project Hope)},
   Volume = {42},
   Number = {12},
   Pages = {1758-1766},
   Year = {2023},
   Month = {December},
   url = {http://dx.doi.org/10.1377/hlthaff.2023.00686},
   Abstract = {During the initial phase of the COVID-19 pandemic, the Food
             and Drug Administration (FDA) halted inspections of most
             overseas drug manufacturing establishments. Looking at data
             from the period 2012-22, we observed steep declines in both
             foreign and domestic inspections in 2020. By 2022, numbers
             of inspections remained well below prepandemic levels, with
             a 79 percent decrease in foreign inspections and a
             35 percent decline in domestic inspections compared with
             2019. There was no corresponding reduction in drug
             manufacturing or imports. Also, the resources allocated per
             inspection surged, although the FDA's overall budget and
             staffing remained steady. Finally, citations rose
             dramatically, despite all establishments being given advance
             notice of inspections. The findings of our study underscore
             the pressing need to explore alternative methods for
             ensuring drug safety.},
   Doi = {10.1377/hlthaff.2023.00686},
   Key = {fds374357}
}


%% Sloan, Frank A.   
@article{fds374393,
   Author = {Myers, A and Ristau, B and Mossanen, M and Tyson, MD and Chisolm, S and Sloan, F and Ball, CT and Smith, A and Lyon, TD},
   Title = {Patient reported treatment burden and attitudes towards
             in-home intravesical therapy among patients with bladder
             cancer.},
   Journal = {Urologic oncology},
   Volume = {42},
   Number = {2},
   Pages = {29.e17-29.e22},
   Year = {2024},
   Month = {February},
   url = {http://dx.doi.org/10.1016/j.urolonc.2023.09.006},
   Abstract = {<h4>Purpose</h4>To quantify patient reported treatment
             burden while receiving intravesical therapy for bladder
             cancer and to survey patient perspectives on in-home
             intravesical therapy.<h4>Materials and methods</h4>We
             conducted a cross-sectional survey of the Bladder Cancer
             Advocacy Network Patient Survey Network. Survey questions
             were developed by investigators, then iteratively revised by
             clinician and patient advocates. Eligible participants had
             to have received at least 1 dose of intravesical therapy
             delivered in an ambulatory setting.<h4>Results</h4>Two
             hundred thirty-three patients responded to the survey with
             median age of 70 years (range 33-88 years). Two-thirds of
             respondents (66%, 151/232) had received greater than 12
             bladder instillations. A travel time of >30 minutes to an
             intravesical treatment facility was reported by 55%
             (126/231) of respondents. Fifty-six percent (128/232)
             brought caregivers to their appointments, and 36% (82/230)
             missed work to receive treatment. Sixty-one respondents
             (26%) felt the process of receiving bladder instillations
             adversely affected their ability to perform regular daily
             activities. Among those surveyed, 72% (168/232) reported
             openness to receiving in-home intravesical instillations and
             54% (122/228) answered that in-home instillations would make
             the treatment process less disruptive to their
             lives.<h4>Conclusions</h4>Bladder cancer patients reported
             considerable travel distances, time requirements, and need
             for caregiver support when receiving intravesical therapy.
             Nearly three-quarters of survey respondents reported
             openness to receiving intravesical instillations in their
             home, with many identifying potential benefits for home over
             clinic-based therapy.},
   Doi = {10.1016/j.urolonc.2023.09.006},
   Key = {fds374393}
}

@article{fds369330,
   Author = {Sloan, FA and Valdmanis, VG},
   Title = {Relative Productivity of For-Profit Hospitals: A Big or a
             Little Deal?},
   Journal = {Medical care research and review : MCRR},
   Volume = {80},
   Number = {4},
   Pages = {355-371},
   Year = {2023},
   Month = {August},
   url = {http://dx.doi.org/10.1177/10775587221142268},
   Abstract = {This study asks: Does the empirical evidence support the
             conclusion that for-profit (FP) hospitals are more
             productive or efficient than private not-for-profit (NFP)
             hospitals or non-federal public (PUB) hospitals? Alternative
             theories of NFP behavior are described. Our review of
             individual empirical hospital studies of quality, service
             mix, community benefit, and cost/efficiency in the United
             States published since 2000 indicates that no systematic
             difference exists in cost/efficiency, provision of
             uncompensated care, and quality of care. But FPs are more
             likely to provide profitable services, higher service
             intensity, have lower shares of uninsured and Medicaid
             patients, and are more responsive to external financial
             incentives. That FP hospitals are not more efficient runs
             counter to property rights theory, but their relative
             responsiveness to financial incentives supports it. There is
             little evidence that FP market presence changes NFP
             behaviors. Observed differences between FP and NFP hospitals
             are mostly a "little deal."},
   Doi = {10.1177/10775587221142268},
   Key = {fds369330}
}

@article{fds370032,
   Author = {Wu, B and Luo, H and Tan, C and Qi, X and Sloan, FA and Kamer, AR and Schwartz, MD and Martinez, M and Plassman, BL},
   Title = {Diabetes, Edentulism, and Cognitive Decline: A 12-Year
             Prospective Analysis.},
   Journal = {J Dent Res},
   Volume = {102},
   Number = {8},
   Pages = {879-886},
   Year = {2023},
   Month = {July},
   url = {http://dx.doi.org/10.1177/00220345231155825},
   Abstract = {Diabetes mellitus (DM) is a recognized risk factor for
             dementia, and increasing evidence shows that tooth loss is
             associated with cognitive impairment and dementia. However,
             the effect of the co-occurrence of DM and edentulism on
             cognitive decline is understudied. This 12-y cohort study
             aimed to assess the effect of the co-occurrence of DM and
             edentulism on cognitive decline and examine whether the
             effect differs by age group. Data were drawn from the 2006
             to 2018 Health and Retirement Study. The study sample
             included 5,440 older adults aged 65 to 74 y, 3,300 aged 75
             to 84 y, and 1,208 aged 85 y or older. Linear mixed-effect
             regression was employed to model the rates of cognitive
             decline stratified by age cohorts. Compared with their
             counterparts with neither DM nor edentulism at baseline,
             older adults aged 65 to 74 y (β = -1.12; 95% confidence
             interval [CI], -1.56 to -0.65; P < 0.001) and those aged 75
             to 84 y with both conditions (β = -1.35; 95% CI, -2.09 to
             -0.61; P < 0.001) had a worse cognitive function. For the
             rate of cognitive decline, compared to those with neither
             condition from the same age cohort, older adults aged 65 to
             74 y with both conditions declined at a higher rate (β =
             -0.15; 95% CI, -0.20 to -0.10; P < 0.001). Having DM alone
             led to an accelerated cognitive decline in older adults aged
             65 to 74 y (β = -0.09; 95% CI, -0.13 to -0.05; P < 0.001);
             having edentulism alone led to an accelerated decline in
             older adults aged 65 to 74 y (β = -0.13; 95% CI, -0.17 to
             -0.08; P < 0.001) and older adults aged 75 to 84 (β =
             -0.10; 95% CI, -0.17 to -0.03; P < 0.01). Our study finds
             the co-occurrence of DM and edentulism led to a worse
             cognitive function and a faster cognitive decline in older
             adults aged 65 to 74 y.},
   Doi = {10.1177/00220345231155825},
   Key = {fds370032}
}