An app-based ecological momentary assessment of undergraduate student mental Health during the COVID-19 pandemic in Canada (Smart Healthy Campus Version 2.0): Longitudinal study.

This paper presents results from the Smart Healthy Campus 2.0 study/smartphone app, developed and used to collect mental health-related lifestyle data from 86 Canadian undergraduates January-August 2021. Objectives of the study were to 1) address the absence of longitudinal mental health overview and lifestyle-related data from Canadian undergraduate students, and 2) to identify associations between these self-reported mental health overviews (questionnaires) and lifestyle-related measures (from smartphone digital measures). This was a longitudinal repeat measures study conducted over 40 weeks. A 9-item mental health questionnaire was accessible once daily in the app. Two variants of this mental health questionnaire existed; the first was a weekly variant, available each Monday or until a participant responded during the week. The second was a daily variant available after the weekly variant. 6518 digital measure samples and 1722 questionnaire responses were collected. Mixed models were fit for responses to the two questionnaire variants and 12 phone digital measures (e.g. GPS, step counts). The daily questionnaire had positive associations with floors walked, installed apps, and campus proximity, while having negative associations with uptime, and daily calendar events. Daily depression had a positive association with uptime. Daily resilience appeared to have a slight positive association with campus proximity. The weekly questionnaire variant had positive associations with device idling and installed apps, and negative associations with floors walked, calendar events, and campus proximity. Physical activity, weekly, had a negative association with uptime, and a positive association with calendar events and device idling. These lifestyle indicators that associated with student mental health during the COVID-19 pandemic suggest directions for new mental health-related interventions (digital or otherwise) and further efforts in mental health surveillance under comparable circumstances.

Disparities in Access to a Regular Primary Care Physician Among First-Generation Migrants with Early Psychosis in Ontario, Canada.

Disparities in primary care utilization among migrants with early psychosis may be related to lack of access to a regular primary care physician. This study aimed to investigate access to a regular primary care physician among first-generation migrants with early psychosis. People aged 14-35 years with first onset non-affective psychotic disorder in Ontario, Canada were identified in health administrative data (N = 39,440). Access to a regular primary care physician through enrollment in the year prior to diagnosis was compared between first-generation migrants (categorized by country of birth) and the general population using modified Poisson regression. Most migrant groups had a lower prevalence of regular primary care physician access relative to the general population, particularly migrants from Africa (African migrants: 81% vs. non-migrants: 89%). Adjustment for sociodemographic and clinical factors attenuated these differences, although the disparities for migrants from Africa remained (PR = 0.96, 95%CI = 0.94-0.99). Interventions aimed at improving primary care physician access in migrant groups may facilitate help-seeking and improve pathways to care in early psychosis.

The association between household food insecurity and healthcare costs among Canadian children.

OBJECTIVE: To examine the relationship between household food insecurity and healthcare costs in children living in Ontario, Canada. METHODS: We conducted a cross-sectional, population-based study using four cycles of the Canadian Community Health Survey (2007-2008, 2009-2010, 2011-2012, 2013-2014) linked with administrative health databases (ICES). We included Ontario children aged 1-17 years with a measure of household food insecurity (Household Food Security Survey Module) over the previous 12 months. Our primary outcome was the direct public-payer healthcare costs per child over the same time period (in Canadian dollars, standardized to year 2020). We used gamma-log-transformed generalized estimating equations accounting for the clustering of children to examine this relationship, and adjusted models for important sociodemographic covariates. As a secondary outcome, we examined healthcare usage of specific services and associated costs (e.g. visits to hospitals, surgeries). RESULTS: We found that adjusted healthcare costs were higher in children from food-insecure than from food-secure households ($676.79 [95% CI: $535.26, $855.74] vs. $563.98 [$457.00, $695.99], p = 0.047). Compared with children living in food-secure households, those in insecure households more often accessed hospitals, emergency departments, day surgeries, and home care, and used prescription medications. Children from food-secure households had higher usage of non-physician healthcare (e.g. optometry) and family physician rostering services. CONCLUSION: Even after adjusting for measurable social determinants of health, household food insecurity was associated with higher public-payer health services costs and utilization among children and youth. Efforts to mitigate food insecurity could lessen child healthcare needs, as well as associated costs to our healthcare systems.

RéSUMé: OBJECTIF: Examiner la relation entre l'insécurité alimentaire des ménages et les coûts des soins de santé chez les enfants vivant en Ontario, au Canada. MéTHODE: Nous avons mené une étude populationnelle transversale en utilisant les quatre cycles de l'Enquête sur la santé dans les collectivités canadiennes (2007­2008, 2009­2010, 2011­2012, 2013­2014) liés à des bases de données administratives sur la santé (ICES). Nous avons inclus les enfants ontariens de 1 à 17 ans et un indicateur d'insécurité alimentaire des ménages (le Module d'enquête sur la sécurité alimentaire des ménages) au cours des 12 mois antérieurs. Les coûts directs des soins de santé publics par enfant au cours de cette période (en dollars canadiens de 2020) ont constitué notre résultat principal. Nous avons utilisé des équations d'estimation généralisées transformées par la fonction logarithme gamma tenant compte du regroupement des enfants pour analyser cette relation, et des modèles ajustés pour les covariables sociodémographiques importantes. Comme résultat secondaire, nous avons analysé l'utilisation de certains services de soins de santé (p. ex. les visites dans les hôpitaux, les chirurgies) et les coûts associés. RéSULTATS: Nous avons constaté que les coûts ajustés des soins de santé étaient plus élevés chez les enfants des ménages aux prises avec l'insécurité alimentaire que chez ceux des ménages à l'abri de l'insécurité alimentaire (676,79 $ [IC de 95%: 535,26 $, 855,74 $] contre 563,98 $ [457,00 $, 695,99 $], p = 0,047). Comparativement aux enfants des ménages à l'abri de l'insécurité alimentaire, ceux qui vivaient dans des ménages aux prises avec l'insécurité avaient plus souvent recours aux hôpitaux, aux services des urgences, aux chirurgies d'un jour et aux soins à domicile, et ils prenaient des médicaments sur ordonnance. Les enfants des ménages à l'abri de l'insécurité alimentaire avaient plus souvent recours aux soins de santé non médicaux (p. ex. l'optométrie) et aux services de leur médecin de famille attitré. CONCLUSION: Même après l'apport d'ajustements pour tenir compte des déterminants sociaux de la santé mesurables, l'insécurité alimentaire des ménages était associée à des coûts de soins de santé publics plus élevés et à une plus grande utilisation de ces soins chez les enfants et les jeunes. Des efforts pour atténuer l'insécurité alimentaire pourraient réduire les besoins de soins de santé des enfants, ainsi que les coûts associés pour nos systèmes de soins de santé.

Alternative approaches to measuring value: an update on innovative methods in the context of the United States Medicare drug price negotiation program.

INTRODUCTION: The United States has begun assessing the value of pharmaceuticals to inform negotiated prices in the Medicare program. Given strong political objections in the United States to the use of QALYs, Medicare will need to adopt an alternative approach to measuring value. AREAS COVERED: In this narrative review, we identified six alternative approaches to measuring value (equal value life-years, health years in total, generalized risk-adjusted cost-effectiveness, severity weighting based on absolute or proportional shortfall, comparative effectiveness based on conventional clinical endpoints, and comparative effectiveness based on both conventional endpoints and patient-centric value elements) and five criteria for assessing these approaches (responsiveness to concerns about discrimination, feasibility, transparency, flexibility, and the ability to incorporate factors beyond traditional value elements). EXPERT OPINION: Four of the alternatives are broadly aligned with the cost-effectiveness framework, but none fully addresses all aspects of the stated concerns that QALYs may be used to unintentionally implement discrimination. We note, however, that the extent to which these concerns lead to discrimination in practice is unknown. Finally, we recommend an approach for measuring value in terms of comparative effectiveness that combines quantitative ranking and weighting of distinct criteria (including patient-centric value elements) with deliberation.

Is there an advantage? Considerations for researchers studying the effects of the type of Medicare coverage.

OBJECTIVE: To describe common methodological problems that arise in comparisons of Medicare Advantage (MA) and Traditional Medicare (TM) and within-MA studies and provide suggestions of how researchers can address these issues. STUDY SETTING: Published research evaluating Medicare coverage options in the United States. STUDY DESIGN: We considered key conceptual challenges and promising solutions that have been used thus far and suggest additional directions. DATA COLLECTION: Not available. PRINCIPAL FINDINGS: Many existing studies of MA versus TM include significant limitations, such as failing to account for unobserved confounders driving both beneficiary coverage choice and health outcomes once enrolled, not accounting for variation in benefit generosity, provider networks, or plan design across MA plans, and/or having been conducted at a time when MA enrollment was less than a third of all Medicare beneficiaries. We provide a review of methods that can help researchers to overcome these weaknesses and suggest additional methods and data sources that may aid future research. CONCLUSIONS: The MA program is becoming an essential part of the US healthcare system. By accounting for non-random movement into and out of MA and studying the heterogeneity of beneficiary experience across plan and market characteristics, researchers can provide the high-quality evidence necessary for policymakers to design the program and reform TM in ways that maximize beneficiary outcomes.

Medicare Advantage Is Associated with Lower Utilization of Total Joint Arthroplasty.

BACKGROUND: Medicare Advantage (MA) insurers use managed care techniques to review the utilization of medical services and control costs. It is unclear if MA enrollees have a lower utilization of elective surgical procedures such as inpatient hip and knee total joint arthroplasty (TJA), which have traditionally been covered by traditional Medicare (TM) without restrictions. METHODS: We conducted a cross-sectional study using a 20% sample of 2018 TM claims and MA encounter records for 5,300,188 TM enrollees and 1,970,032 MA enrollees who were 65 to 85 years of age. We calculated unadjusted and adjusted differences (controlling for beneficiary and market characteristics) in the incidence of TJA for MA compared with TM, and by MA plan type. Finally, we calculated differences in the time to contact with an orthopaedic surgeon and time to the surgical procedure among enrollees with an osteoarthritis diagnosis. RESULTS: After controlling for observable characteristics, there was a 15.6% lower incidence of TJA in MA enrollees compared with TM enrollees (p < 0.001). Compared with TM enrollees, health maintenance organization (HMO) enrollees were 28.1% less likely to undergo TJA, controlling for observable characteristics (p < 0.001). From the initial diagnosis, the time to contact with an orthopaedic surgeon and the time to the surgical procedure were also lower among TM enrollees compared with MA enrollees. At 2 years after an osteoarthritis diagnosis, 10.4% of TM enrollees, 7.9% of preferred provider organization (PPO) enrollees, and 5.7% of HMO enrollees had undergone inpatient TJA. CONCLUSIONS: MA coverage was associated with a lower utilization of elective, inpatient hip and knee TJA. MA was also associated with a longer time to orthopaedic surgeon evaluation and surgical procedure. LEVEL OF EVIDENCE: Prognostic Level III . See Instructions for Authors for a complete description of levels of evidence.

Who sleeps well in Canada? The social determinants of sleep health among middle-aged and older adults in the Canadian Longitudinal Study on Aging.

OBJECTIVES: Sleep health inequities likely contribute to disparities in health outcomes. Our objective was to identify social determinants of sleep health among middle-aged/older adults in Canada, where prior evidence is limited. METHODS: We analyzed cross-sectional data from the Canadian Longitudinal Study on Aging, a survey of over 30,000 community-dwelling adults aged 45-85years. Self-reported measures included sleep duration, sleep satisfaction, and sleep efficiency. We explored associations between sleep measures and social determinants of health. We used modified Poisson regression to estimate prevalence ratios for sleep satisfaction and sleep efficiency, and linear regression for sleep duration. Estimates were adjusted for all social, lifestyle, and clinical covariates. We explored effect modification by sex. RESULTS: Of the 11 social determinants explored, all were significantly associated with at least one domain of sleep health. These associations were reduced to 9 variables with adjustment for all social variables, and 7 with further adjustment for lifestyle and clinical covariates, including differences by sex, age, education, marital status, employment, race/ethnicity, and sexual orientation. Better sleep health in >1 domain was observed among males, older age groups (65 and older), higher income groups, the retired group, and homeowners with adjustment for social variables, and only in males and older age groups with additional adjustment for lifestyle and clinical variables. Only sleep duration associations were modified by sex. CONCLUSIONS: Sleep health disparities among Canadian adults exist across socioeconomic gradients and racial/ethnic minority groups. Poor sleep health among disadvantaged groups warrants increased attention as a public health problem in Canada.

Using Real-World Data to Inform Value-Based Contracts for Cell and Gene Therapies in Medicaid.

OBJECTIVE: High upfront costs and long-term benefit uncertainties of gene therapies challenge Medicaid budgets, making value-based contracts a potential solution. However, value-based contract design is hindered by cost-offset uncertainty. The aim of this study is to determine actual cost-offsets for valoctocogene roxaparvovec (hemophilia A) and etranacogene dezaparvovec (hemophilia B) from Colorado Medicaid's perspective, defining payback periods and its uncertainty from the perspective of Colorado Medicaid. METHODS: This cost analysis used 2018-2022 data from the Colorado Department of Health Care Policy & Financing to determine standard-of-care costs and employed cost simulation models to estimate the cost of Medicaid if patients switched to gene therapy versus if they did not. Data encompassed medical and pharmacy expenses of Colorado Medicaid enrollees. Identified cohorts were patients aged 18+ with ICD-10-CM codes D66 (hemophilia A) and D67 (hemophilia B). Severe hemophilia A required ≥ 6 claims per year for factor therapies or emicizumab, while moderate/severe hemophilia B necessitated ≥ 4 claims per year for factor therapies. Patients were included in the cohort in the year they first met the criteria and were subsequently retained in the cohort for the duration of the observation period. Standard-of-care included factor VIII replacement therapy/emicizumab for hemophilia A and factor IX replacement therapies for hemophilia B. Simulated patients received valoctocogene roxaparvovec or etranacogene dezaparvovec. Main measures were annual standard-of-care costs, cost offset, and breakeven time when using gene therapies. RESULTS: Colorado Medicaid's standard-of-care costs for hemophilia A and B were $426,000 [standard deviation (SD) $353,000] and $546,000 (SD $542,000) annually, respectively. Substituting standard-of-care with gene therapy for eligible patients yielded 8-year and 6-year average breakeven times, using real-world costs, compared with 5 years with published economic evaluation costs. Substantial variability in real-world standard-of-care costs resulted in a 48% and 59% probability of breakeven within 10 years for hemophilia A and B, respectively. Altering eligibility criteria significantly influenced breakeven time. CONCLUSIONS: Real-world data indicates substantial uncertainty and extended payback periods for gene therapy costs. Utilizing real-world data, Medicaid can negotiate value-based contracts to manage budget fluctuations, share risk with manufacturers, and enhance patient access to innovative treatments.

Filgrastim and infliximab biosimilar uptake in Medicare Advantage compared with Traditional Medicare, 2016-2019.

BACKGROUND: Medicare Advantage (MA) and Traditional Medicare face different financing structures and incentives and may implement different strategies to encourage biosimilar uptake. Strategies used by health insurers can influence biosimilar uptake, which can in turn promote savings to insurers and patients. OBJECTIVE: To compare filgrastim and infliximab biosimilar uptake between MA and Traditional Medicare from 2016 to 2019 and examine biosimilar uptake by different MA carriers and plan types (Health Maintenance Organization [HMO] or Preferred Provider Organization). METHODS: We use a 2016-2019 nationally representative random 20% sample of the carrier (physician) and outpatient paid claims for Traditional Medicare data and final-action carrier and outpatient records for MA data. We compare quarterly biosimilar uptake from 2016 to 2019 for the first 2 drugs with biosimilar competition: (1) filgrastim, (Neupogen, originator), and biosimilars tbo-filgrastim (GRANIX) and filgrastim-sndz (ZARXIO), and (2) infliximab (Remicade, originator), and biosimilars infliximab-dyyb (Inflectra) and infliximab-abda (Renflexis). RESULTS: From their introduction, there was consistently greater uptake of filgrastim and infliximab biosimilars in MA compared with Traditional Medicare. By Q4 2019, filgrastim biosimilar uptake was 7.6 percentage points higher in MA (80.3%) than Traditional Medicare (72.7%). By Q4 2019, infliximab biosimilar uptake was 28.7% and 15.4% in MA and Traditional Medicare, respectively. Kaiser HMO plans were primarily responsible for the higher uptake of biosimilars in MA; in Q4 2019, filgrastim and infliximab biosimilar uptake was 98.8% and 78.8%, respectively. CONCLUSIONS: Our findings suggest that filgrastim and infliximab biosimilar uptake is greater in MA compared with Traditional Medicare, which is driven in part by particularly high uptake of biosimilars in MA Kaiser HMO plans. This highlights the need for future work to examine specific strategies and levers employed by MA Kaiser HMO plans and other insurers to increase biosimilar uptake, which can lead to cost savings for physician-administered drugs.

Role of Patient Sorting in Avoidable Hospital Stays in Medicare Advantage vs Traditional Medicare.

Importance: Unlike traditional Medicare (TM), Medicare Advantage (MA) plans limit in-network care to a specific network of Medicare clinicians. MA plans thus play a role in sorting patients to a subset of clinicians. It is unknown whether the performance of physicians who treat MA and TM beneficiaries is different. Objective: To examine whether avoidable hospital stay differences between MA and TM can be explained by the primary care clinicians who treat MA and TM beneficiaries. Design, Setting, and Participants: This was a cross-sectional study of a nationally representative sample of MA and TM beneficiaries in 2019 with any of 5 chronic ambulatory care-sensitive conditions (ACSCs). The relative risk (RR) of avoidable hospital stays in MA compared with TM was estimated with inverse probability of treatment-weighted Poisson regression, both without and with clinician fixed effects. The degree to which the estimated MA vs TM difference could be explained by patient sorting was calculated by comparing the 2 RR estimates. Data were analyzed between February 2022 and April 2023. Exposure: Enrollment in MA. Main Outcome and Measures: Whether a beneficiary had avoidable hospital stays in 2019 due to any of the ACSCs. Avoidable hospital stays included both hospitalizations and observation stays. Results: The study sample comprised 1 323 481 MA beneficiaries (mean [SD] age, 75.4 [7.0] years; 56.9% women; 69.3% White) and 1 965 863 TM beneficiaries (mean [SD] age, 75.9 [7.4] years; 57.1% women; 82.5% White). When controlling for the primary care clinician, the RR of avoidable hospital stays in MA vs TM changed by 2.6 percentage points (95% CI, 1.72-3.50; P < .001), suggesting that compared with TM beneficiaries, MA beneficiaries saw clinicians with lower rates of avoidable hospital stays. This effect size was statistically significant to explain the 2% lower rate of avoidable hospital stays in MA than in TM. Conclusions and Relevance: In this cross-sectional study of MA and TM beneficiaries, the lower rate of avoidable hospital stays among MA beneficiaries than TM beneficiaries was attributable to MA beneficiaries visiting clinicians with lower rates of avoidable hospital stays. The patient sorting that occurs in MA plays a critical role in the lower rates of avoidable hospital stays compared with TM.

Risk stratification for treating people at ultra-high risk for psychosis: A cost-effectiveness analysis.

People who are at ultra-high risk (UHR) for psychosis receive clinical care with the aim to prevent first-episode psychosis (FEP), regardless of the risk of conversion to psychosis. An economic model from the Canadian health system perspective was developed to evaluate the cost-effectiveness of treating all with UHR compared to risk stratification over a 15-year time horizon, based on conversion probability, expected quality-of-life and costs. The analysis used a decision tree followed by a Markov model. Health states included: Not UHR, UHR with <20 % risk of conversion to FEP (based on the North American Prodrome Longitudinal Study risk calculator), UHR with ≥20 % risk, FEP, Remission, Post-FEP, and Death. The analysis found that: risk stratification (i.e., only treating those with ≥20 % risk) had lower costs ($1398) and quality-adjusted life-years (0.055 QALYs) per person compared to treating all. The incremental cost-effectiveness ratio for 'treat all' was $25,448/QALY, and suggests treating all may be cost-effective. The model was sensitive to changes to the probability of conversion.

Incorporating Added Therapeutic Benefit and Domestic Reference Pricing Into Medicare Payment for Expensive Part B Drugs.

OBJECTIVES: Identify expensive Part B drugs and evidence for each drug's added benefit and model a reimbursement policy for Medicare that integrates added benefit assessment and domestic reference pricing. METHODS: A retrospective analysis using a 20% nationally representative sample of 2015 to 2019 traditional Medicare Part B claims. Expensive drugs were defined as having average annual spending per beneficiary exceeding the average annual social security benefit ($17 532 in 2019). For expensive drugs identified in 2019, added benefit assessments conducted by the French Haute Autorité de Santé were collected. For expensive drugs with a low added benefit rating, comparator drugs were identified in French Haute Autorité de Santé reports. For each comparator, average annual spending per beneficiary in Part B was computed. Potential savings from 2 reference pricing scenarios were calculated: reimbursing expensive Part B drugs with low added benefit at the level of each drug's (1) lowest cost comparator and (2) beneficiary-weighted-average cost of all comparators. RESULTS: The number of expensive Part B drugs grew from 56 in 2015 to 92 in 2019. Of the 92 expensive drugs in 2019, 34 offer low added benefit. Implementing reference pricing for these expensive drugs with low added benefit could have saved an estimated $2.1 billion if prices were set based on spending for their lowest cost comparator, or $1 billion if prices were set based on the weighted average of spending for comparators. CONCLUSION: Reference pricing based on added benefit assessment could be used to address the launch prices for expensive Part B drugs with low added benefit.

Estimating Changes in Medicare Part D and Commercial Insurer Insulin Spending Amid Planned State-Led Biosimilar Insulin Production in California.

This cross-sectional study evaluates the cost savings of state-led manufacturing and selling of biosimilar insulin.

Return on investment from service transformation for young people experiencing mental health problems: Approach to economic evaluations in ACCESS Open Minds (Esprits ouverts), a multi-site pan-Canadian youth mental health project.

Introduction: Mental health problems are common globally, and typically have their onset in adolescence and early adulthood-making youth (aged 11-25) an optimal target for prevention and early intervention efforts. While increasing numbers of youth mental health (YMH) initiatives are now underway, thus far few have been subject to economic evaluations. Here we describe an approach to determining the return on investment of YMH service transformation via the pan-Canadian ACCESS Open Minds (AOM) project, for which a key focus is on improving access to mental health care and reducing unmet need in community settings. Approach: As a complex intervention package, it is hoped that the AOM transformation will: (i) enable early intervention through accessible, community-based services; (ii) shift care away toward these primary/community settings and away from acute hospital and emergency services; and (iii) offset at least some of the increased costs of primary care/community-based mental health services with reductions in the volume of more resource-intensive acute, emergency, hospital or specialist services utilized. Co-designed with three diverse sites that represent different Canadian contexts, a return on investment analysis will (separately at each site) compare the costs generated by the intervention, including volumes and expenditures associated with the AOM service transformation and any contemporaneous changes in acute, emergency, hospital or service utilization (vs. historical or parallel comparators). Available data from health system partners are being mobilized to assess these hypotheses. Anticipated results: Across urban, semi-urban and Indigenous sites, the additional costs of the AOM transformation and its implementation in community settings are expected to be at least partially offset by a reduction in the need for acute, emergency, hospital or specialist care. Discussion: Complex interventions such as AOM aim to shift care "upstream": away from acute, emergency, hospital and specialist services and toward community-based programming which is more easily accessible, often more appropriate for early-stage presentations, and more resource-efficient. Carrying out economic evaluations of such interventions is challenging given the constraints of available data and health system organization. Nonetheless, such analyses can advance knowledge, strengthen stakeholder engagement, and further implementation of this public health priority.

Incorporating Dynamic Pricing in Cost-Effectiveness Analysis: Are Known Unknowns Valuable?

BACKGROUND: Current practice in health technology assessment (HTA) of pharmaceuticals conducts cost-effectiveness analyses (CEAs) based on a static price or the estimated price at market launch. Recent publications suggest incorporating dynamic pricing. To test the feasibility and importance of including dynamic pricing, we compared the standard static approach to four dynamic scenarios by replicating US-based HTA evaluations with dynamic pricing inputs. METHODS: The four case examples included omalizumab (Xolair®) for the treatment of allergic asthma, elagolix (Orilissa®) for the treatment of endometriosis, ocrelizumab (Ocrevus®) for the treatment of primary progressive multiple sclerosis (PPMS), and dupilumab (Dupixent®) for the treatment of atopic dermatitis (AD). The primary outcome was the relative percentage change in incremental cost-effectiveness ratios (ICERs) per quality-adjusted life-year (QALY) for two dynamic pricing scenarios versus static pricing. Secondary outcomes included the absolute difference in ICERs versus base-case and an assessment of decision uncertainty. RESULTS: Base-case ICERs were $327,000, $102,000, $700,000, and $102,000 for allergic asthma, endometriosis, PPMS, and AD, respectively. Across scenarios and case examples, the range of ICERs versus base-case varied from decreases of 56% to increases of 232%. The absolute difference in ICERs versus base-case ranged from decreases of $120,000 to increases of $758,000. Conclusions on cost effectiveness were altered in 2/16 scenarios across the four case examples. CONCLUSIONS: Given the decision context that US payers face, with prices varying over time, findings suggest further research to reduce uncertainty around price trajectories, as well as conducting or updating multiple assessments over the lifecycle of pharmaceutical products.

Feasibility Study and Clinical Impact of Incorporating Breast Tissue Density in High-Risk Breast Cancer Screening Assessment.

Breast tissue density (BTD) is known to increase the risk of breast cancer but is not routinely used in the risk assessment of the population-based High-Risk Ontario Breast Screening Program (HROBSP). This prospective, IRB-approved study assessed the feasibility and impact of incorporating breast tissue density (BTD) into the risk assessment of women referred to HROBSP who were not genetic mutation carriers. All consecutive women aged 40-69 years who met criteria for HROBSP assessment and referred to Genetics from 1 December 2020 to 31 July 2021 had their lifetime risk calculated with and without BTD using Tyrer-Cuzick model version 8 (IBISv8) to gauge overall impact. McNemar's test was performed to compare eligibility with and without density. 140 women were referred, and 1 was excluded (BRCA gene mutation carrier and automatically eligible). Eight of 139 (5.8%) never had a mammogram, while 17/131 (13%) did not have BTD reported on their mammogram and required radiologist review. Of 131 patients, 22 (16.8%) were clinically impacted by incorporation of BTD: 9/131 (6.9%) became eligible for HROBSP, while 13/131 (9.9%) became ineligible (p = 0.394). It was feasible for the Genetics clinic to incorporate BTD for better risk stratification of eligible women. This did not significantly impact the number of eligible women while optimizing the use of high-risk supplemental MRI screening.

Improving Prior Authorization in Medicare Advantage.

This Viewpoint discusses the potential benefits and harms of prior authorization in Medicare Advantage and the health policy implications and opportunities for improvement.

Medicare Advantage coverage restrictions for the costliest physician-administered drugs.

OBJECTIVES: To examine the use of step therapy, prior authorization, and Part D formulary exclusion by 4 large Medicare Advantage (MA) insurers to manage 20 physician-administered drugs with the highest total Medicare expenditures (top 20 drugs). STUDY DESIGN: We collected data for United Healthcare, CVS/Aetna, Humana, and Kaiser plans to create a database of 2020 Part B coverage restrictions and conducted a retrospective analysis of 2018-2020 Part D formularies. METHODS: For each insurer, we calculated the number of top 20 physician-administered drugs subject to prior authorization and step therapy. For physician-administered drugs for which there were no similar or interchangeable alternatives, we examined which insurers required prior authorization or step therapy. Finally, we examined whether insurers restricted access to physician-administered drugs by reducing coverage on Part D formularies. RESULTS: Of the top 20 physician-administered drugs, 17 were subject to prior authorization and 10 were subject to step therapy by at least 1 insurer. For 5 physician-administered drugs without a similar or interchangeable alternative, none were subject to step therapy and all were subject to prior authorization by at least 1 insurer. Across the 4 insurers, 16 physician-administered drugs were covered on all or some of the Part D formularies in 2018, which decreased to 6 in 2020. CONCLUSIONS: Four large MA insurers managed access to expensive physician-administered drugs with a combination of prior authorization, step therapy, and Part D formulary design. When a low-cost alternative exists, these tools can help reduce wasteful spending, but the administrative barriers may also reduce access.

Association Between Open Payments-Reported Industry Transfers of Value and Prostaglandin Analog Prescribing in the US.

Importance: Reported transfers of value (TOV) from pharmaceutical companies have been associated with greater use of branded anti-vascular endothelial growth factor agents by ophthalmologists, but payment under the Medicare Part B buy-and-bill model includes a financial incentive to choose costlier agents, potentially confounding analyses of pharmaceutical TOV and prescribing patterns. How these reported TOV are associated with prescribing patterns for prescription eye drops, not subject to the incentives created by Part B payments, should be considered. Objective: To assess the association between prostaglandin analog (PGA) eye drop prescribing and reported nonresearch TOV by makers of branded PGAs to US vision care professionals. Design, Setting, and Participants: This retrospective cohort analysis used a 20% nationally representative sample of 2018 Medicare Part D claims and industry TOV reported to the Open Payments program. Optometrists and ophthalmologists who had more than 10 claims for PGA drops in the 20% sample were analyzed. Analysis took place from June 2021 to February 2022. Main Outcomes and Measures: Multivariable logistic regression assessing the association between membership in strata of reported TOV and branded PGA prescribing rate, controlling for prescriber demographic factors, local area practices, total PGA prescribing volume, and plan formularies involved. Results: A total of 20 612 ophthalmologists and 5426 optometrists (7449 [29%] female and 18 589 [71%] male) prescribed PGA eye drops. Of these, 9685 (37%) were reported to have received TOV from manufacturers of branded PGAs in 2018, totaling $5 060 346. The median (IQR) reported TOV was $65 ($24-$147). Multivariable logistic regression showed that the predicted probability of primarily prescribing branded PGAs among prescribers who reported receiving no TOV was 12.9% (95% CI, 12.4%-13.4%). This figure increased to 19.6% (95% CI, 18.8%-20.4%) among prescribers receiving TOV, a 50% increase. There was a dose-response association, such that the top 10% of TOV recipients had a 29.2% probability (95% CI, 26.4%-31.9%) of preferential branded use. Conclusions and Relevance: While the median reported TOV to a PGA prescriber was relatively low in this study, there was a positive association between amount of reported nonresearch TOV received from PGA makers and the frequency of branded PGA use. This shows that small reported TOV were associated with differences in prescribing. High rates of branded PGA prescribing may pose a cost burden to patients that affects adherence. Clinicians and policy makers should be aware of these associations.