Caregiving for dementia: trends pre-post onset and predictive factors of family caregiving (2002-2018).

Persons living with Alzheimer's and other related forms of dementia rely heavily on care from family and friends for assistance with daily activities ("family care"), but little is known about care transitions over time. We analyzed data from the Health and Retirement Study to describe caregiving patterns, from 2 years before dementia onset and up to 6 years after. Using sociodemographic data from the interview prior to dementia onset, we determined if there are significant factors that predict receipt of family care at dementia onset. We found that one-third (33%) of people living with dementia were receiving help with daily activities 2 years prior to their first positive dementia screen and this increased to 60% during the first positive screen. Nearly all of those receiving assistance received family care. We found multiple significant predictors of receiving family care at onset, including race, education, access to private health insurance, number of activities of daily living that were difficult, number of chronic conditions, and already receiving help. This demonstrates potential gaps in dementia care, and which subpopulations may benefit most from targeted interventions for household members who do not have adequate caregiving resources or programs that provide additional formal care.

Key informant views on potential acceptability and feasibility of long-acting antiretroviral treatment for HIV in Kenya.

BACKGROUND: In 2020, 14% of diagnosed persons living with HIV (PLWH) in Kenya were not taking antiretroviral therapy (ART), and 19% of those on ART had unsuppressed viral loads. Long-acting antiretroviral therapy (LA-ART) may increase viral suppression by promoting ART uptake and adherence. We conducted key informant (KI) interviews with HIV experts in Kenya to identify product and delivery attributes related to the acceptability and feasibility of providing LA-ART to PLWH in Kenya. METHODS: Interviews were conducted via Zoom on potential LA-ART options including intra-muscular (IM) injections, subcutaneous (SC) injections, implants, and LA oral pills. KI were asked to discuss the products they were most and least excited about, as well as barriers and facilitators to LA-ART roll-out. In addition, they were asked about potential delivery locations for LA-ART products such as homes, pharmacies, and clinics. Interviews were recorded and transcribed, and data were analyzed using a combination of inductive and deductive coding. RESULTS: Twelve KI (5 women, 7 men) participated between December 2021 and February 2022. Overall, participants reported that LA-ART would be acceptable and preferable to PLWH because of fatigue with daily oral pills. They viewed IM injections and LA oral pills as the most exciting options to ease pill burden and improve adherence. KI felt that populations who could benefit most were adolescents in boarding schools and stigmatized populations such as sex workers. SC injections and implants were less favored, as they would require new training initiatives for patients or healthcare workers on administration. In addition, SC injections would require refrigeration and needle disposal after use. Some KI thought patients, especially men, might worry that IM injections and implants would impact fertility, given their role in family planning. Pharmacies were perceived by most KI as suboptimal delivery locations; however, given ongoing work in Kenya to include pharmacies in antiretroviral delivery, they recommended asking patients their views. CONCLUSION: There is interest and support for LA-ART in Kenya, especially IM injections and LA oral pills. Identifying patient preferences for modes and delivery locations and addressing misconceptions about specific products as they become available will be important before wide-scale implementation.

Health care resource utilization and costs among patients with multiple myeloma with exposure to double-class or triple-class multiple myeloma treatments: A retrospective US claims database analysis.

BACKGROUND: Despite recent advancements in the therapeutic landscape, multiple myeloma (MM) remains incurable. There are multiple treatment options available with a novel mechanism of action, but there is limited evidence describing the economic burden among patients with MM exposed to different drug classes and combinations and across different health care settings. OBJECTIVE: To describe all-cause and MM-related health care resource utilization (HCRU) and costs among patients with MM exposed to different drug classes and combinations (ie, double-class and triple-class-exposed) and characterize the economic burden in different health care settings among these patients with MM. METHODS: We conducted a retrospective cohort study using the IBM MarketScan databases. The study included adult patients (aged ≥18 years) diagnosed with MM between December 1, 2015, and December 31, 2019. The study sample comprised double-class-exposed (DCE) and triple-class-exposed (TCE) cohorts, categorized based on their earliest exposure to different combinations of immunomodulatory drugs, proteasome inhibitors, or targeted monoclonal antibody. Patients with at least 1 subsequent line of therapy following the categorization were included, and the start date of the first subsequent line of therapy was the index date. The primary outcomes were all-cause and MM-related HCRU and costs during the follow-up period. Costs were stratified across 8 care settings defined by place of service. The Kaplan-Meier sample average technique was used to estimate the cumulative mean outcomes, accounting for differential follow-up periods. The outcomes were reported as per patient per month (PPPM). 18 years) diagnosed with MM between December 1, 2015, and December 31, 2019. The study sample comprised double-class-exposed (DCE) and triple-class-exposed (TCE) cohorts, categorized based on their earliest exposure to different combinations of immunomodulatory drugs, proteasome inhibitors, or targeted monoclonal antibody. Patients with at least 1 subsequent line of therapy following the categorization were included, and the start date of the first subsequent line of therapy was the index date. The primary outcomes were all-cause and MM-related HCRU and costs during the follow-up period. Costs were stratified across 8 care settings defined by place of service. The Kaplan-Meier sample average technique was used to estimate the cumulative mean outcomes, accounting for differential follow-up periods. The outcomes were reported as per patient per month (PPPM). RESULTS: The study included 1,521 patients with MM, of whom 1,016 (66.8%) were DCE and 505 (33.2%) were TCE. The mean total all-cause health care costs were $20,338 PPPM, and approximately 85% of the total all-cause costs were MM-related. The mean all-cause and MM-related total costs were driven by overall drug costs primarily attributed to MM treatment and administration costs. The TCE cohort was associated with more HCRU and incurred higher costs than the DCE cohort across all categories. The hospital-based ambulatory setting had the highest all-cause and MM-related costs during the follow-up period: $7,302 (95% CI = $6,801-$7,784) PPPM and $6,695 (95% CI = $6,239-$7,136) PPPM, respectively. CONCLUSIONS: The study findings suggest that the economic burden following exposure to multiple drug classes and combinations is substantial, especially among the TCE cohort and in the ambulatory setting. These findings highlight the need for more effective treatments that can mitigate the economic burden of patients with MM. Future research on the HCRU and costs related to recently approved MM treatments with novel mechanisms is warranted. DISCLOSURES: At the time of this study, Dr Yang was a postdoctoral fellow and the fellowship was supported by GSK. Dr Boytsov is a full-time employee of GSK. Dr Carlson discloses consulting fees from Pfizer, AbbVie, and Genentech. Dr Barthold reports no disclosures.

U.S. patient preferences for long-acting HIV treatment: a discrete choice experiment.

INTRODUCTION: Recent advances in long-acting antiretroviral therapy (LA-ART) could provide new options for HIV treatment and reduce adherence barriers, if regimens are acceptable to patients. We elicited preferences for key attributes of potential LA-ART regimens among people with HIV (PWH) in the United States, focusing on four treatment modes (oral tablets, subcutaneous injections, intramuscular injections, and implants), product characteristics and location of administration. METHODS: A discrete choice experiment was conducted among PWH aged ≥18 years recruited from HIV clinics in Washington State and Atlanta, Georgia from March 2021 to June 2022. Participants responded to 17 choice scenarios, each with three options: two systematically generated hypothetical LA-ART regimens and a constant opt-out (their current daily oral treatment). LA-ART regimen descriptions included treatment mode, pain, dosing frequency, location, pre-treatment time with undetectable viral load, pre-treatment negative reaction testing and "late-dose leeway" (i.e. flexibility or forgiveness in timing the next dose). We used conditional logistic regression, with an interaction between treatment mode and pain, to estimate preference weights for all attribute levels. RESULTS: Seven hundred participants (350 at each site) enrolled, with median age 51 years (range 18-73); 70% identified as cisgender male, 24% as cisgender female and 6% as non-binary or transgender. LA oral tablets were the only mode preferred over current daily oral treatment, with annual implants and injections the next most preferred LA-ART option. Longer time between doses was preferred, and administration at home was preferred to clinics, which were preferred to pharmacies. Attributes with less impact on preferences included oral lead-in treatment to achieve viral suppression or test for negative reactions and late-dose leeway around the prescribed dosing interval. Participants in Atlanta were more likely to prefer their current daily oral ART than participants from Seattle. CONCLUSIONS: PWH in the United States may soon have several options for LA-ART. Our results suggest that LA oral tablets will be preferred by many patients over their current daily oral treatment, while implants and injections with longer duration may be acceptable to some. Future research should investigate sources of preference heterogeneity and actual uptake of and adherence to LA-ART products, when available.

Preference for daily oral pills over long-acting antiretroviral therapy options among people with HIV.

OBJECTIVE: To examine the characteristics of people with HIV (PWH) who prefer remaining on daily oral antiretroviral therapy (ART), rather than switching to long-acting ART (LA-ART). DESIGN: Building upon a discrete choice experiment (DCE), we examined characteristics of individuals who always selected their current daily oral tablet regimen over either of two hypothetical LA-ART options presented in a series of 17 choice tasks. METHODS: We used LASSO to select sociodemographic, HIV-related, and other health-related predictors of preferring current therapy over LA-ART, and logistic regression to measure the associations with those characteristics. RESULTS: Among 700 PWH in Washington State and Atlanta, Georgia, 11% of participants ( n  = 74) chose their current daily treatment over LA-ART in all DCE choice tasks. We found that people with lower educational attainment, good adherence, more aversion to injections, and who participated from Atlanta to be more likely to prefer their current daily regimen over LA-ART. CONCLUSIONS: Gaps in ART uptake and adherence remain, and emerging LA-ART treatments show promise to address these challenges and help a larger portion of PWH to achieve viral suppression, but preferences for these new treatments are understudied. Our results show that certain drawbacks of LA-ART may help to maintain demand for daily oral tablets, especially for PWH with certain characteristics. Some of these characteristics (lower educational attainment and Atlanta participation) were also associated with a lack of viral suppression. Future research should focus on overcoming barriers that impact preferences for LA-ART among those patients who could benefit most from this innovation.

Opportunity after crisis: enhancing value in the COVID-19 rebound.

As we reset post pandemic, providers and payers are in an excellent position to prioritize a reallocation of health care expenditures driven primarily by individual and population health gains.

Remission and Relapse of Dyslipidemia After Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass in a Racially and Ethnically Diverse Population.

Importance: The comparative effectiveness of the most common operations in the long-term management of dyslipidemia is not clear. Objective: To compare 4-year outcomes associated with vertical sleeve gastrectomy (VSG) vs Roux-en-Y gastric bypass (RYGB) for remission and relapse of dyslipidemia. Design, Setting, and Participants: This retrospective comparative effectiveness study was conducted from January 1, 2009, to December 31, 2016, with follow-up until December 31, 2018. Participants included patients with dyslipidemia at the time of surgery who underwent VSG (4142 patients) or RYGB (2853 patients). Patients were part of a large integrated health care system in Southern California. Analysis was conducted from January 1, 2018, to December 31, 2021. Exposures: RYGB and VSG. Main Outcomes and Measures: Dyslipidemia remission and relapse were assessed in each year of follow-up for as long as 4 years after surgery. Results: A total of 8265 patients were included, with a mean (SD) age of 46 (11) years; 6591 (79.8%) were women, 3545 (42.9%) were Hispanic, 1468 (17.8%) were non-Hispanic Black, 2985 (36.1%) were non-Hispanic White, 267 (3.2%) were of other non-Hispanic race, and the mean (SD) body mass index (calculated as weight in kilograms divided by height in meters squared) was 44 (7) at the time of surgery. Dyslipidemia outcomes at 4 years were ascertained for 2168 patients (75.9%) undergoing RYGB and 3999 (73.9%) undergoing VSG. Remission was significantly higher for those who underwent RYGB (824 [38.0%]) compared with VSG (1120 [28.0%]) (difference in the probability of remission, 0.10; 95% CI, 0.01-0.19), with no differences in relapse (455 [21.0%] vs 960 [24.0%]). Without accounting for relapse, remission of dyslipidemia after 4 years was 58.9% (1279) for those who underwent RYGB and 51.9% (2079) for those who underwent VSG. Four-year differences between operations were most pronounced for patients 65 years or older (0.39; 95% CI, 0.27-0.51), those with cardiovascular disease (0.43; 95% CI, 0.24-0.62), or non-Hispanic Black patients (0.13; 95% CI, 0.01-0.25) and White patients (0.13; 95% CI, 0.03-0.22). Conclusions and Relevance: In this large, racially and ethnically diverse cohort of patients who underwent bariatric and metabolic surgery in clinical practices, RYGB was associated with higher rates of dyslipidemia remission after 4 years compared with VSG. However, almost one-quarter of all patients experienced relapse, suggesting that patients should be monitored closely throughout their postoperative course to maximize the benefits of these operations for treatment of dyslipidemia.

Improvements to Survey Design from Pilot Testing a Discrete-Choice Experiment of the Preferences of Persons Living with HIV for Long-Acting Antiretroviral Therapies.

BACKGROUND AND OBJECTIVE: Development of clear and effective discrete-choice experiment surveys is an important step toward ensuring accurate and usable preference results. Pretest interviews and pilot testing are common in the development of discrete-choice experiments, and it is important for researchers to report details of survey changes resulting from patient feedback elicited in pilot work. This paper details pilot testing of an online discrete-choice experiment to elicit preferences for long-acting antiretroviral therapies among patients with HIV. METHODS: The survey included an introduction to hypothetical treatment options, descriptions of attributes, comprehension questions, instructions for completing a discrete-choice experiment, a discrete-choice experiment with 17 choice tasks, and questions about personal characteristics. We piloted the survey with 50 respondents over ten waves. Each wave incorporated design improvements based on observations made during the previous wave. Respondents completed the online survey while screen sharing with a researcher, allowing interactive discussion. We developed a scheme for assessing and categorizing the survey changes. RESULTS: Changes to the pilot were categorized by ways they impacted aspects of the discrete-choice experiment or the likely quality of resulting data. The four categories of impact are: understanding of attributes, underlying discrete-choice experiment and understanding of the choice question, collection of individual characteristics hypothesized to affect preference, and changes that improved clarity and usability of the survey without directly affecting the other categories (e.g., survey navigation and instructional clarity, formatting changes). CONCLUSIONS: Detailed attention to the respondent experience in this large pilot allowed survey improvements that will likely reduce ambiguity, ensure more accurate capture of patient preferences and, ultimately, improve product development for long-acting antiretroviral therapies.

Comparative effectiveness of gastric bypass and sleeve gastrectomy on predicted 10-year risk of cardiovascular disease 5 years after surgery.

BACKGROUND: Comparative evidence is needed when deciding which bariatric operation to undergo for long-term cardiovascular risk reduction. OBJECTIVES: The Effectiveness of Gastric Bypass vs. Gastric Sleeve for Cardiovascular Disease (ENGAGE CVD) study compared the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) operations for reduction of the American College of Cardiology and the American Heart Association-predicted 10-year atherosclerotic cardiovascular disease (ASCVD) risk 5 years after surgery. SETTING: Data for this study came from a large integrated healthcare system in the Southern California region of the United States. This is one of the most ethnically diverse (64% non-White) bariatric populations in the literature. METHODS: The ENGAGE CVD cohort consisted of 22,095 patients who underwent VSG or RYGB from 2009-2016. The VSG and RYGB were compared using a local instrumental variable approach to address observed and unobserved confounding, as well as to conduct heterogeneity of treatment effects for patients of different age groups, baseline-predicted 10-year CVD risk using the ASCVD risk score, and those who had type 2 diabetes (T2D) at the time of surgery. RESULTS: Patients (2771 RYGB and 6256 VVSG) were primarily women (80.6%), Hispanic or non-Hispanic Black (63.7%), and 46 ± 10 years of age, with a body mass index of 43.40 ± 6.5 kg/m2. The predicted 10-year ASCVD risk at surgery was 4.1% for VSG and 5.1% for RYGB, decreasing to 2.6% for VSG and 2.8% for RYGB 1 year postoperatively. By 5 years after surgery, patients remained with relatively low risk levels (3.0% for VSG and 3.3% for RYGB) and there were no significant differences in predicted 10-year ASCVD risk between VSG and RYGB at any time. CONCLUSION: Predicted 10-year ASCVD risk was low in this population and remained low up to 5 years for those with diabetes, Black and Hispanic patients, and older adults. Literature reporting significant differences between VSG and RYGB in 10-year ASCVD risk may be a result of residual confounding.

Assessing Payers' Preferences for Real-World Evidence in the United States: A Discrete Choice Experiment.

OBJECTIVES: To rank the US payers' preferences for attributes of real-world evidence (RWE) studies in the context of chronic disease and to quantify trade-offs among them. METHODS: We conducted a discrete choice experiment in which 180 employees from payer organizations were tasked to choose between 2 RWE studies assuming they were assessing evidence to inform formulary decisions for chronic disease treatment. Each RWE study was characterized by 7 attributes with 3 levels each: very informative, moderately informative, and not measured. We used a D-optimal main-effects design. Survey data were fitted to a conditional logit model to obtain a relative measure of the ranking of importance for each attribute. RESULTS: Clinical outcomes were the most preferred attribute. It was 4.68 times as important as productivity outcomes-the least preferred attribute. It was followed by health-related quality of life (2.78), methodologic rigor (2.09), resource utilization (1.71), and external validity (1.56). CONCLUSIONS: This study provides a quantification of the value payers place on key RWE attributes. Across attributes, payers have higher preferences for clinical and health-related quality of life outcomes than the other attributes. Between attributes' levels, payers prefer high levels of information in clinical outcomes and methodologic rigor but are indifferent in other attributes. Our results bridge the gap between the information that payers seek and the attributes that RWE studies prioritize and effectively guide future research design.

The systematic development of attributes and levels for a discrete choice experiment of HIV patient preferences for long-acting antiretroviral therapies in the United States.

INTRODUCTION: Patient preferences for long-acting antiretroviral therapies (LA-ART) should inform development of regimens with optimal adherence and acceptability. We describe a systematic process used to identify attributes and levels for a discrete choice experiment (DCE) designed to elicit preferences for potential LA-ART options in the US. METHODS: Our approach was conducted in four stages: data collection, data reduction, removing inappropriate attributes, and optimizing wording. We started with 8 attributes defining potential LA-ART products based on existing literature and knowledge of products in development. We conducted 12 key informant interviews with experts in HIV treatment. The list of attributes, the set of plausible levels for each attribute, and restrictions on combinations of attribute levels were updated iteratively. RESULTS: Despite uncertainty about which products will become available, key informant discussions converged on 4 delivery modes (infusions and patches were not considered immediately feasible) and 6 additional attributes. Treatment effectiveness and frequency of clinical monitoring were dropped. Oral lead-in therapy was split into two attributes: pre-treatment time undetectable and pre-treatment negative reaction testing. We omitted product-specific systemic and local side effects. In addition to mode, the final set of attributes included: frequency of dosing; location of treatment; pain; pre-treatment time undetectable; pre-treatment negative reaction testing; and late-dose leeway. CONCLUSIONS: A systematic process successfully captured elements that are both feasible and relevant to evaluating the acceptability of potential LA-ART alternatives to patients.

Association Between Informant-Reported Sleep Disturbance and Incident Dementia: An Analysis of the National Alzheimer's Coordinating Center Uniform Data Set.

Informants' reports can be useful in screening patients for future risk of dementia. We aimed to determine whether informant-reported sleep disturbance is associated with incident dementia, whether this association varies by baseline cognitive level and whether the severity of informant-reported sleep disturbance is associated with incident dementia among those with sleep disturbance. A longitudinal retrospective cohort study was conducted using the uniform data set collected by the National Alzheimer's Coordinating Center. Older adults without dementia at baseline living with informants were included in analysis. Cox proportional hazards models showed that participants with an informant-reported sleep disturbance were more likely to develop dementia, although this association may be specific for older adults with normal cognition. In addition, older adults with more severe sleep disturbance had a higher risk of incident dementia than those with mild sleep disturbance. Informant-reported information on sleep quality may be useful for prompting cognitive screening.

Association between having a family member with dementia and perceptions of dementia preventability.

BACKGROUND: One's experience with dementia may affect their perceptions about dementia preventability, which in turn could influence preventive health behaviors. We aimed to examine how having a family history of dementia and caregiving experience are associated with perceptions about and self-efficacy for dementia preventability. METHODS: Cross-sectional, self-administered survey. Participants reported whether they have had a family member with dementia and, among those who reported having a family member with dementia, whether they served as a caregiver. Outcomes were perceptions about the likelihood of dementia preventability, self-efficacy for dementia prevention, and benefits of specific dementia prevention strategies. Associations were assessed via partial proportional odds model for ordinal outcome variables and logistic regression for binary outcome variables. RESULTS: Of 1,575 respondents, 71% had a family member with dementia, of which 42% served as a caregiver. People with a family member with dementia were less likely to believe that dementia is preventable (aOR = 0.75, 95% CI: 0.58, 0.96) and had lower self-efficacy for dementia prevention (aOR = 0.71, 95% CI: 0.56, 0.90). The subgroup analysis among those with caregiving experience was consistent with the primary findings, showing less belief in the likelihood of dementia preventability (aOR = 0.69, 95% CI: 0.46, 1.03) and self-efficacy (aOR = 0.75, 95% CI: 0.56, 1.00). CONCLUSION: Having a family member with dementia is associated with unfavorable perceptions about dementia preventability. Incorporating family history of dementia into communication efforts about dementia risk reduction may help address potential barriers to preventive health behaviors.

Minimum Threshold of Bariatric Surgical Weight Loss for Initial Diabetes Remission.

OBJECTIVE: There are few studies testing the amount of weight loss necessary to achieve initial remission of type 2 diabetes mellitus (T2DM) following bariatric surgery and no published studies with use of weight loss to predict initial T2DM remission in sleeve gastrectomy (SG) patients. RESEARCH DESIGN AND METHODS: With Cox proportional hazards models we examined the relationship between initial T2DM remission and percent total weight loss (%TWL) after bariatric surgery. Categories of %TWL were included in the model as time-varying covariates. RESULTS: Of patients (N = 5,928), 73% were female; mean age was 49.8 ± 10.3 years and BMI 43.8 ± 6.92 kg/m2, and 57% had Roux-en-Y gastric bypass (RYGB). Over an average follow-up of 5.9 years, 71% of patients experienced initial remission of T2DM (mean time to remission 1.0 year). With 0-5% TWL used as the reference group in Cox proportional hazards models, patients were more likely to remit with each 5% increase in TWL until 20% TWL (hazard ratio range 1.97-2.92). When categories >25% TWL were examined, all patients had a likelihood of initial remission similar to that of 20-25% TWL. Patients who achieved >20% TWL were more likely to achieve initial T2DM remission than patients with 0-5% TWL, even if they were using insulin at the time of surgery. CONCLUSIONS: Weight loss after bariatric surgery is strongly associated with initial T2DM remission; however, above a threshold of 20% TWL, rates of initial T2DM remission did not increase substantially. Achieving this threshold is also associated with initial remission even in patients who traditionally experience lower rates of remission, such as patients taking insulin.

Geographic variation in the use of triptans and opioids for the acute treatment of migraine attacks.

OBJECTIVE: To assess the geographic variations in triptan and opioid prescribing patterns for patients with migraine. BACKGROUND: Numerous guidelines recommend triptans as the standard of care for migraine attacks, yet opioids are still widely used for migraine treatment. Variation in the use of opioids and triptans for the treatment of migraine by geographic location is not well known. METHODS: Using a US claims database, we conducted a retrospective cohort study of adults diagnosed with migraine between 2016 and 2018. We used a 12-month follow-up period to assess triptan and opioid utilization, stratified by the nine Census Bureau-designated divisions. To examine the geographic factors that affect triptan and opioid use among patients, we conducted two sets of multivariable analyses. First, we analyzed the odds of a patient being a triptan or opioid user in the follow-up period, defined as ≥1 triptan or opioid claim. We then analyzed the medication use rate among triptan or opioid users. RESULTS: Overall, we had a final study population of 113,921 patients. In the follow-up period, 52.9% (60,247/113,921) [range: 48.0%-56.3%] of patients were triptan users and 41.0% (46,708/113,921) [range: 28.9%-48.4%] of patients were opioid users with significant differences across census divisions (p < 0.001). Triptan users had a mean (SD) of 4.8 (4.7) triptan claims annually with no significant differences across divisions (p = 0.188). Opioid users had a mean (SD) of 5.4 (6.8) opioid claims annually with significant differences across divisions (p < 0.001). The observed variation in opioid use stemmed from the proportion of patients using opioids in each region and not from the number of opioid prescriptions per user. CONCLUSIONS: There was a significant geographic variation in the use of opioids and to a lesser degree the use of triptans. The widespread use of opioids and the large variation in use other than triptans as the standard of care suggest that improvements could be made in the acute treatment of migraine attacks.

Industry Payments to Physicians and Prescribing Branded Memantine and Donepezil Combination.

BACKGROUND: Once-daily extended-released memantine with donepezil (hereafter memantine/donepezil) may improve medication adherence but has a 60-fold higher cost compared with combined generic components. Little is known about factors associated with prescribing memantine/donepezil. We examined the association between pharmaceutical industry payments to physicians and prescribing memantine/donepezil in Medicare. METHODS: A cross-sectional study was conducted. Using 2015-2016 Centers for Medicare and Medicaid Services Open Payments and Part D prescription databases, we identified unique physicians who prescribed ≥11 memantine/donepezil prescriptions from 2015 to 2016. Outcome variable was the number of memantine/donepezil prescriptions written per physician per year. The key independent variable was physician receipt of industry payments defined in 2 models: (1) number of payments and (2) amount of payment ($100 units) for memantine/donepezil received per physician per year. Multivariable Poisson regression was used, adjusting for potential confounders. RESULTS: Among 4,895 unique eligible physicians in 2015-2016, the median number of memantine/donepezil prescriptions per physician per year was 19.5 (25th percentile 13, 75th percentile 32). Physicians received between 0 and 75 payments per year (median 1, 25th percentile 0, 75th percentile 2.5) for memantine/donepezil, totaling an average of $92 per year (median $10.5, 25th percentile $0, 75th percentile $33.20). Every 1 additional payment received was associated with a 2% increase in new memantine/donepezil prescriptions prescribed per physician per year (rate ratio [RR] 1.02, 95% confidence interval [CI] 1.02-1.02). Every $100 increase in payment for memantine/donepezil was associated with a 0.3% increase in new memantine/donepezil prescriptions prescribed per physician per pear (RR 1.003, 95% CI 1.002-1.004). CONCLUSIONS: Receipt of industry payments for memantine/donepezil was independently associated with increased likelihood of physician prescribing memantine/donepezil in Medicare.

Alzheimer's Disease-Related Neuropathology Among Patients with Medication Treated Type 2 Diabetes in a Community-Based Autopsy Cohort.

BACKGROUND: Diabetes is a risk factor for Alzheimer's disease and related dementias (ADRD). Epidemiologic evidence shows an association between diabetes medications and ADRD risk; cell and mouse models show diabetes medication association with AD-related neuropathologic change (ADNC). OBJECTIVE: This hypothesis-generating analysis aimed to describe autopsy-measured ADNC for individuals who used diabetes medications. METHODS: Descriptive analysis of ADNC for Adult Changes in Thought (ACT) Study autopsy cohort who used diabetes medications, including sulfonylureas, insulin, and biguanides; total N = 118. ADNC included amyloid plaque distribution (Thal phasing), neurofibrillary tangle (NFT) distribution (Braak stage), and cortical neuritic plaque density (CERAD score). We also examined quantitative measures of ADNC using the means of standardized Histelide measures of cortical PHF-tau and Aß1-42. Adjusted analyses control for age at death, sex, education, APOE genotype, and diabetes complication severity index. RESULTS: Adjusted analyses showed no significant association between any drug class and traditional neuropathologic measures compared to nonusers of that class. In adjusted Histelide analyses, any insulin use was associated with lower mean levels of Aß1-42 (-0.57 (CI: -1.12, -0.02)) compared to nonusers. Five years of sulfonylureas and of biguanides use was associated with lower levels of Aß1-42 compared to nonusers (-0.15 (CI: -0.28, -0.02), -0.31 (CI: -0.54, -0.07), respectively). CONCLUSION: Some evidence exists that diabetes medications are associated with lower levels of Aß1-42, but not traditional measures of neuropathology. Future studies are needed in larger samples to build understanding of the mechanisms between diabetes, its medications, and ADRD, and to potentially repurpose existing medications for prevention or delay of ADRD.

Comparative Effectiveness of Gastric Bypass and Vertical Sleeve Gastrectomy for Hypertension Remission and Relapse: The ENGAGE CVD Study.

[Figure: see text].

Characterizing patient assistance program use and patient responsiveness to specialty drug price for multiple sclerosis in a mid-size integrated health system.

BACKGROUND: There is concern that increasingly common use of patient assistance programs (PAPs), out-of-pocket assistance provided by manufacturers or foundations, distorts our understanding of patient behavior and insurance design incentives. Yet the current literature on prescription drug cost sharing largely overlooks their use. PAPs prevalence and impact on drug demand and price elasticity is a major knowledge gap. OBJECTIVE: To examine the use of PAPs among patients with multiple sclerosis (MS) and the association with drug demand in a specialty pharmacy program within a regional integrated health system that facilitates their use. METHODS: We used pharmaceutical claims data from December 2017 to December 2018 linked to detailed payer information from Kaiser Permanente Washington to characterize the prevalence of PAPs for users of 7 MS specialty drug molecules. We estimated price elasticity of demand (PED) in a two-part model by using the presence of copayment assistance as a source of cost variation. The first part estimated marginal probability of a claim in a given month with a probit model, comparing PAP users and nonusers, whereas the second part estimated days supplied of a medication, given a claim was made as a measure for demand. RESULTS: Of 789 unique patients, 480 (60.7%) used PAPs in at least 1 drug claim during the 13-month time frame, and 248 patients (31.4%) used PAPs for all of their MS drug claims. When used, copay assistance covered 100% of out-of-pocket (OOP) charges for 98% of claims and reduced patient annual OOP cost by $3,493 on average. People who used PAPs had much higher OOP charges, a lower Charlson comorbidity score, and were more likely to have insurance through an exchange. The OOP costs charged to patients was higher for claims where patient assistance was used than claims where assistance was not used ($294 vs $42, P < 0.001). Total claim amount was higher for claims that used assistance ($6,169) than claims that did not ($5,503, P < 0.001). The probability of a patient having a drug claim in a given month was 1.9% higher among those using patient assistance, although this finding was not significant (P = 0.258). An average change in price of -$168.21 with PAP use led to an average change in demand of -0.05 days, for an overall price elasticity of demand (SD = 0.028, P = 0.852) given PAP use of 0.005, indicating that the presence of PAPs did not significantly affect demand. PED estimates were not statistically significant by drug, and the exclusion of Medicare patients did not change this interpretation. CONCLUSIONS: In a mid-size integrated health system in the state of Washington, a program that promotes adherence to specialty drugs via facilitated PAP use was found to reduce patient OOP costs but had no effect on prescription drug utilization. Payers may consider embracing PAPs to remove patient financial barriers to necessary medications and use tools other than cost sharing to influence patient consumption of specialty drugs. DISCLOSURES: This manuscript was funded in part through a Pre-Doctoral Fellowship in Health Outcomes from the PhRMA Foundation awarded to Brouwer for the completion of her dissertation work. Yeung receives some salary support from Kaiser Permanente. The other authors have nothing to disclose.