Innovation, affordability, access: Alzheimer disease drugs and the Inflation Reduction Act.

OBJECTIVES: This analysis examines the implications of new Alzheimer disease drugs in the era of the Inflation Reduction Act (IRA). It focuses on balancing innovation in Alzheimer disease treatment with affordability and access, assessing the impact on Medicare's budget, patient cost, and health care system readiness. STUDY DESIGN: A comprehensive review was conducted, synthesizing information from recent FDA drug approvals, drug pricing models, Medicare coverage policies, and the updated regulations under the IRA. This analysis reflects on the broader clinical and economic consequences of introducing new Alzheimer disease treatments. METHODS: The study employs a qualitative review of existing literature, policy documents, and economic data. It explores the implications of Alzheimer disease drugs on health care policy, analyzing the economic and clinical impacts within the current health care landscape in the US. RESULTS: The study highlights the economic challenges posed by the high costs of new Alzheimer disease drugs, contrasting with their moderate clinical benefits and potential risks. It discusses the limitations of the IRA in regulating drug prices and the resulting implications for Medicare's budget. Additionally, it examines disparities in health care access and system preparedness for these new treatments. CONCLUSIONS: The study findings underscore the need for a comprehensive approach to ensure fair pricing and equitable access to Alzheimer disease treatments. It suggests the application of frameworks such as the ISPOR Value Flower, focusing on diversity, equity, and comprehensive economic evaluations, to navigate the evolving landscape of Alzheimer disease treatment in the context of the IRA.

The impact of a statewide insulin copay cap policy for insured patients with diabetes in Utah.

BACKGROUND: Insulin affordability is a huge concern for patients with diabetes in the United States. On March 30, 2020, Utah signed House Bill 207 into law, aimed at capping copayments for insulin at $30 for a 30-day supply. The bill was enacted on January 1, 2021. OBJECTIVE: To assess patient basal insulin adherence, out-of-pocket costs, health plan costs, total costs on insulin, and hemoglobin A1c (A1c) in prepolicy vs postpolicy periods. METHODS: This study is a retrospective analysis using data from a regional health plan in Utah from October 1, 2019, to September 30, 2021. Inclusion criteria were fully enrolled members of all ages, under commercial insurance, with at least 1 fill for any type of insulin in both the preperiod and the postperiod. Adherence was measured by proportion of days covered (PDC). Paired t-tests and Wilcoxon sign rank tests were conducted to compare the health and economic outcomes. RESULTS: Out of 24,150 commercially insured individuals, a total of 244 patients were included. Across all 244 patients, there was a significant decline in monthly median out-of-pocket costs of insulin by 58.5% (P < 0.001), whereas the monthly median health plan costs of insulin increased by 22.0% (P < 0.001). The total monthly costs of insulin (the sum of out-of-pocket and health plan costs) were unchanged (P = 0.115). Only 74 patients with enough basal insulin fills in both periods were included in the analysis for PDC changes. PDC change was not statistically significant (P = 0.43). Among the 74 patients with PDC calculations, 29 patients had A1c recorded in both periods. The change in A1c was not statistically significant (P = 0.23). CONCLUSIONS: An insulin copayment max of $30 in Utah demonstrated lower patient out-of-pocket costs, subsidized by the health plan. PDC did not change, and HbA1c did not improve. An assessment of a longer period and on a larger population is needed.

Understanding patient cost-sharing thresholds for diabetes treatment attributes via a discrete choice experiment.

BACKGROUND: The process used to prefer certain products across drug classes for diabetes is generally focused on comparative effectiveness and cost. However, payers rarely tie patient preference for treatment attributes to formulary management resulting in a misalignment of value defined by providers, payers, and patients. OBJECTIVES: To explore patients' willingness to pay (WTP) for the predetermined high-value and low-value type 2 diabetes mellitus (T2DM) treatments within a health plan. METHODS: A cross-sectional discrete choice experiment (DCE) survey was used to determine patient preference for the benefit, risk, and cost attributes of T2DM treatments. A comprehensive literature review of patient preference studies in diabetes and a review of guidelines and medical literature identified study attributes. Patients and diabetes experts were interviewed and instructed to identify, prioritize, and comment on which attributes of diabetes treatments were most important to T2DM patients. The patients enrolled in a health plan were asked to respond to the survey. A multinomial logit model was developed to determine the relative importance and the patient's WTP of each attribute. The patients' relative values based on WTPs for T2DM treatments were calculated and compared with the treatments by a health plan. RESULTS: A total of 7 attributes were selected to develop a web-based DCE questionnaire survey. The responses from a total of 58 patients were analyzed. Almost half (48.3%) of the respondents took oral medications and injections for T2DM. The most prevalent side effects due to diabetes medications were gastrointestinal (43.1%), followed by weight gain (39.7%) and nausea (32.8%). Patients were willing to pay more for treatments with proven cardiovascular benefit and for the risk reduction of hospitalization from heart failure. On the other hand, they would pay less for treatments with higher gastrointestinal side effects. Patients were willing to pay the most for sodium-glucose cotransporter 2 inhibitor and glucagon-like peptide 1 receptor agonist agents and the least for dipeptidyl peptidase-4 inhibitors and thiazolidinediones. CONCLUSIONS: This study provides information to better align patient, provider, and payer preferences in both benefit design and value-based formulary strategy for diabetes treatments. A preferred placement of treatments with cardiovascular benefits and lower adverse gastrointestinal side effects may lead to increased adherence to medications and improved clinical outcomes at a lower overall cost to both patients and their health plan. DISCLOSURES: This study was supported by a grant from the PhRMA Foundation.

The Association of Caregiver Characteristics and Caregivers' Perceived Difficulty in Medication Management Tasks.

Background: Medication management tasks are commonly performed by family caregivers caring for patients with dementia, but caregivers also reported difficulties in performing these tasks. Objectives: Using the 2017 National Study of Caregiving (NSOC) and the 2017 National Health and Aging Trends Study (NHATS), this study examined the association between caregiver characteristics and caregiver difficulty in performing medication management tasks (e.g., ordering medications, keeping track of medications, giving shots). Methods: The main independent variable was the number of medication management tasks performed by the caregivers. The dependent variable was difficulty in performing medication management tasks. Other variables of interest included caregiver age, sex, education, co-residence with the care recipient, and use of support services. This study used the Pearlin's Stress and Coping Model to select other control variables from hundreds of variables contained in the NSOC. A lasso logistic regression model was used to account for the large amount of other control variables. Results: Caregiver difficulty was found mainly in keeping track of medications or giving shots (42.4%). More medication management tasks were significantly related to caregiver difficulty [OR=2.71; 95% CI (1.84 - 3.99)]. A significant association linking support service use with task difficulty was also observed [OR=1.82; 95% CI (1.06 - 3.13)], which warrants additional research. Conclusions: Caregiver difficulty was found mainly in keeping track of medications or giving shots. More medication management tasks were significantly related to caregiver difficulty. Since patients with dementia are often on multiple medications, it is crucial to ensure medication management is done correctly to avoid adverse health consequences.

The Effects of Private Health Insurance on Universal Health Coverage Objectives in China: A Systematic Literature Review.

BACKGROUND: We conducted a systematic review on the role of private health insurance to complement the social health insurance system towards achieving universal health coverage in China. This review presents the impacts of private health insurance on expanding coverage, increasing access to healthcare, and financial protection. METHODS: A systematic review was conducted by searching peer-reviewed articles published between January 2000 and March 2018 in Web of Science, PubMed, and China Knowledge Resource Integrated Database. The search terms included coverage prevalence, access and financial protection related to private health insurance in China. A total of 31 studies were selected. RESULTS: Coverage prevalence of private health insurance gradually increased but it was unequally distributed across regions and populations. The expansion of social health insurance has enhanced the total aggregate premium of private health insurance but has had a mixed impact on the take-up of private health insurance. Private insurance beneficiaries were found to limit their utilisation of healthcare services and there was no evidence that it ensured financial protection. CONCLUSION: The role of private health insurance (PHI) in extending universal health coverage in China was limited and therefore should not be overstated.

Violence against health professionals and facilities in China: Evidence from criminal litigation records.

OBJECTIVES: This study aims to extend the current understanding of violence against health professionals and facilities in China, with data from an authoritative, national-representative, but under-researched data source - litigation records, and discuss implications for developing violence prevention strategies. DESIGN: We collected all legal cases relevant to violence against health professionals and facilities from criminal ligation records released by the Supreme Court of China from 2010 to 2016. MAIN OUTCOME MEASURES: (i) Characteristics of perpetrators: gender, age, education, occupation, history of mental illness and alcohol; (ii) characteristics of victims: medical specialization, location, type of violence; (iii) outcome of treatment. RESULTS: 140 cases were collected for analysis. Beating, pushing, verbal abuse, threatening, burning mock paper money, placing a corpse in the hospital, hanging banners, blocking hospital gates and doors, and smashing hospital property were the most frequently reported types of violence. Specifically following patient deaths, the interval between a patient's death and violence by the patient's families and friends was short, with 51% happening on the same day. CONCLUSIONS: Our study provides a comprehensive overview of violence against health professionals and facilities in China, which can be used to inform the development of prevention strategies.

Records of medical malpractice litigation: a potential indicator of health-care quality in China.

OBJECTIVE: To assess the characteristics and incidence of medical litigation in China and the potential usefulness of the records of such litigation as an indicator of health-care quality. METHODS: We investigated 13 620 cases of medical malpractice litigation that ended between 2010 and 2015 and were reported to China's Supreme Court. We categorized each case according to location of the court, the year the litigation ended, the medical specialization involved, the severity of the reported injury, the type of allegation raised by the plaintiff - including any alleged shortcomings in the health care received - and the outcome of the litigation. FINDINGS: The annual incidence of medical malpractice litigation increased from 75 in 2010 to 6947 in 2014. Most cases related to general surgery (1350 litigations), internal medicine (3500 litigations), obstetrics and gynaecology (1251 litigations) and orthopaedics (1283 litigations). Most of the reported injuries were either minor (1358 injuries) or fatal (4111 deaths). The most frequent allegation was of lack of consent or notification (1356 litigations), followed by misdiagnosis (1172 litigations), delay in treatment (1145 litigations) and alteration or forgery of medical records (975 litigations). Of the 11 014 plaintiffs with known litigation outcomes, 7482 (67.9%) received monetary compensation. CONCLUSION: Over our study period, the incidence of litigation over potential medical malpractice increased in China. As many of the cases related to alleged inadequacies in the quality of health care, records of medical malpractice litigation in China may be worth exploring as an indicator of health-care quality.

Dissolution enhancement of cefdinir with hydroxypropyl-ß-cyclodextrin.

The solid state properties and dissolution behavior of binary systems of cefdinir (CEF) with hydroxypropyl-ß-cyclodextrin (HP-ß-CD) were investigated. CEF-HP-ß-CD interaction in the solution state was studied by phase-solubility analysis and demonstrates the ability of HP-ß-CD to complex with CEF giving A(L) type profile with 65.28 ± 1.3 M⁻¹ stability constant. The freeze drying technique was adopted to prepare binary systems of CEF with HP-ß-CD in 1:1 molar ratio. The solid inclusion was characterized by fourier transform infrared spectroscopy (FTIR), differential scanning calorimetry (DSC), X-ray powder diffractometry (XRD), and scanning electron microscopy (SEM). Aqueous solubility of CEF-HP-ß-CD inclusion complex was 2.36-fold of pure CEF. The dissolution profiles of inclusion complexes were determined and compared with those of CEF alone and their physical mixtures. The dissolution rate of inclusion complex was superior than the CEF alone. These approaches indicated that CEF was able to form an inclusion complex with HP-ß-CD, and the inclusion compounds exhibited different spectroscopic features and properties.

In vitro and in vivo studies of galactose-modified liver-targeting liposomes.

Oridonin (ORI) is a bioactive diterpenoid compound extracted from the well known Chinese traditional medicine Rabdosia rubescens. The aim of this study was to prepare ORI loaded liposomes surface-modified with galactose (NOH-ORI-LP) and evaluate their characteristics compared with ORI loaded liposomes (ORI-LP) and ORI solution in vitro and in vivo. The NOH-ORI-LP was prepared by ethanol injection method. The NOH-ORI-LP was characterized by their morphology, particle size, zeta potential and encapsulation efficiency. The concentration of ORI in plasma and tissues at different sampling time points were determined. The liver concentration-time curves of NOH-ORI-LP in mice were determined, and the pharmacokinetic parameters were calculated and compared by statistical analysis. Our data revealed that NOH-ORI-LP has a particle size of about (173 ± 12) nm. The particles exhibit a negative electrical charge (-31.5 ± 1.6 mV), and possess high encapsulation efficiency (94.1 ± 1.2%). There were significantly different parameters of k10 and area under the plasma concentration-time curve (AUC0-t) between liposomes and solution. The mean residence time (MRT0-t) in plasma of NOH-ORI-LP was 5.56 times longer than that of solution. Compared with solution, NOH-ORI-LP delivered about 4.28 times higher ORI into liver. Thus, an optimum intravenous galactose-modified liposome formulation for ORI could be developed as an alternative to the commercial ORI preparations.