Drug Coverage Research Articles

Antipsychotic Use in Older Adults With Dementia: Community and Nursing Facility Trends in Texas, 2015-2020.

To assess recent trends in antipsychotic use among older adults with Alzheimer's disease and related dementias (ADRDs) according to their residential status and determine the factors associated with the use of antipsychotics. Population-based, cross-sectional study using Texas Medicare Fee-for-Service data. Individuals ≥ 65 years of age with ADRDs who had at least 3 months of Medicare Part A and B, and Part D for prescription drug coverage, in any year between 2015 and2020. Temporal trends for antipsychotic use were reported by calendar year, and the associations between antipsychotic use and potential predictors were assessed overall and by residential status. Among an annual average of 161,848 older adults with ADRDs (median age, 82 years; 64.8% female), overall antipsychotic use decreased by 25.8%, from 14.5% in 2015 to 10.8% in 2020. The decline was primarily observed among those with any nursing facility (NF) residence, where use dropped from 22.1% to 12.4%, whereas community-dwelling individuals maintained a steady rate of approximately 10%. Factors associated with increased antipsychotic use included male sex, Black and Hispanic individuals, dual eligibility, Alzheimer's disease, emergency department visits, hospitalization, depression, and anxiety disorders. However, these associations varied across residential statuses. Older age was more strongly associated with decreased antipsychotic use among those with NF residence than those in the community. Compared with White individuals, Black individuals were more likely to receive antipsychotics in the community, whereas Hispanic and Asian individuals were more likely to receive antipsychotics among those with NF residence. Although antipsychotic use substantially decreased among those with NF residence, it remained steady among community-dwelling individuals. Given that two-thirds of individuals with dementia reside in the community, more attention is needed to understand antipsychotic use in this population.

Preferences for public health insurance coverage of new anticancer drugs: a discrete choice experiment among non-small cell lung cancer patients in China

BackgroundEnsuring equal access to affordable, high-quality, and satisfied healthcare for cancer patients is a challenge worldwide. Our study aimed to investigate preferences for public health insurance coverage of new anticancer drugs among non-small cell lung cancer (NSCLC) patients in China.MethodsWe identified six attributes of new anticancer drugs and adopted a Bayesian-efficient design to generate choice scenarios for a discrete choice experiment (DCE). The one-on-one, face-to-face DCE was conducted in four cities in Jiangsu Province. The mixed logit regression model was used to estimate patient-reported preferences for each attribute. The interaction model was used to investigate preference heterogeneity.ResultsData from 486 patients were available for analysis. The most valuable attribute was the out-of-pocket cost if reimbursed (RI = 32.25%), followed by extension of overall survival (RI = 15.99%), and low incidence of serious side effects (RI = 14.45%). Patients had the highest willingness to pay for the comparative 9-month’ extension of overall survival. Patients with advanced NSCLC were more likely to expect new anticancer drugs could improve HRQoL (p < 0.01) and require fewer out-of-pocket costs (p < 0.01). Older patients and patients with low income cared more about the out-of-pocket costs (p < 0.001).ConclusionHealth insurance policymakers need to consider the affordability, comparative survival benefits, comparative safety, and comparative patient-reported outcomes of new anticancer drugs. The findings also highlight the need to ensure affordability for older patients, low-income patients, and patients with advanced cancer.

Projections of Public Spending on Pharmaceuticals: A Review of Methods.

Forecasting future public pharmaceutical expenditure is a challenge for healthcare payers, particularly owing to the unpredictability of new market introductions and their economic impact. No best-practice forecasting methods have been established so far. The literature distinguishes between the top-down approach, based on historical trends, and the bottom-up approach, using a combination of historical and horizon scanning data. The objective of this review is to describe the methods for projections of pharmaceutical expenditure that apply the "bottom-up" approach and to synthesize the knowledge of their predictive accuracy. Projections of public pharmaceutical expenditure applicable to Western economies including a comprehensive method description and published 2000-2024 were searched in scientific databases (MEDLINE, EMBASE, and EconLit) and in gray literature (websites of international health organizations and national healthcare authorities). The data sources, assumptions about the future market dynamics, analytical approaches, and the projection results are summarized. Twenty-four out of 3492 screened publications were included, associated with nine expenditure projection models. Four models were developed for all reimbursable drugs in the USA, the UK, the Stockholm region (Sweden), and seven European Union (EU) countries: France, Germany, Greece, Hungary, Poland, Portugal, and the UK, respectively. The other five models concerned specific groups of medicines: orphan drugs in Belgium, the Eurozone plus the UK, and Canada, respectively; psychotropic medications in the USA; and outpatient intravenous cancer medicines in the Province of Ontario (Canada). For trend analysis, drug coverage claims or sales data were used, applying linear and/or nonlinear models. The budget impact of new launches and patent expirations was estimated through (a form of) horizon scanning, i.e., a systematic monitoring of the pharmaceutical pipeline, with engagement of clinical expert judgment. Projections with a predictive time window greater than 3 years largely relied on previously observed trends to model new market introductions. Four models were validated through an ex post comparison of projected and observed expenditure. The absolute difference between the forecasted and actual percentual change in pharmaceutical expenditure was: 0.3% ("UK model"), 1.9% ("Stockholm model"), and 2% (nonfederal hospitals, "US model"). The "Ontario cancer drug model" overestimated the actual expenditure by 1%. Overall, the largest errors were attributable to new market launches and unforeseen policy reforms. Prediction accuracy decreased substantially for forecasts beyond 1 year in the future. For two not validated projections, a face validity check was feasible. One of the models forecasted a decrease in pharmaceutical expenditure from 2012 to 2016 in six European countries, contrasting with the currently available statistics. A 10-year projection of orphan drug expenditure underestimated the number of rare diseases treated in Europe by over 100%. Published projections of national pharmaceutical expenditure are scarce and marked by significant methodological variability. Short-term forecasts based on high-quality historical data and rigorous horizon scanning tend to be more accurate than long-term forecasts built on theoretical assumptions. The combination of mathematical algorithms and expert judgment should be further explored, to increase the accuracy and efficiency of pharmaceutical expenditure projections.

Mass drug administration coverage evaluation for lymphatic filariasis in selected endemic districts of Jharkhand, India.

This study aimed to evaluate mass drug administration (MDA) coverage for lymphatic filariasis (LF) in selected endemic districts of Jharkhand, India, and to identify household-level determinants of drug consumption. A cross-sectional coverage evaluation survey was conducted in the Deoghar, Giridih and Godda districts of Jharkhand in 2023 within 6 wk of the completion of the MDA campaign. The survey included 9039 individuals from 1680 households across 56 randomly selected clusters (three urban, eight tribal and 45 rural). Approximately 78.5% of households reported that at least one member consumed MDA drugs, with 54.5% reaching 'complete epidemiological drug coverage'. Factors positively associated with achieving 'complete epidemiological drug coverage' included higher education levels (adjusted OR [AOR] 1.02), awareness of LF (AOR 2.32), prior communication about MDA (AOR 1.38) and previous MDA participation (AOR 4.42). By contrast, larger family sizes were associated with a lower likelihood of achieving complete coverage (AOR 0.78). Adverse events were experienced by 14.9% of participants, primarily when MDA drugs were consumed on an empty stomach. Key reasons for non-compliance included perceived absence of disease (25.5%), fear of side effects (22.4%) and absence during the campaign (20.9%). MDA coverage was suboptimal, with only one-half of households achieving 'complete epidemiological drug coverage'. Enhancing MDA coverage and compliance requires intensified Information, Education, and Communication efforts, especially among marginalized communities, both during campaigns and all year round.

Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000-20: a retrospective analysis.

Health systems experience difficult trade-offs when paying for new drugs. In England, funding recommendations by the National Institute for Health and Care Excellence (NICE) for new drugs might generate health gains, but inevitably result in forgone health as the funds cannot be used for alternative treatments and services. We aimed to evaluate the population-health impact of NICE recommendations for new drugs during 2000-20. For this retrospective analysis, we identified technology appraisals for new drugs in England published in NICE's publicly available database of appraisals between 2000 and 2020. We excluded products with terminated appraisals, not recommended, or subsequently withdrawn from the market and excluded appraisals in programmes focusing on medical devices, diagnostics, or interventional procedures. We included drugs that underwent NICE appraisal within 5 years of initial regulatory approval. We collected data on drug name, appraised indication, and specific features of both the drug and its appraisal. We noted the value for money offered by new drugs, expressed as the incremental cost-effectiveness ratio (ICER), and data on health benefits, expressed as quality-adjusted life-years (QALYs). We estimated the number of patients receiving new drugs recommended by NICE using proprietary data on the total volumes of new drugs sold in England between Jan 1, 2000, and Dec 31, 2020. We calculated the net health effect of each appraisal using the difference between the incremental QALY gains from implementing the new drug within the National Health Service (NHS) and the estimated QALYs that could hypothetically be obtained by reallocating the same funds to other NHS services or treatments. We obtained forgone QALYs by dividing the incremental cost of the new drug by the health-opportunity cost of NHS expenditure. NICE appraised 332 unique pharmaceuticals between 2000 and 2020; 276 (83%) had positive recommendations. Of these 276, 207 (75%) had a NICE appraisal within 5 years of regulatory approval. We included 183 (88%) of 207 drugs in this analysis, after excluding drugs that did not meet eligibility criteria. The median QALY gain across all 339 appraisals was 0·49 (IQR 0·15-1·13), equivalent to an additional half a year in full health. Median ICER for recommending new drugs increased from £21 545 (IQR 14 175-26 173) per QALY gained for 14 appraisals published between 2000 and 2004 to £28 555 (19 556-33 712) for 165 appraisals published between 2015 and 2020 (p=0·014). Median ICER varied by therapeutic area, ranging from £6478 (3526-12 912) for 12 appraisals of anti-infective drugs to £30 000 (22 395-45 870) for 144 appraisals of oncology drugs (p<0·0001). New drugs generated an estimated 3·75 million additional QALYs across 19·82 million patients who received new drugs recommended by NICE. The use of new drugs resulted in an estimated additional cost to the NHS of £75·1 billion. If the resources allocated to new drugs had been spent on existing services in the NHS, an estimated 5·00 million additional QALYs could have been generated during 2000-20. Overall, the cumulative population-health impact of drugs recommended by NICE was negative, with a net loss of approximately 1·25 million QALYs. During 2000-20, NHS coverage of new drugs displaced more population health than it generated. Our results highlight the inherent trade-offs between individuals who directly benefit from new drugs and those who forgo health due to the reallocation of resources towards new drugs. The Commonwealth Fund.

Evaluating the Economic Impact of Novel Oncology Drug Coverage Through Patient Assistance Programs.

Despite a universal public health care system, Canadian oncology patients often enroll in patient assistance programs (PAPs) to access oncology drugs that are awaiting funding decisions. Our multicenter study evaluated the pharmacoeconomic and clinical impact of PAPs for patients with cancer in British Columbia (BC). Eligible patients were diagnosed with cancer and enrolled in a PAP between January 2016 and December 2019 in three BC centers. Charts were reviewed for treatment details and survival data. For each drug indication, the hazard ratio from clinical trial data was multiplied by the median overall survival (mOS) or median progression-free survival (mPFS) of our cohort to estimate the mOS or mPFS if the drug was not received. Person life-years gained (PLYG) was the difference between the actual mOS or mPFS and the estimated mOS or mPFS if the drug was not received. Incremental cost-effectiveness ratios and drug costs were obtained from the Canadian Agency for Drugs and Technologies in Health. A total economic value of quality-adjusted life year (QALY) gained for each cohort was calculated and compared with the cost of drugs associated with the gain. Our cohort consisted of 1,025 patients who accessed 40 oncology drugs via PAP. The median time from Health Canada approval to provincial funding was 2.04 years. In the first PAP exposure group (N = 1,025), median PLYG was 0.38 years for OS and 0.80 years for PFS. The total estimated economic value of QALY gained was $83,068,819.32, with total drug costs of $97,026.661.44. PAPs were involved in covering up to $100 million in costs to bridge gaps between regulatory approval and public funding. Economic value and PLYG gained from PAPs are substantial.

Can the Present Canadian Health Care System Provide Evidence-Based Pharmaceutical Care? Consideration of Two Important Cardiovascular Clinical Contexts.

Canada is the only country with universal health care lacking universal pharmaceutical care (pharmacare). Currently, a minority portion of the population has drug coverage. Furthermore, there may be discordance between provincial plans of medications that are covered. We aimed to evaluate present systems for drug coverage and ability to provide evidence-based care according to Canadian cardiovascular (CV) guidelines. The drug review process and formularies for provinces and territories were queried to evaluate concordance between guideline-recommended medications and present coverage. Two common cardiology scenarios, heart failure with reduced ejection fraction and antiplatelet drugs in acute coronary syndrome, were chosen as case studies because of recent Canadian-based CV practice guideline updates. Coverage criteria were extracted to assess for interprovincial variations and determine whether listing decisions are concordant with best evidence and guidelines. Multiple organisations are involved in drug review. Despite Canada's Drug and Health Technology Agency (CADTH) recommendations, there are extensive interprovincial variations in listing decisions for CV drugs, with CADTH recommendations followed only 33% of the time. Among 24 CV drugs reviewed, 23% of listing decisions were discordant from guidelines and best evidence. Novel drugs disproportionately carried the highest discordance from evidence. No systematic process exists for formulary updates based on new evidence, changes in guidelines, or drug pricing. Current Canadian drug review decisions are complex and coverage decisions vary widely, resulting in an inability to provide guideline-recommended CV evidence-based medicine. In developing future pharmacare programs, it is crucial to centralise the drug review process and integrate mechanisms to incorporate up-to-date evidence.

HTA330 Evaluating the Accessibility and Coverage of Orphan Drugs for Rare Disease Patients in Taiwan

HTA330 Evaluating the Accessibility and Coverage of Orphan Drugs for Rare Disease Patients in Taiwan

Predictors of cost-related medication nonadherence in Canada: a repeated cross-sectional analysis of the Canadian Community Health Survey.

In Canada, many patients face substantial out-of-pocket costs for prescription medication, which may affect their ability to take their medications as prescribed. We sought to conduct a comprehensive analysis of the burden and predictors of cost-related nonadherence in Canada. Using pooled data from the 2015, 2016, 2018, 2019, and 2020 iterations of the Canadian Community Health Survey, we calculated weighted population estimates of the burden of cost-related nonadherence in the preceding 12 months and used logistic regression models to measure the association of 15 demographic, health, and health system predictors of cost-related nonadherence overall and stratified by sex. We included 223 085 respondents. We found that 4.9% of respondents aged 12 years or older reported cost-related nonadherence. Those who self-identified as female, belonging to a racial or ethnic minority group, or bisexual, pansexual, or questioning were more likely to report cost-related nonadherence. Younger age, higher disease burden, poorer health, non-employer prescription drug coverage, and not living in the province of Quebec were associated with cost-related nonadherence. Our nationally representative findings reveal inequities that disproportionally affect marginalized people at the intersections of sex, race, age, and disability, and vary by province. This foundational understanding of the state of cost-related nonadherence may be used to inform potential expansion of public drug coverage eligibility, premiums, and cost-sharing policies that address financial barriers to medication adherence.

Herpes zoster vaccination among Medicare beneficiaries with and without prescription drug coverage

IntroductionThe Inflation Reduction Act (IRA) eliminated cost sharing for Medicare Part D-covered vaccines but did not address the cost burden faced by Medicare beneficiaries who did not have prescription drug coverage. This study aimed to determine the characteristics of beneficiaries without prescription drug coverage and to assess the association between the receipt of a herpes zoster vaccine and prescription drug coverage status. MethodsWe used the 2019–2023 National Health Interview Survey and included Medicare beneficiaries aged 65 years and older who enrolled in both Parts A and B or a Medicare Advantage plan. Descriptive statistics were used to examine beneficiaries' characteristics. Logistic regressions were used to examine the associations between the receipt of a herpes zoster vaccine and Medicare prescription drug coverage. ResultsThe study included 33,578 beneficiaries and 93.5 % of beneficiaries had prescription drug coverage. The prevalence of lacking prescription drug coverage was higher among beneficiaries who did not have a college degree, had family income below the poverty level, had no flu shot and well visit within the past year, and had no usual place for care. The probability of receiving a herpes zoster vaccine was higher among beneficiaries with prescription drug coverage than those without prescription coverage (45.2 % versus 25.3 %). ConclusionsHerpes zoster vaccination disparities between beneficiaries with and without prescription drug coverage existed before the IRA. Because the IRA only addresses the cost barrier facing by beneficiaries with prescription drug coverage, vaccination disparities was greater after the IRA implementation.

The Effect of Denosumab on Risk for Emergently Treated Hypocalcemia by Stage of Chronic Kidney Disease : A Target Trial Emulation.

There is a paucity of data on treatment of osteoporosis in patients with advanced chronic kidney disease (CKD). To assess the risk for emergently treated hypocalcemia with denosumab by stage of CKD and presence of CKD-mineral and bone disorder (CKD-MBD). Target trial emulation. Medicare fee-for-service data with prescription drug coverage, 2012 to 2020. Female patients aged 65 years or older initiating denosumab, oral bisphosphonates, or intravenous (IV) bisphosphonates for osteoporosis. Hospital and emergency department admissions (that is, emergent care) for hypocalcemia were assessed in the first 12 treatment weeks. Inverse probability of treatment weighted cumulative incidence and weighted risk differences (RDs) were calculated. A total of 361 453 patients treated with denosumab, 829 044 treated with oral bisphosphonates, and 160 413 treated with IV bisphosphonates were identified. Risk for emergently treated hypocalcemia with denosumab versus oral bisphosphonates increased with worsening CKD stage (P < 0.001), with greatest risk among dialysis-dependent (DD) patients (3.01% vs. 0.00%; RD, 3.01% [95% CI, 2.27% to 3.77%]) and non-dialysis-dependent (NDD) patients with CKD stages 4 and 5 (0.57% vs. 0.03%; RD, 0.54% [CI, 0.41% to 0.68%]). Among patients with stages 4 and 5 CKD (NDD + DD), denosumab had a greater risk for emergently treated hypocalcemia versus oral bisphosphonates in those with CKD-MBD (1.53% vs. 0.02%; RD, 1.51% [CI, 1.21% to 1.78%]) than in those without CKD-MBD (0.22% vs. 0.03%; RD, 0.19% [CI, 0.08% to 0.31%]). Denosumab also showed increased risk compared with IV bisphosphonates. Generalizability to men and non-Medicare populations. Risk for emergently treated hypocalcemia with denosumab increased with worsening CKD stage and was highest in DD patients and those with CKD-MBD. U.S. Food and Drug Administration.

Cover more for less: Targeted drug coverage, chronic disease management, and medical spending

A key challenge in expanding public health insurance programs is how to deliver these programs cost-effectively with limited budget. This paper studies a value-based insurance design that introduced prescription drug coverage for two chronic diseases—hypertension and diabetes. This targeted drug coverage scheme increased the use of primary care and sharply reduced hospitalizations, leading to substantial net savings in total medical expenditure. Three operating channels were in play. First, a hospitalization offset was achieved by stimulating regular use of primary care and improving disease management. Second, the offset occurred more notably for nontargeted chronic diseases, suggesting a strong positive cross-disease spillover effect. Third, learning contributed to more efficient management of both targeted and nontargeted diseases. Our findings highlight a viable value-based insurance design, especially for developing countries with limited funding.

Abstract 4120515: Impact of 2022 AHA/ACC/HFSA Heart Failure Guideline Value Statement Publication on Medicare Drug Coverage Policies

Background: Patients with heart failure (HF) often have difficulty obtaining life-saving medications due to coverage barriers, such as prior authorizations (PA) and high out of pocket (OOP) costs. To promote better insurance coverage of high value therapies, the AHA/ACC/HFSA added Value Statements to HF guidelines to inform policymakers about medication cost effectiveness. We assessed whether these guidelines influenced Medicare drug coverage policies for two life-saving, costly HF medications: angiotensin receptor neprilysin inhibitors (ARNI – guideline “high value”) and sodium glucose cotransporter 2 inhibitors (SGLT2i – guideline “intermediate value”). Methods: We performed an observational study of Medicare drug plans from 4/2020-4/2023 to assess for changes in ARNI and SGLT2i coverage after Value Statement publication (4/2022), and subsequent Medicare plan online update (10/2022). The primary outcome was any barrier to drug coverage (PA, tier ≥ 3 OOP cost-sharing, step therapy, or no coverage). Analysis utilized interrupted time series and difference-in-difference (DiD) approaches. DiD analyses used direct oral anticoagulants as a control due to similar cost and utilization as ARNI and SGLT2i, but with no Value Statement. Results: Among 7,396 Medicare drug plans, 94.3%-97.4% had coverage barriers to ARNI and 93.2%-96.6% to SGLT2i. The majority of barriers were due to tier ≥ 3 OOP cost-sharing requirements (ARNI: 94.3%-95.8%; SGLT2i: 93.2%-95.6%). Coverage barriers remained stable in 4/2022, and declined slightly in 10/2022 (Figure). In DiD analyses, the presence of a Value Statement was associated with a ~1 percentage point decline in coverage barriers for ARNI and SGLT2i. Conclusion: Coverage barriers to ARNI and SGLT2i were common and did not change much in response to Value Statements in HF Guidelines. Increased consideration for Value Statements by Medicare policy-makers is needed to meaningfully improve access to high value therapies.

Risks and Harms to Physicians Reporting Hematologic Adverse Drug Reactions (ADRs) to Health Authorities

Background : The Southern Network on Adverse Reports group (SONAR) has previously identified severe risks and harms to physicians who reported serious ADRs to Heath Authorities related to solid-tumor oncology pharmaceuticals. (eClinMed, PLOS One, Journal of Scientific and Professional Integrity) We investigated whether similar risks and harms occurred to clinicians/scientists who reported hematology-associated ADRS. Methods: Quotes were abstracted from media coverage or Health Authority hearings for individual hematology drugs. Results : Risks and harms were reported in regulatory agency or government agency meetings by eight clinician/scientists physicians who led phase-3 pharmaceutical-sponsored clinical trials (Olivieri N (U Toronto, NEJM 1996, Singh G, Stanford, unpublished 2004), Buse J (U of North Carolina, unpublished 1999, Henke M (Abteilung Universitatsklinik, Lancet 2003, Mangano D (UCSF, NEJM 2005), Topol E and Nissen S (Cleveland Clinic JAMA 2004), meta-analyses (n = 2) (Bennett C (Northwestern, JAMA 2008, Mangano D (UCSF, NEJM 2006); database analyses (n = 1) (Mangano D (UCSF, NEJM 2004), case-control studies (n = 1) (Brass L, Yale, NEJM 2005) and an independent safety review (n = 1) (Solomon S, Harvard, JAMA 2005) including lawsuits, loss of job, public harassment and loss of grants. Three physicians lost academic positions (Topol, Olivieri, Mangano), two physicians lost federal grants (Olivieri, Bennett), and one FDA scientist (Graham) was demoted. ADR findings resulted in drug removal (n = 7; Vioxx, Avandia, Bextra, Celebrex, Trasylol, Phenyl propanolamine, Hydroxy-ethyl starch), revised indications (n = 2) (Procrit, Aranesp 2007, 2008, 2010)) or 10-year delay in FDA-approval (n = 1) (Fereprox). Median time from FDA approval to ADR identification was 8 years (Range, 4 years (Bextra) to 62 years PPA)). Numbers of persons reportedly seriously injured or dying from 1 ADR was 10,00 (Procrit)- 270,000 (Vioxx) (median 120,000). Manufacturer allegations that resulted in pharmaceutical companies actions included violation of secrecy agreement (n = 2) (Fererpox, PPAs) and public reporting of proprietary data (n = 11). Pharmaceutical companies paid $600,000 (Fereprox) to $5.8 billion (Vioxx) in fines and settlements. Discussion: Twelve physicians experienced severe threats and/or harms after reporting hematologic-associated ADRs to Health Authorities and/or in major publications. We suggest physicians not sign secrecy agreements that might jeopardize public safety (as currently established by almost all US medical universities) and should partner with independent drug safety monitoring boards (DSMBs) on ADR evaluations to monitor safety concerns of drugs and medical devices.

State Pharmacopoeia of the Russian Federation Edition XV: Development Priorities

INTRODUCTION. Regular reviews of the current portfolio of general chapters and monographs are essential to ensure the well-balanced development of the State Pharmacopoeia of the Russian Federation (Ph. Rus.) in line with the priorities of the national healthcare system.AIM. This study aimed to identify the most promising areas for further Ph. Rus. development through an analysis of recent legislative changes in Russia and the current compendial portfolio.DISCUSSION. This article compares Ph. Rus. editions XIV and XV, analyses the key features and structure of edition XV, and reviews amendments to the regulations governing the Ph. Rus. publication. The current compendial portfolio is dominated by monographs on chemical active substances; it also includes a substantial number of monographs on herbal drugs and herbal drug preparations. Noteworthy, edition XV is the first Ph. Rus. edition to include a separate section dedicated to monographs on excipients necessary for the development of pharmacy compounding. Moreover, this article analyses the coverage of active substances that are used for the production of listed vital and essential medicines.CONCLUSIONS. The authors outlined the priority areas for the development of quality standardisation. The Ph. Rus. should continue developing monographs on active substances that are used for the manufacturing and compounding of listed vital and essential medicines. In addition, the coverage of herbal drugs should be expanded. The Ph. Rus. should develop monographs on excipients that are used for the manufacturing and compounding of medicinal products. Finally, the Ph. Rus. should complete the development of requirements for biological medicinal products and relevant test methods.

Benzodiazepine Utilization in Ischemic Stroke Survivors: Analyzing Initial Excess Supply and Longitudinal Trends.

Benzodiazepines are commonly prescribed for post-acute ischemic stroke for anxiety, insomnia, and agitation. While guidelines discourage use in those aged ≥65 years, little is known about prescription patterns at the national level. We analyzed a 20% sample of US Medicare claims from April 1, 2013, to September 30, 2021. We selected beneficiaries aged ≥65 years discharged alive following an acute ischemic stroke who had traditional Medicare coverage and 6 months' prior enrollment in Parts A (hospital insurance), B (Medical insurance), and D (drug coverage). We excluded those with prior benzodiazepine prescriptions, self-discharges, or discharge to skilled nursing facilities. We examined demographics, comorbidities, first prescription days' supply, cumulative incidences of benzodiazepine first prescription fills within 90 days after discharge, and geographic and yearly trends. We included 126 050 beneficiaries with a mean age of 78 years (SD, 8); 54% were female and 82% were White. Within 90 days, 6127 (4.9%) initiated a benzodiazepine. Among new prescriptions, lorazepam (40%) and alprazolam (33%) were the most prescribed. Most (76%) of first fills had a day's supply over 7 days and 55% between 15 and 30 days. Female initiation rates were higher (5.5% [95% CI, 5.3-5.7]) than male initiation rates (3.8% [95% CI, 3.6%-3.9%]). Rates were highest in the southeast (5.1% [95% CI, 4.8%-5.3%]) and lowest in the midwest (4.0% [95% CI, 3.8%-4.3%]), with a modest nationwide initiation decline from 2013 to 2021 (cumulative incidence difference, 1.6%). Despite a gradual decline in benzodiazepine initiation from 2013 to 2021, we noted excessive supplies in prescriptions post-acute ischemic stroke discharge, underscoring the need for improved policies.

Mass drug administration to eliminate lymphatic filariasis: a population-based coverage and compliance study in Eastern India

BackgroundNeglected tropical diseases (NTDs) like lymphatic filariasis (LF) affect over 1 billion people globally, with India being a significant hotspot. Challenges persist despite global and national efforts, including the WHO's Global Program to Eliminate Lymphatic Filariasis (GPELF) and India's National Filaria Control Programme. We conducted a study to assess MDA coverage and compliance to improve LF elimination efforts in the Khordha district of Odisha, India. MethodsA sample of 691 participants, including both males and females aged two years or older, was chosen through multistage stratified sampling. These participants were interviewed using a semi-structured questionnaire. Collected data regarding Socio-demographic characteristics, knowledge of filariasis, coverage and consumption of MDA drugs were analyzed. Descriptive statistics were applied to determine coverage and compliance, with results presented alongside a 95% confidence interval. ResultsIn our study, coverage and compliance rates were 86.36% and 91.12% for Albendazole, while 84.12% and 90.62% for DEC. Fear of side effects was the reason for most of the participants' non-consumption. The coverage rate was low in Urban areas because of gated communities and a lack of confidence in drug distributors. ConclusionThis recent round of MDA was effective but still Fear of side effects and lack of awareness were major challenges for the compliance of MDA drugs and need to be addressed for the complete eradication of LF.

Combination of moderate-intensity statins and ezetimibe versus high-intensity statins alone for primary prevention of cardiovascular events

Abstract Background Combination of a moderate-intensity statin with ezetimibe can lead to similar reductions in cardiovascular events as monotherapy with a high-intensity statin in patients with established atherosclerotic cardiovascular disease (ASCVD). The comparative effectiveness of these two cholesterol-lowering strategies in the primary prevention setting is unknown. Purpose To compare incident ASCVD events associated with a combination of moderate-intensity statin and ezetimibe versus monotherapy with a high-intensity statin in adults without prior history of cardiovascular disease. Methods We conducted a new-user active comparator retrospective population-based cohort study in Canada. We included all adults aged ≥ 67 years (eligible for drug coverage) with a first prescription of either a combination of moderate-intensity statin with ezetimibe ("combination therapy") or high-intensity statin alone between January 2010 and December 2022. Patients were excluded if they had not received any prior lipid lowering therapies or had a history of myocardial infarction (MI), stroke, heart failure, peripheral vascular disease or prior coronary revascularisation at any time before or within 3 months of treatment initiation. The primary outcome was a composite of all-cause death, hospitalization for MI or stroke, or coronary revascularization. An inverse probability of treatment weighting propensity score was used to account for confounding (demographics, comorbidities, laboratory tests, other medications). Results Among 67,884 patients (mean age: 74.0±5.5y; 53% females), 8,798 (13%) initiated combination therapy and 59,086 (87%) initiated a high-intensity statin. At 1 year, after weighting, the mean achieved LDL-C was ~1.9 mmol/L in both groups. The median follow-up was 6.5 years. The cumulative incidence of the primary outcome at 10 years in the weighted cohort was 32.7% in the combination therapy group and 36.1% in the high-intensity statin group (HR: 0.87; 95% CI: 0.82 to 0.92; p&amp;lt;0.001; absolute risk reduction: 3.5%; 95% CI: 0.8 to 6.1; Figure 1). This result was primarily driven by a lower risk of all-cause death (HR: 0.85; 95% CI: 0.80 to 0.91; p&amp;lt;0.001; Figure 2) and stroke (cause-specific [cs] HR: 0.86; 95% CI 0.74 to 0.99; p=0.04), whereas no differences were observed in the risk of MI (csHR: 0.97; 95% CI: 0.82 to 1.15) or coronary revascularization (csHR: 0.97; 95% CI 0.85 to 1.11). Conclusion The combination of moderate-intensity statins with ezetimibe was associated with a lower risk of incident ASCVD compared with high-intensity statins alone among primary prevention patients in a real-world setting. These results were driven by a lower risk of all-cause death and stroke, but not coronary events. The influence of statin intolerance on the allocated strategy and adherence to therapy cannot be addressed in this analysis, which, along with verifying these estimates, may be best determined in a prospective randomized trial.

Coverage and evaluation survey of post-mass drug administration for lymphatic filariasis in four endemic districts of Uttar Pradesh: are we on the track?

There is a persistent high microfilaria rate and variable reporting of coverage of Mass Drug Administration (MDA). The study aims to estimate the coverage, effective coverage, and compliance of drugs administered under MDA and to determine the predictors affecting the effective coverage. A community-based cross-sectional study was conducted in Amethi, Lucknow, Raebareli and Sultanpur districts of Uttar Pradesh, India. The study participants were selected using multi-stage random sampling using Probability Proportional to Estimated Size (PPES). The coverage, effective coverage and compliance of drugs were presented as proportion. The multivariable logistic regression model was applied to identify the significant predictors for effective coverage. Of 4151 participants, 997 (24.0%), 340 (8.2%), 1158 (27.9%) and 1656 (39.9%) belonged to Amethi, Lucknow, Raebareli and Sultanpur districts respectively. The coverage ranged from 49.8% to 87.9% and effective coverage ranged from 51.8% to 73.2% across districts. The compliance was the poorest (70.7%) in Sultanpur. The source of information about MDA, the sex of the study participants and the area of residence emerged as predictors for effective coverage in the districts. The effective coverage was poor with good drug complianceacross the districts. There is a need for a well-designed pre-MDA campaign addressing the fear of side effects of drugs and emphasising the presence of the community during the MDA round along with monitoring and evaluation of the round.

Financial realities of fighting cancer: A close look at patient responsibility with part D coverage.

12 Background: Medicare Part D, a prescription drug plan offered by government-contracted private payers, provides coverage for prescription drugs. The plan design encompasses the deductible, initial coverage (IC), coverage gap (CG), and catastrophic coverage (CC) phases. In the earlier phases, patients bear a significant financial burden for drug costs (100% of the deductible, 25% of drug costs during IC and CG) until they reach the out-of-pocket threshold (OOPT) and transition to the CC phase, where the responsibility decreases to 5% of the drug cost with no upper limit. Additionally, Medicare subsidizes or assumes full responsibility for low-income patients through the Low-Income Cost Subsidy (LICS) benefit. We analyzed the patient responsibility (PR) for cancer patients under Medicare Part D and the impact of Part D Anti-Neoplastics (PDAN). Methods: Using Medicare Part D prescription data for 15 practices in The US Oncology Network, we obtained and evaluated the gross drug costs below (GDCB) and above (GDCA) the OOPT, LICS and estimated PR for prescriptions over a 6-year period (July 2016 – June 2022). Results: The analysis of 5.12 million prescriptions for 99,623 cancer patients reveals that 1 in every 5 patients surpassed the OOPT and transitioned to the CC phase. Among the patients receiving PDAN drugs, 3 in every 4 crossed the OOPT. Table 1 provides the percentage of patients entering the CC phase and the estimated per patient, per year PR amounts. Within the PDAN drug recipient group, 85% of patients who reached the OOPT did so within the first 3 months of initiating therapy, often after just 2 prescription dispenses, resulting in a significant portion of the PR being incurred upfront. Approximately 45% of the PR was accumulated prior to crossing the OOPT. Interestingly, only 1 in every 5 patients receiving generic PDAN drugs surpassed the OOPT, in contrast to every patient receiving a branded PDAN. Additionally, patients receiving generic PDAN incurred lower PR costs. About 1 in every 6 patients benefited from the LICS, with 60% of the LICS amounts being paid within the first 3 months of starting therapy, aligning with the timing of patients entering the CC phase. Conclusions: Cancer patients, particularly those taking PDAN drugs, face significant PR costs. The proposed changes to the Part D plan design outlined in the Inflation Reduction Act (IRA) aim to alleviate this burden by reducing PR. These changes include reducing PR in the CC phase to 0%, capping PR in the earlier phases at $2000 and changing cost-sharing between plans, manufacturers, and Medicare. However, the potential effects of these adjustments on Part D plan premiums remain uncertain and require further examination. Without PDAN Drugs With PDAN Drugs Total % of patients Not crossing OOPT 94% 22% 80% Crossing OOPT 6% 78% 20% Patient Responsibility for Patients Not crossing OOPT $292 $1,787 $373 Crossing OOPT $2,448 $6,525 $5,555 Total $422 $5,489 $1,424