Medicare Part D Coverage of Drugs Selected for the Drug Price Negotiation Program.

This cross-sectional study describes and historically benchmarks Medicare Part D coverage in 2019 and 2023 for the first 10 drugs selected for negotiation.

Longitudinal medication adherence group-based trajectories of aging adults in the US: A retrospective analysis using monthly proportion of days covered calculations.

BACKGROUND: It is thought that half of the patients with chronic conditions are not adherent to their medications, which contributes to significant health and economic burden. Many studies estimate medication non-adherence by implementing a threshold of ≥80% of Proportion of Days Covered (PDC), categorizing patients as either adherent or non-adherent. Healthcare quality metrics pertaining to medication use are based on this dichotomous approach of medication adherence, including the Medicare Part D Star Ratings. Among others, the Medicare Part D Star Ratings rewards part D plan sponsors with quality bonus payments based on this dichotomous categorization of beneficiaries' medication adherence. OBJECTIVES: Describe the longitudinal adherence trajectories of adults ≥65 years of age covered by Medicare for 3 classes of drugs in the Part D Star Ratings: diabetes medications, statins, and select antihypertensives. METHODS: This study used Medicare healthcare administrative claims data linked to participants from the Health Retirement Study between 2008 and 2016. Group-based trajectory models (GBTM) elicited the number and shape of adherence trajectories from a sample of N = 11,068 participants for the three pharmacotherapeutic classes considered in this study. Medication adherence was estimated using monthly PDC. RESULTS: GBTM were estimated for the sample population taking antihypertensives (n = 7,272), statins (n = 8,221), and diabetes medications (n = 3,214). The hypertension model found three trajectories: high to very high adherence (47.55%), slow decline (32.99%), and rapid decline (19.47%) trajectories. The statins model found 5 trajectories: high to very high adherence (35.49%), slow decline (17.12%), low then increasing adherence (23.58%), moderate decline (12.62%), and rapid decline (11.20%). The diabetes medications model displayed 6 trajectories: high to very high adherence (24.15%), slow decline (16.84%), high then increasing adherence (25.56%), low then increasing (13.58%), moderate decline (10.60%), and rapid decline (9.27%). CONCLUSIONS: This study showed the fluid nature of long-term medication adherence to the medications considered in the Medicare Part D Star Ratings and how it varies by pharmacotherapeutic class. These challenge previous assumptions about which patients were considered adherent to chronic medications. Policy and methodological implications about medication adherence are discussed.

Cost minimization analysis of short-duration antiviral prophylaxis for hepatitis C positive donor kidney transplants.

BACKGROUND: Trials describing 4-12 week courses of direct-acting antiviral drugs (DAAs) to treat hepatitis C virus (HCV) transmission from infected donors to uninfected kidney transplant recipients (D+/R-transplants), may be limited in application by costs and delayed access to expensive DAAs. A short prophylactic strategy may be safer and cost-effective. Here, we report a cost minimization analysis using the health system perspective to determine the least expensive DAA regimen, using available published strategies. OBJECTIVES: To conduct cost-minimization analyses (CMAs) from the health system perspective of four DAA regimens to prevent and/or treat HCV transmission from D+/R-kidney transplants. METHODS: CMAs comparing 4 strategies: 1) 7-day prophylaxis with generic sofosbuvir/velpatasvir (SOF/VEL), with 12-week branded glecaprevir/pibrentasvir (G/P) for those with transmission; 2) 8-day branded G/P prophylaxis, with 12-week branded SOF/VEL/voxilaprevir for those with transmission; 3) 4-week perioperative generic SOF/VEL prophylaxis, with 12-week branded G/P for those with transmission; and 4) 8-week branded G/P "transmit-and-treat." We included data from published literature to estimate the probability of viral transmission in patients who received DAA prophylaxis, and assumed a 100% transmission rate for those who received the "transmit-and-treat" approach. RESULTS: In base-case analyses, strategies 1 (expected cost [EC]: $2326) and 2 (expected cost: $2646) were less expensive than strategies 3 (EC: $4859) and 4 (EC: $18,525). Threshold analyses for 7-day SOF/VEL versus 8-day G/P suggested that there were reasonable input levels at which the 8-day strategy may be least costly. The threshold values for the SOF/VEL prophylaxis strategies (7-day vs. 4- week) indicated that the 4-week strategy is unlikely to be less costly under any reasonable value of the input variables. CONCLUSIONS: Short duration DAA prophylaxis using 7 days of SOF/VEL or 8 days of G/P has the potential to yield significant cost savings for D+/R- kidney transplants.

The cost-effectiveness of pharmacist-physician collaborative care models vs usual care on time in target systolic blood pressure range in patients with hypertension: a payer perspective.

BACKGROUND: Hypertension is highly prevalent in the United States, affecting nearly half of all adults (43%). Studies have shown that pharmacist-physician collaborative care models (PPCCMs) for hypertension management significantly improve blood pressure (BP) control rates and provide consistent control of BP. Time in target range (TTR) for systolic BP is a novel measure of BP control consistency that is independently associated with decreased cardiovascular risk. There is no evidence that observed improvement in TTR for systolic BP with a PPCCM is cost-effective. OBJECTIVE: To compare the cost-effectiveness of a PPCCM with usual care for the management of hypertension from the payer perspective. METHODS: We used a decision analytic model with a 3-year time horizon based on published literature and publicly available data. The population consisted of adult patients who had a previous diagnosis of high BP (defined as office-based BP ≥ 140/90 mmHg) or were receiving antihypertensive medications. Effectiveness data were drawn from 2 published studies evaluating the effect of PPCCMs (vs usual care) on TTR for systolic BP and the impact of TTR for systolic BP on 4 cardiovascular outcomes (nonfatal myocardial infarction [MI], stroke, heart failure [HF], and cardiovascular disease [CVD] death). The model incorporated direct medical costs, including both programmatic costs (ie, direct costs for provider time) and downstream health care utilization associated with acute cardiovascular events. One-way sensitivity and threshold analyses examined model robustness. RESULTS: In base-case analyses, PPCCM hypertension management was associated with lower downstream medical expenditures (difference: -$162.86) and lower total program costs (difference: -$108.00) when compared with usual care. PPCCM was associated with lower downstream medical expenditures across all parameter ranges tested in the deterministic sensitivity analysis. For every 10,000 hypertension patients managed with PPCCM vs usual care over a 3-year time horizon, approximately 27 CVD deaths, 29 strokes, 21 nonfatal MIs, and 12 incident HF diagnoses are expected to be averted. CONCLUSIONS: This is the first study to evaluate the cost-effectiveness of PPCCM compared to usual care on TTR for systolic BP in adults with hypertension. PPCCM was less costly to administer and resulted in downstream health care savings and fewer acute cardiovascular events relative to usual care. Although further research is needed to evaluate the long-term costs and outcomes of PPCCM, payer coverage of PPCCM services may prevent future health care costs and improve patient cardiovascular outcomes. DISCLOSURES: No funding was received for the completion of this research. The authors have nothing to disclose. Study results were presented as an abstract at the AMCP 2021 Virtual, April 12-16, 2021.

Differences in Exclusive Breastfeeding Rates in US Hospitals According to Baby-Friendly Hospital Initiative Designation and Area Deprivation Index Category.

Background: Disparities in breastfeeding persist placing a greater burden of disease on non-Hispanic black and Hispanic women and infants. Targeted implementation of the Baby-Friendly Hospital Initiative (BFHI) in areas at risk for poor breastfeeding outcomes has been shown to improve disparities in breastfeeding. The area deprivation index (ADI), a measure of the relative socioeconomic disadvantage of a neighborhood, may be useful in exploring the accessibility of BFHI hospitals in highly deprived areas and the differences in exclusive breastfeeding (EBF) rates in hospitals with and without the BFHI designation across deprivation categories. Objective: To evaluate the geographical distribution of BFHI and non-BFHI hospitals across ADI categories and explore the differences in EBF rates in BFHI and non-BFHI hospitals across ADI categories. Methods: Hospital EBF rates obtained from the Joint Commission included 414 BFHI and 1,532 non-BFHI hospitals. State ADI rank scores were determined for each hospital's census block group. Descriptive statistics were used to describe the geographic distribution of BFHI hospitals across three ADI categories (low, medium, and high). EBF rates across ADI categories and BFHI designations were compared using multiway analysis of variance. Results: The distribution of BFHI was similar across all ADI categories, ranging from 18% to 24%. EBF rates were 4.9% lower in highly deprived areas compared to areas with lower deprivation (p < 0.01). BFHI was associated with significantly higher EBF rates across all ADI categories (6.9%-11.2%, p < 0.01). Conclusion: ADI may be a useful tool for targeting the implementation of BFHI in hospitals in highly deprived areas to reduce breastfeeding disparities.

CMS Mega-Rule Update and the Status of Pharmacy-Related Deficiencies in Nursing Homes.

The scope, frequency, and nursing home characteristics associated with pharmacy-related deficiency citations following the Centers for Medicare and Medicaid Services 2016 "Mega-Rule" update are described. A retrospective analysis of data from Nursing Home Compare and LTCfocus.org was conducted on pharmacy-related deficiencies (including pharmacy services, drug regimen review, unnecessary medications, medication errors, and labeling/storage). The most commonly cited pharmacy-related deficiencies (N = 11,678) were related to labeling/storage (comprising 25.1% of pharmacy-related deficiencies), unnecessary psychotropic medications (20.5%), and routine pharmacy services (16.8%). In multivariable analysis, nursing home characteristics significantly associated with receiving any pharmacy-related deficiency included less geographic competition (adjusted odds ratio [aOR]: 0.68), registered nurse hours (aOR: 0.66), occupancy (aOR: 0.67), for-profit status (aOR: 1.27), and Midwest (aOR: 1.50) or West (aOR: 2.95) location. Given the frequency of pharmacy-related citations and the lack of standardization in pharmacists' roles in nursing homes, further research is needed to better understand how pharmacist services can affect inspection compliance.

Medication Adherence Trajectories: A Systematic Literature Review.

BACKGROUND: Traditional adherence measures such as proportion of days covered (PDC) and medication possession ratio (MPR) are limited in their ability to explain patient medication adherence over time. Group-based trajectory modeling (GBTM) is a new methodological approach that visually describes the dynamics of long-term medication adherence and classifies adherence behavior into groups. OBJECTIVES: To describe and compare trajectories of medication nonadherence reported in the medical literature, including identifying consistent trends in adherence trajectories and disease and patient characteristics that predict trajectory group membership. METHODS: A systematic literature review was conducted in April 2020 in PubMed and CINAHL using MeSH terms and key words in appropriate combinations. Citations were screened for relevance using predefined inclusion and exclusion criteria and evaluated according to variables associated with group-based trajectory models. RESULTS: 21 articles met the study criteria and were reviewed. Generally, studies identified 4 to 6 trajectory groups that described longitudinal medication adherence behavior. Most commonly identified trajectories were labeled as (a) consistent, high adherence, (b) declining adherence, (c) early and consistent nonadherence, and (d) initial nonadherence followed by an increase. Several predictors, including socioeconomic status, disease characteristics, and therapy initiation were routinely associated with group membership. CONCLUSIONS: This review suggests that adherence trajectories and predictors of specific group membership may be similar across diverse disease states. GBTM describes longitudinal, dynamic patterns of medication adherence that may facilitate the development of targeted interventions to promote adherence. Implications for value-based payment systems are discussed in this review. DISCLOSURES: No outside funding supported this study. The authors have no conflicts of interest to declare.

The Inclusion of Economic Endpoints as Outcomes in Clinical Trials Reported to ClinicalTrials.gov.

BACKGROUND: As medication expenditures rise, payers are increasingly demanding evidence of economic value for new medications. The 2015 Professional Society for Health Economics and Outcomes Research (ISPOR) Task Force on Cost-Effectiveness Analysis Alongside Clinical Trials noted that clinical trials are increasingly including health care utilization endpoints to address this rising interest in economic information. OBJECTIVES: To (a) describe the prevalence of economic endpoints in clinical trials submitted to ClinicalTrials.gov and (b) examine associations between trial characteristics and the inclusion of economic endpoints. METHODS: This retrospective review of ClinicalTrials.gov data extracted the characteristics of clinical trials that were submitted to ClinicalTrials.gov from January 2004 to December 2018; studied a drug and/or biological; and had a recruitment status of not yet recruiting, recruiting, active but not recruiting, or completed. Studies were classified as containing an economic endpoint based on 2 independent evaluations of the inclusion of endpoints relevant to costs, resource utilization, cost-effectiveness, productivity, absenteeism, presenteeism, or unemployment. Descriptive statistics were used to summarize trial characteristics, and chi-square analyses were used to evaluate differences in characteristics between trials with and without economic endpoints. RESULTS: Of the 104,885 trials included in the study, 1,437 (1.37%) included an economic endpoint; among later phase (phase 2/3, 3, 4) trials, 939 (2.54%) included economic endpoints. Compared with studies that did not include economic endpoints, those that did were less often industry funded (48.0% vs. 52.0%, P < 0.001) and were for a high-spend specialty condition (24.1% vs. 27.4%, P < 0.001). The proportion of trials that included economic endpoints increased by a small but significant amount over the time period studied, from 1.2% (2004-2008) to 1.6% (2014-2018; P < 0.001). CONCLUSIONS: A small but growing number of clinical trials are including economic endpoints. This finding may reflect continued industry concerns surrounding the cost and logistical challenges of piggybacking economic data collection alongside clinical trials and/or manufacturers' preferences for modeling for value demonstration. Future research is needed to better understand barriers to the inclusion of economic endpoints as well as the degree to which incorporating health care resource utilization collected during clinical trials into early economic modeling may reduce payer concerns about model transparency and bias. DISCLOSURES: No outside funding supported this study. Patterson reports past employment by Indivior, unrelated to this study. Mitchell has nothing to disclose. The research included in this study was presented as a nonreviewed student pharmacist poster at AMCP Nexus 2019; October 30-November 1, 2019; National Harbor, MD.

Should the United States government regulate prescription prices? A critical review.

Prescription drug pricing in the United States continues to generate considerable debate. This critical review and commentary summarizes the evidence surrounding four factors often cited as contributing to high drug prices and/or as rationale for increasing government involvement in drug prices: (1) pharmaceutical industry profits, (2) government funding of basic and biomedical research, (3) "me-too" products, and (4) pharmaceutical advertising. Furthermore, it describes the potential impact of increased governmental regulations on prices and innovation in the pharmaceutical industry. Literature indicates that drug companies have consistently made higher profits than companies in other industries. Research suggests that the magnitude of that difference may be smaller than typically reported due to treatment of research and development (R&D) and marketing and promotional expenses. Research provides inconsistent results on the magnitude of that difference and the need for higher profits to compensate for the industry's level of risk. Evidence suggests that me-too drugs effectively decrease innovator products' period of market exclusivity and may modestly reduce drug prices directly or by increasing manufacturer rebates. The direct impact of advertising expenditures on drug prices is likely limited. The literature suggests that restrictions on advertising and me-too drug development would have minimal effects on prices. Government involvement in pricing products developed from government-funded research has been tried and found neither effective nor workable. These findings suggest that more widespread price regulation would likely result in decreased R&D and fewer new products. The impact of reduced R&D would, in turn, depend on the degree to which lower profits and R&D investments would stymie the development high-value, innovative new products or simply decrease the output of low-value duplicative products. In summary, this critical review of the literature found little evidence that targeted or broad government regulation of prescription prices in the United States would provide net positive societal benefits.

Educational Outcomes Resulting From Restructuring a Scholarship Course for Doctor of Pharmacy Students.

Objective. To compare educational outcomes between two iterations of a scholarship and research course for Doctor of Pharmacy (PharmD) students at Virginia Commonwealth University's School of Pharmacy. Methods. The first iteration of a course intended to teach pharmacy students the knowledge and skills necessary to design and conduct research involved lectures and application exercises, including limited guided questions about different aspects of the research process. In the fall of 2015, multiple structured activities and accompanying grading rubrics, each designed around the structure and content of a section of a research proposal, were introduced to the course to supplement lectures. Both iterations of the course culminated with students submitting a research proposal. After establishing interrater reliability, faculty members graded a random sample of 20 research proposals, 10 from each version of the course, and section-specific and overall proposal scores were compared. Results. In the proposals submitted after the course revisions, significant improvements in three areas were identified: the overall score, the section-specific scores for research hypothesis/specific aims, and institutional review board (IRB) discussion/informed consent. Nominal, though not statistically significant, improvements were observed in other sections. Conclusion. Additional research is needed regarding the best instructional strategies to reinforce data analysis and statistical testing knowledge and skills in PharmD students. Overall, our findings support the hypothesis that a more formalized, guided approach for teaching research methods improves learning outcomes for PharmD students.

Pharmacy patronage and service utilization: Associations with patient sociodemographic and health characteristics.

OBJECTIVES: This study describes associations between patient sociodemographic and health characteristics, pharmacy patronage, and service utilization. DESIGN: Cross-sectional survey. SETTING: United States. PARTICIPANTS: A Qualtrics research panel was used to obtain a sample of American adults (N = 741) who had filled at least one prescription at a community pharmacy in the last 12 months. Surveys were completed electronically in January 2017. MAIN OUTCOME MEASURES: Primary pharmacy patronage (chain, independent, grocery, mass merchandiser, or mail order) and utilization of pharmacy services. RESULTS: Respondents most commonly patronized chain pharmacies (51.6%), followed by mass merchandiser (17.1%), grocery (14.4%), and independent (11.0%) pharmacies. In multivariable analysis, geographic factors and age were the primary predictors of pharmacy patronage. Approximately one third (35.1%) of patients stated that their pharmacist knew their name. Being known by their pharmacists was significantly associated with patronage of independent pharmacies, long-term medication use, caregiving activities, and use of medication synchronization or adherence packaging services. Automatic refill (57.9%), e-mail or text reminders (37.4%), and influenza immunizations (26.7%) were the most commonly used pharmacy services surveyed. Younger patients were significantly more likely to report the use of medication synchronization and smartphone apps, whereas use of pharmacist-administered vaccination increased with age. Use of medication synchronization, home delivery, and adherence packaging services was higher among independent pharmacy patrons compared with chain pharmacy patrons. CONCLUSION: This study identified several sociodemographic and health-related predictors of pharmacy patronage and service utilization. Independent pharmacy patronage, caregiving activities, and utilization of some pharmacy services were associated with having an established patient-pharmacist relationship, as indicated by having a pharmacist who knew the patient's name. Future research should explore how patient characteristics affect the use of pharmacy services and combinations thereof to facilitate targeted marketing of expanded pharmacy services to different populations.

The effect of Baby-friendly status on exclusive breastfeeding in U.S. hospitals.

In 2014, a leading hospital accreditation agency, mandated hospitals publicly report their exclusive breastfeeding (EBF) rates. This new regulation provided an opportunity to explore differences in EBF outcomes using a standardized definition across a large hospital sample in the United States. The purpose of this study was to examine the relationships between population demographics and the Baby-friendly (BF) hospital designation on EBF rates in hospitals throughout the United States. We obtained EBF rates from 121 BF hospitals and 1,608 hospitals without the BF designation. Demographic variables were computed using census tract data for the population surrounding each hospital. Relationships were explored using linear regression. We found that EBF rates were positively correlated with a bachelor's degree, log income, and those who identified as White or Asian and negatively correlated with those without college attendance, individuals living below the poverty line, and those who identified as African American or Hispanic. For all models, the BF designation of a hospital was associated with higher EBF rates (p < 0.01; effect sizes, 0.11-0.49) with the exception of the model containing log income. Using a multiple linear regression model that was allowed to contain more than one independent variable, we were able to explain 22% of the variability in EBF rates. The BF hospital designation was associated with significantly higher EBF rates independent of demographic variables. Support for hospitals to attain the BF hospital designation is a meaningful public health goal.

Cost-benefit of appointment-based medication synchronization in community pharmacies.

OBJECTIVES: To evaluate the cost-benefit of appointment-based medication synchronization (ABMS) offered in community pharmacies for patients taking chronic medications to prevent negative outcomes associated with hyperlipidemia, hypertension, and diabetes. STUDY DESIGN: Decision-tree analysis based on published literature and publicly available data. METHODS: Program benefits were based on linking published findings of improvements in medication adherence due to the implementation of an ABMS program to a claims-based study of disease-related medical costs associated with different levels of adherence. The direct cost of the program-increased medication utilization as a result of improved adherence-was calculated from publicly available prescription pricing data. Benefit-cost ratios were assessed from a payer perspective over a 1-year time frame. RESULTS: Additional medication expenditures due to improved adherence associated with ABMS enrollment were offset by lower disease-specific medical costs. Medical savings per additional dollar spent on medications ranged from approximately $1 to $37 depending on the medication and medication class considered. ABMS was most cost-beneficial for metformin and statins. Sensitivity analyses showed that cost-benefit was significantly impacted by medication costs and any service fees associated with ABMS. CONCLUSIONS: ABMS programs have been shown to increase medication adherence in patients taking chronic medications. These programs were shown to have a significant cost-benefit for healthcare payers by reducing medical utilization and costs. Payers should consider supporting the provision of these programs in community pharmacies.