Pharmacoeconomics and Pharmaceutical Economics Commons^™

Quality Improvement (Qi) Project Aimed At Reducing Unnecessary Antibiotic Usage Among Older Adult Patients By Addressing Inappropriate Antibiotic Prescribing In Primary And Long-Term Care Settings, Pamela M. Thomas

Seton Hall University Dissertations and Theses (ETDs)

Antibiotic overuse among older adults remains a significant patient safety and public health concern. Recent national data indicate that approximately 30%–50% of outpatient antibiotic prescriptions may be unnecessary, particularly for viral or self-limiting conditions (Chua et al., 2021). Antimicrobial resistance has been associated with more than 1.27 million deaths globally (Murray et al., 2022). This quality improvement project evaluated a multifaceted antimicrobial stewardship intervention in primary and long-term care settings. Baseline review of 167 antibiotic cases revealed 37.1% were inappropriate or questionable, and 28.7% lacked adequate diagnostic documentation. The intervention incorporated provider education, electronic health record decision-support tools, audit and …

Charity Pharmacies: An Integrative Overview Of Operations: A Continuing Education Program For Pharmacists, Stella Bertram

Honors Theses

PROGRAM DESCRIPTION

The goal of this activity is to educate pharmacists about Charity Pharmacies by creating an integrative overview of their purpose, laws and regulations, processes and procedures, eligibility, and opportunities for involvement. This course will ensure pharmacists are competent in the operations involved in volunteering or working within a charitable pharmacy.

Additionally, the information provided supports pharmacists in understanding their roles as well as roles of volunteers. They will understand the importance of their role in the community and the depth of their service within Charity Pharmacies.

Policies And Price Controls On The Research And Development Of Orphan Drugs In The United States And The European Union, Bena Pearl Filipczak Smith

Master's Theses

There is substantive literature surrounding the impact of price controls on the research and development (R&D) of new pharmaceutical products. The European Union (EU) and United States (US) are often studied in contrast to examine the influence of price controls as the US has fewer pharmaceutical price controls than the EU.

We find moderate evidence that the US spent more on annual domestic pharmaceutical R&D than the EU between 2004 and 2021, on average, before and after adjusting for GDP growth per capita and year. We find strong evidence that the US increased annual domestic R&D spending at a faster …

Approvals, Utilization, And Cost Of Biologics For The Treatment Of Rheumatoid Arthritis, Roya Hosseini

Pharmaceutical Sciences (PhD) Dissertations

Introduction: RA treatment has been revolutionized by the development and approval of biologic disease-modifying antirheumatic drugs (bDMARDs). However, the approval status, utilization, and high cost of bDMARDs pose challenges in RA management.

Objectives: This dissertation evaluated the association between the utilization of bDMARDs and the sociodemographic characteristics of the RA patient population. It also identified the FDA approval status of bDMARDs and assessed the annual cost of bDMARDs used in RA treatment, evaluated the factors explaining annual cost at market entry.

Methods: In the retrospective analysis of Medical Expenditure Panel Survey (MEPS) data from 2010-2021, the population includes RA patients …

Application Of Interpretable Machine Learning Methods To Study The Disease Characteristics And Healthcare Expenditures In Hodgkin’S Lymphoma, Zasim Azhar Dil Hasan Siddiqui

Graduate Theses, Dissertations, and Problem Reports (ETD)

Hodgkin’s lymphoma (HL) is a rare malignancy of lymphocytes that predominantly occurs in young adults aged 20-30 years or elderly individuals aged 65-75 years. Despite its low incidence, there were an estimated 223,512 HL survivors in the US in 2020. Hodgkin’s lymphoma shows a favorable prognosis among young adults, with a high cure rate of 85-90%; however, older adults experience poor prognosis, with a 5-year overall survival rate of 40-55% in patients over 60 years. HL survivors incur high total and out-of-pocket (OOP) healthcare expenditures, averaging $78,183 and $4,180 per patient in the first year after diagnosis, highlighting a considerable …

Treatment Patterns And Clinical And Economic Burden In Patients With Merkel Cell Carcinoma: Statistical And Machine Learning Approaches, Yves Mbous

Graduate Theses, Dissertations, and Problem Reports (ETD)

Although considered a rare form of nonmelanoma skin cancer, Merkel Cell Carcinoma incidence rate has increased to 0.74 per 100,000 and projections expect this number to steadily rise over the next decades and to reach an average of 3,285 cases per year in 2025. MCC incidence increases significantly with age. Among those aged 40-44, it is 0.44, it rises to 1.0/100,000 in the 60-64 age group and soars to 9.8/100,000 among those ≥85 years and above. Due to the small number of cases, MCC is often managed using institutional practices or provider preferences. Formal clinical trials that enroll early stage …

An Economic And Regulatory Analysis Of Gene Therapy Products Authorized By The Us Food And Drug Administration And The European Medicines Agency, Buthainah Ghanem

Pharmaceutical Sciences (PhD) Dissertations

Background: Gene therapy has recently emerged as an alternative for preventing and treating disease. Concerns have been expressed about the clinical value and the high cost of gene therapies.

Objective: This study assessed the authorization process of gene therapy products by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), evaluated the post-marketing safety signals reported to the FDA Adverse Event Reporting System (FAERS), and assessed the cost-effectiveness analysis of three gene therapies axicabtagene ciloleucel(axi-cel), lisocabtagene maraleucel (liso-cel), and tisagenlecleucel (tisa-cel).

Research Design: For aim 1; data was collected using regulatory information from the FDA and the …

Authorizations, Prices, And Labeling Differences Of Therapeutic Biologics Marketed In The United States And Saudi Arabia, Turki Altowairgi

Pharmaceutical Sciences (PhD) Dissertations

BACKGROUND: Since 1982, Saudi Arabia (SA) and the United States (US) have seen an increase in therapeutic biologics authorization. However, each country has regulatory regulations governing the approval of these cutting-edge drugs. The high cost of biologics financially burdens healthcare systems and delays patient access to these treatments. Sometimes a company selling the same medications in various countries will have conflicting information on drug labels.

OBJECTIVES: This study compared the characteristics of therapeutic biologics authorization by the Saudi Food and Drug Authority (SFDA) and Food and Drug Administration (FDA) as of December 31, 2021. The study also compared the US …

An Analysis Of Trends Of Generic Drugs And Biologic Prices In The U.S., Mohammed Jamjoom

Pharmaceutical Sciences (PhD) Dissertations

Introduction: Drug prices are a significant problem for the US healthcare system. Generic and biosimilar market competition reduces drug and biologic prices, results in substantial savings, and improves patient access and outcomes. As the costs of healthcare and prescription drugs continue to rise, the discussion about drug prices has taken a prominent place at the forefront of national discourse. This study assessed impacting trends in prices of generic, biosimilar, and reference products in the US. We also evaluated the effect of the Affordable Care Act (ACA) of 2010 on biologic prices.

Methods: We extracted a list of the new generic …

An Economic And Regulatory Analysis Of Breast Cancer Drugs Approved By The Us Food And Drug Administration, Abdullah Althomali

Pharmaceutical Sciences (MS) Theses

Introduction

Breast cancer is the most common cancer among women and the leading cause of cancer death among women worldwide. The pharmacological options for breast cancer include chemotherapy, hormone therapy, targeted therapy, and immunotherapy, which are used for the prevention or treatment of breast cancer. This study assessed trends in FDA approvals and prices at the market entry of new drugs indicated for breast cancer in the period 1980-2022. The study also evaluated the factors associated with the price of the new breast cancer drugs at market entry.

Material and Methods

Regulatory data were collected from the FDA website, and …

Renal Toxicity Warnings And Precautions Of Drugs Marketed In The Us, Mohammad Al Ghamdi

Pharmaceutical Sciences (MS) Theses

INTRODUCTION: The use of drugs can lead to renal adverse effects prompting the need to include warnings and precautions on medication labels. Studies evaluating renal warnings and precautions need to be improved. This study assessed the characteristics of FDA renal toxicity warnings and precautions included in the labels of drugs approved by the FDA and marked in the US. The study also evaluated the potential factors of including a boxed warning on a drug label.

METHODS: We extracted the labels of human prescription drugs with renal toxicity boxed warnings and warnings and precautions from the “FDA Label: Full-Text Search of …

The Association Of Long Working Hours And The Use Of Prescription Sedatives Among U.S. Workers., Emmanuel Ezekekwu

Electronic Theses and Dissertations

BACKGROUND: Meeting the needs of a round-the-clock and globalized society has led to an increase in long working hours. This trend has been accompanied by a corresponding rise in sleep disorders and subsequent use of sedating medications. Overtime hours have been associated with adverse health outcomes such as cardiovascular diseases, symptoms of psychological distress, and health behaviors, including risky intake of alcohol and smoking. Hence, the main objectives of this three-paper dissertation were to examine the multi-faceted relationship between working hours, the use of prescription sleep aids, the onset of psychological distress, and the use of health care services. METHODS: …

Population-Based Evaluation Of Treatment Patterns, Drug-Drug Interactions, And Cardiovascular Risk In Patients With Metastatic Castration-Resistant Prostate Cancer, Yue Cheng

Theses and Dissertations--Pharmacy

Prostate cancer has the highest increasing rate and new cases among all cancer in men in the United States and has a higher risk in elderly men. Metastatic castration-resistant prostate cancer (mCRPC) is the late stage of prostate cancer and associated with poor prognosis (median survival 13 months). Androgen deprivation therapy (ADT) use with novel hormone therapy or standard chemotherapy are recommended for mCRPC treatment. Although, the treatment options expanded significantly in recent years, new challenges are present because of the aging population, larger treatment spectrum and co-administrated medication use for other underlying medical conditions, especially for cardiovascular disease (CVD), …

Redlining And Opioid Overdose Outcomes: Do Historical Housing Policies Still Impact Health Today?, Sahana Paravantavida

Honors Theses

This study examines the relationship between historical housing policies and current health outcomes, specifically the impact of redlining on opioid overdose rates. Using data collected from the state of New Jersey, neighborhoods with a history of redlining have higher rates of opioid overdose deaths. My findings suggest that historical housing policies, which systematically excluded certain populations from accessing affordable housing and resources, continue to impact health outcomes today.

Long-Term Prescription Opioid Use, Cancer Stage, And Economic Burden Among Older Cancer Survivors With Non-Cancer Chronic Pain Conditions, Rudi Safarudin

Graduate Theses, Dissertations, and Problem Reports (ETD)

Opioids are commonly prescribed to treat pain conditions, which are highly prevalent among older adults (≥65 years). Recent evidence shows that opioids may have carcinogenic effects through immunosuppression and free-radical pathways, which could promote cancer growth. Two population-based studies have reported an association of opioid use with incident cancer. Many individuals with non-cancer chronic pain conditions (NCPCs) may use opioids for a long term. However, the association of long-term prescription opioid (LPO) use with cancer stage at diagnosis is still unknown. Furthermore, evidence suggests that individuals with cancer and pre-existing NCPCs may persistently use opioids, even in the absence of …

Clinical And Economic Burden Of Inflammatory Chronic Conditions Among Adults In The United States: Evidence From Three Nationally Representative Surveys, Mohammad Ikram

Graduate Theses, Dissertations, and Problem Reports (ETD)

A significant proportion of adults in the United States (US) suffer from various inflammatory chronic conditions (ICCs). They include a wide range of diseases such as diabetes, rheumatoid arthritis, asthma, and chronic obstructive pulmonary diseases. ICCs are not curable, and their management typically involves medications such as NSAIDs and corticosteroids. Recently, a whole health approach that places patients’ well-being at the center is increasingly being used for better management of ICCs. The whole health approach uses an integrated approach that includes multimodal management with complementary and alternative medicines (CAM) and prescription drugs. However, the use of CAM and prescription drugs …

Racial And Ethnic Differences In The Receipt Of Metabolic Syndrome Risk Factor Screening And Treatment Among Prostate Cancer Patients Treated With Androgen Deprivation Therapy., Yazan K. Barqawi

Pharmaceutical Sciences ETDs

Background: Racial and ethnic health disparities in prostate cancer prevalence, incidence, mortality, quality of life, screening, and treatment constitute the largest of all cancer disparities. These health disparities are associated with higher morbidity and mortality rates in minority populations. Treatment with androgen deprivation therapy (ADT) has been the most widely used therapeutic modality to reduce the progression of prostate cancer to a worse disease stage and relieve potential obstructive symptoms. However, ADT is associated with possible toxic metabolic and cardiovascular (CVS) adverse events that may occur within six months of ADT initiation. These adverse events include metabolic syndrome, type II …

An Exploration Of Ambulatory Visits And Medications Prescribed For Patients Diagnosed With Lupus Erythematosus In The United States, Salena Marie Preciado

Pharmaceutical Sciences (PhD) Dissertations

This dissertation sought to understand the management and treatment of patients diagnosed with lupus erythematosus. To accomplish the objectives of this research, three studies were conducted. First, a systematic literature review was done to assess the current landscape of available clinical guidelines for disease treatment. This research then used the National Ambulatory Medical Care Survey data from 2006-2016 to explore real-world trends in medications prescribed, comorbidities and chronic conditions associated with lupus. Data is weighted to be nationally representative of the U.S. The third study explored sociological influences or nonclinical factors on the prescribing of medications for patients with lupus. …

Approvals And Prices Of Systemic Antibiotics In Saudi Arabia And The United States, Saad Alharthi

Pharmaceutical Sciences (MS) Theses

Introduction

Antibiotics is one of the therapeutic classes with the highest level of consumption in the world. Despite the global diffusion of antibiotics, their availability and prices vary by country. This study assessed differences in the availability and prices of systemic antibiotics marketed in the United States (US) and Saudi Arabia and evaluated the factors associated with the differences in prices of systemic antibiotics marketed in both countries.

Material and Methods

We collected regulatory data from the US Food and Drug Administration (FDA) and the Saudi Food and Drug Authority (SFDA), the National Average Drug Acquisition Cost (NADAC) and the …

Orphan Drugs: Designations, Approvals, And Prices In The Us, Hana Althobaiti

Pharmaceutical Sciences (PhD) Dissertations

Introduction. Rare disease drug approvals have accelerated significantly in recent years. Even with these advances, patients continue to face challenges in receiving treatment, with most rare diseases lacking any approved treatments. Moreover, even when a treatment is available, it does not always reach the patients who benefit from it.

Objectives. This dissertation assessed the characteristics of orphan drug designations and approvals and the factors associated with the time lag between orphan designation and approval in the US from 1983 to 2021. It also evaluated the treatment cost of orphan and non-orphan drugs and factors explaining the treatment cost of new …

Budget Impact Analysis Of Upadacitinib For The Management Of Moderate-To-Severe Atopic Dermatitis In Patients Treated With Systemic Therapies In The United States, Haya O. Alobaid

Theses and Dissertations

Objective: This study evaluated the budget impact of introducing upadacitinib for patients with uncontrolled moderate-to-severe atopic dermatitis (AD) from a United States (U.S.) private payer perspective.

Methods: The model estimated costs before and after the adoption of upadacitinib for a hypothetical one million covered lives over 3 years. The model included immunosuppressant agents and dupilumab. Market uptake was assumed to be 2% per year. Treatments incur a cost for drug acquisition, and the costs associated with drug administration, laboratory testing, and clinic visits. The model calculated the impact on the budget in 2022 U.S. dollars. Various assumptions on market …

The Economic Value Of Pharmacist-Physician Collaborative Care Models In Hypertension Management, Jessica S. Jay

Theses and Dissertations

Background: Hypertension is highly prevalent in the United States, affecting nearly half of all adults (43%). Studies have shown that pharmacy-physician collaborative care models (PPCCM) 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 (CV) risk. There is no evidence observed improvement in TTR for systolic BP with PPCCM is cost effective.

Objective: This study aimed to compare the cost-effectiveness of PPCCM with usual care for the management of hypertension …

Trajectories Of Medication Non-Adherence With Time-Varying Predictors And Association With Health Outcomes: A Comparison Of Classical Statistical Methods With Machine Learning Algorithms, Vasco Pontinha

Theses and Dissertations

Background: Medication adherence is a major obstacle to improving health care outcomes in long-term therapies for chronic diseases. According to the World Health Organization, interventions for improving medication adherence can have a higher impact on the health of the population than any other advance in medical treatments. Approximately 125,000 individuals die every year in the U.S. because of non-adherence to medication, representing societal costs of $100-289 billion. Previous research has successfully used group-based trajectories methods to identify similar longitudinal medication adherence trajectories. However, medication adherence is not an isolated behavior and is influenced by many factors that current interventions fail …

Incidence Of Cancer, Depression, And Economic Burden Of Prescription Nsaids Among Older Adults With Osteoarthritis: Statistical And Machine Learning Approaches, Nazneen Fatima Mohammed Umer Shaikh

Graduate Theses, Dissertations, and Problem Reports (ETD)

Understanding the role of chronic inflammation among older adults is critical because of its implications on chronic inflammatory conditions as well as its interaction with anti-inflammatory medications. Osteoarthritis (OA) is a heterogeneous multi-faceted joint disease with multi-tissue involvement of varying severity, and increasing evidence demonstrates a key role of chronic inflammation in its pathogenesis. Approximately 30 million adults in the United States have OA, and it is reported that a large proportion (43%) of them are older than 65 years. OA is typically treated using non-steroidal anti-inflammatory drugs (NSAIDs) for minimizing pain and reducing inflammation. NSAIDs have consistently shown clinically …

Pharmacists' Role In Opioid Use Disorder And Overdose Prevention And Treatment And Their Attitudes And Perceptions Towards Distributing Naloxone Under A Standing Order, Stephen C. Ijioma

Theses and Dissertations

Background: Opioids are a class of drugs that bind to opioid receptors (mu, delta, and kappa), located in the central and peripheral nervous systems, to exert responses such as analgesia, respiratory depression, euphoria, and miosis. The opioid epidemic is characterized in large part by an increase in opioid overdose deaths. Community pharmacists are one of the most accessible healthcare professionals who frequently interact with patients and can implement OUD and opioid overdose prevention strategies. Treatment for opioid overdose and OUD include naloxone for overdose deaths as well as medication-assisted treatment for OUD.

Objective: The specific aims of this thesis include …

Cost-Effectiveness Analysis Of Tisagenlecleucel, Blinatumomab, And Clofarabine For Treatment Of B-Cell Precursor Acute Lymphoblastic Leukemia, Kamron Lotfi

Pharmaceutical Sciences (MS) Theses

Acute lymphoblastic leukemia (ALL) is a common type of adolescent and young adult leukemia in the United States (U.S.). Patients who are refractory or relapsed after receiving two or more lines of systemic therapy have the option of taking tisagenlecleucel. Due to the high cost of this treatment, a cost-effectiveness analysis was performed to assess the treatments for tisagenlecleucel, clofarabine combination, and blinatumomab. Objectives

The objective of this study is to evaluate the cost-effectiveness of tisagenlecleucel; clofarabine, etoposide, cyclophosphamide; and blinatumomab for the treatment of relapse- refractory ALL for adolescents and young adults from the U.S. health care payer perspective. …

Clinical Pharmacy Services And Medication Utilization In Hospice Care, Aishwarya Kulkarni

Electronic Theses and Dissertations

Background: As discussed within the guidelines from the American Society of Health-System Pharmacists (ASHP), pharmacists are an integral part of the hospice multidisciplinary team involved in optimizing the treatments. Methadone, a long-active opioid, is particularly useful in this population but may be clinically underutilized. Additionally, the cost share of medication utilization in hospice and palliative care is shifting towards hospice providers. The assessment of medication utilization and methadone use in this setting can help develop overall cost/clinical optimization strategies. Thus, there is a need to understand the use and expenditure of various medications and pharmacists' role in providing methadone …

Association Of Electronic Prescription In Controlled Substances Used, Archana Suwal, Jemima Akinyi Okonjo

Theses, Dissertations and Capstones

Introduction: Controlled substances have been described as pharmaceuticals or illegal medicines that act primarily on the central nervous system and could cause physical and mental dependence, eventually leading to addiction. Prescription opioids were a significant contributor to the opioid epidemic, accounting for more than 70,000 opioid-related overdose deaths, including illicit and prescription opioids, between 2018 and 2019. The Electronic Prescriptions for Controlled Substances (EPCS) initiative recently aimed to reduce rates of prescription opioid addiction, abuse, diversion, and death. The system for controlled substances had become more widely used as providers and governments trying to combat the opioid problem. Because …

Association Of Incident Cancer To Low-Value Care And Healthcare Cost Burden Among Elderly Medicare Beneficiaries, Chibuzo Iloabuchi

Graduate Theses, Dissertations, and Problem Reports (ETD)

In the United States (US), 25% of healthcare spending is considered wasteful because it is spent reimbursing low-value care. Low-value care is the utilization of healthcare services, medical tests, and procedures that have unclear or no clinical benefit to patients but still exposes them to risk. World-wide, low-value care imposes a significant economic burden on patients, payers, governments, and society. Cancer care among older adults > 65 years is one of the biggest drivers of healthcare expenditure in the US and accounts for nearly 40% of all spending, and low-value care among cancer patients is prevalent and contributes to the financial …

Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapies In Cystic Fibrosis: A Retrospective Evaluation Of A Nationwide Specialty Pharmacy Database, Zumi Mehta

Electronic Theses and Dissertations

Background: Cystic fibrosis (CF) is a progressive, genetic disorder caused by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients with CF experience excessive mucus build up and infections leading to complications in the pancreas, lungs, and other organs. There has been a paradigm shift in the treatment of CF with the introduction of CFTR modulator therapies and given their high acquisition cost, assessing their economic burden along with the adherence rate of patients is imperative. Objective: (i) To assess the utilization of CFTR modulator therapies in a specialty pharmacy CF patient population and (ii) to calculate …