Pharmacoeconomics and Pharmaceutical Economics Commons^™

A Cost Variation Analysis Of Various Statin Preparations Available In The Egyptian Market, Radwa Ahmed Ibrahim, Marwa G. Elhennawy, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Introduction: Dyslipidemia is one of the main risk factors for cardiovascular diseases. Statin preparations are the most effective lipid-lowering preparations that reduce the risk of mortality related to cardiovascular diseases. In the Egyptian market, various statin preparations have different strengths and prices. Aim: The current study aims to assess the percentage of cost variations among different statin medications in the Egyptian market. Methods: This is a cost variation study conducted from November to December 2022. The data were collected by using the Egyptian master on therapeutic drugs, edition 2022, and from the Egyptian Drug Database (DDB) website. The maximum and …

Cost-Variation Analysis Of Antihemorrhagic Drugs In The Egyptian Market, Michael A. Kaldas, Aya M. Abdel Magid, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Background: Cardiovascular diseases (CVDs) are considered the leading cause of death worldwide. An important category of the CVDs is the bleeding disorders. There is a significant variation in the drug products used in the treatment of hemorrhagic disorders in the Egyptian market. Therefore, our study aims to evaluate the cost variation of different brands of antihemorrhagic drugs in the Egyptian market. Methods: The study used an analytical method to obtain the different prices of the available antihemorrhagic drug products in the Egyptian market (in Egyptian Pound), from different drug categories considering all the concentrations available. Each generic name was checked …

Efficacy And Safety Of Ciltacabtagene Autoleucel And Idecabtagene Vicleucel In Multiple Myeloma Patients, Buthainah Ghanem, Marc L. Fleming, Lawrence M. Brown, Rosa Rodriguez-Monguio, Enrique Seoane-Vazquez

Student Scholar Symposium Abstracts and Posters

Background: Ciltacabtagene autoleucel (cilta-cel) and idecabtagene vicleucel (ide-cel) are chimeric antigen receptor (CAR) T-cell therapies used to treat adult patients with relapsed or refractory multiple myeloma (rrMM) after at least four lines of therapy. However, no head-to-head clinical trials to compare them have been conducted.

Objective: To compare between CARTITUDE-1 and KarMMa clinical trials in terms of efficacy, safety, and patient characteristics.

Method: Overall response rate (ORR) and safety signals were compared using reporting odds ratios (RORs) with 95% confidence intervals (CIs) at p < 0.05. Overall survival (OS) and progression-free survival (PFS) were compared using the Kaplan–Meier method with a log-rank test. Patient characteristics were compared using the chi-square test. Statistical analyses were conducted using Microsoft Excel and R version 4.0.5.

Results: Statistically significant differences were observed between cilta-cel and ide-cel in terms of ORR, complete response …

Pharmacoeconomics Of Metastatic Colorectal Cancer Treatment With Targeted Therapies Guided By Companion Molecular Diagnostics, Luis E. Fernández-Garza, Hector Sánchez-Ibarra, Daniela Treviño-Sáenz, Hugo A. Barrera-Saldaña

Research Symposium

Background: To guide the treatment with monoclonal antibodies (MAbs) against the epidermal growth factor receptor (EGFR) of metastatic colorectal cancer (mCRC), the FDA recommends prior companion molecular diagnosis (CMDx). It initially recommended screening for mutations in exon 2 of the KRAS gene, and most recently to extend to screening to exons 2, 3, and 4 of KRAS and 2, 3, and 4 of NRAS genes; furthermore, to evaluate the BRAF exon 15 mutation status (including V600E). To date, no studies have been done to compare the cost-benefit of these different CMDXs.

Methods: We have compared the cost of treatment without …

The High Cost Of Pharmaceutical Acquisitions: Increasing Social Welfare Or Furthering Inequality?, Timothy J. Haltermann

Notre Dame Journal on Emerging Technologies

This note will argue that government and regulatory authorities should focus on easing access to downstream innovation by broadening research exemptions to patent infringement. Part I of this note will focus on the current state of patent protection and exclusivity afforded to pharmaceutical companies. Part II will discuss incentives created that lead rational actors to engage in M&A instead of through internal R&D. Part III will address the development of innovation as a standalone theory of harm in merger review, and the fallacies associated with labeling certain transactions as “killer acquisitions.” Finally, Part IV of the note will look at …

The Price Of Competition: Analyzing Anticompetitive Tactics In Pharmaceutical Markets During The Hatch-Waxman Era, William Ulrich

Notre Dame Journal on Emerging Technologies

Pharmaceutical manufacturers can delay the generic entry for a blockbuster drug. In order to keep the generic system on track, it is critical to expose the various avenues of generic delay. Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through …

A Tale Of Two Situations: A Case Report Of The Merger Between Dermatology Outcomes And Prescription Drug Access, Kara Ye, Yasseen Amellal, Will Evans, Theresa Rohr-Kirchgraber

Cooper Rowan Medical Journal

This case report illustrates a case of guttate psoriasis in a young adult and the logistical role dermatologists can play in patients acquiring their prescriptions and improving the quality of their care.

Spending On Phased Clinical Development Of Approved Drugs By The Us National Institutes Of Health Compared With Industry, Edward W. Zhou, Matthew J. Jackson, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The launch of the Advanced Research Projects Agency for Health to advance new cures and address public concern regarding drug prices has raised questions about the roles of government and industry in drug development.

This cross-sectional study examined NIH funding for published research reporting the results of phased clinical trials of drugs approved between 2010 and 2019 and compared the findings with reported industry spending estimates. Data analysis was performed between May 2021 and August 2022 using PubMed data from January 1999 through October 2021 and NIH Research Portfolio Online Reporting Tools Expenditures and Results data from January 1999 through …

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 …

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: …

The Rubik's Cube Of Manufacturers' Coupons: Making The Case For Sneetches, Bruce Wolf

HCA Healthcare Journal of Medicine

Asthma maintenance inhalers are inordinately expensive, inhibiting patients from affording their medication and compromising compliance and adherence and optimal health outcomes. The objective of this article was to examine and highlight the competitive world and challenged opportunity of manufacturers' coupons discounting the inordinate cost of respiratory inhalers and asthma treatment. The cost of asthma treatment, in particular the cost of respiratory medicines, even with health insurance, can be prohibitive (upwards of $700 per month for one inhaler). Medication costs restrict medication access. Compliance and adherence suffer attested by monthly maintenance inhalers being filled less than 50% of the time. Pharmaceutical …

Disentangling The Cost Of Orphan Drugs Marketed In The United States, Hana Althobaiti, Enrique Seoane-Vazquez, Lawrence B. Brown, Marc L. Fleming, Rosa Rodriguez-Monguio

Pharmacy Faculty Articles and Research

The increasing number and high prices of orphan drugs have triggered concern among patients, payers, and policymakers about the affordability of new drugs approved using the incentives set by the Orphan Drug Act (ODA) of 1983. This study evaluated the factors associated to the differences in the treatment cost of new orphan and non-orphan drugs approved by the FDA from 2017 to 2021. A generalized linear model (GLM) with the Gamma log-link analysis was used to ascertain the association of drug characteristics with the treatment costs of orphan and non-orphan drugs. The results of the study showed that the median …

Prescription Drug Retail Sales In The Mountain West, Caren Royce Yap, Caitlin J. Saladino, William E. Brown Jr.

Health

This fact sheet synthesizes data on prescription drug retail sales in the Mountain West (Arizona, Colorado, Nevada, New Mexico, and Utah). "Retail Sales for Prescription Drugs Filled at Pharmacies by Payer," a 2019 report by the Kaiser Family Foundation, includes data on the amount of retail sales for prescription drugs made in each state by dollar amount, along with the method of coverage, including commercial, Medicare, Medicaid and cash payment.

A Quality Improvement Project To Improve Management Of Urinary Tract Infections In A System Of Pediatric Urgent Care Centers, Benjamin Klick, Tammy Speerhas, Jessica Parrott, Jeffrey Bobrowitz, Anne Mcevoy, Debra Conrad, Theresa Guins

Nursing Faculty Publications

Background and objective: Urinary tract infections (UTIs) are a common problem in pediatric urgent care medicine. There are multiple quality improvement (QI) projects related to the management of UTIs documented in the pediatric literature. We developed a project to decrease the prescribing of ultimately unneeded antibiotics for possible UTIs in a pediatric urgent care setting. A similar project has not been described in the pediatric literature.

Methods: We first reviewed the charts of patients presenting to a system of pediatric urgent care centers with a possible UTI over a 2-year period. We then launched a QI project with three plan, …

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

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 …

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.

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 …

Evaluate 503b Facilities For Outsourced Compounds, Sarah Clemente, Brittany Riley, Alberto Coustasse

Pharmacy Practice & Administration

The US health care system has encountered long-standing, complex challenges, including growing costs, overuse of care, staffing shortages and supply chain weaknesses. COVID-19 revived these pressures, transforming the health care landscape. Medication and staffing shortages plague hospital systems, and pharmacies are not exempt. Most health systems have experienced high levels of pharmacy technician turnover, with most reporting a minimum turnover rate of 21% last year. In addition, medication shortages of critical medications and infusions create significant workflow barriers that hospitals must address to ensure patient safety. In the face of these obstacles, health systems are turning to 503B compounding facilities …

Is The 340b Hospitals Battle At The Supreme Court Over?, Casey W.. Baker, Susan W. Lanham, Alberto Coustasse

Accounting Faculty Research

Under the Federal 340B Program, hospitals and eligible health care clinics that serve low income or rural populations can qualify for federally negotiated manufacturer discounts on purchases of prescription drugs. Approximately 50,000 entities participate in the 340B program, where pharmaceutical manufacturers are instructed to supply outpatient medications to participating providers at discounted rates of 20% to 50%. Participating hospitals depend on profits from the differential between their reimbursement for these drugs and the discounted rates they disburse to finance affordable patient care in underserved communities. On June 15, 2022, the US Supreme Court ruled that major cuts to 340B payments …

Methodological Challenges In Pharmacoeconomic Submissions For Cancer Drug Reimbursement In Canada From 2019-2021, Nupur Krishnan

Undergraduate Student Research Internships Conference

Cancer is the leading cause of death in Canada, carrying a mortality rate of 1 in 4 Canadians. As new therapeutic options are developed, high drug costs place a huge burden on patients and the healthcare system. Due to budget limitations, not all pharmaceuticals can be publicly funded, so difficult decisions must be made for which drugs are funded and in what contexts. The pan-Canadian Oncology Drug Review (pCODR) evaluates submissions for new oncological pharmaceuticals to make reimbursement recommendations. Comprehensive analyses assessing limitations in recent oncology drug submissions have not yet been performed. The objective of this project, therefore, was …

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 …

Will Reducing Drug Prices Slow Innovation?, Gregory Vaughan, Fred Ledley

Natural & Applied Sciences Faculty Publications

The pharmaceutical industry has long argued that high drug prices reflect the high cost of innovation and that reducing drug prices would necessarily slow the pipeline of new drugs. These arguments have been bolstered by studies of large pharmaceutical companies showing statistical associations between the projected market size or revenue for pharmaceutical products and research & development (R&D) activity. Our analysis recognizes the increasingly important role of small biopharmaceuticals in drug development , companies that typically have little revenue and negative earnings, but are now responsible for more than 40% of new drug approvals. We examine the relationship between changes …

Will Reducing Drug Prices Slow Innovation?, Gregory Vaughan, Fred Ledley

Mathematical Sciences Faculty Publications

The pharmaceutical industry has long argued that high drug prices reflect the high cost of innovation and that reducing drug prices would necessarily slow the pipeline of new drugs. These arguments have been bolstered by studies of large pharmaceutical companies showing statistical associations between the projected market size or revenue for pharmaceutical products and research & development (R&D) activity. Our analysis recognizes the increasingly important role of small biopharmaceuticals in drug development , companies that typically have little revenue and negative earnings, but are now responsible for more than 40% of new drug approvals. We examine the relationship between changes …

Financial Hardship From Purchasing Prescription Drugs Among Older Adults In The United States Before, During, And After The Medicare Part D “Donut Hole”: Findings From 1998, 2001, 2015, And 2021, Anthony W. Olson, Jon C. Schommer, David A. Mott, Olajide Adekunle, Lawrence M. Brown

Pharmacy Faculty Articles and Research

BACKGROUND: Cost-related nonadherence compromises successful and effective management of chronic disease. The Medicare Modernization Act of 2003 (MMA) and Patient Protection and Affordable Care Act of 2010 (ACA) aimed to increase the affordability of outpatient prescription drugs for older adults (older than age 64 years). The Medicare Part D prescription drug insurance coverage gap (“donut hole”) created by the MMA was fully closed in 2020 by the ACA.

OBJECTIVES: To (1) describe prescription drug coverage and financial hardship from purchasing prescription drugs among older American adults for 2021, (2) compare these results with findings from data collected before the MMA …

Cost-Effectiveness Analysis Of Tpmt Genotype-Guided Azathioprine Treatment Compared To Standard Treatment For Patients With Moderate/Severe Ulcerative Colitis, Ali Unsal

Electronic Thesis and Dissertation Repository

This study assessed cost-effectiveness of pharmacogenomics (PGx)-based azathioprine (AZA) compared to standard AZA therapy for ulcerative colitis (UC) patients in Canada. A patient-level Microsimulation model was developed to compare the lifetime costs and quality-adjusted life years (QALYs) gained by a hypothetical cohort of UC patients with age and sex characteristics. The parameters used in the model were derived from the published literature and costs from the Ontario Schedules of Payments and published sources. The results were summarized in terms of the incremental cost-effectiveness ratio (ICER). Compared to standard AZA, PGx-based AZA care was the dominant strategy with 0.17 incremental QALYs …

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 …

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 …

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 …

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 …