Pharmacoeconomics and Pharmaceutical Economics Commons^™

Considering Returns On Federal Investment In The Negotiated “Maximum Fair Price” Of Drugs Under The Inflation Reduction Act: An Analysis, Edward W. Zhou, Paula G. Chaves Da Silva, Debbie Quijada, Fred D. Ledley

Natural & Applied Sciences Faculty Publications

The Inflation Reduction Act (IRA) of 2022 contained landmark provisions authorizing government to negotiate a “maximum fair price” for selected Medicare Part D drugs considering the manufacturer’s research and development costs, federal support for discovery and development, the extent to which the drugs address unmet medical needs, and other factors. This working paper describes federal investment in the discovery and development of the ten drugs selected for price negotiation in the first year of the IRA as well as the health value created through Medicare Part D spending on these drugs. We identified $11.7 billion in NIH funding for basic …

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 …

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 …

Estimasi Biaya Produktivitas Yang Hilang Akibat Kematian Dini Pasien Covid-19 Di Rs Pku Muhammadiyah Gamping, Yuni Andriani, Sugiyono Sugiyono

Jurnal Ekonomi Kesehatan Indonesia

COVID-19 is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The COVID-19 virus infection has had an impact on the global health and economic system, including in developing countries. This research is an observational study by estimating the indirect costs of lost productivity due to premature deaths in COVID-19 patients at PKU Muhammadiyah Gamping Hospital in 2021 and knowing the characteristics of the patients. This hospital was chosen as the research site because the percentage of Bed Occupancy Rate (BOR) was the highest in Sleman Regency in 2021, reaching 68.94%. The results of the research show …

Menakar Kesiapan Puskesmas Dalam Penuntasan Penanganan Penyakit: Analisa Data Riset Fasilitas Kesehatan 2019, Harimat Hendarwan, Suparmi Suparmi

Jurnal Ekonomi Kesehatan Indonesia

The completion of disease treatment at the health center was important for payment of Capitation Based on Fulfillment of Service Commitment (PCFSC/KBPKP) and the Non-Specialist Case Outpatient Referral (NSOR/RRNS) was one of the key indicators. This study aimed to assess public health center readiness in the completion of disease treatment for those stipulated in Ministerial Decree number 514 of the year 2015. This study used Health Facility Research (Rifaskes) data conducted in 2019 with a total of 9831 health centers as observations. Analysis was conducted by comparing the availability of equipment, laboratories, and medicines with existing regulations. Health center readiness …

Who Marries Whom Matters: Kesamaan Pendidikan Orangtua Dan Berat Badan Saat Lahir Di Indonesia, Mudya Johanna, Omas Bulan Samosir

Jurnal Ekonomi Kesehatan Indonesia

Despite ongoing efforts and commitment to reducing Low Birth Weight (LBW) babies, globally, the incidence of LBW has stagnated. This study uses a combined factor of maternal and husband/partner education variables to analyze the complexity of LBW incidents. This research uses secondary data from the 2017 SDKI with a multilevel logistic regression analysis method to look at the relationship between the similarity of parental education and the baby's birth weight at the individual and community levels. The results of the research show that mothers who have husbands/partners with equivalent education and higher education (≥high school or equivalent) have a lower …

Pelayanan Kesehatan Primer Sebagai Gatekeeper Dan Kebijakan Diskusi Peer Review: Antara Kualitas Dan Realitas Untuk Menurunkan Kasus Rujukan Non Spesialistik, Zahrina Zahrina, Royasia Viki Ramadani, Khairun Nisa Il Hulwah, Siti Nurlatifah, Aldi Andalan, Ascobat Gani, Golda Kurniawaty, Ery Setiawan

Jurnal Ekonomi Kesehatan Indonesia

Almost 80% of the source of funds is spent on hospital. This situation indicates the failure of the gatekeeper function in primary health care. Performance-based capitation is implemented to ensure the cost and quality of primary care, with non-specialist referral rate as one of the particular parameters. The peer review policy is a discussion between BPJS Health, District/City Health Services, IDI, provincial and branch Team of KMKB and other relevant stakeholders to determine which diagnoses must be handled at FKTP also to accommodate and improve the capacity of FKTP to handle patients and minimize referral cases. This study aims to …

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 …

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 …

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 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 …

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 …

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.

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 …

Comments Re: Workshop On Transforming Discoveries Into Products: Maximizing Nih’S Levers To Catalyze Technology Transfer, Fred D. Ledley M.D., Edward Zhou Pharm. D, Paula Chaves Da Silva, Ph. D.

CISI Publication

We are pleased to offer written comments to this workshop focused on “… making federally funded inventions more accessible to the public… .” These comments are informed by recent research from the Center for Integration of Science and Industry at Bentley University that has:

• Quantified the scope of NIH funding for basic or applied research, clinical development, or patents associated with drugs approved by the FDA 2010-2019. This work identified $187 billion in NIH-funded research directly related to these drugs (applied research – 17%) or their biological targets (basic research – 83%), representing a (discounted) investment comparable to reported levels …

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 …

Hubungan Karakteristik Pasien, Prosedur, Dan Penyakit Penyerta Dengan Biaya Langsung Medis Pada Pasien Rawat Inap Jantung Koroner, Rita Tri Wahyuni, Eri Witcahyo, Yennike Tri Herawati

Jurnal Ekonomi Kesehatan Indonesia

Coronary heart disease is a catastrophic disease that causes a high burden of medical costs. At Dr.Iskak Tulungagung hospital, coronary heart disease is the disease with the highest cost. The number of coronary heart patients who are hospitalized is also increasing every year. Several Previous studies have shown that the amount of direct medical costs of coronary heart patients reach more than 50% of the total costs of treatment. Therefore, it is necessary to do research on the factors associated with the increasing direct medical costs of coronary heart patients. The purpose of this study was to analyze the factors …

Evaluasi Penerapan Pilot Project Global Budget Sebagai Sistem Pembayaran Klaim Pada Rsud Wates, Mega Handayani, Laili Rahmatul Ilmi, Zennul Mubarrok1 Mubarrok

Jurnal Ekonomi Kesehatan Indonesia

Claims payment for health services is one of the factors that affect the financial health of a hospital. Indonesia itself has experienced several changes to the existing payment system. BPJS-K started an operational study on the implementation of the INA-CBGs and the Global Budget mixed-method payment system since 2018 with three stages in five districts/city in Indonesia. This study aims to evaluate the implementation of the Global Budget system at RSUD Wates in Kulon Progo Regency that appointed as a BPJS-K pilot project. This research is qualitative research and data collection was carried out by studying documents and interviews. As …