Pharmacoeconomics and Pharmaceutical Economics Commons^™

Developing Public-Private R&D Consortia To Accelerate Alzheimer’S Disease Drug Development, Joel West, Paul Olk

Management: Faculty Scholarship

Efforts to accelerate Alzheimer's disease (AD) drug development have been spurred on by the creation of open science, public-private R&D consortia. An R&D consortium provides an improved structure for generating and disseminating AD knowledge across a range of organizations while also aligning their interests. Drawing from archival and interview data collected on 46 public-private R&D consortia focused wholly or in part on AD, we uncover two important innovations: the creation of novel consortium types that facilitate coordination beyond the individual consortium, and the practice of organizations joining multiple consortia. Collectively these innovations provide member organizations with different pathways for advancing …

Utilizing Biosimilars To Help Increase Patients Access And Minimize The Financial Burden Of Health Care System In Egypt, Doaa M. Abd-El-Rady, Iman A. El-Baraky, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Background: Biologics have provided enhanced clinical advantages, but at expense of enormous expenditures. The exorbitant expense of biologics was somewhat mitigated by the development of biosimilars. But biosimilars market access is still recessed in many countries including Egypt. To achieve biosimilars market sustainability, countries need to evaluate the health economic barriers that biosimilars face in gaining market access.

Methods: A retrospective budget impact analysis was conducted to compare the cost of biosimilars to that of their reference biologics from Egyptian regulatory perspective over a five-year period (2018-2022). Time series forecasting analysis was conducted to predict the cost savings …

Medicare Drug Price Negotiation Program Draft Guidance, Fred Ledley M.D., Edward Zhou Pharmd, Paula Chaves Da Silva Ph.D.

CISI Publication

This comment focuses on Section 50.1, provisions 1 & 3 of the draft guidance regarding the negotiation of a “maximum fair price” under the Inflation Reduction Act (IRA), research and development (R&D) costs of the primary manufacturer, and prior federal financial support for novel therapeutic discovery and development. Specifically, we argue that a negotiated, “maximum fair price” must consider both public sector (federal) and private sector (manufacturer) investments and provide returns to both commensurate with the scale and risk of their investments. This comment addresses three issues and makes specific recommendations regarding each:

1. In negotiating a “maximum fair price,” both …

Analisis Pembiayaan Berdasarkan Lama Rawat Pasien Bpjs Diabetes Melitus Tipe Ii Komplikasi Sirkulasi Perifer Di Rsu Pku Muhammadiyah Bantul, Firman Firman, Kartika Lestari

Jurnal Ekonomi Kesehatan Indonesia

Length of stay (LOS) can increase hospital rates and become a cost issue for patients, potentially resulting in a discrepancy between hospital rates and INA-CBGs rates at the hospital. This study aims to determine the difference between the actual costs and BPJS claim costs for diabetic patients based on the length of stay and class level. The research method is observational with a descriptive approach. The data collection technique used retrospective medical record data from 50 patients. The results showed that the largest average difference between hospital costs and BPJS claim costs was for patients with a length of stay …

Assessing The Impact Of Tuberculosis On Economic Growth In Asean Countries: A Conceptual Framework And Panel Data Analysis, Agus Fitriangga, Alex Alex

Jurnal Ekonomi Kesehatan Indonesia

Tuberculosis (TB) remains a major global health issue, particularly in Southeast Asia, where its impact extends beyond public health to affect economic performance. This study evaluates the economic implications of TB incidence on gross domestic product (GDP) growth across eight ASEAN countries from 2000 to 2020. We employed a panel data regression approach, utilizing Common Effect Model (CEM), Fixed Effects Model (FEM), and Random Effects Model (REM) to analyze the relationship between TB incidence and economic growth. The dataset included annual GDP figures, TB incidence rates, foreign direct investment (FDI), labor force size, and trade openness, sourced from international databases. …

Analisis Penerapan Activity-Based Costing Tindakan Debridemen Bedah Pada Diagnosis Tunggal Di Kamar Operasi Rskd Duren Sawit Tahun 2022, Reynaldi Fattah Zakaria, Mardiati Nadjib

Jurnal Ekonomi Kesehatan Indonesia

In 2022, RSKD Duren Sawit has officially held operating room services. The demand for more comprehensive operating room services increased rapidly. The temporary operating room rates were set by adapting the rates of other regional hospitals and the Governor of DKI Jakarta's regulations. There is a huge difference in costs between the hospital rates and the INA-CBGs claim rates, especially for surgical debridement performed in the operating room. One of the factors causing the difference is the undetermined cost for debridement based on the unit cost component. Knowing the unit-cost debridement in the operating room according to the cost per …

Cost Variation Analysis Of Oral Hypoglycemic Drugs In The Egyptian Market, George G. Abdelmessih, Aya M. Abdelmagid, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Introduction: Type II diabetes mellitus is a lifelong condition requiring lifelong medication. This study aims to analyze the cost variation of the oral hypoglycemic drugs in the Egyptian pharmaceutical market.

Methodology: Egyptian drug database of the Egyptian Drug Authority was used to get the official prices of drugs in the Egyptian pharmaceutical market analyzed in this study. The cost ratio and the percentage cost variation were calculated. The price was documented using unit dose of 1 tablet per EGP.

Results: Out of 15 oral hypoglycemic drugs in the Egyptian market at closing 2022 (9 monotherapy and 6 combination therapy) of …

A Cross – Sectional Observational Study On Pharmacoeconomics Burden Of Covid -19 In Ashmoun Fever Hospital Delta Egypt, Marwa Helmi Desouki, Marwa G. Elhennawy, Samar F. Farid

Bulletin of Faculty of Pharmacy Cairo University

Background: A wide range of respiratory illnesses like common colds, Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) are caused by coronaviruses.

In 2019 scientists in Wuhan, China discovered a new coronavirus (COVID-19). Unknown new coronavirus that infected people for the first time and causes losses for humans. It has caused a large number of deaths around the world and a greater number of injuries, and the countries of the world began to take measures and closures to confront the spread of this virus, and the economy was greatly affected.

Aim of Study: This study provides …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …

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 …