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JOURNAL ARTICLE
Anton Berns
Discovery research is the starting point for the development of more effective anti-cancer treatments. It requires an interdisciplinary research environment with first-class infrastructural support in which curiosity-driven research can lead to new concepts for treating cancer. Translating such research findings to clinical practice requires complementary skills and infrastructures, including high-quality clinical facilities, access to patient cohorts and participation of pharma. This complex ecosystem has yielded many new but also "me too" treatment regimens, especially in immuno-oncology resulting in an extremely high pricing of anti-cancer agents...
April 18, 2024: Molecular Oncology
#2
JOURNAL ARTICLE
Julie K Wisch, Nicole S McKay, Anna H Boerwinkle, James Kennedy, Shaney Flores, Benjamin L Handen, Bradley T Christian, Elizabeth Head, Mark Mapstone, Michael S Rafii, Sid E O'Bryant, Julie C Price, Charles M Laymon, Sharon J Krinsky-McHale, Florence Lai, H Diana Rosas, Sigan L Hartley, Shahid Zaman, Ira T Lott, Dana Tudorascu, Matthew Zammit, Adam M Brickman, Joseph H Lee, Thomas D Bird, Annie Cohen, Patricio Chrem, Alisha Daniels, Jasmeer P Chhatwal, Carlos Cruchaga, Laura Ibanez, Mathias Jucker, Celeste M Karch, Gregory S Day, Jae-Hong Lee, Johannes Levin, Jorge Llibre-Guerra, Yan Li, Francisco Lopera, Jee Hoon Roh, John M Ringman, Charlene Supnet-Bell, Christopher H van Dyck, Chengjie Xiong, Guoqiao Wang, John C Morris, Eric McDade, Randall J Bateman, Tammie L S Benzinger, Brian A Gordon, Beau M Ances
BACKGROUND: In people with genetic forms of Alzheimer's disease, such as in Down syndrome and autosomal-dominant Alzheimer's disease, pathological changes specific to Alzheimer's disease (ie, accumulation of amyloid and tau) occur in the brain at a young age, when comorbidities related to ageing are not present. Studies including these cohorts could, therefore, improve our understanding of the early pathogenesis of Alzheimer's disease and be useful when designing preventive interventions targeted at disease pathology or when planning clinical trials...
May 2024: Lancet Neurology
#3
REVIEW
Morgan R Price, Kaelyn E Mead, Diana M Cowell, Alyssa M Troutner, Tyler E Barton, Sheryl A Walters, Clinton J Daniels
OBJECTIVE: The purpose of this systematic review was to ascertain guideline-recommended pharmaceutical approaches to lumbosacral radicular symptoms, assess the quality of the clinical practice guidelines (CPGs) with the Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool, and qualitatively synthesize the guideline recommendations. LITERATURE SURVEY: Literature searches were performed in PubMed, Cochrane Database of Systematic Reviews, Index to Chiropractic Literature, Allied and Complementary Medicine Database (AMED), Cumulative Index for Nursing and Allied Health Literature (CINAHL), and Physiotherapy Evidence Database (PEDro)...
April 17, 2024: PM & R: the Journal of Injury, Function, and Rehabilitation
#4
JOURNAL ARTICLE
Sergio Di Matteo, Roberto Freilone, Giacomo Matteo Bruno, Rosario Notaro, Sabrin Moumene, Nicoletta Martone, Cristina Teruzzi, Antonio Ciccarone, Giorgio Lorenzo Colombo
BACKGROUND: Paroxysmal nocturnal hemoglobinuria is a rare, acquired disease characterized by hemolytic episodes and associated with significant clinical burden. The introduction of C5 inhibitory monoclonal antibodies (C5i) represented a major breakthrough in PNH treatment, effectively reducing intravascular hemolysis (IVH) but showing limited impact on extravascular hemolysis (EVH). In 2021, the C3 inhibitor pegcetacoplan was approved by EMA and recently reimbursed in Italy, which also has the advantages in the reduction of both IVH and EVH, increasing hemoglobin values and simultaneously improving the quality of life and fatigue of patients...
2024: ClinicoEconomics and Outcomes Research: CEOR
#5
REVIEW
Francesco Versino, Bruno Fattizzo
Complement inhibitors are the mainstay of paroxysmal nocturnal hemoglobinuria (PNH) treatment. The anti-C5 monoclonal antibody eculizumab was the first treatment to improve hemolysis, thrombotic risk, and survival in PNH although at the price of a life-long intravenous fortnightly drug. Additionally, suboptimal response may occur in up to 2/3 of patients with persistent anemia due to incomplete control of intravascular hemolysis, development of upstream C3-mediated extravascular hemolysis (EVH), or concomitant bone marrow failure...
April 15, 2024: International Journal of Laboratory Hematology
#6
JOURNAL ARTICLE
Zi-Jia Chen, Xin Cui, Sheng Han, Meng Qiao, Chang-Kuan Fu, Zhi-Fei Wang, Yan-Ming Xie
The purpose of this study was to evaluate the economics of Annao Pills combined with antihypertensive drugs in the treatment of primary hypertension in the Chinese medical setting. TreeAge pro 2018 was used for cost-effect analysis and sensitivity analysis of the two treatment regimens. The intervention time of the simulation model was 2 weeks. The cost parameters were derived from Yaozhi.com, and the effect parameters were based on Meta-analysis of randomized controlled trial(RCT) involving Annao Pills. The experimental group was treated with Annao Pills combined with anti-hypertensive drugs(nifedipine controlled-release tablets + losartan potassium tablets), and the control group was treated with anti-hypertensive drugs(nifedipine controlled-release tablets + losartan potassium tablets)...
March 2024: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
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JOURNAL ARTICLE
Xia Tian, He Zhu, Wei Li, Sheng Han
Based on literature and questionnaire research, related evidence and related data on Shexiang Tongxin Dropping Pills were collected in terms of safety, effectiveness, economy, innovation, suitability, and accessibility. In addition, multi-criteria decision analysis(MCDA) model was used to comprehensively evaluate the clinical value of Shexiang Tongxin Dropping Pills. Quality control was carried out strictly based on evidence-based medicine evaluation. Shexiang Tongxin Dropping Pills were recommended for stable fatigue angina of coronary heart disease with Qi deficiency and blood stasis by guidelines and experts...
February 2024: Zhongguo Zhong Yao za Zhi, Zhongguo Zhongyao Zazhi, China Journal of Chinese Materia Medica
#8
JOURNAL ARTICLE
Wajeeha Raza, Wahaj Zulfiqar, Mashal Murad Shah, Maryam Huda, Syeda Shehirbano Akhtar, Urooj Aqeel, Saira Kanwal, Muhammad Khalid, Raza Zaidi, Maarten Jansen, Nichola Kitson, Leon Bijlmakers, Sameen Siddiqi, Ala Alwan, Anna Vassall, Sergio Torres-Rueda
BACKGROUND: The Federal Ministry of National Health Services, Regulations and Coordination (MNHSR&C) in Pakistan has committed to progress towards universal health coverage (UHC) by 2030 by providing an Essential Package of Health Services (EPHS). Starting in 2019, the Disease Control Priorities 3rd edition (DCP3) evidence framework was used to guide the development of Pakistan's EPHS. In this paper, we describe the methods and results of a rapid costing approach used to inform the EPHS design process...
January 7, 2024: International Journal of Health Policy and Management
#9
JOURNAL ARTICLE
Jing Zhou, Hao Lu, Jay Pan
BACKGROUND: To investigate the association of launch price and clinical value with reimbursement decisions for anticancer drugs after the implementation of reimbursement-linked price negotiation in China. METHODS: Anticancer drugs approved by the NMPA of China from January 2017 to June 2022 were eligible for inclusion. Approval and reimbursement dates of included drug indications were retrieved from publicly available resources. We collected measures of clinical value, including survival, quality of life, and overall response rate from pivotal clinical trials and calculated treatment price at launch...
March 17, 2024: International Journal of Health Policy and Management
#10
JOURNAL ARTICLE
Shrutangi Vaidya, Shubham Atal, Rajnish Joshi
Introduction Type 2 diabetes mellitus (T2DM) poses a substantial burden globally and particularly in India, affecting health, finances, and overall quality of life. The management of this condition relies on lifestyle modifications and advanced pharmacological interventions, with emerging drugs showing promise in areas such as administration, side effects, efficacy, and cardiovascular benefits. However, their market penetration is hindered by high costs. Understanding the target population's expectations and willingness to pay (WTP) for these drugs is crucial...
March 2024: Curēus
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JOURNAL ARTICLE
Gastrointestinal Acute Radiation Syndrome: Mechanisms, Models, Markers, and Medical Countermeasures.
Thomas A Winters, Libero Marzella, Olivia Molinar-Inglis, Paul W Price, Nyun Calvin Han, Jonathan E Cohen, Sue-Jane Wang, Anthony F Fotenos, Julie M Sullivan, John Esker, Paula J Lapinskas, Andrea L DiCarlo
There have been a number of reported human exposures to high dose radiation, resulting from accidents at nuclear power plants (e.g., Chernobyl), atomic bombings (Hiroshima and Nagasaki), and mishaps in industrial and medical settings. If absorbed radiation doses are high enough, evolution of acute radiation syndromes (ARS) will likely impact both the bone marrow as well as the gastrointestinal (GI) tract. Damage incurred in the latter can lead to nutrient malabsorption, dehydration, electrolyte imbalance, altered microbiome and metabolites, and impaired barrier function, which can lead to septicemia and death...
April 15, 2024: Radiation Research
#12
JOURNAL ARTICLE
Rebecca G Kim, Claire McDonell, Jeff McKinney, Lisa Catalli, Jennifer C Price, Meghan D Morris
BACKGROUND: Telemedicine offers the opportunity to provide clinical services remotely, thereby bridging geographic distances for people engaged in the medical system. Following the COVID-19 pandemic, the widespread adoption of telemedicine in clinical practices has persisted, highlighting its continued relevance for post-pandemic healthcare. Little is known about telemedicine use among people from socially marginalized groups. METHODS: The No One Waits (NOW) Study is a single-arm clinical trial measuring the acceptability, feasibility, and safety of an urban point-of-diagnosis hepatitis C (HCV) treatment initiation model delivered in a non-clinical community setting...
March 25, 2024: Healthcare (Basel, Switzerland)
#13
JOURNAL ARTICLE
Wei Zhang, Daphne P Guh, Paul Grootendorst, Aidan Hollis, Aslam H Anis
BACKGROUND: Canada's Patented Medicine Prices Review Board (PMPRB) uses external and internal reference pricing (IRP) to regulate patented drug list prices. PMPRB has changed external reference countries from 7 to 11 to include countries with prices closer to the OECD median. We examined the impact on the list prices for patented medicines had the amendment been implemented from 2013. METHODS: Using IQVIA MIDAS® quarterly sales data, we selected branded products that were launched in Canada in 2013-2018...
April 7, 2024: Health Policy
#14
JOURNAL ARTICLE
Iris An der Heiden, Guido Schiffhorst, Laura Müller, Martin Albrecht, Arne Bartol, Stefanie Wiberny
BACKGROUND: Based on the legal framework laid down in section 130b (9) of Book V of the German Social Code, various criteria are relevant for the negotiated price for new patented drugs in Germany. European reference prices (ERPs) are one criterion. The ERP is based on the ex-factory prices (EFPs) of the countries included in the European country basket. However, in some of these countries, the EFP is not published due to confidential wholesale margins. Wholesale margins must therefore be estimated and deducted from purchase prices...
April 12, 2024: Health Economics Review
#15
JOURNAL ARTICLE
Jason B Gibbons, Charles L Bennett, Kenneth R Carson, Gerard F Anderson
The Inflation Reduction Act of 2022 (IRA) allows the Medicare program to negotiate drug prices beginning in 2024. Based on the guidance in the statute, CMS has selected specific data items to use to adjust initial price offers for 10 drugs in the decision-making process. Although much of the data are publicly available, some of these data items will need to be collected directly from drug companies. A 2019 US House of Representatives Committee on Oversight and Accountability investigative report collected a wide range of data from manufacturers of 12 high-revenue drugs that show what is available from the drug companies, including development costs, marketing, pricing, competition, and patent status...
April 2024: American Journal of Managed Care
#16
JOURNAL ARTICLE
Ben Teasdale, Amber Hudspeth, Kaury Kucera, David Light, Jill Nailor, Shannon Williams, Arnold Milstein, Kevin A Schulman
OBJECTIVES: Generic medications represent 90% of prescriptions in the US market and provide a tremendous financial benefit for patients. Recently, multiple generic drugs have been recalled due to the presence of carcinogens, predominantly N-nitrosodimethylamine (NDMA), including an extensive recall of extended-release (ER) metformin products in 2020. STUDY DESIGN: Primary pharmaceutical quality testing and database analysis. METHODS: We tested marketed metformin immediate-release (IR) and ER tablets from a wide sample of generic manufacturers for the presence of carcinogenic impurities NDMA and N,N-dimethylformamide (DMF)...
April 2024: American Journal of Managed Care
#17
JOURNAL ARTICLE
Piter Oosterhof, Matthijs Van Luin, Kees Brinkman, David M Burger
OBJECTIVES: Antiretroviral therapy (ART) accounts for a considerable proportion of HIV care expenses. In June 2021, a Dutch healthcare insurer implemented a mandatory policy to de-simplify branded RPV/TDF/FTC (Eviplera®) into a two-tablet regimen containing rilpivirine (Edurant®) plus generic TDF/FTC as part of cost-saving measures. The objectives of this study were to evaluate (1) the acceptance of this policy, (2) the trends in antiretroviral therapy dispensation, and (3) cost developments...
April 10, 2024: AIDS
#18
JOURNAL ARTICLE
Samantha Pan, Anndee Gritte, John Malamakal, Amy Horowitz, Alexa Harris, Sierra J Vig
Background: The balance between reducing patient wait time and mitigating waste of parenteral products has not been well described in literature. Objective: Evaluate the patient wait times and cost-effectiveness of employing a premix versus an on-demand workflow model for compounding parenteral admixtures in a hematology/oncology infusion setting. Methods: This single center, retrospective cost analysis compiled manually documented monthly waste reports and estimated drug pricing for the institution to calculate the cost of waste during both premix and on-demand compounding workflows...
April 10, 2024: Journal of Pharmacy Practice
#19
JOURNAL ARTICLE
Brian E Gawronski, Ramzi G Salloum, Julio D Duarte
Background: The implementation of pharmacogenetic (PGx) testing may contribute to health disparities if access to testing is inequitable, as medically underserved patients are prescribed higher rates of drugs with PGx guidelines and often experience the benefits of emerging health technologies last. Limited research has evaluated potential implementation of PGx testing in populations who are medically underserved and none have evaluated their preferences regarding PGx test characteristics and cost. Our study endeavored to assess the willingness to pay for PGx testing and key PGx test preferences in a nationwide cohort of medically underserved respondents...
2024: Frontiers in Pharmacology
#20
JOURNAL ARTICLE
Yanghaotian Wu, Xuemei Han, Jingfu Qiu
BACKGROUND: In 2016, an innovative medical pricing reform called zero-markup drug policy (ZMDP) was implemented in selected pilot cities in China, which focuses on curbing the unreasonable growth of medical expenses. This study aimed to evaluate the impacts of ZMDP on medical expenditure of stroke in western China. METHODS: The quantitative data of inpatients diagnosed with stroke was extracted from the medical insurance system in 7 tertiary public hospitals. An interrupted time series (ITS) was used to analyze the instantaneous level and long-term trend changes of hospitalization expenses per visit from January 2015 to November 2018...
2024: Risk Management and Healthcare Policy
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