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https://read.qxmd.com/read/30763134/price-competition-and-reimbursement-of-biosimilar-granulocyte-colony-stimulating-factor-in-hungary
#1
Lajos Hornyák, Zsolt Nagy, Lívia Ilku, Zsuzsanna Tálos, Dóra Endrei, István Ágoston, Tímea Csákvári, Nóra Danku, Balázs Répásy, Imre Boncz
OBJECTIVES: After patent expiration of original biological drugs, they can be marketed as biosimilars. In this study, we analyzed the bid approach of the Hungarian National Health Insurance Fund Administration (NHIFA) based on the results of two consecutive bids on colony stimulating factor (CSF). METHODS: The Hungarian NHIFA database was used to analyze the changes in the number of patients treated with CSF and reimbursement paid by NHIFA, 12 months preceding and following the bids...
February 14, 2019: Expert Review of Pharmacoeconomics & Outcomes Research
https://read.qxmd.com/read/30763034/the-drug-price-iceberg-more-than-meets-the-eye
#2
A Mark Fendrick, Darrell George
When it comes to the political iceberg of drug prices, there is more below the surface. Policies that reduce prices but do not lower consumers' out-of-pocket costs will not address the main challenge facing most Americans.
February 2019: American Journal of Managed Care
https://read.qxmd.com/read/30759124/evaluating-the-quality-of-antihypertensive-drugs-in-lagos-state-nigeria
#3
Elizabeth Thithi Ndichu, Kelechi Ohiri, Oluwafemi Sekoni, Olasunmbo Makinde, Kevin Schulman
BACKGROUND: As the burden of noncommunicable diseases grows, access to safe medical therapy is increasing in importance. The aim of this study was to develop a method for evaluating the quality of antihypertensive drugs and to examine whether this prevalence varies by socioeconomic variables. METHODS: We conducted a cross-sectional survey of registered pharmacies in 6 local government areas (LGAs) in Lagos State, Nigeria. In each LGA, we sampled 17 pharmacies from a list of all registered pharmacies derived from the Pharmacists Council of Nigeria...
2019: PloS One
https://read.qxmd.com/read/30758237/economic-evaluation-of-sunitinib-versus-pazopanib-and-best-supportive-care-for-the-treatment-of-metastatic-renal-cell-carcinoma-in-chile-cost-effectiveness-analysis-and-a-mixed-treatment-comparison
#4
C Vargas, C Balmaceda, F Rodríguez, R Rojas, A Giglio, M A Espinoza
BACKGROUD: Sunitinib and Pazopanib are two metastatic renal cell carcinoma (MRCC) treatment alternatives, however the health system in Chile does not consider coverage for any. The cost-effectiveness versus relevant comparator was assessed to support evidence-based decision making. METHODS: A four health states Markov model was built: first, second line treatments, BSC and death. Benefits were measured in QALYs and efficacy estimates were obtained from an indirect treatment comparison...
February 13, 2019: Expert Review of Pharmacoeconomics & Outcomes Research
https://read.qxmd.com/read/30755505/nucleotide-resolution-comparison-of-transcription-of-human-cytomegalovirus-and-host-genomes-reveals-universal-use-of-rna-polymerase-ii-elongation-control-driven-by-dissimilar-core-promoter-elements
#5
Mrutyunjaya Parida, Kyle A Nilson, Ming Li, Christopher B Ball, Harrison A Fuchs, Christine K Lawson, Donal S Luse, Jeffery L Meier, David H Price
The large genome of human cytomegalovirus (HCMV) is transcribed by RNA polymerase II (Pol II). However, it is not known how closely this betaherpesvirus follows host transcriptional paradigms. We applied PRO-Seq and PRO-Cap methods to profile and quantify transcription initiation and productive elongation across the host and virus genomes in late infection. A major similarity between host transcription and viral transcription is that treatment of cells with the P-TEFb inhibitor flavopiridol preempts virtually all productive elongation, which otherwise covers most of the HCMV genome...
February 12, 2019: MBio
https://read.qxmd.com/read/30753786/investigational-drug-therapies-currently-in-early-stage-clinical-development-for-the-treatment-of-clostridioides-clostridium-difficile-infection
#6
Mai-Chi N Tran, Ravina Kullar, Ellie Jc Goldstein
Clostridioides (Clostridium) difficile Infection (CDI) is an urgent global threat causing ~500,000 infections annually in the United States of America (USA) and is associated with a 36% 30-day attributable mortality rate. Despite the availability of three therapeutic agents, CDI recurrence occurs in 20-40% of patients, with a 30-40% second recurrence rate in these patients. Consequently, there is a need for novel agents for treating CDI. Areas covered: We searched MEDLINE, PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and ClinicalTrials...
February 12, 2019: Expert Opinion on Investigational Drugs
https://read.qxmd.com/read/30742256/eribulin-for-treating-locally-advanced-or-metastatic-breast-cancer-after-one-chemotherapy-regimen-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#7
REVIEW
Nigel Fleeman, Adrian Bagust, Rui Duarte, Marty Richardson, Sarah Nevitt, Angela Boland, Eleanor Kotas, Joanne McEntee, Nicky Thorp
Eribulin is a recommended treatment option for locally advanced or metastatic breast cancer (LABC/MBC) in adults whose disease has progressed after at least two chemotherapy regimens. The National Institute for Health and Care Excellence (NICE) invited the manufacturer of eribulin (Halaven® ; Eisai Ltd) to submit evidence for the clinical and cost effectiveness of eribulin for treating LABC/MBC after one chemotherapy regimen in accordance with the institute's Single Technology Appraisal (STA) process. This article presents a summary of the company's evidence, Evidence Review Group (ERG) review and resulting NICE guidance (TA515), issued 28 March 2018...
February 11, 2019: PharmacoEconomics Open
https://read.qxmd.com/read/30738875/disease-modifying-therapies-continue-to-drive-up-health-care-cost-among-individuals-with-multiple-sclerosis
#8
Youngran Kim, Trudy Millard Krause, Philip Blum, Léorah Freeman
BACKGROUND: Multiple sclerosis (MS) is a leading cause of disability in adults and requires lifelong treatment. Specialty drugs referred to as disease-modifying therapies (DMTs) have become the standard for multiple sclerosis treatment since the 1990s as they have been shown to reduce the risk of relapses and to delay disease progression. While more DMTs became available, prices of DMTs including existing drugs continue to rise and remain very expensive. This study is to estimate recent drug costs for DMTs and examine its impact on overall health care costs among individuals with MS enrolled in commercial insurance...
February 5, 2019: Multiple Sclerosis and related Disorders
https://read.qxmd.com/read/30737062/cost-effectiveness-of-sequential-treatment-with-abaloparatide-vs-teriparatide-for-united-states-women-at-increased-risk-of-fracture
#9
Mickael Hiligsmann, Setareh A Williams, Lorraine A Fitzpatrick, Stuart S Silverman, Richard Weiss, Jean-Yves Reginster
OBJECTIVES: There is emerging evidence supporting sequential therapy with an osteoanabolic followed by an antiresorptive in patients at high-risk of fragility fractures. This study assessed the cost-effectiveness of sequential treatment with abaloparatide (ABL) followed by alendronate (ALN) [(ABL/ALN)] compared with teriparatide (TPTD) followed by ALN (TPTD/ALN). METHODS: A previously validated Markov microsimulation model was adapted to estimate the cost-effectiveness of sequential ABL/ALN compared with sequential TPTD/ALN and no treatment with a lifetime horizon from the US payer perspective...
January 10, 2019: Seminars in Arthritis and Rheumatism
https://read.qxmd.com/read/30725539/activities-of-the-pan-canadian-pharmaceutical-alliance-an-observational-analysis
#10
Angela Rocchi, Fergal Mills
BACKGROUND: The pan-Canadian Pharmaceutical Alliance (pCPA) was established in 2010 to negotiate confidential prices for drugs coming forward from Canada's centralized health technology assessment (HTA) agency reviews, on behalf of the participating public drug plans. OBJECTIVE:  To analyze the activities of the pCPA, to determine: alignment of HTA agency recommendations and pCPA negotiation decisions; the role of health economics in pCPA activities; and patterns of implicit prioritization...
August 7, 2018: Journal of Population Therapeutics and Clinical Pharmacology
https://read.qxmd.com/read/30724598/-health-insurance-pharmaceutical-expenditures-in-hungary
#11
Boglárka Eisingerné Balassa, Tímea Csákvári, István Ágoston
INTRODUCTION: In Hungary, health expenditures - especially the question of health insurance subsidies for medicinal products - are becoming increasingly important. AIM: The aim of our analysis is to reveal the state's health insurance expenditure between 2010 and 2016 as well as the amount of health insurance subsidies for medicinal products. DATA AND METHODS: Data were derived from the database of the National Health Insurance Fund of Hungary and of the Hungarian Central Statistical Office...
February 2019: Orvosi Hetilap
https://read.qxmd.com/read/30723727/prospective-observational-study-in-patients-with-obstructive-lung-disease-novelty-design
#12
Helen K Reddel, Maria Gerhardsson de Verdier, Alvar Agustí, Gary Anderson, Richard Beasley, Elisabeth H Bel, Christer Janson, Barry Make, Richard J Martin, Ian Pavord, David Price, Christina Keen, Asparuh Gardev, Stephen Rennard, Alecka Sveréus, Aruna T Bansal, Lance Brannman, Niklas Karlsson, Javier Nuevo, Fredrik Nyberg, Simon S Young, Jørgen Vestbo
Asthma and chronic obstructive pulmonary disease (COPD) have overlapping clinical features and share pathobiological mechanisms but are often considered distinct disorders. Prospective, observational studies across asthma, COPD and asthma-COPD overlap are limited. NOVELTY is a global, prospective observational 3-year study enrolling ∼12 000 patients ≥12 years of age from primary and specialist clinical practices in 19 countries (ClinicalTrials.gov identifier: NCT02760329). NOVELTY's primary objectives are to describe patient characteristics, treatment patterns and disease burden over time, and to identify phenotypes and molecular endotypes associated with differential outcomes over time in patients with a diagnosis/suspected diagnosis of asthma and/or COPD...
February 2019: ERJ Open Research
https://read.qxmd.com/read/30721382/hospitalization-period-and-direct-medical-cost-in-patients-using-warfarin-or-novel-oral-anti-coagulants-after-a-cerebral-embolism
#13
Tomohide Akase, Takanori Tsuchiya, Masami Morita
Background Warfarin has been used in Japan for a long time in patients after cerebral embolism to prevent recurrence. Recently, several novel oral anti-coagulants (NOACs) have been approved for use and are gradually replacing warfarin. However, it remains unclear whether warfarin and other NOACs differ from each other with respect to drug costs and length of stay (LOS) during treatment in Japan. Objective To assess differences in LOS and direct medical cost between patients after cerebral embolism treated with warfarin and those treated with NOACs...
February 5, 2019: International Journal of Clinical Pharmacy
https://read.qxmd.com/read/30716575/wastewater-based-epidemiology-in-beijing-china-prevalence-of-antibiotic-use-in-flu-season-and-association-of-pharmaceuticals-and-personal-care-products-with-socioeconomic-characteristics
#14
Yizhe Zhang, Lei Duan, Bin Wang, Yulin Du, Giovanni Cagnetta, Jun Huang, Lee Blaney, Gang Yu
Wastewater-based epidemiology is an emerging field that has mostly been applied to investigate consumption of illicit drugs. In this study, the wastewater-based epidemiology approach was employed to study consumption of pharmaceuticals and personal care products (PPCPs) and measure their prevalence of use in eight densely populated, urban areas of Beijing, China. Ammonium loads were used to estimate the population equivalents of each sewershed. These estimates were applied to calculate population-normalized antibiotic consumption and prevalence of use during flu season, when antibiotics are frequently misused as a medical treatment...
February 1, 2019: Environment International
https://read.qxmd.com/read/30715973/trends-in-coverage-for-disease-modifying-therapies-for-multiple-sclerosis-in-medicare-part-d
#15
Daniel M Hartung, Kirbee A Johnston, Adriane Irwin, Sheila Markwardt, Dennis N Bourdette
The high cost of multiple sclerosis (MS) disease-modifying therapies can negatively affect access for patients through increased payer restrictions and higher out-of-pocket spending. Our objective was to describe changes in pharmacy benefit coverage and cost-sharing amounts for MS disease-modifying therapies in the Medicare Part D program, using enrollment-weighted Prescription Drug Plan Formulary files for the period 2007-16. Among therapies available throughout the study period, the rate of prior authorization use increased from 61-66 percent of plans to 84-90 percent...
February 2019: Health Affairs
https://read.qxmd.com/read/30711576/luxturna-fda-documents-reveal-the-value-of-a-costly-gene-therapy
#16
Jonathan J Darrow
In 2017, the US Food and Drug Administration (FDA) approved voretigene neparvovec-rzyl (Luxturna), a gene therapy used to treat a rare form of inherited blindness. Widely described as a curative treatment that 'restores vision', it was priced at US$850 000. Although voretigene neparvovec-rzyl represents a substantial therapeutic advance, most reports have failed to adequately describe study outcomes as documented by FDA reviewers. These documents reveal that the drug is not expected to restore normal vision, that only about half of treated patients met the FDA's threshold for minimally meaningful improvement, that improvements might not persist, that the original endpoint was abandoned after yielding mixed results, and that two patients experienced permanent vision loss...
January 31, 2019: Drug Discovery Today
https://read.qxmd.com/read/30711247/usefulness-of-ezetimibe-versus-evolocumab-as-add-on-therapy-for-secondary-prevention-of-cardiovascular-events-in-patients-with-type-2-diabetes-mellitus
#17
Ronen Arbel, Ariel Hammerman, Joseph Azuri
Evolocumab and ezetimibe, were both proven to significantly reduce the incidence of major adverse cardiovascular events (MACE), in type 2 diabetes patients with atherosclerotic cardiovascular disease and low-density lipoprotein (LDL) cholesterol >70 mg/dl despite statin therapy. Providing evolocumab for all such patients may be a significant burden on healthcare systems. Therefore, we analyzed the treatment cost of ezetimibe versus evolocumab to prevent 1 MACE. We extracted the number needed to treat (NNT) with evolocumab or with ezetimibe for avoiding MACE from the published FOURIER and IMPROVE-IT trials respectively...
January 23, 2019: American Journal of Cardiology
https://read.qxmd.com/read/30711118/-the-700-dollar-vitamin-the-epidemic-of-synthetic-cannabinoid-associated-coagulopathy-a-case-study-of-excessive-generic-drug-prices-in-the-american-health-care-system
#18
Satish Shanbhag, Kathryn E Dane, Michael B Streiff
No abstract text is available yet for this article.
February 2019: Mayo Clinic Proceedings
https://read.qxmd.com/read/30711067/was-it-worth-introducing-health-economic-evaluation-of-innovative-drugs-in-the-french-regulatory-setting-the-case-of-new-hepatitis-c-drugs
#19
Valérie Clément, Véronique Raimond
OBJECTIVE: This paper constitutes the first attempt to draw lessons from the recent uptake of health economic evaluation of innovative drugs in the French regulatory framework. STUDY DESIGN: Taking the example of new direct-acting antivirals against hepatitis C virus, the paper asks whether and how the cost-effectiveness (CE) opinions issued by the French National Health Authority improve the information available to support the pricing decisions. METHODS: The analysis compares the assessment of these drugs based on three different sources: CE opinions, clinical opinions, and the published cost-utility analyses (CUA) available in the literature and identified through a systematic review...
February 2019: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://read.qxmd.com/read/30711060/cost-utility-of-voretigene-neparvovec-for-biallelic-rpe65-mediated-inherited-retinal-disease
#20
Marita Zimmermann, Solomon J Lubinga, Reiner Banken, David Rind, Geri Cramer, Patricia G Synnott, Richard H Chapman, Sonya Khan, Josh Carlson
OBJECTIVE: The gene therapy voretigene neparvovec (VN) is the first Food and Drug Administration-approved treatment for vision loss owing to the ultra-rare RPE65-mediated inherited retinal disorders. We modeled the cost-utility of VN compared with standard of care (SoC). STUDY DESIGN: A 2-state Markov model, alive and dead, with a lifetime horizon. METHODS: Visual acuity (VA) and visual field (VF) were tracked to model quality-adjusted life-years (QALYs)...
February 2019: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
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