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Generic drug pricing

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https://www.readbyqxmd.com/read/29769386/global-acceptance-of-biosimilars-importance-of-regulatory-consistency-education-and-trust
#1
REVIEW
Eduardo Cazap, Ira Jacobs, Ali McBride, Robert Popovian, Karol Sikora
Globally, biosimilars are expected to have a key role in improving patient access to biological therapies and addressing concerns regarding the escalating cost of health care. Indeed, in Europe, increased use of biologics and reduced drug prices have been observed after the introduction of biosimilars. Recently, several monoclonal antibody biosimilars of anticancer therapies have been approved, and numerous others are in various stages of clinical development. Biosimilars are authorized via a regulatory pathway separate from that used for generic drugs; they are also regulated separately from novel biologics...
May 16, 2018: Oncologist
https://www.readbyqxmd.com/read/29753369/biosimilars-for-immune-mediated-chronic-diseases-in-primary-care-what-a-practicing-physician-needs-to-know
#2
REVIEW
Steven R Feldman, Jerry Bagel, Shahla Namak
The introduction of biologics has revolutionized the treatment of immune-mediated diseases, but high cost and limited patient access remain hurdles, and some physicians are concerned that biosimilars are not similar enough. The purpose of this narrative review is to describe biosimilar safety, efficacy, nomenclature, extrapolation and interchangeability. In the United States, the Biologics Price Competition and Innovation Act created an abbreviated pathway for licensing of a biologic that is biosimilar to another licensed product (i...
May 2018: American Journal of the Medical Sciences
https://www.readbyqxmd.com/read/29743945/evidence-on-the-cost-of-breast-cancer-drugs-is-required-for-rational-decision-making
#3
Anne Margreet Sofie Berghuis, Hendrik Koffijberg, Leonardus Wendelinus Mathias Marie Terstappen, Stefan Sleijfer, Maarten Joost IJzerman
Background: For rational decision making, assessing the cost-effectiveness and budget impact of new drugs and comparing the costs of drugs already on the market is required. In addition to value frameworks, such as the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology-Magnitude of Clinical benefit Scale, this also requires a transparent overview of actual drug prices. While list prices are available, evidence on treatment cost is not. This paper aims to synthesise evidence on the reimbursement and costs of high-cost breast cancer drugs in The Netherlands (NL)...
2018: Ecancermedicalscience
https://www.readbyqxmd.com/read/29733710/generic-price-competition-for-specialty-drugs-too-little-too-late
#4
Ashley L Cole, Stacie B Dusetzina
The case of generic imatinib demonstrates several potential barriers to effective generic price competition for specialty prescription drugs, including fewer market entrants, smaller-than-expected price reductions, shifts in prescribing toward more expensive brand-name treatments, and limited uptake of the generic product.
May 2018: Health Affairs
https://www.readbyqxmd.com/read/29681174/-the-patients-cost-of-the-montelukast-therapy-due-to-the-generic-substitution
#5
Balázs Répásy, Dóra Endrei, Antal Zemplényi, István Ágoston, Imre Boncz
INTRODUCTION AND AIM: The aim of our study was to analyse the public price of the montelukast sodium therapy in Hungary. METHOD: Data derived from the nationwide pharmaceutical database of the Hungarian National Health Insurance Fund Administration. We observed the turnover and price of the medicaments containing the active substance montelukast sodium from 2007 to 2015. Accordingly, our indicators were: consumer price, DCT (daily cost of therapy), co-payment, quasi co-payment, DOT (days of treatment)...
April 2018: Orvosi Hetilap
https://www.readbyqxmd.com/read/29678413/patient-access-to-medicines-in-two-countries-with-similar-health-systems-and-differing-medicines-policies-implications-from-a-comprehensive-literature-review
#6
REVIEW
Zaheer-Ud-Din Babar, Todd Gammie, Ali Seyfoddin, Syed Shahzad Hasan, Louise E Curley
BACKGROUND: Countries with similar health systems but different medicines policies might result in substantial medicines usage differences and resultant outcomes. The literature is sparse in this area. OBJECTIVE: To review pharmaceutical policy research in New Zealand and Australia and discuss differences between the two countries and the impact these differences may have on subsequent medicine access. METHODS: A review of the literature (2008-2016) was performed to identify relevant, peer-reviewed articles...
April 13, 2018: Research in Social & Administrative Pharmacy: RSAP
https://www.readbyqxmd.com/read/29668215/limited-distribution-networks-stifle-competition-in-the-generic-and-biosimilar-drug-industries
#7
Laura Karas, Kenneth M Shermock, Celia Proctor, Mariana Socal, Gerard F Anderson
A limited distribution network (LDN) restricts the distribution channel for a pharmaceutical drug to 1 or a very small number of distributors. This strategy may allow for more effective allocation of drugs in shortage and is purported to help ensure the safe distribution of high-risk drugs to small patient populations. However, in recent years, some drug companies, including Turing Pharmaceuticals, have used LDNs to prevent generic and biosimilar companies from accessing samples of drug products necessary to perform testing required by the FDA for generic and biosimilar drug applications...
April 1, 2018: American Journal of Managed Care
https://www.readbyqxmd.com/read/29665719/hyperinflation-of-isoproterenol
#8
Julie D'Ambrosi, Nilesh Amin
The hyperinflation of isoproterenol, a 75-year-old drug, in early 2015 was unbelievable. The attention of health-care professionals, health system administrators, legislators, and the general public was quickly focused on Valeant Pharmaceuticals, purchaser of several generics solely to raise their price. With isoproterenol easily launched toward the top of drug expenditures, pharmacists in many hospitals were forced to engage stakeholders in the investigation and implementation of alternatives, explore utilization and optimize inventory, reduce cost through sterile product preparation, where possible, restrict use to settings that were beneficial to their budget, and become legislative advocates...
January 1, 2018: Journal of Pharmacy Practice
https://www.readbyqxmd.com/read/29622941/frustration-over-generic-drug-shortages-and-prices-prompts-federal-and-private-actions-health-systems-take-matters-into-their-own-hands
#9
Stephen Barlas
Generic shortages are draining hospital resources throughout the U.S. and in some cases imperiling inpatient treatment. The author considers the FDA's performance and describes the approach some health systems are taking to create a solution.
April 2018: P & T: a Peer-reviewed Journal for Formulary Management
https://www.readbyqxmd.com/read/29599406/cost-the-focus-of-cancer-panel-report
#10
(no author information available yet)
The President's Cancer Panel issued recommendations aimed at promoting value, affordability, and innovation in cancer drugs. The recommendations include increasing NIH funding, encouraging the development of generic and biosimilar drugs, and instituting value-based pricing policies to encourage the development of cost-effective drugs.
March 29, 2018: Cancer Discovery
https://www.readbyqxmd.com/read/29564146/the-adoption-of-generic-drugs-by-a-hospital-effects-on-drug-dispensation-among-community-pharmacies
#11
Tomoya Tachi, Kosuke Saito, Hiroki Esaki, Ikuto Sugita, Aki Yoshida, Yuta Kanematsu, Yoshihiro Noguchi, Michi Umeda, Masahiro Yasuda, Takashi Mizui, Teruo Tsuchiya, Chitoshi Goto, Hitomi Teramachi
Background: The objective of the current study is to elucidate the effect that the adoption of generic drugs by a large hospital has on the dispensation of generic drugs by community pharmacies. We evaluated the percentage of generic drugs dispensed by pharmacies and the cost of drugs dispensed before and after the adoption of generic drugs by a large hospital. Methods: Participants comprised patients who were admitted to Gifu Municipal Hospital prior to its adoption of generic drugs (November 1, 2013 to November 14, 2013) and after its adoption (November 1, 2014 to November 14, 2014) and who utilized generic drugs dispensed by pharmacies...
2018: Journal of Pharmaceutical Health Care and Sciences
https://www.readbyqxmd.com/read/29555641/affordability-and-availability-of-off-patent-drugs-in-the-united-states-the-case-for-importing-from-abroad-observational-study
#12
Ravi Gupta, Thomas J Bollyky, Matthew Cohen, Joseph S Ross, Aaron S Kesselheim
OBJECTIVES: To evaluate whether off-patent prescription drugs at risk of sudden price increases or shortages in the United States are available from independent manufacturers approved in other well regulated settings around the world. DESIGN: Observational study. SETTING: Off-patent drugs in the USA and approved by the Food and Drug Administration, up to 10 April 2017. STUDY COHORT: Novel tablet or capsule prescription drugs approved by the FDA since 1939 that were no longer protected by patents or other market exclusivity and had up to three generic versions...
March 19, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29444870/canada-makes-deal-to-reduce-generic-drug-prices
#13
Owen Dyer
No abstract text is available yet for this article.
February 14, 2018: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29439078/new-mechanism-to-identify-cost-savings-in-english-nhs-prescribing-minimising-price-per-unit-a-cross-sectional-study
#14
Richard Croker, Alex J Walker, Seb Bacon, Helen J Curtis, Lisa French, Ben Goldacre
BACKGROUND: Minimising prescription costs while maintaining quality is a core element of delivering high-value healthcare. There are various strategies to achieve savings, but almost no research to date on determining the most effective approach. We describe a new method of identifying potential savings due to large national variations in drug cost, including variation in generic drug cost, and compare these with potential savings from an established method (generic prescribing). METHODS: We used English National Health Service (NHS) Digital prescribing data, from October 2015 to September 2016...
February 8, 2018: BMJ Open
https://www.readbyqxmd.com/read/29398158/utilization-and-costs-of-hiv-antiretroviral-drugs-in-europe-during-the-last-ten-years-impact-of-generic-antiretroviral-drugs-on-cost-reduction
#15
Joseph Rwagitinywa, Agnès Sommet, Aurore Palmaro, Jean-Louis Montastruc, Maryse Lapeyre-Mestre
INTRODUCTION: Simulation studies showed that generic antiretroviral (ARV) drug utilization could lead to significant cost reduction of HIV treatment in developed world. This study aimed to quantify ARV utilization and costs in European countries between 2006 and 2015. We also assessed the impact of generic ARV drug utilization on cost reduction in real-life. METHODS: ARV drug utilization in 14 European countries (France, Italy, Germany, Denmark, Netherlands, Norway, Sweden, Finland, Iceland, Croatia, Czech Republic, Estonia, Latvia, and Lithuania) were analysed using defined daily dose (DDD)/1000 inhabitants/year...
March 2018: Health Policy
https://www.readbyqxmd.com/read/29384848/economic-evaluation-of-weekends-off-antiretroviral-therapy-for-young-people-in-11-countries
#16
RANDOMIZED CONTROLLED TRIAL
Luis Enrique Tierrablanca, Jessica Ochalek, Deborah Ford, Ab Babiker, Diana Gibb, Karina Butler, Anna Turkova, Susan Griffin, Paul Revill
OBJECTIVES: To analyze the cost effectiveness of short-cycle therapy (SCT), where patients take antiretroviral (ARV) drugs 5 consecutive days a week and have 2 days off, as an alternative to continuous ARV therapy for young people infected with human immunodeficiency virus (HIV) and taking efavirenz-based first-line ARV drugs. METHODS: We conduct a hierarchical cost-effectiveness analysis based on data on clinical outcomes and resource use from the BREATHER trial...
February 2018: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29383440/-revised-version-of-the-statement-by-the-dgrh-on-biosimilars-update-2017
#17
J Braun, H M Lorenz, U Müller-Ladner, M Schneider, H Schulze-Koops, Ch Specker, A Strangfeld, U Wagner, T Dörner
The treatment of rheumatic diseases with bioloics has significantly improved the prognosis of patients. Currently, there are 13 preparations available in Germany for the treatment of patients with inflammatory rheumatic diseases. These original preparations generally have-depending on the individual country-15 years of patent protection. As soon as the patent has expired, approved biosimilars can be brought into use. For the approval of a biosimilar, authorities such as the European Medical Agency or the American Food and Drug Administration require proof of the best possible comparability with respect to efficacy and safety in comparison to the original or reference product...
February 2018: Zeitschrift Für Rheumatologie
https://www.readbyqxmd.com/read/29380058/patients-and-hematologists-concerns-regarding-tyrosine-kinase-inhibitor-therapy-in-chronic-myeloid-leukemia
#18
Qian Jiang, Lu Yu, Robert Peter Gale
PURPOSE: To explore patients' and hematologists' concerns regarding tyrosine kinaseinhibitor (TKI)-therapy and identify variables associated these concerns. Methods A cross-sectional questionnaire including 16 common issues related to TKI-therapy was distributed to adults with chronic myeloid leukemia (CML) receiving TKIs and hematologists treating CML patients and answered anonymously. RESULTS: Data from 1518 patient respondents receiving TKI-therapy ≥ 3 months were analyzed...
April 2018: Journal of Cancer Research and Clinical Oncology
https://www.readbyqxmd.com/read/29315859/medical-and-economic-factors-influencing-generic-drug-use-in-the-japanese-public-health-system-influencing-factors-in-different-populations
#19
Tomoya Tachi, Kosuke Saito, Hiroki Esaki, Yuta Kanematsu, Aki Yoshida, Ikuto Sugita, Yoshihiro Noguchi, Teppei Makino, Michi Umeda, Masahiro Yasuda, Takashi Mizui, Chitoshi Goto, Hitomi Teramachi
Factors influencing generic drug use must be considered when new drug policies are established and initiatives are implemented to promote generic drug use. This study was conducted to elucidate medical and economic factors that influence generic drug use in the Japanese public health system by evaluating the degree of generic drug use via a multivariate analysis. We conducted a retrospective study of medications administered to inpatients at Gifu Municipal Hospital (Japan) from November 1 to 14, 2014. Details of inpatients (age, sex, and type of medical insurance) and the drugs administered (prescribing institution, dispensing pharmacy, price, and class) were assessed...
January 8, 2018: International Journal of Health Planning and Management
https://www.readbyqxmd.com/read/29236427/sharing-samples-and-generics-an-antitrust-framework
#20
Michael A Carrier
Rising drug prices are in the news. By increasing price, drug companies have placed vital, even life-saving, medicines out of the reach of consumers. In a recent development, brand firms have prevented generics even from entering the market. The ruse for this strategy involves risk-management programs known as Risk Evaluation and Mitigation Strategies ("REMS"). Pursuant to legislation enacted in 2007, the FDA requires REMS when a drug's risks (such as death or injury) outweigh its rewards. Brands have used this regime, intended to bring drugs to the market, to block generic competition...
2017: Cornell Law Review
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