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Generic drug pricing

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https://www.readbyqxmd.com/read/29122813/american-heart-association-principles-on-the-accessibility-and-affordability-of-drugs-and-biologics-a-presidential-advisory-from-the-american-heart-association
#1
REVIEW
Elliott M Antman, Mark A Creager, Steven R Houser, John J Warner, Madeleine Konig
Net US spending on pharmaceuticals reached $309.5 billion in 2015, an 8.5% increase from the year before, and is expected to reach between $370 and $400 billion by 2020. These current and projected levels have raised serious concerns by policy makers, providers, payers, and patient groups that they are unsustainable and threaten the affordability of and accessibility to much-needed therapies for patients. Two trends related to drugs/biologics and generic drugs/biosimilars underlie this overall increase in spending...
November 9, 2017: Circulation
https://www.readbyqxmd.com/read/29120716/cost-comparison-of-commonly-used%C3%A2-postoperative-topical-ophthalmic%C3%A2-antibiotics
#2
Eric L Crowell, Vivek A Koduri, R Scott Groat, David A Lee
PURPOSE: To provide information on the actual fill level and cost of currently available antibiotic drops used perioperatively. DESIGN: Prospective laboratory investigation. SETTING: Robert Cizik Eye Clinic, Houston, Texas USA. METHODS: The following 9 medications were tested: moxifloxacin, gatifloxacin (branded and generic), besifloxacin, levofloxacin, ciprofloxacin, ofloxacin, trimethoprim/polymyxin B, tobramycin, and gentamicin...
October 2017: Journal of Cataract and Refractive Surgery
https://www.readbyqxmd.com/read/29092825/msf-pushes-down-price-of-generic-hepatitis-c-drugs-to-new-low-level
#3
Jacqui Wise
No abstract text is available yet for this article.
November 1, 2017: BMJ: British Medical Journal
https://www.readbyqxmd.com/read/29073983/drug-policy-in-poland
#4
Karina Jahnz-Różyk, Pawel Kawalec, Krzysztof Malinowski, Katarzyna Czok
We presented a general overview of the health care system as well as the pricing and reimbursement environment in Poland. Poland aims to ensure proper access to safe and effective medicines while reducing patients' share in treatment costs. Nevertheless, the co-payment for pharmacotherapy is still high (more than 60%). The key policymaker and regulator in the system is the Ministry of Health, which is supported by the Polish Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji), responsible for evaluating applicant drugs, and the Economic Commission, responsible for negotiating the official sales prices and conditions for reimbursement with pharmaceutical companies (e...
September 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29073981/applying-multi-criteria-decision-analysis-mcda-simple-scoring-as-an-evidence-based-hta-methodology-for-evaluating-off-patent-pharmaceuticals-opps-in-emerging-markets
#5
Diana Brixner, Nikos Maniadakis, Zoltán Kaló, Shanlian Hu, Jie Shen, Kalman Wijaya
Off-patent pharmaceuticals (OPPs) represent more than 60% of the pharmaceutical market in many emerging countries, where they are frequently evaluated primarily on cost rather than with health technology assessment. OPPs are assumed to be identical to the originators. Branded and unbranded generic versions can, however, vary from the originator in active pharmaceutical ingredients, dosage, consistency formulation, excipients, manufacturing processes, and distribution, for example. These variables can alter the efficacy and safety of the product, negatively impacting both the anticipated cost savings and the population's health...
September 2017: Value in Health Regional Issues
https://www.readbyqxmd.com/read/29057086/interprep-internet-based-pre-exposure-prophylaxis-with-generic-tenofovir-df-emtricitabine-in-london-an-analysis-of-outcomes-in-641-patients
#6
EDITORIAL
Isaac Aloysius, Anna Savage, Jey Zdravkov, Roxanna Korologou-Linden, Andrew Hill, Rachel Smith, Vicky Houghton-Price, Marta Boffito, Nneka Nwokolo
INTRODUCTION: HIV pre-exposure prophylaxis (PrEP) is not available on the National Health Service (NHS) in England. People are buying generic versions of tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) on the internet, which is legal under UK import laws. METHODS: HIV-negative individuals attending our clinic who reported purchasing generic PrEP online were provided with risk-reduction advice and were evaluated for HIV, hepatitis B and C, renal function and sexually transmitted infections (STIs)on their first visit...
October 1, 2017: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29057082/high-sustained-virological-response-rates-using-imported-generic-direct-acting-antiviral-treatment-for-hepatitis-c
#7
EDITORIAL
Andrew Hill, Giten Khwairakpam, James Wang, Sergey Golovin, Julia Dragunova, Rachel Smith, Vicky Houghton-Price, Roxanna Korologou-Linden, Sanjay Nath, Anna Savage, Greg Jefferys
BACKGROUND: High prices of direct acting antivirals (DAAs) for hepatitis C virus (HCV) can lead to restrictions on access to treatment in high- and middle-income countries. An increasing number of people in these countries are treating their HCV infection with generic drugs produced in India, China, Bangladesh or Egypt. This analysis assessed the efficacy of generic imported DAAs. METHODS: Patients sourced generic versions of sofosbuvir (SOF), ledipasvir (LDV) and daclatasvir (DCV) from suppliers in India, Bangladesh, China and Egypt via three buyers' clubs...
October 1, 2017: Journal of Virus Eradication
https://www.readbyqxmd.com/read/29033595/drug-tendering-drug-supply-and-shortage-implications-for-the-uptake-of-biosimilars
#8
REVIEW
George Dranitsaris, Ira Jacobs, Carol Kirchhoff, Robert Popovian, Lesley G Shane
Due to the continued increase in global spending on health care, payers have introduced a number of programs, policies, and agreements on pharmaceutical pricing in order to control costs. While incentives to increase generic drug use have achieved significant savings, other cost-containment measures are required. Tendering is a formal procedure to purchase medications using competitive bidding for a particular contract. Although useful for cost containment, tendering can lead to decreased competition in a given market...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/29028656/costs-and-benefits-of-on-demand-hiv-pre-exposure-prophylaxis-in-men-who-have-sex-with-men-analysis-of-the-anrs-ipergay-study-with-a-one-year-follow-up
#9
Isabelle Durand-Zaleski, Pierre Mutuon, Isabelle Charreau, Cecile Tremblay, Daniela Rojas, Gilles Pialoux, Christian Chidiac, Catherine Capitant, Bruno Spire, Laurent Cotte, Julie Chas, Laurence Meyer
OBJECTIVES: We undertook the economic evaluation of the double-blind randomized ANRS-IPERGAY trial which showed the efficacy of on-demand pre-exposure prophylaxis (PrEP) with tenofovir-disoproxil-fumarate (TDF-FTC) in preventing HIV infection among high risk men-who have-sex-with-men (MSM). DESIGN & METHODS: The economic evaluation was prospective. Counseling, drugs (TDF-FTC at &OV0556;500.88 for 30 tablets), tests, visits and hospital admissions were valued based on in-trial use...
October 12, 2017: AIDS
https://www.readbyqxmd.com/read/29020146/trends-in-pricing-and-generic-competition-within-the-oral-antibiotic-drug-market-in-the-united-states
#10
Jonathan D Alpern, Lei Zhang, William M Stauffer, Aaron S Kesselheim
Background: In recent years, many older, generic drugs have increased substantially in price, including numerous antibiotics. We sought to analyze recent price changes and extent of generic competition within a cohort of commonly prescribed off-patent oral antibiotics. Methods: We extracted oral antibiotics recommended for common outpatient conditions within the Infectious Disease Society of America Practice Guidelines. We determined all Food and Drug Administration (FDA)-approved manufacturers for each formulation and strength in 2013 and 2016, and the yearly National Average Drug Acquisition Cost (NADAC) price between 2013 to 2016...
July 23, 2017: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
https://www.readbyqxmd.com/read/28975217/strategies-that-delay-market-entry-of-generic-drugs
#11
Kerstin Noëlle Vokinger, Aaron S Kesselheim, Jerry Avorn, Ameet Sarpatwari
Increasing prescription drug expenditures in the United States are primarily driven by high brand-name drug prices. Although generic competition helps lower drug prices, manufacturers of brand-name drugs often work to delay the availability of generic versions of their products. Strategies to forestall generic competition include patenting peripheral aspects of a drug or modified formulations that do not add clinical value, paying generic manufacturers to settle lawsuits challenging the validity of patents on brand-name drugs ("reverse payment" settlements), denying generic manufacturers access to drug samples necessary for bioequivalence testing, misusing risk evaluation and mitigation strategies, and filing citizen petitions with the US Food and Drug Administration (FDA)...
November 1, 2017: JAMA Internal Medicine
https://www.readbyqxmd.com/read/28964941/tiered-co-payments-pricing-and-demand-in-reference-price-markets-for-pharmaceuticals
#12
Annika Herr, Moritz Suppliet
Health insurance companies curb price-insensitive behavior and the moral hazard of insureds by means of cost-sharing, such as tiered co-payments or reference pricing in drug markets. This paper evaluates the effect of price limits - below which drugs are exempt from co-payments - on prices and on demand. First, using a difference-in-differences estimation strategy, we find that the new policy decreases prices by 5 percent for generics and increases prices by 4 percent for brand-name drugs in the German reference price market...
September 15, 2017: Journal of Health Economics
https://www.readbyqxmd.com/read/28957849/substandard-drugs-among-five-common-antihypertensive-generic-medications-an-analysis-from-10-african-countries
#13
Diane Macquart de Terline, Bara I Diop, Melisande Bernard, Bernard Do, Méo S Ikama, Roland N'guetta, Dadhi M Balde, Yessoufou Tchabi, Abdallahi Sidi Aly, Ibrahim Ali Toure, Patrick Zabsonre, Jean-Marc F Damorou, Jean-Laurent Takombe, Kumar Narayanan, Christine Fernandez, Muriel Tafflet, Pierre-François Plouin, Jean-Philippe Empana, Eloi Marijon, Xavier Jouven, Marie Antignac
OBJECTIVE: Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality...
September 27, 2017: Journal of Hypertension
https://www.readbyqxmd.com/read/28949401/kronisk-myeloisk-leukemi-f%C3%A3-rebild-f%C3%A3-r-m%C3%A3-lstyrd-terapi-revolutionerande-%C3%A3-verlevnadsvinster-med-definitiv-bot-i-sikte-och-kraftigt-f%C3%A3-rb%C3%A3-ttrad-h%C3%A3-lsoekonomi
#14
Johan Richter, Leif Stenke
Chronic myeloid leukemia - a model disease for targeted therapy Chronic myeloid leukemia (CML) pioneered as the first human malignancy linked to a specific cytogenetic aberration (the Philadelphia chromosome), which led the way to specific targeted therapies with imatinib (Glivec) and later tyrosine kinase inhibitors (TKI). Continuous TKI administration, blocking the oncogenic fusion protein Bcr-Abl, has revolutionized the outcome of CML, transforming an almost uniformly deadly disease into a chronic disorder with a near to normal life expectancy for many patients...
September 21, 2017: Läkartidningen
https://www.readbyqxmd.com/read/28929048/brand-versus-generic-dispensing-trend-for-ciprofloxacin-500-mg-levofloxacin-500-mg-and-moxifloxacin-400-mg-oral-dosage-forms-among-pharmacies-of-karachi-pakistan
#15
Fatima Zehra, Atta Abbas Naqvi, Sumbul Tasneem, Rizwan Ahmad, Niyaz Ahmad, Adnan Zia Shamsi, Naqiya Ali Asghar, Ghufran Ullah Khan
INTRODUCTION: Pakistan spends 0.7% of its gross domestic product on health. The public sector health-care system provides services to 22% of population thus paving the way for a dominant private sector. Patients in Pakistan mostly pay their medical expenses directly, and 64% of the health expenditures are borne by the household. Expenditure on medicine constitutes 43% of the total household expenditure. METHODS: A quantitative cross-sectional study was conducted in Karachi, Pakistan, for a month...
April 2017: International Journal of Pharmaceutical Investigation
https://www.readbyqxmd.com/read/28926562/generics-for-the-treatment-of-hepatitis-c-in-monoinfected-and-hiv-coinfected-patients-pros-and-cons
#16
Dario Cattaneo, Alessandro Fossati, Chiara Resnati, Massimo Galli, Cristina Gervasoni
The treatment of hepatitis C virus in monoinfected and HIV-coinfected patients has greatly changed over recent years as a result of the introduction of direct-acting antiviral agents (DAAs), which have revolutionized clinical outcomes and led to sustained virological response rates above 90-95%. The discovery of new molecules and the subsequent competition between pharmaceutical companies, together with the negotiated price policies pursued by many national health systems, have led to a gradual reduction in the cost of DAAs, and expand their use to an increasing number of patients, including those with mild liver damage...
September 19, 2017: AIDS Reviews
https://www.readbyqxmd.com/read/28895827/after-a-big-entrance-it-s-just-so-so-for-entresto
#17
Thomas Reinke
Some industry observers wonder why the wunderkind hasn't done more wonderfully on the market. As a brand name drug, Entresto costs substantially more than the generic ACE inhibitors and ARBs. GoodRx reports the average cash price for uninsured patients for Entresto is $504 per month, compared with $44 for enalapril.
July 2017: Managed Care
https://www.readbyqxmd.com/read/28895814/scott-gottlieb-believes-a-nimbler-speedier-fda-can-spur-competition-lower-prices
#18
Joseph Burns
The new head of the FDA might as well be starring alongside Tom Cruise in the latest installment of Mission Impossible. Since being named commissioner in May, Gottlieb has said he wants the FDA to speed the approval process for generic drugs, introduce competition to drive down prices, and get the opioid crisis under control.
August 2017: Managed Care
https://www.readbyqxmd.com/read/28895227/comparing-generic-drug-markets-in-europe-and-the-united-states-prices-volumes-and-spending
#19
COMPARATIVE STUDY
Olivier J Wouters, Panos G Kanavos, Martin McKEE
Policy Points: Our study indicates that there are opportunities for cost savings in generic drug markets in Europe and the United States. Regulators should make it easier for generic drugs to reach the market. Regulators and payers should apply measures to stimulate price competition among generic drugmakers and to increase generic drug use. To meaningfully evaluate policy options, it is important to analyze historical context and understand why similar initiatives failed previously. CONTEXT: Rising drug prices are putting pressure on health care budgets...
September 2017: Milbank Quarterly
https://www.readbyqxmd.com/read/28892528/determinants-of-market-exclusivity-for-prescription-drugs-in-the-united-states
#20
REVIEW
Aaron S Kesselheim, Michael S Sinha, Jerry Avorn
The high prices of brand-name prescription drugs are a growing source of controversy in the United States. Manufacturers of brand-name drugs can command high prices because they are protected from generic competition by two types of government-granted monopoly rights. The first are patents on the drugs that generally define the basic period of brand-name-only sales. The second is awarded at the time of US Food and Drug Administration (FDA) approval and usually defines the minimum time until a generic can be sold...
November 1, 2017: JAMA Internal Medicine
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