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7.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 685-692, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31847613

RESUMO

Introduction: Governments need to do far more to help curb the emergence and transmission of antibiotic resistance and help protect the efficacy of any new antibiotics that come to the market. Industry is an important stakeholder that must be brought on-board such efforts given its influence on the direction and scale of antibiotic sales. Financial incentives supporting industry R&D of novel antibiotics should structurally remove the drivers of superfluous sales and encourage access to newer antibiotics where infections are otherwise resistant to treatment. Indeed, the use of public money provides an important opportunity to prioritize these public health goals within market structures such that we both adequately reward industry for their efforts and prolong antibiotic efficacy for as long as possible.Areas covered: This work discusses possible financial 'pull' incentives that fully delink the reward paid to the developer from unit sales, examining their primary advantages and limitations.Expert opinion: Pharmaceutical companies need to be rewarded generously for their efforts to develop new, badly needed antibiotics. But the current marketplace does not provide a sustained financial lure and its reliance on unit-sales for profitability jeopardizes the efficacy of antibiotics both new and old. Fully delinked models can make antibiotic R&D more financially appealing and create a market environment that is far less threatening to public health.


Assuntos
Antibacterianos/farmacologia , Indústria Farmacêutica/economia , Farmacorresistência Bacteriana , Antibacterianos/economia , Comércio/economia , Desenvolvimento de Medicamentos/economia , Humanos , Saúde Pública/economia , Apoio à Pesquisa como Assunto/economia
8.
Nature ; 575(7781): 119-129, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31695203

RESUMO

Vaccination against infectious diseases has changed the future of the human species, saving millions of lives every year, both children and adults, and providing major benefits to society as a whole. Here we show, however, that national and sub-national coverage of vaccination varies greatly and major unmet needs persist. Although scientific progress opens exciting perspectives in terms of new vaccines, the pathway from discovery to sustainable implementation can be long and difficult, from the financing, development and licensing to programme implementation and public acceptance. Immunization is one of the best investments in health and should remain a priority for research, industry, public health and society.


Assuntos
Desenvolvimento de Medicamentos/economia , Vacinação/tendências , Vacinas/imunologia , Vacinas/provisão & distribução , Animais , Humanos , Mortalidade , Filipinas/epidemiologia , Mudança Social , Vacinação/economia , Vacinas/economia
9.
Respir Res ; 20(1): 173, 2019 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-31375102

RESUMO

Despite the availability of treatment guidelines and inhaled medications for asthma and chronic obstructive pulmonary disease (COPD), much remains to be done to lessen the burden of these respiratory diseases for patients. The challenge of selecting effective and efficacious drugs for patients is a key focus area for healthcare professionals. Here we discuss the concept of "drivers of effectiveness"- features of a medicine which may increase or decrease its effectiveness in the presence of real-world factors - and highlight the importance of considering these drivers in the early stages of drug development, and exploring their impact in carefully designed pragmatic trials. Using the Salford Lung Studies (SLS) in asthma and COPD as an illustrative example, we discuss various features of the inhaled corticosteroid/long-acting ß2-agonist combination, fluticasone furoate/vilanterol (FF/VI), as potential drivers of effectiveness that may have contributed to the improved patient outcomes observed with initiation of FF/VI versus continuation of usual care in the UK primary care setting.


Assuntos
Antiasmáticos/uso terapêutico , Asma/tratamento farmacológico , Gerenciamento Clínico , Desenvolvimento de Medicamentos/tendências , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Antiasmáticos/economia , Asma/diagnóstico , Asma/economia , Análise Custo-Benefício/métodos , Desenvolvimento de Medicamentos/economia , Humanos , Adesão à Medicação , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Doença Pulmonar Obstrutiva Crônica/economia , Resultado do Tratamento
13.
Recenti Prog Med ; 110(5): 221-229, 2019 05.
Artigo em Italiano | MEDLINE | ID: mdl-31140454

RESUMO

The incentives provided by Orphan Drugs Regulations have promoted the development of drugs that effectively ameliorate the course of serious conditions that had previously been neglected. However, the treatment of each individual patient with any of these drugs - the so-called 'orphan drugs' - is so expensive, that the total burden for publicly funded Health care Service is enormous and may become unsustainable. Italy is no exception, if it is to abide by its basic tenet of providing access to essential medicines - free of charge - to the entire population. We do not see any glimpses of improvement on the horizon: therefore we suggest that radical change must be introduced. First, price negotiation ought to take place at the European level, not at the member state level. Second, pricing should take into account not only value for patients, but also costs of research and development (R&D) plus production. Italian Medicines Agency (AIFA) should also support research focused on optimizing the effective use of orphan drugs in clinical practice. The challenges are complex: but AIFA is recognized as an authoritative body, and may be able to coagulate the agreement of other regulatory agencies for the ultimate purpose of achieving, for each of the orphan drugs a more reasonable 'European price'.


Assuntos
Controle de Medicamentos e Entorpecentes/legislação & jurisprudência , Produção de Droga sem Interesse Comercial/legislação & jurisprudência , Doenças Raras/tratamento farmacológico , Custos de Medicamentos , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência , Humanos , Itália , Produção de Droga sem Interesse Comercial/economia , Doenças Raras/economia
14.
Science ; 364(6435)2019 04 05.
Artigo em Inglês | MEDLINE | ID: mdl-30948524

RESUMO

As antibiotic consumption grows, bacteria are becoming increasingly resistant to treatment. Antibiotic resistance undermines much of modern health care, which relies on access to effective antibiotics to prevent and treat infections associated with routine medical procedures. The resulting challenges have much in common with those posed by climate change, which economists have responded to with research that has informed and shaped public policy. Drawing on economic concepts such as externalities and the principal-agent relationship, we suggest how economics can help to solve the challenges arising from increasing resistance to antibiotics. We discuss solutions to the key economic issues, from incentivizing the development of effective new antibiotics to improving antibiotic stewardship through financial mechanisms and regulation.


Assuntos
Antibacterianos/farmacologia , Bactérias/efeitos dos fármacos , Assistência à Saúde/economia , Farmacorresistência Bacteriana , Economia , Animais , Gestão de Antimicrobianos/economia , Mudança Climática , Desenvolvimento de Medicamentos/economia , Humanos , Controle Social Formal
19.
Int J Infect Dis ; 84S: S74-S79, 2019 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-30641207

RESUMO

INTRODUCTION: Controlled human infection models (CHIM) have been used in vaccine development to up-select and down-select potential vaccine candidates and to provide proof of vaccine efficacy, and have also been used as a basis for licensure of vaccines for cholera and typhoid by regulatory agencies. CHIM IN DENGUE VACCINES DEVELOPMENT: Dengue fever results in ∼400 million infections a year and is of significant health concern especially in India. There are currently no antivirals for the disease and the only licensed vaccine for dengue is not widely used owing to safety concerns. Controlled dengue human challenge models (DHCM) are currently being used to assess the efficacy of vaccines in development for dengue. DENGUE CHIM IN INDIA: Conducting CHIM studies in India especially for evaluation of dengue vaccine candidates will be hugely beneficial as the disease is endemic to India and hence the effect of pre-exposure to the virus on vaccine safety and efficacy can be established. However, to date no CHIM studies have been conducted in India and there is a need to educate ethics committee members, policy makers and the public on the importance of such studies and what they entail.


Assuntos
Bioética , Vacinas contra Dengue/imunologia , Dengue/prevenção & controle , Desenvolvimento de Medicamentos/ética , Animais , Dengue/economia , Dengue/virologia , Vacinas contra Dengue/administração & dosagem , Vacinas contra Dengue/genética , Desenvolvimento de Medicamentos/economia , Humanos , Modelos Biológicos
20.
Duke Law J ; 68(4): 767-805, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30649837

RESUMO

Bacteriophages, or "phages," are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer's front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. subsection 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof.


Assuntos
Aprovação de Drogas/economia , Aprovação de Drogas/legislação & jurisprudência , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/legislação & jurisprudência , Farmacorresistência Bacteriana Múltipla , Farmacoeconomia/legislação & jurisprudência , Patentes como Assunto/legislação & jurisprudência , Terapia por Fagos/economia , Pesquisa/economia , Pesquisa/legislação & jurisprudência , Bacteriófagos , Competição Econômica/legislação & jurisprudência , Humanos , Motivação , Estados Unidos
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