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1.
JAMA ; 329(5): 386-392, 2023 02 07.
Artigo em Inglês | MEDLINE | ID: mdl-36749334

RESUMO

Importance: Some drugs are heavily marketed through direct-to-consumer advertising. Objective: To identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers. Design, Setting, and Participants: Exploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics. Exposures: Drug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data). Main Outcomes and Measures: Proportion of total promotional spending allocated to direct-to-consumer-advertising for each drug. Results: The 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales. Conclusions and Relevance: Among top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.


Assuntos
Publicidade Direta ao Consumidor , Indústria Farmacêutica , Preparações Farmacêuticas , Estudos Transversais , Publicidade Direta ao Consumidor/economia , Programas Nacionais de Saúde , Preparações Farmacêuticas/economia , Estados Unidos , Indústria Farmacêutica/economia
2.
Rev. homeopatia (São Paulo) ; 83(1): 39-41, 2022.
Artigo em Português | LILACS, HomeoIndex | ID: biblio-1359298

RESUMO

Escolhemos o título acima porque, como praticantes de uma atitude médico-filosófica que vê o ser humano como uma unidade e integrado ao todo, jamais conseguimos nos furtar ao diagnóstico sistêmico. É hábito do homeopata o diagnóstico em sua totalidade, das partes integradas ao todo, buscando o porquê em tudo, até em um simples artigo de um simples jornal de uma simples cidade que integra o nosso pequeno planeta, diga ele respeito ou não à homeopatia. Inicialmente a homeopatia começou incomodando as religiões, pois quando Hahnemann experimentou substâncias em humanos, observou o aparecimento de sintomas físicos e psíquicos, estes últimos eram tidos até então como instâncias da alma e portanto propriedade dos religiosos. Além de destruir o tácito acordo entre medicina e religião, onde médicos cuidavam dos males do corpo e os religiosos dos males da alma, resgatou também a unidade que é o ser. Foi a primeira prova testemunhal na medicina ocidental da comprovação dessa unidade. (AU)


Assuntos
Ciência/história , Homeopatia , Filosofia Homeopática , Indústria Farmacêutica/economia
3.
Gastroenterology ; 160(2): 614-623, 2021 01.
Artigo em Inglês | MEDLINE | ID: mdl-33307023

RESUMO

The notion of probiotics as microbes that confer health benefits has its origins in the speculative ideas that are more than a century old, yet remain largely unsubstantiated by scientific evidence. The recent advances in microbiome science have highlighted the importance of intestinal microbes in human physiology and disease pathogenesis. These developments have provided a boost to the probiotics industry, which continues to experience exponential growth driven mainly by creative marketing. Consumers, patients, and most health care providers are not able to discern the underlying science or differentiate the permitted claims that promise vague health benefits from disease-specific claims reserved for drugs. No probiotic product has been able to satisfy the regulatory requirements to be categorized as a drug, a substance intended to cure, mitigate, or prevent disease. However, patients take probiotic products in the belief that they will help to treat their intestinal or systemic diseases. Thus far, the regulators have failed to create policies that would assist to inform the public in this area. In fact, the existing regulatory regime actually creates formidable barriers to research that could provide evidence for clinical efficacy of probiotic products. We propose a potential solution to this vexing problem, where a committee created through a partnership of academia, professional organizations, and industry, but free of potential conflicts of interest, would be charged with rigorous evaluation of specific probiotic products and the evidence in support of their different claims. Companies that would submit to this process would earn the trust of consumers and healthcare providers, as well as a distinction in the marketplace.


Assuntos
Pesquisa Biomédica , Microbioma Gastrointestinal/efeitos dos fármacos , Legislação de Medicamentos , Probióticos , Pesquisa Biomédica/economia , Pesquisa Biomédica/legislação & jurisprudência , Suplementos Nutricionais/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência , Microbioma Gastrointestinal/fisiologia , Humanos , Legislação de Medicamentos/economia , Legislação de Medicamentos/normas , Probióticos/farmacologia , Probióticos/normas , Probióticos/uso terapêutico
4.
Drug Discov Today ; 25(12): 2089-2094, 2020 12.
Artigo em Inglês | MEDLINE | ID: mdl-33031944

RESUMO

In drug development, a crucial step is the transition of a company from preclinical stages to human trials: the so-called 'Valley-of-Death' (VoD) that most efforts do not survive. Here, we analyzed how the valuations of biotech companies in the life science sector change as they cross this valley. Their average valuation increased significantly (87%) when crossing the VoD no later than their fourth funding round. However, companies that received more than four funding rounds saw significantly lower average valuations. Similarly, the volume of website traffic for companies that received no more than four preclinical funding rounds was significantly higher than companies receiving more than four preclinical funding rounds, whereas the number of patents was unrelated to the likelihood of a company of crossing the VoD.


Assuntos
Biotecnologia/economia , Ensaios Clínicos como Assunto , Avaliação Pré-Clínica de Medicamentos , Indústria Farmacêutica/economia , Pesquisa Biomédica/economia , Comércio , Humanos , Internet , Patentes como Assunto
5.
MAbs ; 12(1): 1754999, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32449439

RESUMO

This study aims to benchmark and analyze the process development and manufacturing costs across the biopharmaceutical drug development cycle and their contribution to overall research and development (R&D) costs. This was achieved with a biopharmaceutical drug development lifecycle cost model that captured the costs, durations, risks and interdependencies of the clinical, process development and manufacturing activities. The budgets needed for process development and manufacturing at each phase of development to ensure a market success each year were estimated. The impact of different clinical success rate profiles on the process development and manufacturing costs at each stage was investigated, with a particular focus on monoclonal antibodies. To ensure a market success each year with an overall clinical success rate (Phase I to approval) of ~12%, the model predicted that a biopharmaceutical company needs to allocate process development and manufacturing budgets in the order of ~$60 M for pre-clinical to Phase II material preparation and ~$70 M for Phase III to regulatory review material preparation. For lower overall clinical success rates of ~4%, which are more indicative of diseases such as Alzheimer's, these values increase to ~$190 M for early-phase and ~$140 Mfor late-phase material preparation; hence, the costs increase 2.5 fold. The costs for process development and manufacturing per market success were predicted to represent 13-17% of the R&D budget from pre-clinical trials to approval. The results of this quantitative structured cost study can be used to aid decision-making during portfolio management and budget planning procedures in biopharmaceutical development.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Benchmarking/métodos , Produtos Biológicos/uso terapêutico , Aprovação de Drogas/métodos , Desenvolvimento de Medicamentos/métodos , Indústria Farmacêutica/métodos , Benchmarking/economia , Ensaios Clínicos como Assunto/economia , Aprovação de Drogas/economia , Custos de Medicamentos/estatística & dados numéricos , Desenvolvimento de Medicamentos/economia , Avaliação Pré-Clínica de Medicamentos/economia , Indústria Farmacêutica/economia , Humanos , Modelos Econômicos , Preparações Farmacêuticas/economia , Pesquisa/economia , Pesquisa/estatística & dados numéricos , Tecnologia Farmacêutica/economia , Tecnologia Farmacêutica/métodos
6.
Zhongguo Zhong Yao Za Zhi ; 45(2): 285-289, 2020 Jan.
Artigo em Chinês | MEDLINE | ID: mdl-32237310

RESUMO

Poverty alleviation by Chinese herbal medicine industry is an important way to implement the major strategic plan of the government and to effectively alleviate poverty and increase income of poor farmers in areas with high resource's endowment of Chinese medicinal materials. Based on the analysis of the existing achievements and problems in poverty alleviation by Chinese herbal medicine industry, this paper proposes that improving the comprehensive benefits of Chinese herbal medicine industry is an important direction for poverty alleviation in the poverty-stricken areas with the high endowment of traditional Chinese medicine resources in the future. Then, based on the concept of resource recycling of traditional Chinese medicinal materials, the feasibility and strategies of utilizing by-products in the production process of Chinese medicinal materials and expanding the ways of poverty alleviation were analyzed and discussed. The aim of all these works was to provide the support for enhancing the comprehensive competitiveness of the industry in poverty-stricken regions, enlarging the poverty alleviation effect of Chinese herbal medicine industry, and consolidating the achievements of poverty alleviation.


Assuntos
Indústria Farmacêutica/economia , Medicamentos de Ervas Chinesas , Medicina Herbária/economia , Pobreza , China , Medicina Tradicional Chinesa
7.
Int Health ; 12(4): 272-280, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-31647555

RESUMO

BACKGROUND: This study empirically estimates the magnitude and associated determinants of profit margins that medical providers earn from prescription drugs based on Taiwan's pharmaceutical market. METHODS: Our main data set is from the population-based claims data compiled by the National Health Insurance Research Database covering three waves of price adjustment: July-December 2004, October 2007-September 2008 and October 2009-September 2010. Only drugs whose reimbursement prices were adjusted using the R-zone formula were used as samples for this study. By calculating the difference between retail and wholesale prices for 796 pharmaceutical products, we can estimate the profit margin determinants using the regression model. RESULTS: We found evidence that suppliers of generic drugs tend to offer larger discounts to medical providers than suppliers of brand-name drugs. In addition, the countervailing power of wholesale pharmaceuticals, as measured by the discount rate offered by pharmaceutical manufacturers, is positively associated with the degree of competition within the pharmaceutical market and the size of the market itself. CONCLUSIONS: Our findings imply that the profit-seeking behaviour exhibited by medical providers is the engine of competitive forces in Taiwan's prescription drug market. This creates financial incentives for them, which in turn influences their choices of prescription drugs.


Assuntos
Custos de Medicamentos/estatística & dados numéricos , Medicamentos Genéricos/economia , Padrões de Prática Médica/economia , Medicamentos sob Prescrição/economia , Indústria Farmacêutica/economia , Medicamentos Genéricos/provisão & distribuição , Humanos , Programas Nacionais de Saúde/estatística & dados numéricos , Padrões de Prática Médica/estatística & dados numéricos , Medicamentos sob Prescrição/provisão & distribuição , Taiwan
8.
Soc Sci Med ; 245: 112617, 2020 01.
Artigo em Inglês | MEDLINE | ID: mdl-31739144

RESUMO

This article advances the hypothesis that "traditional" Asian pharmaceutical industries are rapidly growing in size and prominence in contemporary Asia, and identifies a lack of empirical data on the phenomenon. Addressing this gap, the article provides a quantitative outline and analysis of the Sowa Rigpa (Tibetan, Mongolian and Himalayan medicine) pharmaceutical industry in China, India, Mongolia and Bhutan. Using original data gathered through multi-sited ethnographic and textual research between 2014 and 2019, involving 232 industry representatives, policy makers, researchers, pharmacists and physicians, it assembles a bigger picture on this industry's structure, size and dynamics. Revealing a tenfold growth of the Sowa Rigpa pharmaceutical industry in Asia between 2000 and 2017, the study supports its initial hypothesis. In 2017, the industry had a total sales value of 677.5 million USD, and constituted an important economic and public health resource in Tibetan, Mongolian and Himalayan regions of Asia. China generates almost 98 percent of the total sales value, which is explained by significant state intervention on the one hand, and historical and sociocultural reasons on the other. India has the second largest Sowa Rigpa pharmaceutical industry with an annual sales value of about 11 million USD, while sales values in Mongolia and Bhutan are very low, despite Sowa Rigpa's domestic importance for the two nations. The article concludes with a number of broader observations emerging from the presented data, arguing that the Sowa Rigpa pharmaceutical industry has become big enough to exert complex transformative effects on Tibetan, Mongolian and Himalayan medicine more generally. The quantitative and qualitative data presented here provide crucial foundations for further scholarly, regulatory, and professional engagement with contemporary Sowa Rigpa.


Assuntos
Indústria Farmacêutica/tendências , Medicina Tradicional/economia , Ásia , Indústria Farmacêutica/economia , Humanos , Medicina Tradicional/métodos , Medicina Tradicional/tendências
9.
BMJ ; 367: l6015, 2019 Nov 05.
Artigo em Inglês | MEDLINE | ID: mdl-31690553

RESUMO

OBJECTIVE: To evaluate the association between gifts from pharmaceutical companies to French general practitioners (GPs) and their drug prescribing patterns. DESIGN: Retrospective study using data from two French databases (National Health Data System, managed by the French National Health Insurance system, and Transparency in Healthcare). SETTING: Primary care, France. PARTICIPANTS: 41 257 GPs who in 2016 worked exclusively in the private sector and had at least five registered patients. The GPs were divided into six groups according to the monetary value of the received gifts reported by pharmaceutical, medical device, and other health related companies in the Transparency in Healthcare database. MAIN OUTCOME MEASURES: The main outcome measures were the amount reimbursed by the French National Health Insurance for drug prescriptions per visit (to the practice or at home) and 11 drug prescription efficiency indicators used by the National Health Insurance to calculate the performance related financial incentives of the doctors. Doctor and patient characteristics were used as adjustment variables. The significance threshold was 0.001 for statistical analyses. RESULTS: The amount reimbursed by the National Health Insurance for drug prescriptions per visit was lower in the GP group with no gifts reported in the Transparency in Healthcare database in 2016 and since its launch in 2013 (no gift group) compared with the GP groups with at least one gift in 2016 (-€5.33 (99.9% confidence interval -€6.99 to -€3.66) compared with the GP group with gifts valued at €1000 or more reported in 2016) (P<0.001). The no gift group also more frequently prescribed generic antibiotics (2.17%, 1.47% to 2.88% compared with the ≥€1000 group), antihypertensives (4.24%, 3.72% to 4.77% compared with the ≥€1000 group), and statins (12.14%, 11.03% to 13.26% compared with the ≥€1000 group) than GPs with at least one gift between 2013 and 2016 (P<0.001). The no gift group also prescribed fewer benzodiazepines for more than 12 weeks (-0.68%, -1.13% to -0.23% compared with the €240-€999 group) and vasodilators (-0.15%, -0.28% to -0.03% compared with the ≥€1000 group) than GPs with gifts valued at €240 or more reported in 2016, and more angiotensin converting enzyme (ACE) inhibitors compared with all ACE and sartan prescriptions (1.67%, 0.62% to 2.71%) compared with GPs with gifts valued at €1000 or more reported in 2016 (P<0.001). Differences were not significant for the prescription of aspirin and generic antidepressants and generic proton pump inhibitors. CONCLUSION: The findings suggest that French GPs who do not receive gifts from pharmaceutical companies have better drug prescription efficiency indicators and less costly drug prescriptions than GPs who receive gifts. This observational study is susceptible to residual confounding and therefore no causal relation can be concluded. TRIAL REGISTRATION: OSF register OSF.IO/8M3QR.


Assuntos
Indústria Farmacêutica/economia , Prescrições de Medicamentos/estatística & dados numéricos , Clínicos Gerais/estatística & dados numéricos , Doações , Padrões de Prática Médica/estatística & dados numéricos , Adolescente , Adulto , Idoso , Bases de Dados Factuais/estatística & dados numéricos , Indústria Farmacêutica/estatística & dados numéricos , Prescrições de Medicamentos/economia , Medicamentos Genéricos/economia , Feminino , França , Clínicos Gerais/economia , Humanos , Reembolso de Seguro de Saúde/economia , Reembolso de Seguro de Saúde/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Programas Nacionais de Saúde/economia , Programas Nacionais de Saúde/estatística & dados numéricos , Padrões de Prática Médica/economia , Medicamentos sob Prescrição/economia , Estudos Retrospectivos , Adulto Jovem
10.
BMJ Open ; 9(8): e030253, 2019 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-31434780

RESUMO

OBJECTIVES: To describe the nature, frequency and content of non-vitamin K oral anticoagulant (NOAC)-related events for healthcare professionals sponsored by the manufacturers of the NOACs in Australia. A secondary objective is to compare these data to the rate of dispensing of the NOACs in Australia. DESIGN AND SETTING: This cross-sectional study examined consolidated data from publicly available Australian pharmaceutical industry transparency reports from October 2011 to September 2015 on NOAC-related educational events. Data from April 2011 to June 2016 on NOAC dispensing, subsidised under Australia's Pharmaceutical Benefits Scheme (PBS), were obtained from the Department of Health and the Department of Human Services. MAIN OUTCOME MEASURES: Characteristics of NOAC-related educational events including costs (in Australian dollars, $A), numbers of events, information on healthcare professional attendees and content of events; and NOAC dispensing rates. RESULTS: During the study period, there were 2797 NOAC-related events, costing manufacturers a total of $A10 578 745. Total expenditure for meals and beverages at all events was $A4 238 962. Events were predominantly attended by general practitioners (42%, 1174/2797), cardiologists (35%, 977/2797) and haematologists (23%, 635/2797). About 48% (1347/2797) of events were held in non-clinical settings, mainly restaurants, bars and cafes. Around 55% (1551/2797) of events consisted of either conferences, meetings or seminars. The analysis of the content presented at two events detected promotion of NOACs for unapproved indications, an emphasis on a favourable benefit/harm profile, and that all speakers had close ties with the manufacturers of the NOACs. Following PBS listings relevant to each NOAC, the numbers of events related to that NOAC and the prescribing of that NOAC increased. CONCLUSIONS: Our findings suggest that the substantial investment in NOAC-related events made by four pharmaceutical companies had a promotional purpose. Healthcare professionals should seek independent information on newly subsidised medicines from, for example, government agencies or drug bulletins.


Assuntos
Anticoagulantes/uso terapêutico , Indústria Farmacêutica , Educação Médica Continuada/economia , Padrões de Prática Médica/estatística & dados numéricos , Anticoagulantes/economia , Austrália , Estudos Transversais , Dabigatrana/economia , Dabigatrana/uso terapêutico , Indústria Farmacêutica/economia , Indústria Farmacêutica/ética , Educação Médica Continuada/ética , Educação Médica Continuada/estatística & dados numéricos , Humanos , Padrões de Prática Médica/economia , Padrões de Prática Médica/ética , Pirazóis/economia , Pirazóis/uso terapêutico , Piridonas/economia , Piridonas/uso terapêutico , Rivaroxabana/economia , Rivaroxabana/uso terapêutico
13.
Biotechnol Adv ; 37(5): 698-707, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30922993

RESUMO

Biopharmaceuticals manufacturing is a critical component of the modern healthcare system, with emerging new treatments composed of increasingly complex biomolecules offering solutions to chronic and debilitating disorders. While this sector continues to grow, it strongly exhibits "boom-to-bust" performance which threatens its long-term viability. Future trends within the industry indicate a shift towards continuous production systems using single use technologies that raises sustainability issues, yet research in this area is sparse and lacks consideration of the complex interactions between environmental, social and economic concerns. The authors outline a sustainability-focused vision and propose opportunities for research to aid the development of a more integrated approach that would enhance the sustainability of the industry.


Assuntos
Produtos Biológicos , Biotecnologia/métodos , Indústria Farmacêutica/métodos , Técnicas de Cultura Celular por Lotes , Produtos Biológicos/química , Pesquisa Biomédica , Biotecnologia/economia , Técnicas de Cultura de Células/métodos , Descoberta de Drogas , Indústria Farmacêutica/economia , Avaliação de Programas e Projetos de Saúde , Avaliação da Tecnologia Biomédica
15.
Oncologist ; 24(5): 632-639, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30728276

RESUMO

BACKGROUND: Financial relationships between physicians and the pharmaceutical industry are common, but factors that may determine whether such relationships result in physician practice changes are unknown. MATERIALS AND METHODS: We evaluated physician use of orally administered cancer drugs for four cancers: prostate (abiraterone, enzalutamide), renal cell (axitinib, everolimus, pazopanib, sorafenib, sunitinib), lung (afatinib, erlotinib), and chronic myeloid leukemia (CML; dasatinib, imatinib, nilotinib). Separate physician cohorts were defined for each cancer type by prescribing history. The primary exposure was the number of calendar years during 2013-2015 in which a physician received payments from the manufacturer of one of the studied drugs; the outcome was relative prescribing of that drug in 2015, compared with the other drugs for that cancer. We evaluated whether practice setting at a National Cancer Institute (NCI)-designated Comprehensive Cancer Center, receipt of payments for purposes other than education or research (compensation payments), maximum annual dollar value received, and institutional conflict-of-interest policies were associated with the strength of the payment-prescribing association. We used modified Poisson regression to control confounding by other physician characteristics. RESULTS: Physicians who received payments for a drug in all 3 years had increased prescribing of that drug (compared with 0 years), for renal cell (relative risk [RR] 1.81, 95% confidence interval [CI] 1.58-2.07), CML (RR 1.22, 95% CI 1.08-1.39), and lung (RR 1.69, 95% CI 1.58-1.82), but not prostate (RR 0.97, 95% CI 0.93-1.02). Physicians who received compensation payments or >$100 annually had increased prescribing compared with those who did not, but NCI setting and institutional conflict-of-interest policies were not consistently associated with the direction of prescribing change. CONCLUSION: The association between industry payments and cancer drug prescribing was greatest among physicians who received payments consistently (within each calendar year). Receipt of payments for compensation purposes, such as for consulting or travel, and higher dollar value of payments were also associated with increased prescribing. IMPLICATIONS FOR PRACTICE: Financial payments from pharmaceutical companies are common among oncologists. It is known from prior work that oncologists tend to prescribe more of the drugs made by companies that have given them money. By combining records of industry gifts with prescribing records, this study identifies the consistency of payments over time, the dollar value of payments, and payments for compensation as factors that may strengthen the association between receiving payments and increased prescribing of that company's drug.


Assuntos
Antineoplásicos/uso terapêutico , Indústria Farmacêutica/economia , Neoplasias/tratamento farmacológico , Oncologistas/estatística & dados numéricos , Prática Profissional/estatística & dados numéricos , Administração Oral , Antineoplásicos/economia , Antineoplásicos/normas , Conflito de Interesses/economia , Conjuntos de Dados como Assunto , Prescrições de Medicamentos/economia , Prescrições de Medicamentos/normas , Prescrições de Medicamentos/estatística & dados numéricos , Feminino , Humanos , Masculino , Oncologia/economia , Oncologia/ética , Oncologia/normas , Oncologia/estatística & dados numéricos , National Cancer Institute (U.S.)/normas , Neoplasias/economia , Oncologistas/economia , Oncologistas/ética , Prática Profissional/economia , Prática Profissional/ética , Prática Profissional/normas , Estados Unidos
16.
J Manag Care Spec Pharm ; 25(2): 164-173, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30698089

RESUMO

BACKGROUND: Preapproval information exchange (PIE) is the communication of clinical and health care economic information (HCEI) on therapies in development between U.S. population health decision makers (PHDMs) and drug manufacturers before regulatory approval. Early access to HCEI can help PHDMs plan budgets, inform formulary coverage decisions, and accelerate policy development to improve patient access to innovative health technologies. While recent FDA guidelines and proposed legislation aim to clarify definitions and execution of PIE, the level of U.S. PHDMs' awareness and preferences for early engagement with investigational therapies is unclear. OBJECTIVES: To (a) assess U.S. PHDMs' current knowledge and perceptions of PIE and (b) identify their preferences for PIE, in order to shape future development of related guidelines and policy. METHODS: An expert panel of 5 U.S. PHDMs representing national and regional payers from integrated health plans, pharmacy benefit management, and specialty pharmacy organizations participated in a 2-round modified Delphi process. A targeted literature review of PIE was used to develop a web-based survey administered to the panel. Survey responses were grouped by consensus, with ≥ 80% agreement or disagreement as the threshold in round 1. In round 2, content experts moderated an inperson meeting where panelists deliberated and then revoted on round 1 nonconsensus topics. RESULTS: In the round 1 survey, the panelists reached consensus on 35 of 54 (65%) multiple-choice questions. In the round 2 face-to-face discussion, 19 nonconsensus questions were debated. One question was removed due to duplication, and consensus was achieved on 16 additional questions, with 2 items of nonconsensus remaining. Overall, consensus was achieved on 51 of 53 topics (96%). There was full consensus by the panelists that PIE should encompass new molecular entities and new indications of marketed therapies. Panelists completely agreed on the need for a legislative "safe harbor" for PIE. Four of five panelists reported that the value of PIE was high to PHDMs, and they expressed a strong preference for peer-to-peer conversations with manufacturers' medical or outcomes liaisons for PIE. The main topic of nonconsensus was the optimal timing of PIE. CONCLUSIONS: This panel of U.S. PHDMs achieved consensus on the value of PIE to proactively budget, make informed formulary decisions, and develop pharmaceutical policy to facilitate patient access to new therapies. The PHDM panel's preferences for PIE should be considered in legislative discussions and planning for future PIE by PHDMs and manufacturers. The full contribution of PIE to improving the U.S. health system can best be realized under a safe harbor that allows U.S. PHDM and manufacturer experts to engage in robust scientific and economic discourse. Additional research and broad stakeholder engagement is needed to advance the development of formal U.S. PIE guidelines. DISCLOSURES: This study was funded by GlaxoSmithKline (GSK). Brixner, Oderda, and Biskupiak are principals of Millcreek Outcomes Group, a consultancy that received funding from GSK to conduct this study. Marciniak and Woodward are employees of GSK and own stock in GSK. Seifter was employed by GSK at the time of this study. Neumann served as external health policy advisor for this study and has consulted or served on advisory boards with Merck, Bayer, Pacira, Novo Nordisk, Amgen, Abbvie, Boston Health Economics, Vertex, Precision Health Economics, the Congressional Budget Office, CEA Registry Sponsors, Axovant, Veritech, Janssen, Parateck, Avexis, GSK, Celegene, Bluebird, Roche, Sage, Sarepta, Biogen, and Ipsen. Neumann also reports grants from Amgen, Lundbeck, Gates, NPC, Alzheimer's Association, and NIH.


Assuntos
Tomada de Decisões , Atenção à Saúde/economia , Acessibilidade aos Serviços de Saúde , Terapias em Estudo/economia , Orçamentos , Consenso , Atenção à Saúde/organização & administração , Técnica Delphi , Aprovação de Drogas , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Guias como Assunto , Política de Saúde , Humanos , Inquéritos e Questionários , Estados Unidos
17.
Med Sci (Paris) ; 35(12): 1171-1174, 2019 Dec.
Artigo em Francês | MEDLINE | ID: mdl-31903933

RESUMO

Therapeutic antibodies generation has to be faster with less development costs. This requires combination of in silico predictions associated with cutting edge screening and characterization technologies. Here, non-exhaustive examples illustrate this simultaneity need.


TITLE: Exemples d'études de développabilité apportant un éclairage à la prise de décision. ABSTRACT: De nos jours, la génération d'anticorps thérapeutiques doit être plus rapide avec des coûts de développement moins importants. Pour cela, des prédictions in silico sont associées à des technologies de criblage et de caractérisation de pointe. Les exemples choisis ici sont non-exhaustifs mais illustrent ce besoin de travailler en parallèle.


Assuntos
Anticorpos Monoclonais , Simulação por Computador , Tomada de Decisões , Desenho de Fármacos , Desenvolvimento de Medicamentos , Avaliação Pré-Clínica de Medicamentos , Anticorpos Monoclonais/química , Anticorpos Monoclonais/economia , Anticorpos Monoclonais/isolamento & purificação , Anticorpos Monoclonais/uso terapêutico , Desenvolvimento de Medicamentos/economia , Desenvolvimento de Medicamentos/métodos , Desenvolvimento de Medicamentos/organização & administração , Desenvolvimento de Medicamentos/normas , Avaliação Pré-Clínica de Medicamentos/métodos , Avaliação Pré-Clínica de Medicamentos/normas , Indústria Farmacêutica/economia , Indústria Farmacêutica/métodos , Indústria Farmacêutica/normas , Ensaios de Triagem em Larga Escala/economia , Ensaios de Triagem em Larga Escala/métodos , Ensaios de Triagem em Larga Escala/normas , Humanos
18.
Oncologist ; 24(4): 498-504, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30459237

RESUMO

BACKGROUND: The National Comprehensive Cancer Network (NCCN) guidelines are among the most widely used guidance in oncology. It is critical to understand the extent to which the recommendations in these guidelines are supported by evidence and to investigate whether these recommendations have been influenced by payments from industry to authors. MATERIALS AND METHODS: We examined the quality and consistency of evidence, as scored by guidelines authors, for systemic treatment incorporated in the NCCN guidelines. Payments data in 2015 were manually abstracted using the Open Payments database, which discloses all payments between the industry and American physicians. Correlations between the percentage of authors who received payments and the proportion of recommendations developed from low-level evidence per guideline were calculated using Spearman rank correlation. RESULTS: In total, 1,782 recommendations were identified in 29 guidelines, of which 1,282 (71.9%) were based on low-quality or low-consistency evidence (low-level evidence), including "case reports or clinical experience only" (18.9%). A substantial proportion (31/143, 21.7%) of category 1 (the highest level) recommendations were based on low-level evidence. The majority of authors (87.1%) received payments from industry. However, no association was found between the prevalence of payments among authors and the percentage of recommendations developed from low-level evidence per guideline. CONCLUSION: The majority of systemic treatment recommendations in the NCCN guidelines are based on low-level evidence, including more than one in five category 1 recommendations. Payments from industry were prevalent among authors. However, industrial payments among authors were not associated with inclusion of regimen/agent for which there is no conclusive evidence in the guidelines. IMPLICATIONS FOR PRACTICE: The authors found that the majority (71.9%) of systemic treatment recommendations issued in the current National Comprehensive Cancer Network guidelines were based on low-level evidence. Physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.


Assuntos
Conflito de Interesses/economia , Indústria Farmacêutica/economia , Apoio Financeiro , Guias como Assunto/normas , Neoplasias/economia , Médicos/estatística & dados numéricos , Autoria , Fidelidade a Diretrizes , Humanos , Oncologia , Neoplasias/tratamento farmacológico , Organizações sem Fins Lucrativos , Remuneração , Estados Unidos
20.
J Oncol Pharm Pract ; 24(6): 424-432, 2018 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-28714357

RESUMO

Introduction The rising cost of cancer drugs may make treatment unaffordable for some patients. Patients often rely on drug manufacturer-administered Pharmaceutical Assistance Programs (PAPs) to obtain drugs and reduced or no cost. The overall usage of PAPs within cancer care delivery is unknown. Methods We included all cancer patients across an academically affiliated, integrated health system in North Carolina during 2014 ( N = 8591). We identified the subset of patients receiving PAP assistance to afford one or more cancer drugs, in order to calculate the proportion of patients receiving PAP assistance, and the retail value of the assistance. Results Among 8591 cancer patients, 215 unique patients submitted a total of 478 successful PAP requests for cancer drugs. 40% of PAP-utilizing patients were uninsured, 23% had Medicaid coverage, 20% had Medicare coverage, 2% were dual Medicare/Medicaid eligible, and 14% were commercially insured. Among all cancer patients who received medical treatment, 6.0% required PAP assistance, whereas 10.6% receiving an oral agent required PAP assistance. The proportion receiving PAP assistance varied substantially by drug, ranging from <1% of patients (e.g. carboplatin, methotrexate) to 50% of patients (e.g. ponatinib, temsirolimus). The majority of the retail value obtained was for oral agents, including $1,556,575 of imatinib and $1,449,633 of dasatinib, which were the two drugs with the highest aggregate retail value. Conclusions A substantial proportion of cancer patients receive private charitable assistance to obtain standard-of-care treatments. This includes patients with federal and private insurance, suggesting an inability of patients to meet cost-sharing requirements.


Assuntos
Antineoplásicos/administração & dosagem , Indústria Farmacêutica/economia , Neoplasias/tratamento farmacológico , Antineoplásicos/economia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/economia , North Carolina , Estados Unidos
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