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1.
Expert Rev Pharmacoecon Outcomes Res ; 19(6): 749-753, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31825682

RESUMO

Background: Agreements between payers and pharmaceutical/medical device companies are widely implemented to address financial and clinical uncertainties. We analyzed the main characteristics of these agreements in Israel from 2011-2018.Research design and methods: We reviewed all agreements implemented during the study period. Information regarding the type of agreement, therapeutic indications, its time frame and the total budget involved are presented.Results: A total of 56 agreements were signed since 2011, of which 53 (95%) were financial-based and 50 (89%) referred to pharmaceuticals. The annual number of agreements increased from one in 2011 to 21 in 2018. The main therapeutic areas covered were: oncology (41%), hepatitis C (16%), neurology (11%), respiratory (9%), and cardiovascular (7%). The proportion of the annual budget allocated subject to these agreements increased accordingly from 3% in 2011 to 73% in 2018. The majority (63%) of the agreements were signed for 5 years, 9% were shorter-term and 20% have no time-limit. In 14 (44%) of the financial-based agreements implemented through 2017, the actual utilization exceeded the pre-specified threshold and the companies reimbursed the health-plans accordingly.Conclusions: The number of agreements and the allocated budget subject to these agreements increased substantially in recent years. Most agreements are financial-based that, in many cases, shifted the short-term financial risk from health-plans to the industry.


Assuntos
Indústria Farmacêutica/organização & administração , Acesso aos Serviços de Saúde/economia , Programas Nacionais de Saúde/organização & administração , Participação no Risco Financeiro/organização & administração , Orçamentos , Indústria Farmacêutica/economia , Serviços de Saúde/economia , Humanos , Israel , Programas Nacionais de Saúde/economia , Mecanismo de Reembolso/economia , Participação no Risco Financeiro/economia , Incerteza
2.
Nihon Koshu Eisei Zasshi ; 66(12): 746-755, 2019.
Artigo em Japonês | MEDLINE | ID: mdl-31875625

RESUMO

Objectives Multinational R&D pharmaceutical companies operating in many countries and regions have deep ties with patient groups that are recipients of their corporate social responsibility (CSR). CSR activities are diverse and range from direct funding (including donations and sponsorships) to indirect funding (such as expenses associated with company-sponsored lectures); there are rewards for CSR requests for patient groups (writing, supervision, and surveys), and labor is provided by company employees. In developing pharmaceutical products, R&D companies can provide greater benefits to patients by listening to them. It is therefore important for all stakeholders to ensure transparency regarding the relationship between companies and patient groups. This study aimed to identify trends in information disclosure toward ensuring transparency of relations between CSR activities and patient groups based on industry groups regulations in Japan, the United States, and Europe.Methods The contents described in regulations by the European Federation of Pharmaceutical Industries and Associations (EFPIA), Pharmaceutical Research and Manufacturers of America (PhRMA), and the Japan Pharmaceutical Manufacturers Association (JPMA) concerning such transparency were qualitatively and inductively analyzed in terms of four concepts: transparency, equal partnership, mutual benefit, and independence.Results Most of the descriptions relate to transparency. The EFPIA regulation is the most detailed; it states that there should be no influence on patient groups' work or on events and activities organized by companies or patient groups. The rules of the three associations also impose the need to maintain records concerning the purpose and contents of financial support and activity items. However, information disclosure to secure transparency is not required in the PhRMA regulation. The JPMA regulation does not specify a clear update schedule; the EFPIA regulation requires disclosure information to be updated once a year. In terms of equal partnership, such terms as "mutual respect," "equal value," and "establishing a trust relationship" appeared in searches with all three regulations. None of the regulations referred to "mutual benefit." All the regulations either respected or validated the independence of patient groups.Conclusion Each pharmaceutical association set its own regulations and recommended voluntary information disclosure by member companies; however, the extent of such disclosure differed with each association. The regulations of industry associations form the basis for the policies of member companies; thus, it is desirable that the contents and regulations related to mutual information disclosure be established in great detail worldwide.


Assuntos
Revelação , Indústria Farmacêutica , Ética nos Negócios , Internacionalidade , Organizações , Pacientes , Responsabilidade Social , Indústria Farmacêutica/organização & administração , Europa (Continente) , Humanos , Japão , Estados Unidos
3.
Pan Afr Med J ; 33: 313, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31692862

RESUMO

The role of a Medical Science Liaison (MSL) is of growing importance to pharmaceutical, biotechnology, diagnostic and medical device companies. Through scientific engagement MSLs add value to clinical practice, ultimately benefiting patients. The MSL role is dynamic and encompasses in-depth product and disease knowledge together with the ability to communicate relevant, unbiased scientific information concisely and timely. Tasks are focused on contributing towards the advancement of medical knowledge, scientific data generation and dissemination. Professional relationships are developed, fostering collaboration between external experts and typically the medical affairs departments of pharmaceutical companies through a credible liaison. Through such relationships, critical insights are shared that shape the development pipeline, promote successful clinical translation and guide the market deployment strategy of therapeutic interventions through-out their life cycle. Despite the rising number of MSLs in the field and the implicit medical value of the role, there remains a lack of understanding for what the roles of a MSL entails. In Africa, where exponential growth of the pharmaceutical industry is expected, the number of MSLs will increase rapidly. Given the complexities of the African continent, the MSLs in this burgeoning environment will face various challenges including remote locations, time-constraints, regulatory and bureaucratic hurdles and importantly physician misperception of the MSL role that collectively may thwart the goal of meaningful scientific engagement; but these challenges can be surmounted through astute proactive planning and utilization of opportunities including digital communication strategies.


Assuntos
Comunicação , Comportamento Cooperativo , Indústria Farmacêutica/organização & administração , África , Humanos , Indústria Manufatureira/organização & administração , Papel Profissional
5.
An Real Acad Farm ; 85(3): 232-247, jul.-sept. 2019. mapas, graf, tab
Artigo em Espanhol | IBECS | ID: ibc-184873

RESUMO

Este estudio analiza la influencia de los planes urbanísticos, de ordenación del territorio y de descongestión industrial, trazados tanto por el Ayuntamiento de Madrid como por el Gobierno de la Nación, sobre la localización de la industria farmacéutica instalada en la ciudad de Madrid y su entorno provincial, lo que nos lleva a valorar las coincidencias y las singularidades de este tipo de industria respecto del resto de establecimientos que vertebraron el espacio industrial madrileño durante el Franquismo


This paper analyzes the influence of the urban planning, territorial planning and industrial decongestion plans, drawn up both by the Madrid’s City Council and by the Government of the Nation, on the location of the pharmaceutical industry installed in the city of Madrid and its provincial environment, which leads us to assess the coincidences and singularities of this type of industry with respect to the rest of the establishments that formed the backbone of Madrid's industrial space during the Franco regime


Assuntos
História do Século XIX , História do Século XX , Indústria Farmacêutica/história , Indústria Farmacêutica/organização & administração , Farmácias/história , Espanha , População Urbana/história , Farmácias/organização & administração
6.
Am J Health Syst Pharm ; 76(17): 1296-1304, 2019 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-31418790

RESUMO

PURPOSE: The development of a tool to measure medication safety, therapeutic efficacy, and other quality outcomes in patients receiving self-injectable biologic therapy for the management of inflammatory bowel disease (IBD) at a health-system specialty pharmacy is described. SUMMARY: Through a collaborative initiative by pharmacists, gastro-enterologists, and representatives of a pharmacy benefit manager and a pharmaceutical company, a set of clinical and specialty pharmacy quality measures was developed. The clinical measures are intended for use in assessing patient safety, disease status, treatment efficacy, and healthcare resource utilization during 3 assessments (pre-treatment, on-treatment, and longitudinal). The specialty pharmacy measures can be used to assess medication adherence, medication persistence, specialty pharmacy accreditation, and patient satisfaction. The proposed quality measures provide a foundation for evaluating the quality of IBD care and improving patient outcomes within a health-system specialty pharmacy. Future efforts to validate and implement the tool in clinical practice are planned. CONCLUSION: The proposed quality measures provide a foundation for future inquiry regarding the appropriateness and feasibility of integrating the measures into clinical care. Further work is needed to implement and validate these quality measures and determine their impact in optimizing health outcomes.


Assuntos
Produtos Biológicos/administração & dosagem , Doenças Inflamatórias Intestinais/tratamento farmacológico , Serviço de Farmácia Hospitalar/organização & administração , Autoadministração/normas , Terapia Biológica/métodos , Terapia Biológica/normas , Comportamento Cooperativo , Indústria Farmacêutica/organização & administração , Gastroenterologistas/organização & administração , Humanos , Farmacêuticos/organização & administração
7.
BMJ ; 366: l4217, 2019 07 10.
Artigo em Inglês | MEDLINE | ID: mdl-31292127

RESUMO

OBJECTIVES: To develop and pilot a tool to measure and improve pharmaceutical companies' clinical trial data sharing policies and practices. DESIGN: Cross sectional descriptive analysis. SETTING: Large pharmaceutical companies with novel drugs approved by the US Food and Drug Administration in 2015. DATA SOURCES: Data sharing measures were adapted from 10 prominent data sharing guidelines from expert bodies and refined through a multi-stakeholder deliberative process engaging patients, industry, academics, regulators, and others. Data sharing practices and policies were assessed using data from ClinicalTrials.gov, Drugs@FDA, corporate websites, data sharing platforms and registries (eg, the Yale Open Data Access (YODA) Project and Clinical Study Data Request (CSDR)), and personal communication with drug companies. MAIN OUTCOME MEASURES: Company level, multicomponent measure of accessibility of participant level clinical trial data (eg, analysis ready dataset and metadata); drug and trial level measures of registration, results reporting, and publication; company level overall transparency rankings; and feasibility of the measures and ranking tool to improve company data sharing policies and practices. RESULTS: Only 25% of large pharmaceutical companies fully met the data sharing measure. The median company data sharing score was 63% (interquartile range 58-85%). Given feedback and a chance to improve their policies to meet this measure, three companies made amendments, raising the percentage of companies in full compliance to 33% and the median company data sharing score to 80% (73-100%). The most common reasons companies did not initially satisfy the data sharing measure were failure to share data by the specified deadline (75%) and failure to report the number and outcome of their data requests. Across new drug applications, a median of 100% (interquartile range 91-100%) of trials in patients were registered, 65% (36-96%) reported results, 45% (30-84%) were published, and 95% (69-100%) were publicly available in some form by six months after FDA drug approval. When examining results on the drug level, less than half (42%) of reviewed drugs had results for all their new drug applications trials in patients publicly available in some form by six months after FDA approval. CONCLUSIONS: It was feasible to develop a tool to measure data sharing policies and practices among large companies and have an impact in improving company practices. Among large companies, 25% made participant level trial data accessible to external investigators for new drug approvals in accordance with the current study's measures; this proportion improved to 33% after applying the ranking tool. Other measures of trial transparency were higher. Some companies, however, have substantial room for improvement on transparency and data sharing of clinical trials.


Assuntos
Ensaios Clínicos como Assunto , Indústria Farmacêutica/organização & administração , Disseminação de Informação , Estudos Transversais , Aprovação de Drogas , Indústria Farmacêutica/normas , Humanos , Projetos Piloto , Participação dos Interessados , Fatores de Tempo
8.
Gac Med Mex ; 155(3): 319-321, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31219475

RESUMO

Clinical research is the most important tool for the identification of diagnostic and therapeutic strategies that derive in higher efficacy and safety. Despite its significance, successful implementation of clinical research faces numerous difficulties, with one the most relevant being limited availability of resources for the performance of independent clinical trials. Generally, the pharmaceutical industry absorbs the costs associated with most clinical trials; however, this can generate dissociation between subjects of interest and health priorities when economic interest is the main driver of these protocols. In addition to the relevant role played by the pharmaceutical industry, it is important that government agencies favor adequate conditions, both in economic and regulatory aspects, for the implementation of independent clinical research that addresses subjects of medical and therapeutic interest, even if it does not generate corporate economic benefits.


Assuntos
Pesquisa Biomédica/organização & administração , Ensaios Clínicos como Assunto/organização & administração , Indústria Farmacêutica/organização & administração , Pesquisa Biomédica/economia , Ensaios Clínicos como Assunto/economia , Indústria Farmacêutica/economia , Apoio Financeiro , Humanos
10.
J Med Econ ; 22(8): 713-721, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31038374

RESUMO

Aim: Drug innovation is strongly driven by economic incentives. How these incentives work in determining or changing the level of activity of innovators and the direction of their innovation remains understudied. We seek to address these issues in reviewing recent literature on drug innovation, which offers one major unifying theme of pharmacoeconomic scholarship presented at the 2019 AEA-ASSA annual convention. Methods: Drawn from three AEA-ASSA convention panel sessions, papers were reviewed for newly charted research terrains and new research trajectories, and their theoretical and practical implications on efficiency, effectiveness, and value in the production and utilization of pharmaceutical products. Results: While high and continuously rising drug prices are typically claimed as the price of scientific innovation, the reviewed literature finds that this link only partially accounts for the problem. High risk aversion owing to information asymmetries and vastly intractable uncertainties is prevalent among innovating firms. Predatory business models abound. Reverse predatory strategies also exist to maintain product exclusivity without much added clinical benefits, and to constrain generic competition. CEO compensation practices contribute to rising drug prices. Finally, the US government's hands-off policy on drug list prices leave the forces of supply and demand to allocate them and reward innovation (at times perversely), even as the government extensively regulates or over-regulates practically every other aspect of innovation. Conclusions: Price-elasticity of demand is critical in drug innovation. The drug value chain is price-sensitive to the balance of incentives and disincentives to innovation. American health policy should consider charting a middle course that introduces some form of regulatory price control, while stimulating and sustaining the benefits of market competition. That should incentivize stakeholders to take into account both resources and value for money in making decisions based on best-quality, clinical-economic evidence.


Assuntos
Indústria Farmacêutica/organização & administração , Farmacoeconomia/organização & administração , Invenções/economia , Motivação , Custos de Medicamentos/tendências , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência , Medicamentos Genéricos/economia , Política de Saúde , Humanos , Seguro de Serviços Farmacêuticos/tendências , Patentes como Assunto , Medição de Risco , Salários e Benefícios/tendências , Estados Unidos
11.
Bioprocess Biosyst Eng ; 42(9): 1399-1408, 2019 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-31119388

RESUMO

There is a growing interest in mining and handling of big data, which has been rapidly accumulating in the repositories of bioprocess industries. Biopharmaceutical industries are no exception; the implementation of advanced process control strategies based on multivariate monitoring techniques in biopharmaceutical production gave rise to the generation of large amounts of data. Real-time measurements of critical quality and performance attributes collected during production can be highly useful to understand and model biopharmaceutical processes. Data mining can facilitate the extraction of meaningful relationships pertaining to these bioprocesses, and predict the performance of future cultures. This review evaluates the suitability of various metaheuristic methods available for data pre-processing, which would involve the handling of missing data, the visualisation of the data, and dimension reduction; and for data processing, which would focus on modelling of the data and the optimisation of these models in the context of biopharmaceutical process development. The advantages and the associated challenges of employing different methodologies in pre-processing and processing of the data are discussed. In light of these evaluations, a summary guideline is proposed for handling and analysis of the data generated in biopharmaceutical process development.


Assuntos
Produtos Biológicos , Indústria Farmacêutica , Heurística , Modelos Teóricos , Desenvolvimento de Medicamentos , Indústria Farmacêutica/métodos , Indústria Farmacêutica/organização & administração , Indústria Farmacêutica/normas , Humanos
13.
Int J Technol Assess Health Care ; 35(2): 160-167, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31017564

RESUMO

OBJECTIVES: Before an intervention is publicly funded within the United Kingdom, the cost-effectiveness is assessed by the National Institute of Health and Care Excellence (NICE). The efficacy of an intervention across the patients' lifetime is often influential of the cost-effectiveness analyses, but is associated with large uncertainties. We reviewed committee documents containing company submissions and evidence review group (ERG) reports to establish the methods used when extrapolating survival data, whether these adhered to NICE Technical Support Document (TSD) 14, and how uncertainty was addressed. METHODS: A systematic search was completed on the NHS Evidence Search webpage limited to single technology appraisals of cancer interventions published in 2017, with information obtained from the NICE Web site. RESULTS: Twenty-eight appraisals were identified, covering twenty-two interventions across eighteen diseases. Every economic model used parametric curves to model survival. All submissions used goodness-of-fit statistics and plausibility of extrapolations when selecting a parametric curve. Twenty-five submissions considered alternate parametric curves in scenario analyses. Six submissions reported including the parameters of the survival curves in the probabilistic sensitivity analysis. ERGs agreed with the company's choice of parametric curve in nine appraisals, and agreed with all major survival-related assumptions in two appraisals. CONCLUSIONS: TSD 14 on survival extrapolation was followed in all appraisals. Despite this, the choice of parametric curve remains subjective. Recent developments in Bayesian approaches to extrapolation are not implemented. More precise guidance on the selection of curves and modelling of uncertainty may reduce subjectivity, accelerating the appraisal process.


Assuntos
Indústria Farmacêutica/organização & administração , Neoplasias/mortalidade , Avaliação da Tecnologia Biomédica/organização & administração , Teorema de Bayes , Análise Custo-Benefício , Indústria Farmacêutica/normas , Humanos , Modelos Econômicos , Modelos Estatísticos , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , Análise de Sobrevida , Avaliação da Tecnologia Biomédica/normas , Reino Unido
14.
Int J Technol Assess Health Care ; 35(2): 106-115, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30922418

RESUMO

OBJECTIVES: There is no established methodology to assess the feasibility of medicine price data sources. Against this backdrop, a framework to guide the selection of most appropriate price data sources for pharmacoeconomic research has been developed. METHODS: A targeted literature review was carried out. Dimensions discussed in literature as relevant for medicine price comparisons and practical experience of the authors in medicine price studies informed the conceptional work of the framework development. A draft version of the framework was reviewed by peer pricing experts. The feasibility of the framework was tested in case studies. RESULTS: According to the developed framework (called Re-ADAPT), a medicine price data source should meet the following criteria: reliability and sustainability; accessibility at a cost that users can afford; provision of medicine price information at the date(s) required; information for the defined geographic area, or at least in a representative way; coverage of the pharmaceuticals and at the price type(s) required. Easy handling and provision of additional information were defined as supportive assets of candidate data sources (secondary criteria). The case studies confirmed the feasibility of the Re-ADAPT framework. In some cases, however, it can be difficult to disentangle assessment criteria (particularly geographic area, scope of pharmaceuticals and price types) for separate consideration, given their interlinkage. CONCLUSIONS: While selection of the most appropriate data sources will remain a challenge, the Re-ADAPT framework aims to provide practical guidance and thus contribute to a more careful, balanced, and evidence-based selection of data sources for medicine price studies.


Assuntos
Comércio/organização & administração , Farmacoeconomia/organização & administração , Medicamentos sob Prescrição/economia , Avaliação da Tecnologia Biomédica/organização & administração , Comércio/normas , Custos e Análise de Custo , Indústria Farmacêutica/organização & administração , Farmacoeconomia/normas , Acesso aos Serviços de Saúde/economia , Humanos , Reprodutibilidade dos Testes , Características de Residência/estatística & dados numéricos , Avaliação da Tecnologia Biomédica/normas
16.
Int J Technol Assess Health Care ; 35(1): 10-16, 2019 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-30789111

RESUMO

OBJECTIVES: Evidence requirements and assessment methods access differ between health technology assessment (HTA) agencies. The HTA Core Model® provides a standardized approach to HTA, targeting evidence sharing and collaboration between participating HTA bodies. It is fit for purpose from an industry perspective and was used by pharmaceutical company Roche to develop a framework for internal assessment of evidence required for market access and coverage/reimbursement ("access evidence"). METHODS: Tools were developed to systematically scope, assess, plan, and summarize access evidence generation. The tools were based mainly on the first four HTA Core Model® domains and rolled-out in selected development teams in 2017. Five months after full implementation, the impact of tools was assessed in an internal survey. RESULTS: Systematic access evidence generation started with the Access Evidence Questionnaire, to scope evidence requirements and identify evidence gaps. Findings were summarized in the Access Evidence Metric, which assessed the alignment of available/planned evidence against HTA bodies' requirements and developed scope mitigation strategies. The Access Evidence Plan was then used to plan and document (additional) evidence generation. Once generated, evidence was summarized in the Access Evidence Dossier. A survey of twenty-seven Roche employees involved in evidence generation showed that the tools made discussions around access strategies and evidence more efficient and transparent. CONCLUSIONS: The HTA Core Model® provided a useful framework around which to optimize internal evidence generation and assessment. The benefits of using a standardized HTA approach in industry mirror those expected from implementing the HTA Core Model® in HTA agencies.


Assuntos
Indústria Farmacêutica/organização & administração , Marketing de Serviços de Saúde/organização & administração , Preparações Farmacêuticas , Avaliação da Tecnologia Biomédica/organização & administração , Indústria Farmacêutica/normas , Europa (Continente) , Prática Clínica Baseada em Evidências , Humanos , Marketing de Serviços de Saúde/normas , Avaliação da Tecnologia Biomédica/normas , Fatores de Tempo
17.
Am J Public Health ; 109(4): 559-561, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30789768

RESUMO

OBJECTIVES: To examine whether the share of pharmaceutical industry funds allocated to patient advocacy organizations (PAOs) is disproportionately large in the United States relative to other industrialized countries and to compare pharmaceutical companies' disclosure practices across industrialized countries. METHODS: We examined funding of PAOs among the 10 largest pharmaceutical companies in 2016. We compared funding allocated to organizations across 8 large industrialized countries and pharmaceutical companies' disclosure practices in each country. RESULTS: Only 6 of the 10 largest pharmaceutical companies disclosed their financial transactions with PAOs in the United States. All 10 companies disclosed transactions in France, Germany, and the United Kingdom, with varying levels of disclosure in other countries. In 2016, the 6 companies that disclosed transactions in the United States allocated 74% of their patient advocacy funding ($88 million) in the United States. CONCLUSIONS: The disproportionate funding of US PAOs in the absence of any disclosure requirements suggests that the United States should consider adoption of regulatory actions to enhance the transparency of relationships between the pharmaceutical industry and PAOs, and to ensure the integrity of public health decision-making.


Assuntos
Revelação/ética , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Defesa do Paciente/economia , Responsabilidade Social , Conflito de Interesses/economia , Países Desenvolvidos/economia , Indústria Farmacêutica/legislação & jurisprudência , Política de Saúde/economia , Humanos , Formulação de Políticas , Estados Unidos
18.
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 , Assistência à Saúde/economia , Acesso aos Serviços de Saúde , Terapias em Estudo/economia , Orçamentos , Consenso , Assistência à Saúde/organização & administração , Técnica Delfos , Aprovação de Drogas , Indústria Farmacêutica/economia , Indústria Farmacêutica/organização & administração , Guias como Assunto , Política de Saúde , Humanos , Inquéritos e Questionários , Estados Unidos
20.
Toxicol Pathol ; 47(2): 121-128, 2019 02.
Artigo em Inglês | MEDLINE | ID: mdl-30651043

RESUMO

GlaxoSmithKline has recently made significant organizational changes to its nonclinical safety, drug metabolism and pharmacokinetic, and laboratory animal science/veterinary functions, with the goal to increase our focus on scientific partnership with the discovery part of the organization. One specific change was bringing together pathologists and comparative medicine veterinarians and scientists into a single functional unit. We describe our early activities (assessing our capabilities and gaps, external benchmarking, listening to our discovery partners, redesigning some of our working practices) aimed at implementing these changes. In addition, early on we held a Discovery Engagement Workshop attended by all pathologists and comparative medicine veterinarians and scientists, as well as selected discovery scientists. The purpose of this workshop was to share learnings from the above activities and devise plans aimed at achieving our overall goal of functional integration: driving pathobiology expertise into drug discovery and increasing the human (translational) relevance of experimental data. This review describes the new organizational structure, the workshop activities, and implementation plans; updates our progress; and considers the opportunity for a pan-industry network of discovery-focused pathologists and comparative medicine veterinarians and scientists.


Assuntos
Descoberta de Drogas/métodos , Indústria Farmacêutica/organização & administração , Pessoal de Laboratório , Patologistas , Animais , Avaliação Pré-Clínica de Medicamentos/métodos , Humanos , Patologia , Médicos Veterinários
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