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2.
J Manag Care Spec Pharm ; : 1-11, 2024 Jun 21.
Artigo em Inglês | MEDLINE | ID: mdl-38905356

RESUMO

BACKGROUND: The Centers for Medicare and Medicaid Services (CMS) are currently negotiating prices with pharmaceutical manufacturers for the first 10 Part D drugs selected for Medicare drug price negotiation. Non-publicly available data, including the net prices of selected drugs and their therapeutic alternatives, will play a central role in the determination of the maximum fair prices (MFPs). OBJECTIVE: To estimate price benchmarks involved in the derivation of the starting point of the CMS initial price offer for the 10 drugs selected for Medicare price negotiation. METHODS: For the 10 drugs selected for negotiation, we reported (1) the list price, (2) the net price after manufacturer discounts, (3) the maximum negotiated price based on the minimum statutory discount, and (4) the ceiling of the MFP, estimated as the lowest of the latter 2. We also estimated net prices for therapeutic alternatives to the selected drugs. Net prices were estimated using peer-reviewed methodology that isolates commercial discounts negotiated between payers and manufacturers from mandatory discounts under government programs. All price benchmarks were estimated at the product level, for 30-day equivalent dosing, using 2021 data. RESULTS: 6 products (apixaban, rivaroxaban, empagliflozin, sacubitril/valsartan, etanercept, and insulin aspart) had therapeutic alternatives with lower net prices, which will be integrated with clinical benefit data in the derivation of initial price offers. The other 4 products (ustekinumab, ibrutinib, sitagliptin, and dapagliflozin) had therapeutic alternatives with higher net prices than the drugs selected for negotiation. For ibrutinib and ustekinumab, prices based on the minimum discounts were considerably lower than the estimated net prices and will likely set the starting point of the initial price offer. For dapagliflozin and sitagliptin, the starting point of the initial price offer will likely resemble their existing net prices. CONCLUSIONS: Our analyses identify different negotiation scenarios for the first 10 drugs selected for Medicare price negotiation, based on key elements involved in the derivation of the initial price offer. Our analyses can help improve transparency in the negotiation process, because the CMS is not required to reveal the information used in the derivation of price offers.

5.
JAMA Intern Med ; 184(3): 328-330, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38285561

RESUMO

This cohort study analyzes review times and approval outcomes of health technology assessments conducted in 6 high-income countries for novel therapeutic agents approved by the US Food and Drug Administration.


Assuntos
Aprovação de Drogas , Avaliação da Tecnologia Biomédica , Humanos , Estados Unidos , Países Desenvolvidos , United States Food and Drug Administration
6.
J Manag Care Spec Pharm ; 30(3): 218-225, 2024 Mar 01.
Artigo em Inglês | MEDLINE | ID: mdl-38088899

RESUMO

Under the 2022 Inflation Reduction Act, the Centers for Medicare and Medicaid Services (CMS) are able to negotiate prices for topselling drugs in the Medicare Part B and D programs. In determining initial price offers, CMS will compare the prices and clinical benefits of the drugs subject to negotiation to the prices and clinical benefits of therapeutic alternatives. Despite the central role that the selection of therapeutic alternatives will play in the price negotiations, the available guidance published by CMS provides few details about how the organization will undertake this process, which will be particularly complex for drugs approved for more than one indication. To better inform the selection process, we identified all US Food and Drug Administration-approved indications for the first 10 drugs subject to negotiation. Using 2020-2021 Medicare claims data, we identified Medicare Part D beneficiaries using each of the 10 drugs. We extracted medical claims with diagnosis codes for each of the approved indications to report the relative treated prevalence of use by indication for each drug. We reviewed published clinical guidelines to identify relevant therapeutic alternatives for each of the indications. We integrated the evidence on the relative treated prevalence of indications and clinical guidelines to propose therapeutic alternatives for each of the 10 drugs. We describe challenges that CMS may face in selecting therapeutic alternatives.


Assuntos
Medicare Part B , Medicare Part D , Idoso , Humanos , Centers for Medicare and Medicaid Services, U.S. , Negociação , Estados Unidos , United States Food and Drug Administration
7.
JAMA Health Forum ; 4(9): e232798, 2023 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-37656469

RESUMO

This Viewpoint compares the research and development costs for a drug's first indication with supplemental indications to demonstrate that the cost of approval for supplemental indications may be substantially lower.

8.
Health Policy ; 133: 104844, 2023 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-37269803

RESUMO

The crowded global health landscape has been joined by the European Union Health Emergency Preparedness and Response Authority (HERA). HERA will assume four broad areas of responsibility: horizon scanning for major health threats; research and development; support for capacity to manufacture drugs, vaccines, and equipment; and procuring and stockpiling key medical countermeasures. In this Health Reform Monitor article, we outline the reform process and describe HERA's structure and responsibilities, explore issues that arise from the creation of this new organisation, and suggest options for collaboration with existing bodies in Europe and beyond. The COVID-19 pandemic and other infectious disease outbreaks have shown the need to treat health as a cross-border issue, and there is now a broad consensus that greater direction and coordination at the European level is needed. This ambition has been matched with a considerable increase in EU funding to tackle cross-border health threats, and HERA can be used to deploy this funding in an effective manner. Yet this is contingent upon clearly defining its role and responsibilities vis-à-vis existing agencies to reduce redundancies.


Assuntos
COVID-19 , Defesa Civil , Humanos , Pandemias/prevenção & controle , Reforma dos Serviços de Saúde , COVID-19/prevenção & controle , Surtos de Doenças/prevenção & controle , Saúde Global
9.
Vaccine ; 41(17): 2804-2810, 2023 04 24.
Artigo em Inglês | MEDLINE | ID: mdl-36967287

RESUMO

BACKGROUND: The COVID-19 pandemic highlighted the fragmented nature of governmental policy decisions in Europe. However, the extent to which COVID-19 vaccination policies differed between European countries remains unclear. Here, we mapped the COVID-19 vaccination policies that were in effect in January 2022 as well as booster regulations in April 2022 in Austria, Denmark, England, France, Germany, Ireland, Italy, the Netherlands, Poland, and Spain. METHODS: National public health and health policy experts from these ten European nations developed and completed an electronic questionnaire. The questionnaire included a series of questions that addressed six critical components of vaccine implementation, including (1) authorization, (2) prioritization, (3) procurement and distribution, (4) data collection, (5) administration, and (6) mandate requirements. RESULTS: Our findings revealed significant variations in COVID-19 vaccination policies across Europe. We observed critical differences in COVID-19 vaccine formulations authorized for use, as well as the specific groups that were provided with priority access. We also identified discrepancies in how vaccination-related data were recorded in each country and what vaccination requirements were implemented. CONCLUSION: Each of the ten European nations surveyed in this study reported different COVID-19 vaccination policies. These differences complicated efforts to provide a coordinated pandemic response. These findings might alert policymakers in Europe of the need to coordinate their efforts to avoid fostering divergent and socially disruptive policies.


Assuntos
Vacinas contra COVID-19 , COVID-19 , Humanos , Pandemias/prevenção & controle , COVID-19/epidemiologia , COVID-19/prevenção & controle , Europa (Continente)/epidemiologia , Política de Saúde
11.
JAMA ; 329(1): 87-89, 2023 01 03.
Artigo em Inglês | MEDLINE | ID: mdl-36594955

RESUMO

This study quantifies the revenue earned on all brand-name inhalers approved by the US Food and Drug Administration from 2000 to 2021 and compared earnings before and after expiration of primary patents on these products.


Assuntos
Indústria Farmacêutica , Competição Econômica , Nebulizadores e Vaporizadores , Patentes como Assunto , Medicamentos Genéricos , Competição Econômica/economia , Nebulizadores e Vaporizadores/economia , Estados Unidos , Patentes como Assunto/legislação & jurisprudência , Indústria Farmacêutica/economia , Indústria Farmacêutica/legislação & jurisprudência
13.
Int J Health Policy Manag ; 12: 7261, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36243948

RESUMO

Regulation of health technologies must be rigorous, instilling trust among both healthcare providers and patients. This is especially important for the control and supervision of the growing use of artificial intelligence in healthcare. In this commentary on the accompanying piece by Van Laere and colleagues, we set out the scope for applying artificial intelligence in the healthcare sector and outline five key challenges that regulators face in dealing with these modern-day technologies. Addressing these challenges will not be easy. While artificial intelligence applications in healthcare have already made rapid progress and benefitted patients, these applications clearly hold even more potential for future developments. Yet it is vital that the regulatory environment keep up with this fast-evolving space of healthcare in order to anticipate and, to the extent possible, prevent the risks that may arise.


Assuntos
Inteligência Artificial , Sistemas de Apoio a Decisões Clínicas , Humanos , Atenção à Saúde , Instalações de Saúde , Tecnologia
15.
JAMA Netw Open ; 5(9): e2218623, 2022 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-36156148

RESUMO

Importance: Drug companies frequently claim that high prices are needed to recoup spending on research and development. If high research and development costs justified high drug prices, then an association between these 2 measures would be expected. Objective: To examine the association between treatment costs and research and development investments for new therapeutic agents approved by the US Food and Drug Administration (FDA) from 2009 to 2018. Design, Setting, and Participants: This cross-sectional study analyzed 60 drugs approved by the FDA between January 1, 2009, and December 31, 2018, for which data on research and development investments and list or net prices were available. Data sources included the FDA and SSR Health databases. Main Outcomes and Measures: The primary independent variable was estimated research and development investment. The outcome was standardized treatment costs (ie, annual treatment costs for both chronic and cycle drugs, and treatment costs for the maximum length of treatment recommended for acute drugs). Standardized treatment costs were estimated separately using list and net prices obtained from SSR Health at the time of launch and in 2021. To test the association between research and development investments and treatment costs, correlation coefficients were estimated and linear regression models were fitted that controlled for other factors that were associated with treatment costs, such as orphan status. Two models were used: a fully adjusted model that was adjusted for all variables in the data set associated with treatment costs and a parsimonious model in which highly correlated variables were excluded. Results: No correlation was observed between estimated research and development investments and log-adjusted treatment costs based on list prices at launch (R = -0.02 and R2 = 0.0005; P = .87) or net prices 1 year after launch (R = 0.08 and R2 = 0.007; P = .73). This result held when 2021 prices were used to estimate treatment costs. The linear regression models showed no association between estimated research and development investments and log-adjusted treatment costs at launch (ß = 0.002 [95% CI, -0.02 to 0.02; P = .84] in the fully adjusted model; ß = 0.01 [95% CI, -0.01 to 0.03; P = .46] in the parsimonious model) or from 2021 (ß = -0.01 [95% CI, -0.03 to 0.01; P = .30] in the fully adjusted model; ß = -0.004 [95% CI, -0.02 to 0.02; P = .66] in the parsimonious model). Conclusions and Relevance: Results of this study indicated that research and development investments did not explain the variation in list prices for the 60 drugs in this sample. Drug companies should make further data available to support their claims that high drug prices are needed to recover research and development investments, if they are to continue to use this argument to justify high prices.


Assuntos
Custos de Medicamentos , Indústria Farmacêutica , Custos e Análise de Custo , Estudos Transversais , Humanos , Pesquisa
17.
Lancet Reg Health Eur ; 9: 100221, 2021 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-34642675

RESUMO

Since 2005, the world has faced several public health emergencies of international concern arising from infectious disease outbreaks. Of these, the COVID-19 pandemic has had by far the greatest health and economic consequences. During these emergencies, responses taken by one country often have an impact on other countries. The implication is that coordination between countries is likely to achieve better outcomes, individually and collectively, than each country independently pursuing its own self-interest. During the COVID-19 pandemic, gaps in multilateral cooperation on research and information sharing, vaccine development and deployment, and travel policies have hampered the speed and equity of global recovery. In this Health Policy article, we explore how multilateral collaboration between countries is crucial to successful responses to public health emergencies linked to infectious disease outbreaks. Responding to future global infectious disease threats and other health emergencies will require the creation of stronger mechanisms for multilateral collaboration before they arise. A change to the governance of multilateral institutions is a logical next step, with a focus on providing equal ownership and leadership opportunities to all member countries. Europe can be an example and advocate for stronger and better governed multilateral institutions.

18.
Lancet ; 397(10278): 1023-1034, 2021 03 13.
Artigo em Inglês | MEDLINE | ID: mdl-33587887

RESUMO

The COVID-19 pandemic is unlikely to end until there is global roll-out of vaccines that protect against severe disease and preferably drive herd immunity. Regulators in numerous countries have authorised or approved COVID-19 vaccines for human use, with more expected to be licensed in 2021. Yet having licensed vaccines is not enough to achieve global control of COVID-19: they also need to be produced at scale, priced affordably, allocated globally so that they are available where needed, and widely deployed in local communities. In this Health Policy paper, we review potential challenges to success in each of these dimensions and discuss policy implications. To guide our review, we developed a dashboard to highlight key characteristics of 26 leading vaccine candidates, including efficacy levels, dosing regimens, storage requirements, prices, production capacities in 2021, and stocks reserved for low-income and middle-income countries. We use a traffic-light system to signal the potential contributions of each candidate to achieving global vaccine immunity, highlighting important trade-offs that policy makers need to consider when developing and implementing vaccination programmes. Although specific datapoints are subject to change as the pandemic response progresses, the dashboard will continue to provide a useful lens through which to analyse the key issues affecting the use of COVID-19 vaccines. We also present original data from a 32-country survey (n=26 758) on potential acceptance of COVID-19 vaccines, conducted from October to December, 2020. Vaccine acceptance was highest in Vietnam (98%), India (91%), China (91%), Denmark (87%), and South Korea (87%), and lowest in Serbia (38%), Croatia (41%), France (44%), Lebanon (44%), and Paraguay (51%).


Assuntos
Vacinas contra COVID-19/classificação , Vacinas contra COVID-19/economia , Vacinas contra COVID-19/provisão & distribuição , COVID-19/prevenção & controle , Desenvolvimento de Medicamentos , Programas de Imunização , Saúde Global , Acessibilidade aos Serviços de Saúde , Humanos , Cooperação Internacional , Aceitação pelo Paciente de Cuidados de Saúde , Alocação de Recursos
19.
Soc Sci Med ; 263: 113247, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-32799026

RESUMO

In the past decade, the Chinese central government has made sweeping reforms to national pharmaceutical policies. However, provincial authorities have retained control over most drug procurement procedures, potentially leading to cross-province differences in drug prices. The objectives of this study were to (i) examine drug price trends in 31 Chinese provinces and municipalities between 2010 and 2017; (ii) evaluate the association between provincial income levels and drug prices over this period; and (iii) compare the results for Chinese state-owned, Chinese private, and multinational pharmaceutical firms. Using publicly available data on procurement prices of the drugs manufactured by the top 30 pharmaceutical firms in China (in terms of revenues), we ran a generalized country-product-dummy regression to compare drug prices across provinces over the study period. We conducted subgroup analyses to test for differences between types of firms. Between 2010 and 2017, drug prices decreased by an average of 23% across the country. The prices of drugs sold by multinational firms dropped by 32% over this period, while the prices of drugs sold by Chinese private firms declined by 28%. By contrast, the drug prices of state-owned firms went up by 11%. There were statistically significant positive associations between drug prices and provincial income levels for the full sample in 2010, 2011, and 2013. There were no significant associations in other years. Several low-income provinces paid higher procurement prices than some high-income provinces for identical medicines, especially in later study years. The lack of association between income levels and prices poses equity concerns and may place a heavier cost burden on the poor. It also suggests that China's pharmaceutical policies may be failing to balance the dual aims of drug affordability and incentives for innovation.


Assuntos
Acessibilidade aos Serviços de Saúde , Preparações Farmacêuticas , China , Comércio , Custos e Análise de Custo , Custos de Medicamentos , Humanos
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