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1.
N Engl J Med ; 2020 Apr 14.
Artigo em Inglês | MEDLINE | ID: mdl-32289216
3.
Clin Infect Dis ; 2020 Jan 30.
Artigo em Inglês | MEDLINE | ID: mdl-32022228
6.
Clin Infect Dis ; 2019 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-31630159

RESUMO

BACKGROUND: To address the growing threat of multidrug resistant organisms, policymakers are seeking ideas to promote development of novel antibiotics. In 2018, the REVAMP Act was proposed in Congress to reward manufacturers of certain novel antibiotics with transferrable market exclusivity vouchers. METHODS: We estimated the economic impact of this proposal by identifying antimicrobial drugs approved by the FDA from 2007 - 2016 that would likely have qualified for an exclusivity voucher and matching each drug to the highest-revenue fast-track drug facing generic entry within 4 years after the antibiotic was approved. Assuming a spending decrease of 75% after generic entry, we calculated the per-drug and total societal costs of these transferrable market exclusivity extensions over a decade. RESULTS: We identified 10 antimicrobials that would have qualified for an exclusivity voucher, each of which was matched with one of 17 fast-track drugs facing generic entry through July 2019. These 10 drugs had a median annual revenue prior to generic entry of $249 million (range: $26 million - $2.7 billion). Accounting for a 75% spending reduction after generic entry, the median excess spending associated with 12 months of extended exclusivity was $187 million, for a total of $4.5 billion over 10 years. CONCLUSIONS: While market exclusivity extensions are a politically appealing mechanism to encourage novel antibiotic development, this approach would cost public and private payers billions of dollars over the next decade.

8.
Health Aff (Millwood) ; 36(2): 362-370, 2017 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-28100464

RESUMO

To incentivize pharmaceutical manufacturers to invest in areas of unmet medical need, policy makers frequently propose extending the market exclusivity period of desired drugs. Some such proposals are modeled after the pediatric exclusivity patent extension program, which since 1997 has provided six additional months of market exclusivity for drugs studied in children. The most recent proposal would encourage rare disease research by providing six months of extended exclusivity for any existing drug that is granted subsequent FDA approval for a new rare disease indication. Yet the economic impact of such proposals is rarely addressed. We found that for the thirteen FDA-approved drugs that gained supplemental approval for a rare disease indication from 2005 through 2010, the median projected cost of clinical trials leading to approval was $29.8 million. If the exclusivity extension had been in place, the median discounted financial gain to manufacturers would have been $94.6 million. Median net returns would have been $82.4 million, with higher returns for drugs with higher annual sales. Extending market exclusivity would provide substantial compensation to many manufacturers, particularly for top-selling products, far in excess of the cost of conducting these trials. Alternative strategies to incentivize the study of approved drugs for rare diseases may offer similar benefits at a lower cost.


Assuntos
Ensaios Clínicos como Assunto , Custos e Análise de Custo/estatística & dados numéricos , Indústria Farmacêutica/economia , Doenças Raras/tratamento farmacológico , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/legislação & jurisprudência , Ensaios Clínicos como Assunto/normas , Aprovação de Drogas , Custos de Medicamentos , Humanos , Marketing/economia , Pesquisa , Estados Unidos , United States Food and Drug Administration
9.
Curr Cardiol Rep ; 16(6): 489, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24760423

RESUMO

Since 1976, the US Food and Drug Administration (FDA) has used the premarket approval (PMA) process to approve high-risk medical devices, including implantable cardioverter defibrillators (ICDs), coronary stents, and artificial heart valves. The PMA process is widely viewed as a rigorous evaluation of device safety and effectiveness, though recent recalls-most notably related to underperforming ICD leads-have raised concerns about whether physicians and patients should sometimes be more wary about devices approved via this pathway. The FDA must utilize a "least burdensome" approach to approve new medical devices, and many widely used device models have been approved as supplements to existing PMA-approved devices with limited clinical testing. A recent Supreme Court ruling has made it difficult for patients harmed by unsafe PMA-approved devices to seek damages in court. Cardiologists who utilize high-risk medical devices should be aware that FDA approval of new devices relies on variable levels of evidence and does not necessarily indicate improved effectiveness over existing models. Clinician and patient engagement in postmarket surveillance and comparative effectiveness research remains imperative.


Assuntos
Cardiologia/instrumentação , Desfibriladores Implantáveis , Aprovação de Equipamentos/normas , Próteses Valvulares Cardíacas , Vigilância de Produtos Comercializados/normas , Segurança de Equipamentos , Feminino , Humanos , Masculino , Medição de Risco , Estados Unidos , United States Food and Drug Administration
10.
J Arthroplasty ; 29(7): 1378-1382.e1, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24684938

RESUMO

Range of motion (ROM) is an important component of the assessment of total knee arthroplasty (TKA) outcome. We compared patient-reported versus clinically observed ROM in a prospective cohort. Clinically observed ROM was measured using a goniometer by a trained research assistant. Self-reported ROM was estimated using a set of lateral knee photographs depicting varying levels of flexion and extension. All measures were taken pre-operatively, three, and six months postoperatively. We found statistically significant associations between self-reported ROM and clinically observed ROM for flexion and extension (all P < 0.001). We dichotomized flexion at 90° and found that self-report had a specificity of 94% and sensitivity of 65%. We conclude that patient-reported ROM may be a useful outcome measure for TKA.


Assuntos
Artroplastia do Joelho , Osteoartrite do Joelho/fisiopatologia , Amplitude de Movimento Articular , Idoso , Feminino , Humanos , Articulação do Joelho/cirurgia , Masculino , Pessoa de Meia-Idade , Ortopedia/métodos , Estudos Prospectivos , Autorrelato , Sensibilidade e Especificidade , Fatores de Tempo , Resultado do Tratamento
11.
JAMA ; 311(4): 385-91, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24449317

RESUMO

IMPORTANCE: The US Food and Drug Administration (FDA) evaluates high-risk medical devices such as cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy devices, via the premarket approval (PMA) process, during which manufacturers submit clinical data demonstrating safety and effectiveness. Subsequent changes to approved high-risk devices are implemented via "supplements," which may not require additional clinical testing. OBJECTIVE: To characterize the prevalence and characteristics of changes to CIEDs made through the PMA supplement process. DESIGN: Using the FDA's PMA database, we reviewed all CIEDs approved as original PMAs or supplements from 1979 through 2012. For each supplement, we collected the date approved, type of supplement (panel-track, 180-day, real-time, special, and 30-day notice), and the nature of the changes. We calculated the number of supplements approved per PMA and analyzed trends relating to different supplement regulatory categories over time. For supplements approved via the 180-day regulatory pathway, which often involve significant design changes, from 2010-2012, we identified how often additional clinical data were collected. RESULTS: From 1979-2012, the FDA approved 77 original and 5829 supplement PMA applications for CIEDs, with a median of 50 supplements per original PMA (interquartile range [IQR], 23-87). Excluding manufacturing changes that do not alter device design, the number of supplements approved each year was stable around a mean (SD) of 2.6 (0.9) supplements per PMA per year. Premarket approvals remained active via successive supplements over a median period of 15 years (IQR, 8-20), and 79% of the 77 original PMAs approved during our study period were the subject of at least 1 supplement in 2012. Thirty-seven percent of approved supplements involved a change to the device's design. Among 180-day supplements approved from 2010-2012, 23% (15/64) included new clinical data to support safety and effectiveness. CONCLUSIONS AND RELEVANCE: Many CIED models currently used by clinicians were approved via the PMA supplement process, not as original PMAs. Most new device models are deemed safe and effective without requiring new clinical data, reinforcing the importance of rigorous postapproval surveillance of these devices.


Assuntos
Desfibriladores Implantáveis , Aprovação de Equipamentos/normas , Marca-Passo Artificial , United States Food and Drug Administration , Desfibriladores Implantáveis/efeitos adversos , Desfibriladores Implantáveis/normas , Segurança de Equipamentos , Marca-Passo Artificial/efeitos adversos , Marca-Passo Artificial/normas , Vigilância de Produtos Comercializados , Estados Unidos
12.
BMC Musculoskelet Disord ; 14: 290, 2013 Oct 12.
Artigo em Inglês | MEDLINE | ID: mdl-24119081

RESUMO

BACKGROUND: Utilization of total knee arthroplasty is increasing rapidly. A substantial number of total knee arthroplasty recipients have persistent pain after surgery. Our objective was to design a randomized controlled trial to establish the efficacy of a motivational-interviewing-based telephone intervention aimed at improving patient outcomes and satisfaction following total knee arthroplasty. METHODS/DESIGN: The study was conducted at Brigham and Women's Hospital in Boston, Massachusetts. The study focused on individuals 40 years or older with a primary diagnosis of osteoarthritis who were scheduled for total knee arthroplasty. The study compared two management strategies over the first six months postoperatively: 1) enhanced postoperative care with frequent follow-up by a care navigator; 2) usual postoperative care. Those who were randomized into the enhanced postoperative care arm received ten calls from a trained non-clinician care navigator over the first six postoperative months. The navigator used motivational interviewing techniques to engage patients in discussions related to their rehabilitation goals, including patient's plans for and confidence in achieving those goals. Patients in the usual care arm received standard postoperative management and received no navigator phone calls. Patients in both arms were assessed at baseline, three months, and six months postoperatively. DISCUSSION: The primary outcome of the study was improvement in function as measured by the difference in Western Ontario and McMaster Universities Osteoarthritis Index function score between preoperative (baseline) status and six months postoperatively. Data were collected to identify factors that may be related to total knee arthroplasty outcomes, including preoperative pain, pain catastrophizing, self-efficacy, and depression. A formal economic analysis is also planned to determine the cost-effectiveness of the care navigator as a component of total knee arthroplasty care. TRIAL REGISTRATION: ClinicalTrials.gov NCT01540851.


Assuntos
Artroplastia do Joelho/reabilitação , Entrevista Motivacional , Osteoartrite do Joelho/cirurgia , Dor Pós-Operatória/prevenção & controle , Navegação de Pacientes , Cuidados Pós-Operatórios/métodos , Projetos de Pesquisa , Adulto , Artroplastia do Joelho/efeitos adversos , Artroplastia do Joelho/economia , Boston , Análise Custo-Benefício , Custos de Cuidados de Saúde , Humanos , Entrevista Motivacional/economia , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/economia , Osteoartrite do Joelho/fisiopatologia , Medição da Dor , Dor Pós-Operatória/diagnóstico , Dor Pós-Operatória/economia , Dor Pós-Operatória/etiologia , Navegação de Pacientes/economia , Satisfação do Paciente , Cuidados Pós-Operatórios/economia , Recuperação de Função Fisiológica , Inquéritos e Questionários , Telefone , Fatores de Tempo , Resultado do Tratamento
13.
PLoS One ; 8(5): e62709, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23671626

RESUMO

BACKGROUND: Total knee arthroplasty (TKA) is common, effective, and cost-effective. Innovative implants promising reduced long-term failure at increased cost are under continual development. We sought to define the implant cost and performance thresholds under which innovative TKA implants are cost-effective. METHODS: We performed a cost-effectiveness analysis using a validated, published computer simulation model of knee osteoarthritis. Model inputs were derived using published literature, Medicare claims, and National Health and Nutrition Examination Survey data. We compared projected TKA implant survival, quality-adjusted life expectancy (QALE), lifetime costs, and cost-effectiveness (incremental cost-effectiveness ratios or ICERs) of standard versus innovative TKA implants. We assumed innovative implants offered 5-70% decreased long-term TKA failure rates at costs 20-400% increased above standard implants. We examined the impact of patient age, comorbidity, and potential increases in short-term failure on innovative implant cost-effectiveness. RESULTS: Implants offering ≥50% decrease in long-term TKA failure at ≤50% increased cost offered ICERs <$100,000 regardless of age or baseline comorbidity. An implant offering a 20% decrease in long-term failure at 50% increased cost provided ICERs <$150,000 per QALY gained only among healthy 50-59-year-olds. Increasing short-term failure, consistent with recent device failures, reduced cost-effectiveness across all groups. Increasing the baseline likelihood of long-term TKA failure among younger, healthier and more active individuals further enhanced innovative implant cost-effectiveness among younger patients. CONCLUSIONS: Innovative implants must decrease actual TKA failure, not just radiographic wear, by 50-55% or more over standard implants to be broadly cost-effective. Comorbidity and remaining life span significantly affect innovative implant cost-effectiveness and should be considered in the development, approval and implementation of novel technologies, particularly in orthopedics. Model-based evaluations such as this offer valuable, unique insights for evaluating technological innovation in medical devices.


Assuntos
Artroplastia do Joelho/economia , Prótese do Joelho/economia , Osteoartrite do Joelho/cirurgia , Fatores Etários , Idoso , Análise Custo-Benefício , Humanos , Prótese do Joelho/normas , Pessoa de Meia-Idade , Modelos Econômicos , Osteoartrite do Joelho/economia , Falha de Prótese , Melhoria de Qualidade , Qualidade de Vida , Sensibilidade e Especificidade , Falha de Tratamento
14.
N Engl J Med ; 368(18): 1675-84, 2013 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-23506518

RESUMO

BACKGROUND: Whether arthroscopic partial meniscectomy for symptomatic patients with a meniscal tear and knee osteoarthritis results in better functional outcomes than nonoperative therapy is uncertain. METHODS: We conducted a multicenter, randomized, controlled trial involving symptomatic patients 45 years of age or older with a meniscal tear and evidence of mild-to-moderate osteoarthritis on imaging. We randomly assigned 351 patients to surgery and postoperative physical therapy or to a standardized physical-therapy regimen (with the option to cross over to surgery at the discretion of the patient and surgeon). The patients were evaluated at 6 and 12 months. The primary outcome was the difference between the groups with respect to the change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) physical-function score (ranging from 0 to 100, with higher scores indicating more severe symptoms) 6 months after randomization. RESULTS: In the intention-to-treat analysis, the mean improvement in the WOMAC score after 6 months was 20.9 points (95% confidence interval [CI], 17.9 to 23.9) in the surgical group and 18.5 (95% CI, 15.6 to 21.5) in the physical-therapy group (mean difference, 2.4 points; 95% CI, -1.8 to 6.5). At 6 months, 51 active participants in the study who were assigned to physical therapy alone (30%) had undergone surgery, and 9 patients assigned to surgery (6%) had not undergone surgery. The results at 12 months were similar to those at 6 months. The frequency of adverse events did not differ significantly between the groups. CONCLUSIONS: In the intention-to-treat analysis, we did not find significant differences between the study groups in functional improvement 6 months after randomization; however, 30% of the patients who were assigned to physical therapy alone underwent surgery within 6 months. (Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases; METEOR ClinicalTrials.gov number, NCT00597012.).


Assuntos
Osteoartrite do Joelho/cirurgia , Osteoartrite do Joelho/terapia , Modalidades de Fisioterapia , Lesões do Menisco Tibial , Feminino , Humanos , Análise de Intenção de Tratamento , Traumatismos do Joelho/cirurgia , Traumatismos do Joelho/terapia , Masculino , Meniscos Tibiais/cirurgia , Pessoa de Meia-Idade , Medição da Dor , Modalidades de Fisioterapia/efeitos adversos , Complicações Pós-Operatórias , Recuperação de Função Fisiológica , Índice de Gravidade de Doença
15.
J Bone Joint Surg Am ; 95(5): 385-92, 2013 Mar 06.
Artigo em Inglês | MEDLINE | ID: mdl-23344005

RESUMO

BACKGROUND: In the last decade, the number of total knee replacements performed annually in the United States has doubled, with disproportionate increases among younger adults. While total knee replacement is a highly effective treatment for end-stage knee osteoarthritis, total knee replacement recipients can experience persistent pain and severe complications. We are aware of no current estimates of the prevalence of total knee replacement among adults in the U.S. METHODS: We used the Osteoarthritis Policy Model, a validated computer simulation model of knee osteoarthritis, and data on annual total knee replacement utilization to estimate the prevalence of primary and revision total knee replacement among adults fifty years of age or older in the U.S. We combined these prevalence estimates with U.S. Census data to estimate the number of adults in the U.S. currently living with total knee replacement. The annual incidence of total knee replacement was derived from two longitudinal knee osteoarthritis cohorts and ranged from 1.6% to 11.9% in males and from 2.0% to 10.9% in females. RESULTS: We estimated that 4.0 million (95% confidence interval [CI]: 3.6 million to 4.4 million) adults in the U.S. currently live with a total knee replacement, representing 4.2% (95% CI: 3.7% to 4.6%) of the population fifty years of age or older. The prevalence was higher among females (4.8%) than among males (3.4%) and increased with age. The lifetime risk of primary total knee replacement from the age of twenty-five years was 7.0% (95% CI: 6.1% to 7.8%) for males and 9.5% (95% CI: 8.5% to 10.5%) for females. Over half of adults in the U.S. diagnosed with knee osteoarthritis will undergo a total knee replacement. CONCLUSIONS: Among older adults in the U.S., total knee replacement is considerably more prevalent than rheumatoid arthritis and nearly as prevalent as congestive heart failure. Nearly 1.5 million of those with a primary total knee replacement are fifty to sixty-nine years old, indicating that a large population is at risk for costly revision surgery as well as possible long-term complications of total knee replacement.


Assuntos
Artroplastia do Joelho/estatística & dados numéricos , Osteoartrite do Joelho/cirurgia , Adulto , Distribuição por Idade , Idoso , Idoso de 80 Anos ou mais , Simulação por Computador , Efeitos Psicossociais da Doença , Progressão da Doença , Feminino , Humanos , Incidência , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Modelos Biológicos , Osteoartrite do Joelho/epidemiologia , Reoperação/estatística & dados numéricos , Risco , Distribuição por Sexo , Estados Unidos/epidemiologia
16.
Arthritis Care Res (Hoboken) ; 65(5): 703-11, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23203864

RESUMO

OBJECTIVE: To estimate the incidence and lifetime risk of diagnosed symptomatic knee osteoarthritis (OA) and the age at diagnosis of knee OA based on self-reports in the US population. METHODS: We estimated the incidence of diagnosed symptomatic knee OA in the US by combining data on age-, sex-, and obesity-specific prevalence from the 2007-2008 National Health Interview Survey, with disease duration estimates derived from the Osteoarthritis Policy (OAPol) Model, a validated computer simulation model of knee OA. We used the OAPol Model to estimate the mean and median ages at diagnosis and lifetime risk. RESULTS: The estimated incidence of diagnosed symptomatic knee OA was highest among adults ages 55-64 years, ranging from 0.37% per year for nonobese men to 1.02% per year for obese women. The estimated median age at knee OA diagnosis was 55 years. The estimated lifetime risk was 13.83%, ranging from 9.60% for nonobese men to 23.87% in obese women. Approximately 9.29% of the US population is diagnosed with symptomatic knee OA by age 60 years. CONCLUSION: The diagnosis of symptomatic knee OA occurs relatively early in life, suggesting that prevention programs should be offered relatively early in the life course. Further research is needed to understand the future burden of health care utilization resulting from earlier diagnosis of knee OA.


Assuntos
Longevidade , Osteoartrite do Joelho/diagnóstico , Osteoartrite do Joelho/epidemiologia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Estudos Transversais/tendências , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fatores de Risco , Estados Unidos/epidemiologia
17.
J Bone Joint Surg Am ; 94(3): 201-7, 2012 Feb 01.
Artigo em Inglês | MEDLINE | ID: mdl-22298051

RESUMO

BACKGROUND: Total knee replacement utilization in the United States more than doubled from 1999 to 2008. Although the reasons for this increase have not been examined rigorously, some have attributed the increase to population growth and the obesity epidemic. Our goal was to investigate whether the rapid increase in total knee replacement use over the past decade can be sufficiently attributed to changes in these two factors. METHODS: We used data from the Nationwide Inpatient Sample to estimate changes in total knee replacement utilization rates from 1999 to 2008, stratified by age (eighteen to forty-four years, forty-five to sixty-four years, and sixty-five years or older). We obtained data on obesity prevalence and U.S. population growth from federal sources. We compared the rate of change in total knee replacement utilization with the rates of population growth and change in obesity prevalence from 1999 to 2008. RESULTS: In 2008, 615,050 total knee replacements were performed in the United States adult population, 134% more than in 1999. During the same time period, the overall population size increased by 11%. While the population of forty-five to sixty-four-year-olds grew by 29%, the number of total knee replacements in this age group more than tripled. The number of obese and non-obese individuals in the United States increased by 23% and 4%, respectively. Assuming unchanged indications for total knee replacement among obese and non-obese individuals with knee osteoarthritis over the last decade, these changes fail to account for the 134% growth in total knee replacement use. CONCLUSIONS: Population growth and obesity cannot fully explain the rapid expansion of total knee replacements in the last decade, suggesting that other factors must also be involved. The disproportionate increase in total knee replacements among younger patients may be a result of a growing number of knee injuries and expanding indications for the procedure.


Assuntos
Artroplastia do Joelho/estatística & dados numéricos , Obesidade/epidemiologia , Osteoartrite do Joelho/cirurgia , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/epidemiologia , Prevalência , Estados Unidos
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