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1.
Value Health ; 25(5): 761-769, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-35197225

RESUMO

OBJECTIVES: COVID-19 is associated with significant morbidity and mortality. This study aims to synthesize evidence to assess the cost-effectiveness of remdesivir (RDV) for the treatment of hospitalized patients with COVID-19 in England and Wales. METHODS: A probabilistic cost-effectiveness analysis was conducted informed by 2 large trials and uses a partitioned survival approach to assess short- and long-term clinical consequences and costs associated with COVID-19 in a hypothetical cohort of hospitalized patients requiring supplemental oxygen at the start of treatment. Given that it is uncertain whether RDV reduces death, 2 analyses are presented, assuming RDV either reduces death or does not. Published sources were used for long-term clinical, quality of life, and cost parameters. RESULTS: Under the assumption that RDV reduces death, the incremental cost-effectiveness ratio for RDV is estimated at £11 881 per quality-adjusted life-year gained compared with standard of care (SoC) (probabilistic incremental cost-effectiveness ratio £12 400). The probability for RDV to be cost-effective is 74% at a willingness-to-pay threshold of £20 000 per quality-adjusted life-year gained. RDV was no longer cost-effective when the hazard ratio for overall survival compared with SoC was >0·915. CONCLUSIONS: Results from this study suggest that using RDV for the treatment of hospitalized patients with COVID-19 is likely to represent a cost-effective use of National Health Service resources at current willingness-to-pay threshold in England and Wales, only if it prevents death. Results needs to be interpreted caution as vaccination was introduced and the SoC and evidence available have also evolved considerably since the analysis is conducted.


Assuntos
Tratamento Farmacológico da COVID-19 , Monofosfato de Adenosina/análogos & derivados , Alanina/análogos & derivados , Análise Custo-Benefício , Humanos , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , País de Gales/epidemiologia
2.
Value Health ; 24(6): 770-779, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-34119074

RESUMO

OBJECTIVES: Approximately 20% of UK women aged 70+ with early breast cancer receive primary endocrine therapy (PET) instead of surgery. PET reduces surgical morbidity but with some survival decrement. To complement and utilize a treatment dependent prognostic model, we investigated the cost-effectiveness of surgery plus adjuvant therapies versus PET for women with varying health and fitness, identifying subgroups for which each treatment is cost-effective. METHODS: Survival outcomes from a statistical model, and published data on recurrence, were combined with data from a large, multicenter, prospective cohort study of over 3400 UK women aged 70+ with early breast cancer and median 52-month follow-up, to populate a probabilistic economic model. This model evaluated the cost-effectiveness of surgery plus adjuvant therapies relative to PET for 24 illustrative subgroups: Age {70, 80, 90} × Nodal status {FALSE (F), TRUE (T)} × Comorbidity score {0, 1, 2, 3+}. RESULTS: For a 70-year-old with no lymph node involvement and no comorbidities (70, F, 0), surgery plus adjuvant therapies was cheaper and more effective than PET. For other subgroups, surgery plus adjuvant therapies was more effective but more expensive. Surgery plus adjuvant therapies was not cost-effective for 4 of the 24 subgroups: (90, F, 2), (90, F, 3), (90, T, 2), (90, T, 3). CONCLUSION: From a UK perspective, surgery plus adjuvant therapies is clinically effective and cost-effective for most women aged 70+ with early breast cancer. Cost-effectiveness reduces with age and comorbidities, and for women over 90 with multiple comorbidities, there is little cost benefit and a negative impact on quality of life.


Assuntos
Antineoplásicos Hormonais/economia , Antineoplásicos Hormonais/uso terapêutico , Neoplasias da Mama/economia , Neoplasias da Mama/terapia , Custos de Medicamentos , Mastectomia/economia , Fatores Etários , Idoso , Antineoplásicos Hormonais/efeitos adversos , Neoplasias da Mama/mortalidade , Neoplasias da Mama/patologia , Quimioterapia Adjuvante/economia , Tomada de Decisão Clínica , Comorbidade , Pesquisa Comparativa da Efetividade , Análise Custo-Benefício , Feminino , Nível de Saúde , Humanos , Mastectomia/efeitos adversos , Mastectomia/mortalidade , Modelos Econômicos , Modelos Estatísticos , Aptidão Física , Qualidade de Vida , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento , Reino Unido
3.
Health Technol Assess ; 23(30): 1-328, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-31264581

RESUMO

BACKGROUND: Breast cancer and its treatment can have an impact on health-related quality of life and survival. Tumour profiling tests aim to identify whether or not women need chemotherapy owing to their risk of relapse. OBJECTIVES: To conduct a systematic review of the effectiveness and cost-effectiveness of the tumour profiling tests oncotype DX® (Genomic Health, Inc., Redwood City, CA, USA), MammaPrint® (Agendia, Inc., Amsterdam, the Netherlands), Prosigna® (NanoString Technologies, Inc., Seattle, WA, USA), EndoPredict® (Myriad Genetics Ltd, London, UK) and immunohistochemistry 4 (IHC4). To develop a health economic model to assess the cost-effectiveness of these tests compared with clinical tools to guide the use of adjuvant chemotherapy in early-stage breast cancer from the perspective of the NHS and Personal Social Services. DESIGN: A systematic review and health economic analysis were conducted. REVIEW METHODS: The systematic review was partially an update of a 2013 review. Nine databases were searched in February 2017. The review included studies assessing clinical effectiveness in people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, stage I or II cancer with zero to three positive lymph nodes. The economic analysis included a review of existing analyses and the development of a de novo model. RESULTS: A total of 153 studies were identified. Only one completed randomised controlled trial (RCT) using a tumour profiling test in clinical practice was identified: Microarray In Node-negative Disease may Avoid ChemoTherapy (MINDACT) for MammaPrint. Other studies suggest that all the tests can provide information on the risk of relapse; however, results were more varied in lymph node-positive (LN+) patients than in lymph node-negative (LN0) patients. There is limited and varying evidence that oncotype DX and MammaPrint can predict benefit from chemotherapy. The net change in the percentage of patients with a chemotherapy recommendation or decision pre/post test ranged from an increase of 1% to a decrease of 23% among UK studies and a decrease of 0% to 64% across European studies. The health economic analysis suggests that the incremental cost-effectiveness ratios for the tests versus current practice are broadly favourable for the following scenarios: (1) oncotype DX, for the LN0 subgroup with a Nottingham Prognostic Index (NPI) of > 3.4 and the one to three positive lymph nodes (LN1-3) subgroup (if a predictive benefit is assumed); (2) IHC4 plus clinical factors (IHC4+C), for all patient subgroups; (3) Prosigna, for the LN0 subgroup with a NPI of > 3.4 and the LN1-3 subgroup; (4) EndoPredict Clinical, for the LN1-3 subgroup only; and (5) MammaPrint, for no subgroups. LIMITATIONS: There was only one completed RCT using a tumour profiling test in clinical practice. Except for oncotype DX in the LN0 group with a NPI score of > 3.4 (clinical intermediate risk), evidence surrounding pre- and post-test chemotherapy probabilities is subject to considerable uncertainty. There is uncertainty regarding whether or not oncotype DX and MammaPrint are predictive of chemotherapy benefit. The MammaPrint analysis uses a different data source to the other four tests. The Translational substudy of the Arimidex, Tamoxifen, Alone or in Combination (TransATAC) study (used in the economic modelling) has a number of limitations. CONCLUSIONS: The review suggests that all the tests can provide prognostic information on the risk of relapse; results were more varied in LN+ patients than in LN0 patients. There is limited and varying evidence that oncotype DX and MammaPrint are predictive of chemotherapy benefit. Health economic analyses indicate that some tests may have a favourable cost-effectiveness profile for certain patient subgroups; all estimates are subject to uncertainty. More evidence is needed on the prediction of chemotherapy benefit, long-term impacts and changes in UK pre-/post-chemotherapy decisions. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017059561. FUNDING: The National Institute for Health Research Health Technology Assessment programme.


Breast cancer is the most commonly diagnosed cancer in women in England and Wales. Breast cancer, and its treatment, can have an impact on a person's health-related quality of life and survival. Tumour profiling tests are used before chemotherapy. They test small samples of a patient's tumour (removed during surgery) to find out whether the genes in it mean that a person has a high or low risk of the disease returning (relapse). If the risk is low, the patient may be able to avoid having chemotherapy and, therefore, avoid its side effects. Some tests might also be able to identify which patients will respond to chemotherapy. This study looked at the evidence for five tumour profiling tests. A total of 153 studies were identified. This study considered the results and the quality of the studies to find out if the tests are helpful. Most studies had design flaws (e.g. some patients had already had chemotherapy) that meant that the studies were of low quality overall. The results suggest that all of the tests can give information on the risk of relapse; however, some tests may be less useful in patients whose disease has spread to the lymph nodes (lymph node-positive disease). There was limited and varying evidence about whether or not two of these tests can also predict which patients will respond to chemotherapy. This study also looked at whether or not these tests represent good value for money for the NHS through cost-effectiveness analyses. The analyses showed that some of the tests may represent a good use of NHS resources for some patient groups; however, there was still a lot of uncertainty about this.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Quimioterapia Adjuvante , Análise Custo-Benefício , Prognóstico , Neoplasias da Mama/genética , Feminino , Humanos , Anos de Vida Ajustados por Qualidade de Vida , Avaliação da Tecnologia Biomédica , Resultado do Tratamento
4.
Pharmacoeconomics ; 37(6): 763-775, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30345464

RESUMO

The National Institute for Health and Care Excellence (NICE) published guidance on the use of pirfenidone (Esbriet®, Roche) for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in 2013. NICE decided to review existing guidance following publication of an additional clinical trial, and invited the manufacturer of pirfenidone to submit evidence of its clinical and cost effectiveness for the treatment of mild to moderate IPF when compared with best supportive care (BSC) or nintedanib; nintedanib was a comparator only for moderate IPF. An independent Evidence Review Group (ERG) critiqued the company submission and this paper summarises their report and subsequent NICE guidance. The key clinical effectiveness evidence was based on three randomised controlled trials (RCTs) and an open-label extension study. Supportive data were provided from two additional RCTs conducted in Japan, while one additional open-label study was included for safety outcomes. Meta-analysis of the three key RCTs found pirfenidone to be effective at reducing disease progression compared with placebo, but statistically significant differences were not identified in all of the RCTs. A statistically significant reduction in all-cause mortality was only demonstrated when pooling data across studies. The treatment effects of pirfenidone and nintedanib were broadly similar, based on an indirect comparison using network meta-analysis, although they have slightly different adverse event profiles. There remains considerable uncertainty in the cost-effectiveness estimates for pirfenidone versus BSC, particularly due to uncertainty regarding the duration of treatment effect and the method used to implement the stopping rule within the economic model.


Assuntos
Fibrose Pulmonar Idiopática/tratamento farmacológico , Piridonas/uso terapêutico , Análise Custo-Benefício , Humanos , Fibrose Pulmonar Idiopática/mortalidade , Metanálise em Rede , Ensaios Clínicos Controlados Aleatórios como Assunto , Encaminhamento e Consulta
5.
Pharmacoeconomics ; 36(10): 1143-1151, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-29594951

RESUMO

As part of its single technology appraisal process, the UK National Institute for Health and Care Excellence (NICE) invited the manufacturer of obinutuzumab (Roche) to submit evidence on its clinical and cost effectiveness when used in combination with bendamustine in patients with follicular lymphoma (FL) refractory to rituximab. The Evidence Review Group (ERG), the School of Health and Related Research Technology Appraisal Group at the University of Sheffield, produced a document summarising the key points from the company submission alongside a critical review. Efficacy for progression-free survival (PFS) and safety was positively demonstrated in the pivotal GADOLIN trial, which compared obinutuzumab in combination with bendamustine followed by obinutuzumab maintenance (O-Benda+O) against bendamustine monotherapy. Data on overall survival were immature. The company submitted a model-based economic analysis, including a patient access scheme. The ERG identified a number of limitations, in particular the absence of subgroup analysis and the approach used by the company to estimate overall survival (OS), which was more favourable to the intervention arm. The key uncertainty was the duration of the treatment effect on OS. This uncertainty is expected to be reduced when the final analysis of the GADOLIN trial is reported. Consequently, the NICE appraisal committee recommended O-Benda+O in the population covered by the marketing authorisation within the Cancer Drug Fund until NICE is able to review the guidance following publication of the final analysis of GADOLIN.


Assuntos
Anticorpos Monoclonais Humanizados/economia , Protocolos de Quimioterapia Combinada Antineoplásica/economia , Cloridrato de Bendamustina/economia , Quimioterapia Combinada/economia , Avaliação da Tecnologia Biomédica/estatística & dados numéricos , Anticorpos Monoclonais Humanizados/uso terapêutico , Antineoplásicos Alquilantes/economia , Antineoplásicos Alquilantes/uso terapêutico , Antineoplásicos Imunológicos/economia , Antineoplásicos Imunológicos/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Cloridrato de Bendamustina/uso terapêutico , Resistência a Medicamentos , Humanos , Linfoma Folicular , Modelos Econômicos , Intervalo Livre de Progressão , Anos de Vida Ajustados por Qualidade de Vida , Rituximab/uso terapêutico
6.
Int J Technol Assess Health Care ; 33(1): 32-45, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-28486999

RESUMO

OBJECTIVES: The aim of this report was to assess the clinical effectiveness of two Gene expression profiling (GEP) and two expanded immunohistochemistry (IHC) tests compared with current prognostic tools in guiding the use of adjuvant chemotherapy in patients with early breast cancer. METHODS: A systematic review of the evidence on clinical effectiveness of OncotypeDX, IHC4, MammaPrint, and Mammostrat, compared with current clinical practice using clinicopathological parameters, in women with early breast cancer was conducted. Ten databases were searched to include citations to May 2016. RESULTS: Searches identified 7,064 citations, of which forty-one citations satisfied the criteria for the review. A narrative synthesis was performed. Evidence for OncotypeDX demonstrated the impact of the test on decision making and there was some support for OncotypeDX predicting chemotherapy benefit. There were relatively lower levels of evidence for the other three tests included in the analysis. MammaPrint, Mammostrat, and IHC4 tests were limited to a small number of studies. Limitations in relation to study design were identified for all tests. CONCLUSIONS: The evidence base for OncotypeDX is considered to be the most robust. Methodological weaknesses relating to heterogeneity of patient cohorts and issues arising from the retrospective nature of the evidence were identified. Further evidence is required for all of the tests using prospective randomized controlled trial data.


Assuntos
Neoplasias da Mama/tratamento farmacológico , Perfilação da Expressão Gênica , Imuno-Histoquímica , Análise Custo-Benefício , Feminino , Humanos , Estudos Prospectivos , Estudos Retrospectivos
7.
Pharmacoeconomics ; 34(12): 1241-1253, 2016 12.
Artigo em Inglês | MEDLINE | ID: mdl-27480631

RESUMO

As part of its single technology appraisal process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer of vedolizumab (Takeda UK) to submit evidence of the clinical effectiveness and cost effectiveness of vedolizumab for the treatment of patients with moderate-to-severe, active Crohn's disease. The School of Health and Related Research (ScHARR) at the University of Sheffield was commissioned as the Evidence Review Group (ERG) and produced a critical review of the evidence of the clinical effectiveness and cost effectiveness of the technology, based upon the company's submission to NICE. The GEMINI II and III trials formed the main supporting evidence for the intervention. Both studies were phase III, randomised, double-blind, placebo-controlled, multicentre trials designed to evaluate the efficacy and safety of vedolizumab. They included patients who were naïve to tumour necrosis factor alpha antagonist (anti-TNF-α) therapy and patients who had an inadequate response to, loss of response to or intolerance of immunomodulators or anti-TNF-α agents. GEMINI II was designed to evaluate the efficacy and safety of vedolizumab as an induction treatment (dosing at weeks 0 and 2, with assessment at week 6) and maintenance treatment (during weeks 6-52). In contrast, GEMINI III was designed to evaluate the efficacy and safety of vedolizumab as an induction treatment only, with doses at weeks 0, 2 and 6, and assessment at weeks 6 and 10. In the absence of any direct head-to-head, randomised, controlled trials comparing vedolizumab with other relevant biologic therapies (adalimumab and infliximab) for the treatment of moderate-to-severe Crohn's disease, the company conducted a network meta-analysis, which compared vedolizumab, adalimumab, infliximab and placebo for the outcomes of clinical response, enhanced clinical response, clinical remission and discontinuation due to adverse events. The company model estimated the incremental cost-effectiveness ratio (ICER) for vedolizumab compared with the standard of care (consisting of 5-aminosalicylic acids, corticosteroids and immunosuppressants) to be £21,620 per quality-adjusted life-year (QALY) gained within the anti-TNF-α-failure population (which included a confidential patient access scheme for vedolizumab). The ICERs were above £30,000 per QALY gained for the mixed intention-to-treat population (including both anti-TNF-α-naïve and anti-TNF-α-failure populations) and in patients who were anti-TNF-α naïve only. The ERG identified a number of limitations that were believed to limit the robustness of the results presented by the company. These limitations could not be addressed by the ERG without major restructuring of the economic model. Therefore, the ERG concluded that the results from the company's model needed to be interpreted with caution and that it was unclear whether the ICERs would increase or decrease following amendment of the identified structural issues.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Doença de Crohn/tratamento farmacológico , Fármacos Gastrointestinais/uso terapêutico , Anticorpos Monoclonais Humanizados/economia , Análise Custo-Benefício , Doença de Crohn/economia , Doença de Crohn/fisiopatologia , Fármacos Gastrointestinais/economia , Humanos , Modelos Econômicos , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Índice de Gravidade de Doença , Avaliação da Tecnologia Biomédica
8.
Value Health ; 19(4): 404-12, 2016 06.
Artigo em Inglês | MEDLINE | ID: mdl-27325332

RESUMO

BACKGROUND: Currently in the United Kingdom, the National Health Service (NHS) Breast Screening Programme invites all women for triennial mammography between the ages of 47 and 73 years (the extension to 47-50 and 70-73 years is currently examined as part of a randomized controlled trial). The benefits and harms of screening in women 70 years and older, however, are less well documented. OBJECTIVES: The aim of this study was to examine whether extending screening to women older than 70 years would represent a cost-effective use of NHS resources and to identify the upper age limit at which screening mammography should be extended in England and Wales. METHODS: A mathematical model that allows the impact of screening policies on cancer diagnosis and subsequent management to be assessed was built. The model has two parts: a natural history model of the progression of breast cancer up to discovery and a postdiagnosis model of treatment, recurrence, and survival. The natural history model was calibrated to available data and compared against published literature. The management of breast cancer at diagnosis was taken from registry data and valued using official UK tariffs. RESULTS: The model estimated that screening would lead to overdiagnosis in 6.2% of screen-detected women at the age of 72 years, increasing up to 37.9% at the age of 90 years. Under commonly quoted willingness-to-pay thresholds in the United Kingdom, our study suggests that an extension to screening up to the age of 78 years represents a cost-effective strategy. CONCLUSIONS: This study provides encouraging findings to support the extension of the screening program to older ages and suggests that further extension of the UK NHS Breast Screening Programme up to age 78 years beyond the current upper age limit of 73 years could be potentially cost-effective according to current NHS willingness-to-pay thresholds.


Assuntos
Neoplasias da Mama/economia , Política de Saúde/economia , Mamografia/economia , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/diagnóstico , Neoplasias da Mama/terapia , Simulação por Computador , Análise Custo-Benefício , Detecção Precoce de Câncer/economia , Inglaterra , Feminino , Humanos , Uso Excessivo dos Serviços de Saúde , Método de Monte Carlo , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida , Medicina Estatal , País de Gales
9.
Addiction ; 111(9): 1616-27, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-26990598

RESUMO

AIMS: To determine whether the provision of contingency management using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of health-care resources. DESIGN: A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. SETTINGS AND PARTICIPANTS: Data on attendance to vaccination from a UK cluster randomized trial. INTERVENTION: Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. MEASUREMENT: Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. FINDINGS: The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programme was estimated to be £6738 (95% CI = £6297-7172), with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). CONCLUSIONS: Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%.


Assuntos
Vacinas contra Hepatite B/uso terapêutico , Hepatite B/prevenção & controle , Motivação , Transtornos Relacionados ao Uso de Opioides/terapia , Abuso de Substâncias por Via Intravenosa/terapia , Carcinoma Hepatocelular/economia , Carcinoma Hepatocelular/etiologia , Carcinoma Hepatocelular/prevenção & controle , Carcinoma Hepatocelular/cirurgia , Análise Custo-Benefício , Árvores de Decisões , Gerenciamento Clínico , Custos de Cuidados de Saúde , Hepatite B/complicações , Hepatite B/economia , Vacinas contra Hepatite B/economia , Humanos , Cirrose Hepática/economia , Cirrose Hepática/etiologia , Cirrose Hepática/prevenção & controle , Cirrose Hepática/cirurgia , Neoplasias Hepáticas/economia , Neoplasias Hepáticas/etiologia , Neoplasias Hepáticas/prevenção & controle , Neoplasias Hepáticas/cirurgia , Transplante de Fígado/economia , Cadeias de Markov , Mortalidade , Anos de Vida Ajustados por Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Reino Unido
10.
Pharmacoeconomics ; 31(6): 471-8, 2013 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-23568332

RESUMO

The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of trabectedin (PharmaMar) to submit evidence for the clinical and cost effectiveness of this drug for the treatment of advanced metastatic soft tissue sarcoma (aMSTS), as part of the Institute's single technology appraisal (STA) process. The School of Health and Related Research (ScHARR) was commissioned to act as the Evidence Review Group (ERG). This paper provides a description of the company submission, the ERG review and NICE's subsequent decisions. The ERG produced a review of the evidence for the clinical and cost effectiveness of the technology contained within the manufacturer's submission to NICE. The ERG also independently modified the manufacturer's decision analytic model to examine the impact of altering some of the key assumptions. The main evidence was derived from a single phase II randomized controlled trial (RCT) conducted in liposarcoma and leiomyosarcoma only, in which the licensed dose of trabectedin was compared with a different dose of trabectedin. Additional data were also presented from three uncontrolled phase II trials. Supplementary studies were used to represent best supportive care (BSC). The median overall survival (OS) was 13.9 months for the licensed dose of trabectedin in the main randomized controlled trial (RCT) and ranged from 9.2 months to 12.8 months in the other studies included. Supplementary studies supplied by the manufacturer, and assumed to represent BSC, had median OS of 5.9-6.6 months. The progression-free survival (PFS) rates at 6 months for trabectedin were 35.5 % in the main RCT and 24.4-29 % in the other studies included. The PFS rates at 6 months were 8-14 % for BSC. In the manufacturer's original submission to NICE, the base-case incremental cost-effectiveness ratio (ICER) of trabectedin compared with BSC was approximately £44,000 per QALY gained. After amendment of errors identified by the ERG, the ICER reported by the manufacturer increased to approximately £61,000. The ERG concluded that, despite clarifications from the manufacturer and the revisions made to the model, there was still considerable uncertainty in the ICER. The NICE Appraisal Committee (AC) gave a negative initial recommendation, although indicated that trabectedin in aMSTS met the end-of-life criteria. Subsequently, the manufacturer submitted a patient access scheme (PAS) where any cycles beyond the fifth were provided at no cost by the manufacturer. This improved the ICER to approximately £34,000 per QALY gained. The AC gave a positive recommendation, subject to the implementation of the PAS.


Assuntos
Antineoplásicos Alquilantes/uso terapêutico , Dioxóis/uso terapêutico , Sarcoma/tratamento farmacológico , Tetra-Hidroisoquinolinas/uso terapêutico , Antineoplásicos Alquilantes/economia , Ensaios Clínicos como Assunto , Análise Custo-Benefício , Técnicas de Apoio para a Decisão , Dioxóis/economia , Intervalo Livre de Doença , Humanos , Modelos Teóricos , Metástase Neoplásica , Anos de Vida Ajustados por Qualidade de Vida , Sarcoma/economia , Sarcoma/patologia , Taxa de Sobrevida , Tetra-Hidroisoquinolinas/economia , Trabectedina , Reino Unido
11.
Alcohol Alcohol ; 48(2): 180-8, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23015608

RESUMO

AIMS: To estimate the cost-effectiveness and resourcing implications of universal alcohol screening and brief intervention (SBI) programmes in primary care in England. METHODS: This was a health economic model, combining evidence of the effectiveness and health care resource requirements of SBI activities with existing epidemiological modelling of the relationship between alcohol consumption and health harms. RESULTS: Screening patients on registration with a family doctor would steadily capture ~40% of the population over a 10-year programme; screening patients at next primary care consultation would capture 96% of the population over the same period, but with high resourcing needs in the first year. The registration approach, delivered by a practice nurse, provides modest cost savings to the health care system of £120 m over 30 years. Health gains over the same period amount to 32,000 quality-adjusted life years (QALYs). This SBI programme still appears cost-effective (at £6900 per QALY gained) compared with no programme, under pessimistic effectiveness assumptions. Switching to a consultation approach, delivered by a doctor, would incur an incremental net cost of £108 m, with incremental health gains equivalent to 92,000 QALYs, giving an incremental cost-effectiveness ratio of £1175 per QALY gained compared with current practice. CONCLUSION: A universal programme of alcohol SBI in primary care is estimated to be cost-effective, under all but the most pessimistic assumptions for programme costs and effectiveness. Policymakers should ensure that SBI programmes are routinely evaluated and followed up, given the substantial uncertainty over the effects of many of the implementation details.


Assuntos
Consumo de Bebidas Alcoólicas/economia , Consumo de Bebidas Alcoólicas/epidemiologia , Intervenção Médica Precoce/economia , Programas de Rastreamento/economia , Modelos Econômicos , Atenção Primária à Saúde/economia , Adolescente , Adulto , Idoso , Alcoolismo/diagnóstico , Alcoolismo/economia , Alcoolismo/epidemiologia , Análise Custo-Benefício/economia , Análise Custo-Benefício/métodos , Intervenção Médica Precoce/métodos , Inglaterra/epidemiologia , Feminino , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Atenção Primária à Saúde/métodos , Adulto Jovem
12.
Rheumatology (Oxford) ; 49(10): 1949-56, 2010 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-20581376

RESUMO

OBJECTIVES: The primary aim of this study was to estimate annual health care costs for biologic-naïve patients with PsA in the UK. The relationship between disease severity, defined by physical limitations, and costs was also explored. METHODS: This study utilized data from the British Society of Rheumatology Biologics Register (BSRBR) to develop a multivariate model estimating disease severity from parameters available in routine primary care data. The HAQ Disability Index was used to determine disease severity. This algorithm was then applied to routine data from The Health Improvement Network (THIN). Annual costs were estimated for drugs, contacts with a general practitioner and other health care professionals, tests, hospital outpatient attendances and inpatient admissions from a National Health Service perspective using official tariffs. The relationship between disease severity and health care costs was estimated using a generalized linear model. RESULTS: Three hundred and fifty-six cases with PsA were identified in the BSRBR and 4492 in THIN. Total mean annual health care costs ranged from £11 to £20 782 with a mean of £1446 (s.d. £1756). When costs were sub-grouped by the predicted HAQ score, the mean annual observed costs ranged from £548 per person for the least severely affected (HAQ ≤ 1.2) to £4832 for the most severely affected (HAQ > 2.6). Prescription costs and secondary care episodes accounted for more than a third of total care costs each (38 and 34%, respectively). When the relationship between disease severity and costs was examined, estimated HAQ was found to be a significant predictor of total health care costs. CONCLUSIONS: Treatment of people with PsA resulted in considerable financial costs and these costs varied markedly by disease severity.


Assuntos
Artrite Psoriásica/economia , Custos de Cuidados de Saúde , Índice de Gravidade de Doença , Adulto , Algoritmos , Artrite Psoriásica/fisiopatologia , Artrite Psoriásica/terapia , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Teóricos , Análise de Regressão , Reino Unido
13.
Curr Med Res Opin ; 24(5): 1473-83, 2008 May.
Artigo em Inglês | MEDLINE | ID: mdl-18413014

RESUMO

OBJECTIVE: Based on positive safety and efficacy data, a quadrivalent Human PapillomaVirus (HPV) vaccine has been approved in Switzerland to prevent HPV types 6, 11, 16 and 18 infections. The objective of this study was to explore the cost-effectiveness of an HPV vaccination in Switzerland. DESIGN AND METHODS: A Markov model of the natural history of HPV infection was adapted to the Swiss context and followed a hypothetical cohort of 41,200 girls aged 11 years over their lifetime. Main epidemiological and economic parameters were extracted from the literature. Two strategies were compared: conventional cytological screening only and HPV vaccination followed by conventional cytological screening. A coverage rate of 80% was used and the vaccine was assumed to provide a lifelong protection. Analyses were performed from the direct health care cost perspective including only direct medical costs. RESULTS: Compared to screening only, adding a quadrivalent HPV vaccine could prevent over lifetime 62% of cervical cancers and related deaths, 19% of Cervical Intraepithelial Neoplasia (CIN 1), 43% of CIN 2, 45% of CIN 3 and 66% of genital warts per cohort. Incremental cost-effectiveness ratios (ICER) were estimated to be CHF 45,008 per Life Year Gained (LYG) and CHF 26,005 per Quality Adjusted Life Year (QALY) gained. Sensitivity analyses demonstrated that the ICER was robust to all parameters, but was most sensitive to the need for a booster and discount rates. CONCLUSIONS: Compared to commonly accepted standard thresholds in Europe and other vaccination strategies implemented in Switzerland, adding a quadrivalent HPV vaccine alongside the current cervical cancer screening programme is likely to be cost-effective in Switzerland.


Assuntos
Programas de Rastreamento/economia , Vacinação em Massa/economia , Infecções por Papillomavirus/prevenção & controle , Vacinas contra Papillomavirus/economia , Neoplasias do Colo do Útero/prevenção & controle , Adolescente , Adulto , Fatores Etários , Criança , Análise Custo-Benefício , Estudos de Avaliação como Assunto , Feminino , Humanos , Cadeias de Markov , Programas de Rastreamento/métodos , Vacinação em Massa/métodos , Pessoa de Meia-Idade , Infecções por Papillomavirus/economia , Vacinas contra Papillomavirus/administração & dosagem , Vacinas contra Papillomavirus/classificação , Anos de Vida Ajustados por Qualidade de Vida , Sensibilidade e Especificidade , Suíça , Neoplasias do Colo do Útero/economia , Neoplasias do Colo do Útero/virologia
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