Abstract:
:As part of its single technology appraisal (STA) 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 ulcerative colitis (UC). The Evidence Review Group (ERG) produced a critical review of the evidence for the clinical effectiveness and cost effectiveness of the technology, based upon the company's submission to NICE. The evidence was derived mainly from GEMINI 1, a Phase 3, multicentre, randomised, double-blinded, placebo-controlled study of the induction and maintenance of clinical response and remission by vedolizumab (MLN0002) in patients with moderate-to-severe active UC with an inadequate response to, loss of response to or intolerance of conventional therapy or anti-tumour necrosis factor (TNF)-α. The clinical evidence showed that vedolizumab performed significantly better than placebo in both the induction and maintenance phases. In the post hoc subgroup analyses in patients with or without prior anti-TNF-α therapy, vedolizumab performed better then placebo (p value not reported). In addition, a greater improvement in health-related quality of life was observed in patients treated with vedolizumab, and the frequency and types of adverse events were similar in the vedolizumab and placebo groups, but the evidence was limited to short-term follow-up. There were a number of limitations and uncertainties in the clinical evidence base, which warrants caution in its interpretation--in particular, the post hoc subgroup analyses and high dropout rates in the maintenance phase of GEMINI 1. The company also presented a network meta-analysis of vedolizumab versus other biologic therapies indicated for moderate-to-severe UC. However, the ERG considered that the results presented may have underestimated the uncertainty in treatment effects, since fixed-effects models were used, despite clear evidence of heterogeneity among the trials included in the network. Results from the company's economic evaluation (which included price reductions to reflect the proposed patient access scheme for vedolizumab) suggested that vedolizumab is the most effective option compared with surgery and conventional therapy in the following three populations: (1) a mixed intention-to-treat population, including patients who have previously received anti-TNF-α therapy and those who are anti-TNF-α naïve; (2) patients who are anti-TNF-α naïve only; and (3) patients who have previously failed anti-TNF-α therapy only. The ERG concluded that the results of the company's economic evaluation could not be considered robust, because of errors in model implementation, omission of relevant comparators, deviations from the NICE reference case and questionable model assumptions. The ERG amended the company's model and demonstrated that vedolizumab is expected to be dominated by surgery in all three populations.
journal_name
Pharmacoeconomicsjournal_title
PharmacoEconomicsauthors
Essat M,Tappenden P,Ren S,Bessey A,Archer R,Wong R,Lobo A,Hoque Sdoi
10.1007/s40273-015-0334-3subject
Has Abstractpub_date
2016-03-01 00:00:00pages
245-57issue
3eissn
1170-7690issn
1179-2027pii
10.1007/s40273-015-0334-3journal_volume
34pub_type
杂志文章abstract:OBJECTIVES:Patients with chronic kidney disease (CKD) are commonly treated with renin-angiotensin-aldosterone system inhibitors (RAASi) in order to delay progression of renal disease. However, research has shown that RAASi in CKD patients increases hyperkalaemia (HK) prevalence, which leads to RAASi discontinuation or ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-020-00902-w
更新日期:2020-07-01 00:00:00
abstract:BACKGROUND:Heart failure (HF) is a well-recognized public health concern and imposes high economic and societal costs. Decision analytic models exist for evaluating the economic ramifications associated with HF. Despite this, studies that appraise these modelling approaches for augmenting best-practice decisions remain...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0755-x
更新日期:2019-03-01 00:00:00
abstract:BACKGROUND:Invasive fungal infections in neutropenic patients treated for haematological malignancies are associated with a high mortality rate and, therefore, require early treatment. As the diagnosis of invasive fungal infections is difficult, effective antifungal prophylaxis is desirable. So far, fluconazole has bee...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200826010-00007
更新日期:2008-01-01 00:00:00
abstract:OBJECTIVES:To obtain utility estimates suitable for use in economic models for chronic spontaneous (idiopathic) urticaria (CSU). METHODS:Patient-level data from three randomized clinical trials-ASTERIA I, ASTERIA II and GLACIAL-were analysed. Health states were derived from the Urticaria Activity Score over 7 days (UA...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-015-0375-7
更新日期:2016-05-01 00:00:00
abstract::Hepatitis B virus (HBV) infection is an important public health problem all over the world. Vaccination is one way to prevent it, and several strategies can be used depending on endemicity, the main pattern of HBV transmission and the demographic structure of the population. In this study, an economic comparison of 3 ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199507050-00007
更新日期:1995-05-01 00:00:00
abstract::We review regulation of two important parameters for third-party payers and manufacturers of prescription drugs: regulation of reimbursement and pricing. We find that centralised regulation of reimbursement and pricing prevails in the 15 original EU member countries (EU-15) and in European Free Trade Association (EFTA...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200725060-00001
更新日期:2007-01-01 00:00:00
abstract::The efficacy of granisetron in preventing acute nausea and vomiting during the 24 hours following chemotherapy in patients with cancer is equivalent to that of other serotonin 5-HT3 receptor antagonists (ondansetron and tropisetron) and similar to or greater than that of conventional antiemetic regimens such as metocl...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199609040-00009
更新日期:1996-04-01 00:00:00
abstract::Total hip and knee replacements (THR and TKR) are high-risk settings for venous thromboembolism (VTE). This review summarizes the cost effectiveness of VTE prophylaxis regimens for THR and TKR. We searched MEDLINE (January 1997 to October 2009), EMBASE (January 1997 to June 2009) and the UK NHS Economic Evaluation Dat...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/11535210-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::The manufacturer of olaratumab (Lartruvo®), Eli Lilly & Company Limited, submitted evidence for the clinical and cost effectiveness of this drug, in combination with doxorubicin, for untreated advanced soft tissue sarcoma (STS) not amenable to surgery or radiotherapy, as part of the National Institute for Health and C...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.1007/s40273-017-0568-3
更新日期:2018-01-01 00:00:00
abstract::Open-heart surgery (OHS) is performed to bypass occluded arteries, replace malfunctioning cardiac valves or correct congenital abnormalities. The average cost of OHS varies from $US25 057-$US79 795 (1997 values). The objective of this paper was to review economic studies of pharmacological strategies in open-heart sur...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200321040-00003
更新日期:2003-01-01 00:00:00
abstract::Uncertainty in the decision-making process for reimbursement of health technologies could be reduced if additional information were available. Although methods to evaluate the monetary value of the uncertainty have been previously described, an economic evaluation of alternative methods to acquire additional informati...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200725110-00002
更新日期:2007-01-01 00:00:00
abstract::The role of economic evaluation in the efficient allocation of healthcare resources has been widely debated. Whilst economic evidence is undoubtedly useful to purchasers, it does not address the issue of affordability which is an increasing concern. Healthcare purchasers are concerned not just with maximising efficien...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200119060-00001
更新日期:2001-01-01 00:00:00
abstract:BACKGROUND:Interventions in health care often not only have an effect on patients, but also on their informal caregivers. Caregiving can have a profound impact on the health and wellbeing of carers. Ignoring these spillovers in economic evaluations risks labelling interventions mistakenly as cost-effective, at the expe...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0724-4
更新日期:2019-04-01 00:00:00
abstract::Advanced controlled release (CR) dosage forms are relative newcomers to pharmaceutical markets, and few studies relate their efficacy, safety or compliance benefits to economic value. This literature review was undertaken to assess the cost effectiveness of CR dosage forms using such measures as purchase costs, total ...
journal_title:PharmacoEconomics
pub_type: 杂志文章,meta分析
doi:10.2165/00019053-199405060-00005
更新日期:1994-06-01 00:00:00
abstract::Our objective was to assess the quality of reporting of original economic research articles in PharmacoEconomics from inception to the end of 1995, in order to identify areas of strength and weakness, and analyse trends over time. Each regular issue of the journal was examined for original economic evaluations. Accept...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199712060-00008
更新日期:1997-12-01 00:00:00
abstract::The pharmaceutical industry's core business is the innovation, development and marketing of new drugs. Pharmacogenetic (PG) testing and technology has the potential to increase a drug's value in many ways. A critical issue for the industry is whether products in development should be teamed with genetic tests that cou...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200624040-00004
更新日期:2006-01-01 00:00:00
abstract::In this review, the economic aspects of pneumococcal pneumonia are analysed, including the costs, cost effectiveness and cost benefit of treatment and prevention. We identified eight cost-of-illness studies, 15 analyses comparing the costs of different treatment options and 15 economic evaluations of prevention that m...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200422110-00003
更新日期:2004-01-01 00:00:00
abstract:OBJECTIVE:Patients with cancer-associated neutropenia are at high risk of developing severe infections which can be fatal if treatment is not promptly administered. For this reason, fever is treated as soon as possible with broad spectrum antibacterial therapy. The objective of this study was to conduct a cost analysis...
journal_title:PharmacoEconomics
pub_type: 临床试验,杂志文章
doi:10.2165/00019053-199915010-00006
更新日期:1999-01-01 00:00:00
abstract::Fluconazole (FLU) is an alternative to amphotericin B (AMB) for the treatment of candidemia in non-neutropenic patients. This agent has similar clinical efficacy but significantly reduced adverse effects compared with AMB. Using the database from a Canadian randomised multicentre comparative trial of FLU versus AMB in...
journal_title:PharmacoEconomics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.2165/00019053-199813050-00004
更新日期:1998-05-01 00:00:00
abstract:BACKGROUND:Combination therapies with cetuximab (Erbitux®; Merck Serono UK Ltd) and panitumumab (Vectibix®; Amgen UK Ltd) are shown to be less effective in adults with metastatic colorectal cancer who have mutations in exons 2, 3 and 4 of KRAS and NRAS oncogenes from the rat sarcoma (RAS) family. OBJECTIVE:The objecti...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0630-9
更新日期:2018-07-01 00:00:00
abstract:OBJECTIVES:Discrete choice experiments (DCEs) are increasingly advocated as a way to quantify preferences for health. However, increasing support does not necessarily result in increasing quality. Although specific reviews have been conducted in certain contexts, there exists no recent description of the general state ...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0734-2
更新日期:2019-02-01 00:00:00
abstract:BACKGROUND:The recently completed ALEX trial demonstrated that alectinib improved progression-free survival, and delayed time to central nervous system progression compared with crizotinib in patients with anaplastic lymphoma kinase-positive non-small-cell lung cancer. However, the long-term clinical and economic impac...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-018-0625-6
更新日期:2018-04-01 00:00:00
abstract:OBJECTIVES:This study provides the results of a cost-effectiveness analysis of levetiracetam as an adjunctive treatment for refractory epilepsy from the Canadian Ministry of Health perspective. The main objective is to estimate the expected cost-effectiveness ratio expressed as the incremental cost per seizure-free day...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200523050-00008
更新日期:2005-01-01 00:00:00
abstract:OBJECTIVE:To estimate savings in the cost of caring for patients with Alzheimer's disease (AD) during 6 months, 1 year and 2 years of treatment with rivastigmine. An intermediate objective was to estimate the relationship between disease progression and institutionalisation. DESIGN AND SETTING:We assessed the relation...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200017040-00005
更新日期:2000-04-01 00:00:00
abstract:BACKGROUND:The COUGAR-02 trial recently showed survival and quality-of-life benefits of docetaxel and active symptom control (DXL + ASC) over active symptom control (ASC) alone in patients with refractory oesophagogastric adenocarcinoma. AIM:The aim of this study was to conduct an economic evaluation conforming to Nat...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-015-0324-5
更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:To evaluate the cost effectiveness of dabrafenib versus dacarbazine and vemurafenib as first-line treatments in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma from a Canadian healthcare system perspective. METHODS:A partitioned-survival analysis model with three mutually exclus...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.1007/s40273-014-0241-z
更新日期:2015-04-01 00:00:00
abstract:BACKGROUND:Swedish formulary committees are expected to influence prescribing practice by establishing and issuing drug lists and clinical practice guidelines, particularly now that financial responsibility for prescription drugs has been transferred from the national to the county council level. OBJECTIVE:The purpose...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200017020-00006
更新日期:2000-02-01 00:00:00
abstract::Currently, the most important issue in US pharmaceutical policy is probably cost containment. Research into pharmaceutical issues should therefore concentrate on this area. Analysis of changing trends in pharmaceutical expenditures, particularly during the early 1990s, would be a useful starting point. Research into t...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-199600102-00019
更新日期:1996-01-01 00:00:00
abstract::Darunavir boosted by low-dose ritonavir (DRV/r), at a daily dose of 600/100 mg twice a day (bid), has been shown to be superior to alternative highly active antiretroviral therapy (HAART) regimens for the management of treatment-experienced, HIV-infected adults in the phase IIb POWER trials and the phase III TITAN tri...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/11587410-000000000-00000
更新日期:2010-01-01 00:00:00
abstract::Potential conflict between the goals of the investigators and the sponsors of pharmacoeconomic and clinical research has been well documented. Although there have been efforts to formalise relationships between sponsors and investigators in some areas of clinical research, no set of guidelines or standardised contract...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199507030-00004
更新日期:1995-03-01 00:00:00