Abstract:
:The National Institute for Health and Clinical Excellence (NICE) invited the manufacturer of denosumab (Amgen Inc., UK) to submit evidence for the clinical and cost effectiveness of denosumab for the prevention of fragility fractures in post-menopausal women, as part of the Institute's single technology appraisal (STA) process. The University of Aberdeen Health Technology Assessment Group were commissioned to act as the Evidence Review Group (ERG); the role of the ERG being to appraise the manufacturer's submission and to produce an independent report. This article provides a description of the company submission, the ERG review and NICE's subsequent decisions. The manufacturer considered that denosumab would be appropriate for patients unable to take, comply with or tolerate oral bisphosphonates. Comparator treatments selected for the submission were, therefore, 'no treatment', raloxifene, strontium ranelate, intravenous zoledronic acid, intravenous ibandronate and teriparatide. The main effectiveness evidence for denosumab was derived from a large randomized controlled trial comparing denosumab with placebo. Given by subcutaneous injection at 6-monthly intervals for 3 years, denosumab reduced the incidence of hip fracture by 40%, and reduced the incidence of clinical vertebral fracture by 69%. An indirect treatment comparison was used to derive adjusted relative risk (RR) estimates for different types of fracture for each comparator versus placebo. The RRs (95% CI) applied for denosumab were 0.316 (0.208, 0.478) for clinical vertebral fracture, 0.605 (0.373, 0.983) for hip fracture and 0.842 (0.638, 1.110) for wrist fracture. Despite a number of concerns surrounding the methodology of the indirect comparison, the ERG was satisfied with the robustness of the effect estimates. The RR estimates were applied in a good-quality Markov model that took account of drug costs, administration and monitoring costs, costs associated with fractures, and long-term nursing home costs. Utility weights were used to adjust time spent in fracture states, allowing QALYs to be estimated. The base-case analysis was conducted for women aged 70 years with a T-score of -2.5 or less and no prior fracture, and women aged 70 years with a T-score of -2.5 or less with a prior fragility fracture. Subgroup analyses based on T-score and independent clinical risk factors were also undertaken. Applying a willingness-to-pay (WTP) threshold of £30 000 per QALY, the manufacturer's results suggested that denosumab would offer a cost-effective alternative to all treatment comparators for the primary and secondary prevention of fractures. The ERG was concerned about an assumption that denosumab would be administered in general practice at the average cost of two standard GP visits a year. As a result, the ERG requested some further sensitivity analysis and undertook some further modelling, applying an assumption that denosumab would be provided primarily in secondary care. This modification altered the cost effectiveness of denosumab versus 'no treatment' (in women with no prior fragility fracture) and zoledronic acid. The NICE Appraisal Committee concluded that, as a treatment option for the prevention of osteoporotic fractures, denosumab should be recommended only in post-menopausal women at increased risk of fracture who cannot comply with the special instructions for administering oral bisphosphonates, or have an intolerance of, or contraindication to, those treatments. For primary prevention, the Appraisal Committee also stipulated specific levels of fracture risk at which denosumab is recommended.
journal_name
Pharmacoeconomicsjournal_title
PharmacoEconomicsauthors
Scotland G,Waugh N,Royle P,McNamee P,Henderson R,Hollick Rdoi
10.2165/11589310-000000000-00000subject
Has Abstractpub_date
2011-11-01 00:00:00pages
951-61issue
11eissn
1170-7690issn
1179-2027journal_volume
29pub_type
杂志文章,评审abstract:BACKGROUND:Cost-effectiveness analyses worldwide assume that the price of any single drug increases with inflation. New guidance from the Pharmaceutical Management Agency in New Zealand suggests that, when it is known that a generic drug will be available in the near future, a best estimate of the lower price of the ge...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200826070-00006
更新日期:2008-01-01 00:00:00
abstract::A number of recent findings from the literature imply that the value of a QALY varies depending on the concentration or dispersion of that QALY over treated individuals. Given that funding decisions are currently made under either the assumption of distributive-neutrality or some combination of explicit decision crite...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200624090-00003
更新日期:2006-01-01 00:00:00
abstract::Community-acquired pneumonia (CAP) is a common diagnosis and care of CAP is responsible for significant healthcare expenditures, the majority of which are for patients who require hospitalisation. Studies have shown that significant variation exists among institutions with respect to antibacterial costs and length of ...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-200422070-00001
更新日期:2004-01-01 00:00:00
abstract::Pharmacoeconomic data may be obtained within the context of randomised clinical trials (RCTs) and from effectiveness studies in the 'real world'. The differences between the 2 types of study design have implications for the types of data that can be obtained and the interpretation of the resulting findings. Because RC...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199915050-00001
更新日期:1999-05-01 00:00:00
abstract::External genital warts (EGW) are a sexually transmitted infection caused by various strains of human papillomavirus (HPV). Several studies have described the direct and indirect costs of EGW, while others have reported on the burden of EGW in terms of the impact on the quality of life (QOL) of patients. The arrival of...
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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...
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doi:10.2165/00019053-200321040-00003
更新日期:2003-01-01 00:00:00
abstract::The broad spectrum of antibacterial activity and favourable pharmacokinetic profile of ciprofloxacin permit oral treatment of many serious infections which have traditionally necessitated parenteral antibacterial therapy. This has been demonstrated in comparative studies, in which ciprofloxacin was as effective and w...
journal_title:PharmacoEconomics
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更新日期:1993-05-01 00:00:00
abstract:AIM:To assess the relative cost effectiveness of escitalopram compared with venlafaxine XR in patients with major depressive disorder (MDD). METHODS:An economic evaluation was conducted alongside a double-blind, multinational, randomised clinical trial and examined the costs and quality of life of 251 patients taking ...
journal_title:PharmacoEconomics
pub_type: 临床试验,杂志文章,随机对照试验
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abstract:OBJECTIVE:The objective of this study was to examine the cost effectiveness of fluvoxamine compared with tricyclic antidepressants (TCAs) in the treatment of patients with depressive episodes. DESIGN AND SETTING:A Markov process model was constructed to model the effectiveness, as measured by time without depression, ...
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doi:10.2165/00019053-199814040-00009
更新日期:1998-10-01 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...
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更新日期:2016-01-01 00:00:00
abstract:OBJECTIVE:The study aimed to conduct a systematic literature search to identify health state utilities for weight change in type 2 diabetes mellitus (T2DM) and to review those values for appropriateness for inclusion in a submission to the National Institute for Health and Clinical Excellence (NICE). METHODS:The searc...
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doi:10.2165/11599420-000000000-00000
更新日期:2012-12-01 00:00:00
abstract::Randomized controlled trials provide unbiased estimates of treatment effect through reducing the attribution of observed differences in outcome to the play of chance or the treatment of interest. Issues in the design of randomized trials may lead to a dilution or magnification of treatment effect when compared with cl...
journal_title:PharmacoEconomics
pub_type: 杂志文章
doi:10.2165/00019053-200927010-00002
更新日期:2009-01-01 00:00:00
abstract::Since the inception of the National Health Service in 1948, successive British governments have taken various measures to restrain the growth of the medicines bill. A total of 10 different measures have been introduced with very limited success. The most effective measures have been those directed at increasing the le...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199610030-00003
更新日期:1996-09-01 00:00:00
abstract:OBJECTIVE:The reliability and validity of generic utility measures have not yet been summarized in people with multiple sclerosis (MS). It is important to assess the psychometric properties of these measures, to ensure that the values obtained by the scoring system are valid for interpretation and utilization by clinic...
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更新日期:2014-08-01 00:00:00
abstract::In the current climate of cost containment and quality control, nosocomial infection is a worrisome adverse event in hospital care. Hospitalised patients require care for increasingly severe illnesses, and are therefore more susceptible to infection, especially by opportunistic micro-organisms. It is thus necessary to...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199507020-00005
更新日期:1995-02-01 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
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doi:10.2165/00019053-200119060-00001
更新日期:2001-01-01 00:00:00
abstract::Cefotaxime is a parenterally administered third generation cephalosporin with a broad spectrum of antimicrobial activity. After more than a decade of use, cefotaxime continues to play an important role in the treatment of patients with serious infections, particularly those caused by Gram-negative bacteria. Clinical t...
journal_title:PharmacoEconomics
pub_type: 杂志文章,评审
doi:10.2165/00019053-199813010-00009
更新日期:1998-01-01 00:00:00
abstract::In today's environment, the demand for efficient healthcare resource allocation is increasing. As new technologies become available, allocation decisions become more complex and tools to assist decision makers in determining efficient allocations of healthcare resources are encouraged. Mathematical programs have multi...
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doi:10.2165/00019053-200321120-00001
更新日期:2003-01-01 00:00:00
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journal_title:PharmacoEconomics
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doi:10.2165/00019053-199916060-00002
更新日期:1999-12-01 00:00:00
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doi:10.2165/00019053-199916001-00010
更新日期:1999-01-01 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
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更新日期:2005-01-01 00:00:00
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journal_title:PharmacoEconomics
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更新日期:1996-01-01 00:00:00
abstract:BACKGROUND AND AIM:Buprenorphine offers an alternative to methadone in the treatment of heroin dependence, and has the advantage of allowing alternate-day dosing. This study is the first to examine the cost effectiveness of buprenorphine as maintenance treatment for heroin dependence in a primary care setting using eco...
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pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:2005-01-01 00:00:00
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更新日期:2010-01-01 00:00:00
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journal_title:PharmacoEconomics
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doi:10.2165/00019053-200725050-00006
更新日期:2007-01-01 00:00:00
abstract::There is a global perspective to the economic consequences of diabetes, which is illustrated in the many publications now being produced on this subject. Because of the higher prevalence of type II diabetes, its impact is greater than that of type I diabetes in both developed and developing countries (but particularly...
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pub_type: 杂志文章,评审
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更新日期:1995-01-01 00:00:00
abstract::Answering the demanding questions asked of pharmacotherapy in the 21st century will require more reliance on the disciplines of pharmacoepidemiology and pharmacoeconomics. Pharmacoepidemiology can help assess patterns and appropriateness of drug utilisation, provide explanations for poor compliance, quantify the frequ...
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更新日期:2004-01-01 00:00:00
abstract:BACKGROUND:The measurement and valuation of health-related quality of life for and by young people are increasingly important, yet research on the impact of study perspective and validity of preferences obtained from young populations remains limited. OBJECTIVE:The objective of this study was to evaluate the feasibili...
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更新日期:2020-05-01 00:00:00
abstract::Which costs and benefits to consider in economic evaluations of healthcare interventions remains an area of much controversy. Unrelated medical costs in life-years gained is an important cost category that is normally ignored in economic evaluations, irrespective of the perspective chosen for the analysis. National gu...
journal_title:PharmacoEconomics
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更新日期:2008-01-01 00:00:00