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Scoliosis-structural lateral curvature of the spine-affects around four children per 1,000. The MAGEC system comprises a magnetically distractible spinal rod implant and an external remote controller, which lengthens the rod; this system avoids repeated surgical lengthening. Rod implants brace the spine internally and are lengthened as the child grows, preventing worsening of scoliosis and delaying the need for spinal fusion. The Medical Technologies Advisory Committee at the National Institute for Health and Care Excellence (NICE) selected the MAGEC system for evaluation in a NICE medical technologies guidance. Six studies were identified by the sponsor (Ellipse Technologies Inc.) as being relevant to the decision problem. Meta-analysis was used to compare the clinical evidence results with those of one conventional growth rod study, and equal efficacy of the two devices was concluded. The key weakness was selection of a single comparator study. The External Assessment Centre (EAC) identified 16 conventional growth rod studies and undertook meta-analyses of relevant outcomes. Its critique highlighted limitations around study heterogeneity and variations in baseline characteristics and follow-up duration, precluding the ability to draw firm conclusions. The sponsor constructed a de novo costing model showing that MAGEC rods generated cost savings of £9,946 per patient after 6 years, compared with conventional rods. The EAC critiqued and updated the model structure and inputs, calculating robust cost savings of £12,077 per patient with MAGEC rods compared with conventional rods over 6 years. The year of valuation was 2012. NICE issued a positive recommendation as supported by the evidence (Medical Technologies Guidance 18).
OBJECTIVES: To evaluate the cost-effectiveness of everolimus plus exemestane (EVE+EXE) versus chemotherapy agents [docetaxel (DOC), vinorelbine (VIN), doxorubicin (DOX) and capecitabine (CAPE) ] for the treatment of hormone receptor positive (HR+) HER2 negative (HER2-) advanced or metastatic breast cancer in the United Kingdom (UK).
METHODS: A partitioned survival model was developed to compare treatment with EVE+EXE versus DOC, VIN, DOX and CAPE in patients with ER+ HER2- metastatic breast cancer over a 10-year time horizon from a UK NHS perspective. Progression-free survival and overall survival for EVE+EXE were taken from the BOLERO-2 trial. Log-logistic functions were used to extrapolate trial data beyond the follow-up period. In the absence of head-to-head evidence comparing EVE+EXE versus chemotherapy a naïve chained comparison was conducted with the link between EVE+EXE established via tamoxifen using the Bucher method. A class effect was assumed for the four chemotherapy agents. Background health state and terminal care resource use were derived from NICE Clinical Guideline 81. Drug costs were taken from the British National Formulary. Utilities for stable and progressive states were obtained from the literature (Lloyd et al. 2006).
RESULTS: Over a ten year time horizon, EVE+EXE led to a life expectancy of 3.55 years, compared to 1.88 for chemotherapy agents (DOC, VIN, DOX and CAPE). EVE+EXE resulted in 2.06 QALYs, compared to 0.95 for chemotherapy agents. Total costs were £48,085 for EVE+EXE compared to £31,835 vs. DOC, £25,021 vs. VIN, £23,743 vs. DOX and £21,851 vs. CAPE. The incremental costs per QALY were £14,550 vs. DOC, £20,653 vs. VIN, £21,797 vs. DOX and £23,491 vs. CAPE. Results were most sensitive to changes in PFS for chemotherapy and disease related costs.
CONCLUSIONS: Everolimus in combination with exemestane is a cost effective option compared with commonly used chemotherapeutic agents (docetaxel, vinorelbine, doxorubicin and capecitabine) in UK clinical practice.
OBJECTIVE: The aim of this study was to determine the budget impact of everolimus (in combination with letrozole/anastrozole) as a second-line treatment for ER+ HER2- negative advanced and metastatic breast cancer in post-menopausal women.
RESEARCH DESIGN & METHODS: A cumulative cohort model was developed to estimate the 5-year costs associated with introducing everolimus to the Kazakh healthcare system. Two alternative market share scenarios were compared: with everolimus and without everolimus. PFS and OS data were taken from the trial and extrapolated. The background costs of the pre-progressed and post-progressed health states, drug costs and costs associated with adverse events were included in the model.
RESULTS: The 5-year results from the budget impact analysis demonstrate that the introduction of everolimus leads to a 12% increase in drug costs, a 2% reduction in pre-progression health state costs, a 1% increase in post-progression health state costs, and a 2% reduction in adverse event costs. The net result is only a modest increase in total costs; a 2.69% increase of T201 million, from T7.5 billion to T7.7 billion over a period of 5 years.
CONCLUSIONS: The analysis estimated that, if everolimus were to be introduced to the Kazakh healthcare market for the treatment of ER+ HER2- advanced breast cancer, there would be minimal impact upon overall healthcare expenditure. An increase in drug acquisitions costs was almost exactly offset by a reduction in other healthcare costs, due to improved management of the disease.
OBJECTIVES: This study evaluated the cost-effectiveness of everolimus plus exemestane (EVE+EXE) versus exemestane (EXE) and fulvestrant (FUL) in the treatment of postmenopausal women with ER+ HER2- metastatic breast cancer in the United Kingdom (UK) from a societal perspective.
METHODS: A partitioned survival model was developed to compare treatment with EVE+EXE versus EXE and FUL over a 10-year time horizon. Progression-free survival and overall survival for EVE+EXE and EXE were estimated from the BOLERO-2 trial. Log-logistics functions were used to extrapolate trial data beyond the follow-up period. In the absence of head-to-head evidence vs. FUL an indirect treatment comparison was conducted using a Bayesian fixed effect model. Background health state and terminal care resource use were derived from NICE Clinical Guideline 81. Drug costs were taken from the British National Formulary. Productivity loss, defined as working days lost due to disease, was included in the analysis. Utilities from published sources were combined with trial data to calculate quality-adjusted life years (QALYs) for the model health state.
RESULTS: EVE+EXE led to an incremental gain in life years of 0.20 vs. EXE and 0.19 vs. FUL. The incremental QALY gain was 0.31 vs. EXE and 0.27 vs. FUL. The cost of lost productivity was £66,163 in the EVE+EXE compared to £75,067 in the EXE arm and £73,434 in the FUL arm. The incremental cost per QALY was £27,644 vs. EXE and £14,030 vs. FUL. Probabilistic sensitivity analysis demonstrated that, at a threshold of £30,000 per QALY gained, EVE+EXE had a 51.6% likelihood of being cost-effective vs. EXE and 59.0% vs. FUL.
CONCLUSIONS: Patients receiving EVE+EXE experienced an improvement in survival which translated into health gains in terms of both LYs and QALYs. EVE+EXE was associated with savings in productivity costs compared to both EXE and FUL.
BACKGROUND: Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures.
METHODS: A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index – Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed.
RESULTS: From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD-10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes.
CONCLUSIONS: The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored.
PURPOSE: The aim of this study was to evaluate the cost effectiveness of ranibizumab compared with verteporfin photodynamic therapy (vPDT) or no treatment (observation) in patients with visual impairment due to myopic choroidal neovascularization (CNV).
METHODS: A Markov model with health states defined by best-corrected visual acuity and a 3-month cycle length was developed. It had a healthcare provider (UK National Health Service and personal social services) perspective, a lifetime time horizon, and was based on 2011 prices; future costs and health outcomes were discounted at 3.5 % per annum. Baseline characteristics were based on the phase III RADIANCE (Ranibizumab and vPDT Evaluation in Myopic CNV) study, and year 1 health-state transitions were based on this and the VIP (Verteporfin in Photodynamic Therapy) study. Extensive sensitivity analyses tested the robustness of the model.
RESULTS: The lifetime cost of treating myopic CNV with ranibizumab was £12,866, whereas vPDT and observation were associated with total costs of £14,421 and £8,163, respectively. Ranibizumab treatment produced higher cumulative quality-adjusted life-years (QALYs; 12.99) than vPDT (12.60) or observation (12.45). Ranibizumab treatment was therefore dominant, with greater health gains and lower overall costs than vPDT. Ranibizumab was cost effective compared with observation, with an incremental cost-effectiveness ratio of £8,778/QALY. In the probabilistic sensitivity analysis, ranibizumab had a 100 % and 88 % probability of being cost effective compared with vPDT and observation, respectively, at a willingness-to-pay threshold of £20,000/QALY.
CONCLUSION: This study indicates that ranibizumab therapy is dominant over vPDT for the treatment of visual impairment due to CNV secondary to pathologic myopia in the UK healthcare setting and cost effective compared with observation.
