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PubMed | University of Groningen, Sanofi S.A., ICON Health Economics and Aix - Marseille University
Type: Journal Article | Journal: Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research | Year: 2016

Designed to overcome influenza B mismatch, new quadrivalent influenza vaccines (QIVs) contain one additional B strain compared with trivalent influenza vaccines (TIVs).To examine the expected public health impact, budget impact, and incremental cost-effectiveness of QIV versus TIV in the United States.A dynamic transmission model was used to predict the annual incidence of influenza over the 20-year-period of 2014 to 2034 under either a TIV program or a QIV program. A decision tree model was interfaced with the transmission model to estimate the public health impact and the cost-effectiveness of replacing TIV with QIV from a societal perspective. Our models were informed by published data from the United States on influenza complication probabilities and relevant costs. The incremental vaccine price of QIV as compared with that of TIV was set at US $5.40 per dose.Over the next 20 years, replacing TIV with QIV may reduce the number of influenza B cases by 27.2% (16.0 million cases), resulting in the prevention of 137,600 hospitalizations and 16,100 deaths and a gain of 212,000 quality-adjusted life-years (QALYs). The net societal budget impact would be US $5.8 billion and the incremental cost-effectiveness ratio US $27,411/QALY gained. In the probabilistic sensitivity analysis, 100% and 96.5% of the simulations fell below US $100,000/QALY and US $50,000/QALY, respectively.Introducing QIV into the US immunization program may prevent a substantial number of hospitalizations and deaths. QIV is also expected to be a cost-effective alternative option to TIV.


Quigley J.M.,ICON Health Economics | Bryden P.A.,University of Bristol | Scott D.A.,ICON Health Economics | Kuwabara H.,Janssen Pharmaceutical | And 2 more authors.
Hepatology Research | Year: 2015

Aim: Simeprevir (SMV) is an oral, once-daily protease inhibitor for the treatment of chronic hepatitis C virus (HCV) genotype 1 infection. In phase II/III randomized controlled trials (RCT) conducted in Japan, SMV, in combination with peginterferon-α and ribavirin (PEG IFN/RBV), demonstrated potent efficacy in HCV genotype 1-infected patients relative to PEG IFN/RBV and was generally well tolerated. Telaprevir (TVR) in combination with PEG IFN/RBV is licensed for the treatment of HCV in Japan. In the absence of head-to-head comparisons of TVR and SMV in a Japanese population, we undertook a network meta-analysis (NMA) to examine the relative efficacy and safety of SMV and TVR in combination with PEG IFN/RBV. Methods: A systematic review identified SMV and TVR RCT in Japanese treatment-naïve patients. Bayesian NMA was performed assuming fixed study effects. Results: Three studies met our inclusion criteria: two SMV and one TVR. SMV showed a higher mean odds ratio (OR) of achieving SVR versus TVR (OR, 1.68 (95% credible interval 0.66-4.26)). SMV showed a lower mean OR of discontinuation: overall, 0.35 (0.12-1.00); and due to AE, 0.87 (0.23-3.34) versus TVR. SMV showed a lower mean OR of experiencing anemia 0.20 (0.07-0.56) and rash 0.41 (0.17-0.99) but a higher mean OR of experiencing pruritus 1.26 (0.46-3.47) versus TVR. Conclusion: In this indirect treatment comparison, SMV, in combination with PEG IFN/RBV, showed a favorable risk-benefit profile compared with TVR with PEG IFN/RBV in Japanese treatment-naïve HCV patients. Copyright © 2015 John Wiley & Sons, Ltd.


PubMed | Aarhus University Hospital, Coloplast, ICON Health Economics, Kessler Institute for Rehabilitation and University College London
Type: Journal Article | Journal: PloS one | Year: 2016

People suffering from neurogenic bowel dysfunction (NBD) and an ineffective bowel regimen often suffer from fecal incontinence (FI) and related symptoms, which have a huge impact on their quality of life. In these situations, transanal irrigation (TAI) has been shown to reduce these symptoms and improve quality of life.To investigate the long-term cost-effectiveness of initiating TAI in patients with NBD who have failed standard bowel care (SBC).A deterministic Markov decision model was developed to project the lifetime health economic outcomes, including quality-adjusted life years (QALYs), episodes of FI, urinary tract infections (UTIs), and stoma surgery when initiating TAI relative to continuing SBC. A data set consisting of 227 patients with NBD due to spinal cord injury (SCI), multiple sclerosis, spina bifida and cauda equina syndrome was used in the analysis. In the model a 30-year old individual with SCI was used as a base-case. A probabilistic sensitivity analysis was applied to evaluate the robustness of the model.The model predicts that a 30-year old SCI patient with a life expectancy of 37 years initiating TAI will experience a 36% reduction in FI episodes, a 29% reduction in UTIs, a 35% reduction in likelihood of stoma surgery and a 0.4 improvement in QALYs, compared with patients continuing SBC. A lifetime cost-saving of 21,768 per patient was estimated for TAI versus continuing SBC alone.TAI is a cost-saving treatment strategy reducing risk of stoma surgery, UTIs, episodes of FI and improving QALYs for NBD patients who have failed SBC.


Laws A.,ICON Health Economics | Kendall R.,ICON Health Economics | Hawkins N.,London School of Hygiene and Tropical Medicine
Value in Health | Year: 2014

Objectives Within technology appraisals, it is necessary to compare the complete set of treatments that may be used in the patient group under consideration. Randomized controlled trials are a key source of evidence for these comparisons. The techniques of network meta-analysis allow the networks of trial evidence to be evaluated to obtain estimates of comparative efficacy between sets of treatments. These techniques may be the only source of estimates of comparative effectiveness if trials directly comparing the treatments of interest have not been conducted, and may provide useful additional evidence if both direct and indirect comparisons exist. Methods We examined both published and draft guidelines from reimbursement and health technology appraisal bodies, and considered their recommendations using appropriate methodology for the conduct of indirect comparisons and the assessments of their validity. Results Guidelines from 33 countries were reviewed. Of these, guidelines from 9 countries - Australia, Belgium, Canada, France, Germany, Scotland, Spain, South Africa, and the United Kingdom (England and Wales) - included detailed recommendations on the conduct of network meta-analysis. The recommendations were summarized. Conclusions No two recommendations from the multiple national guidelines are mutually exclusive. It is possible to perform one network meta-analysis for submission to multiple national jurisdictions. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


PubMed | Albany College of Pharmacy and Health Sciences, Pharmaceutical Services and Ambulatory Infusion Center, ICON Health Economics, The Medicines Company and Hartford Hospital
Type: Journal Article | Journal: Clinical drug investigation | Year: 2016

Nearly 10% of all US hospital admissions are attributed to acute bacterial skin and skin structure infections (ABSSSIs). While most antibacterials used to treat these infections require multi-day and multi-dose regimens, a single-dose treatment is now available. The objective of this analysis is to estimate the annual budget impact of using single-dose oritavancin in patients with moderate to severe ABSSSIs receiving intravenous methicillin-resistant Staphylococcus aureus (MRSA)-active antibacterials from a US hospital perspective.A decision-analytic model based on current clinical practice was developed to estimate the economic impact of oritavancin. Utilization of antibacterials and rates of hospital admission were derived from the Premier Research Database. Demographic and clinical data were informed by the published literature and 2014 wholesale drug acquisition costs were used. Other costs were based on the published literature and Medicare National Limitation amounts. All costs were inflated to 2014 US dollars. Two base-case scenarios were considered: one for hospitals with ambulatory services and one for hospitals without ambulatory services.For a US hospital with ambulatory services with 1000 ABSSSI patients receiving intravenous MRSA antibiotics annually, use of oritavancin in 26% of patients is estimated to reduce the total annual budget by 12.9% (US$1.23 million), or approximately US$1234.67 per patient. Total inpatient costs will be reduced by 22.3% (US$1.40 million) and outpatient costs will increase slightly by 1.7% (US$55,310). Pharmaceutical cost increases are offset by savings in the inpatient setting from fewer hospital admissions. Hospitals without ambulatory services are estimated to receive overall cost savings of 9.3% (US$0.63 million).Use of single-dose oritavancin in select ABSSSI patients with suspected or confirmed MRSA involvement is estimated to save US hospitals approximately 9.3-12.9% per year by reducing hospital admissions and lowering drug administration burden.


Loveman E.,University of Southampton | Copley V.R.,University of Southampton | Scott D.A.,ICON Health Economics | Colquitt J.L.,University of Southampton | And 2 more authors.
BMC Pulmonary Medicine | Year: 2015

Background: The treatment landscape for idiopathic pulmonary fibrosis, a devastating lung disease, is changing. To investigate the effectiveness of treatments for idiopathic pulmonary fibrosis we undertook a systematic review, network meta-analysis and indirect comparison. Methods: We searched MEDLINE, EMBASE and The Cochrane library for relevant studies. Randomised controlled trials of pirfenidone, nintedanib or N-acetylcysteine were eligible. Predefined processes for selecting references, extracting data and assessing study quality were applied. Our network meta-analysis of published data used a fixed effect model. For forced vital capacity measures a standardised mean difference approach was used and converted to odds ratios for interpretation. Results: Of 1076 references, 67 were retrieved and 11 studies included. Studies were of reasonable size, populations were similar, and the overall quality was good. Only two treatments, pirfenidone (odds ratio 0.62, 95% credible interval 0.52, 0.74) and nintedanib (0.41, 95% credible interval 0.34, 0.51) produced a statistically significant slowing in the rate of forced vital capacity decline compared with placebo. In an indirect comparison, results indicate that nintedanib is statistically significantly better than pirfenidone in slowing forced vital capacity decline (odds ratio 0.67, 95% credible interval 0.51, 0.88). Results were stable in scenario analysis and random effects models. Indirect comparisons of mortality were not statistically significant between nintedanib and pirfenidone. Conclusions: Two treatments show beneficial effects and when compared indirectly nintedanib appears to have superior benefit on forced vital capacity. Limitations to indirect comparisons should be considered when interpreting these results, however, our findings can be useful to inform treatment decisions. © 2015 Loveman et al.; licensee BioMed Central.


Hux M.,ICON Health Economics | Ng C.,ICON Health Economics | Ortega G.L.,ICON Health Economics | Ferrazzi S.,Actavis Specialty Pharmaceuticals | Goeree R.,McMaster University
Expert Review of Pharmacoeconomics and Outcomes Research | Year: 2015

Background: Uterine fibroids (UF) represent the most common benign uterine tumor in women of reproductive age. Symptoms including heavy, prolonged menstrual bleeding, pelvic pain/pressure, and/or urinary frequency have a substantial impact on women's quality of life and utility values for UF have not been published. Methods: Health state descriptions associated with UF symptoms and treatment side effects were developed based on patient focus groups; validated using expert clinical input; and pilot tested for understandability. Using a web-based questionnaire, 909 community-dwelling, Canadian women were surveyed to assess their perceived value associated with these states. Results: Utility for uncontrolled bleeding was 0.55 (95% CI: 0.54, 0.57) and the decrement associated with hot flashes was 0.06 (95% CI: -0.07, -0.04). Utility improvement associated with bleeding control was 0.18 (95% CI: 0.17, 0.19) and with smaller fibroid size was 0.03 (95% CI: 0.02, 0.04). Conclusion: These values illustrate the high utility associated with control of excessive menstrual bleeding. © 2015 Informa UK, Ltd.


Bryden P.,ICON Health Economics | Sidhu M.K.,ICON Health Economics | Huang H.,ARIAD Pharmaceuticals Inc. | McGarry L.J.,ARIAD Pharmaceuticals Inc. | And 5 more authors.
Leukemia Research | Year: 2015

We compared the efficacy of ponatinib and second-generation tyrosine kinase inhibitors (2G-TKIs: bosutinib, dasatinib, and nilotinib) in chronic phase CML resistant/intolerant to ≥1 prior 2G-TKI. Estimated probabilities of CCyR with 2G-TKI ranged from 22% to 26%, compared with 60% (95% CrI 52-68%) with ponatinib. The estimated probability of ponatinib providing higher response rate than all other included treatments was 99% (CCyR) and 97% (MCyR). Use of further 2G-TKI may provide limited benefit in CP-CML patients resistant/intolerant to prior 2G-TKI treatment. Compared with 2G-TKIs, ponatinib is estimated to provide substantially higher probability of achieving CCyR and MCyR; safety was not compared. © 2014 Elsevier Ltd.


Griffiths A.,ICON Health Economics | Paracha N.,ICON Health Economics | Davies A.,ICON Health Economics | Branscombe N.,Servier Laboratories Ltd | And 3 more authors.
Heart | Year: 2014

Objective: Ivabradine, a specific heart rate lowering therapy, has been shown in a randomised placebo-controlled study, Systolic HF Treatment with the If Inhibitor Ivabradine Trial (SHIfT), to significantly reduce the composite end point of cardiovascular death and hospitalisation for worsening heart failure (HF) in patients with systolic HF who are in sinus rhythm and with a heart rate ≥70 bpm, when added to optimised medical therapy (HR: 0.82, 95% CI 0.75 to 0.90, p<0.0001). We assessed the cost effectiveness of ivabradine, from a UK National Health Service perspective, based on the results of SHIfT. Methods: A Markov model estimated the cost effectiveness of ivabradine compared with standard care for two cohorts of patients with HF (heart rate ≥75 bpm in line with the EU labelled indication; and heart rate ≥70 bpm in line with the SHIfT study population). Modelled outcomes included death, hospitalisation, quality of life and New York Heart Association class. Total costs and quality adjusted life years (QALYs) for ivabradine and standard care were estimated over a lifetime horizon. Results: The incremental cost per additional QALY for ivabradine plus standard care versus standard care has been estimated as £8498 for heart rate ≥75 bpm and £13 764 for heart rate ≥70 bpm. Ivabradine is expected to have a 95% chance of being cost-effective in the EU licensed population using the current National Institute for Health and Care Excellence cost effectiveness threshold of £20 000 per QALY. These results were robust in sensitivity analyses. Conclusions: This economic evaluation suggests that the use of ivabradine is likely to be cost-effective in eligible patients with HF from a UK National Health Service perspective.


PubMed | ICON Health Economics
Type: Journal Article | Journal: Expert review of pharmacoeconomics & outcomes research | Year: 2015

Uterine fibroids (UF) represent the most common benign uterine tumor in women of reproductive age. Symptoms including heavy, prolonged menstrual bleeding, pelvic pain/pressure, and/or urinary frequency have a substantial impact on womens quality of life and utility values for UF have not been published.Health state descriptions associated with UF symptoms and treatment side effects were developed based on patient focus groups; validated using expert clinical input; and pilot tested for understandability. Using a web-based questionnaire, 909 community-dwelling, Canadian women were surveyed to assess their perceived value associated with these states.Utility for uncontrolled bleeding was 0.55 (95% CI: 0.54, 0.57) and the decrement associated with hot flashes was 0.06 (95% CI: -0.07, -0.04). Utility improvement associated with bleeding control was 0.18 (95% CI: 0.17, 0.19) and with smaller fibroid size was 0.03 (95% CI: 0.02, 0.04).These values illustrate the high utility associated with control of excessive menstrual bleeding.

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