Michelle Jenks

Warfarin monitoring economic evaluation of point of care self-monitoring compared to clinic settings.

Abstract Objective: To determine the cost-effectiveness of home-based point-of-care self-monitoring compared to clinic-based care for patients managed on long-term warfarin medication. Current evidence is inconsistent; results should reduce uncertainty and inform service delivery. Methods: A Markov model compared self-testing and self-management, using point-of-care devices to usual care in patients with atrial fibrillation and mechanical heart valves. The primary clinical end-points were stroke and mortality avoided; costs and utilities were associated with these events. The costs of warfarin monitoring were included in the model. Results: Over 10 years, self-monitoring saved £1187 per person compared to usual care. Patients who self-monitored had notably fewer strokes and deaths. The results were sensitive to life-years gained and cost of the device. If the NHS purchased the device, financial break-even was achieved at the end of the second year; if the patient bought the device the NHS saved money every year. If 10% of the current 950,000 patients switched to point-of-care devices for 10 years, the NHS could save over £112million. Limitations: Clinical studies had a relatively short duration and only data on composite end-points were reported. Conclusions: With training, self-testing and self-management are safe, reliable, and cost-effective for a sizable proportion of patients receiving long-term warfarin. Compared to clinic-based services, self-monitoring offers the NHS the potential to make cost savings and release bed-days by reducing the number of strokes experienced by these high-risk patients.

An Economic Evaluation of Tofacitinib Treatment in Rheumatoid Arthritis: Modeling the Cost of Treatment Strategies in the United States

BACKGROUND Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). Tofacitinib is approved in the United States for use in adults with moderately to severely active RA and an inadequate response or intolerance to methotrexate. OBJECTIVES To (a) evaluate, using an economic model, the treatment costs of an RA strategy including tofacitinib, compared with adalimumab, etanercept, certolizumab and tocilizumab biologic RA treatment strategies, which are commonly prescribed in the United States, and (b) assess the economic impact of monotherapy and combination therapy in patients who had an inadequate response to methotrexate therapy (MTX-IR analysis) and to combination therapy in patients who had an inadequate response to a tumor necrosis factor inhibitor (TNF-IR analysis). METHODS A transparent, Excel-based economic model with a decision-tree approach was developed to evaluate costs over a 1- and 2-year time horizon. The model compared tofacitinib 5 mg twice a day (BID) either as monotherapy or in combination with MTX with similarly labeled biologic therapies. Response to treatment was modeled as American College of Rheumatology (ACR) 20/50/70 response. ACR20 represented clinical response and determined whether patients continued therapy. ACR response rates at 6-month intervals were sourced from prescribing information and safety event rates from a published meta-analysis. Following an adverse event or a lack of response to treatment, it was assumed that 75% of patients switched to the next line of treatment (first to abatacept and then to rituximab). The perspective was that of a U.S. payer. Costs were reported in 2015 U.S. dollars and included drug wholesale acquisition costs, monitoring, drug administration, and treatment for minor and serious adverse events. The patient population eligible for treatment was based on the total number of members (i.e., RA and non-RA) in a payer organization; members with RA treated with biologic therapies were estimated using epidemiological data. Sensitivity analyses were conducted to explore the impact of varying key parameters, including treatment-switching probability, product rebate, major rates of adverse drug reaction, and ACR20 rates, on the model outcomes. RESULTS Tofacitinib combination therapy after MTX failure was associated with the lowest cost per member per month (PMPM) over a 2-year time frame at

Cost-utility analysis of the insufflation of warmed humidified carbon dioxide during open and laparoscopic colorectal surgery

5.53, compared with

Spectra Optia(®) for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance.

6.49 for adalimumab,

Cost-effectiveness analysis of the use of high-flow oxygen through nasal cannula in intensive care units in NHS England

6.43 for etanercept,

Use of Expert Judgement Across NICE Guidance-Making Programmes: A Review of Current Processes and Suitability of Existing Tools to Support the Use of Expert Elicitation

5.95 for certolizumab, and

The XprESS Multi-Sinus Dilation System for the Treatment of Chronic Sinusitis: A NICE Medical Technology Guidance

5.89 for tocilizumab. Similar savings were observed when all biologics were administered as monotherapy. Tofacitinib combination therapy was also associated with the lower PMPM cost compared with adalimumab combination therapy in the TNF-IR analysis. Tofacitinib was also among the lowest cost per ACR20 responder in each analysis. Sensitivity analyses demonstrated that tofacitinib would potentially be cost saving even in the least optimistic scenarios. CONCLUSIONS This analysis suggests that tofacitinib 5 mg BID following MTX failure is a lower cost per patient treatment option when used either as monotherapy or combination therapy, compared with adalimumab, etanercept, certolizumab and tocilizumab biologic regimens. Tofacitinib + MTX in TNF-IR patients was also predicted to be a lower-cost treatment option compared with adalimumab+MTX and was associated with the lowest cost per ACR 20/50/70 responder. DISCLOSURES This study was funded by Pfizer, which determined the research topic and paid York Health Economics Consortium to develop the analysis and conduct the research. York Health Economics Consortium has received consultancy fees from Pfizer. Gerber, Wallenstein, Mendelsohn, Bourret, Singh, and Moynagh are employees and shareholders of Pfizer. Editorial support was funded by Pfizer and was provided by Claxton, Jenks, and Taylor, who are employees of York Health Economics Consortium. Study concept and design were contributed primarily by Taylor, Jenks, Gerber, and Singh, along with the other authors. Gerber, Moynagh, and Singh collected the data, assisted by Bouret and Mendelsohn; data interpretation was performed by Claxton, Gerber, Bouret, and Mendelsohn. The manuscript was written primarily by Claxton, with assistance from the other authors, and revised by Claxton, Gerber, Bouret, and Mendelsohn, with assistance from the other authors.

Systematic review and meta-analysis of the additional benefit of local prophylactic antibiotic therapy for infection rates in open tibia fractures treated with intramedullary nailing

ABSTRACT Background: An evaluation was conducted to estimate the cost-effectiveness of insufflation of warmed humidified CO2 during open and laparoscopic colorectal surgery compared with usual care from a UK NHS perspective. Methods: Decision analytic models were developed for open and laparoscopic surgery. Incremental costs per quality-adjusted life year (QALY) were estimated. The open surgery model used data on the incidence of intra-operative hypothermia and applied risks of complications for hypothermia and normothermia. The laparoscopic surgery model utilised data describing complications directly. Sensitivity analyses were conducted. Results: Compared with usual care, insufflation of warmed humidified CO2 dominated. For open surgery, savings of £20 and incremental QALYs of 0.013 were estimated per patient. For laparoscopic surgery, savings of £345 and incremental QALYs of 0.001 per patient were estimated. Results were robust to most sensitivity analyses. Conclusions: Considering the current evidence base, the intervention is likely to be cost-effective compared with usual care in patients undergoing colorectal surgery.

The MAGEC System for Spinal Lengthening in Children with Scoliosis: A NICE Medical Technology Guidance

The Spectra Optia® automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.

Examining the implementation of NICE guidance: cross-sectional survey of the use of NICE interventional procedures guidance by NHS Trusts

ABSTRACT Objective: To estimate the cost-effectiveness of Nasal High Flow (NHF) in the intensive care unit (ICU) compared with standard oxygen or non-invasive ventilation (NIV) from a UK NHS perspective. Methods: Three cost-effectiveness models were developed to reflect scenarios of NHF use: first-line therapy (pre-intubation model); post-extubation in low-risk, and high-risk patients. All models used randomized control trial data on the incidence of intubation/re-intubation, events leading to intubation/re-intubation, mortality and complications. NHS reference costs were primarily used. Sensitivity analyses were conducted. Results: When used as first-line therapy, Optiflow™ NHF gives an estimated cost-saving of £469 per patient compared with standard oxygen and £611 versus NIV. NHF cost-savings for high severity sub-group were £727 versus standard oxygen, and £1,011 versus NIV. For low-risk post-intubation patients, NHF generates estimated cost-saving of £156 versus standard oxygen. NHF decreases the number of re-intubations required in these scenarios. Results were robust in most sensitivity analyses. For high-risk post-intubation patients, NHF cost-savings were £104 versus NIV. NHF results in a non-significant increase in re-intubations required. However, reduction in respiratory failure offsets this. Conclusions: For patients in ICU who are at risk of intubation or re-intubation, NHF cannula is likely to be cost-saving.