The impact of increased post-progression survival on the cost-effectiveness of interventions in oncology.

Purpose: Cost-effectiveness analyses (CEA) of new technologies typically include "background" costs (eg, all "related" health care costs other than the specific technology under evaluation) as well as drug costs. In oncology, these are often expensive. The marginal cost-effectiveness ratio (ie, the extra costs and QALYs associated with each extra period of survival) calculates the ratio of background costs to QALYs during post-progression. With high background costs, the incremental cost-effectiveness ratio (ICER) can become less favorable as survival increases and the ICER moves closer to the marginal cost-effectiveness ratio, making cost-effectiveness prohibitive. This study assessed different methods to determine whether high ICERs are caused by high drug costs, high "background costs" or a combination of both and how different approaches can alter the impact of background costs on the ICER where the marginal cost-effectiveness ratio is close to, or above, the cost-effectiveness threshold. Methods: The National Institute for Health and Care Excellence oncology technology appraisals published or updated between October 2012 and October 2017 were reviewed. A case study was selected, and the CEA was replicated. Three modeling approaches were tested on the case study model. Results: Applying one-off "transition" costs during post-progression reduced the ongoing "incremental" costs of survival, which meant that the marginal cost-effectiveness ratio was substantially reduced and problems associated with additional survival were less likely to impact the ICER. Similarly, the use of two methods of additional utility weighting for end-of-life cases meant that the marginal cost-effectiveness ratio was reduced proportionally, again lessening the impact of increased survival. Conclusion: High ICERs can be caused by factors other than the cost of the drug being assessed. The economic models should be correct and valid, reflecting the true nature of marginal survival. Further research is needed to assess how alternative approaches to the measurement and application of background costs and benefits may provide an accurate assessment of the incremental benefits of life-extending oncology drugs. If marginal survival costs are incorrectly calculated (ie, by summing total post-progressed costs and dividing by the number of baseline months in that state), then the costs of marginal survival are likely to be overstated in economic models.

A systematic review and cost analysis of repeat colonoscopies due to inadequate bowel cleansing in five European countries.

Background: Colonoscopies are carried out for a range of reasons including for the detection of colon cancer and investigation of abdominal and bowel related symptoms. Inadequate preparation can increase the burden of repeat procedures.Methods: A systematic review aimed to identify the rate of repeat colonoscopies due to inadequate bowel preparation in France, Germany, Italy, Spain and the United Kingdom. The information obtained populated a decision analytic model to estimate the cost implications of inadequate bowel cleansing in the same five countries. The model explored scenarios by comparing one and two-litre polyethylene glycol-based bowel preparation.Results: The systematic review identified 14 eligible studies reporting on the proportion of patients with inadequate bowel cleansing indicated for a repeat procedure. Data were available for Italy (27.5%-35.9%), Spain (63%) and the UK (24.5%) only. The decision analytic model demonstrates that improving the proportion of adequate bowel cleansing at first colonoscopy is likely to generate cost savings.Conclusions: Based on the available evidence, increasing the proportion of people who have adequate bowel cleansing at index colonoscopy will likely have financial benefits in Italy, Spain and the UK. A paucity of data, for France and Germany, limits the robustness of conclusions in these countries.

Mepilex Border Sacrum and Heel Dressings for the Prevention of Pressure Ulcers: A NICE Medical Technology Guidance.

Mepilex Border Sacrum and Heel dressings are self-adherent, multilayer foam dressings designed for use on the heel and sacrum aiming to prevent pressure ulcers. The dressings are used in addition to standard care protocols for pressure ulcer prevention. The National Institute for Health and Care Excellence (NICE) selected Mepilex Border Sacrum and Heel dressings for evaluation. The External Assessment Centre (EAC) critiqued the company's submission. Thirteen studies (four randomised controlled trials and nine nonrandomised comparative studies) were included. The majority of studies compared Mepilex Border Sacrum dressings (plus standard care) with standard care alone. Comparative evidence for Mepilex Border Heel dressings was limited. A meta-analysis indicated a non-statistically significant difference in favour of Mepilex Border Sacrum dressings for pressure ulcer incidence [RR 0.51 (95% CI 0.22-1.18)]. The company produced a de novo cost model, which was critiqued by the EAC. After the EAC updated input parameters, cost savings of £19 per patient compared with standard care alone for pressure ulcer prevention were estimated with Mepilex Border dressings predicted to be cost saving in 57% of iterations. The Medical Technologies Advisory Committee reviewed the evidence and judged that, although Mepilex Border Heel and Sacrum dressings have potential to prevent pressure ulcers in people who are considered to be at risk in acute care settings, further evidence is required to address uncertainties around the claimed benefits of the dressings and the incidence of pressure ulcers in an NHS acute-care setting. After a public consultation, NICE published this as Medical Technology Guidance 40.

Correction to: Use of Expert Judgement Across NICE Guidance­Making Programmes: A Review of Current Processes and Suitability of Existing Tools to Support the Use of Expert Elicitation.

In Sect. 3.3.1, the second sentence of the second paragraph.

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.

OBJECTIVES: This study aimed to review current use of experts within National Institute for Health and Care Excellence (NICE) guidance-making programmes, identify improvements in use of expert judgement, and to assess tools and protocols to support the elicitation of information from experts for use by NICE. METHODS: The study comprised a review of NICE process guides; semi-structured interviews with individuals representing each NICE guidance-making programme and a comparison of the suitability of currently available tools and protocols for expert elicitation to the requirements of NICE programmes. RESULTS: Information elicited from experts and the way in which it is used varies across NICE guidance-making programmes. Experts' involvement can be as intensive as being a member of a committee and thus having direct influence on recommendations or limited one-off consultations on specific parameters. We identified 16 tools for expert elicitation that were potentially relevant. None fully met the requirements of NICE, although an existing tool could be potentially adapted. Ongoing research to develop a reference protocol for expert elicitation in healthcare decision making may be of use in future. CONCLUSIONS: NICE uses expert judgement across all its guidance-making programmes, but its uses vary considerably. There is no currently available tool for expert elicitation suitable for use by NICE. However, adaptation of an existing tool or ongoing research in the area could address this in the future.

The Memokath-051 Stent for the Treatment of Ureteric Obstruction: A NICE Medical Technology Guidance.

Memokath-051 is a thermo-expandable, nickel-titanium alloy spiral stent used to treat ureteric obstruction resulting from malignant or benign strictures. The National Institute for Health and Care Excellence (NICE) selected Memokath-051 for evaluation. The company, PNN Medical, claimed Memokath-051 has clinical superiority and cost savings compared with double-J stents. It identified five studies reporting clinical evidence on Memokath-051 and constructed a de novo cost model comparing Memokath-051 to double-J stents. Results indicated that Memokath-051 generated cost savings of £4156 per patient over 2.5 years. The External Assessment Centre (EAC) critiqued the company's submission and completed substantial additional work. Sixteen studies were identified assessing Memokath-051 and all listed comparators in the scope (double-J stents, reconstructive surgery and metallic and alloy stents) except nephrostomy. Similar success rates were reported for Memokath-051 compared with double-J and Resonance stents and worse outcomes compared with other options with evidence available. The EAC updated the company's cost model structure and modified several inputs. The EAC's model estimated that Memokath-051 generated savings of at least £1619 per patient over 5 years compared with double-J stents, was cost neutral compared with other metallic stents and was cost saving compared with surgery up to month 55. Overall, Memokath-051 is likely to be cost saving in patients not indicated for reconstructive surgery and those expected to require a ureteral stent for at least 30 months. The Medical Technologies Advisory Committee (MTAC) reviewed the evidence and supported the case for adoption, issuing partially supportive recommendations published after public consultation as Medical Technologies Guidance 35.

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

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.

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

The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company's conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model's inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.

Spectra Optia® for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: 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.

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

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.

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 $5.53, compared with $6.49 for adalimumab, $6.43 for etanercept, $5.95 for certolizumab, and $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.

Review of Economic Submissions to NICE Medical Technologies Evaluation Programme.

The economic evaluation of medical devices is increasingly used to inform decision making on adopting new or novel technologies; however, challenges are inevitable due to the unique characteristics of devices. Cost-consequence analyses are recommended and employed by the English National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) to help address these challenges. The aim of this work was to review the critiques raised for previous MTEP submissions and explore if there were common problems across submissions. We reviewed a sample of 12 economic submissions to MTEP representing 50 % of 24 sets of guidance issued to July 2015. For each submission, we reviewed the External Assessment Centre's (EAC) report and the guidance document produced by NICE. We identified the main problems raised by the EAC's assessments and the committee's considerations for each submission, and explored strategies for improvement. We found that the identification and measurement of costs and consequences are the main shortcomings within economic submissions to MTEP. Together, these shortcomings accounted for 42 % of criticisms by the EACs among the reviewed submissions. In certain circumstances problems with these shortcomings may be unavoidable, for example, if there is a limited evidence base for the device being appraised. Nevertheless, strategies can often be adopted to improve submissions, including the use of more appropriate time horizons, whilst cost and resource use information should be taken, where possible, from nationally representative sources.

Tegaderm CHG IV Securement Dressing for Central Venous and Arterial Catheter Insertion Sites: A NICE Medical Technology Guidance.

Catheters are widely used for vascular access and for the administration of drugs or fluids in critically ill patients. This exposes patients to an infection risk. Tegaderm chlorhexidine gluconate (CHG) (developed by 3M)-a transparent securement dressing-covers and protects catheter sites and secures devices to the skin. It comprises a transparent adhesive dressing to act as a barrier against external contamination and an integrated gel pad containing an antiseptic agent. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected Tegaderm CHG for evaluation. One study was identified by the sponsor as relevant to the decision problem. From this, the sponsor concluded that compared with standard dressings, Tegaderm CHG is associated with lower rates of catheter-related infection, but increased dermatitis incidence. The External Assessment Centre (EAC) identified four paired comparative studies between Tegaderm CHG, other CHG dressings or standard dressings. The EAC agreed with the sponsor's conclusion, finding that CHG dressings reduce infections compared with standard dressings. The sponsor constructed a de novo costing model. Tegaderm CHG generated cost savings of £77.26 per patient compared with standard dressings and was cost saving in 98.5 % of a sample of sets of inputs (2013 prices). The EAC critiqued and updated the model's inputs, yielding similar results to those the sponsor estimate. The MTAC reviewed the evidence and decided to support the case for adoption, issuing a positive draft recommendation. After a public consultation, NICE published this as Medical Technology Guidance 25.

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

BACKGROUND: In the UK, NHS hospitals receive large amounts of evidence-based recommendations for care delivery from the National Institute for Health and Care Excellence (NICE) and other organisations. Little is known about how NHS organisations implement such guidance and best practice for doing so. This study was therefore designed to examine the dissemination, decision-making, and monitoring processes for NICE interventional procedures (IP) guidance and to investigate the barriers and enablers to the implementation of such guidance. METHODS: A cross-sectional survey questionnaire was developed and distributed to individuals responsible for managing the processes around NICE guidance in all 181 acute NHS hospitals in England, Scotland, Wales and Northern Ireland. A review of acute NHS hospital policies for implementing NICE guidance was also undertaken using information available in the public domain and from organisations' websites. RESULTS: The response rate to the survey was 75 % with 135 completed surveys received. Additionally, policies from 25 % of acute NHS hospitals were identified and analysed. NHS acute hospitals typically had detailed processes in place to implement NICE guidance, although organisations recognised barriers to implementation including organisational process barriers, clinical engagement and poor targeting with a large number of guidance issued. Examples of enablers to, and good practice for, implementation of guidance were found, most notably the value of shared learning experiences between NHS hospitals. Implications for NICE were also identified. These included making improvements to the layout of guidance, signposting on the website and making better use of their shared learning platform. CONCLUSIONS: Most organisations have robust processes in place to deal with implementing guidance. However, resource limitations and the scope of guidance received by organisations create barriers relating to organisational processes, clinician engagement and financing of new procedures. Guidance implementation can be facilitated through encouragement of shared learning by organisations such as NICE and open knowledge transfer between organisations.

The MAGEC system for spinal lengthening in children with scoliosis: A NICE Medical Technology Guidance.

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).

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.

PURPOSE: This analysis compared the rate of deep wound infections in patients with open tibia fractures, treated with intramedullary nails, receiving additional locally-delivered antibiotics to those receiving standard care. METHODS: Two systematic literature searches identified studies reporting infection rates in patients treated with intramedullary nails for tibia fractures receiving systemic antibiotics only (search one) and in patients receiving adjunctive locally-administered antibiotics peri-operatively at the tissue-implant interface (search two). After applying inclusion and exclusion criteria, 14 and seven papers from searches one and two, respectively, were included in meta-analyses. RESULTS: The absolute rate of infection was lower for all Gustilo-Anderson grades of tibia fractures when local antibiotics were administered as adjunctive prophylactic therapy. For severe fractures, classified as GAIII fractures, patients receiving systemic antibiotics only had an infection rate of 14.4 % [95 % CI: 10.5 %, 18.5 %]; adding local antibiotics reduced the rate to 2.4 % [0.0 %, 9.4 %], with an odds ratio of 0.17. Risk of deep wound infections increased with severity of fracture, rising to over 31 % in GIIIB&C fractures for patients receiving systematic antibiotics only, but to below 9 % with additional local antibiotics. CONCLUSION: The findings support consideration of augmenting the antibiotic prophylaxis regimen to include locally-delivered antibiotics. Patients with severe fractures will obtain greatest benefit from infections avoided. No trial directly compared the two treatments for open tibia fractures, limiting the ability to attribute the differences in observed infection rates directly to the treatments themselves. A large comparative study to improve the evidence on relative effect size is merited. LEVEL OF EVIDENCE: Level III.

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

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.