Getting cost-effectiveness technologies into practice: the value of implementation

Getting cost-effective health technologies into practice is one of the priorities for the NHS identified in Innovation, Health and Wealth [1]. This involves not only identifying cost-effective technologies, which is the responsibility of the National Institute of Health and Care Excellence (NICE), but also understanding the potential barriers to the uptake of these technologies and evaluating possible solutions to these barriers (implementation initiatives). The research presented here sets out a framework for examining the latter (i.e. the solutions to the barriers), in a manner consistent with the estimation of value of the technologies by NICE.The aim of this research is not to create an additional barrier (or “fifth hurdle”) for health care technologies to get into regular use in the NHS but instead to set out a formal analytic framework to allow for the evaluation of different implementation initiatives in a manner consistent with those methods currently employed for health technology assessment by NICE in England and Wales. The use of this framework recognises that the different types of barriers identified and the range of possible implementation approaches that maybe considered appropriate will invariably be associated with different resource implications and potential outcomes. Consequently, it will be important to ensure that the type and intensity of the implementation approach adopted is commensurate with the anticipated value to the NHS.1.2 NICE and cost-effectiveness The value of the new health care technology to the NHS is established by the Appraisal Committee after reviewing evidence. The value of the new technology, in terms of an incremental cost per QALY, is then compared to the cost-effectiveness threshold (k) to see if it represents a cost-effective use of resources. Alternatively, but equivalently, the net value to the NHS of treating a patient with the technology can be calculated in terms of monetary or health benefits.In 1999 the National Institute of Health and Clinical Excellence (NICE) was created with the aim of ensuring that everyone have equal access to medical treatments and high quality care from the UK National Health Service (NHS) [2]. Further, it aimed to maximise the health produced by the NHS (i.e. to use resources efficiently). These objectives are, however, constrained by the budget allocated to the NHS by the government. One of the ways NICE accomplishes these objectives is through their Medical Technology Evaluation Programme [3], which provides recommendations on the use of new and existing medicines and treatments within the NHS. Recommendation decisions are based on the value of treatments and the uncertainty around that value. Importantly, these decisions require an assessment of both the costs and health effects of a new intervention, as well as the health effects of activities that will have to be displaced elsewhere in the NHS in order to fund any new (and more costly) health care technology.The methods recommended by NICE provide standardised and systematic ways to evaluate the overall cost and health effects of new health care technologies [3]. Health effects contain both changes in the quality and length of life. NICE recommends measuring health effects in quality adjusted life-years (QALY) using the EQ-5D instrument [4]. The use of a generic measure of quality of life is important both in ensuring consistency in decision making across different treatments and diseases, as well as ensuring that decisions are consistent with the objective of maximising health gain within a fixed NHS budget. The current perspective used by NICE considers the impact of a new intervention on the resource use and costs on the NHS and Personal Social Services [3].</p

The likely impact of earlier diagnosis of cancer on costs and benefits to the NHS

Overview This report presents a critical review of the five early awareness policy intervention models developed by Frontier Economics. For each issue highlighted within the review, the likely direction of the bias is discussed together with a suggestion of the extent to which these concerns could be rectified within the existing model structure.Frontier Economics modelling approach The model sets out to address two specific questions:1.How would the costs to the NHS change if certain cancers (specifically, breast, colorectal, lung, prostate and melanoma) were detected and diagnosed appreciably earlier than is currently the norm (i.e. according to current survival rates)?2.How would the benefits to individuals change if these cancers were detected and diagnosed appreciably earlier than is currently the norm?The model seeks to examine the impact that earlier detection and diagnosis would have on survival rates and on downstream costs and benefits. Benefits are limited to patient health benefits in terms of improved survival, i.e. change in life years. Costs include those that fall on the NHS, including diagnostics, screening, treatment, follow-up and end of life care.The general approach is to produce projections under a set of assumptions relating to current incidence and screening rates, referred to as the „Business As Usual‟ (BAU) model. Also, to re-run this model making alternative assumptions about awareness and screening rates, referred to as the „Policy Intervention‟ scenario. The impact of earlier diagnosis is measured by comparing the two scenarios (BAU and Policy Intervention), where the key difference between the scenarios relates to the assumptions about the effectiveness of the awareness programme and the efficiency of the screening programme in the given cancer area (when there is screening programme in place - colorectal and breast).The goal of the awareness programme is to inform the population about the risks of developing cancer and the signs that alert a patient to symptoms suspicious of underlying malignant disease. It is expected that individuals would present earlier to their GP, with the result that diagnosis will occur at an earlier stage of cancer, leading to higher survival rates. The early awareness programme seeks to achieve Europe‟s best practice survival rates, i.e. the group of comparable countries in Europe with the highest survival rates. The key assumptions in the model relating to the effectiveness of the awareness campaign and the efficiency of the screening programme, in terms of recruiting more individuals, are altered to achieve the target 1-year survival rates of EUROCARE-4 good practice.</p

Rapid review of existing literature on the cost effectiveness of alternative systems for diagnosis and referral of any cancer in primary care

Introduction: A rapid review has been conducted to explore the existing literature on the cost-effectiveness of interventions/strategies for diagnosis and referral of patients with symptoms that might be suspected for cancer. The aim of the review was to assess whether existing literature could be useful in informing UK policy in these areas.Methods: A systematic literature search was undertaken that considered for inclusion all economic evaluations in the subject areas described above. Data extracted included details of condition (type of cancer) examined, study design, findings (including incremental cost-effectiveness ratios (ICERs), assessment of uncertainty) and quality assessment. In order to maximise the usefulness of this report, papers deemed of high quality represented the priority for discussion. However, data extracted from all papers meeting the inclusion criteria have been presented in an Appendix. Further appendices describe the search strategy methods, results and individual abstracts. Subsequently, interventions/strategies were assessed for their relevance to UK policy and decision making by a group of clinical experts in the relevant fields.Results: The search identified 1,478 references. After excluding papers that were duplicates, non-English language, not economic evaluations, not focussed on cancer or not related to diagnosis/referral for symptoms potentially related to cancer, 28 were finally identified as potentially relevant. These articles were ordered or retrieved from the web. After exclusion of non-relevant studies based on examination of full text, a total of 16 articles were included in the analysis.Conclusions: Cervical cancer was the most common (n=4) cancer type in these studies. Breast (n=2), colorectal (n=2), gastro-oesophageal (n=2), back pain related to cancer (n=2), skin (n=1), lung (n=1), hepatocellular (n=1) and endometrial (n=1) were also studied. The higher quality studies and expert opinion suggested the following:Cervical• In the UK, referral to colposcopy after one mild result during cervical screening rather than after two consecutive mild results appears a cost-effective option. • Published studies suggest that the addition of HPV triage to standard repeat of Pap smear for women with ASC-US might provide good value for money, but that this is already implemented in the NHSColorectal• Colonoscopy might be the most cost-effective strategy in patients presenting to their GP with rectal bleeding compared to other diagnostic options as sigmoidoscopy or watchful waiting.• Immediate colonoscopy could lead to cost savings compared to a traditional system of “waiting list” for colonoscopy.Breast• Immediate fine needle aspiration cytology (FNAC) appears a cost-effective option for patients with a suspicious lesion identified with mammography and clinical examination, and this is fairly routine in the NHS.Low back pain related• Magnetic resonance imaging (MRI) might not be a cost-effective option for patients with low-back pain related to cancer and implementation would likely cause capacity problems in primary care.Gastro-oesophageal• Performing early endoscopy in all patients presenting with dyspepsia would lead to very large costs per malignancy detected.• Endoscopy appears a cost-effective option only in a selected subgroup of patients, namely those considered “appropriate” on the basis of American Society of Gastrointestinal Endoscopy (ASGE) or European Panel on the Appropriateness of Gastrointestinal Endoscopy (EPAGE) guidelines.The suggestions described above should be interpreted with caution. Some of the studies were not UK based, several were dated and there was limited evidence that all relevant data had been synthesised or considered. In addition, the relevance of the comparators included may be questioned. Subsequent evidence from expert clinicians indicates that, where there was a demonstrably cost-effective intervention or strategy, this is often in place in the UK NHS setting.</p

Rapid review of existing literature on the cost-effectiveness of follow-up strategies after cancer treatment

Introduction: A rapid review has been conducted to explore the cost-effectiveness of follow up strategies of patients previously treated for cancer. The aim of the review was to assess whether existing literature could be useful in informing UK policy in these areas.Methods: A systematic literature was undertaken. All papers that were considered to be economic evaluations in the subject areas described above were extracted. Data extracted included details of condition (type of cancer) examined, study design, findings (including incremental cost-effectiveness ratios (ICERs), assessment of uncertainty) and quality assessment. In order to maximise the usefulness of this report, papers deemed of high quality and high relevance have been considered as the priority for discussion. However, data extracted from all papers meeting the inclusion criteria are presented in an Appendix. Further appendices describe the search strategy methods, results and individual abstracts. Subsequently, interventions/strategies were assessed for their relevance to UK policy and decision making by a group of clinical experts in the relevant fieldsResults: The search identified 1,637 references. After excluding papers that were duplicates, non-English, not economic evaluations, not focussed on cancer or not related to follow-up of patients previously treated for cancer, 78 papers were identified as potentially relevant and these articles were ordered or retrieved from the web. After full text assessment, a total of 34 articles were included in the analysis. Results are presented separately for each cancerConclusions: Colorectal cancer was the most common (n=9) cancer type considered. Breast (n=7), lung (n=4), bladder (n=3), cervical (n=2), skin (n=2), gastro-oesophageal (n=1), ovarian (n=1), renal (n=1), seminoma (n=1), Hodgkins (n=1), uterine (n=1) and general cancer (n=1) were also studied. The higher quality studies and expert opinion suggested the following:Colorectal• An intensive follow-up strategy for patients who had received curative resection for colorectal cancer appears a cost-effective strategy compared to minimal follow-up.• The optimal follow-up time with an intensive programme for this patient population is likely to be between 2 and 4 years.• Nurse-led follow-up appears a cost-effective option. Similarly, follow-up in primary care is likely to be less costly and similarly effective as follow-up at hospital by surgeons. • Expert input suggested that the method of follow-up (eg remotely) is a potential method of reducing costs without impacting on patient outcomes.Breast• In general, intensive follow-up programmes do not appear a cost-effective option for women with previously treated breast cancer.• A move to open access after a certain follow-up period (5 years) is popular with patients and clinicians, and is likely to reduce costs with no impact on outcomes.Lung• Follow-up programmes involving nurses or GPs rather than follow-up at hospital clinics might represent efficient strategies for patients previously treated for lung cancer. However, clinical input suggests that it is important to conduct the follow-up in the same place as imaging (hospital), though there is potential for nurse specialists to be involved.Cervical• PET-CT does not appear a cost-effective option in addition to standard imaging in the UK for follow-up of women treated for cervical cancer.The suggestions described above should be interpreted with caution. Some of the studies were not UK based, several were dated and there was limited evidence that all relevant data had been synthesised or considered. In addition, the relevance of the comparators included may be questioned. In order to identify the most relevant studies for UK decision makers, an expert panel of clinicians has been assembled to provide advice. The following review combines evidence from the published literature with the opinion of clinical experts to highlight relevant studies of acceptable quality.</p

Research to inform resource allocation in health and social care. Results of a scoping study

BACKGROUNDThe Department of Health faces a number of challenges in allocating resources. The first relates to the expectation that budgets available to allocate to various areas of health and care activities are unlikely to increase markedly in real terms. A second challenge is the possible change in the pattern of health and care need over time. A third challenge is to ensure that the most cost-effective prevention, treatment and care services are funded regardless of budgetary responsibilitiesAIMS AND OBJECTIVESThe research aims to provide an initial scope of the types of appropriate analytical methods, evidence sources and research activities that will inform policy responses to these challenges. The objectives of the scoping project were:i. To define an analytical framework for assessing the benefits of reallocating resources within and between sectors.ii. To establish what types of research have been undertaken or are on-going relating to the cost effectiveness of medical services, public health, social care and non-health and social care spending that has an influence on health and well-being.iii. To describe relevant data sources that could be used for empirical analysis consistent with the analytical framework.iv. In collaboration with the DH, to hold a workshop involving relevant stakeholders to help to define the key policy questions and the research to address them.ANALYTICAL FRAMEWORKThe analytical framework is based on the tools of cost-effectiveness analysis (CEA) to inform decisions with an objective of maximising benefits from constrained budgets. It is developed as an analytical support for decisions about resource reallocation, with a particular focus on shifts in resources between medical services (treatments), and preventive and care interventions. It introduces the concept of directed investment and disinvestment where the DH would identify specific interventions for additional funding and/or for disinvestment or reduced funding. This is distinguished from undirected investment and disinvestment where general budget transfers are implemented by the DH, but the specific investments and disinvestments relating to those transfers are left to other decision makers to define (e.g. at a local level).Depending on the type of reallocation being considered and the budgets to which they relate, the framework defines the specific analyses to be undertaken and the evidential implications. The general approach assumes a common health outcome measure with relevance across treatment, prevention and care. In the case of undirected investment and disinvestment, estimates of the marginal productivity of the relevant budget(s) (cost-effectiveness thresholds) would be required. For directed investment or disinvestment, the costs falling on different budgets and health outcomes would need to be quantified, although the value of potential reallocation options would need to be benchmarked against relevant cost-effectiveness thresholds. Further developments of the framework are explored including how to deal with evidential uncertainty, handling costs and effects falling outside health and care budgets and the implications of potential changes in cost-9effectiveness thresholds over time. The implications of potentially different outcome measures between treatment/prevention and care are also explored.EVIDENCEThe types of available evidence to populate the analytical framework are characterised. With respect to the costs and benefits of specific interventions, this is most abundant for medical interventions, particularly new treatments such as branded pharmaceuticals. There is appreciably less evidence relating to public health, and little evidence on social care interventions. The National Institute of Health and Care Excellence (NICE)’s activities in technology appraisal and public health are important contributors to the evidence base of UK studies; its new social care programme may deliver important evidence in the future. The National Institute of Health Research funds important primary research in all three areas. It can be expected, however, that evidence is available for a very small proportion of the interventions, programmes and services being routinely funded by the NHS and local authorities. There is a marked lack of cost-effectiveness evidence relating to candidate interventions for disinvestment.Estimates of the cost-effectiveness thresholds relating to treatment, prevention and care budgets are a key source of evidence. Recent work using routine data to estimate the NHS cost-effectiveness threshold can guide investment in and disinvestment from NHS budgets. No estimates of the cost-effectiveness thresholds associated with public health expenditure by local authorities are available. Work is ongoing to estimate relevant thresholds for social care.WORKSHOPA workshop was undertaken in May 2014 involving a range of academic and public sector analysts, decision makers and other stakeholders. On the basis of a series of presentations regarding the analytical framework and available evidence, participants provided feedback and further ideas in small groups.</p

Economics of medicines optimisation

1. EXECUTIVE SUMMARY1.1. BACKGROUNDThe UK National Health Service (NHS) faces the triple challenge of improving health outcomes while coping with the increasing demand for services and achieving efficiency savings. Medicines optimisation can improve health outcomes and reduce costs. However, addressing suboptimal use of medicines in an effective and cost-effective manner requires an understanding of the size and nature of the evidence base. The objectives of this work are, firstly, to undertake a scoping review relating to the suboptimal use of medicines in the NHS, both in terms of the scale, costs and health lost; and, secondly, to review the extent of the evidence on effectiveness and cost-effectiveness of interventions to address suboptimal use of medicines.1.2. METHODSSystematic searches (up to February 2013) of the NHS Economic Evaluation Database, the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effects are undertaken to identify for systematic reviews on the effectiveness or cost-effectiveness and for primary research on cost-effectiveness of interventions. Studies in English set in any country are included. Suboptimal use of medicines is categorised in a number of different aspects on discussions with advisors and a brief review of the area: compliance with guidelines, inappropriate prescribing, prescriptions errors, medicines reconciliation and discharge, dispensing errors, administration errors, medicines management in care homes, adherence and monitoring errors.1.3. RESULTSIn total, 107 studies are included in the review (29 economic evaluations and 78 systematic reviews) from 646 records identified.Systematic reviews on effectiveness of interventionsWith the exception of insufficient prescribing of low cost generics and record keeping, every one of the aspects of suboptimal medicines use is addressed by the systematic reviews. The majority of the studies (51, 65%) focussed on interventions to improve adherence, either in any disease area (21; 27%) or in specific conditions (30, 38%). Randomised controlled trials (RCTs) are available for all aspects. There is considerable evidence on the different aspects of suboptimal medicines use specific to the UK setting. Most studies report intermediate outcomes: measures of adherence (53, 68%), clinical outcomes (24, 31%) and adverse drug events (16, 21%). No study reports quality-adjusted life years but four (5%) report measures of quality of life.Economic evaluationsThe majority of the studies (16, 55%) examines interventions to improve adherence, followed by prescription errors (8, 28%) and inappropriate prescribing (4, 14%). Six studies (21%) address more than one aspect of suboptimal use of medicines. Most studies (19, 66%) conduct a within-trial economic evaluation using data from a single study. Clinical outcome measures are the most frequently used (8, 28%), followed by measures of adherence (6, 21%) and appropriateness of medication (5, 17%). Quality-adjusted life years (QALYs) are used in five studies (17%).</p

Cost-effectiveness analysis of genomic tests: what are the methods challenges?

The development of genomic tests has been rapid; however, the link between the identification of gene-mutations and long-term patient health is still developing. [1, 2] As a result, the clinical value of genomic tests is not always apparent, and very few tests have demonstrated cost-effectiveness. Cost-effectiveness analysis is used to inform resource allocation by assessing the health benefits and cost implications of new interventions. This approach is well established for considering investment in new technologies through the National Institute for Health and Care Excellence’s (NICE) technology appraisals, and diagnostics assessment programme. However, the appropriateness of the current NICE approach for genomic tests has been questioned.The main objective of this report is to determine whether the current principles and methods of cost-effectiveness analysis are appropriate for the assessment of genomic tests. First, a systematic literature review is undertaken to understand the challenges associated with applying the methods of economic evaluation to genomic tests, together with potential solutions previously identified. Second, the defining features, from an economic perspective, of genomic tests are established from the literature and used to define the key challenges associated with economic evaluation in genomic testing. Finally, the methods challenges associated with these defining features are identified. There are many practical issues remaining, however. Most are similar to problems faced in applying economic evaluation to other health technologies. We have discussed some practical issues commonly considered in the literature, such as the dearth of relevant evidence, but other general practical issues in economic evaluation have not been discussed in this report when they are covered in current methods guides.Our review highlights two main differences between cost-effectiveness analysis of genomic tests and that of other technologies: the evaluation of tests for multiple disorders and the potential for infinite time horizons. In common with other diagnostic technologies, there is also a question of whether assessing health gain alone is sufficient to capture all the benefits of the intervention. Current methods for combining diagnostic evidence with treatment patterns and health consequences are well established. However, this could be difficult to implement with genomic tests given the large number of possible treatment disorders and treatment patterns. This report suggests three alternative approaches to economic evaluation to address this issue: an iterative approach, an aggregate approach or a pragmatic approach. The iterative approach suggests that the use of a genomic test would be considered independently in each disease area of potential use, this is the process used by the NICE Diagnostic Assessment Programme. The aggregate approach suggests that all diseases for which the genomic test could be useful would be assessed in a combined analysis, where the costs and consequences of all diseases would be assessed at once. The pragmatic approach requires some upfront clinical decision guidance to determine which disease areas are most likely to drive the cost-effectiveness of the test, and then to undertake a more qualitative approach for determining the direction of bias for those disease areas not fully included in the analysis.A further potential challenge of assessing the cost-effectiveness of genomic tests is the potential for an infinite time horizon. This is because it depends on whether the information could and would be shared in the future. Currently there is no national system for sharing genomic information so information sharing ultimately depends on the individual. The principle of economic evaluation is that all future costs and consequences should be considered. Current methods capture costs and consequences over the lifetime of a patient. However, there is a potential for the genomic information collected to have consequences for future generations. This issue is the same for other types of diagnostics, but is not currently considered by the NICE Diagnostic Assessment Programme in terms of formal analysis. This challenge suggests the need to understand the cost-effectiveness of a national system that could store and share genomic information.As with other technologies, genomic tests are associated with many non-health consequences. This is a broader issue that requires decision makers to determine, firstly, whether non-health consequences should be considered and paid for by the NHS. Subsequently it would be important to determine how these non-health consequences should be traded-off against health and how to take account of non-health benefits in the opportunity costs.Many of the issues in the genomics literature have been identified for other types of technologies including the addition of non-health benefits such as information value, the lack of relevant evidence, the quickly changing environment and the benefits to non-patient populations. Many of the features of conducting economic evaluation of genomic tests are the same as for more general diagnostic testing. The diagnostic nature of genomic tests implies the same common challenges, such as test error and the difficulty in establishing the added value of a test to the decision maker and patient populations. Solutions to many of these problems are well established, and the assessment of the cost-effectiveness of diagnostic tests is increasingly well practiced.Many of the sections in this report refer to a lack of relevant evidence. This is invariably the case in economic evaluation and does not preclude the need to follow the methods given the available information. Many clinical questions remain regarding the use of genomic testing and particularly whole genome sequencing. Economic evaluation will not provide additional clinical evidence but provides a framework in which to consider the implications of available clinical information and recommended treatment patterns. Economic evaluations that use model-based analyses also provide a framework for assessing the value of additional research to generate further evidence.The commonalities and shared challenges with other health technologies suggest that the principles and methods of economic evaluation, in general, are appropriate for genomic tests. In terms of cost-effectiveness analysis, further methods research would be valuable on approaches for trading-off health and non-health consequences of tests, assessing the value of sharing genomic information across generations and for choosing among multiple disorders. This methodological research is needed to understand more fully whether current standard methods of cost-effectiveness analysis could be made more directly relevant to health system resource allocation decisions for genomic based diagnostics.</p

Getting cost-effective technologies into practice: the value of implementation. An application to b-type natriuretic peptide (BNP) testing in diagnosing chronic heart failure

In 2010 NICE released a clinical guideline recommending that natriuretic peptide (NP) testing in patients with suspected heart failure without previous myocardial infarction can accelerate diagnosis of heart failure and also avoid unnecessary echocardiography. A framework for the evaluation of the value of implementation activities is applied to this recommendation for NP testing.1.2 MethodsThe following quantities were estimated: expected value of perfect implementation (the maximum the NHS can invest on implementation activities whilst still accruing some positive value from the intervention); expected value of actual implementation (the maximum the NHS can invest on implementation activities for specific increases in utilisation); and value of the implementation activity (the additional value of the specific implementation activity given its expected costs and effectiveness).Data sources used to inform the model included: published data on disease incidence; cost-effectiveness data from a published Health Technology Assessment (HTA) which informed the clinical guidelines; cost and effectiveness evidence from an intervention designed to increase NP utilisation in London; data on utilisation and disease incidence from a clinical expert; audit data on NP testing utilisation; and a systematic review of implementation initiatives. Diffusion curves were estimated based on historic data to produce predictions of future utilisation. Incremental costs and quality-adjusted life years (QALYs) of N testing compared to ‘do nothing’ were estimated to be -£3.88 and 0.08 respectively. The annual suspected Heart Failure (HF) population in England and Wales was estimated to be 210,000. Current utilisation and optimal maximum utilisation of NP testing were estimated to be 4.4 and 8.6 per 1,000 population respectively. The implementation intervention was estimated to cost approximately £24K and assumed to result in an absolute increase in utilisation of 5%. Both a static population analysis and multi-period analysis were undertaken and results are presented for cost-effectiveness thresholds of £20,000 and £30,000 per QALY gained.1.3 ResultsThere appeared to be considerable value in additional implementation efforts directed towards encouraging the utilisation of NP testing for persons with suspected HF. At a threshold of £20,000 per QALY gained, additional investment in an activity that increases utilisation by 5% (absolute increase in utilisation rates) would generate an additional 799 QALYs (£16 million in terms of monetary equivalent) across England and Wales, compared to the use of these resources in other (health generating) National Health Service (NHS) activities. Scenario analyses demonstrated that value to the NHS was sensitive to uncertain model inputs such as the size of the eligible population and the efficacy of the implementation intervention. The analysis highlighted a lack of evidence on: cost effectiveness, effectiveness of implementation intervention, utilisation, and population size.1.4 ConclusionsThis framework can be applied to any existing cost effectiveness analysis, thus helping a decision maker to quantify the value of investing resources into increasing utilisation in a manner consistent with the value assessment of new interventions conducted by the National Institute for Health and Care Excellence (NICE). This case study provides a useful demonstration of the practical challenges faced in populating such a model. In particular, the importance of publishing incremental costs and QALYs related to clinical guidelines compared to current care is highlighted. Data on diffusion of utilisation is crucial for such evaluations.</p

Getting cost-effective technologies into practice: the value of implementation. Report on framework for valuing implementation initiatives

Getting cost-effective health technologies into practice is one of the priorities for the NHS identified in Innovation, Health andWealth [1]. This involves not only identifying cost-effective technologies, which is the responsibility of the National Institute of Health and Care Excellence (NICE), but also understanding the potential barriers to the uptake of these technologies and evaluating possible solutions to these barriers (implementation initiatives). The research presented here sets out a framework for examining the latter (i.e. the solutions to the barriers), in a manner consistent with the estimation of value of the technologies by NICE.The aim of this research is not to create an additional barrier (or “fifth hurdle”) for health care technologies to get into regular use in the NHS but instead to set out a formal analytic framework to allow for the evaluation of different implementation initiatives in a manner consistent with those methods currently employed for health technology assessment by NICE in England and Wales. The use of this framework recognises that the different types of barriers identified and the range of possible implementation approaches that maybe considered appropriate will invariably be associated with different resource implications and potential outcomes. Consequently, it will be important to ensure that the type and intensity of the implementation approach adopted is commensurate with the anticipated value to the NHS.1.2 NICE and cost-effectiveness The value of the new health care technology to the NHS is established by the AppraisalCommittee after reviewing evidence. The value of the new technology, in terms of an incremental cost per QALY, is then compared to the cost-effectiveness threshold (k) to see if it represents a cost-effective use of resources. Alternatively, but equivalently, the net value to the NHS of treating a patient with the technology can be calculated in terms of monetary or health benefits.In 1999 the National Institute of Health and Clinical Excellence (NICE) was created with the aim of ensuring that everyone have equal access to medical treatments and high quality care from the UK National Health Service (NHS) [2]. Further, it aimed to maximise the health produced by the NHS (i.e. to use resources efficiently). These objectives are, however, constrained by the budget allocated to the NHS by the government. One of the ways NICE accomplishes these objectives is through their Medical Technology Evaluation Programme [3], which provides recommendations on the use of new and existing medicines and treatments within the NHS. Recommendation decisions are based on the value of treatments and the uncertainty around that value. Importantly, these decisions require an assessment of both the costs and health effects of a new intervention, as well as the health effects of activities that will have to be displaced elsewhere in the NHS in order to fund any new (and more costly) health care technology.The methods recommended by NICE provide standardised and systematic ways to evaluate the overall cost and health effects of new health care technologies [3]. Health effects contain both changes in the quality and length of life. NICE recommends measuring health effects in quality adjusted life-years (QALY) using the EQ-5D instrument [4]. The use of a generic measure of quality of life is important both in ensuring consistency in decision making across different treatments and diseases, as well as ensuring that decisions are consistent with the objective of maximising health gain within a fixed NHS budget. The current perspective used by NICE considers the impact of a new intervention on the resource use and costs on the NHS and Personal Social Services [3].A new health care technology is considered valuable if it provides more overall health than it displaces as a result of any additional cost displacing other health care interventions elsewhere in the NHS. In other words, there are two types of outcomes to be considered when deciding whether to fund a new health care technology. The first is the effect on the patient receiving the health care technology. The second is the effect on others who must then be treated from a reduced budget.Currently NICE assumes the value of displaced treatments is between £20,000 and £30,000 per QALY. This suggests that the marginal treatment in the NHS (i.e. the treatment that would no longer be funded to release resources to fund a new treatment) provides 1 additional QALY for an additional £20,000-£30,000 spent. To ensure that the funding of a new intervention is consistent with the objective of maximising health gain subject to a budget constraint, new health care technologies must, therefore, provide an incremental cost per QALY compared to current care of less than £20,000-£30,000 per QALY. The incremental cost per QALY of a health care technology is referred to as its incremental cost-effectiveness ratio, or ICER. </p

Getting cost-effective technologies into practice: the value of implementation. An application to novel anticoagulants in the prevention of stroke and systemic embolism

Key findingsThere appears to be value in additional implementation efforts directed towards encouraging the utilisation of novel anticoagulants for the prevention of stroke and systemic embolism in people with nonvalvular atrial fibrillation. This additional value can be represented both in terms of health and monetary benefits to the NHS. At a cost-effectiveness threshold of £20,000 per QALY gained, additional investment in an education outreach activity that increases utilisation by 5% (absolute increase in uptake rates) would generate an additional 71 QALYs (£1.42 million in terms of a monetary equivalent) across England and Wales compared to the use of these resources in other (health generating) NHS activities. In an average clinical commissioning group (CCG) population, the equivalent gains would be 0.16 QALYs (£3,161).There remain issues about the heterogeneity and quality of the existing evidence-base surrounding the effectiveness of alternative implementation strategies and their generalisability to the specific case study. Consequently, it has not been possible to compare a range of alternative implementation activities, and educational outreach was selected as a specific example. However, the framework can also be applied more generically to indicate the level of uptake that would be required per £ spent by the NHS in order for an implementation activity to provide additional value to the NHS. At a threshold of £20,000 per QALY gained, an activity costing one million pounds across England and Wales (or £4,095 for the average CCG) would need to increase utilisation by at least 1% to be considered of value to the NHS. These can provide indicative estimates which could be applied to a broader range of implementation activities.The findings also indicate that the value of implementation appears highest in targeting efforts to increase utilisation of novel anticoagulants in patients with average to poor warfarin control. For example, an increase of 5% in utilisation in such patients could potentially generate an additional 790 QALYs (£15,798,276) across England and Wales and 3.06 QALYs (£61,187) in an average CCG population. This is more than ten times the value of increasing utilisation in the overall population on warfarin.Most importantly, greater (absolute) value to the NHS would potentially be achieved with higher uptake of anticoagulation more generally (i.e. including warfarin) given the high proportion of patients with atrial fibrillation who are currently receiving no treatment or antiplatelet therapy only. Switching 5% of patients potentially eligible for anticoagulation but currently on no treatment or on antiplatelet therapy to warfarin would generate an additional 7,550 QALYs (£151,004,965) across England and Wales and 30 QALYs (£606,866) in an average CCG population.Additional investment on implementation at a CCG level also needs to take into account local circumstances and particularly the local cost of warfarin clinics. The results presented here are based on an annual per- patient cost of £242 as applied in the original NICE appraisal. Lower warfarin monitoring costs reduce the value of implementation of novel anticoagulants; hence, there is less scope for investment in increasing their utilisation. Conversely, higher value would be realised in local settings where the current annual per-patient costs of providing warfarin clinics exceed these estimates.1.4. Implications for NICE technology appraisalsThe framework and its application to novel anticoagulants also highlight issues which may have wider implications for the NICE technology appraisal and implementation processes. Specifically:(i) The importance of clearly documenting the cost-effectiveness (incremental cost and incremental QALY) estimates based on the Committee’s preferred assumptions both for the entire reimbursed population and also relevant subgroups. This would increase the efficiency of subsequent implementation activities by ensuring that their type and intensity can be tailored to the areas with the greatest value to the NHS.(ii) Difficulty in defining the optimum (target) utilisation rate for interventions, particularly when a intervention is appraised through the single technology appraisal process and recommended as an ‘option’. When several alternative interventions are listed as options, it may be difficult for local commissioners to determine where additional implementation activities should be targeted and determining the appropriate level of investment. In situations where there exist high levels of uncertainty regarding the optimal treatment pathway and/or position of specific treatments and this is perceived as a significant barrier to uptake, referral to the NICE multiple technology appraisal process or clinical guidelines may be a potential route to encouraging wider (and more efficient) implementation.(iii) Recognition that the separation of budgets over primary and secondary care may present additional challenges to the NHS and local commissioners in implementing particular interventions (and/or impose additional transaction costs which should be considered). More routine reporting of total costs (and longer-term cost offsets) disaggregated by setting (e.g. primary, secondary care) in NICE Technology Appraisals (TAs) would provide an indication of where additional transaction costs may be incurred and/or where financial incentives maybe required to encourage further uptake.(iv) Recognising that the long-term time horizon underpinning the cost-effectiveness estimates reported in many TAs maybe inconsistent with the local constraints faced by commissioners (e.g. shorter budgetary cycles operated by the NHS). Encouraging the time profile of the cost-effectiveness results to be more routinely reported (and particularly the time horizon over which a particular technology is expected to ‘break even’ and start to confer additional value to the NHS) would provide further information to local commissioners in planning implementation activities and in identifying which specific investments provide clear long-term value but may be difficult to implement within existing constraints (i.e. the requirement for CCGs to breakeven year on year). At both a national and local 7 level, this could inform whether re-profiling of long-term investment prospects may be required to ensure greater consistency between national and local constraints.</p