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

Odds ratios, and 95% confidence intervals, of poor health for tertiles of the REAT score and its components, with the tertile of highest quality as reference, both unadjusted and adjusted (1) for individual-level covariates of age, gender, housing tenure, marital status and employment status and (2) for individual-level covariates and area deprivation.

<p>Odds ratios, and 95% confidence intervals, of poor health for tertiles of the REAT score and its components, with the tertile of highest quality as reference, both unadjusted and adjusted (1) for individual-level covariates of age, gender, housing tenure, marital status and employment status and (2) for individual-level covariates and area deprivation.</p

Characteristics of residents of the tertiles of REAT scores.

<p>Characteristics of residents of the tertiles of REAT scores.</p

The percentage, with 95% confidence interval, of subjects in poor health, by socio-demographic and neighbourhood quality categories.

<p>The percentage, with 95% confidence interval, of subjects in poor health, by socio-demographic and neighbourhood quality categories.</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

SUPPORTING THE ROUTINE COLLECTION OF PATIENT REPORTED OUTCOME MEASURES IN THE NATIONAL CLINICAL AUDITS FOR ASSESSING COST EFFECTIVENESS Work Package 1 - What patient reported outcome measures should be used in the 13 health conditions specified in the 2013/14 National Clinical Audit programme? Appendix I, Schizophrenia

EEPRU was approached by Jason Cox (R&D Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a R&D template prepared by Simon Bennett, Steve Fairman and Keith Willett at NHS England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the National Health Service (NHS), 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the Department of Health (DH) (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the EuroQoL 5 dimensions (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature and the specific review objectives and methodologies are described in detail in the following sections.</p

SUPPORTING THE ROUTINE COLLECTION OF PATIENT REPORTED OUTCOME MEASURES IN THE NATIONAL CLINICAL AUDITS FOR ASSESSING COST EFFECTIVENESS Work Package 1 - What patient reported outcome measures should be used in the 13 health conditions specified in the 2013/14 National Clinical Audit programme? Appendix C, Inflammatory Bowel Disease.

The Policy Research Unit in Economic Evaluation of Health and Care Interventions (EEPRU) was approached by Jason Cox (Research and Development (R&D) Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a R&D template prepared by Simon Bennett, Steve Fairman and Keith Willett at National Health Service (NHS) England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the NHS, 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the Department of Health (DH) (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2.OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the EuroQol-5D (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature.EEPRU NCA Appendix C: Inflammatory Bowel Disease This Appendix provides the detailed results for the condition inflammatory bowel disease (IBD) and should be read in conjunction with both the main report and the methods/search strategy appendices.</p

SUPPORTING THE ROUTINE COLLECTION OF PATIENT REPORTED OUTCOME MEASURES IN THE NATIONAL CLINICAL AUDITS FOR ASSESSING COST EFFECTIVENESS Work Package 1 - What patient reported outcome measures should be used in the 13 health conditions specified in the 2013/14 National Clinical Audit programme? Appendix J, Dementia

EEPRU was approached by Jason Cox (Research and development (R&D) Division) to prepare a programme of research to support the appropriateness of, and use of, patient reported outcome measures (PROMs) collected for the National Clinical Audit (NCA). The EEPRU programme was informed by a R&D template prepared by Simon Bennett, Steve Fairman and Keith Willett at National Health Service (NHS) England.The purpose of introducing PROMs into the NCA programme is to be able to 1) compare performance between providers and commissioners in the NHS, 2) compare the cost-effectiveness of alternative providers in delivering the specific services (i.e. linking outcomes and resource use), and 3) assess the cost-effectiveness of alternative interventions and other changes in the NHS. The intention is to introduce PROMs across a range of conditions over the next 3 years commencing with 13 conditions in the 2014/15 NCA programme.The agreed research programme consists of 3 concurrent work packages (WP) as described in the document submitted to the Department of Health (DH) (8th November 2013). The current document provides details on the objectives, methodology and results for Work Package 1 (WP1): to determine what PROMS should be used in the 13 health conditions specified in the 2014/15 NCA programme.2. OVERVIEWWP1 is split into three separate components consisting of:WP1.1 To examine whether the EuroQol 5 dimensions (EQ-5D) is appropriate in the 13 health conditions specified in the 2013/14 NCA programme.WP1.2 To identify what measure could be used when the EQ-5D is not appropriate in the 13 health conditions, taking into account that the proposed measure would be used to generate preference-based utility measures (either directly through existing preference-based weights, or indirectly through existing mapping functions suitable for the proposed measure).WP1.3 To identify the evidence required to address questions of cost-effectiveness using the NCA data.Each component consists of a series of reviews of the literature.This Appendix provides the detailed results for the condition dementia and should be read in conjunction with both the main report and the methods/search strategy appendices.</p