NATIONAL INSTITUTE FOR CLINICAL EXCELLENCE (NICE)

2002 ◽  
Vol 18 (2) ◽  
pp. 166-170 ◽  
Author(s):  
Rod Taylor
Keyword(s):  
Cost Effectiveness ◽  
Policy Making ◽  
National Policy ◽  
Clinical Excellence ◽  
Clinical Effectiveness ◽  
Technology Appraisal ◽  
England And Wales ◽  
Appraisal Process ◽  
Healthcare Technologies

The technology appraisal program of the National Institute for Clinical Excellence (NICE) was established on April 1, 1999. Its role is to advise the NHS in England and Wales on the clinical effectiveness, cost-effectiveness, and service impact of new and emerging as well as established healthcare technologies. This paper describes the role of HTA in the NICE technology appraisal process, discusses some of the challenges of the use of HTA in national policy making, and considers some of the potential ways forward.

scholarly journals Romiplostim for the treatment of chronic immune or idiopathic thrombocytopenic purpura: a single technology appraisal

2009 ◽  
Vol 13 (Suppl 2) ◽  
pp. 63-68
Author(s):  
G Mowatt ◽  
C Boachie ◽  
M Crowther ◽  
C Fraser ◽  
R Hernández ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Idiopathic Thrombocytopenic Purpura ◽  
Economic Model ◽  
Clinical Excellence ◽  
Sensitivity Analyses ◽  
Base Case ◽  
Technology Appraisal ◽  
Platelet Response ◽  
Single Technology Appraisal ◽  
Thrombocytopenic Purpura

This paper presents a summary of the evidence review group (ERG) report into the clinical and cost-effectiveness of romiplostim for the treatment of adults with chronic immune or idiopathic thrombocytopenic purpura (ITP) based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s evidence came from two relatively high-quality randomised controlled trials (RCTs). The ERG found no evidence that any important data were missed or that data extraction was inaccurate. In both RCTs more patients in the romiplostim than in the placebo group achieved a durable platelet response [non-splenectomised patients: romiplostim 25/41 (61%), placebo 1/21 (5%), odds ratio (OR) 24.45, 95% confidence interval (CI) 3.34 to 179.18; splenectomised patients: romiplostim 16/42 (38%), placebo 0/21 (0%), OR 8.5 (95% CI 1.15 to 372)] and an overall platelet response [non-splenectomised patients: romiplostim 36/41 (88%), placebo 3/21 (14%), OR 34.74, 95% CI 7.77 to 155.38; splenectomised patients: romiplostim 33/42 (79%), placebo 0/21 (0%), OR 16.6 (95% CI 2.37 to 706]. The difference in mean period with a platelet response was 13.9 weeks (95% CI 10.5 to 17.4) in favour of romiplostim in the RCT of non-splectomised patients and 12.1 weeks (95% CI 8.7 to 15.6) in favour of romiplostim in the RCT of splectomised patients. The manufacturer’s economic model evaluated the cost-effectiveness of romiplostim compared with standard care. The ERG had concerns about the way the decision problem was addressed in the economic model and about the non-adjustment of findings for confounding factors. In non-splenectomised patients, using romiplostim as a first option treatment, the base-case incremental cost-effectiveness ratio (ICER) was £14,840 per quality-adjusted life-year (QALY). In splenectomised patients the ICER was £14,655 per QALY. Additional sensitivity analyses performed by the ERG identified two issues of importance: whether individuals entered the model on watch and rescue or on active therapy in the comparator arm (ICER £21,674 per QALY for non-splenectomised patients, £29,771 per QALY for splenectomised patients); whether it was assumed that any unused medicine would be wasted. Combining all of the separate sensitivity analyses, and assuming that watch and rescue was not the first-line treatment, increased the ICERs further (non-splenectomised £37,290 per QALY; splenectomised £131,017 per QALY). In conclusion, the manufacturer’s submission and additional work conducted by the ERG suggest that romiplostim has short-term efficacy for the treatment of ITP, but there is no robust evidence on long-term effectiveness or cost-effectiveness of romiplostim compared with relevant comparators.

scholarly journals Febuxostat for the treatment of hyperuricaemia in people with gout: a single technology appraisal

2009 ◽  
Vol 13 (Suppl 3) ◽  
pp. 37-42
Author(s):  
M Stevenson ◽  
A Pandor
Keyword(s):  
Cost Effectiveness ◽  
Severe Disease ◽  
Treatment Algorithm ◽  
Clinical Excellence ◽  
Fixed Dose ◽  
Technology Appraisal ◽  
Tree Model ◽  
Open Label ◽  
Single Technology Appraisal ◽  
The Cost

This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of febuxostat for the management of hyperuricaemia in patients with gout based upon a review of the manufacturer’s submission to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process. The submission’s evidence came from two randomised controlled trials comparing the efficacy and safety of febuxostat with allopurinol. The trials were of reasonable methodological quality and measured a clinically relevant range of outcomes. A pooled clinical efficacy analysis showed that a daily dose of 80 mg or 120 mg of febuxostat was significantly more effective than fixed-dose allopurinol (300/100 mg/day) at lowering serum uric acid (sUA) levels to therapeutic targets (< 6 mg/dl); however, a large percentage of febuxostat patients did not achieve the primary end point and the fixed-dose allopurinol regimen may have introduced bias. There were no differences between treatments in more clinically important outcomes such as gout flares and tophi resolution after 52 weeks of treatment. No subgroup analyses were conducted for patients with renal impairment, non-responders to allopurinol or patients with severe disease. Supplementary data from a 2-year open-label extension study were also provided, but were difficult to interpret and poorly reported. The incidence of adverse events was similar between treatments, although more febuxostat recipients discontinued treatment prematurely. A decision tree model was developed to determine the cost-effectiveness of febuxostat. The scope was limited to the comparison of continual febuxostat treatment with continual allopurinol treatment. Switching between treatments or withdrawing treatment in patients whose sUA levels had not decreased was not permitted. The model predicted a cost-effectiveness of £16,324 [95% confidence interval (CI) £6281 to £239,928] per quality-adjusted life-year (QALY) gained for febuxostat compared with allopurinol after 2 years of treatment. The incremental cost per QALY was below £20,000 in 63% of the simulations undertaken. Changes in the time horizon did not materially affect the results. The ERG believes that the modelling structure employed was not appropriate to estimate the cost-effectiveness of febuxostat within a treatment algorithm. In addition, there were concerns about the methodology used for collecting data on key model inputs. Given these reservations the cost-effectiveness of febuxostat could not be determined. The guidance issued by NICE in August 2008 as a result of the STA states that febuxostat is recommended as an option for the management of chronic hyperuricaemia in gout only for people who are intolerant of allopurinol or for whom allopurinol is contraindicated.

20. Policy-making

2017 ◽  
Author(s):  
Christoph Knill ◽  
Jale Tosun
Keyword(s):  
Policy Making ◽  
National Policy ◽  
Policy Formulation ◽  
Policy Transfer ◽  
Process Models ◽  
Policy Cycle ◽  
Political Activities ◽  
Policy Choices ◽  
Policy Styles

This chapter examines the process related to policy-making as well as potential determinants of policy choices. It begins with a discussion of conceptual models of policy-making, namely: the institutional, rational, incremental, group, elite, and process models. It then considers the policy cycle, which models the policy process as a series of political activities, consisting of agenda setting, policy formulation, policy adoption, implementation, and evaluation. It also analyses the role of institutions, frames, and policy styles in policy-making and concludes with an assessment of the most crucial domestic and international factors shaping the design of policies, focusing in particular on theories of policy diffusion, policy transfer, and cross-national policy convergence, along with international sources that affect domestic policy-making.

Designing Policies

2018 ◽  
pp. 221-248
Author(s):  
Barry Hoffmaster ◽  
Cliff Hooker
Keyword(s):  
Health Care ◽  
Cost Effectiveness ◽  
Clinical Excellence ◽  
Deliberative Process ◽  
England And Wales ◽  
The Cost ◽  
Fundamental Values ◽  
Over Time ◽  
Health Care Technologies

Designing ethical policies is illustrated with two real examples. The first, allocating cadaver kidneys for transplantation, needs to develop a policy that satisfies the two conflicting fundamental values of equality and efficiency. Equality would require a lottery or a first-come, first-served policy. Efficiency would allocate kidneys to the candidates who would benefit the most. Because neither value may be dismissed, the values must be compromised. That compromise happens in two ways: by compromising the values of equality and efficiency within a policy at a time, and by cycling across policies over time, shifting the preference given to the two values back-and-forth. The second example is an illuminating account of how the National Institute for Health and Clinical Excellence in England and Wales designed a deliberative process for assessing the cost effectiveness of health care technologies.

scholarly journals Clinical effectiveness and cost effectiveness of zanamivir (Relenza): translating the evidence into clinical practice, a National Institute for Clinical Excellence view

2001 ◽  
Vol 356 (1416) ◽  
pp. 1899-1903 ◽  
Author(s):  
David Barnett
Keyword(s):  
Clinical Practice ◽  
Cost Effectiveness ◽  
Health Professionals ◽  
New Technology ◽  
Clinical Excellence ◽  
Clinical Effectiveness ◽  
Appraisal Committee ◽  
Important Process ◽  
Appropriate Use ◽  
The Uk

The UK National Institute for Clinical Excellence (NICE) is charged with the duty of providing informed guidance on clinical practice (clinical effectiveness and cost effectiveness) to patients and health professionals. The Appraisal Committee through its process of review of evidence advises NICE on the clinical effectiveness and cost effectiveness of new and existing technologies and their appropriate use within the National Health Service in England and Wales. The appraisal process takes into account both published and unpublished evidence as well as input from professional and patient and carer groups when coming to its decisions. The appraisal of a new technology often has to bridge the gap between the evidence required for licensing purposes and that needed to provide pragmatic advice to practising clinicians. The appraisal of zanamivir (Relenza) is an excellent working example of this difficult and important process.

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