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This information collection is a core HTA, i.e. an extensive analysis
of one or more health technologies using all nine domains of the HTA Core Model.
The core HTA is intended to be used as an information base for local
(e.g. national or regional) HTAs.
Immunoglobulins (IGG) compared to placebo, not doing anything or Usual supportive care in the treatment of Alzheimer’s disease in elderly AD is diagnosed mostly in people over 65 years of age, although there is an early-onset form that can occur much earlier. According to Wikipedia in 2006, there were 26.6 million sufferers worldwide.
(See detailed scope below)
Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment
<< Clinical EffectivenessEthical analysis >>Table of contents
Collection summaryCollection methodologyIntroduction to collectionScopeHealth Problem and Current Use of the TechnologyDescription and technical characteristics of technologySafetyClinical EffectivenessCosts and economic evaluation
Authors: Anna-Theresa Renner, Neill Booth, Esther Kraft, Ingrid Rosian-Schikuta, Matthias Schwenkglenks
Summary
In the absence of any discernible difference against placebo, no estimates of a trade-off between costs and benefits can be made at present
Introduction
In principle, economic evaluations of medical interventions provide one basis for decisions which involve the distribution of scarce resources. However, an economic evaluation is not the only relevant input to informed decision making and itself relies on other evidence (see, e.g., Strech D., 2007 {1}. Prior to considering costs and efficiency, it is usually regarded as appropriate and useful to incorporate evidence from two other forms of evaluation:
- Efficacy (“Can it work?”)
- Effectiveness (“Does it work?”)
(From: Drummond et al., {2} )
Of these two forms of evaluation, evaluation of efficacy, including related safety considerations, is generally considered as a prerequisite for undertaking economic evaluation. Without reliable evidence as to the (potential) effect of an intervention, spending scarce resources on an intervention can be seen as being economically irrational.
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ -domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation. At this stage in the development of the intervention, we therefore refrained from producing (necessarily incomplete) assessment elements in this domain.
Methodology
Frame
The collection scope is used in this domain.
| Technology | Immunoglobulins (IGG)
DescriptionNaturally occurring proteins produced by the body’s immune system to combat foreign antigens |
|---|---|
| Intended use of the technology | Treatment Treatment of Alzheimer’s disease Target conditionAlzheimer’s diseaseTarget condition descriptionAlzheimer's disease (AD) or Alzheimer disease, is the most common form of dementia. There is no cure for the disease, which worsens as it progresses, and eventually leads to death. Target populationTarget population sex: Any. Target population age: elderly. Target population group: Patients who have the target condition. Target population descriptionAD is diagnosed mostly in people over 65 years of age, although there is an early-onset form that can occur much earlier. According to Wikipedia in 2006, there were 26.6 million sufferers worldwide. |
| Comparison | placebo, not doing anything or Usual supportive care
DescriptionThere is no MA for IGGs for AD yet and there is no other intervention licensed for use in AD so the comparison would have to be against placebo or best supportive care |
| Outcomes |
|
Assessment elements
| Topic | Issue | Relevant | Research questions or rationale for irrelevance | |
|---|---|---|---|---|
| E0001 | Resource utilization | What types of resources are used when delivering the assessed technology and its comparators (resource-use identification)? | yes | What types of resources are used when delivering IGG and its comparators (resource-use identification)? |
| E0002 | Resource utilization | What amounts of resources are used when delivering the assessed technology and its comparators (resource-use measurement)? | yes | What amounts of resources are used when delivering IGG and its comparators (resource-use measurement)? |
| E0009 | Resource utilization | What were the measured and/or estimated costs of the assessed technology and its comparator(s) (resource-use valuation)? | yes | What were the measured and/or estimated costs of IGG and its comparator(s) (resource-use valuation)? |
| E0005 | Measurement and estimation of outcomes | What is(are) the measured and/or estimated health-related outcome(s) of the assessed technology and its comparator(s)? | yes | What is(are) the measured and/or estimated health-related outcome(s) of IGG and its comparator(s)? |
| E0006 | Examination of costs and outcomes | What are the estimated differences in costs and outcomes between the technology and its comparator(s)? | yes | What are the estimated differences in costs and outcomes between IGG and its comparator(s)? |
| E0010 | Characterising uncertainty | What are the uncertainties surrounding the costs and economic evaluation(s) of the technology and its comparator(s)? | yes | What are the uncertainties surrounding the costs and economic evaluation(s) of IGG and its comparator(s)? |
| E0011 | Characterising heterogeneity | To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using the technology and its comparator(s)? | yes | To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using IGG and its comparator(s)? |
| E0012 | Validity of the model(s) | To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of the technology and its comparator(s)? | yes | To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of IGG and its comparator(s)? |
Result cards
Resource utilization
Result card for ECO1: "What types of resources are used when delivering IGG and its comparators (resource-use identification)?"
View full cardECO1: What types of resources are used when delivering IGG and its comparators (resource-use identification)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Result card for ECO2: "What amounts of resources are used when delivering IGG and its comparators (resource-use measurement)?"
View full cardECO2: What amounts of resources are used when delivering IGG and its comparators (resource-use measurement)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ - domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Result card for ECO3: "What were the measured and/or estimated costs of IGG and its comparator(s) (resource-use valuation)?"
View full cardECO3: What were the measured and/or estimated costs of IGG and its comparator(s) (resource-use valuation)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Measurement and estimation of outcomes
Result card for ECO4: "What is(are) the measured and/or estimated health-related outcome(s) of IGG and its comparator(s)?"
View full cardECO4: What is(are) the measured and/or estimated health-related outcome(s) of IGG and its comparator(s)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Examination of costs and outcomes
Result card for ECO5: "What are the estimated differences in costs and outcomes between IGG and its comparator(s)?"
View full cardECO5: What are the estimated differences in costs and outcomes between IGG and its comparator(s)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Characterising uncertainty
Result card for ECO6: "What are the uncertainties surrounding the costs and economic evaluation(s) of IGG and its comparator(s)?"
View full cardECO6: What are the uncertainties surrounding the costs and economic evaluation(s) of IGG and its comparator(s)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Characterising heterogeneity
Result card for ECO7: "To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using IGG and its comparator(s)?"
View full cardECO7: To what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using IGG and its comparator(s)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
Validity of the model(s)
Result card for ECO8: "To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of IGG and its comparator(s)?"
View full cardECO8: To what extent can the estimates of costs, outcomes, or economic evaluation(s) be considered as providing valid descriptions of IGG and its comparator(s)?
Result
Given the lack of available data and lack of published evidence on the efficacy and/or the effectiveness of the intervention, the researchers (and internal reviewers) of this ‘Costs and economic evaluation’ domain agreed that it would not be prudent to undertake research into costs or undertake an economic evaluation.
Importance: Unspecified
Transferability: Unspecified
References
- Strech D., 2007 Four levels of value judgments in the medical outcome assessment--a systematic approach to the analysis of implicit normativity in evidence based medicine. Zeitschrift fur arztliche Fortbildung und Qualitatssicherung. 2007;101(7):473-80)
- Drummond et al., 2005 Methods for the Economic Evaluation of Health Care Programmes
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