Disclaimer
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.

Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment

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)

HTA Core Model Application for Pharmaceuticals (2.0)
Core HTA
Published
Tom Jefferson (Agenas - Italy), Marina Cerbo (Agenas - Italy), Nicola Vicari (Agenas - Italy)
Alessandra Lo Scalzo (Agenas), Anna-Theresa Renner (GOG), Antonio Migliore (Agenas), Ingrid Wilbacher (HVB), Luca Vignatelli (ASSR RER), Luciana Ballini (ASSR RER), Nadine Berndt (CEM), Nicola Vicari (Agenas), Plamen Dimitrov (NCPHA), Susanna Maltoni (ASSR RER), Ricardo Ramos (INFARMED), Tom Jefferson (Agenas)
Agenas - Agenzia nazionale per i servizi sanitari regionali
AAZ (Croatia), ASSR RER (Italy), Avalia-t (Spain), CEM (Luxembourg), GÖG (Austria), HAS (France), HVB (Austria), IER (Slovenia), INFARMED (Portugal), ISC III (Spain), NCPHA (Bulgaria), NIPH (Slovenia), NSPH (Greece), NSPH MD (Romania), SBU (Sweden), SNHTA (Switzerland), THL (Finland), UTA (Estonia).
13.1.2014 12.32.00
30.11.2015 11.18.00
Jefferson T, Cerbo M, Vicari N [eds.]. Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali ; 2015. [cited 19 September 2021]. Available from: http://corehta.info/ViewCover.aspx?id=267

Use of Intravenous immunoglobulins for Alzeheimer’s disease including Mild Cognitive Impairment

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Costs 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.

TechnologyImmunoglobulins (IGG)
Description

Naturally occurring proteins produced by the body’s immune system to combat foreign antigens

Intended use of the technologyTreatment

Treatment of Alzheimer’s disease

Target condition
Alzheimer’s disease
Target condition description

Alzheimer'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 population

Target population sex: Any. Target population age: elderly. Target population group: Patients who have the target condition.

Target population description

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. 

Comparisonplacebo, not doing anything or Usual supportive care
Description

There 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
  • Description of aims of technology (TECH)
  • Regulatory status (CUR)
  • Cognitive function (EFF)
  • Harms (SAF)
  • Cost effectiveness compared to alternatives (ECO)
  • Potential impact on plasma derivative market (ORG/Medico-legal)
  • Impact on family and carers (SOC)
  • Appropriateness of use in relation to solidity of evidence(ETH)

Assessment elements

TopicIssue RelevantResearch questions or rationale for irrelevance
E0001Resource utilizationWhat types of resources are used when delivering the assessed technology and its comparators (resource-use identification)?yesWhat types of resources are used when delivering IGG and its comparators (resource-use identification)?
E0002Resource utilizationWhat amounts of resources are used when delivering the assessed technology and its comparators (resource-use measurement)?yesWhat amounts of resources are used when delivering IGG and its comparators (resource-use measurement)?
E0009Resource utilizationWhat were the measured and/or estimated costs of the assessed technology and its comparator(s) (resource-use valuation)?yesWhat were the measured and/or estimated costs of IGG and its comparator(s) (resource-use valuation)?
E0005Measurement and estimation of outcomesWhat is(are) the measured and/or estimated health-related outcome(s) of the assessed technology and its comparator(s)?yesWhat is(are) the measured and/or estimated health-related outcome(s) of IGG and its comparator(s)?
E0006Examination of costs and outcomesWhat are the estimated differences in costs and outcomes between the technology and its comparator(s)?yesWhat are the estimated differences in costs and outcomes between IGG and its comparator(s)?
E0010Characterising uncertaintyWhat are the uncertainties surrounding the costs and economic evaluation(s) of the technology and its comparator(s)?yesWhat are the uncertainties surrounding the costs and economic evaluation(s) of IGG and its comparator(s)?
E0011Characterising heterogeneityTo what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using the technology and its comparator(s)?yesTo what extent can differences in costs, outcomes, or ‘cost effectiveness’ be explained by variations between any subgroups using IGG and its comparator(s)?
E0012Validity 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)?yesTo 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 card
ECO1: What types of resources are used when delivering IGG and its comparators (resource-use identification)?
Result

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 card
ECO2: What amounts of resources are used when delivering IGG and its comparators (resource-use measurement)?
Result

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 card
ECO3: What were the measured and/or estimated costs of IGG and its comparator(s) (resource-use valuation)?
Result

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 card
ECO4: What is(are) the measured and/or estimated health-related outcome(s) of IGG and its comparator(s)?
Result

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 card
ECO5: What are the estimated differences in costs and outcomes between IGG and its comparator(s)?
Result

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 card
ECO6: What are the uncertainties surrounding the costs and economic evaluation(s) of IGG and its comparator(s)?
Result

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 card
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)?
Result

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 card
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)?
Result

Importance: Unspecified

Transferability: Unspecified

References

  1. 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)
  2. Drummond et al., 2005 Methods for the Economic Evaluation of Health Care Programmes
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