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

<< Organisational aspectsCollection appendices >>

Social aspects

Authors: Alessandra Lo Scalzo, Cristina Mototolea, Ingrid Wilbacher

Summary

In the absence of any discernible difference against placebo the social aspects cannot be defined

Introduction

The technology under assessment is still in its early stage of development and evidence based answers to the AEs of SOC domain we selected during the protocol, cannot be given. The issues of this domain should not be included in the HTA on the “Use of Intravenous immunoglobulins for Alzheimer disease including Mild Cognitive Impairment”. On the other hand decisions about their  use for treating one category of patients or another rise ethical questions related to how to use limited resources (ETH domain).

From a micro-sociological point of view (related to the impact of the technology on patients QoL) the EFF domain had included the QoL outcome (D0012 and D0013) and the reader can be referred to this domain. In short, for Mild Cognitive Impairment, and Moderate to Severe there is no available evidence, while for Mild to Moderate Alzheimer disease there is upcoming evidence (ongoing RCT and before and after study by Relkin 2012). For the phase 3 double-blind, placebo-controlled, two dose arm RCT, aiming at testing the safety and effectiveness of IVIG for patients with mild-to-moderate AD whose results were posted on clinical trial register in October 23rd 2014, after completion of this report,  see EFF domain’s comment.  As regard to  outcomes such as activity of daily living (ADCS-ADL) and quality of life (both in patients and caregivers according to QOLAD), EFF domain’s report that there is no difference between IVIG and placebo groups.

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
H0100IndividualWhat kind of changes do patients or citizens expect?yesWhat kind of changes do patients or citizens expect?
H0002IndividualWho are the important others that may be affected, in addition to the individual using the technology?yesWho are the important others that may be affected, in addition to the individual using IGG?
H0004IndividualWhat kind of changes may the use of the technology generate in the individual's role in the major life areas?yesWhat kind of changes may the use of IGG generate in the individual's role in the major life areas?
H0006IndividualHow do patients, citizens and the important others using the technology react and act upon the technology?yesHow do patients, citizens and the important others using IGG react and act upon IGG?
H0012IndividualAre there factors that could prevent a group or persons to participate?yesAre there factors that could prevent a group or persons to participate?
H0003IndividualWhat kind of support and resources are needed for the patient or citizen as the technology is introduced?noThe technology doesn not seem to imply any support for patients
H0001Major life areasWhich social areas does the use of the technology influence?yesWhich social areas does the use of IGG influence?
H0009Major life areasWhat influences patients’ or citizens’ decisions to use the technology?yesWhat influences patients’ or citizens’ decisions to use IGG?
H0011Major life areasWhat kinds of reactions and consequences can the introduction of the technology cause at the overall societal level?noThis technology should not have this effect
H0007Information exchangeWhat is the knowledge and understanding of the technology in patients and citizens?noThe use of the technology does not necessarly imply a specific understanding/knowledge
H0013Information exchangeWhat are the social obstacles or prospects in the communication about the technology?noThe use of this technology does not seem to depend on social obastcles

Result cards

Individual

Result card for SOC1: "What kind of changes do patients or citizens expect?"

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SOC1: What kind of changes do patients or citizens expect?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for SOC2: "Who are the important others that may be affected, in addition to the individual using IGG?"

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SOC2: Who are the important others that may be affected, in addition to the individual using IGG?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for SOC3: "What kind of changes may the use of IGG generate in the individual&#39;s role in the major life areas?"

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SOC3: What kind of changes may the use of IGG generate in the individual&#39;s role in the major life areas?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for SOC4: "How do patients, citizens and the important others using IGG react and act upon IGG?"

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SOC4: How do patients, citizens and the important others using IGG react and act upon IGG?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ETH12 / SOC5: "Are there factors that could prevent a group or persons to participate?"

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ETH12 / SOC5: Are there factors that could prevent a group or persons to participate?
Result

Importance: Unspecified

Transferability: Unspecified

Major life areas

Result card for SOC6: "Which social areas does the use of IGG influence?"

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SOC6: Which social areas does the use of IGG influence?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for SOC7: "What influences patients’ or citizens’ decisions to use IGG?"

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SOC7: What influences patients’ or citizens’ decisions to use IGG?
Result

Importance: Unspecified

Transferability: Unspecified

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