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 20 September 2021]. Available from: http://corehta.info/ViewCover.aspx?id=267

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

<< Ethical analysisSocial aspects >>

Organisational aspects

Authors: Pseudo117 Pseudo117, Pseudo451 Pseudo451, Pseudo136 Pseudo136, Pseudo262 Pseudo262

Summary

It is not possible to determine with certainty whether use of Intravenous immunoglobulins for Alzheimer disease including Mild Cognitive Impairment affects significantly organisational aspects.

The current overview can be used as a starting point for further research on the organisational impact of use of Intravenous immunoglobulins for Alzheimer disease including Mild Cognitive Impairment.

Introduction

The most issues of this domain should not be included in the HTA on the “Use of Intravenous immunoglobulins for Alzheimer disease including Mild Cognitive Impairment”.

From a organisational point of view the “Health Problem and Current Use of the Technology” domain, “Description and technical characteristics of technology” domain already includes the use and technical characteristics of technology.

For Mild Cognitive Impairment, and Moderate to Severe there is no available evidence, while for Mild to Moderate Alzheimer disease there is upcoming evidence.

The technology under assessment is still in its early stage of development and evidence based answers to the AEs of ORG domain we selected during the protocol, cannot be given. 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).

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
G0001Health delivery processHow does the technology affect the current work processes?yesHow does IGG affect the current work processes?
G0100Health delivery processWhat kind of patient/participant flow is associated with the new technology?yesWhat kind of patient/participant flow is associated with IGG?
G0002Health delivery processWhat kind of involvement has to be mobilized for patients/participants and important others?yesWhat kind of involvement has to be mobilized for patients/participants and important others?
G0003Health delivery processWhat is the process ensuring proper education and training of the staff?yesWhat is the process ensuring proper education and training of the staff?
G0004Health delivery processWhat kind of co-operation and communication of activities have to be mobilised?yesWhat kind of co-operation and communication of activities have to be mobilised?
G0012Health delivery processHow is the quality assurance and monitoring system of the new technology organised?yesHow is the quality assurance and monitoring system of IGG organised?
G0005Structure of health care systemHow does de-centralisation or centralization requirements influence the implementation of the technology?yesHow does de-centralisation or centralization requirements influence the implementation of IGG?
G0101Structure of health care systemWhat are the processes ensuring access to care of the new technology for patients/participants?yesWhat are the processes ensuring access to care of IGG for patients/participants?
G0006Process-related costsWhat are the processes related to purchasing and setting up the new technology?yesWhat are the processes related to purchasing and setting up IGG?
G0007Process-related costsWhat are the likely budget impacts of implementing the technologies being compared?yesWhat are the likely budget impacts of implementing the technologies being compared?
G0008ManagementWhat management problems and opportunities are attached to the technology?yesWhat management problems and opportunities are attached to IGG?
G0009ManagementWho decides which people are eligible for the technology and on what basis?yesWho decides which people are eligible for intravenous immunoglobulin (IVIG) therapy and on what basis?
G0010CultureHow is the technology accepted?yesHow is IGG accepted?
G0011CultureHow are the other interest groups taken into account in the planning / implementation of the technology?yesHow are the other interest groups taken into account in the planning / implementation of IGG?

Methodology description

The project scope is applied in this domain.

Result cards

Health delivery process

Result card for ORG1: "How does IGG affect the current work processes?"

View full card
ORG1: How does IGG affect the current work processes?
Result

Importance: Critical

Transferability: Partially

Result card for ORG2: "What kind of patient/participant flow is associated with IGG?"

View full card
ORG2: What kind of patient/participant flow is associated with IGG?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG3: "What kind of involvement has to be mobilized for patients/participants and important others?"

View full card
ORG3: What kind of involvement has to be mobilized for patients/participants and important others?
Result

Importance: Important

Transferability: Not

Result card for ORG4: "What is the process ensuring proper education and training of the staff?"

View full card
ORG4: What is the process ensuring proper education and training of the staff?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG5: "What kind of co-operation and communication of activities have to be mobilised?"

View full card
ORG5: What kind of co-operation and communication of activities have to be mobilised?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG6: "How is the quality assurance and monitoring system of IGG organised?"

View full card
ORG6: How is the quality assurance and monitoring system of IGG organised?
Result

Importance: Unspecified

Transferability: Unspecified

Structure of health care system

Result card for ORG7: "How does de-centralisation or centralization requirements influence the implementation of IGG?"

View full card
ORG7: How does de-centralisation or centralization requirements influence the implementation of IGG?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG8: "What are the processes ensuring access to care of IGG for patients/participants?"

View full card
ORG8: What are the processes ensuring access to care of IGG for patients/participants?
Result

Importance: Unspecified

Transferability: Unspecified

Process-related costs

Result card for ORG9: "What are the processes related to purchasing and setting up IGG?"

View full card
ORG9: What are the processes related to purchasing and setting up IGG?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG10: "What are the likely budget impacts of implementing the technologies being compared?"

View full card
ORG10: What are the likely budget impacts of implementing the technologies being compared?
Result

Importance: Unspecified

Transferability: Unspecified

Management

Result card for ORG11: "What management problems and opportunities are attached to IGG?"

View full card
ORG11: What management problems and opportunities are attached to IGG?
Result

Importance: Important

Transferability: Partially

Result card for CUR16 / ORG12: "Who decides which people are eligible for intravenous immunoglobulin (IVIG) therapy and on what basis?"

View full card
CUR16 / ORG12: Who decides which people are eligible for intravenous immunoglobulin (IVIG) therapy and on what basis?
Result

Importance: Important

Transferability: Completely

Culture

Result card for ORG13: "How is IGG accepted?"

View full card
ORG13: How is IGG accepted?
Result

Importance: Unspecified

Transferability: Unspecified

Result card for ORG14: "How are the other interest groups taken into account in the planning / implementation of IGG?"

View full card
ORG14: How are the other interest groups taken into account in the planning / implementation of IGG?
Result

Importance: Important

Transferability: Partially

Discussion

According to the information available at the time of writing, IVIG are not used for Alzheimer’s disease including Mild Cognitive Impairment in any of the EUnetHTA partners, and is quite difficult to find available information on the organizational aspects.

References

  1. White-Reid K, Scherf R. Giving intravenous immunoglobulin. Modern Medicine, 2008; Accessed the 17th of November 2014 from http://www.modernmedicine.com/modern-medicine/content/giving-intravenous-immunoglobulin
  2. Silvergleid, A.J, Berger, M. General principles in the use of immune globulin. UpToDate; Accessed 9 of October 2013.
  3. Brodaty H, Breteler MM, Dekosky ST, Dorenlot P, Fratiglioni L, Hock C, Kenigsberg PA, Scheltens P, De Strooper B.; The world of dementia beyond 2020; 2011; J Am Geriatr Soc.
  4. Department of Health. 2008. Demand Management Plan for Immunoglobulin Use. United Kingdom. Available from http://www.ivig.nhs.uk/documents/Demand_Management_Plan_SECOND_EDITION.pdf ; Accessed the 4th December 2014.
  5. National Blood Authority. 2014. Home » Best Practice » Immunoglobulin Product Authorisation and Management » Ig Program. Commonwealth of Australia. Available from http://www.blood.gov.au/Ig-program; Accessed the 4th December 2014.
  6. Provincial Health Services Authority. 2014. IVIG Provincial Program [Internet]. BC, Canada. Available from http://www.pbco.ca/index.php/programs/ivig-provincial-program; Accessed the 4th December 2014.
  7. National Blood Authority. 2014. Home » Best Practice » Immunoglobulin Product Authorisation and Management » Ig Program. Commonwealth of Australia. Available from http://www.blood.gov.au/Ig-program; Accessed the 4th December 2014.
  8. Loeffler DA. Intravenous immunoglobulin and Alzheimer’s disease: what now? J Neuroinflamm 2013, 10:70.
<< Ethical analysisSocial aspects >>