Currently, IVIG is not an approved as a treatment option in Mild Cognitive Impairment and Alzheimer’s disease (AD), therefore there are no relevant clinical guidelines on its position in the treatment pathway (for example whether it would replace existing pharmacological and other interventions or constitute an add-on therapy).

In terms of its impact on the patient pathway, with regard to AD, IVIG has a different route of administration compared to pharmacological treatments used in the management of AD. In specific, administration of IVIG for its approved indications is mainly done in the hospital setting or in infusion clinics ({White-Reid K, 2008}{1}, although depending on the clinical characteristics of the patients, alternative site of care (GP office, home care) can be used.

Taking into consideration recommendations on IVIG use for its licensed indications, patients may also need to undergo pre-treatment testing and routine monitoring for development of complications after treatment with IVIG {Silvergleid and Berger} {2}. Finally, delayed disease progression would affect AD prevalence and consequently impact the service delivery models {Brodaty el al}{ {3}.

Refer to TEC 4, TEC 5, TEC8.

None of our included studies provided information on this topic.

Intravenous immunoglobulin (IVIG) is administered by infusion, predominantly in the hospital setting.

Since it is a product with limited availability and high cost, special management programs may be in place regarding its administration to patients such as the Department of Health Demand Management Plan for Immunoglobulin Use in the UK{Department of Health} {4}, the Immunoglobulin (Ig) Governance Program in Australia {National Blood Authority} {5} or the IVIG Utilization Management Program ran by the BC Provincial Blood Coordinating Office (PBCO) in Canada {Provincial Health Services Authority} {6}. Management programs may also be in place at the regional or the hospital level.

According to instructions relating to its administration in other groups of patients for its licensed indications in the aforementioned jurisdictions, patient written consent is required. Information provided to the patients relates to immunoglobulin products; reason for treatment; how the products are given; risks and benefits of the treatment; alternative treatments; side effects; and also requirements regarding collection and sharing of personal private information that apply for  IVIG administration. Patients must also have instructions on how to act if serious reactions after treatment appear.

None of our included studies provided information on this topic.

None of our included studies provided information on this topic.

None of our included studies provided information on this topic.

None of our included studies provided information on this topic.

None of our included studies provided information on this topic.

None of our included studies provided information on this topic.

None of our included studies provided information on this topic.

There is not information available about management problems of IVIGs for AD as this treatment has not been approved for AD but as an experimental therapy. In general, for various other conditions there is some information. The IVIG therapy is usually administered in hospitals or hospital-based outpatient clinics under clinical protocols, and is usually based on national policies {National Blood Authority} {7}.

By the management viewpoint the most critical points is to ensure availability of the IVIG products. There could be problems within the supply of IVIG. It is prepared from the purified plasma immunoglobulins of large numbers of healthy donors. The process of plasma into IVIG takes about 9 months. Solution to the problems of supply includes new manufacturing process, use of recombinant technology to produce IVIG, or an administration of specific antibodies in place of IVIG { Loeffler} {8}.

In addition, it has to be ensured that there are appropriate policies and procedures for the whole process. For example, IVIG products need specific storage and prescribing requirements and detailed documentation of infusions. {National Blood Authority} {7} (Refer to TEC 7 and TEC 10).

Adequate training and skills of the personnel have to be ensured. The personnel need specific knowledge and skills of treating patients with IVIG. Training of administrating IVG includes e.g. knowledge of infusion technique and use of equipment, as well as identification of possible adverse reactions of the product. (Refer to TEC 13).

As IVIG have not been approved for Alzheimer’s disease including Mild Cognitive Impairment, IVIG therapy does not have a formal prescription pathway for such indications. Considering the contextual differences among the countries, a generalisation of the off-label prescription strategies of the IVIG therapy is not possible and remains out of the scope of the present results card.

The current setting for the administration of IVIG therapy (for any condition) is use within hospitals {Appendix CUR-3}.

None of our included studies provided information on this topic.

IVIG is an experimental therapy for AD and therefore there is not information about stakeholders.

In Australia {National Blood Authority} {7}, the key stakeholders involved with the supply, prescribing, dispensing, administration and use of IVIG are:

• National Blood Authority which e.g. manage contracts with suppliers;
• Funding Governments which e.g. provide funding for supply of IVIG;
• National and local committees which e.g. provide advice on options to strengthen prescribing practices;
• Prescribers who prescriber IVIG treatments in accordance with the Criteria;
• Patients who e.g. understand treatment risks and benefits;
• Authoriser which e.g. authorize access to government funded product for eligible patients;
• Dispenser who e.g. plan and manage product ordering appropriate to clinical demand;
• Distributor who e.g. plan and manage inventory levels according to the standards and clinical demand;
• Nurse who e.g. ensure patient’s authorization and consent to IVIG treatment.