Summary of Stakeholder responses to the Imported
Immunoglobulin products consultation paper.
Item
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
Stakeholder response
Product demand
It is likely that a 10-12% annual increase in requirements for IVIg will continue
For immunological indications, the need for immunoglobulin replacement therapy will continue
The uptake of SCIg is likely to increase as more health professionals and patients choose this method of delivery
Up to 50% of patients on replacement Ig may switch from IVIg to SCIg without significant change in Ig requirements
Product range and choice
It is important that once a patient has been successfully established on a product there is ongoing supply of this product
Having a number of options is useful for patients who have tolerability problems with one or more products.
It is therefore important that there are at least two suitable imported products for SCIg and at least two suitable imported products for IVIg for
diagnosed antibody deficiency due to a PID disease or secondary immune deficiency
Ongoing supply of these products needs to be maintained
It is important, particularly for SCIg, that products with higher concentrations are available, to minimise infusion volume and times.
It is important that there continues to be a range of vial sizes to minimise product wastage, especially in children.
Change in product brands
Advantage - Higher concentration SCIg products could reduce infusion volume and time
Advantage - Greater choice of products can benefit patients with adverse reactions to other products.
Disadvantage - Continuity of product supply is particularly important for PID patients who are on long term IRT.
Disadvantage - Some patients can react to a particular product and if they have to change product this can have adverse effects
Disadvantage - In patients for whom a product has worked well, changing to a new product can cause anxiety and problems.
Appropriate planning and communication is required when changing products for health care professionals and patients
Valuable product characteristics
It is preferable that all imported products for SCIg and IVIg are suitable for various indications
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
Adequate screening and selection processes of donors to ensure that products are not sourced from populations recognised to be at high risk
of communicable diseases.
Proven effective removal and inactivation of infectious agents including viruses and prions is important to minimise risk of infection.
Higher concentration SCIg products reduce infusion volume and time
It is important that there continues to be a range of vial sizes to minimise product wastage
Shelf life should be as long as possible to minimise wastage and increase patient convenience
For SCIg room temperature is the most convenient storage option for home use. However if ambient or room temperature is higher than 25°C
then storage in an insulated container is required for transport and in a refrigerator for storage.
Issue of storage temperature for IVIg is not as important
Sufficient quantity of appropriate IgG is important to protect against common infection in Australia
It is important that there are negligible quantities of IgA, to minimise allergic risk of allergic reactions.
Declaration of sugar content and other additives and avoidance of products containing sugar and additives associated with unwanted side
effects is important
Ordering and delivery of products
Maximise patient convenience, with local delivery to patient’s home, local pharmacy or general practitioner of sufficient quantity to last at least
one month.
Consider allowing delivery or pick-up of more than one month’s supply for patients who are on long term immunoglobulin replacement therapy
(IRT) and have the capacity to store product
Product supply
Useful resources include product information, training and education resources, adverse reactions, inquiry line
Consistent information is important
No formal mechanism of feedback is known
2