Control rules fail to dampen IVIg plasma demand
DEMAND for a highly sought-after plasma product, intravenous immunoglobulin (IVIg), will continue to rise in Australia despite the release of new criteria meant to ration supplies and encourage responsible use by clinicians.
The popularity of IVIg, used primarily in cases of immune deficiency, has brought an end to self-sufficiency in Australia, with imports now necessary to cope with demand increasing at almost 15 per cent per year.
After a contentious plasma fractionation review, which saw overseas companies such as the American giant Baxter fail in their bid to break Melbourne-based CSL’s hold on the Australian market, federal health authorities have now updated the criteria for the use of IVIg.
The previous criteria, released in 2000, were being ignored in some sectors as clinicians identified a broader range of conditions where IVIg could be of use to patients, making supply arrangements even more volatile.
The new criteria — which will come into effect on March 3 — are intended to reserve IVIg for those in greatest need. They describe 12 conditions for which IVIg has an established therapeutic role, 22 where there is an emerging role, 25 where IVIg should be used in exceptional circumstances only, and 36 where there is no evidence to support its use.
Demand for IVIg has increased more rapidly in Australia than in the United States or Europe, and the criteria endorse the use of IVIg for a greater number of conditions, even if some conditions listed on the previous criteria have been dropped.
Australia’s per capita consumption of IVIg is below the US but higher than in Europe.
National Blood Authority chief Alison Turner said the review of the IVIg criteria started before the plasma fractionation review and the changes were not expected to have any impact on demand.
Doctor Turner said despite its best efforts, the Australian Red Cross Blood Service had only been able to increase collections by about 6 per cent a year, leaving a ‘‘ growing gap between demand and our ability to produce IVIg domestically’’.
In 2005-06, the cost to Australian governments of providing blood and plasma products was half a billion dollars, of which IVIg accounted for $103 million. Two IVIg products are now imported, making up about 18 per cent of total supplies under contracts worth about $25 million a year.
CSL spokeswoman Rachel David said the company was trying to improve the yields for its main Australian IVIg product, Intragam P, and had a new IVIg product undergoing clinical testing and likely for release in 2010.
Swiss-based Octapharma provides its IVIg product Octagam to the Australian market — the other import comes from CSL’s offshore operations — and remains keen to increase supplies.
‘‘ Octapharma has five more plasma products TGA-registered but not yet funded, and continues to question the monopolistic arrangements in Australia,’’ Octapharma director Frederic Marguerre said.
Former health minister Tony Abbott vowed to reduce IVIg imports but the new minister, Nicola Roxon, has not committed to any such goals, and imports are expected to account for more than 18 per cent of IVIg supplies in the coming years.