Con­trol rules fail to dampen IVIg plasma de­mand

The Weekend Australian - Travel - - Health - Sean Par­nell

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.

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