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72 Plasma KCE Reports 120 Table 23: Distribution of the number of cases treated with immunoglobulins, per disease, in four studies in three countries, 2000-2004 (New Zealand, Canada, US). New Massach Canada Total Studies Zealand Toronto US Atlantic cases Diseases/year 2004 2000 2004 2003-04 Guillain-Barré syndrome 7% 11% 4% 5% 106 Chronic inflammatory demyelinating polyneuropathy 10% 11% 7% 149 Multifocal motor neuropathy 3% 1% 29% 3% 27 Relapsing-remitting multiple sclerosis 2% 6 Myasthenia gravis 2% 2% 5% 5% 44 Dermatomyositis 1% 1% 1% 12 Total neurology - muscular 23% 26% 39% 22% 24% Idiopathic thrombocytopenic purpura 12% 15% 10% 15% 190 Primary immune deficiencies 30% 6% 13% 19% 253 Secondary immune deficiency in general 18% 8% 61 - Chronic lymphocytic leukaemia 5% 24 - Multiple myeloma 1% 5 - Bone marrow / stem cell transplant 5% 15% 7% 113 - Children with HIV 1% 2 - solid organ transplants 1% 1% 7 Acute leukaemia in childhood 3% 12 Autoimmune haemolytic anaemia 3% 1% 14 Total immuno-hemato 56% 39% 45% 50% 48% Kawasaki disease in children 0% 3% 11 Toxic shock syndrome Others 4% 2% 1% 24 Total amount IG 457 429 194 339 1419 Table 24: Immunoglobulin amount used per patient, per year and per disease, in four studies in three countries, 2000-2004 (New Zealand, Canada, US). Weighted average of the four studies. Studies New Zealand Toronto Massach US Canada Atlantic Weighted average Diseases/year 2004 2000 2004 2003-04 Guillain-Barré syndrome 188 g 160 g 190 g 174 g 173 g Chronic inflammatory demyelinating polyneuropathy 297 g 182 g 348 g Multifocal motor neuropathy 248 g 708 g 530 g 486 g Relapsing-remitting multiple sclerosis 354 g 354 g Myasthenia gravis 219 g 169 g 190 g 200 g 198 g Dermatomyositis 439 g 490 g 453 g Idiopathic thrombocytopenic purpura 170 g 243 g 190 g 217 g 210 g Primary immune deficiencies Secondary immune deficiencies: 239 g 233 g 170 g 229 g - Chronic lymphocytic leukaemia - Multiple myeloma 219 g 219 g - Bone marrow / stem cell transplant 342 g 287 g 302 g - Children with HIV 150 g 150 g - solid organ transplants 426 g 80 g 286 g Acute leukaemia in childhood 299 g 299 g Autoimmune haemolytic anaemia 166 g 10 g 146 g Kawasaki disease in children 20 g 52 g 51 g Toxic shock syndrome 160 g 120 g 87 g 140 g
KCE Reports 120 Plasma 73 3.3.1.2 Trends over time An increase in overall IG consumption has been described worldwide. For instance, annual utilisation in Australia rose by an average of 14.8% from 1994-95 to 2004-05. 16 In Canada, the IG use has steadily risen since 1990, at a mean annual rate of 12.5%. 146 However, only a few studies have analyzed the distribution of IG use per indication (or specialty) over time. An unpublished US study shows that the weight of each medical specialty has undergone noticeable changes within a 5-year period of time (2002-2007, Table 25). The Toronto study reported that dermatological conditions increased from 0% of annual consumption in 1995 to 16% by 2000, and this was linked to the establishment of specialized dermatological clinics. 148 This suggests that diversification in IG use or IG demand, resulting from either newly approved indications or changes in prescription practices, may appear in any country in a relatively short period of time. Table 25: Distribution of the total amount of immunoglobulin used per medical specialty in the US, 2002-2007 Medical Specialty 2002 2007 Allergy Immunology 19,0% 21,6% Rheumatology Nephrology 2,1% 7,8% Dermatology 6,3% 7,6% Neurology 20,2% 22,0% Hematology 30,8% 11,3% Cardiology 0,0% 3,4% Obstetrics Gynecology 0,0% 6,7% Infectious Diseases 14,1% 10,0% Ophtalmology 2,0% 9,1% Others 5,5% 0,0% Source: presentation of Marketing Research Bureau/ IPPC-PPTA Congress 3-4 March 2009 3.3.1.3 Unlabelled use of immunoglobulin Several studies compared the proportion of IG used or the proportion of patients treated with IG for an unlabelled indication, as defined in each country (Table 26). 146 It is noteworthy that these unlabelled indications represented more than half of the total number of patients receiving IG (52-64%) in all studies. However, most of these IG administrations were scientifically accepted and often included in the national recommendations, in accordance with the last guidelines. This concept of labelled and unlabelled indication for IG is thus no longer related to the concept of scientifically proven benefit. In Canada (Atlantic Provinces), the introduction of detailed recommendations did not impact on the proportion of IG administered for unlabelled indications, at least in the first year. 146 Table 26: Use of immunoglobulins for unlabeled indications in the US and Canada, 2000-2005. Country % total (year) Comments US, 12 academic centres 52% patients (Chen, 2000) Drug authority allows all uses US, Massachusset 54% patients (Darabi, 2004) Drug authority allows all uses hospital Canada, Atlantic provinces 64% of IVIG amount (Constantine 2005) Study pre and post recommendations
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KCE Reports 120B Plasma i PRÉFACE
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