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December 10, 1997, Vol 278, No. 22 >
ARTICLE | December 10, 1997

Outcome Analysis and Cost Assessment in Immunologic Disorders FREE

Gary Stadtmauer, MD; Charlotte Cunningham-Rundles, MD, PhD
JAMA. 1997;278(22):2018-2023. doi:10.1001/jama.1997.03550220224028
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Article
References

A number of novel biologic agents are being introduced to replace, enhance, or modulate immune responses in medical illnesses. The use of these therapies has become crucial in treating some of these diseases, yet there is relatively little available information about their cost-effectiveness. Two examples are presented. Interferon gamma, used in chronic granulomatous disease, costs about $140 for a 100-ÎĽg vial; yearly costs average $21 840 per patient. Study data estimated a 69% to 76% reduction in serious illness with interferon gamma treatment; a reduced incidence of infections could cover drug costs. Intravenous immunoglobulin is used lifelong in antibody deficiency and clearly reduces the number of serious illnesses. Projected savings derive from fewer hospital admissions and reduced organ damage, but infusion costs vary widely because of the prices charged for the drug and infusion services.

REFERENCES

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Bousquet J, Bullinger M, Fayol C, Marquis P, Valentin B, Burtin B.  Assessment of quality-of-life in patients with perennial allergic rhinitis with French version of the SF-36 health status question-naire . J Allergy Clin Immunol . 1994;;94:182-188.
2 +
Blaiss MS.  Outcomes research and its importance to the allergist/immunologist . Insights Allergy . 1994;;9:1-8.
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Curnutte JT.  Classification of chronic granulomatous disease . Hematol Oncol Clin North Am . 1988;;2:241-252.
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The International Chronic Granulomatous Disease Comparative Study Group.  A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease . N Engl J Med . 1991;;324:509-516.
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Woodman RC, Erickson RW, Rae J, Jaffe HS, Curnutte JT.  Prolonged recombinant interferongamma therapy in chronic granulomatous disease: evidence against enhanced neutrophil oxidase activity . Blood . 1992;;79:1558-1562.
6 +
1997Drug Topics Red Book. Montvale, NJ: Medical Economics; 1997.
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Gallin JI, Farber JM, Holland SM, Nutman TB.  Interferon-gamma in the management of infectious diseases . Ann Intern Med . 1995;;123:216-224.
8 +
Cohn EJ, Strong LE, Hughes WL, et al.  Preparation and properties of serum and plasma proteins, IV: a system for the preparation into fractions of the protein and lipoprotein components of biological tissues and fluids . J Am Chem Soc . 1946;;68:459-475.
9 +
Janeway CA.  The development of clinical uses of immunoglobulins: a review . In: Merler E, ed. Immunoglobulins: Biologic Aspects and Clinical Uses . Washington, DC: National Academy of Sciences; 1970;:3-14.
10 +
Hill LE, Mollison PL.  Conclusions . In: Hypogammaglobulinemia . London, England: United Kingdom Medical Research Council; 1971;. MRC Special Report Series No. 310.
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Ammann AJ, Ashman RF, Buckley R, et al.  Use of intravenous gammaglobulin in antibody immunodeficiency: results of a multicentre controlled trial . Clin Immunol Immunopathol . 1982;;22:60-67.
12 +
Cunningham-Rundles C, Smithwick EM, Siegal FP, et al.  Efficacy of intravenous gammaglobulin in humoral immunodeficiency disease . Ann Intern Med . 1984;;101:435-439.
13 +
Nolte MT, Pirofsky B, Gerritz GA, Golding B.  Intravenous immunoglobulin therapy for antibody deficiency . Clin Exp Immunol . 1979;;36:237-243.
14 +
Roifman CM, Lederman HM, Lavi S, Stein LD, Levison H, Gelfand EW.  Benefit of intravenous IgG replacement in hypogammaglobulinemic patients with chronic sinopulmonary disease . Am J Med . 1985;;79:171-174.
15 +
NIH Consensus Conference.  Intravenous immunoglobulin: prevention and treatment of disease . JAMA . 1990;;264:3189-3193.
16 +
Siegal J.  Viral safety issues in IVIg products . Pharm Ther . 1996;;21:21S-24S.
17 +
Centers for Disease Control and Prevention.  Outbreak of hepatitis C associated with intravenous immune globulin administration . MMWR Morb Mortal Wkly Rep . 1994;;43:259-262.
18 +
Bresee JS, Mast EE, Coleman PJ, et al.  Hepatitis C virus infection associated with administration of intravneous immune globulin: a cohort study . JAMA . 1996;;276:1563-1567.
19 +
Schiff RI.  Transmission of viral infections through intravenous immunoglobulin . N Engl J Med . 1994;;331:1649-1650.
20 +
Liese JG, Wintergerst U, Tympaer KD, Belohradsky BH.  High vs low dose immunoglobulin therapy in the long term treatment of X-linked agammaglobulinemia . AJDC . 1995;;146:325-339.
21 +
Lederman HM, Winkelstein JA.  X-linked agammaglobulinemia: an analysis of 96 patients . Medicine . 1985;;64:145-156.
22 +
 Cefpodoxime proxetil: an oral cephalosporin . Med Lett . 1992;;34:107-108.
23 +
 Clarithromycin and azithromycin . Med Lett . 1992;;34:45-46.
24 +
Kobayashi RH, Kobayashi AD, Lee N, Fischer S, Ochs HD.  Home intravenous immunoglobulin therapy in children . Pediatrics . 1990;;85:705-709.
25 +
Bielory L, Long GC.  Home health care costs: intravenous immunoglobulin home infusion therapy . Ann Allergy Asthma Immunol . 1995;;74:265-268.
26 +
Ashida ER, Saxon A.  Home intravenous immunoglobulin therapy by self-administration . J Clin Immunol . 1986;;6:306-309.
27 +
Ochs HD, Lee MC, Fisher SH, Delson ES, Chang BS, Wedgwood RJ.  Self-infusion of intravenous immunoglobulin by immunodeficient patients at home . J Infect Dis . 1987;;156:652-654.
28 +
Berger M, Cupps TR, Fauci AS.  Immunoglobulin replacement by slow subcutaneous infusion . Ann Intern Med . 1980;;93:55-56.
29 +
Gardulf A, Andersen V, Bjorkander J, et al.  Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs . Lancet . 1995;;345:365-369.
30 +
Mier JW, Atkins MB.  Mechanisms of action and toxicity of immunotherapy with cytokines . Curr Opin Oncol . 1993;;5:1067-1072.
31 +
Schattner A.  Lymphokines in autoimmunity: a critical review . Clin Immunol Immunopathol . 1994;;70:177-189.
32 +
Kuskal BA, Ezekowitz AB.  Cytokines in treatment of primary immunodeficiency . Biotherapy . 1994;;7:249-259.
33 +
Parlevliet KJ, Schellekens PT.  Monoclonal antibodies in renal transplantation: a review . Transpl Int . 1992;;5:234-246.
34 +
Ronda N, Hurez V, Kazatchkine MD.  Intravenous immunoglobulin therapy of autoimmune and systemic inflammatory diseases . Vox Sang . 1993;;64:65-72.
35 +
Pirofsky B, Kinzey DM.  Intravenous immune globulins: a review of their uses in selected immunodeficiency and autoimmune diseases . Drugs . 1992;;43:6-14.
36 +
Hershfield MS.  PEG-ADA replacement therapy for adenosine deaminase deficiency: an update after 8.5 years . Clin Immunol Immunopathol . 1995;;76:228-232.
37 +
Kaplan G.  Recent advances in cytokine therapy in leprosy . J Infect Dis . 1993;;167( (suppl 1) ):S18-S22.
38 +
Hadden JW, Smith DL.  Immunopharmacology: immunomodulation and immunotherapy . JAMA . 1992;;268:2964-2969.
39 +
Ratko TA, Burnett DA, Foulke GE, Matuszewski KA, Sacher RA.  Recommendations for off-label use of intravenously administered immunoglobulin preparations . JAMA . 1995;;273:1865-1870.
40 +
Yim JM, Matuszewski KA, Vermeulen LC, Ratko TA, Burnett DA, Vlasses PH.  Surveillance of colony-stimulating factor use in US academic health centers . Ann Pharmacother . 1995;;29:475-481.
41 +
Walley T, Barton S.  A purchaser perspective of managing new drugs: interferon beta as a case study . BMJ . 1995;;311:796-799.
42 +
Jolicoeur LM, Jones-Grizzle AJ, Boyer JG.  Guidelines for performing a pharmacoenonomic analysis . Am J Hosp Pharm . 1992;;49:1741-1747.
43 +
Ware JE, Sherbourne CD.  The MOS 36-Item Short-Form Health Survey (SF-36) . Med Care . 1992;;30:473-483.

Figures

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal

1 +
Bousquet J, Bullinger M, Fayol C, Marquis P, Valentin B, Burtin B.  Assessment of quality-of-life in patients with perennial allergic rhinitis with French version of the SF-36 health status question-naire . J Allergy Clin Immunol . 1994;;94:182-188.
2 +
Blaiss MS.  Outcomes research and its importance to the allergist/immunologist . Insights Allergy . 1994;;9:1-8.
3 +
Curnutte JT.  Classification of chronic granulomatous disease . Hematol Oncol Clin North Am . 1988;;2:241-252.
4 +
The International Chronic Granulomatous Disease Comparative Study Group.  A controlled trial of interferon gamma to prevent infection in chronic granulomatous disease . N Engl J Med . 1991;;324:509-516.
5 +
Woodman RC, Erickson RW, Rae J, Jaffe HS, Curnutte JT.  Prolonged recombinant interferongamma therapy in chronic granulomatous disease: evidence against enhanced neutrophil oxidase activity . Blood . 1992;;79:1558-1562.
6 +
1997Drug Topics Red Book. Montvale, NJ: Medical Economics; 1997.
7 +
Gallin JI, Farber JM, Holland SM, Nutman TB.  Interferon-gamma in the management of infectious diseases . Ann Intern Med . 1995;;123:216-224.
8 +
Cohn EJ, Strong LE, Hughes WL, et al.  Preparation and properties of serum and plasma proteins, IV: a system for the preparation into fractions of the protein and lipoprotein components of biological tissues and fluids . J Am Chem Soc . 1946;;68:459-475.
9 +
Janeway CA.  The development of clinical uses of immunoglobulins: a review . In: Merler E, ed. Immunoglobulins: Biologic Aspects and Clinical Uses . Washington, DC: National Academy of Sciences; 1970;:3-14.
10 +
Hill LE, Mollison PL.  Conclusions . In: Hypogammaglobulinemia . London, England: United Kingdom Medical Research Council; 1971;. MRC Special Report Series No. 310.
11 +
Ammann AJ, Ashman RF, Buckley R, et al.  Use of intravenous gammaglobulin in antibody immunodeficiency: results of a multicentre controlled trial . Clin Immunol Immunopathol . 1982;;22:60-67.
12 +
Cunningham-Rundles C, Smithwick EM, Siegal FP, et al.  Efficacy of intravenous gammaglobulin in humoral immunodeficiency disease . Ann Intern Med . 1984;;101:435-439.
13 +
Nolte MT, Pirofsky B, Gerritz GA, Golding B.  Intravenous immunoglobulin therapy for antibody deficiency . Clin Exp Immunol . 1979;;36:237-243.
14 +
Roifman CM, Lederman HM, Lavi S, Stein LD, Levison H, Gelfand EW.  Benefit of intravenous IgG replacement in hypogammaglobulinemic patients with chronic sinopulmonary disease . Am J Med . 1985;;79:171-174.
15 +
NIH Consensus Conference.  Intravenous immunoglobulin: prevention and treatment of disease . JAMA . 1990;;264:3189-3193.
16 +
Siegal J.  Viral safety issues in IVIg products . Pharm Ther . 1996;;21:21S-24S.
17 +
Centers for Disease Control and Prevention.  Outbreak of hepatitis C associated with intravenous immune globulin administration . MMWR Morb Mortal Wkly Rep . 1994;;43:259-262.
18 +
Bresee JS, Mast EE, Coleman PJ, et al.  Hepatitis C virus infection associated with administration of intravneous immune globulin: a cohort study . JAMA . 1996;;276:1563-1567.
19 +
Schiff RI.  Transmission of viral infections through intravenous immunoglobulin . N Engl J Med . 1994;;331:1649-1650.
20 +
Liese JG, Wintergerst U, Tympaer KD, Belohradsky BH.  High vs low dose immunoglobulin therapy in the long term treatment of X-linked agammaglobulinemia . AJDC . 1995;;146:325-339.
21 +
Lederman HM, Winkelstein JA.  X-linked agammaglobulinemia: an analysis of 96 patients . Medicine . 1985;;64:145-156.
22 +
 Cefpodoxime proxetil: an oral cephalosporin . Med Lett . 1992;;34:107-108.
23 +
 Clarithromycin and azithromycin . Med Lett . 1992;;34:45-46.
24 +
Kobayashi RH, Kobayashi AD, Lee N, Fischer S, Ochs HD.  Home intravenous immunoglobulin therapy in children . Pediatrics . 1990;;85:705-709.
25 +
Bielory L, Long GC.  Home health care costs: intravenous immunoglobulin home infusion therapy . Ann Allergy Asthma Immunol . 1995;;74:265-268.
26 +
Ashida ER, Saxon A.  Home intravenous immunoglobulin therapy by self-administration . J Clin Immunol . 1986;;6:306-309.
27 +
Ochs HD, Lee MC, Fisher SH, Delson ES, Chang BS, Wedgwood RJ.  Self-infusion of intravenous immunoglobulin by immunodeficient patients at home . J Infect Dis . 1987;;156:652-654.
28 +
Berger M, Cupps TR, Fauci AS.  Immunoglobulin replacement by slow subcutaneous infusion . Ann Intern Med . 1980;;93:55-56.
29 +
Gardulf A, Andersen V, Bjorkander J, et al.  Subcutaneous immunoglobulin replacement in patients with primary antibody deficiencies: safety and costs . Lancet . 1995;;345:365-369.
30 +
Mier JW, Atkins MB.  Mechanisms of action and toxicity of immunotherapy with cytokines . Curr Opin Oncol . 1993;;5:1067-1072.
31 +
Schattner A.  Lymphokines in autoimmunity: a critical review . Clin Immunol Immunopathol . 1994;;70:177-189.
32 +
Kuskal BA, Ezekowitz AB.  Cytokines in treatment of primary immunodeficiency . Biotherapy . 1994;;7:249-259.
33 +
Parlevliet KJ, Schellekens PT.  Monoclonal antibodies in renal transplantation: a review . Transpl Int . 1992;;5:234-246.
34 +
Ronda N, Hurez V, Kazatchkine MD.  Intravenous immunoglobulin therapy of autoimmune and systemic inflammatory diseases . Vox Sang . 1993;;64:65-72.
35 +
Pirofsky B, Kinzey DM.  Intravenous immune globulins: a review of their uses in selected immunodeficiency and autoimmune diseases . Drugs . 1992;;43:6-14.
36 +
Hershfield MS.  PEG-ADA replacement therapy for adenosine deaminase deficiency: an update after 8.5 years . Clin Immunol Immunopathol . 1995;;76:228-232.
37 +
Kaplan G.  Recent advances in cytokine therapy in leprosy . J Infect Dis . 1993;;167( (suppl 1) ):S18-S22.
38 +
Hadden JW, Smith DL.  Immunopharmacology: immunomodulation and immunotherapy . JAMA . 1992;;268:2964-2969.
39 +
Ratko TA, Burnett DA, Foulke GE, Matuszewski KA, Sacher RA.  Recommendations for off-label use of intravenously administered immunoglobulin preparations . JAMA . 1995;;273:1865-1870.
40 +
Yim JM, Matuszewski KA, Vermeulen LC, Ratko TA, Burnett DA, Vlasses PH.  Surveillance of colony-stimulating factor use in US academic health centers . Ann Pharmacother . 1995;;29:475-481.
41 +
Walley T, Barton S.  A purchaser perspective of managing new drugs: interferon beta as a case study . BMJ . 1995;;311:796-799.
42 +
Jolicoeur LM, Jones-Grizzle AJ, Boyer JG.  Guidelines for performing a pharmacoenonomic analysis . Am J Hosp Pharm . 1992;;49:1741-1747.
43 +
Ware JE, Sherbourne CD.  The MOS 36-Item Short-Form Health Survey (SF-36) . Med Care . 1992;;30:473-483.

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