PMID- 16300417
OWN - NLM
STAT- MEDLINE
DCOM- 20060216
LR  - 20230823
IS  - 1083-4087 (Print)
IS  - 1944-706X (Electronic)
IS  - 1083-4087 (Linking)
VI  - 11
IP  - 9
DP  - 2005 Nov-Dec
TI  - Evaluation of omalizumab from a health plan perspective.
PG  - 735-45
LID - 10.18553/jmcp.2005.11.9.735
AB  - OBJECTIVE: To review the pathophysiology of allergic asthma and information on 
      the pharmacology, clinical efficacy, safety profile, and direct drug costs for 
      omalizumab to provide a basis for a defined role of this agent in allergic asthma 
      therapy in managed care organizations. SUMMARY: Omalizumab is a monoclonal 
      antibody targeting the high-affinity receptor binding site on human 
      immunoglobulin E (IgE). When bound by omalizumab, IgE does not bind to basophils. 
      As a result, degranulation is attenuated and allergic asthma symptoms are 
      reduced. In asthma trials, omalizumab reduced inhaled corticosteroid and rescue 
      medication requirements and improved asthma control and asthma quality of life in 
      moderate-to-severe allergic asthmatics with disease poorly controlled by inhaled 
      corticosteroids. Omalizumab has generally been well tolerated. However, injection 
      site reactions occur in nearly 1 of every 2 patients, a problem that generally 
      becomes less with continued dose administration. Severe injection site reactions 
      are reported in 12% of patients. Other adverse events commonly reported in 
      clinical trials include viral infections (23%), upper respiratory infections 
      (20%), sinusitis (16%), headache (15%), and pharyngitis (11%). Because the 
      acquisition cost of omalizumab is high (generally $15,000 to $44,000 per patient 
      per year, before contractual discounts), its use is cost-prohibitive in all but 
      the most severe, poorly controlled allergic asthmatic patients who are utilizing 
      large amounts of emergency health care resources to manage exacerbations. 
      Experience with use of this drug beyond 52 weeks is lacking. CONCLUSION: Although 
      omalizumab has demonstrated efficacy and safety in adults and adolescents with 
      uncontrolled moderate-to-severe allergic asthma, its use should be restricted to 
      a narrowly defined population of allergic asthmatics who utilize large amounts of 
      health care resources. If targeted only toward this population, cost-of-care 
      studies suggest that the high cost of this product in these patients could be 
      offset by savings resulting from the less frequent use of high-intensity medical 
      services for asthma exacerbations. The use of omalizumab beyond 52 weeks needs 
      evaluation.
FAU - Belliveau, Paul P
AU  - Belliveau PP
AD  - Department of Pharmacy Practice, Massachusetts College of Pharmacy and Health 
      Sciences, Worcester, MA 01608, USA. paul.belliveau@wor.mcphs.edu
FAU - Lahoz, Monina R
AU  - Lahoz MR
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - United States
TA  - J Manag Care Pharm
JT  - Journal of managed care pharmacy : JMCP
JID - 9605854
RN  - 0 (Antibodies, Anti-Idiotypic)
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 2P471X1Z11 (Omalizumab)
SB  - IM
CIN - J Manag Care Pharm. 2005 Nov-Dec;11(9):774-6. PMID: 16300422
MH  - Antibodies, Anti-Idiotypic
MH  - Antibodies, Monoclonal/economics/*pharmacology
MH  - Antibodies, Monoclonal, Humanized
MH  - Asthma/*drug therapy/physiopathology
MH  - Cost of Illness
MH  - Dose-Response Relationship, Drug
MH  - Humans
MH  - Managed Care Programs
MH  - Omalizumab
MH  - Quality of Life
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
PMC - PMC10438166
EDAT- 2005/11/23 09:00
MHDA- 2006/02/17 09:00
PMCR- 2005/11/01
CRDT- 2005/11/23 09:00
PHST- 2005/11/23 09:00 [pubmed]
PHST- 2006/02/17 09:00 [medline]
PHST- 2005/11/23 09:00 [entrez]
PHST- 2005/11/01 00:00 [pmc-release]
AID - 2005(11)9: 735-745 [pii]
AID - 10.18553/jmcp.2005.11.9.735 [doi]
PST - ppublish
SO  - J Manag Care Pharm. 2005 Nov-Dec;11(9):735-45. doi: 10.18553/jmcp.2005.11.9.735.