November 10, 2008
Landmark Allergy Study Uncovers Significant Healthcare Savings Associated With Immunotherapy in Children
Research findings presented at the 2008 American College of Allergy, Asthma and Immunology (ACAAI) Scientific Meeting revealed a significant cost savings associated with allergy immunotherapy (IT) in children with allergic rhinitis (AR). This pioneering study, supported by Greer, was summarized during an oral presentation by Cheryl Hankin, Ph.D., President and Chief Scientific Officer of BioMedEcon and principal investigator of the study, at the ACAAI meeting, held Nov. 6-11 in Seattle, Wash.
The study aimed to address the lack of available information regarding the potential cost benefits of IT, a treatment shown to effectively and safely reduce allergy symptoms and prevent the development of new allergies and asthma among children with AR. An estimated 40 percent of children suffer from AR, which is responsible for approximately two million missed school days and $2.6 billion in annual direct healthcare costs for children under age 12 in the United States.
In a previous study conducted by BioMedEcon and published in the Journal of Clinical Allergy and Immunology, researchers showed that among newly-diagnosed children with AR, there were significant reductions in the use and cost of healthcare services during the six months following IT compared to the six months preceding IT. Accrued cost savings were sufficient to offset the cost of IT. However, the study had several limitations, including its short time frame. The current study sought to remedy these limitations by employing a more robust design and extending the time period over which healthcare utilization and costs were examined.
Researchers analyzed claims data of children enrolled in Florida Medicaid who were newly diagnosed with AR during 1997-2006, and who had at least 18 months of follow-up data following IT initiation. Identified patients were matched (by age at diagnosis, presence of asthma, atopic dermatitis, and conjunctivitis, sex, and race) to children newly diagnosed with AR who did not receive IT. The study compared the two groups in terms of healthcare utilization and costs during the 18 months following IT initiation.
The average cost per IT administration was $44.00 (SD $35.30), and the mean 18-month cost of IT was $944 (SD $1,006). During the 18 months following treatment initiation, children receiving IT had a significantly lower median number of inpatient stays (1.0 vs 1.4, p=0.02) and outpatient visits exclusive of IT (14.0 vs 28.6, pless than0.0001) than children who did not receive IT. There were no significant group differences in the median number of outpatient visits inclusive of IT (42.2 vs 38.3) or pharmacy claims (21.0 vs 22.8).
Children who received IT had significantly lower 18-month mean outpatient costs excluding IT ($3,628 vs $6,504) or including IT ($4,502 vs $6,450), pharmacy costs ($2,737 vs $3,261), and total healthcare costs ($8,344 vs $11,934) than those who did not receive IT (all pless than0.0001). Investigators noted that there was also a trend toward lower 18-month mean costs for inpatient services among those who received IT ($12,933 vs $13,347, p=0.052).
"Our results suggest that among children with allergic rhinitis, allergy immunotherapy may produce a significant healthcare cost-offset benefit within the first 18 months," said Dr. Hankin. "This finding is even more impressive considering that patients had not yet completed a full course of immunotherapy and the study was conducted in the context of 'real world' healthcare delivery where patient selection factors and adherence to treatment protocols are not as tightly controlled as they are in clinical trials."
The study found that among children who were diagnosed with AR, only two percent received IT. This finding corroborates other reports that IT is frequently underutilized as a treatment for AR. Untreated or inadequately treated AR can substantially impair children's well-being and school performance by causing fatigue, headache, cognitive impairment, and worsening AR symptoms, as well as increasing the risk for comorbid conditions such as asthma, otitis media and obstructive sleep apnea.
"These results are encouraging since allergy immunotherapy is the only treatment that can alter the course of the disease," added Linda Cox, M.D., study investigator. "However, this study also reinforces the fact that, despite its effectiveness and relatively low cost, there are still barriers that prevent patients from receiving immunotherapy."
Currently in the United States, immunotherapy is administered via a series of subcutaneous injections by a clinician. For many patients, however, barriers to adherence of this schedule of injections (personal time, out of pocket expenses), can impact the success of these treatments. Greer is currently conducting clinical trials evaluating the efficacy of sublingual-oral immunotherapy (SLIT) as a treatment for allergic rhinitis. The aim of the research program is to support changes in the route of administration for Greer's currently licensed allergenic extracts, which are at present indicated for subcutaneous administration. Since SLIT is self-administered by the patient at home under physician supervision, researchers hypothesize that this delivery option may offer improved access to IT, thereby modifying the diseases process and improving the well-being of patients with allergies.
"At Greer, we are investing in allergy immunotherapy research and are proud to support this groundbreaking work," said Dr. Robert Esch, Greer Executive Vice President of Research & Development. "Economic evaluations are becoming increasingly important to provide support for the cost-effectiveness of allergen immunotherapy in patients with allergic rhinitis and allergic asthma. These data are critical as we work to increase the availability and the use of immunotherapy."
Further research is needed to demonstrate the long-term cost effectiveness of IT compared to standard treatment in allergic children, and to address the factors associated with the underdiagnosis and undertreatment of allergy. BioMedEcon is currently conducting a related study which examines patterns of immunotherapy use (e.g., adherence to therapy, duration of treatment, predictors of early discontinuation) among children and adults treated in allergy clinics across 11 states.
BioMedEcon provides a wide range of biomedical consulting services, including health economics (modeling, interactive tools, burden of illness studies), data synthesis (systematic literature reviews, meta-analyses), outcomes research (payer claims, data analysis, clinical trials), reimbursement and market access (advisory boards, payer research, formulary dossiers), and communications (publications strategy support, journal articles, poster and podium presentations, product monographs, package inserts, continuing medical education). BioMedEcon applies rigorous scientific methods to create coherent, objective and practical formulary decision models, pharmaceutical and drug delivery market entry strategies, and healthcare policy recommendations to pharmaceutical and biotech companies, managed care organizations and advocacy groups. For more information, call 650.563.9475 or visit http://biomedecon.com.
Greer is a leading developer and provider of allergy immunotherapy products and services for treating humans and animals. Greer's expert scientists provide technical support for customers by continuing to focus on improving the lives of allergic patients. Greer's clinical development programs are focused on supporting and expanding the use of immunotherapy through oral administration of allergy immunotherapy. Greer's goal is to establish the efficacy of standardized products for oral administration through clinical trials. The company was founded in 1904 and is located in Lenoir, N.C. For more information, visit www.greerlabs.com.