Future allergy shots show promise

May 8, 2006

To prepare for the seasonal onslaught of pollen, mostallergy-stricken patients will try to find relief throughnonsedating antihistamines and nasal inhalers. Many others willundergo allergen immunotherapy as a next step, receiving theestimated 60 to 90 injections necessary for each treatment period.Although allergy shots can be effective, treatment is often atime-consuming and costly process. Preliminary results for newtherapies show promise and may soon offer allergy sufferers moreoptions with fewer injections.

Results of a two-year phase II/III clinical trial were presented in March at the 2006 annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI). It showed that treatment with a six-week course of Tolamba prior to the 2004 ragweed season led to a significant reduction in total nasal symptom scores compared with placebo. Prinicipal investigator William W. Busse, M.D., professor of medicine at University of Wisconsin-Madison, said the results suggest that Tolamba has potential as a disease-modifying agent that can reprogram the immune system and reduce the allergic response. Dynavax plans to test the therapy with a higher dosage regimen in a new trial expected to begin in the second quarter of 2006. The company also intends to produce similar ISS allergen-linked products for treating grass, birch, cedar, and peanut allergies.

In other news, the Office of Inspector General (OIG) released a report in February on Medicare reimbursement for allergy shots. The report said that of the $130 million that Medicare allowed in 2001 for allergen immunotherapy, 62% of therapy and services provided did not meet program requirements-resulting in $75 million in improper payments. According to OIG, medical reviewers using standards set by the Joint Task Force on Practice Parameters found that 31% of immunotherapy allowed by Medicare was not medically necessary and services provided were either not indicated or were part of an allergy shot regimen that lasted longer than clinically acceptable.

The OIG called the payment errors a significant Medicare vulnerability and recommended that the Centers for Medicare & Medicaid Services require carriers to provide education to physicians about coverage, coding, and documentation requirements of immunotherapy. OIG also suggested that CMS develop national coverage criteria for allergen immunotherapy based on professionally recognized standards of care. CMS has said establishing such criteria would require at least 12 months to create and implement.