cost of care, and patient safety risk. Dr. Ramirez shares those concerns in looking at how allergen extract treat- ments in his office normally work. Once Dr. Ramirez has mixed the
appropriate compound, the treat- ments start with extremely diluted injections on a weekly basis before patients work their way up to a more highly concentrated maintenance dose, which induces tolerance in the patient’s immune system. Dr. Ramirez
says the process of reaching the main- tenance shot should take between eight weeks and 28 weeks, according to immunotherapy guidelines. Work- ing up to the maintenance dose too fast puts the patient at risk for an ana- phylactic reaction. Once the patient is ready for the maintenance dose, the allergist may start administering the shot every two weeks to four weeks instead of weekly. Treatments continue until the vial ei-
ther runs out or expires, which is usu- ally about one year from the mixing date. At that point, the allergist and the patient reevaluate the treatment and figure out how to proceed from there. The treatments can generally continue for three to five years, Dr. Ramirez says. “Normally, we’ve been used to
working with one-year expiration dates. Now, we’re saying that we’re doing this on a monthly basis? That brings up a couple of issues,” he said. Efficacy is one issue. AAAAI says
discarding the allergen preparation every 28 days or 42 days means the patient would never reach the crucial maintenance dose “because the sched- ule would have to be restarted with each newly prepared allergen extract material.” Cost is also a major concern. Dr.
Ramirez says the first year’s vial, which includes the diluting agents for the initial injections, costs $500 or more. A one-year refill vial costs around $250. But with the proposed 28-day expiration date, those annual costs would suddenly become month- ly costs, meaning a one-year refill would cost about $3,000. “We are already having a hard enough time as it is with some insur- ance companies saying they’ll only cover a number of units that will last about a 12-month period; they will only pay for one of these refills once every 12 months,” Dr. Ramirez said. “If a patient comes in a little sooner, and we know that’s going to lead to the vial running out before the 12-month period, we might actually say to our patients, ‘You may want to wait anoth- er two weeks because it’s going to run out before we are allowed to submit a claim for a new refill.’ “Just imagine if we had to refill vials
on a monthly basis. Immunotherapy mixing and billing would need a dra- matic overhaul,” he added. The AAAAI letter also noted the
cost issue, saying that the few large groups or laboratories that can meet the proposed standards would have to
66 TEXAS MEDICINE May 2016
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