Later this spring, allergy sufferers will have access to a new form of help: a pill that can replace allergy shots. But the pill works only for grass allergies, and it's not clear how much it's going to cost.
The Food and Drug Administration just approved Oralair, the first sublingual allergy immunotherapy tablet for use in the United States. That's how regulators describe a pill that you stick under your tongue to tamp down your immune system.
Just like allergy shots, the tablets help the body gradually become accustomed to allergens.
"This is a really important advance," says Dr. David Lang, the chairman of allergy and clinical immunology at the Cleveland Clinic, who isn't involved with the testing of new pill. The most common seasonal allergen is grass pollen, Lang tells Shots, and a daily pill will be a lot more convenient than going to a doctor's office for shots.
Greer Laboratories, the company that will market the tablet, says that 29 million Americans are allergic to grass pollens.
Immunotherapy pills have been used for years in Europe, and recently some doctors in the United States started giving patients oral doses of the injectable extracts to do the same thing. But that use was off-label. FDA approval means that many more doctors will feel comfortable using the pills and that insurers will pay for them.
The pills, which are made from freeze-dried grass extracts, need to be taken daily starting months before allergy season. How much will they cost?
To find out, we called up John Roby, Greer's president and CEO, in Lenoir, N.C. His company specializes in extracting the allergens that doctors use for allergy shots.
"Anything I say would be my opinion," Roby told Shots. "We'll wait and see how the product is priced by specialty pharmacies."
Does that mean cheaper than allergy shots? More expensive? "It's completely impossible to make those connections," Roby says. "The current immunotherapy is reimbursed as a medical benefit. Oralair is a pharmacy benefit."
Roby is confident that the product will be covered by most insurers. But patients will have to wait until Oralair is on the market, which Roby says should happen in May, to find out about cost and insurance coverage.
So, cost is unclear. And perhaps a bigger issue than expense is that most people with allergies are allergic to many different things.
The Oralair pill includes five different strains of grass. But it's zero help for people who are allergic to cats, tree pollen or mold. A second pill, for ragweed allergy, is awaiting FDA approval.
But that will only help a little, the Cleveland Clinic's Lang says. "Many patients have year-round symptoms, not just grass season," he says. It would be rare to have a patient allergic only to grass. Lang says that the Oralair pill could be useful for people who have the worst symptoms during grass season. But for year-round symptoms, Lang says, it would be best to go with shots. "With allergy shots we can cover all the bases."
Oh. Shots. Anyone who has spent months or years making weekly treks to the allergist for a shot and a half-hour wait knows what a royal pain they are. But they do work. That's because the doctor customizes the mix of extracts to address each person's known allergens.
Both allergy shots and the Oralair pill can spark rare but life-threatening allergic reactions. For that reason, people are required to take the first pill in a doctor's office, to see how they do. The FDA gave the product a black-box warning, the strongest kind, and recommends that patients also be given a prescription for an epinephrine pen, so that they can respond immediately to swelling of the mouth or other symptoms of a severe reaction.