Sublingual Immunotherapy Tablets
Are tablets an option for me?
With the FDA’s announcements approving sublingual immunotherapy tablets for seasonal grass and short ragweed allergy (Oralair, Grastek and Ragwitek), many allergy sufferers are asking what that means for them. The good news is that this approval confirms what we’ve experienced for decades: that the sublingual (under the tongue) route is a safe, effective route of administration to treat allergic rhinitis and asthma. And from our experience, the benefits don’t end there.
The concept of treating through the sublingual route isn’t new — we’ve used this method for 45+ years through multi-antigen liquid drops taken under the tongue. The newly approved, single-antigen tablet with one “standard” dose addresses a narrower range of patients and allergens that are not typical of the patients we see in the US; the vast majority of U.S. allergy sufferers are sensitive to many allergens.
Most U.S. allergy patients are treated for multiple allergies. Many have related conditions (moderate/severe uncontrolled asthma, need for beta blockers) or are of an age that precludes them from tablet treatment. We have refined our approach and found that a more optimal way to treat patients is to consider the patient’s total allergic load and level of sensitivity through thorough diagnostics, followed by patient-specific treatment that addresses their unique allergies and sensitivity levels. That’s the concept behind the La Crosse Method™ Protocol, which offers treatment options not only for the seasonal sufferer, but also for the broad range of patients who would benefit from tailored treatment that’s designed to maximize therapeutic benefit and minimize risk of reactions and unnecessary symptoms in a cost-effective way.
The tablets offer another option for patients, which is good. But it might also be helpful to see a comparison of tablets versus drops via the La Crosse Method Protocol to help make a decision on what is right for you.
|La Crosse Method Protocol|
|Delivery Method||FDA-approved liquid antigen under the tongue. Currently considered “off label” use of FDA-approved antigens.||FDA-approved antigens in tablet form delivered under the tongue. Approved for grass and ragweed only.|
|Customized to Patient Sensitivity||Yes. Dose is based on individual patient sensitivity, dosed to provide therapeutic benefit and minimize risk of reactions.||No. Standardized dosing for all patients.|
|Treats Multiple Sensitivities Simultaneously||Yes, multi-antigen treatment available to address sensitivities based on patient test results, most flexible protocol available.||No, focused on individual pollens (grass & ragweed).|
|Patient Ages Treated||Protocol addresses all ages.||Indicated for ages starting at 5, 10 or 18, up to 65.|
|Addresses food allergy||Yes||No, treats only specific pollens indicated.|
|Patients Treated Clinically in the U.S.||195,000+||Trial populations in U.S., patients treated since recent approval.|
|Estimated Cost||Roughly $1 day for custom multi-antigen inhalant threshold treatment.||Roughly $4-10/day for single antigen prescriptions.|
|Insurance Coverage||Not currently in most cases; check with carriers, employer coverage growing.||Will likely be once reviewed by Insurers/PBM formularies, subject to Tier 3 or 4 co-pays (co-pay est. $50-100 month, varies by carrier).|
|Extremely safe and adjustable for virtually any condition or level of severity, dosing escalated based on patient tolerance. Estimated over 1 billion doses taken by patients with no severe adverse events.||Variety of contraindications including uncontrolled asthma, eosinophilic esophagitis, those currently on beta blockers, immunotherapy, and pregnancy. Adverse event profile is high with rapid escalation.|
|Considerations||Developed based on clinical experience with multi-sensitized U.S. patients treated concurrently with a variety of related conditions including asthma, atopic dermatitis, food & mold allergies.||Developed by European manufacturers based on European patient profiles, not treated concurrently for asthma, AD, and related conditions.|
|Require Emergency Epinephrine Device||Not required for general use. Only required for those whose underlying allergic conditions require it (anaphylaxis history).||Required with all prescriptions.|
|Long-term Efficacy||Majority of patients see sustained improvement after treatment conclusion.||Inconclusive evidence of ongoing sustained efficacy after two seasons of treatment.|