What is immunotherapy?
Immunotherapy is a method for treating an individual’s allergic response to a single or a multitude of antigens (pet dander, dust mites, plant pollens, fungal spores, insect venoms and certain foods). Immunity to these antigens is accomplished by subjecting the patient to small doses of the specific antigen(s) for which they exhibit an allergic reaction. This treatment is administered over an extended period of time ranging from 1 to 2 years. Currently there are two different applications of Immunotherapy: Subcutaneous Immunotherapy (allergy shots) and Sublingual Immunotherapy (SLIT).
What are the differences between Subcutaneous Immunotherapy (allergy shots) and Sublingual Immunotherapy (SLIT)?
Allergy shots are ONLY administered by a physician in his/her office by injecting the patient with a vaccine up to three times per week. Allergy shots represent a time consuming, painful and expensive treatment method. SLIT on the other hand is a painless, home-based treatment option that is accomplished by placing a diluted allergen extract solution under the tongue twice a day.
Is Sublingual Immunotherapy (SLIT) safe and effective?
SLIT has been utilized as a treatment for allergies for more than 40 years internationally. There are more than 150 peer reviewed articles and a number of books written regarding the safety and efficacy of SLIT.
Is Sublingual Immunotherapy (SLIT) safe and effective for children?
The favorable safety profile of SLIT is reported in children as young as 3 years of age.
Fiocchi A, Pajno G, La Grutta S, et al. Ann Allergy Asthma Immunology 2005; 95:254-258.
Is sublingual immunotherapy an FDA approved therapy?
Sublingual immunotherapy is not an FDA approved therapy. The use of sublingual immunotherapy in United States is considered to be an off-label use of an FDA-approved antigen product.
Is it permissible to use the US licensed extracts for subcutaneous immunotherapy for SLIT, i.e. ‘off-label’ use?
The off-label use of products is not illegal. You are responsible for knowing the indications (on or off label) as well as the risks and benefits of any product you use in treatment of a patient. While pharmaceutical companies are prohibited by law from advertising off-label use of any of their products, physicians may use any FDA approved products for any indication she/he thinks appropriate. There should be published literature substantiating the off-label use indication. Use of approved medications off-label should also include a thorough risk/benefit/alternative discussion with the patient and documentation of the discussion and mutual decision to pursue treatment.
Do I need Informed Consent from a patient and/or their family, if I am providing off-label use of a medication? If so, what sort of information should be discussed during the informed consent process?
Yes — the patient must be informed of the off-label use of the medication and the reason for using this product off-label. As in any informed consent, all components of the informed consent must be provided to the patient including diagnosis, reason for use, risks, benefits, alternative therapies, risks if no treatment is provided, and probability of success. There should be a recording of the informed consent discussion. In a case such as SLIT, it is recommended that a patient sign the consent form as this is the best indication that the consent was obtained.
What type of information should be provided to patients receiving SLIT treatment?
One important factor to consider is that SLIT treatment is administered at home with no direct medical supervision. Physicians will need to provide specific instructions to the patients on how to administer the allergy extract, manage adverse reactions, prevent treatment interruptions, recognize situations in which the dose should be withheld, and manage dosing adjustments for any or all of these variables. Other considerations include whether injectable epinephrine should be routinely prescribed, the patient’s ability to comply with the regimen and the patient’s response to a potential adverse reaction. The EAACI Immunotherapy Task Force recommended the following in their “Standards for Allergen-specific Immunotherapy”:
“The scientific documentation for treatment schedules and dose modifications is limited. For routine treatment, following the guidelines from the manufacturers is sensible.
The administration of sublingual immunotherapy must be postponed in the following circumstances:
- In the presence of oropharyngeal infection.
- In the case of major dental surgery.
- Acute gastroenteritis.
- Exacerbation of the asthma.
- PEFR <80% of personal best value.
- Simultaneous administration of viral vaccines”
Can I get reimbursed for SLIT?
There is no FDA approved formulation and no CPT (billing code) for this therapy in the United States. An FDA approved SLIT formulation would be needed to apply for a new reimbursable CPT code. Medicare specifically states that it does not cover sublingual immunotherapy (see excerpt below). Most insurers would not reimburse for SLIT services, if there is no CPT code or FDA approved formulation. Therefore, the patient would need to personally pay for the costs associated with SLIT.
Source: Page 14 of Medicare National Coverage Determinations Manual Chapter 1, Part 2 (Sections 90 – 160.25) Coverage Determinations (Rev. 45, 12-06-05)110.9 – Antigens Prepared for Sublingual Administration (Rev. 1, 10-03-03) CIM 45-28
For antigens provided to patients on or after November 17, 1996, Medicare does not cover such antigens if they are to be administered sublingually, i.e., by placing drops under the patient’s tongue. This kind of allergy therapy has not been proven to be safe and effective. Antigens are covered only if they are administered by injection.