Due to the rapid progression of coronavirus transmission in the US, healthcare providers who offer allergy immunotherapy are facing difficult decisions regarding the continuity of care for patients receiving subcutaneous immunotherapy (SCIT) injections in the office.

The following information includes both general guidance and practical considerations related to modifying allergy immunotherapy dosing schedules to help accommodate patients who are unable or unwilling to appear in person for their scheduled allergy injections.

Additional information and resources from allergy specialist organizations are available at the end of this technical bulletin. For the most up-to-date information and guidance on preventing the spread of coronavirus and managing patients with suspected symptoms of COVID-19, as well as how to protect your practice and staff, please visit the Centers for Disease Control & Prevention (CDC) website as well as your local and state public health websites.

 

Q: How do we manage office-administered allergy immunotherapy injections during a pandemic?

 

Allergy immunotherapy is a highly valuable medical intervention that offers tremendous clinical benefits to patients suffering from allergies, especially those with asthma who may be particularly vulnerable to COVID-19 complications. Any disruption to a patient’s allergy injection schedule can lead to a loss of tolerance as well as a return of allergic symptoms.  It is, therefore critical that a patient remains compliant with the prescribed treatment plan & dosing schedule.

However, during a pandemic, patients may be instructed to withhold unnecessary travel outside their home, so adherence to an office-administered allergy injection schedule may be challenging, if not impossible.

Practices have several options when adjusting a patient’s immunotherapy treatment due to restrictions in office-delivered care:

  • Continue offering injections for patients who can make their scheduled appointments for allergy injections. This will likely require some modification of your typical patient workflow for allergy immunotherapy.
    • Offer additional screening of patient’s health prior to administering injections – this may include a same-day phone consult before having patient traveling to the clinic for their scheduled injection
    • Allow only limited daily allergy injection appointments to avoid excessive patient volume
    • Arrange the waiting area for allergy patients to allow for proper social distancing during the 30-minute wait period following injections
    • Some allergists have suggested offering curbside injections (i.e., patient waits in a car) – this may require additional consideration of how to observe patients for possible allergic reactions
  • Implement a modified build-up & maintenance immunotherapy schedule for current patients on treatment:
    • Have all build-up patients come every other week for scheduled injections (i.e., every two weeks)
    • Have all maintenance patients extend their time between maintenance doses. Bi-weekly injections can be pushed to every 3 or 4 weeks. Monthly shot patients can be extended to every 6 weeks.
    • For any patients being asked to extend the time between injections (i.e., a longer gap than outlined initially in the treatment plan), it will be important to carefully monitor for any loss of tolerance (e.g., reactions after injection or a return of symptoms). Returning to more frequent injections may be necessary for some patients.
    • Notify patients when they can expect to return to their original treatment schedule
  • Temporarily suspend all office-administered immunotherapy until pandemic-related restrictions are lifted:
    • Communicate to all immunotherapy patients that their injection schedule will be suspended and provide instructions on how to manage any recurring symptoms
    • Create a plan to reinitiate patients after the pandemic has resolved and in-office injections can be resumed
    • If needed, contact Innovation Compounding for additional guidance on dose adjustments for any patients experiencing an extended gap in treatment
    • Offer sublingual immunotherapy (SLIT) as an option for patients who want to continue treatment at home

 

Q: How to deal with the Beyond-Use-Date (BUD) for my patient’s SCIT vials?

 

Allergenic extracts that are mixed and diluted for SCIT will experience decay in potency over time, though specific decay rates for each allergen (or mixtures of allergens) is unknown. A patient’s SCIT vials are typically assigned a Beyond-Use-Date (BUD) of 12 months from the date they are mixed. This has been widely accepted as an appropriate expiration to ensure a sufficient amount of potency remains during the course of treatment, and before a refill is required.

A patient may not complete all doses prepared for a number of reasons which may include:

  • intolerance (i.e., reactions requiring multiple repeated/reduced doses)
  • non-compliance whether it be voluntary (e.g., Summer vacation) or forced (e.g., pandemic lockdown)

If a patient is unable to complete all scheduled doses, then a refill set of vials should be ordered.

  • For patients who didn’t reach the Yellow or Red vial, a “refill” order may be another 5-vial build-up set, and vials will be diluted down to an appropriate strength to continue treatment
  • Insurance should be billed just as any other refill. The practice is entitled to bill for all doses prepared under CPT 95165

It is not advised to use SCIT vials past their assigned BUD – if injections are inadvertently administered from vials that are expired, then additional precautions should be taken.

  • Patients may be exposed to a greater than expected potency difference
  • Extra precautions may include a deeper dose reduction & additional observation of patient after injection

 

Q: How do we manage SCIT patients with extended gaps in treatment?

 

Patients who experience a long gap in treatment may continue their injections after the pandemic restrictions are lifted, and in-office SCIT can resume. Each patient should be evaluated for previous tolerance to SCIT and the length of the gap in treatment, so an appropriate dose reduction can be selected.

  • Many patients in early build-up (Silver or Green vial) can likely re-start where they left off, while some may require a modest dose reduction (50-90% by volume)
  • Patients who had reached higher doses may require a dose reduction of 50-90% by volume (typically staying in the same vial)
  • Especially sensitive patients or those who missed >2months of treatment may require a dose cutback to a lower strength vial, while others with especially longer gaps in treatment may need to start over altogether

 

Q: Can patients switch to Sublingual Immunotherapy (SLIT) or Oral-Mucosal Immunotherapy (OMIT)?

 

If patients are unable or unwilling to come to your medical office for their allergy injections, sublingual immunotherapy (SLIT) or oral-mucosal immunotherapy (OMIT) may be a useful alternative. SLIT and OMIT can have a similar formulation of allergens that are administered at home by the patient as drops under the tongue (SLIT) or as a toothpaste (OMIT).

Here are a few points to discuss with patients who are interested in this option:

  • SLIT & OMIT are formulated similarly to SCIT and will target the same allergens
  • These formulations are not routinely covered by insurance, so for most patients this is a cash-pay option
    • Transitioning from SCIT to either SLIT or OMIT will result in a minimal disruption to the patient’s treatment plan:
    • Patients starting SLIT will complete a 30-day build-up to reach maintenance
    • Patients starting OMIT require no build-up phase

For patients who decide to switch to SLIT or OMIT, it should be explained that transitioning back to SCIT is not as simple; most patients will require a significant dose reduction from any previously tolerated SCIT dose, and some may have to start over entirely.

 

 

 

Additional Resources
For further information and guidance on how to manage your allergy practice and immunotherapy patients during this time, visit the American College of Allergy Asthma & Immunology (ACAAI) website.

References

  1. Cox, Linda, et al. “Allergen immunotherapy: a practice parameter third update.” Journal of Allergy and Clinical Immunology 127.1 (2011): S1-S55.
  2. https://college.acaai.org/sites/default/files/Resources/covid19_us_final_3.17.20.pdf
  3. https://www.alk.net/us/sites/www.alk.us/files/portrait/us-ext-1900044_-_2020_alk_product_catalog.pdf

Our staff is full of compassionate health care professionals ready to counsel practitioners and patients alike. We’re here to listen to you, research your needs, and provide you with not only medication, but also the knowledge to reach your desired health goals.

Information contained on this site is provided as an informational aide and for reference use only. The content herein is not intended to be, act as, or replace medical advice or diagnosis for individual health conditions nor is it making evaluations as to the risks or benefits of particular preparations. Please consult a licensed healthcare professional about diagnosis and treatment. Information and statements on this site have not been evaluated by the Food and Drug Administration.

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