BackTable / ENT / Podcast / Episode #46
Biologics for Nasal Polyps: What’s the Role?
with Dr. Cecelia Damask and Dr. Matthew Ryan
We talk with Dr. Cecelia Damask and Dr. Matt Ryan about the role of Biologics for Nasal Polyps, including patient selection and its place in the treatment plan.
BackTable, LLC (Producer). (2022, February 1). Ep. 46 – Biologics for Nasal Polyps: What’s the Role? [Audio podcast]. Retrieved from https://www.backtable.com
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Dr. Cecelia Damask
Dr. Cecelia Damask is a practicing otolaryngologist in the Orlando, Florida area.
Dr. Matthew Ryan
Dr. Ryan is a Professor of Otolaryngology - Head and Neck Surgery at UT Southwestern Medical Center.
Dr. Gopi Shah
Dr. Gopi Shah is a practicing ENT at UT Southwestern Medical Center in Dallas, TX.
In this episode of BackTable ENT, Dr. Ashley Agan, Dr. Gopi Shah, Dr. Cecelia Damask (Lake Mary ENT and Allergy), and Dr. Matt Ryan (UT Southwestern Otolaryngology) discuss the growing role of biologics for nasal polyps.
Biologics are monoclonal antibodies that block T2-mediated immune responses (IL-3, IL-4, IL-13, IgE). They are administered subcutaneously and follow various dosing regimens. Biologics are a viable treatment option in patients with recurrent nasal polyps who have failed conventional therapies, such as high doses of antihistamines, topical steroids, and systemic steroids. It is still considered as a last line treatment because of the high cost associated with production of monoclonal antibodies.
However, not all patients with recurrent nasal polyps are good candidates for biologics. The patient must present with a specific endotype––the T2-mediated etiology. T2-mediated patients can be identified through their high responsiveness to steroid therapy, positive history for allergic asthma and atopic dermatitis, and high peripheral eosinophil and serum IgE levels on a CBC with differential. In a surgery-naive patient with a temporary steroid response, it is best to perform sinus surgery first in order to widen the nasal mucosal surface area for efficient delivery of topical therapies. However, if post-surgical intranasal steroid sprays and saline irrigations are ineffective, biologics should be considered. It is best to avoid surgery and skip straight to biologics in patients with comorbid conditions that prevent surgery, patients with severe asthma, and patients with high peripheral IgE counts (>1000).
Once the decision to start biologic therapy is made, many factors have to be considered, such as insurance pre-authorization, administration methods, and frequency of dosing. Each biologic manufacturer has a “hub” that assists physicians and patients in navigating biologic dosing, delivery, and insurance paperwork. They will often have co-pay assistance programs for patient benefit as well. Common side effects observed in biologic trials are arthralgia, injection site inflammation, oropharyngeal pain, and headaches. However, all the doctors agree that these side effects are more mild than those of long-term systemic steroid use, which include avascular necrosis, cataracts, sepsis, and thromboembolic events.
Picking which biologic to prescribe is a clinical decision because they have not been subjected to comparative trials yet. The three biologics currently on the market are: Dupilumab (anti-IL-4 receptor), Omalizumab (anti-IgE), and Mepolizumab (anti-IL-5 receptor). All work to prevent T2 immune signaling by targeting different receptors. Factoring in comorbid conditions, payer systems, and dosing regimens can help a physician choose the best biologic for a nasal polyps patient.
[Cecelia Damask MD]
So there are multiple factors and different types of biologics that the patients can be put on. So it is an actual long conversation with a patient to try to decide which one. And then even once we decide which one, is this something that is going to be administered in the office so I can monitor you and make sure that you're compliant, or is this something that you're going to self administer at home or someone's going to administer to you?
And then there's questions about frequency in terms of dosing. So one of them dupilumab, for everybody, is every two weeks and NUCALA or mepolizumab for everybody is every four weeks. Omalizumab can be dosed based on their IgE and their weight, and so it can be variable. It can be something that they might get every two weeks, or it could be something that they might get every four weeks. And also with the omalizumab, the number of injections can vary. So some people could get one injection, some people could get three injections every two or four weeks. So there's that discussion about frequency
And each one of the biologic companies has what I'll call a hub, where you fill out an enrollment form, which basically tells the patient's insurance. It tells some baseline things about the patient. Like they have failed with topical steroids, or they have been on so many bursts of oral steroids. And you sign it kind of like a prescription and the patient signs it saying that they give this hub permission to evaluate the patient's insurance for a benefits investigation. And then that benefits investigation will come back to the office and it will give you information about if the patient has any out-of-pockets, if they have any deductible, how much this would cost. And then also it will tell the office how the patient is to obtain the drug.
So some patients get the drug through what's called a specialty pharmacy. So it's not your local Walgreens or CVS. It's a pharmacy that specializes in taking care of medicines that require special handling because they have to be refrigerated at a, at a certain degree between two to eight degrees Celsius, like our immunotherapy and the specialty pharmacies will coordinate delivery.
Some patients, their insurance, especially our Medicare patients for some of the biologics require what's called “buy and bill.” And so that means the biologic has to be purchased by either your office or by an infusion center and then billed to the insurance. So these hubs are very helpful and we'll sort all that out for you and send it back so that then you know which way the patient would have to go for a particular biologic. And then also what those hubs will do, as long as the patient signs permission for them to do so, they will look into copay assistance or different assistance programs to help the patients. And for all the different manufacturers that are out there, they all have really wonderful copay assistance programs that help the patient, not only for the cost of the drug, but if you do administer in the office for administration in the office as well.
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