This webinar was recorded on July 25, 2024

SMART therapy is for patients with moderate to severe asthma who need a combination treatment. This combined treatment consists of an inhaled corticosteroid and an inhaled long-acting beta-2 agonist (LABA). Under asthma guidelines, SMART therapy is recommended for people with moderate to severe asthma, including children ages 5 and older. It is considered an easier and patient friendly treatment plan to follow. In this webinar, learn about SMART therapy and other patient friendly asthma management strategies.

Speaker:

  • Angela Hogan, MD

Dr. Hogan is double board certified in allergy and immunology and pediatrics. She practices at the Childrenโ€™s Hospital of the Kingโ€™s Daughter in Virginia. Dr. Hogan is passionate about community education in asthma and food allergies. She feels it is very important to not only get the correct diagnosis for food allergies but also important to understand the impact such a diagnosis has on the child and the family. She formed a regional food allergy support group called FASGOT.com, which helps healthcare providers, schools and families deal with food allergies. She is extensively involved in the education of the school nurses in the seven districts in her area and has organized outreach programs for community physicians. For Dr. Hogan, CHKD really is more than a hospital. It allows her to teach not only families but also future doctors in pediatrics and allergy. It supports her as she tries to work in the community, and it allows her to do clinical research. Dr. Hogan chairs the asthma committee of the American College of Allergy, Asthma, and Immunology.

This Advances webinar is in partnership with the American College of Allergy, Asthma & Immunology. ACAAI offers CMEs for physicians for this webinar. If you are a member of ACAAI, you can obtain CME through the member portal for Advances webinars.

All attendees will be offered a certificate of attendance. No other continuing education credit is provided.


CME is available throughย ACAAI for this webinar.


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Transcript:ย While this transcript is believed to be accurate, errors sometimes occur. It remains your responsibility to evaluate the accuracy and completeness of the information in this transcript. This transcript is not intended to substitute for professional medical advice.

Catherine:ย hello, everyone.ย We are going to get started inย just a minute.ย We are going to give everyone aย chance to get in.ย We have a lot of people tryingย to get in.ย In the meantime, while we wait,ย if you would not mind puttingย where you are calling from inย the chat so I can see where youย are in the world.ย That would be great.ย OK.ย Well, hello, everyone.ย Thank you for joining us today.ย I am the chief health equityย officer for the Allergy andย Asthma Network.ย We are in for a real treatย today with Dr. Angela Hogan asย today’s presenter.ย We have a few housekeepingย items before we start today’sย program.ย First, all participants will beย on mute for the webinar.ย We will record today’s webinarย and post it on our websiteย within a few days.ย You can find all of ourย recorded webinars on ourย website atย allergyasthmanetwork.org.ย Just scroll down to the bottomย of the page to find ourย recorded an upcoming webinarย set in case you would like toย turn in to those.ย This webinar will be about anย hour long, and that it time forย questions.ย We will take those questions atย the end of the webinar, but youย can put your questions in theย Q&A box at any time, and thatย is located at the bottom ofย your screen.ย We will have somebodyย monitoring the chat if you haveย questions or need some help.ย We will get to as manyย questions as we can but weย conclude.ย This webinar is in partnershipย with the American College ofย allergy, asthma, andย immunology.ย It offers CME’s for positionsย and attendance credits for allย others.ย You can create a freeย ACPAII account.ย Attendees will be offered aย certificate of attendance, andย no other continuing educationย will be provided.ย A few days after the webinar,ย you will receive an email withย additional information and aย link to download theย certificate of attendance.ย We will also try to add thatย link into the chat for you, soย let’s get started.ย Today’s topic is smart — isย SMART therapy and other patientย centered approaches towardย asthma management.ย SMART therapy is for patientsย with moderate to severe asthmaย we need a combinationย treatment.ย This combined treatmentย consists of an inhaledย corticosteroid and an inhaledย long acting beta two agonists.ย Under asthma guidelines, SMARTย therapy is recommended forย people with moderate to severeย asthma, including children agesย five and older.ย It is considered an easier andย patient-friendly treatment planย to follow.ย It is my esteemed pleasure toย introduce our speaker, Dr.ย Angela Hogan.ย Dr. Hogan is double boardย certified in allergy immunologyย and pediatrics.ย She practices at the Children’sย Hospital of the king’s daughterย in Virginia.ย Dr. Hogan is passionate aboutย community education in asthmaย and food allergies.ย She feels it is very importantย to not only get the correctย diagnosis for food allergiesย but also important toย understand the impact such as aย diagnosis have on a child andย family.ย She performed a regional foodย allergy support groupย which helps health careย providers, schools, andย families deal with foodย allergies.ย She is extensively involved inย the education of the schoolย nurses in the seven districtsย in her area and has organizedย outreach programs for communityย physicians.ย For Dr. Hogan, CHKD really isย more than just a hospital.ย It allows her to teach not onlyย families but also futureย doctors in pediatrics andย allergies.ย It supports her as she tries toย work in a community and allowsย her to do pinnacle research.ย Dr. Hogan chairs the asthmaย committee of the Americanย College of Asthma andย Immunology.ย I’m going to turn it over toย you now.

Dr. Hogan:ย Thank you all for joining usย this afternoon.ย Our learning objectives — weย will talk mostly about SMART,ย but we will also discuss how toย practically implement theseย into your practice and why thatย is important, and then we willย talk a little bit aboutย focusing on patient-centeredย treatment and how that canย improve the quality of careย that we deliver to ourย families.ย Let’s review first again whatย is asthma.ย It is a chronic disorder.ย It has a couple of mainย components.ย Most important is airwayย inflammation and the second isย bronchial hyperresponsiveness.ย In order to be asthma, we knowย that airway obstruction needsย to be reversible.ย We know that asthma is not justย one disease.ย We talk about it as if it is,ย but there are multipleย different risk factors for theย development of asthma.ย There are differences inย triggers, differences inย symptoms and severity, and evenย responses to therapy.ย One therapy does notย necessarily fit all asthmatics.ย We know what other conditionsย patients may have may alsoย impact their sponsorshipย therapy and the severity ofย their asthma.ย We know asthma is a really bigย deal financially in thisย country.ย It is the most common chronicย disease of childhood.ย In children, we know that aboutย 50% of them have uncontrolledย asthma, and if they haveย uncontrolled asthma, it mayย cost a lot more health careย dollars.ย They over utilize the healthย care system when they areย poorly controlled, and actualย severe asthma in children onlyย makes up about 5% of pediatricย asthmatics, but that accountsย for about 50% of health careย that are spent economically inย this country, asthma costsย about $56 billion, which,ย obviously, has a big impact onย our health care system.ย In terms of speaking brieflyย about asthma and epidemiology,ย we know there are differentย prevalences across theย different populations.ย It does vary by race andย ethnicity, and we know thatย asthma disproportionatelyย affects the black population.ย As you can see from this graphย from the CDC looking at age andย sex and ethnicity, there areย some disparities noted here.

We also know that asthmaย mortality has overall beenย pretty stable.ย We know that about 11 people inย the U.S.ย die each day from asthma.ย We did see when we looked atย asthma mortality trends that weย were on a downward slope, butย in 2020, we saw the first toย rise in asthma deaths, and mostย recent statistics say that thisย trend may be ongoing.ย We also know that adults areย six times more likely than aย child to die from their asthmaย and that, again, there is aย disproportionate effect.ย Black individuals are threeย times more likely to die fromย their asthma than white people.ย We know that the death rate isย the highest among individualsย who are 65 years old or olderย compared to the other ageย groups.ย We know that asthma reallyย impacts utilization.ย There are 750,000 80 visits perย year for asthma, 200 thousandย hospitalizations annually, andย we know currently the mainstayย for ER visit or hospitalizationย is still in bronchial dilatorsย and systemic corticosteroids.ย The biggest place to make anย impact on asthma improvement inย health care is — can we doย that as an outpatient and tryย to keep them from needing to goย to the emergency room and beingย hospitalized?ย What we have found mostย recently is that our thinkingย about asthma is probably allย wrong.ย We have been thinking aboutย asthma as a disease thatย involves predominantly broncoย did not — bronco dilation andย that the airways areย restricted, and we reallyย under-understand the problemย that airway inflammation playsย a huge role in this and thatย asthma morbidity and mortalityย are actually very preventableย when we understand theย importance of addressing airwayย inflammation.ย When we think about whatย resources you could go to toย understand asthma a little bitย better, there are two mainย resources available for mostย people.ย There are the national asthmaย guidelines put out from theย NHLBI.ย The most recent update wasย published in 2020.ย Then there is the internationalย guidelines or initiative thatย people use as a resource calledย the global initiative forย asthma, and they update yearly,ย and the most recent publicationย for 2024 is already publishedย now.ย The global initiative forย asthma , as I said, do notย necessarily consider themselvesย a guideline but more a globalย strategy, and those are gearedย towards PCP’s and focus veryย much on the newestย evidence-based medicine.

The NHLBI guidelines were firstย published way back in, like,ย 1997.ย One of the biggest asthmaย updates was in 2007 where weย used a lot of our resources,ย but in 2020, they did put out aย new updated focus on five orย six different areas of asthmaย that we currently are followingย also.ย How do these guidelines differย from each other?ย They are minor things overall.ย Also when they assess asthmaย severity is different.ย In our national guidelines,ย severity determines the initialย visit.ย So what are the goals of ourย asthma management?ย It depends on a lot of things.ย It depends on what the patientsย are able to understand and alsoย what are their preferences inย terms of how they want toย manage their asthma, but GINAย feels like all patients shouldย have few to no symptoms andย should be able to sleep andย work and play without anyย impairment.ย It would be nice if they couldย maintain normal lung function.ย We would like for them to haveย no flares at all and we wouldย like for whatever medicationsย we pick for them to haveย minimal side effects.ย An overall, whenever possible,ย we would like to avoid neuralย corticosteroids because theyย have such long-term impacts.ย They can be helpful but in theย long run lead to a lot ofย morbidity.ย When we think about our asthmaย management, we need to thinkย about what is the asthmaย phenotype we are treating, howย well a patient can adhere toย what we are asking them to do.ย Are they current smokers?ย We also want to make sure thatย what we pick is cost effectiveย for that family and that it isย available.ย Again, we want to constantlyย review what we put them on,ย reassess how they are doing onย it and adjust those therapies.

The little circle on the bottomย is taken from GINA, and GINAย says every visit we seeย asthmatic patients, we shouldย be reviewing and assessing andย adjusting their asthma care.ย First, let us talk aboutย albuterol or short acting betaย agonist in a very new light.ย Albuterol used only by itselfย can be dangerous.ย If we use a regular shortย acting beta agonist for onlyย one to two weeks a couple ofย times a day, then we actuallyย lead to tolerance in theย airways to responding to thatย short acting beta agonist, andย we see reduced effectivenessย and increased airwayย hyperresponsiveness, so we needย to quit thinking that all weย need to respond for a patientย is albuterol because actually,ย short acting beta agonists haveย been shown to have a lot ofย risks associated withย exacerbation.ย We propagate this responseย because albuterol is anย expensive and does provideย rapid relief, so it — theย family focus is back on theย fact of let me grab that rescueย inhaler, and we always askย those questions — where isย your rescue inhaler?ย How much are you using yourย rescue inhaler?ย We don’t talk about the otherย part which is addressing airwayย inflammation.ย What we know is that we shouldย be thinking and talking a lotย more about inhaledย corticosteroids.ย We know and him corticosteroidsย decreased that airwayย hyperresponsiveness and theย risk for an asthma flare.ย They decrease mortality.ย They decrease the build up inย the air were also which we knowย is important to address when weย think about the best managementย of asthma inflation, and theyย also keep us from remodelingย our airways.ย Inhaled corticosteroids play aย very important role when youย think about asthma.ย Even mild asthma does notย necessarily mean that you areย safe.ย We know individuals who do haveย mild asthma can have a veryย severe asthma attack andย possibly even a fatalย exacerbation.

Part of the problem with asthmaย being mild is everybody thinksย it is mild asthma, so they doย not always think — take theirย medicine the way it isย prescribed and when they startย having symptoms, the inhalerย they reach for is that shortย acting beta agonist, so theyย may be at risk for developingย tolerance to their response toย that.ย Even when we do prescribed andย inhaled corticosteroid forย patients, oftentimes, thatย maintenance medication is onlyย consistently taken about 30% toย 40% of the time.ย In a recent systematic review,ย and found that 24% of hospitalsย — sorry, 24% of exacerbationsย were related to poor adherenceย to their controller therapy andย 60% of hospitalizations wereย because patients were takingย their inhaled corticosteroid.ย There’s strong evidence toย suggest we need a safer way ofย teaching patients to manageย their asthma than just a actingย beta agonist. That’s where weย are going to come in with SMARTย smart –SMART Mart therapy.ย The terms are interchangeable.ย Mart is actually using aย particular type of medicationย that is two in one inhaler’s,ย and it uses an ICS, and it usesย formoterol, and long actingย beta Venus that has the abilityย to act a lot like a shortย acting beta agonist alsoย because it has very rapidย onset.ย Mart is using both of theseย medications today in oneย inhaler, so we are going toย spend a fair amount of timeย reviewing that and talkingย about how we should applyย those.ย For MAEย RT with SMART therapy, you haveย an inhaler and you increase theย use of it when you are sick andย when you are well, we dial itย back down.ย In this particular country,ย there are two preparations thatย are available.ย There is a budesonide forย Motorola had inhaler —ย formoterol inhaler.

Again, it has to be formoterolย or it does not count for allย the studies and things we willย talk about that make SMARTย helpful.ย There’s another product on theย mark that can be used — on theย market that can be used butย should not be used forย maintenance.ย In the 2023 GINA, they sort ofย re-changed our terminology, andย that is where the word MARTย came from.ย The terms I want you to knowย and understand today are first,ย we talk a little bit about air,ย andย AIR is just usingย anti-inflammatory as aย believer.ย You will have this combinationย of products, and they are usedย only when the need, so they areย just rapid relief.ย The thinking is if you areย using a short acting betaย agonist by itself for symptomย relief, something made you needย to use that for symptom relief,ย so when we put the twoย medicines together, and inhaledย steroid will help chase awayย whatever it was that made youย need to use that inhaler, so itย is better to have both the costย and symptoms addressed — theย cause and the symptomsย addressed together in oneย inhaler, and that is what weย are moving towards.ย This particular combination ofย medicines, they can be usedย before exercise, also.ย When we talk about asthmaย therapies, we use them in stepsย one and two.ย MART or SMART uses them forย both maintenance and reliefย therapy.

That is what SMART stands for,ย single maintenance and relieverย therapy.ย Or MART, maintenance relieverย therapy — maintenance andย reliever therapy.ย A couple other terms that theyย also redefine in 2023 is theyย like the word maintenance toย replace the word controller,ย and I also like the wordย reliever to reflect what yourย as needed medication is forย quick relief.ย Now that you know all theย terms, how do they work?ย Let’s first attack asthma inย adolescents and in adults 12ย years of age and older.ย One of the huge points fromย GINA is that they feel like noย patient should ever beย prescribed a short acting betaย agonist alone ever.ย Again, because the short actingย beta agonist gives you reliefย of the symptoms but does notย address whatever the cause was,ย so the feeling is that thereย should always be twoย medications together accordingย to GINA.ย What we know is that thisย particular combination can beย used a couple of differentย ways, and in GINA, theyย proposed certain asthma tracksย on how we look at treatingย asthma.ย This is what the GINA 2024ย guidelines look at, and I wantย to spend a minute to go overย these and understand them.ย There are basically two tracks.ย There’s the top track, which isย track one, and the bottomย track, which is track two.ย Track one is the preferredย track.ย We see there are basically fiveย different steps for asthmaย .ย Current guidelines recommend weย just use an as-needed low-doseย ICS formoterol in mild asthma.ย As it gets a little worse, weย step it up and at maintenanceย and rescue, and a little bitย higher dose in step four.ย In step five, it becomes aย little more difficult to manageย asthma, and we start looking atย additional ad-on medicines andย start considering asthmaย phenotypes that we mightย consider for Biologics, whichย is beyond the scope of theย lecture that we want to talkย about today.ย Again, I want to point outย track one here, which is again,ย using ICS formoterol as bothย the primary reliever medicationย and also as the controller.ย What we know is that thisย particular way is a very goodย way of managing asthma becauseย what we know is that thisย particular way allows you toย step up and step down withoutย having any particular issues.ย You dial up for increasedย symptoms. It avoids confusionย about different inhalerย techniques with differentย devices and that a singleย medication can be used for bothย symptom relief and maintenance,ย so patients are not trying toย jumble or figure out whichย inhaler they should be usingย win.ย They just have one singleย inhaler.ย Sometimes the insuranceย companies, as you know — oneย month they like one particularย inhaler in the next month aย different device.ย Sometimes I have patients whoย will bring in their bag ofย medicine and have three or fourย different things, and each ofย them may have a differentย technique of how they areย supposed to use thoseย medicines, and it can becomeย very confusing, and patientsย can do them improperly, andย then they will not get optimalย asthma control either.ย With this particular method, itย allows them to dial up and dialย down.ย We also know there is a greatย amount of science that showsย that GINA does have goodย evidence-based medicine toย support that this works.ย We know that in steps one andย two, when ICS formoterol isย used alone as rescue, thatย there are more than 10,000ย patients in these long-termย 12-month studies that show thatย this is superior than justย using albuterol alone or evenย using an ICS-plus — ICS plusย albuterol if the ICS is usedย every day.ย We also know that for MART inย steps three to five that thereย are more than 30,000 patientsย in the studies that demonstrateย that not only is this superiorย in terms of effectiveness, butย it is also very safe.ย So we have many studies thatย demonstrate that this is theย preferred method for asthmaย treatment.

So when we look at our nationalย guidelines from 2020, theyย actually adhere to what GINAย recommends in steps three andย four.ย Our guidelines from 2020 areย based on some outdatedย information, and they stillย prefer as needed albuterol forย intermittent asthma, and thenย every time you get an inhaledย steroid or every time you get aย sawbuck, they want you to matchย it with an inhaled steroid inย step two, but you can see inย steps three and four that theyย actually parallel GINA exactly.ย You want to have a littleย science behind this to say whyย it is the preferred way, and Iย have that in the next slide.ย What I want to show you is aย Cochrane database systematicย review from 2021.ย In this particular slide, whatย I am demonstrating for you isย that ICS formoterol whenย compared to albuterol alone isย able to demonstrate a 52%ย reduction in the use of oralย steroids in patients with mildย asthma and ICS-formoterol whenย compared to albuterol alone hasย a 65% reduction in usage of theย emergency department orย hospitalizations.ย Most people think that Cochraneย analysis is a very good way toย demonstrate evidence-basedย medicine.ย If we also look at the Cochraneย review for how doesย ICS-formoterol compared toย people that are on daily ICSย and as hyphenated SABA — andย as-needed SABA, there is aย significant reduction in oralย steroid use and 37% reductionย in emergency room visits andย hospitalizations when the oneย inhaler is used instead of twoย separate inhalers.ย In addition to that, we knowย that GINA doesn’t say sometimesย insurance does not allow you toย use the ICS-formoterol product.ย What they are recommending isย that in step two, perhaps weย consider using an ICS-SABA soย that we don’t have abuse orย overuse of albuterol alone, butย it doesn’t recognize there willย still be some insurance plansย and individuals who will stillย be using other ICS SABA’s andย ICS LABA’s.ย We usually don’t recommendย using two different LABAsย together because there’s noย evidence it is safe.ย In January 23, we had a productย that links an inhaledย corticosteroid to albuterol,ย and the product is available onย the market now, and it isย available for 18 and up, so ifย you had someone thatย traditionally might have justย prescribed albuterol alone for,ย they would say don’t do that.ย You should make it albuterolย and budesonide together in oneย inhaler because that will beย much safer for thoseย individuals.ย This is what it looks likeย together.ย Both tracks are there.ย As you can see again, stepย three and step four talk aboutย MART, and that is what we willย focus on for just a minute.

Again, MART is the same as SMART , and it means maintenance and reliever therapy. The previous slides were for steps one and two and now we move on to steps three and four. Let’s talk just a minute, again, why we think SMART is better, not only because it is simpler, but be because — because we have only one inhaler the patient needs to deal with and there’s good evidence to show putting together one inhaler also reduces the risk for them to use oral corticosteroids and also reduces exacerbations, so there is even some data that shows using ICS-formoterol products actually improves blood eosinophils levels. Dexamethasone was the ICS used with ICS in the study and showed it was effective in reducing the number of a sinner fills — eosinophils in the blood and seem to have an even bigger impact on those patients that had more eosinophils. It is important to note that not only is it helping symptoms, but even at cellular level. When we look at national guidelines, again, by step three and step four, this particular age group, it looks very much like GINA. You can see that again, they talk about using the combination of an ICS formoterol basically as a maintenance medicine and also as a rescue medicine, use a lower dose at stage three and at step four, we increased to a higher dose of that medicine, meaning more puffs, so that we can control their asthma better. So what do you need to tell patients? One of the things you need to tell patients is that this combination product will work just as well as albuterol. Occasionally, patients are so dependent on albuterol and they are anxious to give it up, and they are afraid, what if it does not in fact help me as quickly? But you can reassure patients that it has both the ability to have a rapid onset, and also like long-acting beta agonist, it has the ability to have a long-acting effect also. And the question comes up — what do you do for school? Are we going to send an albuterol inhaler to school and have them have their controller medication at home? It is a combination therapy, and the current recommendations are actually we should be giving the multiple combination ICS formoterol products all in the same month so they can have one to bring to school. In our state of Virginia, we have been able to get state Medicaid to improve three inhalers for our patients per month so they can have one to send to school, one in the soccer bag, and also 14 home because that is what we will need to do. Oftentimes, we will even have patients who go to the emergency room, they are treated there, and then the ER physician or ER provider will want to immediately prescribe them albuterol if they leave. We need to quit confusing the picture and continue to focus on the fact that they need to have combination therapy available in multiple places and that they just need the one medication.

Then, the question always comes up with previous inhalers, and we have always said to brush her teeth right after you take it and rinse and spit and drink something. What we are really finding is that with most of these medications, specifically budesonide and formoterol products, we are seeing very little thrush. Current recommendations are that maybe if you are doing two puffs and it is your maintenance medication for the day, you may want to go ahead and rinse and spit, but if you are doing pretreatment with exercise or doing and as-needed dose, you probably don’t need to rinse and spit. Again, the rich — the risk of thrush is very low. We know it is important for patients to have an active asthma plan. That is not anything new. It has been in our guidelines for lots of years, but as we start to explain to them, it can be a little confusing, so we want to make sure we spell out very clearly what an action plan would entail if they are going into the yellow or red zone. First, let’s talk a little bit about how many puffs we use for each part of it, and then we look a little bit about action plans. When we look at GINA, GINA says if we are using the combination product in step one or two, they probably only need to have probably just one inhaler and one pup should be fun — fine — one puff should be fine. They were to step three, it is the same inhaler and they can take one puff as their maintenance medicine once or twice daily and as a rescue, they would take an additional one puff, and as they moved to step 4, maybe having more significant asthma, again, the same inhaler, but they would take two puffs twice a day and one additional puff as a rescue inhaler. It is a little bit tricky because the way that we looked at asthma inhalers in the U.S. and what is currently FDA approved for these inhalers is not the same way that GINA says we should be using it. Puff the Magic Dragon on this slide basically says a rescue puff is all that would be needed, but most of are MDI’s in this — most of our MDI’s in this country, when you look at their wording, it says it is not approved for rescue, and it also says that most of those inhalers should be given with two puffs.

That is kind of based on old information. Some of our early NDI — NDI — M DIs but like the medicine was not going all the way through the inhaler, so they would do two puffs to push it through. We found that one puff can effectively get all the way through the device and be delivered effectively. As stated, GINA says we really only need one inhalation for symptom relief and if we are not seeing significant improvement after a few minutes, we could do a second puff. The other thing again that GINA says his other ICS-formoterol products available have not really been studied as well internationally and in most of the trials, so when we talk about it in this country, the only combination therapy that has been studied well and is available on the market is the budesonide formoterol product. There is also the mom met his own — then that his own product available in this country. In Europe, there is a Beckley Methodism — beclamedisone product, but that is not available in the U.S.. What strength are you going to try for a patient and how many puffs are you going to give them, both for maintenance and rescue. Let’s walk through this table for a moment. If you have a patient over 12, current recommendations from GINA are you should prescribe the 160/4.5. They would take one puff as needed for exercise or for reliever. If they are going to be on SMART or MART, depending on severity, they would start with one puff once a day or twice a day, in step three with one puff as a believer and if they had more significant disease, they would get two inhalations twice a day with one puff to rescue. I want to note for you that the maximum daily number of puffs in someone over 12 should be getting his 12. That’s how I always remember, 12 for 12. Beyond that, it is not recommended to go beyond that. If you have an asthmatic that is younger than that, we know six to 11 you will groups, if we were using this particular therapy, we would want 80 per 4.5 budesonide formoterol.

Currently, there is no evidence, although there are ongoing studies, there is not enough evidence for GINA to recommend air therapy in patients six to 11, but they do endorse MART therapy at steps three and four, and the appropriate way to begin in step 3, 1 inhalation once daily with one rescue puff, and in step 4, 1 inhalation twice daily with one inhalation as a rescue. You can see the number of total puffs in this particular age group is eight. I have gone ahead and put on this table for you if you were going to use them that his own formoterol, which is a product available in this country and want the — what the standard dosing would be for SMART or MART if that is the inhaler the insurance company wants to pay for. Let’s talk about asthma in six to 11-year-olds. There are some things that again are a little bit different. As I mentioned, we do not have air therapy improved, but if they had to use a SABA, you would want to match that with an inhaled corticosteroid, and you can see at step three and four, we then can begin using more as we mentioned in the previous table. You can see here when it is all put together in the GINA 2020 for schematic for six to 11-year-olds, I, prior to that, SABA would be used for step one and two and in three and four, we would make it a combination product. The dosing, as I mentioned, is very simple. Again, we do not want to use ICS formoterol with other ICS LABA ‘s. This is what it looks like in our NHLBI guidelines. In terms of matching GINA in steps three and 4. And then, bringing to you that I just mentioned about the Mometasone. Let’s spend a few minutes talking about what we can do to have patient-centered asthma care. One of the most important things we need to do is have shared decision-making. When I am meeting with my families, I talk about for them what they use in the past and how it is working. We spent a lot of time talking about our new understanding that if we use albuterol excessively that that can be dangerous, and I have tried to mention how we dose their ICS-formoterol combination once a day, easier in the morning or at night, and make sure we have the appropriate inhalers available at school, so we discussed the pros and cons of different treatment options, because I think it is important we give them a say in what they’re looking for. I think it is important to have personalized asthma action plans. It is very important that patients know what to do on an everyday basis and also what to do when things are not going well. Here is an example of an asthma action plan that is available on the Allergy and Asthma Network. You can see SMART is incorporated in that. We would tell patients how many puffs to take when, how many would be their rescue, remembering again it is 12 above 12, and under 12, it would be eight, and then there’s also a certain number of puffs when they are in the red zone. In this particular example, if they are in the red zone, they would take one puff of an S&L formoterol product. Weight one to three minutes. If they are no better, they can take an additional one 23 puffs. This is what our action plan looks like in the state of Virginia. This is an example. It again incorporates both the ability to use SMART and also more traditional asthma combination medications.

This is the asthma action plan from NHLBI, so I recommend you get an action plan that fits your community, that can easily be utilized, and I think it is very important. In our particular pediatric asthma plan, we wanted one that could populate our EMR so it could stay there and parents could go on the portal and pull off the action plan and use it at the YMCA or somewhere else. I think it made it very helpful for patients to be able to have their action plans. I think it is also important, as we mentioned, from the little circular things at the top of the screen. I think each time we see an asthma patient in follow-up, we need to see what is working and what is not. We need to try to teach them again the importance of their inhalers and encourage self-monitoring of symptoms. There are lots of apps that are available that patients can go in and rate their asthma for the day. I have ACT scores built in the apps. Some cactuses that are very savvy with electronics, they even have those communicate back with their provider. I think it is important that we utilize all the people in our facilities to help provide patient care. It may be that we need to have a team approach. I think it is important that specialists are talking to primary care so everybody is on the same page. As we involve the emergency room, people also need to understand what SMART is and how that works, and I think things like clinically integrated networks can be helpful also. Everybody is helping to provide the vision and understanding of asthma management. In addition to that, I think it is important to have regular follow-ups. Some individuals have difficulty managing asthma and should probably be seen at least every three months, and it is good to see them when they are well just as it is to see them when they are not well. Again, I’m amazed every time I try to review asthma techniques. People can forget how to use their spacer, and we have to review that over and over again. And also, telemedicine, for those of you that have the ability to use that, can be very helpful in establishing a routine care and follow-up. We just checking in and seeing how you’re doing with your asthma. I also find being able to subtract how often they refill their medications is helpful and also lets me tell them how — tell them I know how often they are refilling their medications. It is an opportunity for me to stress to them the importance of refills on medications. I think it is important when we see patients that we also addressed health care disparities. It is difficult to want to manage asthma from my seat if when they go home they are having difficulties getting transportation or they do not feel safe or potentially do not feel supported by their family in terms of the adjustments that need to be made for families with chronic illness. We want to provide things that build independence, so patients see we want to address asthma disparities as they occur across the health care system, and I think it is important that we think about medication costs. It is difficult to say go get this wonderful new asthma medication and I want you to have three of these inhalers, one for every word though, and the cost of those inhalers is prohibitive. We also need to make sure the action plan we use and the information we communicate to the families is understandable to everyone, including the kids need to understand a little bit about the importance of their asthma medications if they are old enough to understand that. I think having resources at each point of care can help address — that can help some of these barriers is important. There was good news that came out on June 1. At least three different pharmaceutical companies place a price cap on several of their brands of asthma inhalers.

They are to be no more than $35, so what I found in my particular area is that I have been able to print a coupon for certain brands to hand to the families to give to the pharmacies or in the state of Virginia, as I mentioned, we have been very fortunate, and Medicaid have embraced that inhalers are important and are covering them. Additionally, sometimes I will tell them that they should — if the insurance says it’s going to be $60 or $160, I tell them to have the pharmacy just take the insurance out and run their prescription through as if they had no insurance, and what I’m finding then is it is popping up at $35, so I think this price cap from these pharmaceutical companies will have a very good impact on patients’ accessibility to be able to get these inhalers, so I think that there are many, many hurdles we still have to overcome. There are still a lot of people really hung up on the fact that here we are advocating this is the way to treat asthma, and the FDA has not approved that these inhalers can be used as a rescue inhaler, but I think that if it comes, it will come in due time and that we need to follow where the evidence or science is. We have two great asthma documents that say this is how we should be managing asthma. This is how we provide safe asthma care for patients. We need to throw out our old view that asthma is just a disease of bronco restriction, and we need to make these available and we need to focus on health care system integration, and we need everyone to understand, and I think that somewhere I read recently that any time new guidelines are written, that it can take up to 12 years before new guidelines in any chronic disease actually take hold and that everyone learns about it and is able to implement those for patient care. What I’m hoping is that we don’t take 12 years to be able to implement our new understanding of asthma, that it is really important that we prevent disease, prevent exacerbations, and make one inhaler available for most patients in step three and step four that makes it easier for them to manage their asthma. I think that is all I want to say other than here are some additional resources from the Academy of allergies, the College of allergy, the allergy and asthma network, and the asthma and allergy foundation of America. They all have great websites with lots of information about SMART.

Catherine:ย Dr. Hogan, thank you so much.ย That was a lot of greatย information.ย We need more time.ย I wish you could see all theย questions.ย We have a lot of questions inย the Q&A but also in the chat.ย I’m going to do my best toย summarize everything so we canย answer everybody’s question.ย There were a lot of questions,ย as you can probably imagine,ย about the insurance issue,ย about insurance not beingย familiar with GINA, and becauseย of that, they are not able toย process the prescription.ย Someone was saying they areย having a difficult time withย insurance coverage for ICS forย Motorola inhalers and thatย insurance companies often willย not cover these inhalers.ย A lot of the patients areย unable to afford theย out-of-pocket cost .ย Basically, this is what I haveย been hearing throughout theย webinar with all the questions,ย do you have any suggestions onย how to educate insuranceย companies regarding guidelines,ย SMART/MART and changing theย coverage.>> yes, I do.ย First of all, if you are aย member of a college or haveย access to the ACAAI website,ย there is a letter that wasย recently written that helps theย get authorization.ย It is a multifaceted level withย good evidence-based medicine,ย and you could adapt that toย your individual patient andย argue why this particularย medication could be or shouldย be covered.ย I think that there are manyย people working across theย country to try and overcomeย obstacles.ย I know in our particular area,ย I have recently written aย five-page letter to some of ourย insurance providers discussingย why this is the superior way.ย I think things are going to getย better, but on a practicalย note, I so far — knock on woodย — have been able to tell myย families again because of thisย recent price cap, to tell theย pharmacy to take theirย insurance completely out andย run it through as if they hadย no insurance, and so far, fromย what I have heard, andย hopefully, I’m still right,ย then it is $35 because of theย price cap, so that may enableย them to at least get oneย inhaler for $35.

Catherine:ย OK, there was another commentย and question.ย At a recent conference, we wereย informed that the shelf life ofย an inhaler decreasedย drastically once and inhalersย open, that the expiration dateย on the box is the date ofย expiration if the inhaler hasย not been used.ย How do we assist families ifย they need inhalers for schoolย or home every 30 to 90 days dueย to shelf life?>> I’m not sure that the shelfย life is the same for all ofย those inhalers.ย I think it depends on what theย preparation is.ย Certainly for dry powderedย inhalers, we know that theย moisture can get into those,ย and they may have a shorterย half-life.ย In NDI has a longer shelf life,ย as clearly evidenced on theย box, so I’m not sure thatย applies universally across allย inhalers.>> OK, there’s a question aboutย ICS and Perry oriole dermatitisย for patients with asthma fiveย to six years old.ย How do you successfully manageย someone’s asthma when that herย face is constantly battlingย this rash on their face?>> we do see that less with theย budesonide for Motorola —ย budesonide formoterol.ย Also, you see less thrush.ย That is what my experience hasย been.ย I make sure the spacer isย clean.ย It is usually patients thatย have a mask spacer.ย If it is someone I can switchย to ML these spacer, thatย sometimes will overcome it.ย We know that topical steroidย creams do not make that anyย better, so don’t apply topicalย steroid creams. Sometimes youย can use — a little canย sometimes be helpful.ย Sometimes we will use MetroGel.ย That can also help with theย Perry oral dermatitis.

Catherine:ย There was a question — are youย currently writing prescriptionsย S two puffs per day?

Dr. Hogan:ย Actually, especially if theyย are an AIR patient, I write itย as two puffs twice a dayย because that is what theย description says, and then Iย tell them to use their actionย plan.ย We all are hopeful.ย We cannot wait until the systemย changes.ย We have to do our work aroundย that we need to do because thisย is too important to wait untilย the FDA decides, oh, yeah, Iย think it is a good idea.ย So, yes, I’m not quite sayingย on the prescription what I amย actually having them do in realย life.

Catherine:ย OK.ย Let’s see here.ย Are there equity studies on whoย is being prescribed SMARTย versus just albuterol so we canย learn more about access and howย we can improve it?

Dr. Hogan:ย I’m sure there are.ย I am probably not able toย answer that at this moment, butย the current thinking is, again,ย this particular way of treatingย asthma, because it is so muchย more accessible across a largeย population, could potentially,ย especially if you don’t need toย have an inhaler every day, thatย you can dial up when you areย having symptoms for AIR or whenย you are having mild, persistentย asthma, the number of puffs youย need on a daily basis is muchย less than what is contained inย the inhaler, and we probablyย will be able to level — or notย level, but at least decreasedย some health care disparities atย least in terms of access toย quantity of medication.

Catherine:ย OK.ย I am sorry.ย We’re at the top of the hourย now.ย There were a lot of questionsย we did not get to, and we areย sorry for that.ย Thank you so much.ย This has been reallyย informative.ย We have two webinars coming upย in August. First, we willย welcome back Dr. David stuckย us.ย He will talk about childhoodย asthma and how to teachย children to use inhalersย properly.ย On August 27 at 12:00 p.m.ย Eastern, we will welcome Dr.ย and Maitland to discussย seasonal allergies andย optimizing treatment for eachย patient.ย You will receive an email fromย Zoom in a few days with a linkย to the recording and anย evaluation.ย That is really important toย give us feedback, and someย additional resources.ย Again, thank you so much, fromย all of us here at the allergyย and asthma network.ย Join us as we work every day toย breathe better together.ย Have a good evening, everyone,ย and we will see you at the nextย webinar.