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Service Overview1United Allergy Services -- Confidential and Proprietary
AgendaAllergy Economic ImpactTreatment OptionsImmunotherapy (IT)Patient IdentificationAbout UASWhat We DoSafety, Efficacy and Protocols Certified Clinical Allergy Specialist (CAS) QualificationsTeam ApproachProvider and Patient Survey Results2
Allergy EpidemicMore than 50 million Americans suffer from allergies.Allergies are the 5th leading chronic disease in the U.S. among all ages.A recent nationwide survey found that approximately 55% of all U.S. citizens test positive for one or more allergens.4Source: 6, 7, 8, 16
Asthma & Allergies strike 1 out of 5 AmericansCombined with asthma, it is the most prevalent chronic disease, ranking higher than cancer, diabetes and heart disease.5Source: 8Leading Diseases in the U.S.
Economic Impact of AllergiesThe costs associated with allergic disease are extraordinarily high:One analysis estimated it at $7.9 billion per year, of which $4.5 billion was spent on direct care and $3.4 billion on indirect costs, related primarily to lost work productivity.6Source: 15
Shortage of AllergistsThe number of full-time equivalent (FTE) allergists/immunologists is projected to decline about 7% from 3,660 in 2006 to 3,400 in 2020.Demand for these physicians is projected to increase by 35% over the same period (to more than 5,550 in 2020).7Source: 9
Treatment OptionsAvoidance or Environmental ControlPharmacotherapyImmunotherapy9Source: 6, 7, 8, 16UAS in the News6 Tips for Exercising Through Allergy SeasonMSN Fitbie, April 30, 2012“Generally, pollen counts peak in the morning between 6 a.m. and 10 a.m.,” says Frederick M. Schaffer, M.D., chief medical officer of United Allergy Services. “Unless you can get yourself in the habit of rising with the sun, consider moving your run to lunchtime or immediately after work.”
Pharmacotherapy36 states have laws prohibiting driving while under the influence of OTC and prescription antihistamines. People are 50% more likely to have a work-related accident when using non-prescription sedating antihistamines.A study in the American Journal of Managed Care reports that workers are 25% less productive for two weeks each year if they use sedating drugs to manage allergy symptoms.10Source: 9
Pharmacotherapy, cont.According to the FAA Pilot Handbook, “Medications such as antihistamines may impair critical functions. Any medication that depresses the nervous system, such as an antihistamine, can make a pilot more susceptible to hypoxia.” The handbook states that “14 CFR (Code of Federal Regulations) prohibits pilots from performing crewmember duties while using any medication that affects the body in any way contrary to safety.”11Source: 11
ImmunotherapyProven Benefits of ImmunotherapyIT is the only known disease-modifying treatment for allergies.Many people also benefit from being able to reduce the use of allergy medications and an improved quality of life.IT may prevent the development of asthma in people with hay fever and may prevent the development of new allergies in people who already have one kind of allergy.12Source: 2, 12, 13, 14of complete immunotherapy treatment,most patients experience little or noallergy symptoms.3-5 yearsof people treated with immunotherapy for hay fever may achieve symptom relief within the first year of starting immunotherapy.85%
Immunotherapy leads to lower total healthcare cost13Source: 19Patients who were administered SCITPatients who were not administered SCITOver an 18-month periodTotal cost savings per patient on SCIT41%
Patient identification 14
Who is appropriate for IT?15
Are those symptoms really allergies?Without testing, how are a patient’s allergies confirmed as the cause of the symptoms?Allergic rhinitis vs. non-allergic rhinitis – same symptoms, different treatment.Physicians don’t prescribe insulin or blood pressure medications without testing.16
Children and ITSTUDYIn a long-term study that evaluated 147 allergic pediatric patients, specific immunotherapy in children with allergic rhino conjunctivitis demonstrated long-term clinical effects, as well as preventative effect for development of asthma.Studies of children receiving allergen immunotherapy have demonstrated:Improvement in symptom control for asthma and allergic rhinitis.Decrease in the risk of asthma.Decrease in the development of new sensitivities.Modification in the release of mediators in children receiving immunotherapy that correlates with decreased clinical symptoms.Reduction in pharmacy, outpatient and total healthcare costs.17Source: 1
About United Allergy Services18
What We DoUAS works incident to the physician to assist in their practice with Advanced Allergy services.Under the direct supervision of the primary care physician, UAS tests, analyzes, and performs dilutions.The physicians utilize the UAS proprietary protocol to provide a customized treatment program with the best individual patient treatment outcome.UAS protocols focus on patient safety, outcomes and compliance.19
Primary Care Safety - Studies 20Are Primary Care Offices Equipped To Handle Allergy Immunotherapy-Related Adverse Events? Source: 5
Primary Care Safety - Studies21The Study Demonstrated:“Allergy assessment in a primary care setting is equivalent to that of certified allergists.” Is structured allergy history sufficient when assessing patients with asthma and rhinitis in general practice?Source: 21
UAS ProtocolsUAS protocols have been developed and are continuously evaluated by the Chief Medical Officer Frederick M. Schaffer, M.D., a board-certified allergist.The protocols are also overseen and evaluated by the UAS Medical & Scientific Advisory Board, which is comprised of:Three board-certified allergistsTwo primary care physicians who serve as medical advisorsTwo academic doctors from the largest antigen suppliers in the country, Greer Labs and Jubliant HollisterStier, who serve as scientific advisorsA member and protocol committee participant for AAAAI22
Premise for UAS Safe IT ProtocolA slow IT Build-up phase was designed to minimize SARs. Patients are taught safe IT administration, then tested, and are required to have an EpiPen® available.Patients are directed to self-administer IT only in the presence of an “IT-partner” who is knowledgeable in the use of an EpiPen®.Only one set of IT vials are dispensed per month which minimizes the chance of SARs due to the administration of a wrong dose.23
Immunotherapy Build Up Phase24Source: 2
UAS Safety Results30,000 patients being treated equaling nine million injections with no fatal anaphylaxis.23,614 patients undergoing home-based SCIT, which yielded an annual SR rate of 0.18%.No grade V anaphylactic reactions or deaths occurred in more than two million injections administered.25Source: 17,18UAS Systemic Reaction Rate for home IT is 0.18% compared to the Allergist rate of 4-7%
UAS EfficacyThe UAS immunotherapy model has shown:Significant improvement in clinical scores – 95% of patients reported improvement in allergic rhinitis scores82% of the subjects reported improvement in medication scores (i.e. diminished antihistamine, ophthalmic antihistamines & nasal steroid use) after IT.88% of the subjects reported improved Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores after IT26of patients reported a significantimprovement in allergic rhinitis95%of patients reported a decrease inmedication use82%Source: 17,18
Home-based IT has been proven to be safeSTUDIES“Home and office injections had similar rates of total systemic reactions, but home-based immunotherapy had far fewer major reactions. Home-based immunotherapy was found to be safe.”“Home immunotherapy at effective doses, as given by an experienced practice, is not more hazardous than immunotherapy in mixed medically supervised settings.” The study compared the home immunotherapy safety experience at a physician practice with primarily medically supervised settings. The practice documented zero fatalities in more than 2 million doses, thus the fatality risk was estimated at one death/2.9 million doses vs. the AAAAI estimate of one death/2.5 million doses in primarily medically supervised settings.27Source: 3,4
UAS Continuing Service28
Team of dedicated clinical and business professionalsOperations – every practice has a dedicated Account Manager who oversees the daily operations of the Allergy Center and is the main point-of-contact. In addition, the Operations Implementation Team is on site during the first week of allergy services to ensure a successful startup of the service line.Quality Assurance – at least once a year, a highly trained QA professional assesses every detail of the Allergy Center to ensure the highest standards of care and protocols are being met. A comprehensive medical records review process ensures providers document for services and assists in the records review.29
Team, cont.Compliance – reviews payor guidelines, including state and federal regulations to ensure compliance.Reimbursement – every practice has a dedicated Reimbursement Specialist who is available to answer questions, provide feedback and will work directly with insurance carriers to follow up on issues, denials and outstanding claims.Clinical Training – besides overseeing the development of the CAS, the Clinical Training Department has a dedicated team to provide education and ongoing learning tools to the providers and practices on allergies and the UAS Allergy Center.30
Team, cont.Marketing – every practice has a dedicated Marketing Coordinator who will develop marketing tools to suit individual practice needs including direct mail to current patients and community, advertising, patient education and more.Chief Medical Officer and Scientific & Medical Advisory Board – access to the thought leaders who review and update UAS protocols based on evidence-based medicine.31
Physician Education32Our 3 phase Clinic Implementation program educates not only the physicians but also office staff on key elements of allergy diagnostics & allergen-immunotherapy with emphasis on Patient SafetyWe inform our provider-customers of CME programs that specifically pertain to immunotherapy, allergy & asthmaWe offer on going allergy related seminars throughout the year, in-Services, and refresher lunch and learns as needed from Account Managers and a member and protocol committee participant for AAAAIPhysicians have exposure to countless hours of specific Allergy CME at major medical conferences like AAFPWe provide monthly Allergy based phone conferences that are clinically and patient oriented with the CMOWe are developing webinars directed to the physicians that review topics of Allergy & AsthmaWe are developing a literature review club that will cover salient journal articles relevant to the fields of Allergy, Immunotherapy, and AsthmaUAS augments the basic Allergy/Immunology training that physicians experience in medical school & during residency
The practice has access to extensive marketing resources to reach current and prospective patients.UAS educates the patient on the entire process from testing and treatment, to cost, benefits, compliance and safety.Patient Education33
Certified Clinical Allergy Specialist (CAS) QualificationsThrough the guidance of the University of the Incarnate Word (UIW) and UAS CMO Frederick M. Schaffer, M.D., UAS has built the only national certification in the allergy testing and immunotherapy industry. UAS partnered with UIW through their credentialing department to verify recruiting and training methods to ensure they meet the highest standards of training. UIW is an accredited university, nationally recognized for their healthcare degree programs and certifications. CAS staff must have a four-year degree from an accredited university with an emphasis in biosciences or have a nursing degree and be licensed.CAS staff complete 125 hours of training:45 hours of classroom training resulting inUSP 797 qualification40 hours of implementation training40 hours of additional training that includes shadowing, OSHA training and corporate sessions34
Provider Survey Results90% would recommend UAS to colleagues. The remaining 10% neither agreed nor disagreed with the statement.100% believed the Certified Clinical Allergy Specialist (CAS) in their practice was knowledgeable of allergy testing and immunotherapy.99% believed the CAS in their practice interacted well with patients and with clinic personnel.98% believed allergy testing and immunotherapy services are an integral part of the practice’s patient services.35of providers would recommendUAS to colleagues.90%of providers believed allergy testing andimmunotherapy services are an integralpart of the patient services.98%Surveys conducted by a third party.
36“The allergy service line has integrated well into my practice and has given me the ability to treat my patients for seasonal allergies without having to refer to a specialist.”– Martin G. McElya, D.O., Dallas, TX“The United Allergy Services staff is extremely efficient and reliable and I have a high level of comfort and trust in their standard operating procedures, compliance and quality initiatives. The CAS is very knowledgeable and interacts well with patients to ensure they understand every step of the process.”– David Hassman, D.O., Advocare Berlin Medical Associates, Berlin, NJUAS in the NewsUnited Allergy gets big booster shot from private‐equity firm Serent CapitalSan Antonio Business JournalApril 27, 2012United Allergy gets big booster shot from private‐equity firm Serent Capital, San Antonio Business Journal, April 27, 2012“From our side, there is a massive, under-served market,” says Serent Capital founding partner David Kennedy about the growing population affected by allergies. Serent Capital’s principals have extensive experience in the healthcare and financial arenas. UAS President and CEO Nick Hollis says Serent Capital’s leadership will work with UAS to draft a game plan to grow the company. That plan will include contracting with more physicians in more states.Serent Capital investors include Harvard Endowment Fund and Rockefeller Fund.
Patient Survey Results86% would recommend allergy testing and immunotherapy to their friends and family.82% feel comfortable administering immunotherapy injections.95% reported a significant improvement in allergic rhinitis.82% reported improvement in medication scores (i. e. diminished antihistamine, ophthalmic antihistamines and nasal steroid use) after IT.82% reported a decrease in medication use.88% reported improved Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scores after IT.37Surveys conducted by a third party.
38“My physician recommended the allergy testing because I’ve had many sinus infections, earaches and general tirednessbecause of airborne allergies. I am excited to be able to treat these symptoms through immunotherapy, as opposed to all the years I’ve taken OTC allergy medicine, which makes me feel tired and drowsy.”– Patient in Fort Worth, TX“Years ago, I had allergy shots, but found it very inconvenient because I had to go to the doctor’s office weekly. Being able to administer the shots at home is much more convenient and easier to keep up with.”– Patient in Arlington, TXUAS in the NewsAllergy Treatment Nothing to Sneeze atMedical EconomicsAugust 25, 2011“It’s interesting to me that many physicians treat the symptoms without knowing what specific allergies a patient has. Testing allows us to determine the allergens that cause the problem and to monitor the effectiveness of treatment just like we do for diabetes or other diseases.” Bernice Gonzalez, M.D., Vital Life Wellness CenterUAS in the NewsNothing to Sneeze AtEbony magazineOctober 2011Allergy shots (or allergen immunotherapy) offer the only permanent (allergy) relief, yet only one of fewer than 2,800 allergists nationwide could administer the shot – until now. Thanks to United Allergy Services, primary care physicians can safely offer testing and shots in their offices.
39“I have tried every medication and was to the point where nothing seemed to work when testing was suggested. I was excited to learn my insurance paid the full cost of testing and treatment.”– Patient in Saint Joseph, MO“I have not suffered from an allergy attack in morethan a year. Since beginning immunotherapy, I’ve been able to play with my dogs and not suffer any adverse effects. It has freed me from the confines of my home and the need for medications. It has changed my life!”– Patient in Oklahoma City, OK“My son developed asthma (aggravated, if not caused, by allergies) at two-and-a-half years old after we moved to San Antonio, TX. After receiving injections for his allergies, he is no longer on inhalers, except during extremely high pollen or poor air quality days and only needs antihistamines on occasion. My son is so happy and I no longer have to watch him constantly suffer.”– Mother of a pediatric patient in San Antonio, TXUnited Allergy Services Helping Patients Find ReliefSan Antonio Business JournalJuly 1, 2011Dr. Bernice Gonzalez, a physician with the Vital Life Wellness Center at 2520 Broadway, has used United Allergy Services for two years and says it has been beneficial for both her practice and her patients.“Here in San Antonio, we have some of the worst allergy problems in the United States,” she says. “(UAS) provides us with a high quality service and excellent safety protocols. It has been very popular with our patients.”Gonzalez says she has had excellent feedback from her patients who say the allergy treatments have allowed them to be more active, with fewer trips to the ER and less missed time at work.UAS in the News
UAS By The NumbersWe are a national organization headquartered in San Antonio, expanding our services in: 30+ states1,900+ practitioners4.8+ million allergy tests85,000+ patients.19.4+ million allergen doses83% of treatment doses at home.40
2012 Impressions: 45,354,260UAS in the News
Partnering with United Allergy Services43
UAS Operating ModelUAS hires a Certified Clinical Allergy Specialist (CAS) who tests, analyzes, performs dilutions and educates patients on the therapy and results (with support of attending physician). UAS provides all office equipment and supplies, testing and therapy supplies and necessary education materials.All services are provided at no out-of-pocket or start up investments to the practice.Your practice provides:150-300 square foot area to test and educate patients away from flow of current practice.Designated refrigerator to store raw antigens and patient finished product.Formulation area.44
Allergy TestingCAS uses “Scratch Testing” for best overall results.Scratch Testing creates a microscopic puncture through the skin introducing a small amount of allergen extract to create a reaction that is compared to our control puncture.Advantages of this testing are:Most reliable method available.Results in 15-20 minutes. Physician/CAS can visually gauge severities and show patients actual responses.No need for expensive equipment or outsourcing.45
Financial AspectThe practice completes the billing procedures as normal.All collections are paid directly to the practice and UAS will invoice the practice for contracted service fees.Your practice can recognize a new profit stream equating to approximately $700-$1,200 per patient who elects immunotherapy (dependent on payor source).46
Assumption Projection Model Results47
Sources1. Specific Immunotherapy has long-term preventive effect on seasonal and perennialasthma: 10-year follow-up on the PAT study. L. Jacobsen, B. Niggemann, S. Dreborg,H.A. Ferdousi, S. Halken, A. Host, A. Koivikko, L.A. Norberg, E. Vaklovirta, U. Wahn, C. Moller.20072. Allergen immunotherapy: A practice parameter third update. Linda Cox, M.D., HaroldNeson, M.D. and Richard Lockey, M.D. American Academy of Allergy, Asthma & Immunology.September 23, 2010.3. Safety of Home Immunotherapy. W.V. Filley, C.E. Aston, R.E. Coifman, J.R. Claflin, D.L.Kough,P.J. Mills. Journal of Allergy and Clinical Immunology. Volume 117, Number 2.4. Safety of home-based and office allergy immunotherapy: a multicenter prospectivestudy. David S. Hurst, M.D., Bruce R. Gordon, M.D., John A. Fornadley, M.D. and Darrell H.Hunsaker, M.D.American Academy of Otolaryngology-Head and Neck Surgery Foundation,Inc. 1999.5. Are Primary Care Offices Equipped To Handle Allergy Immunotherapy Related AdverseEvents? Lunn, Leuenberger, Houser and Tracy. Penn State University Hershey MedicalCenter. Journal of Allergy and Clinical Immunology. Volume 127, Number 26. “Chronic Conditions; A Challenge for the 21st Century”. National Academy on an AgingSociety, 2000.7. Arbes SJ et al. “Prevalences of positive skin test responses to 10 common allergens in theUS population: Results from the Third National Health and Nutrition Examination Survey.” JAllergy Clin Immunol. 2005; 116:377-383.8. Asthma Allergy Foundation of America9. Allergist Report. American College of Allergy, Asthma and Immunology. 200710. Uncovering the hidden costs of allergies - includes list of allergies/asthma resources.Leighton Collis, Karen Pellegrini. 199711. FAA Pilot Handbook. Chapter 16 Aeromedical Factors.4812. American College of Allergy, Asthma and Immunology. Allergy treatment. Availableat: http://acaai.org/allergist/allergies/Treatment/Pages/default.aspx. AccessedFebruary 1, 2011.13. National Institute of Allergy and Infectious Disease. Airborne allergens. Something inthe air. NIH Publication No. 03-7045. Available at: http://www.niaid.nih.gov/topics/allergicdiseases/documents/airborne_allergens.pdf. Accessed February 1, 2011.14. Möller C, Dreborg S, Ferdousi HA, et al. Pollen immunotherapy reduces the development of asthma in children with seasonal rhinoconjunctivitis (the PAT-Study). J Allergy Clin Immunol. 2002;109:251-256.15. Stempel DA. The health and economic impact of rhinitis. A roundtable discussion. AmJ Manag Care. 1997;3:S8-S18.16. Gergen, P.J., Turkeltaub, P.C., Kaovar, M.G.: The Prevalence of Allergic Skin Reactivity to Eight Common Allergens in the US Population: Results from the Second National Health and Nutrition Examination Survey; J. Allergy Clinical Immunol.: 800:669-79, 198717. Frederick M. Schaffer, M.D., Lisa Welchel, FNPc, Hope Soliz, Tim Crimmins, Myla Ebeling, PhD, Tom Hulsey, PhD, Larry Garner, CPT, BA, . “The Safety of Home Immunotherapy Utilizing the United Allergy Services Protocol. Manuscript in preparation. (2012)18. Larry Garner, CPT, BA, Lisa Welchel, FNP, Matt Ryall, Myla Ebeling, PhD, Tom Hulsey, PhD, Frederick M. Schaffer, M.D., “The Safety & Efficacy of the United Allergy Services Immunotherapy Protocol. Submitted. (2012)19. Allergen immunotherapy practice in the United States: guidelines, measures, andoutcomes. Linda Cox, MD*; Robert E. Esch, PhD†; Mark Corbett, MD; Cheryl Hankin,PhD; Michael Nelson, MD, PhD; Greg Plunkett, PhD. Ann Allergy Asthma Immunol.2011;107:289 –30020. Journal of Allergy and Clinical Immunology. 123(3):646-50, 200921. Smith HE, Hogger C, Lallemant, C, et al. Is structured allergy history sufficient when assessing patients with asthma and rhinitis in general practice? J Allergy Clin Immunol. 123(3):646-50, 2009.