Subcutaneous Immunotherapy: Is it Worth a Shot? Cost-effectiveness of Allergen Immunotherapy

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  • Much more needs to be done to identify, understand, collaborate, learn from, and educate stakeholders and decision-makersIdentify constituentsUnderstand gaps that will compellingly support intended value propositions for each constituentCollaborate so that outcomes of efforts are meaningfulLearn!!!Then educate… The role of SIT as “Preventive Care” may be key Poor adherence (even the face of extraordinary efficacy) always = failure
  • Much more needs to be done to identify, understand, collaborate, learn from, and educate stakeholders and decision-makersIdentify constituentsUnderstand gaps that will compellingly support intended value propositions for each constituentCollaborate so that outcomes of efforts are meaningfulLearn!!!Then educate… The role of SIT as “Preventive Care” may be key Poor adherence (even the face of extraordinary efficacy) always = failure
  • Estimates based on the Household Component of the Medical Expenditure Panel Survey (MEPS-HC) on the use of and expenditures for ambulatory care and prescribed medications to treat allergic rhinitis among the U.S. civilian noninstitutionalized population. Average annual estimates (in 2005 dollars) for the years 2000 and 2005 are shown by type of service and source of payment. All differences between estimates noted in the text are statistically significant at the 0.05 level or better. Total and average reported mean health care expenditures on allergic rhinitis, by ageA total of $6.1 billion (in 2005 dollars) was spent on health care and treatment of allergic rhinitis in 2000 (excluding over-the-counter medications). By 2005, total expenditures to treat allergic rhinitis almost doubled to $11.2 billion (figure 2). CPI-adjusted to 2010. In a grpwing market you don’t think about it so much, because your boat is rising too Might be losing share and don’t know it. Accorind to this your share is flat or declinig. The overall growth of the market is masking that you’re not penetrating this market. Should be 165% not 80% If better and save $, why not a [preferred tx.
  • Number of reported cases for allergic rhinitis, by sexIn 2005, 7.3 percent of the U.S. population or 22 million persons reported experiencing related symptoms, visiting a physician, or obtaining a prescription drug to treat allergic rhinitis (figure 1). In 2000, the same was reported by 6.3 percent of the population. In both 2000 and 2005, more females reported experiencing allergic rhinitis than males (7.6 percent versus 4.9 percent in 2000 and 8.2 percent versus 6.4 percent in 2005).
  • The majority of allergic patients are never seen by the allergist . In terms of the ones who are seen the majority are skin testing but only a small minority are prescribed immunotherapy
  • Inconvenience was the number one barrier to SCIT is this survey of Primary care physician the blue bars and allergists greed bars with needle phobia and cost concerns in a dead heat for 2 nd place
  • When it comes to immunotherapy prescriptions, the United States is far from a super power. Europe dominates the immunotherapy market with Germany in the lead with 32% of the immunotherapy prescription, followed by the other European companies that ranged from 11 to 15% of the market and the US being buried in the 15% referred to as the rest of the world. The other graph depicts the percentage of immunotherapy sales by company worldwideand you can see there are two major companies ALK and Stallergenes represent ing about 56% of the immunotherapy market and Greer one the largest US manufacturers is buried in the other category
  • Subcutaneous Immunotherapy: Is it Worth a Shot? Cost-effectiveness of Allergen Immunotherapy

    1. 1. The Present: <br />Health Economics and Immunotherapy<br />Linda Cox, MD, FAAAAI, FACAAI, FACP<br />1<br />Many of the slides provided with permission by Cheryl Hankin, PhD<br />A portion of this research was jointly funded by the American Academy of Allergy, Asthma, and Immunotherapy and the American College of Allergy, Asthma, and Immunology<br />
    2. 2. Disclosure<br />Linda Cox, MD <br />Allergist/Immunologist: solo private practice<br />Associate Clinical Professor of Medicine Nova Southeastern University <br />Medical advisory board/consultant: Stallergenes, Genentech/Novartis, ISTA<br />Speakers fee: Phadia<br />Organizational interests:<br /><ul><li>FDA Allergenic Products Advisory Committee –consultant
    3. 3. AAAAI-Secretary/Treasurer
    4. 4. Joint Task Force on Practice Parameters-member
    5. 5. ABAI Board of Directors -member</li></ul>Cheryl Hankin , Ph.D.<br />President and Chief Scientific OfficerBioMedEcon LLC Health Economics and Outcomes Research<br />Ph.D. in ClinicalPsychology<br />Two-year postdoctoral fellowship in Pharmacoeconomics and Outcomes Research<br />Research funding from AAAAI/ACAAI & JCAAI<br />Julie Andrews in Victor Victoria (1982)<br />
    6. 6. Learning objectives<br />At the end of the session attendees will be able to discuss:<br />The evidence demonstrating the clinical and economic comparative effectiveness of SIT<br />Potential gaps in SIT access, coverage, reimbursement, and utilization <br />Adherence to immunotherapy: problems and potential solutions<br />3<br />
    7. 7. Discussion points<br />The Present<br />Increased body of evidence demonstrates the clinical and economic comparative effectiveness of SIT<br />However, SIT access, coverage, reimbursement, and utilization has not gained ground <br />The Past <br />Must be critically evaluated to identify gaps<br />Can direct our course<br />The Future<br />Requires identification, understanding, collaboration, learning, and then education<br />Identify constituents<br />Understand needs that will compellingly support AIT value propositions for each constituent<br />Collaborate so that outcomes of efforts are meaningful<br />Learn!!! Then educate… <br />The role of AIT as “preventive care” may be key<br /> Poor adherence (even in the face of extraordinary efficacy) always = failure<br />This needs to be addressed for AIT adoption /acceptance by the non-A/I health care community<br />4<br />
    8. 8. Trends in Total Annual AR-Related Expenditures: 2000 to 2005<br />5<br />% Distribution of Total U.S. AR-Related Expenditures <br />Prescription medications consistently account for over half of U.S. AR-related<br />health care expenditures <br />Shares in treatment type have not changed despite increase in published research demonstrating benefits of SIT<br />Soni A. Allergic rhinitis: Trends in use and expenditures, 2000 and 2005. Statistical Brief #204, 2008.<br />Note that dollars originally reported in USD 2005 were adjusted o USD 2010 values using the U.S. Department of Labor Bureau Consumer Price Index for Health Care (http://data.bls.gov/cgi-bin/surveymost?cu) . <br />
    9. 9. Trends in the U.S. Estimated Prevalence of AR: 2000 and 2005<br />6<br />Based on the Household Component of the Medical Expenditure Panel Survey Respondents reported experiencing related symptoms, visiting a physician, or obtaining a prescription drug to treat allergic rhinitis. <br />Total U.S. AR-related expenditures<br />nearly doubled from 2000 to 2005<br />U.S. Estimated Prevalence of AR: 2000 and 2005<br /> 85%<br />% of Total U.S. Population<br />$ Billions <br />22 Million<br />In both 2000 and 2005, more females reported experiencing allergic rhinitis than males (7.6 percent versus 4.9 percent in 2000 and 8.2 percent versus 6.4 percent in 2005).Differences between females and males significant (P<.05) for both 2000 and 2005.<br />Soni A. Allergic rhinitis: Trends in use and expenditures, 2000 and 2005. Statistical Brief #204, 2008. <br />
    10. 10. U.S. SCIT Penetration is Minimal<br />2006 US Allergic Rhinitis Sales — Total Sales = $6.72 B<br />$1252%<br />$1,10016%<br />$5,49782%<br />Rx<br />OTC<br />Immunotherapy<br />Sources: Rx figures from IMS; OTC figures from Chain Drug Review; Immunotherapy based on average of several sources <br />
    11. 11. Source of A/I Practice Revenues<br />8<br />AIT per new patient visit was 29% in 2009, 33% in 2010, and thus far 27% in 2011: includes old AIT patient restarting<br />Provided with permission David Brown, MD president of Allergy Partners<br />
    12. 12. Source: physician diary survey provided with permission Schering-Plough<br />Source: market research, provided with permission by Greer<br />
    13. 13. Perceptions of Barriers to Subcutaneous Immunotherapy By Specialty<br />Significantbarrier<br />Not a barrier<br />Source: Market Research Survey, April 2007.<br />
    14. 14. Immunotherapy market<br />US & Rest of World 15%<br />Germany<br />32%<br />Northern Europe<br />14%<br />Italy<br />11%<br />France<br />15%<br />Spain<br />13%<br />Currently: SIT in the U.S.<br />Received by few potentially appropriate patients (2%-3%)1,2<br />High rates of premature discontinuation2,3<br />Wide variation in initiation and persistence by demographic, illness, and insurance characteristics2,3<br />Provided with permission by Stallergenes<br />1. Donahue et al . Ann Allergy Asthma Immunol 1999;82:339-47.<br />2. Hankinet al, . J Allergy ClinImmunol 2008;121:227-32.<br />3. Hankin, LockeyJ Allergy ClinImmunol 2011;127(1):46-8.<br />
    15. 15. SCIT Adherence in US Published Studies<br />12<br />Hankin CS, Lockey RF. Patient characteristics associated with allergen immunotherapy initiation and adherence. J Allergy ClinImmunol. 2011;127(1):46-8, 8 e1-3. <br />
    16. 16. SCIT Adherence in US Published Studies<br />258 patients were private and 57 were nonprivate. 59% (n = 152) of private patients and 46% (n = 26) of nonprivate patients were compliant<br />Hankin CS, Lockey RF.. J Allergy ClinImmunol. 2011;127(1):46-8, 8 e1-3. <br />
    17. 17. SLIT: What About Adherence/Compliance?<br />Swim With Dolphins, Cut DepressionDesignA trainer directed half of each session; patients played freely with the dolphins during remainder<br />Control group was given an equal amount of attention from human staff.<br />Results. Greater reduction in mean severity of the depressive symptoms in the dolphin therapy group than in the control group<br />
    18. 18. SLIT Adherence<br />
    19. 19. Children’s compliance with allergenimmunotherapy according to administration routes <br />Open study 1998 to 2003 comparing SCIT (1886 pts), SLIT (806 pts), LNIT (82 pts) 1234 hospital setting, 1540 private<br />Coverage for immunotherapy services varied per region “Noncompliance” SCIT 10.9% vs SLIT 21.5% (p<.0005)<br />Panjo et al JACI 2005;116<br />
    20. 20. Comparison of Reason for Discontinuation Of Immunotherapy Between Different Administration Routes<br />Panjo et al JACI 2005;116:1380-81 <br />
    21. 21. SLIT Compliance<br />Design: Survey of 433 pollen & dust mite pts with AR ± asthma to asses compliance with daily SLITonemonodose containers<br /><ul><li>Compliance assessed by unscheduled telephone calls during 3rd and 6th month of therapy. </li></ul>Results<br /><ul><li>>90% compliance
    22. 22. 76.3% of pts at 3 months
    23. 23. 74.8% at 6 months
    24. 24. By coverage status: higher compliance group:
    25. 25. 81% of full coverage group
    26. 26. 70% of partially covered group
    27. 27. 82% of pts with no coverage</li></ul>Passalacqua JACI;2006:177<br />
    28. 28. How adherent to sublingual immunotherapy prescriptions are patients? The manufacturers' view<br />Collected the Italian sales figures from 2 large manufacturers representing 60% of AIT market<br /><ul><li>Number of SLIT treatments sold in 2006 as first prescriptions,
    29. 29. How many of the same SLIT prescriptions were prescribed as renewals in subsequent years, until 2009.
    30. 30. In Italy SLIT is a named patient product, and each treatment sold can be tracked</li></ul>19<br />Senna et al, J Allergy Clin Immunol. 2010;126(3):668-9<br />
    31. 31. Is Proving Treatment Efficacy/ Safety Sufficient?What Cost-effectiveness?<br />20<br />
    32. 32. Public and Private Payer “Push Back”: The Zero-Sum Game<br />Oregon Medicaid, Spring 2010<br />Prioritized List: AR on Line 573<br />Below the current funding line (Line 502)<br />“Most patients with AR will not qualify for any treatment for the condition. Patients who also have asthma have immunotherapy available to them on Line 11.” <br />PRIORITIZATION OF HEALTH SERVICES A Report to the Governor and the 76th Oregon Legislative Assembly 2011<br />Condition: SPASTIC DYSPHONIA Treatment: MEDICAL THERAPY Line: 584<br />Condition: MACROMASTIA Treatment: BREAST REDUCTION Line: 585<br />Condition: ALLERGIC RHINITIS AND CONJUNCTIVITIS, CHRONIC RHINITIS Treatment: MEDICAL THERAPY Line: 586 (line 574 in 2008)<br />Condition: CANCER OF LIVER AND INTRAHEPATIC BILE DUCTS Treatment: LIVER TRANSPLANT<br />21<br />
    33. 33. Health Economics of SIT (15 Studies from 1995 to 2011) <br />22<br />Poor outcomes for SIT are shown in red font.<br />AR = allergic rhinitis; Clin = clinical; FU = follow-up; MR = medical records review; RC = retrospective claims analysis; SDT = symptomatic drug therapy; SIT = allergen-specific immunotherapy; SLIT = sublingual immunotherapy. <br />
    34. 34. Pharmacoeconomics of allergen immunotherapy compared with symptomatic drug treatment in patients with allergic rhinitis and asthma<br />Method: 30 pts (mean age, 35 yrs ) with Parietaria-induced rhinitis & asthma randomized to SCIT (20 pts) or medications (10 pts) for 3 years<br />Inclusion: PST >5 mm wheal, AR + Ashma (GINA class 2 or 3) for 2 years<br />Evaluated before treatment and annually for 6 years in the pollen period <br />Nose, eyes, and lung symptom scores, and drug consumption via patent diary <br />Economic costs: pt registered monthly:# of medical visit, medications, allergy injections<br />Ariano et al, Allergy Asthma Proc 2006;27<br />
    35. 35. Pharmacoeconomics of allergen immunotherapy<br />Significant improvement in symptom scores and medication use after 1st year of treatment<br />Ariano et al, Allergy Asthma Proc 2006;27<br />
    36. 36. Sustained significant reductions in cost beginning in the 3rd year subcutaneous allergen immunotherapy<br />Results: significant difference in costs favor of SIT vs control<br />15% the second year<br />48% the third year (80% reduction )<br />80% reduction maintained up to 6th year, 3 years after stopping immunotherapy<br />Net saving per patient: $830/year. <br />Conclusion: SCIT has significant economic advantages over pharmocotherapy alone<br />Ariano et al Allergy Asthma Proc 2006;27<br />
    37. 37. U.S. Health Economics of SIT <br />26<br />AR = allergic rhinitis; RC = retrospective claims analysis; SDT = symptomatic drug therapy; SIT = allergen-specific immunotherapy.<br /><ul><li>Donahue 1995: Patients with AR completing 3.5 years of SIT incurred higher health care costs than those with <3.5 years of SIT (not adjusted for baseline differences in disease severity and costs)
    38. 38. Sullivan 2000: $8,851/5 years = $1,770 annual benefit for SITvs SDT among patients with AR
    39. 39. Hankin 2008: $401/6 months = $802 median annual benefit for SIT(children with AR in the 6 months after SIT discontinuation vs 6 months prior to SIT initiation)
    40. 40. Hankin 2010: $1,625/18 months = $1,218 mean annual benefit for SITamong children with AR vs match controls not receiving SIT
    41. 41. Hankin 2011: 7,286/18 months = $5,465 mean annual benefit for SITamong adults with AR vs match controls not receiving SIT</li></li></ul><li>Background: Florida Medicaid (1997-2008)<br /><ul><li>Computerized Florida Medicaid claims records contain</li></ul>HIPAA-compliant unique patient identifiers <br />Basic demographics (e.g., sex, age, and race/ethnicity) <br />Family identifiers (e.g., mother-child)<br />Health services use <br />ICD diagnosis and HCPCS/CPT treatment codes <br />By settings, dates, physician specialties <br />NDC prescription drug claims<br />Include doses, quantities filled, dates of fill <br />Primary and secondary insurers (e.g., Medicaid with Medicare or self-pay )<br />27<br />
    42. 42. Exploratory Study: Pre-Post SCIT Study in Children<br />Hankin CS, Cox L, Lang D, et al. J Allergy ClinImmunol2008;121:227-32.<br />
    43. 43. (among 4,807,429 total Florida Medicaid enrollees)<br />No IT at any <br />time during <br />study period <br />(N=99,342)<br />Newly-diagnosed AR Patients <br />aged < 18 years <br />(N=102,390)<br />< 4 years of <br />data following <br />1st AR dx<br /> (N=2,358)<br />Rec’d IT at <br />any time during <br />study period<br />(N =3,048)<br />IT preceded <br />1st AR dx<br /> (N=170)<br />Sample Identification<br />> 4 years of <br />data following <br />1st AR dx <br />(N=690)<br />< 6 months FU <br />data after last <br />IT admin <br />(N=166)<br />IT followed <br />1st AR dx <br />(N=520)<br />3.0% of <br />children with <br />AR received IT<br />> 6 months FU <br />data after <br />last IT admin<br />(N=354)<br />Hankin CS, Cox L, Lang D, et al. J Allergy ClinImmunol2008;121:227-32.<br />
    44. 44. Duration of Treatment (n=520)Poor Adherence to SCIT<br />% of Patients<br />Only 16% of patients received IT for 3 years<br />39%<br />18%<br />16%<br />14%<br />13%<br />1 Yr<br />to <br />< 2 Yr<br />6 Mo<br />to <br />< 1 Yr<br />2 Yr<br />to<br />< 3 Yr<br /><6 Mo<br />3+ Yr<br /><ul><li>Patients received an average of 31.3 IT administrations (SD 34.3).
    45. 45. The mean duration of treatment was 17 months (SD 17.6). </li></ul>Hankin CS, Cox L, Lang D, et al. J Allergy ClinImmunol2008;121:227-32.<br />
    46. 46. Exploratory Study: Pre-Post SCIT Study in Children<br /><ul><li>7-year (1997-2004) retrospective claims analysis of Florida Medicaid-enrolled children (age <18 years) newly diagnosed with AR (with or without asthma) and naïve to SIT
    47. 47. Compared health care use and costs of SAME CHILDREN 6 months pre-SIT initiation versus 6 months post-SIT discontinuation</li></ul>31<br />Hankin CS, Cox L, Lang D, et al. Allergy immunotherapy among Medicaid-enrolled children with allergic rhinitis: Patterns of care, resource use, and costs. J Allergy ClinImmunol2008;121:227-32.<br />
    48. 48. Matched Cohort Study in Children<br />Florida Medicaid data set from 1997-2007 <br /><ul><li>Definition of Terms:
    49. 49. AR = ICD-9 code 477.X. IT = CPT 95115, 95117, 95120, 95125,95144, 95165, 95180, and 95199.
    50. 50. Comorbid allergy-related illness: Asthma = 493.X; Atopic dermatitis = 691.8; Conjunctivitis = 372.X
    51. 51. Newly diagnosed AR = those whose first AR diagnosis was preceded by a full year in which no AR diagnoses occurred
    52. 52. De novo immunotherapy = first documented immunotherapy claim followed (rather than preceded) their first AR diagnosis </li></ul>Analysis: Data were highly skewed<br />Wilcoxon signed rank tests to compare the groups’ 18-month median per-patient health care use and costs <br />Health care components included total inpatient stays, total outpatient visits , total pharmacy fills, and total health care use.<br />32<br />Hankin CS, Cox L, Lang D, Ann Allergy Asthma Immunol2010;103:79-85. <br />
    53. 53. 1-to-5 match<br />Each IT-treated patients was matched on up to 5 controls based on age at first AR diagnosis, sex, race/ethnicity, and (4) diagnosis of asthma (493.X), conjunctivitis (372.X), or atopic dermatitis (691.8).<br />No AR dx <br />(n=3,208,639) <br />Pts aged <18 yrs (1997-2007)<br />(N=3,472,786) <br />AR dx in<br />yr before 1st AR dx<br />(n=82,326)<br />Only one IT (n=909) <br />IT in yr preceding<br />1st AR dx<br />(n=139)<br />AR-dx (n=264,147)<br />Pool of control candidates <br /><2 IT admin at any time after 1st AR dx (n=177,111) <br />No AR dx in yr before 1st AR dx<br />(n=181,821)<br />No IT (n=176,202) <br />Represents number of children with AR diagnosis from 1997 to 2007= 7.6% (264,147 / 3,472,786)<br />No IT in yr preceding<br />1st AR dx<br />(n=181,682)<br /><18 mo of data after 1st IT (n=1,586)<br />≥2 IT admin at any time after 1st AR dx (n=4,571)<br />“ IT-Treated Patients”<br />Represents newly- AR- diagnosed children = 5.2% (181,821 / 3,472,786)<br />≥18 mo of data after 1st IT (n=2,985)<br />Represents newly-AR-diagnosed children receiving course of de novo IT= 2.5% (4571 / 181,821) <br />33<br />1. Hankin CS, Cox L, Lang D, et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study. Ann Allergy Asthma Immunol2010;103:79-85. <br />
    54. 54. Matched Cohort Study in Children<br /><ul><li>10-year (1997-2007) retrospective, matched cohort, claims analysis of Florida Medicaid-enrolled children (age <18 years) newly diagnosed with AR (with or without asthma) and naïve to SIT
    55. 55. Compared 18-month health care use and costs: SIT versus matched non-SIT groups*</li></ul>34<br />Hankin CS, Cox L, Lang D, et al. Allergen immunotherapy and health care cost benefits for children with allergic rhinitis: a large-scale, retrospective, matched cohort study. Ann Allergy Asthma Immunol2010;103:79-85. <br />
    56. 56. COST-EFFECTIVENESS ATTRACTS MEDIA ATTENTION<br />35<br />
    57. 57. 36<br />
    58. 58. 37<br />Does Allergen-Specific Immunotherapy Provide Cost Benefits for Children and Adults with Allergic Rhinitis?<br /> Results from Large-Scale Retrospective Analyses Jointly Funded by AAAAI and ACAAI <br />Cheryl Hankin, PhD;1 Linda Cox, MD;2 Zhaohui Wang, MS;1 Amy Bronstone, PhD11BioMedEcon, LLC, Moss Beach, CA2Nova Southeastern University College of Osteopathic Medicine, Fort Lauderdale, FL<br />Session #274 March 19, 2011, 2:00-3:15 pm<br />Presented at the 2011 Annual Meeting of the American Academy of Allergy, Asthma, and Immunotherapy, March 18-21, 2011<br /> San Francisco, CA <br />Research jointly funded by the American Academy of Allergy, Asthma, and Immunotherapy and the American College of Allergy, Asthma, and Immunology<br />
    59. 59. Identification of Children Newly Diagnosed with AR Who Received De Novo SIT (for Matching)<br />Medicaid Children (<18 yrs)<br /> 7/97-6/08 N=3,604,711<br /><1 year of data preceding 1st AR claim (“index diagnosis”) with no AR claim filed<br />N=88,688<br />No AR <br />N=3,310,933<br />No SIT N=198,729<br />SIT in prior year N=145<br />AR <br />N=293,778<br /><2 SIT admin after index AR dx N=199,772<br />≥1 year of data preceding 1st AR claim (“index diagnosis”) with no AR claim filed<br />N=205,090<br /><18 months of data following 1st SIT N=1,618<br />≥2 SIT admin<br />after index AR dx N=5,173<br />For children, there were 3,305 SIT patients matched to 13,151 non-SIT patients. <br />No SIT in prior year N=204,945<br />≥ 18 months of data following 1st SIT <br />N=3,555<br />38<br />Hankin et al, Session #274 March 19, 2011 Presented at the 2011 AAAAI<br />
    60. 60. Identification of Adults Newly Diagnosed with AR Who Received De Novo SIT (for Matching)<br /><1 year of data preceding 1st AR claim (“index diagnosis”) with no AR claim filed<br />N=29,505<br />1 SIT N=657<br />SIT in prior year N=127<br />No SIT N=58,725<br />No AR <br />N=2,917,762<br />Medicaid Adults (≥18 yrs)<br /> 7/97-6/08 N=3,008,865<br />< 2 SIT admin after index AR dx N=59,382<br />No SIT in prior year N=61,471<br /><18 months of data following 1st SIT N=590<br />≥1 year of data preceding 1st AR claim (“index diagnosis”) with no AR claim filed<br />N=61,598<br />AR <br />N=91,103<br />≥ 18 months of data following 1st SIT <br /> N=1,499<br />≥2 SIT admin<br />after index AR dx N=2,089<br />For adults, there were 1,306 SIT patients matched to 5,137 non-SIT patients. <br />Hankin et al, Session #274 March 19, 2011 Presented at the 2011 AAAAI<br />
    61. 61. Adults: Significant and progressive differences in all components of health care costs including hospitalization<br />11-year (1997-2008) retrospective matched cohort claims analysis of Florida Medicaid-enrolled adults newly diagnosed with AR compared 18-month health care use and costs of patients who received SIT and a matched cohort who did not receive SIT* <br />40<br />
    62. 62. Mean, per-Patient, 18-Month Savings for Children with Newly Diagnosed AR Who Received versus Did Not Receive SITNegative Values Denote Savings Conferred by SIT versus Non-SIT<br />Hankin et al, Session #274 March 19, 2011 Presented at the 2011 AAAAI<br />41<br />
    63. 63. SIT Duration<br />Only 18.8% of adults completed a 3-year course of SIT<br />Adults (N=1,265)<br />Only 17.5% of children completed a 3-year course of SIT<br />Children (N=2,886)<br />
    64. 64. Managed Care Round Table and Working Group (2006)<br />Payers from the public and private sectors were unaware of<br />SIT as preventive care<br />Although overwhelmed by the costs for treatment of asthma, were not familiar with disease-modifying potential of SIT<br />Specialty expertise required<br />Patient identification and evaluation <br />Testing<br />Preparation and administration<br />Monitoring <br />Documentation and record-keeping<br />43<br />Once informed, they “connected the dots” to acknowledge<br /><ul><li>SIT as preventive care
    65. 65. Agreed that SIT could mitigate the high costs and burden of asthma
    66. 66. Substantial barriers to access to treatment
    67. 67. Poor coordination of care
    68. 68. Primary care’s lack of awareness and low referral rates</li></ul>Called upon the specialty to <br />“assume a leadership role in collaborating with primary care physicians to educate them regarding the benefits and risks of immunotherapy and appropriate referral of patients with allergic rhinitis.”<br />Levin A, Eavy G, Burgoyne D, Bordeaux M, Hankin CS. Allergy Immunotherapy Working Group consensus statement. Drug Benefit and Trends2008;20:14-20.<br />
    69. 69. Public and Private Payer “Push Back”: Fighting Back<br />Presentations and letters to Oregon Medicaid’s medical director, Health Services Commission (Ariel K. Smits, MD MPH) spearheaded by David Coutin<br /> “At this point, additional literature on the effectiveness of treatments for allergic rhinitis would not be helpful.”<br />“The Commission...would be interested in information regarding how treatment of allergic rhinitis impacts healthy life years, burden of suffering, impacts on vulnerable populations, need for medical care, and our other prioritization criteria.” <br />I've spoken again w Director of Oregon HSC. The Commission accepts the findings of Hankin and Cox, but has a rather common issue with Federally Qualified Health Centers (FQHC) payment methodologies for allergy injections, as does Florida.<br />FQHC, where most of medical assistance (MA) patients in OR receive care. They are under federal mandates to bill MA for Dr visits for all encounters with MA patients, thereby driving up overall costs to states to deliver IT Rx.<br />44<br />
    70. 70. SIT as Preventive Care<br />2010 Patient Protection and Affordable Care Act (PPACA)<br />Mission: to identify and reduce the incidence of preventable chronic illness and disability <br />“Preventive Clinical Services” designation <br />U.S. Preventive Services Task Force (USPSTF) supported by the U.S. Department of HHS AHRQ<br />Based on rigorous, evidence-based methods to evaluate the expected net health benefit (benefit minus harm) associated with delivery of a specified service <br />As of September 2010, all new insurance policies fully cover preventive care and screening services that receive a USPSTF grade of A or B <br />No patient co-pays or deductibles can be applied to the cost for these services<br />
    71. 71. SIT as Preventive Care: A/I Organization’s Response<br />Specific Allergen Immunotherapy: A Model of Preventive Care for a Large Segment of the United States Population. Ira Finegold, MD, Linda Cox, MD, Cheryl Hankin, PhD:<br />Final draft completed 2/27/2011 approved and submitted by AAAAI/ACAAI/JCAAI<br />
    72. 72. 47<br />
    73. 73. Past Initiatives, Current Efforts, and Future Directions<br />48<br />
    74. 74. Past Initiatives, Current Efforts, and Future Directions<br />49<br />
    75. 75. Future Directions: The IMprovedAccess to AllerGen-Specific ImmuNothErapy (IMAGINE) Studies<br />50<br />
    76. 76. Allergen Immunotherapy Adherence Task Force <br />Members Amy Bronstone, David Bernstein , Linda Cox, Cheryl Hankin, Dennis Ledford, Karen Murphy & Jim Peterson,<br />Phase 1. Conduct Survey of AAAAI Members to Identify Practice-based Interventions to Improve Patient Adherence to SIT<br />Review and summary of the literature on AIT adherence-<br />Contact extract manufacturers to request they share data on AIT adherence: <br />Collect information from VA/Armed services on AIT refills, adherence, etc<br />Develop questionnaire for membership survey <br />Database for first AIT adherence survey- possibly use the existing AAAAI/ACAAI Immunotherapy Safety Surveillance study data base <br />More intensive survey of randomly selected practices and their patients: <br />Identify when, where and why patient prematurely discontinue ATT<br />Identify Patient-Reported Factors that Influence Adherence to AIT <br />Identify practice interventions used to improve patient adherence<br />Phase 2. Test Interventions Expected to Improve Patient Adherence to AIT<br />Phase 3 Develop Report with In-Depth Description of Interventions that Most Effectively and Efficiently Improve Patient Adherence to AIT<br />51<br />
    77. 77. ALL Medicaid-enrolled patients July 1997- June 2009 (N= 7,524,231 ) <br />Patients diagnosed with AR (477.x) in childhood: AR-Diagnosed patients < 18 years at 1st AR claim (“index AR diagnosis”) (N= 330,993 ) <br />Sufficient data to conduct follow up analyses: > 1 year of claims data following index AR diagnosis (N=181,933 ) <br />Sufficient data to examine presence of premorbid asthma: > 1 year of claims data prior to index AR diagnosis (N=234,451 ) <br />Pediatric IMAGINE AIRE Study<br />No premorbid asthma: Ptswho had no asthma diagnosis (493.x) > 1 year prior to their index AR diagnosis (N= 117,273 )<br />No concomitant asthma: Pts who had no asthma diagnosis (493.x) within 1 year (365 days) after their index AR diagnosis (N=102,895) )<br />No premorbid confounding dx :Ptswho had no “‡‡” > 1 year prior to their index AR diagnosis (N= 114,818 ) <br />No Previous IT: Patients who received no IT> 1 year prior to their index AR diagnosis (N= 102,358 ) <br />B. Remaining pool of patients with AR diagnosed in childhood who had no premorbid or concomitant asthma or counfounding diagnoses, never received IT, and did not receive their 1st asthma diagnosis during pregnancy (N= 100,282 )<br />1st De novo IT in childhood: Patients < 18 years at 1st IT (N= 1,960 )<br />Active Tx in childhood: Patients < 18 years at 2nd IT (N=1,755 ) <br />Had <3 years follow-up data after 2nd IT administration (N=774 )<br />Had >3 years follow-up data after 2nd IT administration (N=981 )<br />A. Remaining pool of patients with AR diagnosed in childhood who had no premorbid or concomitant asthma or counfounding diagnoses, received de novo active IT in childhood, and did not receive their 1st asthma diagnosis during pregnancy (N= 981 )<br />
    78. 78. Allergy-related Illness AR versus noAR<br />Children<br />P<0.0001 between AR vs noAR <br />Adults<br />P<0.0001 between AR vs noAR <br />From Florida Medicaid 1997-2008 adult and pediatric database not published<br />
    79. 79. 54<br />Allergy-related Illness AR versus no AR in Adults: Asthma, Atopic Dermatitis, Conjunctivitis, Acute Respiratory Infections<br />From Florida Medicaid 1997-2008 adult and pediatric database not published<br />
    80. 80. 55<br />Allergy-related Illness AR versus noAR in Adults:<br />Acute Respiratory Infections<br />
    81. 81. 56<br />Allergy-related Illness AR versus noAR in Adults:<br />Other diseases of the upper respiratory tract <br />From Florida Medicaid 1997-2008 adult and pediatric database not published<br />
    82. 82. 57<br />Allergy-related Illness AR versus noAR in Adults:<br />Asthma, Atopic Dermatitis, Conjunctivitis, Acute Respiratory Infections<br />From Florida Medicaid 1997-2008 adult and pediatric database not published<br />
    83. 83. Conclusions <br />AIT is effective and cost-effective but underutilized<br />Reasons for underutilization are likely multi-factorial with patient factors being significant but payers may begin to restrict access<br />Much more needs to be done to identify, understand, collaborate, learn from, and educate stakeholders and decision-makers<br />Identify constituents<br />Understand gaps that will compellingly support intended value propositions for each constituent<br />Collaborate so that outcomes of efforts are meaningful<br />The role of SIT as “preventive care” may be key<br />Poor adherence (even in the face of extraordinary efficacy) always = failure <br />Several A/I organization sponsored efforts focused on enhancing adherence, and evaluating preventive and cost-efficacy of AIT<br />58<br />
    84. 84. 59<br />FPL's Riviera Beach plant demolition expected to bring brief traffic stoppage<br />

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