Allan T. Luskin, MD Associate Clinical Professor of Medicine, University of Wisconsin Director, Respiratory Institute, Dean Medical Center Madison, Wisconsin Past Chair, Patient and Public Education Committee, NAEPP Past Co-Chair, Managed Care Liaison, NAEPP Committee on Asthma Measures, AMA Asthma Expert Panel, JCAHO Evolving Xolair Health Outcomes Data: What Does (or Should) it Mean to Patients, Clinicians and Payors
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Allan T. Luskin, MD Associate Clinical Professor of Medicine, University of Wisconsin
Evolving Xolair Health Outcomes Data: What Does (or Should) it Mean to Patients, Clinicians and Payors. Allan T. Luskin, MD Associate Clinical Professor of Medicine, University of Wisconsin Director, Respiratory Institute, Dean Medical Center Madison, Wisconsin - PowerPoint PPT Presentation
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Allan T. Luskin, MDAssociate Clinical Professor of Medicine, University of Wisconsin
Director, Respiratory Institute, Dean Medical CenterMadison, Wisconsin
Past Chair, Patient and Public Education Committee, NAEPP
• Emotions Domain– “fear of not having medication available”– p<0.01
• Environment Domain– “symptoms from being exposed to dust”– p<0.001
Summary and Conclusions (cont)
• ARQL assessment provides non-overlapping information on clinical benefit distinct from other outcomes
• Examination of variability in mean scores reveals item-level responses strongly influence symptom and activity improvement
• Symptoms likely to be important to patients are significantly improved by omalizumab compared to placebo in patients with mod-severe asthma
Health-Care Utilization:Omalizumab vs. Placebo
0
0.5
1
1.5
2
2.5
3
Incidence rates/100
patient-years
Hospitalization ED Visits
Omalizumab Placebo
Oba Y J Allergy Clin Immunol 2004;114:265-9
Cost of Therapy~0.5 exacerbations/pt/year (~1 in pts on po CS) compared to pl
0
0.2
0.4
0.6
0.8
1
1.2
Daily Treatment
Costs
Hospital ED visits OV B-agonist ICS
Omalizumab Placebo
Oba Y J Allergy Clin Immunol 2004;114:265-9
Cost of Symptom Free Day
ICS $3.35-$7.50
Zafirlukast $5.71-$12.08
Sal/FP $3.79-$9.06
Omalizumab $523
Omalizumab (>0.05 AQLQ) $378
Oba Y J Allergy Clin Immunol 2004;114:265-9
Xolair Cost-Effectiveness:Issues with Current Data
• RCT data not representative of “real-world”– Overestimates placebo arm– Underestimates active drug arm
• Placebo and Protocol effect– 67% of placebo patients improved at 1 year– ED visits and likely hospitalizations lower
because of use of study investigator and with more frequent OV than usual
Xolair Cost-Effectiveness:Issues with Current Data
• RCT data not representative of “real-world”– Overestimates placebo arm– Underestimates active drug arm
• Placebo and Protocol effect– 67% of placebo patients improved at 1 year– ED visits and likely hospitalizations lower
because of use of study investigator and with more frequent OV than usual
Asche CV. JACI.2005
Xolair Cost-Effectiveness:Issues with Current Data
• Hospitalization rate ~16% in the literature– Placebo-3%– Xolair-<1%
• Dropout rates for Rx failure not quantified– 14:1 placebo:xolair
• QALY not used– comparisons with other drugs not valid
• No data on economic benefit of AQLQ (QOL)
Asche CV. JACI.2005
• Conclusions reflect studies that were designed to assess efficacy, rather than effectiveness
– Conclusions dependent on key assumptions about dosing and efficacy in a controlled clinical setting--not actual clinical practice
– Retrospective C-E analyses have limited generalizability to actual clinical practice
– If the RCT underestimate benefits patients achieve in actual clinical practice, then C-E ratios for omalizumab are overestimated
• Without assessing cost and efficacy in the same patient population, direct comparisons of cost-effectiveness are misleading
– Incremental C-E ratios for other asthma therapies should only provide context: ICS, LTRAs, and ICS-LABA combination are indicated for different patient populations
– Omalizumab is indicated for patients with moderate-to-severe persistent IgE-mediated asthma who have failed other therapy
• Identifying eligible patients based on “break-even” criteria for cost-effectiveness would exclude most patients the clinical benefit that a therapy like omalizumab can deliver
– Omalizumab is intended to address the disease process to prevent exacerbations and related cascade of healthcare utilization
– Patients with persistent IgE-mediated asthma who may benefit significantly from omalizumab therapy are likely to be excluded from receiving therapy
Public Health Impact of Omalizumab in High-Risk Patients
• Risk difference: omalizumab prevented exacerbations in about 17 additional patients for every 100 treated
• Prevented fraction: 50% of potential exacerbations were prevented by treatment with omalizumab
• Number needed to treat: 5.7 patients needed to be treated with omalizumab to maintain 1 patient free of an exacerbation
Holgate S, et al.Curr Med Res Opin. 2001;17(4):233-240.
Societal Burden of Asthma
• Calculating societal burden of asthma requires assessment of both direct and indirect costs
• Direct costs include– Costs attributed to medical care (office visits,
– Dollars expended by the patient, family, employer, and/or society because of illness (including loss of productivity and quality of life)
• Can be determined using either a cost of illness or cost of wellness approach
Stempel DA, et al. J Allergy Clin Immunol. 2003;111:1203-4.
Cost of Illness Approach
• Traditional view of government and other third party payers– Determines costs by multiplying average
medical costs for one person with asthma by the total number of expected patients in the population
– Focused on direct cost of care– Minimal emphasis on prevention or long-term
control
Stempel DA, et al. J Allergy Clin Immunol. 2003;111:1203-4.
Wall Street Journal, July 18, 2001
Cost of Wellness Approach• Goal of wellness is to minimize expenses caused by
treatment failures and enhance productivity– Direct costs targeted for preventative health care and use
of effective controller medications
• Indirect costs are used for environmental control, lifestyle changes, and other interventions that promote better health
• On balance, an investment in wellness promotes– Enhanced disease control– Greater productivity at work or school– Improved quality of life
Stempel DA, et al. J Allergy Clin Immunol. 2003;111:1203-4.
Direct and Indirect Costs of Asthma
Asthma Severity
Meds Am. CareHospital
Use
Other Medical
*
Total Direct Costs
Indirect Costs**
Total Costs
Mild 47% 7% 4% 5% $1681 22% $2646
Moderate 39% 7% 5% 4% $2473 33% $4530
Severe 19% 7% 17% 8% $6354 46% $12,813
N = 401 adults with asthma 18-50 yrs old
*transportation to ED and outpatient procedures, purchase of asthma-control products, asthma-related home repairs, etc.**Lost productivity at work and inability to perform daily activities
Cisternas, MG et al. J Allergy Clin Immunol. 2003;111:1212-8.
• Hospital Care– Inpatient $2B– ER $500M– Hosp outpatient $700M
Sullivan SD, and Weiss KB, Health economics of asthma and rhinitis, I and II. Assessing the value of interventions, Current Reviews of Allergy and Clinical Immunology, January 2001, Volume 107, No. 1&2, p. 3-8 and 203-210.
• In an attempt to reduce costs, payors will shift costs to patients: – “consumer-driven health plans”– Utilization control and influence choice
• This will demand a FULLY educated consumer
• We will need to help patient evaluate the full cost-benefit (not just HCU but QOL)
Rx Noncompliance due to Costs
0246
81012
141618
Medicare Medicaid Private NoInsurance
Total
1997 2002
NHIS Surveys
Discussion Questions
• Are the current outcomes that we consider in the treatment algorithm for asthma adequate?
• If not, what else should we be considering?
• What are the benefits and challenges of looking at these other outcomes?
• What endpoints would help clarify and communicate the value proposition for Xolair?
Discussion Questions
• What indirect costs are most strongly associated with poor control of asthma symptoms?
• With increasing focus on the concept of control, should we rethink the conventional cost-effectiveness approach for asthma interventions? – Is an outcome measure other than the symptom free-day
warranted?
– Should analyses take into account the significant burden associated with indirect costs that may be mitigated by therapies that reduce activity limitations?