NIH Asthma Guidelines. Versus. Asthma: Cost Beyond Non-Compliance

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1 Asthma: Cost Beyond Non-Compliance WILLIAM CRAWFORD, MD OCTOBER 24, 2014 Outpatient Management of Asthma NIH Asthma Guidelines-Based Care Stepping Up Controller Therapy Newer Treatments for Severe Asthma Measuring Asthma Quality of Care NIH Asthma Guidelines Established by Expert Panel Review Created in 1991 Revised in 1997 (EPR-2) Updated in 2002 Revised Again in 2007 (EPR-3) Fourth Revision Under Consideration Versus 1

2 Classifying Asthma Severity and Initiating Therapy in Adults Components of Severity Intermittent Persistent Mild Moderate Severe Symptoms Nighttime awakenings 2 days/week 2x/month >2 days/week but not daily 3-4x/month Daily >1x/week but not nightly Throughout the day Often 7x/week Short-acting beta2-agonist use for symptom control (not prevention of EIB) Interference with normal activity Lung Function >2 days/week but Several times per 2 days/week not daily and not >1 Daily day day None Minor limitation Some limitation Extremely limited Versus Normal FEV1 FEV1 > 80% FEV1 /FEC normal FEV1 > 80% predicted FEV1 /FEC Normal FEV1 >60% but <80% predicted FEV1 /FEC reduced 5% FEV1 <60% predicted FEV1 /FEC reduced >5% Exacerbations requiring oral systemic corticosteroids 0-1/year 2x/year Recommended Step for Initiating Therapy Step 1 Step 2 Step 3 Step 4 Assessing Asthma Control and Adjusting Therapy in Adults Classification of Asthma Control Components of Control WELL- CONTROLLED NOT WELL- CONTROLLED VERY POORLY CONTROLLED Symptoms 2 days/week >2 days/week but not daily Throughout the day Impairment Normal FEV1/FVC: 8-19 yr 85% yr 80% yr 75% yr 70% Nighttime awakenings 2x/month 1-3x/week 4x/week SABA Use for symptoms 2 days/week >2 days/week Several times per day Interference with normal None Some limitation Extremely limited activity FEV1 or peak flow >80% 60-80% <60% ACT Questionnaire Exacerbations requiring oral steroids 0-1/year 2x/year Risk Progressive loss of lung function Evaluation requires long-term follow-up care. Treatment-related adverse effects Intensity of medication side effects does not correlate to specific levels of control, but should be considered in the overall assessment of risk. 2

3 Intermittent Asthma Step 1: Preferred: SABA PRN Step 2: Preferred: Low-dose ICS Alternative: Cromolyn, LTRA, or Theophylline Step 3: Preferred: Low-dose ICS plus LABA OR Medium-dose ICS Alternative: Low-dose ICS plus either LTRA, Theophylline, or Zileuton Persistent Asthma: Daily Medication Step 4: Preferred: Medium-dose ICS plus LABA Alternative: Medium-dose ICS plus either LTRA, Theophylline, or Zileuton Step 5: Preferred: High-dose ICS plus LABA AND Consider Omalizumab for patients who have allergies Step 6: Preferred: High-dose ICS plus LABA plus oral corticosteroid AND Consider Omalizumab for patients who have allergies Stepwise Approach to Asthma Therapy Step 1: PRN Albuterol Step 2: Low Dose ICS vs. LTRA Step 3: Low Dose ICS/LABA vs. Low Dose ICS + LTRA vs. Medium Dose ICS Step 4: Medium Dose ICS/LABA Step 5: High Dose ICS/LABA Step 6: High Dose ICS/LABA + PO Corticosteroid Patient Education and Environmental Control at Each Step Dosage Guide for Inhaled Corticosteroids Age 12 and Up Exacerbations requiring oral steroids 0-1/year 2x/year Progressive loss of lung Risk function Treatment-related adverse effects Recommended Action for Treatment Assessing Asthma Control and Adjusting Therapy in Adults Classification of Asthma Control Components of Control WELL- NOT WELL- VERY POORLY CONTROLLED CONTROLLED CONTROLLED >2 days/week but not Symptoms 2 days/week Throughout the day daily Impairment Nighttime awakenings 2x/month 1-3x/week 4x/week Normal FEV1/FVC: SABA Use for symptoms 2 days/week >2 days/week Several times per day 8-19 yr 85% Interference with normal None Some limitation Extremely limited yr 80% activity yr 75% FEV1 or peak flow >80% 60-80% <60% yr 70% ACT Questionnaire Evaluation requires long-term follow-up care. Intensity of medication side effects does not correlate to specific levels of control, but should be considered in the overall assessment of risk. Maintain Step up 1 step. Consider oral current step. Re-evaluate in 2-6 steroids. Regular weeks. Step up 1-2 follow-up steps. every 1-6 Re-evaluate in 2 mos. weeks. Consider step down if wellcontrolled for 3 mos. 3

4 Versus ICS/LABA vs ICS + LTRA Clinical Trials Favor ICS/LABA Over ICS + LTRA Early Clinical Trials Clearly Favored ICS/LABA Concern and Controversy Regarding LABA s Real World Studies Suggest That LTRA s May Work Better Than Originally Thought LTRA Monotherapy = ICS Monotherapy ICS + LTRA = ICS/LABA Meta-Analysis of 18 Studies with > 7000 Subjects Patients Inadequately Controlled with ICS Randomized to Add LABA or Add LTRA Modest Reduction of Exacerbation Risk with ICS/LABA vs ICS + LTRA 13% vs 11% (p < 0.05) NNT to Prevent One Exacerbation: 62 Better FEV1 Modest Improvement in Symptom Scores, Rescue Inhaler Use and Quality of Life Cochrane Database Syst Rev Jan 24;1:CD

5 Real World Studies Suggest Equivalence Between ICS/LABA and ICS + LTRA LABA Risks 352 Primary Care Patients Inadequately Controlled with ICS Randomly Assigned to Open Label Add LABA or Add LTRA Under Care of PCP Outcomes at 2 Months and 2 Years No Difference in Asthma Exacerbations No Difference in Symptom Scores Similar Results for ICS vs LTRA as Initial Therapy Price D et al. N Engl J Med. 2011;364(18): : FDA announces on 1/23/03 that Salmeterol may be associated with an increased risk of life-threatening asthma episodes or asthma-related deaths GlaxoSmithKline simultaneously halts large safety trial of Salmeterol (SMART study) SMART Study Halted 1/23/03 GlaxoSmithKline statement indicates that interim study results were inconclusive Findings suggest that two sub-groups may be at increased risk of respiratory adverse events with Salmeterol Patients not on concomitant IAI African-Americans FDA Advisory 2005: FDA issues Public Health Advisory regarding LABAs on 11/23/05 Salmeterol, Formoterol, and Fluticasone/Salmeterol are included FDA Advisory states: these medicines may increase the chance of severe asthma episodes, and death when those episodes occur 5

6 Black Box Warning 2006: Black box warning added to the labels of Salmeterol and Fluticasone/Salmeterol on 3/2/06 WARNING Long-acting beta2-adrenergic agonists, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, may increase the risk of asthma-related death. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on other asthma-controller medications (e.g., low- to medium-dose inhaled corticosteroids) or whose disease severity clearly warrants initiation of treatment with 2 maintenance therapies. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 deaths out of 13,179 patients on placebo) (see WARNINGS). Gly/Gly, Gly/Arg, or Arg/Arg Human Beta 2 -Adrenergic Receptor LABA Monotherapy and Beta 2 -Adrenergic Receptor Polymorphism Gly-Gly Arg-Arg Caucasian: 13% African-American: 28% Wechsler et al; AJRCCM; Mar

7 Isopreterenol Sales in the UK During the 1960 s Asthma Deaths Lancet October, 1969 Ongoing stimulation of the beta2-adrenergic receptor: beneficial or detrimental? Yes! Take Home Message ICS/LABA Likely to Be Most Effective Step-Up Be Vigilant for Worsening Asthma After Adding LABA More Likely in African-Americans than in Other Ethnic Groups Adding LTRA Is Reasonable Steroid Phobic Cost Conscious No LABA Monotherapy No! 7

8 Assess for Comorbidities Consider Masqueraders Cigarette Smoking Rhinosinusitis GERD CHF Pulmonary Embolism Vocal Cord Dysfunction ACE Inhibitor-Induced Cough Newer Therapies in Asthma Omalizumab Omalizumab Bronchial Thermoplasty Humanized Mouse IgG Anti-Human IgE Antibody Binds to the Constant Region of the IgE Molecule Produces 89 99% Reduction in Free Circulating IgE Induces Downregulation of IgE Receptors on Mast Cells and Basophils Studied for Use in Patients with Allergic Asthma 8

9 Clinical Effectiveness of Omalizumab 4 Trials of Patients on Medium to High Dose ICS Reduced Exacerbations in 3 of 4 Trials Reduced Dose of ICS Needed to Control Symptoms One Trial of Patients on High Dose ICS + LABA Reduced Exacerbations by 25% Improved Symptom Scores, Rescue Inhaler Use Hanania NA et al. Ann Intern Med. 2011;154(9):573 Potential Adverse Effects of Omalizumab Omalizumab s Place in Therapy? Increased Cancer Risk Anaphylaxis Must Be Administered in Monitored Setting Patients Must Have Epi-Pens Increased Risk of Cardiovascular and Cerebrovascular Events Step 5 or Step 6 Therapy per NIH Guidelines Variable Response to Treatment 12-Week s of Treatment Before Gauging Response 30 50% of Patients Respond Optimum Duration of Treatment Not Known Cost of Therapy Is a Consideration $4,000 $20,000 per Year Depending on Dose $12,000 per Year Average Cost 9

10 Bronchial Thermoplasty FDA Approved in 2010 Uses a Radiofrequency Probe to Apply Heat to the Airways During Bronchoscopy Reduces the Increased Smooth Muscle Mass Associated with Asthma Findings Demonstrated in Dogs Requires 3 Separate Bronchoscopies; 3 Weeks Apart 10

11 Clinical Effectiveness of Bronchial Thermoplasty Asthma Intervention Research (AIR2) Trial 3 Clinical Trials with 429 Participants Only 1 Trial Included a Sham Treatment Arm Meta-Analysis of the 3 Trials Showed: Modest Improvement in Quality of Life Reduced Asthma Exacerbations No Change in Asthma Symptom Scores Increased Risk of Asthma Exacerbations and Hospitalization During the Treatment Period 288 Patients Randomized to BT or Sham Treatment Statistically (But Not Clinically) Significant Improvement in Asthma Symptom Scores Increased Risk for BT During 6-Week Treatment Period: 16 BT Subjects (8%) Required 19 Hospitalizations 2 Sham Subjects (2%) Required 2 Hospitalizations Cochrane Database Syst Rev. 2014;3:CD Asthma Intervention Research (AIR2) Trial Bronchial Thermoplasty s Place in Therapy 5-Year Follow-Up of 162 Subjects in the BT Arm Average 44% Reduction in Exacerbations for Post- BT Years 1 5 Compared to the Pre-BT Year Average 78% Reduction in ED Visits for Post-BT Years 1 5 Compared to the Pre-BT Year 18% Reduction in Average Daily ICS Use Stable FEV1 No Data for the Sham Treatment Group Wechsler ME et al. J Allergy Clin Immunol Dec;132(6):

12 Bronchial Thermoplasty s Place in Therapy Not Addressed in NIH Asthma Guidelines Marketed to Patients Who Are Over 18 and Having Little Success Controlling Their Asthma Symptoms with ICS/LABA Active Debate in the Scientific Community Perhaps Best Undertaken in the Context of a Clinical Trial HEDIS Asthma Quality of Care Measures HEDIS Measure Data Collection Began First Publicly Reported Year Any Controller Asthma Medication Adherence Asthma Medication Ratio

13 Appropriate Medication for People with Asthma Did you dispense at least one canister of controller medication during the measurement year? The following medications are considered valid controller medications: Inhaled corticosteroids Oral leukotriene modifier and theophylline medications HEDIS One Controller Per Year Measure Is Associated With Increased Risk % ED/ Hosp Controller No Controller Berger, et al. Ann Allergy Asthma Immunol 2004; 93:538 Asthma Medication Ratio Relationship of Medication Ratio to Asthma ED/Hospital Care % ED or 5 Hospital P < < 0.5 > 0.5 Medication Ratio Schatz, et al. Chest 2005; 128:

14 Relationship of Ratio >0.5 to Poor Symptom Control Medication Management for People with Asthma % AQLQ < 3.9 ATAQ > 1 AOMS > 3 Patient-Reported Outcome Tool Schatz, et al. Chest 2006; 130:43 Ratio < 0.5 Ratio > 0.5 All p < Percentage of Persistent Asthma Patients Who Remained on Asthma Controller Medications for at Least 75% of the Treatment Period Adherence Determined by the Number of Canisters of Asthma Controllers Dispensed and the Dosing Instructions The HEDIS MMA Measure: Conceptual Concerns Penalizes Appropriate Step-Down of Asthma Controller Therapy per NIH Guidelines Penalizes Appropriate Management of Seasonal Asthma Relationship Between the HEDIS MMA Measure and Improved Asthma Outcomes Is Unknown Percent of Population 35% 30% 25% 20% 15% 10% 5% 0% 75% Adherent in 2012 Not 75% Adherent in 2012 Hospitalization ED Visit >6 SABA Canisters Asthma Outcomes in 2013 Oral Corticosteroid Dispensing 14

15 6% 75% Adherent in 2012 Not 75% Adherent but Ratio 0.5 in % Percent of Population 4% 3% 2% 1% 0% Hospitalization ED Visit >6 SABA Canisters Asthma Outcomes in 2013 HEDIS One Controller per Year Measure Is Associated With Increased Risk 49,637 patients with HEDIS-defined persistent asthma in health plans in 3 regions Outcome: Asthma-related ED visit or hospitalization (ED/Hosp) in 6 months following first medication % ED/ Hosp Controller No Controller Berger, et al. Ann Allergy Asthma Immunol 2004; 93:538 Relationship of Medication Ratio to Acute Episodes 38,433 Southern California Kaiser Permanente patients with persistent asthma Medication ratio determined in 2002 Acute episodes (one or more asthma emergency department visits or hospitalizations) determined in 2003 Schatz, et al. Chest 2005; 128:

16 Relation of Medication Ratio to Patient-Reported Outcomes Random sample of 2250 adult patients (aged 18-56) with persistent asthma (1999) Northern California, Southern California, and Northwest Kaiser Permanente Survey completed in Fall, 2000 Survey included quality of life (AQLQ), control (ATAQ) and symptom severity (AOMS) Medication ratio from year 2000 computerized pharmacy records Schatz, et al. Chest 2006; 130:43 Medication Management for People with Asthma (MMA) Index dispensing event = In measurement year, earliest dispensing event of a controller medication identified Treatment period = time between index dispensing event and end of calendar year Number of days covered = total controller amount dispensed daily dose Percentage of days covered (PDC) = number of days covered total number of days in treatment period 75% MMA adherent = patients who have a PDC of at least 75% 50% MMA adherent = patients who have a PDC of at least 50% Asthma controller medications = inhaled corticosteroids, inhaled corticosteroid/long acting beta 2 agonist combination agents, leukotriene modifiers, theophylline, and cromolyn sodium Methods 30,040 KPSC patients met persistent asthma criteria for ,750 patients had oral steroid dispensing data available for 2013 MMA status for 2012 assessed Asthma outcomes for 2013 tracked asthma related hospitalizations asthma related ED visits oral steroid dispensing > 6 SABA canisters dispensed 16

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