Proposed Retirement for HEDIS : Use of Appropriate Medications for People With Asthma (ASM)

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1 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Proposed Retirement for HEDIS : Use of Appropriate Medications for People With Asthma (ASM) Proposed Changes to Existing Measures for HEDIS 2016: Medication Management for People With Asthma (MMA) Asthma Medication Ratio (AMR) NCQA seeks comments on proposed changes to the HEDIS Asthma measure set: Retire Use of Appropriate Medications for People With Asthma. Expand the upper age limit for Medication Management for People With Asthma and Asthma Medication Ratio to include health plan members up to 85 years of age; add Medicare as a reporting product line. The proposed retirement of Use of Appropriate Medications for People With Asthma measure results from consistently high HEDIS performance rates and little variation in plan performance for both commercial and Medicaid plans. Additionally, Medication Management for People With Asthma is a more effective way of assessing asthma medication management. The Medication Management for People With Asthma and Asthma Medication Ratio measures evaluate the effectiveness of asthma management in members 5 64 years of age. Stakeholders expressed interest in expanding the measures to include older adults. NCQA tested the feasibility of expanding the eligible population to ages 65 and older and whether it would provide meaningful and valid HEDIS performance information: specifically, because the frequency of clinical measure exclusions increases with age, would health plans have a sufficient denominator? Based on test findings, a sufficient number of adults 65 and older remain after applying exclusions to the older commercial and Medicare populations, which supports including these adults in the HEDIS Asthma measure set. Supporting documents for this measure include the current measure specifications and measure work-up. NCQA acknowledges the contributions of the Respiratory Measurement Advisory Panel and the Geriatric Measurement Advisory Panel. 1 HEDIS is a registered trademark of the National Committee for Quality Assurance (NCQA).

2 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Medication Management for People With Asthma (MMA) SUMMARY OF CHANGES TO HEDIS 2016 Expanded age range up to 85 years Added the Medicare product line Description The percentage of members years of age during the measurement year who were identified as having persistent asthma and were dispensed appropriate medications that they remained on during the treatment period. Two rates are reported: 1. The percentage of members who remained on an asthma controller medication for at least 50% of their treatment period. 2. The percentage of members who remained on an asthma controller medication for at least 75% of their treatment period. Definitions IPSD Treatment period PDC Oral medication dispensing event Index prescription start date. The earliest prescription dispensing date for any asthma controller medication during the measurement year. The period of time beginning on the IPSD through the last day of the measurement year. Proportion of days covered. The number of days that a member is covered by at least one asthma controller medication prescription, divided by the number of days in the treatment period. One prescription of an amount lasting 30 days or less. To calculate dispensing events for prescriptions longer than 30 days, divide the days supply by 30 and round down to convert. For example, a 100-day prescription is equal to three dispensing events (100/30 = 3.33, rounded down to 3). The organization should allocate the dispensing events to the appropriate year based on the date when the prescription is filled. Multiple prescriptions for different medications dispensed on the same day count as separate dispensing events. If multiple prescriptions for the same medication are dispensed on the same day, sum the day s supply and divide by 30. Use the Drug ID to determine if the prescriptions are the same or different. Refer to the Oral medication dispensing event definition in ASM for examples. Inhaler dispensing event When identifying the eligible population, use the definition below to count inhaler dispensing events. All inhalers (i.e., canisters) of the same medication dispensed on the same day count as one dispensing event. Medications with different Drug IDs dispensed on the same day are counted as different dispensing events. For example, if a member received three canisters of Medication A and two canisters of Medication B on the same date, it would count as two dispensing events.

3 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Allocate the dispensing events to the appropriate year based on the date when the prescription was filled. Use the Drug ID field in the NDC list to determine if the medications are the same or different. Injection dispensing event Calculating number of days covered for multiple prescriptions Injections count as one dispensing event. Multiple dispensing events of the same medication or a different medication count as separate dispensing events. Allocate the dispensing events to the appropriate year based on the date when the prescription was filled. If multiple prescriptions for different medications are dispensed on the same day, calculate number of days covered by a controller medication (for the numerator) using the prescriptions with the longest day s supply. For multiple different prescriptions dispensed on different days with overlapping day s supply, count each day within the treatment period only once toward the numerator. If multiple prescriptions for the same medication are dispensed on the same or different day, sum the day s supply and use the total to calculate the number of days covered by a controller medication (for the numerator). For example, three controller prescriptions for the same medication are dispensed on the same day, each with a 30- day supply, sum the day s supply for a total of 90 days covered by a controller. Subtract any day s supply that extends beyond December 31 of the measurement year. Use the drug ID provided by the NDC to determine if the prescriptions are the same or different. Eligible Population Product lines Ages Commercial, Medicaid, Medicare (report each product line separately) years by December 31 of the measurement year. Report five four age stratifications and a total rate: 5 11 years years years years years. Total The total is the sum of the age stratifications. Continuous enrollment Allowable gap Anchor date Benefits The measurement year and the year prior to the measurement year. No more than one gap in enrollment of up to 45 days during each year of continuous enrollment. To determine continuous enrollment for a Medicaid beneficiary for whom enrollment is verified monthly, the member may not have more than a 1-month gap in coverage during each year of continuous enrollment year. December 31 of the measurement year. Medical. Pharmacy during the measurement year.

4 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Event/diagnosis Step 1 Step 2 Step 3: Required exclusions Follow the steps below to identify the eligible population for the measure. Identify members as having persistent asthma who met at least one of the following criteria during both the measurement year and the year prior to the measurement year. Criteria need not be the same across both years. At least one ED visit (ED Value Set), with a principal diagnosis of asthma (Asthma Value Set). At least one acute inpatient encounter (Acute Inpatient Value Set), with a principal diagnosis of asthma (Asthma Value Set). At least four outpatient visits (Outpatient Value Set) or observation visits (Observation Value Set) on different dates of service, with any diagnosis of asthma (Asthma Value Set) and at least two asthma medication dispensing events (Table ASM-C). Visit type need not be the same for the four visits. At least four asthma medication dispensing events (Table ASM-C). A member identified as having persistent asthma because of at least four asthma medication dispensing events, where leukotriene modifiers or antibody inhibitors were the sole asthma medication dispensed in that year, must also have at least one diagnosis of asthma (Asthma Value Set), in any setting, in the same year as the leukotriene modifier or antibody inhibitor (i.e., measurement year or year prior to the measurement year). Exclude members who met any of the following criteria: Members who had any diagnosis from any of the following value sets, any time during the member s history through December 31 of the measurement year: Emphysema Value Set. Other Emphysema Value Set. COPD Value Set. Obstructive Chronic Bronchitis Value Set. Chronic Respiratory Conditions Due to Fumes/Vapors Value Set. Cystic Fibrosis Value Set. Acute Respiratory Failure Value Set. Members who have no asthma controller medications (Table ASM-D) dispensed during the measurement year. Administrative Specification Denominator The eligible population. Numerators Medication compliance 50% Medication compliance 75% The number of members who achieved a PDC of at least 50% for their asthma controller medications (Table ASM-D) during the measurement year. The number of members who achieved a PDC of at least 75% for their asthma controller medications (Table ASM-D) during the measurement year. Follow the steps below to identify numerator compliance.

5 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Step 1 Step 2 Step 3 Step 4 Identify the IPSD. The IPSD is the earliest dispensing event for any asthma controller medication (Table ASM-D) during the measurement year. To determine the treatment period, calculate the number of days from the IPSD (inclusive) to the end of the measurement year. Count the days covered by at least one prescription for an asthma controller medication (Table ASM-D) during the treatment period. To ensure that day s supply that extends beyond the measurement year is not counted, subtract any day s supply that extends beyond December 31 of the measurement year. Calculate the member s PDC using the following equation. Round (using the.5 rule) to two decimal places. Total Days Covered by a Controller Medication in the Treatment Period (step 3) Total Days in Treatment Period (step 2) Medication compliance 50% Medication compliance 75% Sum the number of members whose PDC is 50% for their treatment period. Sum the number of members whose PDC is 75% for their treatment period. Data Elements for Reporting Organizations that submit HEDIS data to NCQA must provide the following data elements. Table ASM-1/2: Data Elements for Use of Appropriate Medications for People With Asthma Administrative Measurement year Data collection methodology (Administrative) Eligible population For each age stratification and total Number of required exclusions For each age stratification and total Numerator events by administrative data For each age stratification and total Reported rate For each age stratification and total Lower 95% confidence interval For each age stratification and total Upper 95% confidence interval For each age stratification and total

6 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Medication Management for People with Asthma and Asthma Medication Ratio Measures Work-Up Medication Management for People With Asthma Measure Description The percentage of members 5 85 years of age who were identified as having persistent asthma and were dispensed appropriate medications, which they remained on during the treatment period. Two rates are reported: 1. The percentage of members who remained on an asthma controller medication for at least 50 percent of their treatment period. 2. The percentage of members who remained on an asthma controller medication for at least 75 percent of their treatment period. Asthma Medication Ratio Measure Description The percentage of members over 5-85 years of age who were identified as having persistent asthma and had a ratio of controller medications to total asthma medications of 0.50 or greater during the measurement year. Topic Overview Importance and Prevalence Health importance Asthma is one of the most prevalent chronic diseases. In 2010, 25.7 million Americans had asthma: 7 million children, 15.6 million adults under 65 and 3.1 million adults 65 and older (Akinbami et al. 2012). Asthma has become more common over the past decade, occurring in 7.3 percent of the population in 2001, compared with 8.4 percent in 2010 (Akinbami et al. 2012). Asthma is responsible for more than 3,000 deaths in the U.S. annually (American Lung Association 2012b). In 2010, approximately 17.8 million clinical visits (hospital, outpatient, emergency department, and physician offices) were attributed to asthma (Centers for Disease Control and Prevention [CDC] 2014). The incidence rate, and subsequently the number of asthma-related health visits, is expected to increase by an additional 100 million globally by 2025 (World Health Organization 2007). Appropriate medication adherence could ameliorate the severity of many asthmarelated symptoms (Akinbami et al. 2009). According to the Asthma Regional Council of New England, two-thirds of adults and children who display asthma symptoms are considered not well controlled or very poorly controlled as defined by clinical practice guidelines (Stillman 2010). Pharmacologic therapy is used to prevent and control asthma symptoms, improve quality of life, reduce frequency and severity of asthma exacerbations and reverse airflow obstruction (National Heart, Lung, and Blood Institute [NHLBI]/National Asthma and Education Prevention Program [NAEPP] 2007). Utilization, outcome by age, race/ ethnicity, gender The National Health Interview Survey (NHIS) examined asthma prevalence among a range of subgroups from the late 1980s to 2006 (CDC 2009). Survey results showed that children consistently demonstrated higher prevalence and hospitalization rates than adults (CDC 2009). Asthma is among the leading causes of hospitalization for children (American Lung Association 2012b). It disproportionately affects a higher percentage of boys than girls (CDC 2009).

7 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, In addition, children of low-income families experience more urgent care visits, hospitalizations and mortality due to asthma (CDC 2009). In terms of racial/ethnic disparities, asthma prevalence rates are highest for non-hispanic African-American children (14.2 percent) and lowest for Asian children (7.1 percent), with the greatest amount of variability among Hispanic subgroups (CDC 2009). For the adult subgroup, African-Americans have a higher prevalence of asthma than Whites; non-hispanic African-Americans have higher rates of asthma than Hispanics and non-hispanic Whites (CDC 2009). African Americans are also more likely to be hospitalized or die as a result of asthma-based complications (CDC 2009). Women consistently outrank men in prevalence of asthma (CDC 2009), and historically have had higher hospital discharge rates and higher mortality rates due to asthma (CDC 2009). Asthma in the older adult population Asthma prevalence in older adults is comparable to other age groups; clinical practice guidelines suggest the same treatments for all asthma patients over 12 years old. One study found that asthma is more likely to be uncontrolled in older adults (Melani 2013). Asthma in older adults tends to be more severe than asthma developed earlier in life, which can be exacerbated by other comorbid conditions (Reed 2010). Factors such as patients attribution of symptoms to aging and confusing symptoms with other chronic conditions or comorbidities prevent proper recognition and diagnosis of asthma in the older population (Melani 2013). Non-adherence to medication is also an issue, increasing the risk of adverse events, ED visits and hospitalizations, as well as cost (Melani 2013). In adults over 40 years of age, COPD becomes more common and distinguishing asthma from COPD becomes problematic (Global Initiative for Asthma [GINA] 2012). Many patients have symptoms of both asthma and COPD. One study found that from , approximately 7 percent of people 65 and older were estimated to have asthma and 9 percent had COPD. 3 percent were estimated to have co-occurring current asthma and COPD (Oraka et al. 2012). The prevalence of asthma decreases and the prevalence of COPD increases with advancing age (Oraka et al. 2012). The authors concluded that although asthma affects a substantial proportion of the elderly population, increased diagnosis of COPD may overshadow correct diagnosis and treatment of asthma. Financial importance and costeffectiveness Asthma accounted for more than $50 billion spent on health care in the United States in 2007, an increase of almost $2 billion from 2002 (CDC 2011). Inpatient hospitalization accounted for over 50 percent of overall asthma-related costs (Bahadori et al. 2009). In addition to the direct financial burden, asthma is also a leading cause of absenteeism and productivity an estimated 14.2 million missed workdays for adults and more than 14 million missed school days for children (Akinbami et al. 2009). Studies have shown that the indirect costs of asthma are a growing financial burden on patients and result in significant additional costs (Bahadori et al. 2009). Appropriate medication management has the potential to prevent a significant proportion of asthma-related costs (Akinbami et al. 2009). The Asthma Regional Council supports this, stating that proper management could potentially save at least 25 percent ($5 billion) of total national asthma costs, nationally by reducing health care costs (American Lung Association 2012a). The Children s Health Fund s Childhood Asthma Initiative examined patients enrolled in an asthma intervention program. Treatment that aligned with clinical guidelines reduced the severity of symptoms and asthma-related events (Berger 2010). Subsequent savings attributed to improved clinical outcomes totaled nearly $4.2 million, or $4,525 per patient, translating to a significant reduction in federally subsidized and private, insurance-based costs for this population (Berger 2010).

8 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Supporting Evidence for Management of Asthma The goals of therapy for adults and children with asthma are to reduce symptoms and impairment (e.g., coughing, breathlessness, ED visit, hospitalizations, progressive loss of lung function); and to minimize the risk of adverse effects from medication (NHLBI/NAEPP 2007). Numerous randomized control trials have found that a step approach to asthma management improves outcomes (NHLBI/NAEPP 2007; GINA 2014). It involves adjusting medication (increasing doses if necessary, decreasing doses when possible) throughout a cycle of assessment, treatment and review (NHLBI/NAEPP 2007; GINA 2014). Clinical practice guidelines contain different recommendations for children with asthma than for adults with asthma. Guidelines generally reference the age groups 0 4 years, 5 11 years and 12 years and older (Table 1). Asthma Medications Controller medications These medications reduce airway inflammation, control symptoms and reduce future risks such as exacerbations and decline in lung function (GINA 2014). Inhaled corticosteroids (ICS) are the most effective long-term-control medications because they alleviate the underlying inflammation that is characteristic of asthma (NHLBI/NAEPP 2007; British Thoracic Society [BTS]/Scottish Intercollegiate Guidelines Network [SIGN] 2014; Singapore Ministry of Health [SMOH] 2008; GINA 2014; Sveum et al. 2012; Joint Task Force on Practice Parameters 2005). However, sensitivity (and, consequently, clinical response) to ICSs can vary among patients (NHLBI/NAEPP 2007). Leukotriene receptor antagonists or chromones are alternative medications, although they have lower efficacy than ICSs (NHLBI/NAEPP 2007; GINA 2014; Joint Task Force on Practice Parameters 2005). Reliever (rescue) medications Reliever medications are provided to all patients for as-needed relief of symptoms during worsening asthma and exacerbations. Reducing (and, ideally, eliminating) the need for reliever treatment is an important goal in asthma management and a measure of success of asthma treatment (GINA 2014). Short-acting β-agonists (SABA) are bronchodilators that relax smooth muscle and are the preferred therapy for quick relief of asthma symptoms (NHLBI/NAEPP 2007; BTS/SIGN 2014; SMOH 2008; GINA 2014; Sveum et al. 2012; Joint Task Force on Practice Parameters 2005). Anticholinergics can be used as an alternative in patients who do not tolerate SABAs (NHLBI/NAEPP 2007; BTS/SIGN 2014; SMOH 2008). Combination therapy Patients with moderate to severe asthma who have persistent symptoms or exacerbations despite optimized treatment with high-dose controller medications can have other medications added to their primary medication therapy (NHLBI/NAEPP 2007; BTS/SIGN 2014; SMOH 2008; GINA 2014; Sveum 2012; Joint Task Force on Practice Parameters 2005). LABAs, leukotriene modifiers, and theophylline can be added to ICSs (NHLBI/NAEPP 2007; GINA 2014; BTS/SIGN 2014; Sveum 2012); immunomodulators can be added for patients 12 years or older who have allergies and severe persistent asthma (NHLBI/NAEPP 2007). For patients with moderate to severe exacerbations, anticholinergics and oral systemic corticosteroids can be added to SABA treatment to provide added benefit (NHLBI/NAEPP 2007).

9 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Gaps in Care Recent data from the HEDIS Health Plan measures continue to show room for improvement. Medicaid plans consistently perform at lower rates than commercial plans and there is a significant difference in performance rates between the 10th and 90th percentiles for both measures. Performance on the HEDIS asthma measures is summarized below: Medication Management for People With Asthma Asthma Medication Ratio Commercial plan performance on rate 1 ( remained on controller medication for 50 percent of treatment period ) was 67.3 percent from ; Medicaid plans averaged 52.5 percent. Both commercial and Medicaid plans had consistently lower performance on rate 2 ( remained on controller medication for 75 percent of treatment period ) with 43.9 and 30.1 percent, respectively, from Commercial plan performance from was 77.8 percent; Medicaid was 61.4 percent. Health Care Disparities One study highlights disparities in the delivery of care when considering socioeconomic status and race/ ethnicity. Data were collected using the Medical Expenditure Panel Survey (MEPS) ( ), surveying 982 children with asthma younger than 18 years. Results showed that non-hispanic African-American children utilized urgent care services more frequently than preventive care services (Kim et al. 2009). Additionally, children from low-income families were less likely to have prescriptions filled and receive annual primary health examinations (Kim et al. 2009). The study also examined insurance coverage, showing that children with insurance coverage utilized primary health care services for asthma more often (Kim et al. 2009). References Akinbami, L.J., J.E. Moorman, P.L. Garbe, E.J. Sondik Status of Childhood Asthma in the United States Pediatrics 123;S (July 8, 2014) doi: /peds C. Akinbami, L.J., J.E. Moorman, C. Bailey, H.S. Zahran, M. King, C.A. Johnson, X. Liu Trends in Asthma Prevalence, Health Care Use, and Mortality in the United States, NCHS Data Brief, no. 94 (May). (July 9, 2014) American Lung Association. 2012a. Trends in Asthma Morbidity and Mortality. (July 8, 2014) American Lung Association. 2012b. Asthma & Children Fact Sheet, October (July 8, 2014) Bahadori, K., M.M. Doyle-Waters, C. Marra, L. Lynd, K. Alasaly, J. Swiston, J.M. FitzGerald Economic Burden of Asthma: A Systematic Review. BMC Pulmonary Medicine 9: 24. (July 8, 2014) doi: / Berger, S Best Practice Asthma Program Saves the US Healthcare System More Than $4500 A Year Per Child. Columbia University Mailman School of Public Health, May 13. (July 8, 2014) year-child. British Thoracic Society (BTS)/Scottish Intercollegiate Guidelines Network (SIGN) British Guideline on the Management of Asthma: A National Clinical Guideline. Edinburgh (Scotland): Scottish Intercollegiate Guidelines Network (SIGN) (October). (February 11, 2015) https://www.brit-thoracic.org.uk/documentlibrary/clinical-information/asthma/btssign-asthma-guideline-2014/. Centers for Disease Control and Prevention (CDC). Asthma: A Presentation of Asthma Management and Prevention, September (July 8, 2014)

10 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Centers for Disease Control and Prevention (CDC) Asthma Attacks Among Persons with Current Asthma United States, Morbidity and Mortality Weekly Report 62(03); (November), (July 8, 2014) Centers for Disease Control and Prevention (CDC) FastStats: Asthma. Last modified February 25. (July 8, 2014) Centers for Disease Control and Prevention (CDC). Vital Signs: Asthma in the US, May (July 8, 2014) Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention. (July 10, 2014) Joint Task Force on Practice Parameters Attaining Optimal Asthma Control: A Practice Parameter. Journal of Allergy and Clinical Immunology 116(5): S3-11. Kim, H., G.M. Kieckhefer, A.A. Greek, J.M. Joesch, N. Baydar Health Care Utilization by Children with Asthma. Preventing Chronic Disease 6(1): A12. Melani, A.S Management of Asthma in the Elderly Patient. Clinical Interventions in Aging 8: National Heart Lung and Blood Institute/National Asthma Education and Prevention Program Expert Panel Report 3: Guidelines for the Diagnosis and Management of Asthma. Washington (DC): National Heart Lung and Blood Institute (NHLBI), NIH Publication No (July 8, 2014) Oraka, E., H.J. Kim, M.E. King, D.B. Callahan Asthma Prevalence Among US Elderly by Age Groups: Age Still Matters. Journal of Asthma 49(6): Reed, C.E Asthma in the Elderly: Diagnosis and Management. Journal of Allergy and Clinical Immunology 126(4): Singapore Ministry of Health (SMOH) Clinical Practice Guidelines: Management of Asthma. Singapore: Singapore Ministry of Health. (July 8, 2014) Stillman, L Living with Asthma in New England: Results from the 2006 BRFSS and Call-back Survey. A report by the Asthma Regional Council of New England (February). (July 8, 2014) Sveum, R., J. Bergstrom, G. Brottman, et al Institute for Clinical Systems Improvement: Diagnosis and Management of Asthma (July). (July 8, 2014) https://www.icsi.org/_asset/rsjvnd/asthma.pdf. World Health Organization Global Surveillance, Prevention and Control of Chronic Respiratory Diseases: A Comprehensive Approach. Switzerland: World Health Organization. (July 8, 2014)

11 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Table 1: Guidelines Organization, Guideline, Date British Thoracic Society/ Scottish Intercollegiate Guidelines Network (SIGN) (2014) Recommendation & Grade STEPWISE MANAGEMENT OF ASTHMA Step 1: Mild intermittent asthma Prescribe an inhaled short-acting β2 agonist as short term reliever therapy for all patients with symptomatic asthma. Age Group >12 years 5-12 years <5 years Grade A B D Step 2: Introduction of regular preventer therapy Inhaled steroids are the recommended preventer drug for adults and children for achieving overall treatment goals. Age Group >12 years 5-12 years <5 years Grade A A A Step 3: Initial add-on therapy The first choice as add-on therapy to inhaled steroids in adults and children (5-12 years) is an inhaled long-acting β2 agonist, which should be considered before going above a dose of 400 micrograms BDP or equivalent per day and certainly before going above 800 micrograms BDP. Age Group >12 years 5-12 years <5 years Grade A B NR Step 4: Poor control on moderate dose of inhaled steroid + additional therapy: addition of fourth drug If control remains inadequate on 800 micrograms BDP daily (adults) and 400 micrograms daily (children) of an inhaled steroid plus a long-acting β2 agonist, consider the following interventions: Increasing inhaled steroids to 2000 micrograms BDP/day (adults) or 800 micrograms BDP/day (children 5-12 years) * Leukotriene receptor antagonists Theophyllines Slow release β2 agonist tablets, though caution needs to be used in patients already on long-acting β2 agonists.

12 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date continued Age Group >12 years 5-12 years <5 years Grade D. D NR Recommendation & Grade Step 5: Continuous or frequent use of oral steroids For the small number of patients not controlled at step 4, use daily steroid tablets in the lowest dose providing adequate control. Global Initiative for Asthma (2014) ACUTE ASTHMA Use high-dose inhaled β2 agonists as first line agents in acute asthma and administer as early as possible. Reserve intravenous β2 agonists for those patients in whom inhaled therapy cannot be used reliably (Grade: A) Add nebulized ipratropium bromide (0.5 mg 4-6 hourly) to β2 agonist treatment for patients with acute severe or life threatening asthma or those with a poor initial response to β2 agonist therapy (Grade: B) Consider giving a single dose of IV magnesium sulphate for patients with acute severe asthma who have not had a good initial response to inhaled bronchodilator therapy or life threatening or near fatal asthma (Grade: B) TREATMENT STEPS FOR ACHIEVING CONTROL Step 1: As-Needed Reliever Medication Reserved for untreated patients with occasional daytime symptoms of short duration comparable with controlled asthma. When symptoms are more frequent, and/or worsen periodically, patients require regular controller treatment (see Steps 2 or higher) in addition to as-needed reliever medication (Evidence B). For the majority of patients, a rapid-acting inhaled β2-agonist is the recommended reliever treatment (Evidence A). An inhaled anticholinergic, short-acting oral β2-agonist, or short-acting theophylline may be considered as alternatives, although they have a slower onset of action and higher risk of side effects (Evidence A). Step 2: Reliever Medication Plus a Single Controller At Step 2, a low-dose inhaled corticosteroid is recommended as the initial controller treatment for asthma patients of all ages (Evidence A). Alternative controller medications include leukotriene modifiers (Evidence A), appropriate particularly for patients who are unable or unwilling to use inhaled corticosteroids, or who experience intolerable side effects such as persistent hoarseness from inhaled corticosteroid treatment and those with concomitant allergic rhinitis (Evidence C).

13 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date continued Recommendation & Grade Other options are available but not recommended for routine use as initial or first-line controllers in Step 2. Sustainedrelease theophylline has only weak anti-inflammatory and controller efficacy (Evidence B) and is commonly associated with side effects that range from trivial to intolerable. Cromones (nedocromil sodium and sodium cromoglycate) have comparatively low efficacy, though a favorable safety profile (Evidence A). Step 3: Reliever Medication Plus One or Two Controllers For children, adolescents and adults recommendation is to combine a low-dose of inhaled corticosteroid with an inhaled long-acting β2-agonist, either in a combination inhaler device or as separate components (Evidence A). Because of the additive effect of this combination, the low-dose of corticosteroid is usually sufficient, and need only be increased if control is not achieved within 3 or 4 months with this regimen (Evidence A). The long-acting β2-agonist formoterol, which has a rapid onset of action whether given alone or in combination inhaler with budesonide, has been shown to be as effective as short-acting β2-agonist in acute asthma exacerbation. However its use as monotherapy as a reliever medication is strongly discouraged since it must always be used in association with an inhaled corticosteroid. For all children but particularly those 5 years and younger, combination therapy has been less well studied and the addition of a long-acting β2-agonist may not be as effective as increasing the dose of inhaled corticosteroids in reducing exacerbations. If a combination inhaler containing formoterol and budesonide is selected, it may be used for both rescue and maintenance. This approach has been shown to result in reductions in exacerbations and improvements in asthma control in adults and adolescents at relatively low doses of treatment (Evidence A). Whether this approach can be employed with other combinations of controller and reliever requires further study. Another option for both adults and children, but the one recommended for children, is to increase to a medium-dose of inhaled corticosteroids (Evidence A). For patients of all ages on medium- or high-dose of inhaled corticosteroid delivered by a pressurized metered-dose inhaler (MDI), use of a spacer device is recommended to improve delivery to the airways, reduce oropharyngeal side effects, and reduce systemic absorption (Evidence A). Another option at Step 3 is to combine a low-dose inhaled corticosteroid with leukotriene modifiers (Evidence A). Alternatively, the use of sustained-release theophylline given at low-dose may be considered (Evidence B). These options have not been fully studied in children 5 years and younger.

14 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date continued Recommendation & Grade Step 4: Reliever Medication Plus Two or More Controllers The selection of treatment at Step 4 depends on prior selections at Steps 2 and 3. However, the order in which additional medications should be added is based upon evidence of their relative efficacy in clinical trials. The preferred treatment at Step 4 is to combine a medium- or high-dose of inhaled corticosteroid with a long-acting inhaled β2-agonist. However, in most patients, the increase from a medium- to a high-dose of inhaled corticosteroid provides relatively little additional benefit (Evidence A), and the high-dose is recommended only on a trial basis for 3 to 6 months when control cannot be achieved with medium-dose inhaled corticosteroid combined with a long-acting β2- agonist and/or a third controller (e.g., leukotriene modifiers or sustained-release theophylline) (Evidence B). Prolonged use of high-dose inhaled corticosteroid is also associated with increased potential for adverse effects. At medium- and high-doses, twice-daily dosing is necessary for most but not all inhaled corticosteroid (Evidence A). With budesonide, efficacy may be improved with more frequent dosing (four times daily) (Evidence B). Leukotriene modifiers as add-on treatment to medium-to high-dose inhaled corticosteroids have been shown to provide benefit (Evidence A), but usually less than that achieved with the addition of a long-acting β2-agonist (Evidence A). The addition of a low-dose of sustained-release theophylline to medium- or high-dose inhaled corticosteroid and long-acting β2-agonist may also provide benefit (Evidence B). Step 5: Reliever Medication Plus Additional Controller Options Addition of oral corticosteroid to other controller medications may be effective (Evidence D) but is associated with severe side effects (Evidence A) and should only be considered if the patient's asthma remains severely uncontrolled on Step 4 medications with daily limitation of activities and frequent exacerbations. Patients should be counseled about potential side effects and all other alternative treatments must be considered. Addition of anti-immunoglobulin E (anti-ige) treatment to other controller medications has been shown to improve control of allergic asthma when control has not been achieved on combinations of other controllers including high-doses of inhaled or oral corticosteroids (Evidence B).

15 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date Institute for Clinical Systems Improvement (ICSI) (2012) Recommendation & Grade OVERVIEW Clinicians should follow the stepwise approach in asthma management therapy. Clinicians should use inhaled corticosteroids as the preferred treatment over leukotriene receptor antagonists in mild persistent asthma in adults and children. Based on data comparing leukotriene receptor antagonists (LTRAs) to inhaled corticosteroids, inhaled corticosteroids are the preferred treatment option for mild persistent asthma in adults and children. LTRAs are an alternative, although not preferred, treatment. (High Quality Evidence) MANAGEMENT APPROACH FOR ASTHMA IN CHILDREN 5-11 YEARS OF AGE (High Quality Evidence) Step 1: Short-acting Beta2-Agonist prn Step 2: Low-Dose ICS Alternative: Leukotriene Modifier Step 3: Medium-Dose ICS Alternative: Medium-Dose ICS plus (add one) LABA or Leukotriene Modifier Step 4: Medium-Dose ICS plus (add one) LABA or Leukotriene Modifier Step 5: High-dose ICS plus one or more LABA Alternative: High-dose ICS plus leukotriene modifier Alternative: High-dose ICS plus LABA plus oral systemic corticosteroid Alternative: High-dose ICS plus leukotriene modifier plus oral systemic corticosteroid Step 6: High-dose ICS plus LABA plus oral systemic corticosteroid Alternative: High-dose ICS plus leukotriene modifier plus oral systemic corticosteroid MANAGEMENT APPROACH FOR ASTHMA 12 YEARS OF AGE AND OLDER (High Quality Evidence) Step 1: Short-acting Beta2-Agonist as needed Step 2: Low-Dose ICS Alternative: Leukotriene Modifier Step 3: Medium- Dose ICS Alternative: Low-Dose ICS plus LABA Alternative: Low-Dose ICS plus Leukotriene Modifier

16 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date continued Joint Task Force on Practice Parameters (American Academy of Allergy, Asthma & Immunology [AAAAI], American College of Allergy, Asthma & Immunology [ACAAI], and the Joint Council of Allergy, Asthma & Immunology [JCAAI]) (2005) National Heart Lung and Blood Institute/National Asthma and Education Prevention Program (NHLBI/NAEPP) (2007) Step 4: Medium-Dose ICS plus LABA Recommendation & Grade Alternative: Medium-Dose ICS plus Leukotriene Modifier Step 5: High-dose ICS plus LABA Alternative: High-dose ICS plus LABA plus one or more leukotriene modifier or Anti-IgE if applicable Step 6: High-Dose ICS plus LABA plus oral corticosteroid Alternative: High-Dose ICS plus LABA plus oral corticosteroid plus one or more leukotriene modifier or Anti-IgE if applicable GUIDELINES FOR THE PHARMACOTHERAPY OF ASTHMA The step care of asthma should be based on asthma control. (A) Step 1: Short-acting β-agonist as needed (indicated for all patients) Step 2: Low-dose ICSs, leukotriene modifiers, theophylline, cromolyn, or nedocromil Step 3: Low-dose/medium-dose ICSs plus inhaled LABA or medium-dose ICSs; low-dose/medium-dose ICSs plus either leukotriene modifier or theophylline Step 4: High-dose ICSs and LABA plus systemic corticosteroids if needed (consider monoclonal anti-ige) LONG-TERM CONTROL MEDICATIONS The Expert Panel recommends that long-term control medications (including ICSs, inhaled long-acting bronchodilators, leukotriene modifiers, cromolyn, theophylline, and immunomodulators) be taken daily on a longterm basis to achieve and maintain control of persistent asthma. The most effective long-term-control medications are those that attenuate the underlying inflammation that is characteristic of asthma (Evidence A). Inhaled Corticosteroids (for children and adults with mild persistent asthma) The Expert Panel concludes that ICSs are the most potent and consistently effective long-term control medication for asthma (Evidence A). The Expert Panel concludes that sensitivity and consequently clinical response to ICS can vary among patients (Evidence B). The Expert Panel concludes that studies demonstrate that ICSs improve asthma control more effectively in both children and adults than LTRAs or any other single long-term control medication (Evidence A). Inhaled Long-Acting Beta2-Agonists LABAs are not recommended for use as monotherapy for long-term control of persistent asthma (Evidence A). Use of LABA is not currently recommended to treat acute symptoms or exacerbations of asthma (Evidence D).

17 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date continued Recommendation & Grade Oral Systemic Corticosteroids The Expert Panel recommends that, because the magnitude of adverse effects is often related to the dose, frequency of administration, and the duration of corticosteroid use (Evidence A), every consideration should be given to minimize systemic corticosteroid doses and maximize other modes of therapy (Evidence D). It is necessary, therefore, to monitor for the development and progression of adverse effects and to take appropriate steps to minimize the risk and impact of adverse corticosteroid effects (Evidence D). Cromolyn Sodium and Nedocromil for mild persistent asthma Cromolyn and nedocromil are alternative, not preferred, medications for the treatment of mild persistent asthma (Evidence A). Immunomodulators for persistent severe asthma The Expert Panel recommends that omalizumab may be considered as adjunctive therapy in step 5 or 6 care for patients who have allergies and severe persistent asthma that is inadequately controlled with the combination of high-dose ICS and LABA (Evidence B). Leukotriene Modifiers for mild persistent asthma The Expert Panel recommends that LTRAs are an alternative, not preferred, treatment option for mild persistent asthma (Step 2 care) (Evidence A). Combination Therapy (for children and adults with moderate to severe persistent asthma) The Expert Panel recommends that when patients 12 years of age require more than low-dose ICS alone to control asthma (i.e., step 3 care or higher), a therapeutic option is to add LABA to ICS (Evidence A). Alternative, but not preferred adjunctive therapies include LTRA (Evidence B), theophylline (Evidence B), or, in adults, zileuton (Evidence D). For children 0 11 years of age, LABA, LTRA, and, in children 5 11 years of age, theophylline may be considered as adjunctive therapies in combination with ICS (Evidence B). QUICK RELIEF MEDICATIONS Inhaled Short-Acting Beta2-Agonists The Expert Panel recommends that SABAs are the drug of choice for treating acute asthma symptoms and exacerbations and for preventing EIB (Evidence A). The Expert Panel recommends the use of SABA as the most effective medication for relieving acute bronchoconstriction; SABAs have few negative cardiovascular effects (Evidence A). The Expert Panel does not recommend regularly scheduled, daily, long-term use of SABA (Evidence A).

18 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date Singapore Ministry of Health (SMOH) (2008) Recommendation & Grade Systemic Corticosteroids The Expert Panel recommends the use of oral systemic corticosteroids in moderate or severe exacerbations (Evidence A). Combination Therapy: AnticholinergicsThe Expert Panel concludes that ipratropium bromide, administered in multiple doses along with SABA in moderate or severe asthma exacerbations in the ED, provides additive benefit (Evidence B). OBJECTIVES OF ASTHMA MANAGEMENT Inhaled corticosteroids are best used at low to moderate doses (Grade A, Level 1+) Long acting β2-agonists including salmeterol and formoterol should never be used as monotherapy in asthma (Grade A, Level 1+) The strategy of add on therapy with long acting β2-agonists is recommended when a low to medium-dose of inhaled corticosteroids alone fails to achieve control of asthma (Grade A, Level 1++) Formoterol is a long acting β2-agonist which has a rapid onset of action comparable to that of a rapid acting β2-agonist drug. If a combination inhaler containing formoterol and budesonide is considered, it may be used for both rescue and maintenance. This has been shown to reduce exacerbations and improve asthma control in adults and adolescents at relatively low doses of treatment (Grade A, Level 1+) Theophylline has a bronchodilator action and also modest anti-inflammatory properties. It cannot however be used as a controller drug. It may be useful as an add-on drug in patients who do not achieve good control on inhaled corticosteroids alone Leukotreine modifiers such as montelukast have a small and variable bronchodilator effect, reducing symptoms including cough, improving lung function and reducing exacerbations and airway inflammation. It can either be used as an alternative to low dose inhaled corticosteroids in patients with mild persistent asthma, or as an add-on drug when low dose inhaled corticosteroids or when the combination of inhaled corticosteroids with long acting β2-agonist have not given the desired effect (Grade A, Level 1+) The combination of inhaled ipratropium and inhaled β2-agonist may be used in the treatment of acute severe asthma exacerbation (Grade A, Level 1+) Short-term burst oral corticosteroids may be given at the dose of mg/day for 5-10 days as treatment of severe acute exacerbation of asthma and in worsening asthma (Grade A, Level 1+) Regular low doses of oral steroids cause severe and intolerable long-term side effects and should not be used in primary care

19 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, Organization, Guideline, Date continued MANAGEMENT OF ASTHMA IN CHILDREN: Recommendation & Grade Rapid-acting inhaled β2-agonists are the medications of choice for relief of bronchoconstriction and for the pre-treatment of exercise induced asthma. β2-agonist metered-dose-inhaler (MDI) delivered by the holding chamber/spacer has been shown to be at least as effective as the nebulizer. Hence routine use of nebulizers is not recommended. During asthma exacerbations, as many as 4-8 puffs of salbutamol inhaler or puffs/kg (max 10 puffs) may be used (Grade A, Level 1++) Long acting inhaled β2-agonists may be used as add-on therapy for children with symptoms which are not controlled with low dose inhaled steroids. These should not be used without concomitant inhaled corticosteroids (Grade A, Level 1+) Only formoterol may be used as a reliever medicine in view of its rapid onset of action (Grade A, Level 1+) For the younger children with nocturnal symptoms, oral long acting β2-agonists may be useful. Sustained release theophylline can be useful for a short duration. It is important to monitor for side effects such as agitation, muscle tremors, palpitations and headache (Grade B, Level 2+) In older children above 5 years, leukotriene modifiers may be used as they provide clinical benefit at all levels of asthma severity. However, clinical benefits are generally less than those with inhaled corticosteroids (Grade A, Level 1++) Leukotriene modifiers may be used as an add-on therapy in children on low to moderate doses of inhaled steroids. In children with poor asthma control, adding a leukotriene modifier may provide additional benefit, including reducing the number of exacerbations (Grade A, Level 1+) A long acting β-agonist or a leukotriene modifier should be added rather than increasing the dose of inhaled steroids if children with mild persistent asthma do not show clinical improvement with inhaled steroids alone (Grade A, Level 1+) Combination agents containing long acting β2-agonists and inhaled steroids may be used in children above 5 years of age whose control is not optimum with low dose inhaled steroids

20 Draft Document for HEDIS 2016 Public Comment Obsolete After March 18, GRADING SYSTEM KEY: British Thoracic Society/SIGN Recommendation Grade A: At least one meta-analysis, systematic review, or RCT rated as 1++, and directly applicable to the target population; or A body of evidence consisting principally of studies rated as 1+, directly applicable to the target population, and demonstrating overall consistency of results B: A body of evidence including studies rated as 2++, directly applicable to the target population, and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 1++ or 1 C: A body of evidence including studies rated as 2+, directly applicable to the target population and demonstrating overall consistency of results; or Extrapolated evidence from studies rated as 2++ D: Evidence level 3 or 4; or Extrapolated evidence from studies rated as 2+ Evidence Level 1++ High quality meta-analyses, systematic reviews of RCTs, or RCTs with a very low risk of bias 1+ Well conducted meta-analyses, systematic reviews, or RCTs with a low risk of bias 1 - Meta-analyses, systematic reviews, or RCTs with a high risk of bias 2++ High quality systematic reviews of case control or cohort studies; High quality case control or cohort studies with a very low risk of confounding or bias and a high probability that the relationship is causal 2+ Well conducted case control or cohort studies with a low risk of confounding or bias and a moderate probability that the relationship is causal 2 - Case control or cohort studies with a high risk of confounding or bias and a significant risk that the relationship is not causal 3 Non-analytic studies, eg case reports, case series 4 Expert opinion Global Initiative for Asthma Evidence Levels: A : Randomized controlled trials (RCT). Rich body of data. Evidence is from endpoints of well-designed RCTs that provide a consistent pattern of findings in the population for which the recommendation is made. Category A requires substantial numbers of studies involving substantial numbers of participants. B: RCTs. Limited body of data. Evidence is from endpoints of intervention studies that include only a limited number of patients, post hoc or subgroup analysis of RCTs, or meta-analysis of RCTs. In general, Category B pertains when few randomized trials exist, they are small in size, they were undertaken in a population that differs from the target population of the recommendation, or the results are somewhat inconsistent. C: Nonrandomized trials. Observational studies. Evidence is from outcomes of uncontrolled or nonrandomized trials or from observational studies. D: Panel consensus judgment. This category is used only in cases where the provision of some guidance was deemed valuable but the clinical literature addressing the subject was insufficient to justify placement in one of the other categories. The Panel Consensus is based on clinical experience or knowledge that does not meet the above-listed criteria. ICSI High Quality Evidence = Further research is very unlikely to change our confidence in the estimate of effect. Moderate Quality Evidence = Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low Quality Evidence = Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate or any estimate of effect is very uncertain.

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