Proposed New Measure for HEDIS : Statin Therapy for Patients With Cardiovascular Disease

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1 Proposed New Measure for HEDIS : Statin Therapy for Patients With Cardiovascular Disease NCQA seeks comments on the proposed new measure for inclusion in the HEDIS 2016 measurement set: Statin Therapy for Patients With Cardiovascular Disease. The percentage of males years of age and females years of age during the measurement year, who were identified as having clinical atherosclerotic cardiovascular disease (ASCVD) and were dispensed at least moderate-intensity statin therapy that they remained on for at least 80 percent of the treatment period. Two rates are reported: 1. Received Statin Therapy. The percentage of members who were identified as having clinical ASCVD and were dispensed at least moderate intensity statin therapy during the measurement year. 2. Statin Adherence 80 percent. The percentage of members who were identified as having clinical ASCVD and were dispensed at least moderate-intensity statin therapy that they remained on for at least 80 percent of the treatment period. This measure represents an important area for quality improvement in patients with cardiovascular disease by assessing the use of statin therapy at an appropriate intensity and adherence to reduce the risk for cardiovascular events. The measure is based on 2013 blood cholesterol guidelines from the American College of Cardiology and the American Heart Association (ACC/AHA). 2 Convincing evidence estimates the benefit of statin therapy and adherence to reduce the risk for cardiovascular events: Moderate intensity statin therapy lowers low-density lipoprotein cholesterol (LDL-C) by 30 percent to less than 50 percent, on average. High-intensity statin therapy lowers LDL-C by 50 percent or more, on average. 2 Every 25 percent increase in adherence to statin therapy results in a 3.8 mg/dl reduction in LDL-C levels. 3 Every 10 mg/dl reduction in LDL-C levels results in a 10 percent reduction in overall cardiovascular risk. 4 NCQA tested this measure in a large research database of commercially insured and Medicare Advantage individuals to assess importance, feasibility, validity and overall performance. We tested multiple aspects of the specifications including denominator identification and age ranges, exclusions, statin dosage intensities, statin dispensing events and adherence to statin medications. Testing results revealed that the methods used to identify the denominator are appropriate. The age limit for females captures the patient population to benefit from statin therapy, while accounting for the risk of pregnancy. NCQA s advisory panels agreed with the specified denominator identification methods and age limits. 1 HEDIS is a registered trademark of the National Committee for Quality Assurance (NCQA). 2 Stone, N.J., J. Robinson, A.H. Lichtenstein, C.N. Bairey Merz, D.M. Lloyd-Jones, C.B. Blum, P. McBride, R.H. Eckel, J.S. Schwartz, A.C. Goldberg, S.T. Shero, G.D. Smith, Jr, D. Levy, K. Watson, P.W.F. Wilson ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. Journal of the American College of Cardiology doi: /j.jacc Ho, P.M., C.L. Bryson, J.S. Rumsfeld Medication adherence: its importance in cardiovascular outcomes. Circulation 119(23): C.R. Rahilly-Tierney, E.V. Lawler, R.E. Scranton, J.M. Gaziano Cardiovascular benefit of magnitude of lowdensity lipoprotein cholesterol reduction. Circulation 120: National Committee for Quality Assurance 1

2 The prevalence of conditions that are contraindications for statin therapy was very low in the measure s denominator. Our advisory panels recommended pregnancy, ESRD, cirrhosis and rhabdomyolysis as exclusions for this measure for face validity. The measure also proposes to exclude women trying to become pregnant and will use claims for clomiphene and in vitro fertilization to identify these patients. Our advisory panels debated excluding patients with claims for myalgia, myositis or myopathy. They recognized that although muscle pain or weakness is a common side effect of statin therapy, indicating statin intolerance, patients experiencing those issues should not necessarily stop receiving treatment; lower dosage intensity or alternative statins may be prescribed instead. However, there is currently no method for using administrative data to accurately identify patients who experience intolerance to statins. With these considerations in mind, we seek comments specific to excluding patients with claims for myalgia, myositis or myopathy. Testing results also revealed low rates of patients taking the recommended statin dosage intensity and poor rates of adherence to statin therapy. NCQA s advisory panels strongly support a measure to assess at least moderate-intensity statins to improve quality care and reduce the risk for cardiovascular events in patients with established disease. Furthermore, our panels recommend aligning with the accepted standard of 80 percent proportion of days covered, to measure high medication adherence. We request comments on these issues: Patients on statin therapy often experience muscle pain and weakness as symptoms of statin intolerance. However, there is currently no method for accurate identification of patients who experience intolerance to statins using administrative data. Although the codes for myalgia, myositis or myopathy are nonspecific, it is possible that claims for these conditions could serve as a proxy for statin intolerance. NCQA seeks comments on the following options for consideration: 1. Exclude patients with claims for myalgia, myositis and myopathy. 2. Exclude patients with claims for only myositis and myopathy. Do not exclude patients with claims for myalgia because it is the least severe of the conditions. 3. Do not exclude patients with claims for myalgia, myositis or myopathy. Supporting documents for the proposed measure include the draft measure specification and associated measure rationale work-up. NCQA acknowledges the contributions of the Cardiovascular Measurement Advisory Panel, the Technical Measurement Advisory Panel and the HEDIS Coding Panel and the Pharmacy Panel National Committee for Quality Assurance 2

3 Statin Therapy for Patients With Cardiovascular Disease SUMMARY OF CHANGES TO HEDIS 2016 First-year measure. Description The percentage of males years of age and females years of age during the measurement year who were identified as having clinical atherosclerotic cardiovascular disease (ASCVD) and were dispensed at least moderate-intensity statin therapy that they remained on for at least 80 percent of the treatment period. Two rates are reported: 1. Received Statin Therapy. The percentage of members who were identified as having clinical ASCVD and were dispensed at least moderate-intensity statin therapy during the measurement year. 2. Statin Adherence 80 Percent. The percentage of members who were identified as having clinical ASCVD and were dispensed at least moderate-intensity statin therapy that they remained on for at least 80 percent of the treatment period. Definitions Clinical ASCVD IPSD Treatment period PDC Calculating number of days covered for multiple prescriptions Refer to Eligible Population Event/Diagnosis for member identification instructions. Index prescription start date. The earliest prescription dispensing date for any statin medication of at least moderate intensity 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 the member is covered by at least one statin medication prescription of appropriate intensity, divided by the number of days in the treatment period. If multiple prescriptions for different medications are dispensed on the same day, calculate the number of days covered by a statin medication (for the numerator) using the prescriptions with the longest days supply. For multiple different prescriptions dispensed on different days with overlapping days supply, count each day in the treatment period only once toward the numerator. If multiple prescriptions for the same medication are dispensed on the same day or on different days, sum the days supply and use the total to calculate the number of days covered by a statin medication (for the numerator). For example, three prescriptions for the same medication are dispensed on the same day, each with a 30-day supply. Sum the days supply for a total of 90 days covered by a statin. Subtract any days 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 National Committee for Quality Assurance 3

4 Eligible Population: Rate 1 Received Statin Therapy Product line Age Continuous enrollment Allowable gap Anchor date Benefit Event/Diagnosis Step 1: Commercial, Medicaid, Medicare (report each product line separately). Males years as of December 31 of the measurement year. Females years as of December 31 of the measurement year. 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 (i.e., a member whose coverage lapses for 2 months [60 days] is not considered continuously enrolled). December 31 of the measurement year. Medical during the measurement year and the year prior. Pharmacy during the measurement year. Follow the steps below to identify the eligible population. Members are identified for the eligible population in two ways: by event or by diagnosis. The organization must use both methods to identify the eligible population, but a member only needs to be identified by one method to be included in the measure. Event. Any of the following during the year prior to the measurement year meet criteria: MI. Discharged from an inpatient setting with an MI (MI Value Set). Use both facility and professional claims to identify MI. CABG. Discharged from an inpatient setting with a CABG (CABG Value Set). Use both facility and professional claims to identify CABG. PCI. Members who had PCI (PCI Value Set) in any setting. Other revascularization. Members who had any other revascularization procedures (Other Revascularization Value Set) in any setting. Diagnosis. Identify members as having ischemic vascular disease (IVD) 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 outpatient visit (Outpatient Value Set) with an IVD diagnosis (IVD Value Set), or At least one acute inpatient encounter (Acute Inpatient Value Set) with an IVD diagnosis (IVD Value Set). Step 2: Required exclusions Exclude members who meet any of the following criteria: Pregnancy (Pregnancy Value Set) during the measurement year or year prior to the measurement year. In vitro fertilization (IVF Value Set) in the measurement year or year prior to the measurement year. Dispensed at least one prescription for clomiphene (Table XXX-X) during the measurement year or the year prior to the measurement year National Committee for Quality Assurance 4

5 ESRD (ESRD Value Set) during the measurement year or the year prior to the measurement year. Table XXX-X: Medications to Identify Exclusions Description Estrogen agonists Clomiphene Cirrhosis (Cirrhosis Value Set) during the measurement year or the year prior to the measurement year. Myalgia, myositis, myopathy, or rhabdomyolysis (Muscular Pain and Disease Value Set) during the measurement year. Prescription Note: An NDC list will be available on Administrative Specification: Rate 1 Received Statin Therapy Denominator Numerator The Rate 1 eligible population. The number of members who had at least one dispensing event for a statin of at least moderate dosage intensity (Table XXX) during the measurement year. Table XXX: High and Moderate-Intensity Statin Prescriptions Description Prescription High-intensity statin therapy Atorvastatin mg Rosuvastatin mg Moderate-intensity statin therapy Atorvastatin mg Rosuvastatin 5 10 mg Simvastatin mg Pravastatin mg Lovastatin 40 mg Fluvastatin XL 80 mg Fluvastatin 40 mg bid Pitavastatin 2 4 mg Eligible Population: Rate 2 Statin Adherence 80 Percent Product line Age Continuous enrollment Allowable gap Anchor date Benefit Commercial, Medicaid, Medicare (report each product line separately). Males years as of December 31 of the measurement year. Females years as of December 31 of the measurement year. 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 (i.e., a member whose coverage lapses for 2 months [60 days] is not considered continuously enrolled). December 31 of the measurement year. Medical during the measurement year and the year prior. Pharmacy during the measurement year. Event/Diagnosis All members who meet the numerator criteria for Rate National Committee for Quality Assurance 5

6 Administrative Specification: Rate 2 Statin Adherence 80 Percent Denominator Numerator The Rate 2 eligible population. The number of members who achieved a PDC of at least 80% during the treatment period. Follow the steps below to identify numerator compliance. Step 1 Step 2 Step 3 Step 4 Step 5 Identify the IPSD. The IPSD is the earliest dispensing event for any medication in Table XXX 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 statin medication during the treatment period. To ensure the measure does not give credit for supply that extends beyond the measurement year, subtract any days 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 Statin Medication in the Treatment Period (step 3) Total Days in Treatment Period (step 2) Sum the number of members whose PDC is 80% for the treatment period National Committee for Quality Assurance 6

7 Statin Therapy for Patients With Cardiovascular Disease Measure Work-Up Measure Description The percentage of males years of age and females years of age during the measurement year who were identified as having clinical atherosclerotic cardiovascular disease (ASCVD) and were dispensed at least moderate-intensity statin therapy that they remained on for at least 80 percent of the treatment period. Two rates are reported: 1. Received Statin Therapy. The percentage of members who were identified as having clinical ASCVD and were dispensed at least moderate-intensity statin therapy during the measurement year. 2. Statin Adherence 80 Percent. The percentage of members who were identified as having clinical ASCVD and were dispensed at least moderate-intensity statin therapy that they remained on for at least 80 percent of the treatment period. Topic Overview Importance and Prevalence Cardiovascular disease is the leading cause of death in the United States. The death rate due to cardiovascular disease fell by 39 percent between 2001 and However, the public health burden remains significant. More than 85 million American adults have one or more types of cardiovascular disease (Mozaffarian et al., 2015). It is estimated that by 2030 more than 43 percent of Americans will have a form of cardiovascular disease (Heidenreich et al., 2011). National initiatives to improve cardiovascular health include the Million Hearts initiative to prevent 1 million heart attacks and strokes by 2017 (Million Hearts, 2011) and the American Heart Association (AHA) goal to reduce deaths from cardiovascular disease and stroke by 20 percent by 2020 (Mozaffarian et al., 2015). Data from the National Health and Nutrition Examination Survey (NHANES) estimate that more than 15 million American adults 20 and older have coronary heart disease. Coronary heart disease is more prevalent in men than in women (7.6 percent vs. 5.0 percent). Slight differences also exist based on race/ethnicity. The prevalence of coronary heart disease is highest in non-hispanic White men (7.8 percent) and lowest in non- Hispanic White women (4.6 percent). Just over 7 percent of non-hispanic Black men and 7 percent of non- Hispanic Black women have coronary heart disease. In the Hispanic population, 6.7 percent of men and nearly 6 percent of women have coronary heart disease (Mozaffarian et al., 2015). Data from the Framingham Heart Study estimate that the incidence of coronary heart disease is 10 years ahead in men (Thom, 2001). In addition, the incidence of cardiovascular events, such as myocardial infarction and sudden death, is 20 years ahead in men (Thom, 2001). In 2011, coronary heart disease was an underlying cause in 1 of 7 deaths in the United States. Coronary heart disease death rates per 100,000 were highest in males (161.5 for Black males and for White males). Deaths due to coronary heart disease per 100,000 were 99.7 for Black females and 80.1 for White females (CDC/NCHS, 2014). Atherosclerosis is a systemic disease process that occurs when plaque builds up within the walls of arteries. Plaque consists of fat, cholesterol, calcium, inflammatory cells and scar tissue that can harden overtime and narrow arteries. The narrowing of arteries reduces the flow of oxygen to organs and throughout the body, which results in most cardiovascular events, including heart attack and stroke (NHLBI, 2014). Coronary heart disease occurs when plaque builds up in arteries that supply oxygen to the heart (NHLBI, 2014). Chest pain or discomfort due to the reduced flow of oxygen rich blood to the heart is called angina pectoris. More than 8 million adults (3.3 percent) 20 and older have angina in the United States (Mozaffarian et al.,2015). The prevalence of angina is higher in women than in men between ages 40 and 74 (Ford, 2003). Plaque buildup can lead to peripheral arterial disease, which results when plaque builds up in arteries that 2015 National Committee for Quality Assurance 7

8 supply oxygen to the legs, arms and pelvis (NHLBI, 2014). Nearly 7 million adults 40 years of age and older have peripheral artery disease. The prevalence is higher in older adults, non-hispanic Blacks and women (Mozaffarian et al.,2015, Eraso, 2012 and Ostchega, 2007). A myocardial infarction (heart attack) occurs when oxygen rich blood is suddenly blocked from reaching the heart. More than 7 million adults 20 and older have had a myocardial infarction; the rate is twice as high in men than in women (Mozaffarian et al.,2015). Data show that 15 percent of people with myocardial infarction will die from it (Mozaffarian et al.,2015). Financial importance and cost-effectiveness In 2011, the total cost of cardiovascular disease and stroke in the United States was estimated to be $320 billion. This total includes direct costs such as the cost of physicians and other health professionals, hospital services, prescribed medications and home health care, as well as indirect costs due to loss of productivity from premature mortality. Interventions to address cardiovascular disease are increasing: since 2000, the number of inpatient cardiovascular operations and procedures increased by 28 percent, from 5,939,000 to 7,588,000 (Mozaffarian et al., 2015). By 2030, direct medical costs for cardiovascular disease are projected to increase to nearly $918 billion (Heidenreich, 2011). Evidence Supporting Statin Therapy Statins (HMG CoA reductase inhibitors) are a class of drugs that lower blood cholesterol. Statins work in the liver by preventing the formation of cholesterol, thus lowering the amount of cholesterol in the blood (AHA, 2014). Statins are most effective in lowering low-density lipoprotein cholesterol (LDL-C). The amount of cholesterol lowering effect is based on statin intensity, which is classified as either high, moderate or low intensity. Table 1. Statin Therapy Dosage Intensities High-Intensity Statin Therapy Moderate-Intensity Statin Therapy Low-Intensity Statin Therapy Daily dose lowers LDL C by approximately 50 percent on average Atorvastatin mg Rosuvastatin mg Daily dose lowers LDL C by approximately 30 percent to <50 percent on average Atorvastatin mg Rosuvastatin 5 10 mg Simvastatin mg Pravastatin mg Lovastatin 40 mg Fluvastatin XL 80 mg Fluvastatin 40 mg bid Pitavastatin 2 4 mg Daily dose lowers LDL C by <30 percent on average Simvastatin 10 mg Pravastatin mg Lovastatin 20 mg Fluvastatin mg Pitavastatin 1 mg Statins are among the most commonly prescribed medications in the United States, accumulating $17 billion in sales in 2012 (Consumer Reports, 2014). According to recent blood cholesterol treatment guidelines from the American College of Cardiology and American Heart Association (ACC/AHA), statins of moderate or high intensity are recommended for adults with established clinical ASCVD. Many studies support the use of statins to reduce ASCVD events in primary and secondary prevention. One meta-analysis of data from 170,000 patients in 26 randomized controlled trials found that intensive statin therapy reduces major vascular events by 15 percent (CTT, 2010). The study also found a 13 percent reduction in coronary death or nonfatal myocardial infarction, a 19 percent reduction in coronary revascularization and a 16 percent reduction in ischemic stroke (CTT, 2010). Another systematic review and meta-analysis estimates that long term statin therapy reduces the risk for ASCVD events by 25 percent 45 percent (Law, 2003) National Committee for Quality Assurance 8

9 Safety considerations and contraindications Statin therapy is a first-line treatment for lowering blood cholesterol. While statins are considered safe for most patients, there are safety concerns to consider before prescribing and throughout treatment. Statins are contraindicated for women who are pregnant or breastfeeding and should not be used in women of childbearing potential, unless they are using effective forms of contraception (Stone et al., 2013). Evidence also shows that statin therapy should be avoided in patients with ESRD. Conclusions from a review of clinical trials, review articles and treatment guidelines found that statin therapy in ESRD patients fails to significantly alter the course of cardiovascular events (Nemerovski, 2013). The most common side effect of statin therapy is muscle pain or weakness, which can occur in varying forms of severity. However, the extent of muscle pain due to statin therapy is unclear (Thompson, 2003 and Parker et al., 2013). Statin therapy should not be used in patients with rhabdomyolysis, the most severe form of muscle symptoms (Stone et al., 2013). Clinicians can discontinue or adjust statin therapy in patients that develop mild to moderate muscle symptoms to assess other muscle related conditions and determine a tolerated statin intensity (Stone et al., 2013). Statins are cleared in the liver and can cause elevated liver biochemistries. This presents a concern for patients with existing liver disease. Research suggests that patients with decompensated cirrhosis and acute liver failure should not receive statin therapy due to the unlikely benefit of cholesterol lowering (Tandra, 2009). Statin adherence The ACC/AHA guidelines state adherence to both medication and lifestyle regimens are required for ASCVD risk reduction (Stone et al., 2013). This measure uses the proportion of days covered (PDC) to assess adherence. According to the Pharmacy Quality Alliance, a PDC threshold of 80 percent is considered highly adherent for most classes of chronic medications (Nau, 2012). The impact of adherence on statin efficacy has been shown: each 25 percent increase in statin adherence is associated with a ~3.8 mg/dl reduction in lowdensity lipoprotein cholesterol (Ho, 2009). Non-adherence to statin therapy can result in an increased risk for mortality. One study found a 12 percent 25 percent increase in the risk for mortality with non-adherence to statins after an acute myocardial infarction (Rasmussen, 2007). Research shows that adherence to statin medications is poor in the United States. In a randomized trial of medication coverage, 50 percent of patients in the control group (usual coverage) stopped using statin medications within one year of starting treatment (Choudhry, 2011). NCQA seeks to improve statin adherence in patients with cardiovascular disease and thereby reduce the risk for cardiovascular related mortality. Gaps in care A recent cohort study analyzed data from the National Cardiovascular Data Registry Practice Innovation and Clinical Excellence registry. The study identified more than 1 million patients that would benefit from statin therapy, according to the updated ACC/AHA guidelines. More than 91 percent of the patients studied had ASCVD. The study found that more than 32 percent of patients were not receiving statin therapy; more than 22 percent of patients were on non-statin therapies for cholesterol management (Maddox, 2014). NCQA s testing found similar results in a research database of commercial and Medicare Advantage health plans. NCQA reviewed statin dose intensities 2015 National Committee for Quality Assurance 9

10 and found that among patients with ASCVD, only 6 percent 9 percent were on high-intensity statins. We also found low adherence to statin therapy. Results highlight gaps in care for patients with cardiovascular disease and the need for improvement. Alignment with the new blood cholesterol guidelines will improve quality of care for patients with cardiovascular disease. Health care disparities Health disparities among genders exist when comparing the use of statins for secondary prevention of cardiovascular disease. One study found that although women with cardiovascular disease had higher LDL-C levels than men, they were less likely to receive any statin therapy (Virani et al., 2015). In another study, a meta-analysis found that among patients prescribed a statin medication, women were 10 percent more likely to be nonadherent. Non-White patients were 53 percent more likely to be nonadherent to statin therapy than White patients (Lewey, 2013). These gender-based and racially-based disparities signal gaps in quality that could relate to higher cardiovascular mortality rates in some groups, compared with mortality rates in White men. References American Heart Association (AHA) Drug therapy for cholesterol. Therapy-for-Cholesterol_UCM_305632_Article.jsp. Accessed January 11, Centers for Disease Control and Prevention/National Center for Health Statistics (NCHS) Mortality multiple cause micro-data files, Public-use data file and documentation. NHLBI tabulations. Accessed July 3, Cholesterol Treatment Trialists (CTT) Collaboration Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet 376(9753): doi: /s (10) Choudhry, N.K., J. Avorn, R.J. Glynn, et al Full coverage for preventive medications after myocardial infarction. New England Journal of Medicine. 365(22): Consumer Reports Are you taking the right treatment for your high cholesterol? March. Eraso, L.H., E. Fukaya, E.R. Mohler 3rd, et al Peripheral arterial disease, prevalence and cumulative risk factor profile analysis. Eur J Prev Cardiol. 21: Ford, E.S., W.H. Giles Changes in prevalence of nonfatal coronary heart disease in the United States from Ethn Dis. 13: Heidenreich, P.A., J.G. Trogdon, O.A. Khavjou, et al Forecasting the future of cardiovascular disease in the United States: a policy statement from the American Heart Association. Circulation.123: Ho, P.M., C.L. Bryson, J.S. Rumsfeld Medication adherence: its importance in cardiovascular outcomes. Circulation 119(23): Law, M.R., N.J. Wald, A.R. Rudnicka Quantifying effects of statins on low density lipoprotein cholesterol, ischaemic heart disease, and stroke: systematic review and meta-analysis. BMJ. 326(7404):1423. Lewey, J., W.H. Shrank, A.D. Bowry, et al Gender and racial disparities in adherence to statin therapy: a meta-analysis. American Heart Journal. 165(5): doi: /j.ahj Maddox, T.M., W.B. Borden, F. Tang, et al Implications of the 2013 ACC/AHA cholesterol guidelines for adults in contemporary cardiovascular practice: insights from the NCDR Pinnacle registry. Journal of American College of Cardiology. 64(21): doi: /j.acc Million Hearts The initiative. Accessed January Mozaffarian, D., E.J. Benjamin, A.S. Go, et al Heart disease and stroke statistics 2015 update: a report from the American Heart Association. Circulation. 131:e29-e322. doi: /CIR National Heart, Lung, and Blood Institute (NHLBI) What is Atherosclerosis? Accessed January National Committee for Quality Assurance 10

11 Nau, D.P Proportion of Days Covered (PDC) as a Preferred Method of Measuring Medication Adherence. Pharmacy Quality Alliance (PQA). Accessed November Nemerovski, C.W., J. Lekura, P.T. Mehta, C.L. Moore Safety and efficacy of statins in patients with end-stage renal disease. The Annals of Pharmacotherapy. 47(10): doi: / Ostchega, Y., R. Paulose-Ram, C.F. Dillon, Q. Gu, J.P. Hughes Prevalence of peripheral arterial disease and risk factors in persons aged 60 and older: data from the National Health and Nutrition Examination Survey J Am Geriatr Soc. 55: Parker, B.A., J.A. Capizzi, A.S. Grimaldi, et al Effect of statins on skeletal muscle function. Circulation. 127(1): doi /CIRCULATIONAHA Rasmussen, J.N., A. Chong, D.A. Alter Relationship between adherence to evidence-based pharmacotherapy and long-term mortality after acute myocardial infarction. Journal of the American Medical Association. 297(2): Stone, N.J., J. Robinson, A.H. Lichtenstein, et al ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. J Am Coll Cardiol. 63(25 Pt B): doi: /j.jacc Epub 2013 Nov 12. Tandra, S. and R. Vuppalanchi Use of statins in patients with liver disease. Current Treatment Options in Cardiovascular Medicine. 11(4): Thom, T.J., W.B. Kannel, H. Silbershatz, R.B. D Agostino Sr Cardiovascular disease in the United States and prevention approaches. In Hurst s the Heart, edited by V. Fuster, R.W. Alexander, R.A. O Rourke, R. Roberts, S.B. King 3rd, H.J.J. Wellens, th ed. New York, NY: McGraw-Hill. Thompson, P.D., P. Clarkson, R.H. Karas Statin-associated myopathy. Journal of the American Medical Association. 289(13): Virani, S.S., L.D. Woodard, D.J. Ramsey, et al Gender disparities in evidence-based statin therapy in patients with cardiovascular disease. American Journal of Cardiology. 115(1): doi: /j.amjcard National Committee for Quality Assurance 11

12 Recommendations for Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults Statin Treatment Organization, Guideline Date Age Population Other risk factors Recommendation Type/ Grade years High-intensity statin therapy should be initiated or continued as firstline therapy, unless contraindicated. I A American College of Cardiology/American Heart Association (2013) years >75 years Clinical ASCVD If high-intensity statin therapy is contraindicated or when characteristics predisposing to statin-associated adverse effects are present, moderate-intensity statin should be used as the second option if tolerated It is reasonable to evaluate the potential for ASCVD risk-reduction benefits and for adverse effects, drug-drug interactions and to consider patient preferences, when initiating a moderate- or highintensity statin. It is reasonable to continue statin therapy in those who are tolerating it. I A IIa B 2015 National Committee for Quality Assurance 12

13 Grading System Key: ACC/AHA Classification of Recommendation and Level of Evidence Size of Treatment Effect Class I Benefit >>> Risk Procedure/treatment should be performed/ administered Class IIa Benefit >> Risk Additional studies with focused objectives needed It is reasonable to perform procedure/administer treatment Class IIb Benefit Risk Procedure/treatment may be considered Class II No Benefit or Class III Harm Estimate of Certainty (Precision) of Treatment Effect Level A Multiple populations evaluated Level B Limited populations evaluated Level C Very limited populations evaluated Recommendation that procedure or treatment is useful/effective Sufficient evidence from multiple randomized trials or meta-analyses Recommendation the procedure or treatment is useful/effective Evidence from single randomized trial or nonrandomized studies Recommendation that procedure or treatment is useful/effective Only expert opinion, case studies, or standard of care Recommendation in favor of treatment or procedure being useful/effective Some conflicting evidence from multiple randomized trials or meta-analyses Recommendation in favor of treatment or procedure being useful/effective Some conflicting evidence from single randomized trial or nonrandomized studies Recommendation in favor of treatment or procedure being useful/effective Only diverging expert opinion, case studies, or standard of care Recommendation s usefulness/efficacy less well established Greater conflicting evidence from multiple randomized trials or meta-analyses Recommendation s usefulness/efficacy less well established Greater conflicting evidence from single randomized trial or nonrandomized studies Recommendation s usefulness/efficacy less well established Only diverging expert opinion, case studies, or standard of care Recommendation that procedure or treatment is not useful/effective and may be harmful Sufficient evidence from multiple randomized trials or meta-analyses Recommendation that procedure or treatment is not useful/effective and may be harmful Evidence from single randomized trial or nonrandomized studies Recommendation that procedure or treatment is not useful/effective and may be harmful Only expert opinion, case studies, or standard of care References for Recommendations Stone, N.J., J. Robinson, A.H. Lichtenstein, et al ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults. J Am Coll Cardiol. 63(25 Pt B): doi: /j.jacc Epub 2013 Nov National Committee for Quality Assurance 13