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The American Journal of Managed Care December 2017
Chronic Disease Outcomes From Primary Care Population Health Program Implementation
Jeffrey M. Ashburner, PhD, MPH; Daniel M. Horn, MD; Sandra M. O’Keefe, MPH; Adrian H. Zai, MD, PhD; Yuchiao Chang, PhD; Neil W. Wagle, MD, MBA; and Steven J. Atlas, MD, MPH
Expanding the "Safe Harbor" in High-Deductible Health Plans: Better Coverage and Lower Healthcare Costs
A. Mark Fendrick, MD, and Rashna Soonavala
Impact of Consumer-Directed Health Plans on Low-Value Healthcare
Rachel O. Reid, MD, MS; Brendan Rabideau, BA; and Neeraj Sood, PhD
Insurance Switching and Mismatch Between the Costs and Benefits of New Technologies
David Cutler, PhD; Michael Ciarametaro, MBA; Genia Long, MPP; Noam Kirson, PhD; and Robert Dubois, MD, PhD
ED-Based Care Coordination Reduces Costs for Frequent ED Users
Michelle P. Lin, MD, MPH; Bonnie B. Blanchfield, ScD, CPA; Rose M. Kakoza, MD, MPH; Vineeta Vaidya, MS; Christin Price, MD; Joshua S. Goldner, MD; Michelle Higgins, PA-C; Elisabeth Lessenich, MD, MPH; Karl Laskowski, MD, MBA; and Jeremiah D. Schuur, MD, MHS
Evaluation of the Quality Blue Primary Care Program on Health Outcomes
Qian Shi, PhD, MPH; Thomas J. Yan, MS; Peter Lee, BS; Paul Murphree, MD, MHA; Xiaojing Yuan, MPH; Hui Shao, PhD, MHA; William H. Bestermann, MD; Selina Loupe, BS; Dawn Cantrell, BA; David Carmouche, MD; John Strapp, BA; and Lizheng Shi, PhD, MSPharm
Investigating the Impact of Intervention Refusal on Hospital Readmission
Alexis Coulourides Kogan, PhD; Eileen Koons, MSW, ACSW; and Susan Enguidanos, PhD
Real-World Economic Value of a 21-Gene Assay in Early-Stage Breast Cancer
Stanley E. Waintraub, MD; Donna McNamara, MD; Deena Mary Atieh Graham, MD; Andrew L. Pecora, MD; John Min, BS; Tommy Wu, BA; Hyun Gi Noh, MSC; Jacqueline Connors, RN, OCN; Ruth Pe Benito, MPH, BS; Kelly Choi, MD; Eric Schultz, BS; and Stuart L. Goldberg, MD
Trends in Bisphosphonate Initiation Within an Integrated Healthcare Delivery System
Rami J. Hosein, MD, MPH; Joan C. Lo, MD; Bruce Ettinger, MD; Bonnie H. Li, MS; Fang Niu, MS; Rita L. Hui, PharmD, MS; and Annette L. Adams, PhD, MPH
Reduction of Emergency Department Use in People With Disabilities
Lihao Chu, PhD; Neeraj Sood, PhD; Michael Tu, MS; Katrina Miller, MD; Lhasa Ray, MD; and Jennifer N. Sayles, MD
Currently Reading
Impact of Statin Guidelines on Statin Utilization and Costs in an Employer-Based Primary Care Clinic
Holly E. Gurgle, PharmD, BCACP, CDE; Marisa B. Schauerhamer, PharmD; Simón A. Rodriguez, PharmD; and Carrie McAdam-Marx, MSCI, PhD, RPh

Impact of Statin Guidelines on Statin Utilization and Costs in an Employer-Based Primary Care Clinic

Holly E. Gurgle, PharmD, BCACP, CDE; Marisa B. Schauerhamer, PharmD; Simón A. Rodriguez, PharmD; and Carrie McAdam-Marx, MSCI, PhD, RPh
Adherence to clinical guidelines in practice is often suboptimal and controversial. This study compares actual statin utilization and cost with full adoption of major clinical guidelines in a real-world population.

Objectives: The purpose of this study was to describe statin utilization and costs in an employer-based patient cohort by comparing actual practice and assumed adoption of the 2013 American College of Cardiology/American Heart Association (ACC/AHA) or 2016 US Preventive Services Task Force (USPSTF) statin recommendations versus the guidelines described in 2001 (and supplemented in 2004) in the Third Report of the National Cholesterol Education Program’s Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (ATPIII).

Study Design: Descriptive cohort analysis included patients treated in an employer-based primary care clinic between January 2012 and April 2014. 

Methods: ATPIII, ACC/AHA, and USPSTF recommendations were retrospectively applied at the patient level based on lipid levels and statin prescribing data collected from a health risk assessment and electronic health record. Actual statin prescribing was compared with prescribing predicted by guideline recommendations. Costs for each strategy were estimated using employer pharmacy claims data.

Results: The study included 555 patients, of whom 112 (20.2%) were treated with a statin at baseline. ATPIII and ACC/AHA recommended statin use in 284 (51.2%) and 279 (50.3%) patients, respectively. Within the subgroup of 479 primary prevention patients, ACC/AHA recommended statin use in 203 (42.4%) versus USPSTF, which recommended statin use in 91 (19.0%). The 90-day cost per patient was similar to baseline with implementation of ATPIII or ACC/AHA recommendations, excluding use of brand name–only high-intensity statins, and costs could be reduced slightly with implementation of USPSTF guidelines.

Conclusions: Despite differences in ATPIII, ACC/AHA, and USPSTF guidelines, application of any of these statin recommendations would result in optimized statin utilization and fairly neutral effects on cost in this real-world employer-based population. 

Am J Manag Care. 2017;23(12):e387-e393
Takeaway Points
  • The 2013 American College of Cardiology/American Heart Association (ACC/AHA) guidelines for treatment of cholesterol defined new criteria for therapy with statins to reduce atherosclerotic cardiovascular disease risk. 
  • The US Preventive Services Task Force released statin guidelines in 2016, which suggested statin treatment for fewer primary prevention patients compared with ACC/AHA guidelines. 
  • Full adoption of any of the major statin guidelines would improve statin utilization with neutral cost effects when generic statins are emphasized. 
  • Substantial opportunity exists within real-world patient cohorts to improve statin utilization. A greater understanding of barriers to guideline implementation is needed.
The use of statins for primary prevention and evidence-based management of atherosclerotic cardiovascular disease (ASCVD) is of interest to employers and other payers eager to improve health outcomes and reduce costs.1-4 The Third Report of the National Cholesterol Education Program’s Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (ATPIII) was published in 2001, followed by a supplemental publication in 2004 that incorporated additional risk assessment strategies.2,3 ATPIII focuses on assessing patient risk for coronary heart disease (CHD), establishing low-density lipoprotein cholesterol (LDL-C) goals, and identifying when to initiate statin therapy or lifestyle modifications.2,3 Patient risk is assessed using the Framingham Risk Score (FRS) and risk factors such as age, comorbid conditions, and family history.2,3 

In 2013, the American College of Cardiology (ACC) and American Heart Association (AHA) released the ACC/AHA guideline for the treatment of cholesterol.4 The emphasis of ACC/AHA shifted toward identifying patients in whom the strongest evidence existed to support the benefit of statin therapy to reduce ASCVD.4 In contrast to ATPIII, ACC/AHA determined there was insufficient evidence from randomized controlled trials to support the use of specific LDL-C goals to guide therapy. Instead, ACC/AHA recommended moderate- or high-intensity statin therapy for individuals in 4 statin benefit groups. ACC/AHA also utilized a new risk assessment, the pooled cohort equation, which incorporated risk factors such as diabetes and race. In contrast with FRS, which calculates 10-year risk of CHD, the pooled cohort equation estimates 10-year risk of ASCVD, including stroke.4

In 2016, the US Preventive Services Task Force (USPSTF) released recommendations for statin use for primary prevention of ASCVD.5 USPSTF cited several studies' results which found that the pooled cohort equation overestimates actual ASCVD risk in certain cohorts.6-8 USPSTF also noted that randomized clinical trials evaluating statin use for primary prevention typically utilized low- to moderate-intensity statins, in comparison with ACC/AHA, which emphasized moderate- to high-intensity statins. Given these critiques, USPSTF recommends low- to moderate-intensity statins for primary prevention in adults aged 40 to 75 years with 1 or more cardiovascular disease (CVD) risk factors and a calculated 10-year ASCVD risk of at least 10%. Clinicians are encouraged to selectively offer statins to adults within the same population with a risk score of 7.5% to less than 10%, weighing potential risks versus benefits. Finally, USPSTF concludes that current evidence is insufficient to recommend statins for primary prevention to patients older than 75 years. Investigators have described the impact of ACC/AHA guideline adoption as resulting in as many as 12.8 million additional statin candidates in the United States.9 Adoption of USPSTF recommendations instead would be expected to reduce the number of adults  newly treated with statins, assuming patients with 10-year ASCVD risk scores between 7.5% and 10% or those without 1 or more risk factors for CVD were not routinely started on statins.

The impact of statin guideline implementation on an employer or similar payer is not fully understood. The purpose of our research was to evaluate the impact of full adoption of ACC/AHA or USPSTF guidelines on statin utilization and cost to a self-funded employer. The projected utilization and costs were compared with actual statin use and with estimated utilization and costs associated with full adoption of APTIII guidelines to help isolate the impact of guideline changes versus greater adherence to alternative guidelines.


This descriptive retrospective cohort study used patient-level clinical and cost data from patients treated at an on-site primary care clinic operated by a self-insured employer between January 2012 and April 2014. 

Study Population

The self-insured employer in this study operates an on-site primary care clinic for employees and their dependents. Clinic patients who completed an employer-sponsored health risk assessment (HRA) between January and October 2013 were identified. Those with 1 or more of the following characteristics associated with potential benefit from statin therapy were included: treatment with a cholesterol medication in year prior to HRA, LDL-C above ATPIII goal, self-reported ASCVD or ATPIII CHD risk equivalent, 65 years or older, ASCVD risk at least 7.5%, or FRS risk at least 20%. The date the HRA was conducted was defined as the patient’s baseline. 

Data Collection

The electronic health record (EHR) provided demographic and clinical information, including biometrics (body mass index, blood pressure [BP]), medication history, and laboratory results (lipid panel, glycated hemoglobin [A1C]). The HRA provided patient-reported medical history. In addition, population-level statin utilization and reimbursement information were obtained from the employer’s pharmacy claims data to calculate the average cost of statins to the employer. 

Guideline Recommendation Determination

EHR and HRA data were used to calculate 10-year risk of ASCVD and FRS for each patient and to identify ATPIII risk level. Hypertension was defined as BP at least 140/90 mm Hg at time of the HRA or self-reported hypertension. Hypertension and treatment for hypertension, smoking status, and clinical ASCVD were self-reported through the HRA. Patients were categorized as having diabetes if they self-reported diabetes or had an A1C of at least 6.5% at time of HRA. Those with unknown race were assumed to be white or "other" for the purposes of calculating an ASCVD risk score, as less than 2% of the patient cohort was black.

Baseline statin use was identified through review of medication orders in the EHR. Those with a statin order any time in the year prior to HRA were assumed to be using a statin at baseline. Incorporating baseline statin use and risk assessment, ATPIII, ACC/AHA, and USPSTF statin recommendations (summarized in Table 1) were applied to each patient. 

The recommendation to start statins in ATPIII guidelines was determined using an LDL-C goal and thresholds for starting medication determined by patient risk factors and FRS. For patients taking no statin at the time of their HRA, ATPIII recommended either starting a statin or continuing with no statin. For patients taking a statin at the time of their HRA, recommendations could include intensifying therapy or no change. Through evaluation of HRA data, it was not possible to determine if any patients were currently using a statin but were not indicated according to ATPIII. ATPIII does not recommend a specific intensity of statin therapy.4 Thus, a statin intensity was assigned to each patient based on the percent LDL-C reduction needed to reach ATPIII LDL-C goal (<30%, low-intensity; 30% to <50%, moderate-intensity; ≥50%, high-intensity statin).4 Statin use adherence with ATPIII guidelines after the HRA was determined at the patient level by comparing statin prescription orders in the EHR for 6 months post HRA against ATPIII recommendations.

Determination of ACC/AHA recommendation at the time of the HRA required that patients be categorized into statin benefit groups that dictated recommended statin intensity. Patients who did not fall into 1 of 4 statin benefit groups were classified as having no recommendation. Statin use adherence with ACC/AHA guidelines after the HRA was determined at the patient level by comparing statin prescription orders in the EHR for 6 months post HRA against ACC/AHA recommendations. 

USPSTF recommendations were applied to patients aged 40 to 75 years without clinical ASCVD and with LDL-C lower than 190 mg/dL and 1 or more cardiovascular (CV) risk factors (LDL-C 130-189 mg/dL, high-density lipoprotein cholesterol <40 mg/dL, hypertension, or smoking). USPSTF recommends low- or moderate-intensity statins for primary prevention of ASCVD if patients meet these criteria and have a 10-year risk of ASCVD of 10% or higher. According to USPSTF, a patient-specific approach should be utilized in primary prevention patients with 10-year risk of ASCVD between 7.5% and 10% and with 1 or more CV risk factors. Clinicians may weigh potential risk versus benefits of statin therapy with these patients. No recommendation for statin therapy is made for patients without CV risk factors or with a 10-year ASCVD risk lower than 7.5%.

Statin Cost Determination

Although patient-level prescribing data were available for this study, patient-level drug costs were not. However, statin utilization aggregated at the product/strength level was known, as were network reimbursement rates. These data were used to calculate the 90-day average cost (US dollars) to the employer per statin at the product and strength levels (contracted amount minus a standard patient co-payment). An average 90-day statin cost was estimated for each intensity, weighted by the amount each product/strength contributed to the utilization within the intensity group. The recent availability of generic rosuvastatin has driven down the cost substantially. Given that this change occurred after collection of cost data for this study, rosuvastatin was excluded from our model. Using this method, the weighted average cost to the employer for a 90-day supply of statin was calculated to be $7.79 for low-, $4.79 for moderate-, and $20.53 for high-intensity statins. 

Based on baseline use and projected utilization and intensity according to guideline recommendations, 90-day statin costs per patient were calculated from the perspective of the employer. For ATPIII recommendations, those with no recommended change in therapy were assigned the cost to the employer of the statin used at the time of the HRA. For those recommended to intensify statin therapy, the intensity of the statin used at the time of the HRA was increased by 1 intensity level. If the patient was on a high-intensity statin at the time of the HRA and the recommendation was to intensify the statin, then no change in cost was assumed. For patients for whom there was no specific recommendation (ACC/AHA or USPSTF) or no statin was recommended (ATPIII), it was assumed the patient would have no cost.

Utilization Data Analysis

Descriptive statistics summarized cohort characteristics overall and by baseline statin group. To report concordance between guidelines within the study cohort, as a measure of the impact of guideline changes, the number and percentage of patients were identified by statin recommendation and intensity. Baseline (actual) statin use was also compared with guideline recommendations.

Cost Data Analysis

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