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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; & 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; & 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
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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.
Baseline costs were calculated based on actual statin use and weighted average cost per product and dose. The 90-day statin cost to the employer with full adoption of each guideline was estimated by statin intensity. Subgroup analysis of cost estimates were completed to determine whether cost with ACC/AHA guideline implementation differed among those patients with diabetes, with ASCVD risk scores 7.5% or higher, or those 65 years and older. 

RESULTS

Of 3938 patients completing an HRA, 555 (14.1%) patients had 1 or more characteristics associated with potential benefit from statin therapy and are described in Table 2. The mean (SD) age of the cohort was 48.5 (12.8) years, and 314 (56.6%) were male. The majority of patients were white, with a small proportion of black patients. Those in the “other” race category were predominately Asian, Latino, or Native American. 

Table 3 compares recommendations for each guideline. Statin use was recommended in 284 (51.2%) and 279 (50.3%) patients per ATPIII and ACC/AHA, respectively. Adherence to ATPIII guidelines would have resulted in 31% of patients starting a statin, 5.2% intensifying their current statin therapy, 15% continuing their current statin, and 48.8% remaining on no therapy. Even among the 253 patients in the highest-risk group (LDL-C goal <100 mg/dL) according to ATPIII, 74 (29.2%) were meeting their LDL-C goal at baseline and had no recommendation to start a statin. Adherence to ACC/AHA guidelines would result in treatment with a high-intensity statin in 24.1%, a moderate- to high-intensity statin in 13.7%, and a moderate-intensity statin in 12.1% of statin-eligible patients within the cohort. Adherence to USPSTF guidelines within the primary prevention cohort resulted in 82 fewer patients treated with a statin compared with ACC/AHA. These 82 individuals were aged 40 to 75 years and recommended by ACC/AHA to receive a statin, but were not recommended to receive a statin according to USPSTF because their 10-year ASCVD risk score was lower than 7.5%. The 30 patients in the “selectively offer” statin group had a 10-year ASCVD risk score between 7.5% and <10%. No statin was specifically recommended for 69.9% versus 49.7% of primary prevention patients applying USPSTF and ACC/AHA guidelines, respectively. 

Overall rates of adherence to ATPIII guidelines were 67.6% after HRA, with the highest adherence to the recommendation for “no statin” (Table 4). Of the 172 patients with ATPIII recommendations to start a new statin, only 35 (20.3%) actually received a new statin prescription within 6 months of completing the HRA (Table 4). Although ACC/AHA recommendations had not yet been released, only 42 (7.6%) patients would have been treated according to ACC/AHA guidelines and 276 (49.7%) had fallen into ACC/AHA’s “no recommendation” category (Table 4). Of the 112 patients taking a statin prior to the HRA, 35 (31.3%) were not included in any of the 4 ACC/AHA statin benefit groups (Table 2), meaning that clinicians would need to reassess if ongoing statin therapy was warranted, as there was no clear recommendation for statin use. Although USPSTF recommendations had not yet been released, only 25.3% of the primary prevention cohort who was statin-eligible, according to USPSTF, were receiving statin treatment at baseline. 

Cost Analysis

The 90-day statin cost to the employer per patient in the overall cohort at baseline ($9) was less than the cost within several subgroups: diabetes ($11), ASCVD 7.5% or greater ($10), or 65 years or older ($15). Overall, 90-day costs were slightly higher with full adherence to ACC/AHA ($8) versus ATPIII ($4) guidelines in the overall cohort. Ninety-day costs per patient were similar between baseline and full adherence to ACC/AHA recommendations, even among subgroups in which high-intensity treatment is emphasized: patients with 10-year ASCVD score 7.5% or higher ($10 vs $19), patients 65 years or older ($15 vs $17), and patients with diabetes ($11 vs $9). Within the primary prevention cohort, 90-day costs per patient were lowest with USPSTF guidelines ($1) compared with baseline ($5), ATPIII ($4), or ACC/AHA ($4) statin utilization.

DISCUSSION

The ACC/AHA guidelines in 2013 represented a significant shift in the approach to preventing ASCVD. Retrospective cohort evaluations have predicted that implementation of ACC/AHA would result in an overall 15% to 30% increase in the number of patients eligible for treatment with statins, primarily driven by adults classified on the basis of their 10-year risk.9-12 Similar to our results, Pencina et al noted fairly stable rates of statin eligibility with ATPIII versus ACC/AHA among adults aged 40 to 59 years. In contrast, the percentage of men aged 60 to 75 years eligible for a statin for primary prevention increased from 30.4% to 87.4% with ACC/AHA guideline implementation.9 These findings suggest that the predicted increase in statin eligibility among primary prevention patients is most apparent in older adults, which may explain why overall statin eligibility remained stable in our younger employer-based cohort with implementation of ACC/AHA versus ATPIII guidelines. 

Controversy surrounds the clinical utility of treating more patients, particularly those at lower risk, with statins for primary prevention. Recent investigations suggest that ACC/AHA may better predict patients at risk than ATPIII, perhaps enabling clinicians to better prevent ASCVD through the use of statins.12 On the other hand, concerns exist that the pooled cohort equation may overestimate actual ASCVD risk in certain cohorts.5-8 The optimal intensity of statins for primary prevention also remains controversial, with USPSTF recommending low- to moderate-intensity statins, compared with ACC/AHA’s suggestion of moderate- to high-intensity statins.4,5 Comparisons of the real-life clinical and economic impact of implementing the ATPIII versus ACC/AHA or USPSTF guidelines are limited. 

Chia et al conducted a retrospective cohort study in 847 Asian patients and found that although ACC/AHA would increase eligibility for statin treatment, there would also be a large cohort of patients potentially treated inappropriately with statins.10 Similarly, we observed that 17.4% of our cohort with no statin at baseline would become eligible for statin therapy with ACC/AHA but not with ATPIII guidelines, whereas 8.5% of patients would start a statin according to ATPIII but not according to ACC/AHA. These results suggest that utilization of ACC/AHA may not result in an absolute increase in the use of statins but instead an improved ability to identify patients for treatment. Within the primary prevention cohort specifically, fewer patients were eligible for statins with USPSTF (19.0%) versus ACC/AHA (42.4%), further refining statin-eligible patients to those presumably with increased risk. 

Acknowledging that real-world application of guidelines is usually imperfect, we compared actual statin use with full adherence to guidelines. Undertreatment with statins is well documented, with significant gaps between clinical guidelines and actual practice.13 We found that nearly one-third of patients were not being treated in accordance with ATPIII at the time of ACC/AHA publication, comparable with rates of nonadherence to guidelines published by others.13 Implementation of ACC/AHA within our cohort would require an adjustment in therapy for more than 40% of the patients, making full implementation a substantial undertaking within the primary care setting and one that is still ongoing. The USPSTF recommendations for statins for primary prevention, which were released after ACC/AHA, would require an adjustment in therapy for only 14.2% of primary prevention patients compared with baseline use, although like ACC/AHA, USPSTF relies heavily on patient–provider discussions of the risk versus benefit of statins.

With the recent availability of generic rosuvastatin, adopting ACC/AHA guidelines in an employer-based primary care setting had a neutral effect on cost of statin treatment from a payer perspective. Subgroup analysis identified slight increases in costs driven by a shift toward the use of higher-intensity statins and new statin eligibility among older patients or those identified using the ASCVD risk score. Cost per patient with diabetes was similar to the cost for the overall cohort. Implementation of USPSTF, which limits statin use to higher-risk primary prevention patients and emphasizes low- to moderate-intensity statins, resulted in a decrease in statin prescribing costs compared with baseline or with ATPIII and ACC/AHA implementation in the primary prevention cohort.

Limitations

It is important to balance the cost of statins and statin-related adverse effects with potential cost savings through reduction in ASCVD events. Maddox et al also identified a reduction in the use of nonstatin cholesterol treatments and reduced laboratory costs following implementation of ACC/AHA.11 Our study was not able to account for total cost effectiveness, including costs of adverse effects, ASCVD events, nonstatin medications, nonadherence, or laboratory testing.

The patient cohort in our study was composed of adults treated in an employer-based clinic. Although the population was diverse in socioeconomic status and level of education, those demographics may not be applicable to other patient populations. For example, the average age in our cohort was 48.5 versus 56 years in Pencina et al, 9 which may explain why a large increase in overall statin-eligible patients was not observed, unlike other studies with older patient cohorts. The weighted cost estimates for low-, moderate-, and high-intensity statins may not be generalizable, reflecting reimbursement rates and prescribing patterns within 1 patient cohort.

Using both EHR and patient-reported data for calculation of risk scores and determination of guideline application enhanced our ability to identify several important risk factors. For example, patients with either self-reported diabetes or laboratory data demonstrating an A1C 6.5% or greater were considered to have diabetes for the purposes of calculating a 10-year ASCVD risk score. For other variables, including history of prior ASCVD, only patient-reported data were available, and incomplete self-reporting is a potential limitation. However, this is a limitation shared by similar studies.9 

Finally, the study required the use of several assumptions, such as estimating costs based on full adherence to guidelines or assumptions when guidelines are not specific. However, reporting estimated use and costs assuming full adherence to ATPIII alongside baseline and ACC/AHA projections helps to understand the incremental impact of ACC/AHA guideline adoption relative to both real-world and fully adherent situations. 

CONCLUSIONS

 
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