Currently Viewing:
The American Journal of Managed Care May 2016
Greater Potential Cost Savings With Biosimilar Use
Benjamin Yu, PharmD
Implementing a Hybrid Approach to Select Patients for Care Management: Variations Across Practices
Christine Vogeli, PhD; Jenna Spirt, MPH; Richard Brand, PhD; John Hsu, MD, MPH; Namita Mohta, MD; Clemens Hong, MD, MPH; Eric Weil, MD; and Timothy G. Ferris, MD, MPH
Medicaid Managed Care Penetration and Drug Utilization for Patients With Serious Mental Illness
Aaron L. Schwartz, PhD; Jacqueline Pesa, PhD, MPH; Dilesh Doshi, PharmD; John Fastenau, PhD, MPH; Seth A. Seabury, PhD; Eric T. Roberts, PhD; and David C. Grabowski, PhD
Clinical Interventions Addressing Nonmedical Health Determinants in Medicaid Managed Care
Laura M. Gottlieb, MD, MPH; Kim Garcia, MPH; Holly Wing, MA; and Rishi Manchanda, MD, MPH
Physician Perceptions of Choosing Wisely and Drivers of Overuse
Carrie H. Colla, PhD; Elizabeth A. Kinsella, BA; Nancy E. Morden, MD, MPH; David J. Meyers, MPH; Meredith B. Rosenthal, PhD; and Thomas D. Sequist, MD, MPH
Potential of Risk-Based Population Guidelines to Reduce Cardiovascular Risk in a Large Integrated Health System
Galina Inzhakova, MPH; Hui Zhou, PhD, MS; Macdonald Morris, PhD; Megan I. Early, MD, MPH; Anny H. Xiang, PhD; Steven J. Jacobsen, MD, PhD; and Stephen F. Derose, MD, MSHS
Enhanced Primary Care and Impact on Quality of Care in Massachusetts
Asaf Bitton, MD, MPH; Amy W. Baughman, MD, MPH; Sara Carlini, BA; Joel S. Weissman, PhD; and David W. Bates, MD, MSc
Breast Cancer Multigene Testing Trends and Impact on Chemotherapy Use
G. Thomas Ray, MBA; Jeanne Mandelblatt, MD; Laurel A. Habel, PhD; Scott Ramsey, MD, PhD; Lawrence H. Kushi, ScD; Yan Li, MD; and Tracy A. Lieu, MD, MPH
Currently Reading
A Cost-Effectiveness Analysis of Over-the-Counter Statins
Christopher Stomberg, PhD; Margaret Albaugh, MA; Saul Shiffman, PhD; and Neeraj Sood, PhD

A Cost-Effectiveness Analysis of Over-the-Counter Statins

Christopher Stomberg, PhD; Margaret Albaugh, MA; Saul Shiffman, PhD; and Neeraj Sood, PhD
This paper estimates the costs and benefits of over-the-counter (OTC) statins using data on statin use and cardiovascular risk, clinical studies of statin safety and efficacy, and an OTC statin use trial.

Ultimately, the effects of OTC statins are uncertain and highly dependent on product labeling and consumer education. The results from our study suggest that with proper labeling and consumer education, it is very likely that OTC statins would be cost-effective, as they significantly improve population health without large increases in healthcare costs.


The authors wish to thank Andrew Huson of Bates White for help with the cost-effectiveness model and manuscript preparation.

Author Affiliations: University of Pittsburgh (SS), Pittsburgh, PA; University of Southern California (NS), Los Angeles, CA; Bates White, LLC (CS, MA), Washington, DC.

Source of Funding: This study was funded by Pfizer, with additional support from Bates White, LLC.

Author Disclosures: Dr Stomberg and Ms Albaugh are employees of, and Dr Sood was contracted by, Bates White, which was a paid consultant to Pfizer in connection with the development of this manuscript. Dr Shiffman is a consultant to Pinney Associates, which is a paid consultant to Pfizer.

Authorship Information: Concept and design (MA, NS, CS); analysis and interpretation of data (MA, SS, NS, CS); drafting of the manuscript (MA, NS, CS); critical revision of the manuscript for important intellectual content (MA, SS, NS, CS); statistical analysis (MA, NS, CS); obtaining funding (CS, MA); and supervision (MA, CS).

Address correspondence to: Neeraj Sood, PhD, Associate Professor, University of Southern California, Sol Price School of Public Policy and Schaeffer Center for Health Policy and Economics, University Park Campus, Los Angeles, CA, USA 90089. E-mail:

1. Chen YH, Feng B, Chen ZW. Statins for primary prevention of cardiovascular and cerebrovascular events in diabetic patients without established cardiovascular diseases: a meta-analysis. Exp Clin Endocrinol Diabetes. 2012;120(2):116-120. doi: 10.1055/s-0031-1297968.

2. Baigent C, Blackwell L, Emberson J, et al; Cholesterol Treatment Trialists’ 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. 2010;376(9753):1670-1681. doi: 10.1016/S0140-6736(10)61350-5.

3. Kashani A, Phillips CO, Foody JM, et al. Risks associated with statin therapy: a systematic overview of randomized clinical trials. Circulation. 2006;114(25):2788-2797.

4. Pencina MJ, Navar-Boggan AM, D’Agostino RB Sr, et al. Application of new cholesterol guidelines to a population-based sample. N Engl J Med. 2014;370(15):1422-1431. doi: 10.1056/NEJMoa1315665.

5. Kaufman HW, Blatt AJ, Huang X, Odeh MA, Superko HR. Blood cholesterol trends 2001-2011 in the United States: analysis of 105 million patient records. PLoS One. 2013;8(5):e63416. doi:10.1371/journal.pone.0063416.

6. Stomberg C, Philipson T, Albaugh M, Sood, N. Utilization effects of Rx-OTC switches and implications for future switches. Health. 2013;5(10):1667-1680.

7. Sood N, Sun E, Zhuo X. Behind-the-counter statins: a silver bullet for reducing costs and increasing access?. Health Serv Res. 2012;47(1, pt 1):174-187. doi: 10.1111/j.1475-6773.2011.01315.x.

8. FDA Center for Drug Evaluation and Research. Summary minutes of the joint meeting of the Nonprescription Drugs Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee. FDA website. Published December 13, 2007. Accessed November 8, 2014.

9. Joint session of the Nonprescription Drugs Advisory Committee and the Endocrinology and Metabolic Drugs Advisory Committee. FDA website. Published December 13, 2007. Accessed December 11, 2014.

10. Barter PJ, Rye KA. Is it appropriate to make statins available over the counter? the argument against the appropriateness of over-the-counter statins. Circulation. 2006;114(12):1315-1320; discussion 1320.

11. Gotto AM Jr. Is it appropriate to make statins available over the counter? over-the-counter statins are worth considering in primary prevention of cardiovascular disease. Circulation. 2006;114(12):1310-1314; discussion 1314..

12. Melin JM, Struble WE, Tipping RW, et al. A consumer use study of over-the-counter lovastatin (CUSTOM). Am J Cardiol. 2004;94(10):1243-1248.

13. Brass EP, Allen SE, Melin JM. Potential impact on cardiovascular public health of over-the-counter statin availability. Am J Cardiol. 2006:97(6):851-856.

14. Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014;129(25, suppl 2):S1-S45. doi: 10.1161/01.cir.0000437738.63853.7a.

15. NHANES 2007-2008 demographics data [demographic variables & sample Weights]. CDC website. Published September 2009. Accessed October 1, 2014.

16. NHANES 2007-2008 Laboratory data [cholesterol – HDL]. CDC website. Published April 2010. Accessed October 1, 2014.

17. NHANES 2007-2008 laboratory data [cholesterol - LDL & triglycerides]. CDC website. Updated September 2010. Accessed October 1, 2014.

18. NHANES 2007-2008 laboratory data [cholesterol – total]. CDC website. Updated February 2010. Accessed October 1, 2014.

19. NHANES 2007-2008 laboratory data [plasma fasting glucose & insulin]. CDC Website. Published January 2010. Accessed October 1, 2014.

20. NHANES 2007-2008 questionnaire data [blood pressure & cholesterol]. CDC website. Published September 2009. Accessed October 1, 2014.

21. NHANES 2007-2008 questionnaire data [cardiovascular health]. CDC website. Published September 2009. Accessed October 1, 2014.

22. NHANES 2007-2008 questionnaire data [diabetes]. CDC website. Updated April 2011. Accessed October 1, 2014.

23. NHANES 2007-2008 questionnaire data [smoking – cigarette use]. CDC website. Updated May 2015. Accessed October 1, 2014.

24. Brass EP, Vassil T, Replogle A, et al. Can consumers self-select for appropriate use of an over-the-counter statin? The Self Evaluation of Lovastatin To Enhance Cholesterol Treatment Study. Am J Cardiol. 2008;101(10):1448-1455. doi: 10.1016/j.amjcard.2008.01.020.

25. FDA Advisory Committee briefing document: NDA 21-213 proposing over-the-counter Mevacor (lovastatin) 20 mg. FDA website. Published December 13, 2007. Accessed December 11, 2014.

26. Medical Expenditure Panel Survey [MEPS HC-147: 2011 full year consolidated data file]. Agency for Healthcare Research and Quality website. Published September 2013. Accessed October 20, 2014.

27. Consumer Price Index - all urban consumers, 2000-2014. Bureau of Labor Statistics website. Accessed October 16, 2014.

28. NARP reference file—January 2013 (based on November 2012 claims data) [DRAFT - NARP]. Medicaid website. Accessed October 28, 2014.

29. NARP reference file—June 2013 (based on April 2013 claims data) [DRAFT - NARP]. CMS website. Accessed October 28, 2014.

30. MinuteClinic price list. CVS website. Updated January 28, 2015. Accessed December 10, 2014.

31. Health test services. Walgreens website. Accessed December 10, 2014.

32. Sood N, Sun E, Zhuo X, Blume-Kohut M. Potential effects of introducing behind the counter drugs [RAND working paper WR-608-ASPE]. RAND website. Published August 2008. Accessed October 22, 2014.

33. Using Stata [namcs2010-stata.exe]. CDC website. Accessed October 1, 2014.

34. Employer costs for employee compensation—March 2015. Bureau of Labor Statistics website. Published June 10, 2015. Accessed July 31, 2015.

35. Table A-1. Employment status of the civilian population by sex and age (civilian noninstitutional population and employed population for men and women 20 years and over, June 2015). Bureau of Labor Statistics website. Accessed July 31, 2015.

36. Etemad LR, McCollam PL. Total first-year costs of acute coronary syndrome in a managed care setting. J Manag Care Pharm. 2005;11(4):300-306.

37. Brandle M, Davidson MB, Schriger DL, Lorber B, Herman WH. Cost effectiveness of statin therapy for the primary prevention of major coronary events in individuals with type 2 diabetes. Diabetes Care. 2003;26(6):1796-1801.

38. Straka RJ, Mamdani M, Damen J, et al. Economic impacts attributable to the early clinical benefit of atorvastatin therapy—a US managed care perspective. Curr Med Res Opin. 2007;23(7):1517-1529.

39. Luengo-Fernandez R, Gray AM, Rothwell PM. Costs of stroke using patient-level data: a critical review of the literature. Stroke. 2009;40(2):e18-e23. doi: 10.1161/STROKEAHA.108.529776.

40. Demaerschalk BM, Hwang HM, Leung, G. US cost burden of ischemic stroke: a systematic literature review. Am J Manag Care. 2010;16(7):525-533.

41. Mihaylova B, Emberson J, Blackwell L, et al; Cholesterol Treatment Trailists’ Collaborators. The effects of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012;380(9841):581-590. doi: 10.1016/S0140-6736(12)60367-5.

42. Mills EJ, Wu P, Chong G, et al. Efficacy and safety of statin treatment for cardiovascular disease: a network meta-analysis of 170,255 patients from 76 randomized trials. QJM. 2011;104(2):109-124. doi: 10.1093/qjmed/hcq165.

43. Taylor F, Huffman MD, Macedo AF, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2013;1:CD004816. doi:10.1002/14651858.CD004816.pub5.

44. Gutierrez J, Ramirez G, Rundek T, Sacco RL. Statin therapy in the prevention of recurrent cardiovascular events: a sex-based meta-analysis. Arch Intern Med. 2012;172(12):909-919. doi: 10.1001/archinternmed.2012.2145.

45. de Vries FM, Denig P, Pouwels KB, Postma MJ, Hak E. Primary prevention of major cardiovascular and cerebrovascular events with statins in diabetic patients: a meta-analysis. Drugs. 2012;72(18):2365-2373. doi: 10.2165/11638240-000000000-00000.

46. Bulbulia R, Bowman L, et al; Heart Protection Study Collaborative Group. Effects on 11-year mortality and morbidity of lowering LDL cholesterol with simvastatin for about 5 years in 20,536 high-risk individuals: a randomised controlled trial. Lancet. 2011;378(9808):2013-2020. doi: 10.1016/S0140-6736(11)61125-2.

47. Mills EJ, O’Regan C, Eyawo O, et al. Intensive statin therapy compared with moderate dosing for prevention of cardiovascular events: a meta-analysis of >40 000 patients. Eur Heart J. 2011;32(11):1409-1415. doi: 10.1093/eurheartj/ehr035.

48. Graham DJ, Staffa JA, Shatin D, et al. Incidence of hospitalized rhabdomyolysis in patients treated with lipid-lowering drugs. JAMA. 2004;292(21):2585-2590.

49. Chang JT, Staff JA, Parks M, Green L. Rhabdomyolysis with HMG-CoA reductase inhibitors and gemfibrozil combination therapy. Pharmacoepidemiol Drug Saf. 2004;13(7):417-426.

50. FDA expands advice on statin risks. FDA website. Updated January 31, 2014. Accessed December 22, 2014.

51. Shah RV, Goldfine, AB. Statins and risk of new-onset diabetes mellitus. Circulation. 2012:126(18):e282-e284. doi: 10.1161/CIRCULATIONAHA.112.122135.

52. Vergouwen MDI, de Hann RJ, Vermeulen M, Roos YB. Statin treatment and the occurrence of hemorrhagic stroke in patients with a history of cerebrovascular disease. Stroke. 2008:39(2):497-502. doi: 10.1161/STROKEAHA.107.488791.

53. Heart Protection Study Collaborative Group. Statin cost-effectiveness in the United States for people at different vascular risk levels. Circ Cardiovasc Qual Outcomes. 2009;2(2):65-72. doi: 10.1161/CIRCOUTCOMES.108.808469.

54. Wagner M, Goetghebeur M, Merikle E, Pandya A, Chu P, Taylor DC. Cost-effectiveness of intensive lipid lowering therapy with 80 mg of atorvastatin, versus 10 mg of atorvastatin, for secondary prevention of cardiovascular disease in Canada. Can J Clin Pharmacol. 2009;16(2):e331-e345.

55. Kaestner R, Darden M, Lakdawalla D. Are investments in disease prevention complements? the case of statins and health behaviors. J Health Econ. 2014;36:151-163. doi: 10.1016/j.jhealeco.2014.04.006. 
Copyright AJMC 2006-2020 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
Welcome the the new and improved, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up