Prescription Switching and Reduced LDL-C Goal Attainment

Transcription

1 Prescription Switching and Reduced LDL-C Goal Attainment JoAnne M. Foody, MD, FACC, FAHA Brigham and Women's Hospital, Boston, MA

2 Disclosures Consultant for Merck and Pfizer

3 Why Address Adherence? Increasing the effectiveness of adherence interventions may have a far greater impact on the health of the population than any improvement in specific medical treatments. 1,2 World Health Organization 1. Haynes RB et al. Interventions for helping patients follow prescriptions for medications. Cochrane Database of Systematic Reviews, World Health Organization. Adherence to Long-Term Therapies: Evidence for Action. [World Health Organization Web site] Available at: Accessed March 16, 2004

4 HealthCare Landscape 62% of physician office visits generate a prescription medicine 1 Non-Compliant Behaviors 2 But what happens to those prescriptions? 1 Cherry DK, Burt CW, Woodwell DA. National Ambulatory Medical Care Survey: 2001 Summary. Advance data from vital and health statistics; no 337. Hyattsville, Maryland; National Center for Health Statistics The Hidden Epidemic: Finding a Cure for Unfilled Prescriptions and Missed Doses. December, The Boston Consulting Group and Harris Interactive. Available at Accessed August 16, 2004.

5 Why Didn t They Take Their Medication? 10% difficulties in getting the prescription filled 14% decided they didn't need the drug 17% medication was too costly 20% undesirable or debilitating side effects 24% forgetfulness The Hidden Epidemic: Finding a Cure for Unfilled Prescriptions and Missed Doses, December, The Boston Consulting Group and Harris Interactive. Available at Accessed August 16, 2004.

6 Cost Sharing Is Increasing Co-payments - At Retail Pharmacies: up ~10% across all 3 tiers - By Mail Order: up ~10-20% - 1 st tier: 16% - 2 nd tier up 20% - 3 rd tier up 10% Co-insurance - 26% percent of employers are using coinsurance for second-tier retail cost sharing -- up from 22% Drug Benefit Trends 15(12):7-8, Employers Embrace Cost Sharing. Available at: Accessed August 16, 2004.

7 Cost Sharing Is Increasing * * * * * * * * * * * * Estimate is statistically different from previous year by drug tier Kaiser Family Foundation, Health Research and Educational Trust. Employer health benefits: 2004 Annual Survey, Chart 16. Available at: Accessed September 13, 2004.

8 Benefit Design and Consumerism Dor looked at the impact of benefit design on a population of 27,000 diabetic patients from a large multi-employer database. He found that increasing cost sharing levels decreased full compliance. % Reduction in Full Compliance* *Patients taking oral anti-diabetic drugs Dor A, Encinosa WE. Does Cost Sharing Affect Compliance? The Case of Prescription Drugs. National Bureau of Economic Research. NBER Working Paper Series. No August 2004.JEL No I11,L11

9 Impact of Benefit Design Dor then looked at the impact of benefit design on pharmaceutical costs and total medical costs. His model, based on the database, shows that if co-pays for 10 million diabetics (in the US) were increased from $6 to $10: RX spend decreased by $125M per year DIRECT medical costs increased by $320M per year $350 $250 $150 $50 $320M $195M increased overall spend This yields an annual net direct cost of $195M --without including absenteeism or disability -$50 -$150 -$125M Dor A, Encinosa WE. Does Cost Sharing Affect Compliance? The Case of Prescription Drugs. National Bureau of Economic Research. NBER Working Paper Series. No August 2004.JEL No I11,L11

10 Impact of cost-shifting and copayment Retrospective study to examine the effect of changes in cost sharing in the chronically ill and privately insured. Increasing copayment reduced 8 therapeutic classes including antihypertensive, antihyperlipidemic,and antidiabetic meds Overall, there is a concern with potential adverse health consequences due to increase copayment. Goldman DP, Joyce GE, Escarce JJ, et al. (2004). Pharmacy benefits and the use of drugs by the chronically ill. JAMA. 291 :

11 Demand is Elastic The Level of Cost Sharing Drives Behavior Ellis analyzed adherence in a non-medicaid MCO population of adults taking 2 statins. He found that patients with co-pays of $20 or more were more than 4 times as likely as patients with copays of less than $10 to discontinue statin therapy. Survival Curves for Discontinuation by Co-Pay Range Ellis JJ, Fendrick M, et al. Suboptimal Statin Adherence and Discontinuation in Primary and Secondary Prevention Populations. Should We Target Patients with the Most to Gain? J Gen Intern Med 2004;19:

12 Unintended consequences of formulary changes? different changes in formularies may have dramatically different effects on utilization and spending and may in some instances lead enrollees to discontinue therapy. the associated changes in copays can substantially alter out-of-pocket spending, the continuation of the use of medications, and possibly the quality of care. "The discontinuation of the use of medications such as statins and ACE inhibitors that are needed for the treatment of chronic illnesses raises important questions about potentially harmful effects of formulary changes and the associated changes in copayments, Huskamp, H. et al. (2003). The Effect of Incentive-Based Formularies on Prescription-Drug Utilization and Spending. The New England Journal of Medicine, 394(23).

13 Audit of Switching R Butler, J Wainwright. Cholesterol lowering in patients with CHD and metabolic syndrome. Lancet : 27.

14 Switch from atorvastatin to simvastatin significantly increased risk of death/first major CV event Observational study in UK Phillips et al, 2007 B J Cardiol

15 Total 2-year costs and cost components for matched patients treated with atorvastatin or simvastatin. Simpson R J et al. Mayo Clin Proc. 2009;84: Mayo Foundation for Medical Education and Research

16 Analysis of trends in LDL-C levels and goal attainment in high-risk patients Study design Retrospective, cross-sectional study, Jan Aug Large, managed-care claims database in US High-risk CHD/AVD patients (ICD-9 and/or procedure codes) age 18 years with 1 LDL-C test (n=284,915) Monthly average LDL-C values and attainment of LDL-C <70 mg/dl were assessed Treated population: 1 LLT Rx (statins, niacin, fibrates, bile acid sequestrants, ezetimibe) before LDL-C test Untreated population: patients who did not receive LLT prior to monthly LDL-C test and those newly enrolled Linear trend analysis with first-order autocorrelated errors was conducted Foody et al, JCL, (2010) 4,

17 Proportion of high risk CHD/AVD patients treated with LLT increased during % of patients treated with LLT Treated Untreated Foody et al, JCL, (2010) 4,

18 LDL-C levels decreased in treated high risk patients, then plateaued from TREATED UNTREATED 115 LDL-C [mg/dl] Jan-04 Mar-04 May-04 Jul-04 Sep-04 Nov-04 Jan-05 Mar-05 May-05 Jul-05 Sep-05 Nov-05 Jan-06 Mar-06 May-06 Jul-06 Sep-06 Nov-06 Jan-07 Mar-07 May-07 Jul-07 Sep-07 Nov-07 Feb-08 Apr-08 Jun-08 Aug-08 Foody et al, JCL, (2010) 4,

19 Percentage of patients switched to lower, equivalent/higher LDL-C lowering efficacy doses of simvastatin % of patients Lower Equivalent/ Higher 8.6 Lower Equivalent/ Higher LDL-C lowering efficacy level Atovastatin Rosuvastatin E/S 2.2 Lower Equivalent/ Higher Lower Equivalent/higher >60% of patients on atorvastatin prescribed simvastatin doses of equivalent/higher LDL-C lowering efficacy Most patients on rosuvastatin (91.4%) and E/S (97.8%) switched to less-efficacious doses of simvastatin Tunceli et al, JCL (2010) 4,

20 Greater LDL-C reductions in patients who switched to combination therapy vs those who titrated statins % change from baseline in LDL-C Statin to E/S Statin titrated Not titrated All Patients Patients not at goal

21 Switching to E/S provided better LDL-C goal attainment vs titrating to higher statin levels regardless of potency 100 Baseline Follow-up % goal attainment Switch to E/S Titrate Statins Non-titrate Statins Switch to E/S Titrate Statins Non-titrate Statins Switch to E/S Titrate Statins Non-titrate Statins Low Medium High LDL-C lowering efficacy level

22 Ezetimibe added onto statins provided greater LDL-C reductions vs titrating statins 5 Add-on Titraters 0 % change from baseline * -27.0* -27.0* Simvastatin Atorvastatin Rosuvastatin

23 Ezetimibe added-on to statins provided greater LDL-C goal attainment vs titrating statins 100 Add-on Titraters % patient attainment BL FU LDL-C <2.59 mmol/l (100 mg/dl) BL FU LDL-C <1.81 mmol/l (70 mg/dl) BL FU LDL-C <2.59 mmol/l (100 mg/dl) BL FU BL FU LDL-C LDL-C <1.81 mmol/l <2.59 mmol/l (70 mg/dl) (100 mg/dl) BL FU LDL-C <1.81 mmol/l (70 mg/dl) Simvastatin Atorvastatin Rosuvastatin

24 Adherence to statins, subsequent healthcare costs, and cardiovascular hospitalizations. Assess relation among statin adherence, subsequent hospitalizations, and healthcare costs Retrospective cohort study of 381,422 patients, aged 18 to 61 years, using an integrated pharmacy and medical claims database. Of those studied, 258,013 (67.6%) were adherent (MPR 80%), 65,795 (17.3%) had an MPR of 60% to 79%, and 57,614 (15.1%) had an MPR of <60%. The adjusted all-cause total healthcare costs were lowest in the adherent group at $10,198 ± $39.4 (mean ± SE) versus $11,102 ± $84.3 (p <0.001) for an MPR of <60%. The adjusted total healthcare costs were lowest for the MPR 90% to 100% group and significantly greater statistically (p <0.001) for each lower level of adherence. Compared to the statin-adherent patients, cardiovascular disease-related hospitalizations were 26% more likely in nonadherent patients. Am J Cardiol Jun 1;107(11): Epub 2011 Mar 23.

25 Summary Progress has been made in reducing CVD morbidity and mortality, due largely to improved cholesterol management particularly higher efficacy LDL-C lowering agents Nonetheless, upward gains in LDL-C goal attainment rates in high risk CVD patients have plateaued and many patients still do not meet recommended LDL-C goals These observations are likely multifactorial including cost, formulary changes, decreases in combination therapy coupled with poor adherence. Given a rising prevalence of CVD risk patients and a trend toward use of less efficacious LDL-C lowering agents, continued efforts toward reducing the burden of high LDL-C are needed