Drug discontinuation and switching during the Medicare Part D coverage gap

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1 Drug discontinuation and switching during the Medicare Part D coverage gap Jennifer M. Polinski, ScD, MPH William H. Shrank, MD, MSHS; Haiden A. Huskamp, PhD; Robert J. Glynn, PhD, ScD; Joshua N. Liberman, PhD; Sebastian Schneeweiss, MD, ScD Division of Pharmacoepidemiology and Pharmacoeconomics Brigham and Women s Hospital Harvard Medical School

2 Disclosures Dr. Polinski: Consultant to Buccaneer Computer Systems and Services, Inc Dr. Glynn: Investigator-initiated unrestricted grant from Astra-Zeneca to study statins Co-investigator of a Novartis grant for the design and monitoring of an RCT Dr. Schneeweiss: Paid member of the Scientific Advisory Board of HealthCore Member of the PCORI Methods Committee Consultant to HealthCore, WHISCON, Booz&Co PI, DEcIDE Center on Comparative Effectiveness Research (AHRQ), DEcIDE Methods Center (AHRQ) Investigator-initiated grants from Pfizer and Novartis Dr. Shrank: PI of grants from CVS Caremark, Express Scripts, Aetna Consultant to United Healthcare Group Dr. Liberman: Was an employee of CVS Caremark at the time of the study

3 Funding National Institute on Aging T32 AG (Dr. Polinski) National Institute of Health U01MH (Dr. Schneeweiss) National Heart Lung and Blood Institute K23 HL (Dr. Shrank) Research grant from CVS Caremark (Dr. Shrank) Robert Wood Johnson Foundation Investigator Award in Health Policy Research (Dr. Huskamp) The sponsors had no role in the design, data collection and analysis, or decision to present/publish.

4 Medicare Part D and the coverage gap Standard benefit

5 Coverage gap exposure: Who has financial assistance during the coverage gap? The UNEXPOSED: Dually-eligible for Medicare & Medicaid Receive low income subsidy Able to enroll in an employer-sponsored retiree plan

6 Coverage gap exposure: Who has financial assistance during the coverage gap? The UNEXPOSED: Dually-eligible for Medicare & Medicaid Receive low income subsidy Able to enroll in an employer-sponsored retiree plan Otherwise, EXPOSED

7 Gaps in knowledge Limited evidence is available about drug utilization, adherence in the coverage gap: Small, single plan samples of Medicare Advantage beneficiaries (younger, healthier, richer) No link to medical data, no comparator groups observing drug use in a vacuum Drug discontinuation, switching may occur for clinical reasons (Sources: Raebel, Med Care, 2008; Schmittdiel, Am J Manag Care, 2009; Zhang, Health Aff, 2009; Hoadley, KFF, 2008; Polinski, Arthr Care Res, 2008)

8 Specific aim What is the impact of the Part D coverage gap on rates of drug discontinuation and drug switching, comparing beneficiaries who do and do not receive financial assistance during this time?

9 Study population Data source: Caremark prescription drug claims + Medicare A and B for Cohorts Early Part D cohort: (N=380,297) Established Part D cohort: (N=289,264) Population of interest Community-dwelling Age 65 + Caremark eligibility At least one Medicare claim in baseline year and study year Comparable drug information: reached coverage gap spending threshold at least 60 days after plan enrollment in the study year

10 Study design Part D plan is chosen, plan benefits begin Reach gap spending threshold End of follow-up period Jan 1, baseline year Jan 1, gap year Coverage gap

11 Exposure Exposed: received no financial assistance to pay for drugs after reaching the coverage gap spending threshold (non-subsidy enrollees) Unexposed: received financial assistance to pay for drugs after reaching the coverage gap spending threshold (full or partial subsidy, retirees)

12 Outcomes Considered discontinuation or switching for drugs used to treat 5 diseases of interest: Rheumatoid arthritis (RA) Cardiovascular conditions (AF, hypertension, hyperlipidemia, MI, angina, atherosclerosis, CHF) Diabetes Depression Dementia

13 Drug discontinuation outcome Reach coverage gap spending threshold: Available days' supply of Drug X Follow-up begins, discontinuation outcome 30 days

14 Drug switching outcome Reach spending threshold with available days' supply of Drug X Follow-up begins, switching outcome 1 day

15 Confounding by health system use Part D plan is chosen, plan benefits begin Reach gap spending threshold End of follow-up period Jan 1, baseline year Jan 1, gap year Coverage gap Baseline, demographics, health status Plan enrollment Health behaviors, health status Reach coverage gap spending threshold

16 Confounding by health system use Part D plan is chosen, plan benefits begin Reach gap spending threshold End of follow-up period Jan 1, baseline year Jan 1, gap year Coverage gap Baseline, demographics, health status Plan enrollment Health behaviors, health status Reach coverage gap spending threshold

17 Greedy-matched propensity score Propensity score: Predicts the probability that a patient will experience a gap in coverage (Pr(gap in cov=1)) Exposed patients are greedy matched 1: 5 to unexposed patients using their propensity scores Age Gender Race Region of the U.S. Rural/urban residence Median household income Charlson comorbidity score at baseline Number of hospitalizations at baseline Number of physician visits at baseline Diagnosis of: Cancer Rheumatoid arthritis Cardiovascular condition Diabetes Depression Dementia Medicare Parts A and B spending (Sources: Seeger, Am J Cardiol, 2003; Kurth and Seeger, HSPH, 2006)

18 Outcome models Propensity score-adjusted, with additional adjustment for post-baseline, pre-coverage gap variables In the 6 months prior to reaching the threshold: Number of hospitalizations Number of physician visits Charlson comorbidity score Time to reach coverage gap spending threshold, in days In the 2 months prior to reaching the threshold: Number of unique medications used Total drug spending (plan + beneficiary)

19 Statistical analysis Cox proportional hazards models Each cohort Pooled cohort Generalized estimating equations, robust standard errors

20 Table 1. Baseline characteristics of 121,760 beneficiaries who reached the coverage gap spending threshold in 2006 Exposed (experience gap in coverage) Unexposed (do not experience a gap in coverage) Non-subsidy Full subsidy Partial subsidy Retirees N=1,084 N=19,255 N=1,699 N=99,722 Female gender 689 (64) 14,634 (76) 1,153 (68) 56,754 (57) White race 1,041 (96) 13,805 (72) 1,584 (93) 93,907 (94) # physician visits # unique medications Coronary artery disease 12 ± ± ± ± 10 3 ± 2 5 ± 2 5 ± 3 5 ± (31) 5,274 (27) 520 (31) 28,399 (28) Diabetes 400 (37) 10,277 (53) 758 (45) 35,014 (35) Congestive heart failure 141 (13) 4,145 (22) 287 (17) 12,619 (13)

21 Table 2. Baseline covariates among propensity score-matched beneficiaries Early Part D cohort, 2006 N=6,504 Established Part D cohort, 2007 N=5,454 Exp Unexp Exp Unexp N=1084 N=5420 Delta N=909 N=4545 Delta Female gender 689 (64) 3439 (63) -1% 603 (66) 2996 (66) 0% White race 1041 (96) 5198 (96) 0% 878 (97) 4401 (97) 0% Charlson comorbidity score # of physician visits # hospitalizations 2 ± 2 2 ± 2 0 points 13 ± ± 12 0 visits 0.3 ± ± 1 0 hosp. 2 ± 2 2 ± 2 0 points 12 ± ± 11 0 visits 0.1 ± ± 1 0 hosp. CV condition 1014 (94) 5062 (93) -1% 844 (93) 4253 (94) +1% Diabetes 436 (40) 2181 (40) 0% 349 (38) 1750 (39) +1%

22 Table 3. Hazards of discontinuing a drug Discontinue a drug Cardiovascular (CV) drug Generic CV drug Branded CV drug Early Part D cohort, 2006 Established Part D cohort, 2007 Pooled cohorts Hazard ratio (95% confidence interval) 1.76 ( ) 1.94 ( ) 2.02 ( ) 1.81 ( ) 2.33 ( ) 2.20 ( ) 1.51 ( ) 4.48 ( ) 2.00 ( ) 2.06 ( ) 1.79 ( ) 2.63 ( )

23 Table 4. Hazards of switching a drug Switch a drug Cardiovascular (CV) drug To a branded CV drug To a generic CV drug Early Part D cohort, 2006 Established Part D cohort, 2007 Pooled cohorts Hazard ratio (95% confidence interval) 0.75 ( ) 0.69 ( ) 0.90 ( ) 0.50 ( ) 0.52 ( ) 0.40 ( ) 0.38 ( ) 0.25 ( ) 0.60 ( ) 0.57 ( ) 0.72 ( ) 0.43 ( )

24 Conclusions When faced with a gap in coverage, beneficiaries stop taking their drugs Gap in coverage does not incentivize beneficiaries to switch to more inexpensive drugs or generics Consistent with studies of Medicare Advantage Part D plan enrollees Warning signal of an increase in adverse health outcomes during the coverage gap? (Sources: Fung, Health Serv Res, 2010; Raebel, Med Care, 2008; Schmittdiel, Am J Manag Care, 2009)

25 Policy implications Necessity and timeliness of Part D coverage gap reform Affordable Care Act (ACA), 2010 Questions remain: Generic drugs v. 50% off branded drugs Competing proposals to repeal ACA reforms: Path to Prosperity Will reform be rapid enough? (Sources: Shrank, Arch Intern Med, 2006; Hoadley, KFF, 2008, Polinski, J Am Geriatr Soc, 2010; Ryan, House Budget Committee, 2011)

26 Thank you

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