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The American Journal of Managed Care July 2019
Changing Demographics Among Populations Prescribed HCV Treatment, 2013-2017
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Impact of a Co-pay Accumulator Adjustment Program on Specialty Drug Adherence
Bruce W. Sherman, MD; Andrew J. Epstein, PhD; Brian Meissner, PharmD, PhD; and Manish Mittal, PhD
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Jane M. Zhu, MD, MPP; Amol Navathe, MD, PhD; Yihao Yuan, MSc; Sarah Dykstra, BA; and Rachel M. Werner, MD, PhD
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Impact of a Co-pay Accumulator Adjustment Program on Specialty Drug Adherence

Bruce W. Sherman, MD; Andrew J. Epstein, PhD; Brian Meissner, PharmD, PhD; and Manish Mittal, PhD
Commercial health plan initiation of a co-pay accumulator adjustment program for specialty medications treating autoimmune diseases was associated with significant reductions in medication adherence and persistence.
RESULTS

After exclusions for no autoimmune SpRx claims (n = 2752) and health plan coverage changes (n = 25), 603 patients were in the main study sample, including 365 HSA enrollees and 238 PPO enrollees. Mean (SD) age was 48 (13) years, 60% were women, and mean (SD) AGI was $68,273 ($25,294). These characteristics were not statistically significantly different between HSA and PPO enrollees. Of note, during 2017, 92% of enrollees in the HSA and PPO groups used at least 1 co-pay assistance coupon (eAppendix Table 1). Coupon use during 2016 was not tracked by the PBM.

Unadjusted trends in monthly mean fills per person by plan type are shown in Figure 1. Across the 22-month study period, there were, on average, 284 HSA patients (range, 252-307) and 184 PPO patients (range, 166-196) with insurance coverage in each month. During 2016, although adjusted monthly fills per person increased nominally for both plan types, the adjusted HSA slope was 0.010 (95% CI, 0.001-0.019) fills per person-month lower, translating to 118 (95% CI, 12-224) fewer fills per 1000 patients by December 2016. After the CAAP started, fills decreased for HSA enrollees and increased for PPO enrollees nominally, and the adjusted difference in slopes was 0.023 (95% CI, 0.012-0.035) fills per person-month lower for HSA patients, which translated to 233 (95% CI, 117-349) fewer fills per 1000 patients by October 2017.

For the treatment discontinuation analyses, 199 patients had active autoimmune prescriptions on February 1, 2016; 278 had them on January 1, 2017. Kaplan-Meier curves of unadjusted discontinuation risk are shown in Figure 2 (A [2016] and B [2017]). Adjusted discontinuation risk was comparable between HSA and PPO enrollees in 2016 (HR, 0.97; 95% CI, 0.57-1.65) and statistically significantly higher for HSA enrollees in 2017 (HR, 2.17; 95% CI, 1.39-3.40). Based on predicted values from the adjusted Cox model, on October 31, 2017, discontinuation was 20.0 (95% CI, 3.9-36.1) percentage points higher for HSA (42.2%) versus PPO (22.3%) enrollees. In comparison, at the end of the pre-CAAP follow-up (December 31, 2016), discontinuation was not statistically different (HSA, 14.8% vs PPO, 15.2%; difference, −0.5 percentage points; 95% CI, −40.3 to 39.4).

Findings for the adjusted risk of absolute treatment discontinuation were similar. The risk was comparable for HSA versus PPO enrollees before the CAAP (HR, 0.99; 95% CI, 0.42-2.35) and significantly larger for HSA enrollees after (HR, 4.98; 95% CI, 2.35-10.59). Likewise, predicted absolute discontinuation was not statistically different (HSA, 87.2% vs PPO, 87.2%; difference, −0.05 percentage points; 95% CI, −36.9 to 37.0) at the end of pre-CAAP follow-up, but it was higher by 25.6 (95% CI, 10.5-40.6) percentage points for HSA (33.3%) versus PPO (7.7%) enrollees at the end of post-CAAP follow-up.

In the PDC analyses, 185 patients as of February 1, 2016, and 217 as of January 1, 2017, had an active prescription. Unadjusted trends in PDC are shown in Figure 3 (A [2016] and B [2017]). From 30 days after February 1, 2016, through December 31, 2016, adjusted PDC declined nominally faster for HSA enrollees by 0.3 (95% CI, −0.6 to 1.2) percentage points per 30 days. In contrast, from 30 days after January 1, 2017, through October 31, 2017, adjusted PDC declined faster for HSA enrollees by 1.7 (95% CI, 0.8-2.5) percentage points per 30 days. Based on the intercepts and slopes of the fitted trendlines, adjusted mean PDC was 11.7 (95% CI, 2.7-20.6) percentage points lower for HSA patients on October 31, 2017 (HSA, 63.0%; PPO, 74.7%), compared with 0.2 (95% CI, −9.6 to 10.0) percentage points lower on December 31, 2016 (HSA, 70.9%; PPO, 71.1%).

Results of the first 2 sensitivity analyses were consistent with the main findings. Resetting the post-CAAP index date from January 1, 2017, to February 1, 2017, yielded a minor change in the post-CAAP risk of SpRx treatment discontinuation (adjusted HR, 2.32; 95% CI, 1.46-3.70) (eAppendix Figure 1). The same change led to a small increase in the HSA–PPO difference in PDC slopes (adjusted slope, 1.9 percentage points; 95% CI, 1.0-2.8) (eAppendix Figure 2).

Post-CAAP differences between HSA and PPO enrollees were similar in the subset of 225 patients who had continuous enrollment throughout the study period and used a co-pay assistance card in the first quarter of 2017. The adjusted slope difference in fills per person-month grew to 0.028 (95% CI, 0.018-0.038), the adjusted HSA versus PPO HR for the risk of treatment discontinuation grew to 2.41 (95% CI, 1.43-4.09), and adjusted PDC remained steeper for HSA enrollees (slope difference, 1.6 percentage points; 95% CI, 0.6-2.5).

The third sensitivity analysis compared HSA and PPO patients’ use of MS drugs, finding no statistically significant adjusted difference in trends in monthly fills (slope difference, 0.010 fills per person-month higher for HSA enrollees; 95% CI, −0.010 to 0.030), risk of discontinuation (HR, 0.69; 95% CI, 0.30-1.58), risk of absolute discontinuation (HR, 0.74; 95% CI, 0.25-2.24), or PDC (slope difference, −0.06 percentage points; 95% CI, −1.1 to 1.0) after CAAP implementation. As of October 31, 2017, predicted discontinuation risk and adjusted mean PDC were statistically no different between plan types (eAppendix Table 2).


 
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