<a><b>Objectives</b></a>: <a>Using the 2016 Medicare
part D coverage gap as an example, we explored effects of increased out-of-pocket
costs on adherence to branded </a>dipeptidyl
peptidase-4 inhibitors (DPP-4i) in patients without financial subsidies, relative to subsidized patients who do not
experience increased spending during the gap. We also explored seasonality of re-initiation,
as discontinuers may be more likely to reinitiate in January when benefits
reset.
<p><b>Methods: </b>DPP-4i or
sulfonylureas initiators, aged <u>></u>66 years, from a 20% sample of 2015-2016
Medicare claims were identified. We used difference-in-differences Poisson
regression to compare adherence before and after entering the coverage gap
between non-subsidized and subsidized patients. Among discontinuers, monthly
hazard ratios (HRs) for re-initiation relative to January 2016 were derived with
Cox models. As a second control, we repeated analyses using
sulfonylureas, generic low-cost alternatives.</p>
<p><b>Results</b>: In 2016, 8,096 subsidized
and 6,173 non-subsidized DPP-4i initiators entered the coverage gap. Non-subsidized patients,
copayment in the coverage gap was 45% ($227 per DPP-4i prescription), and adherence
decreased from 68.4% to 49.0% after gap entry.
Accounting for adherence differences in subsidized patients, non-subsidized
patients demonstrated reduced adherence to DPP-4is [Difference-in-difference:-16.9%;CI(-18.7%,-15.1%)]
but not sulfonylureas [-1.6%(-3.4%,0.2%)]. Re-initiation was lowest in the
months before January (HR=0.4-0.5) among non-subsidized DPP-4i patients,
demonstrating a strong seasonal pattern. </p>
<p><b>Conclusions: </b>Increased
out-of-pocket costs negatively affect adherence and re-initiation of branded
antihyperglycemic drugs among patients without financial subsidies. Despite closure
of the coverage gap, affordability remains a concern given increasing list
prices for many drugs on Medicare and the growing use of deductibles and
coinsurance by commercial health plans. <b></b></p>