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High Cost Sharing and Specialty Drug Initiation Under Medicare Part D: A Case Study in Patients With Newly Diagnosed Chronic Myeloid Leukemia
Jalpa A. Doshi, PhD; Pengxiang Li, PhD; Hairong Huo, PhD, MS; Amy R. Pettit, PhD; Rishab Kumar; Brendan M. Weiss, MD; and Scott F. Huntington, MD, MPH

High Cost Sharing and Specialty Drug Initiation Under Medicare Part D: A Case Study in Patients With Newly Diagnosed Chronic Myeloid Leukemia

Jalpa A. Doshi, PhD; Pengxiang Li, PhD; Hairong Huo, PhD, MS; Amy R. Pettit, PhD; Rishab Kumar; Brendan M. Weiss, MD; and Scott F. Huntington, MD, MPH
A Medicare claims analysis of patients newly diagnosed with chronic myeloid leukemia revealed that high cost sharing was associated with reduced and/or delayed tyrosine kinase inhibitor initiation under Part D.
To examine how changes in our selection criteria would influence the resulting sample, we began with the most relaxed criterion (identifying new CML patients by requiring 2 or more CML claims, including the index claim) and then applied additional criteria in sequence to examine the impact: a) requiring ≥2 CML claims 30 days apart; b) requiring ≥2 CML claims 30 days apart and requiring a claim for a molecular oncogene diagnostic test (during the 30 days before or the 30 days after the index date); c) requiring ≥2 CML claims and excluding ALL patients (defined as ≥2 ALL claims during the pre- or postindex period); d) requiring ≥2 CML claims 30 days apart and excluding ALL patients (defined as ≥2 ALL claims 30 days apart during the pre- or postindex period); e) requiring ≥2 CML claims 30 days apart, excluding ALL patients (defined as ≥2 ALL claims 30 days apart during the pre- or postindex period), and requiring a molecular oncogene diagnostic test (as defined above); and f) excluding patients whose index CML claim occurred during an inpatient stay, since a lengthy stay may have included an initial course of a TKI during the hospitalization. (Oral drugs administered in inpatient settings are not captured in inpatient claims data.)

All statistical analyses were performed using SAS version 9.2 (SAS Institute, Cary, North Carolina) and STATA/MP version 13 (StataCorp LP, College Station, Texas). The University of Pennsylvania Institutional Review Board deemed the study exempt from informed consent procedures, as no data were collected directly from human subjects.

RESULTS
Our main sample selection criteria identified 1053 patients with newly diagnosed CML between 2011 and 2013. Baseline characteristics for this sample are reported in Table 1. The non-LIS group was older and had a higher percentage of males and white patients, compared with the LIS group. The non-LIS group also had a lower mean Charlson comorbidity score but a larger proportion of patients with moderate to severe CML severity at diagnosis, as well as a greater percentage of patients who faced prior authorization requirements for TKIs, compared with the LIS group.

All non-LIS patients were subject to 25% to 33% coinsurance for TKIs during the initial coverage phase, regardless of whether their plan had a distinct specialty tier. Further, given mean total costs of ~$6800 per 30-day TKI prescription, the first drug fill “straddled” Part D benefit phases (pushing beneficiaries out of the initial coverage phase and into the coverage gap phase) and generated an out-of-pocket cost for the initial TKI fill of approximately $2600 or more for non-LIS patients (data not shown). On the other hand, the full LIS patients faced out-of-pocket costs of $5 or less for the initial TKI fill (data not shown).

The Figure shows Kaplan-Meier curves for TKI initiation, stratified by LIS status. The time to TKI initiation was significantly longer in the non-LIS group compared with the LIS group (log-rank P <.001). A significantly lower proportion of the non-LIS group initiated a TKI within 1 month (21% vs 53%; P <.001) and within 3 months (36% vs 65%; P <.001) of initial CML diagnosis compared with the LIS group. Six months after the first CML claim, the non-LIS group was still less likely than the LIS group to have initiated a TKI (45% vs 67%; P <.001) (Table 2).

On average, non-LIS patients who did fill a TKI took twice as long to do so (mean = 50.9 vs 23.7 days; P <.001). After controlling for sociodemographic, clinical, and plan characteristics in Cox regression analysis, LIS status remained highly associated with TKI initiation, with the non-LIS group having a lower hazard of TKI initiation compared with the LIS group (hazard ratio, 0.59; 95% CI, 0.45-0.76; P <.001) (eAppendix Table [available at www.ajmc.com]). Subgroup analyses in elderly versus disabled Medicare beneficiaries showed consistent findings, with non-LIS patients having a lower hazard of TKI initiation than LIS patients (data not shown). Extensive sensitivity analyses using varying outcome definitions, analytic techniques, and sample selection criteria showed findings consistent with the main results (Table 2).

DISCUSSION
Our study offers new insights into the relationship between high cost sharing and cancer treatment initiation in Medicare Part D beneficiaries. We found significantly lower fill rates and significantly longer time to initiation of TKIs among beneficiaries newly diagnosed with CML who were responsible for high out-of-pocket costs compared with their counterparts who faced minimal out-of-pocket costs due to receipt of LIS. The robustness of these results was confirmed via a wide range of sensitivity analyses, suggesting that patient out-of-pocket burden is associated with delayed and/or reduced initiation of critical treatments under Medicare Part D.

To our knowledge, this is the first study to utilize a 100% data extract of national Medicare Part A, B, and D claims linked with Part D plan and formulary characteristics information to explore the relationship between high cost sharing and access to specialty cancer drugs. Use of this data set allowed us to extend prior findings on this topic in a number of ways. First, most prior evidence in this area comes from data on privately insured populations from 2009 or earlier, wherein specialty drugs were subject to substantially lower levels of cost sharing.12-16 In fact, the specialty drugs examined in all of these studies had median monthly out-of-pocket payments of $30 or less.1 As a result, those findings have limited generalizability to the complicated cost-sharing structure and high out-of-pocket costs currently present under Medicare Part D. Two prior studies that included data on Medicare patients using specialty cancer drugs either did not conduct subgroup analyses in Medicare patients17 or averaged cost-sharing amounts across the high and low cost-sharing coverage phases under Part D,18 and thus, the specific impact of out-of-pocket costs on treatment during periods of high cost sharing was obscured. Furthermore, both studies lacked medical claims data and were unable to control for important clinical characteristics.17,18

Second, all prior studies lacked information on plan formulary characteristics and, hence were unable to account for the confounding effect of utilization management tools, such as prior authorization, quantity limits, and step therapy, which are increasingly applied to specialty drugs as a complement or substitute to cost-sharing strategies.12-18 Our study is the first to use detailed information on Part D plan formularies to control for the extent of formulary coverage and utilization management for the studied cancer drug class. Finally, although the literature in general suggests a stronger association between cost sharing and treatment initiation than treatment adherence and/or discontinuation,1 prior studies examining specialty cancer drug treatment initiation have lacked a large sample size (given their data source) and/or a more clinically nuanced approach to identify patients newly diagnosed with cancer, or to examine treatment history in a way that would reveal whether patients may have delayed treatment initiation.12,13,15,17

The magnitude of the discrepancies in the outcomes we measured—double-digit differences in the percentage of patients initiating TKI treatments within 6 months of initial diagnosis and, on average, those filling Part D TKI prescriptions within 6 months taking roughly twice as long to start treatment—are striking. This is especially notable given that, unlike some cancer treatments that extend survival by months, TKIs can extend survival by many years and allow most patients to live with CML as a chronic disease.8 Further, oral TKIs do not carry additional burdens associated with many specialty drugs that require self-injection or infusions (eg, needle anxiety, pain with administration, need for refrigeration or special handling, travel to an infusion center), so there may be fewer potential barriers beyond out-of-pocket burden for patients to consider when deciding to initiate treatment promptly or at all. In these ways, TKIs represent particularly high-value medications from a patient perspective. Although the relatively short duration of follow-up in our observational analyses did not allow us to assess the impact of TKI delay on long-term clinical outcomes, recent data suggest that prolonged delays in TKI initiation can have a deleterious effect on survival in patients with CML.19

Limitations

Several study limitations should be noted. First, this was a cross-sectional analysis that used LIS patients as a control group and, hence, the study documents associations and is not able to establish causal relationships between high cost sharing and treatment initiation. As with all observational studies, there is the potential for unobserved confounding (eg, related to additional clinical or treatment history variables not available in our claims data) to contribute to observed differences in initiation. Of note, many of the issues that are relevant for other oncology studies, such as differences in patient perceptions of the benefits and costs of an expensive treatment that may have more limited potential to improve quality of life or extend survival, would be expected to play less of a role in decisions about whether to initiate a TKI. In addition, whereas patient-level demographic and clinical differences could have contributed to the observed differences in TKI initiation, evidence suggests that age and comorbidities have little effect on the success of TKI treatment for CML.20 Thus, all patients would be expected to be similarly eligible for TKI treatment. Further, we sought to offset the limitations of our observational design by employing multivariable regression to control for a variety of sociodemographic, clinical, and plan-level characteristics that could influence treatment decisions. We also conducted extensive sensitivity analyses, with consistent findings that suggest our results are robust.

 
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