BackgroundPatients on treatment for CLL can incur significant OOP costs, but little is known about length of time to reach OOP maximums, and variance of cost-sharing between IV and oral medications, especially among privately-insured patients. These issues have both practice and policy implications. First, from a practice perspective, insurance plans can vary their cost-sharing for IV versus oral chemotherapy, and cost-sharing can impact adherence and outcomes. Second, from a policy perspective, 43 states have enacted laws to ensure cost-sharing parity between oral and IV chemotherapy, but there is little evidence that these laws actually lower costs for patients. Thus, our objective was to determine, for both oral and IV drugs, how quickly patients reach their annual OOP maximums.MethodsUsing Health Insurance Marketplace Public Use Files that contain cost-sharing data for all private insurance plans participating in the Affordable Care Act's (ACA) Federally Facilitated Marketplace, we determined the relative impact on OOP cost of oral (ibrutinib) vs. IV (bendamustine/rituximab; BR) chemotherapy on time to reaching OOP maximums. With this data, we created a model of guideline-based, first-line CLL treatment regimens for ibrutinib and BR. We used Current Procedural Terminology (CPT) codes for procedures, and Healthcare Common Procedure Coding System (HCPCS) J-codes for drugs. We used a patient weight of 70kg and body surface area of 1.8m2 for dosing. Ibrutinib was dosed at 420mg. BR was dosed at bendamustine 70mg/m2 and rituximab 375mg/m2 for the first dose and bendamustine 500mg/m2 for all subsequent doses. We accounted for billing of professional fees, facility fees, infusional drugs, oral specialty drugs, supportive care medications, imaging, and blood tests. The average bill for each visit was applied to ACA Marketplace plans at 100% of Medicare fee schedule. As a sensitivity analysis, we varied costs to 120% and 150% of the Medicare Fee schedule based on an evidence-based multiplier for estimation of private insurance fees. Descriptive statistics and t-tests for comparison were calculated for number of days to reach OOP maximum for each insurance plan. We assessed variation according to metal tier (Catastrophic, Bronze, Silver, Gold, Platinum).ResultsOf the nearly 55,000 ACA plans nationally, 3092 unique insurance plan designs were identified on the ACA Marketplace for 2017. The average OOP maximum of these plans by metal tier was $7150 for catastrophic (maximum allowed by the ACA in 2017), $6883 for bronze, $6463 for silver, $4931 for gold, and $2284 for platinum. On average, patients on 95% of plans will reach the OOP maximum for the year for both BR and ibrutinib. A patient on BR will reach the OOP maximum in a mean of 3 clinic visits (29 days) for 100%, 120% and 150% of Medicare pricing. Using the 100% Medicare pricing estimate, a patient on ibrutinib will reach the OOP maximum in a mean of 3 visits (36 days) based on the typical timing of office visits. For the 120% and 150% of Medicare pricing estimates, the maximum OOP costs for ibrutinib are reached after only 2 visits (8 days). Metal tier also impacted time to maximum. For a patient on BR at 100% of Medicare, the maximum OOP expense was reached after 1 visit (1 day) for catastrophic, 2 visits (2 days) for bronze, 3 visits (28 days) for silver, 4 visits (29 days) for gold, 10 visits (113 days) for platinum. For a patient receiving ibrutinib at 100% of Medicare, the maximum OOP expense was reached after 1 visit (1 day) for catastrophic, 2 visits (8 days) for bronze, and 3 visits (28 days) for silver, gold, and platinum.ConclusionsFirst, using standard Medicare pricing, we found that patients receiving BR or ibrutinib quickly reached their maximum annual OOP caps within an average of 29 days (3 clinic visits) for BR and 36 days (3 visits) for ibrutinib. Using pricing schedules more reflective of private insurance, patients are likely to reach their cap even faster. Second, drug costs contributed most to reaching the maximums despite accounting for standard professional fees, labs, and imaging. These data suggest a limited benefit of state parity laws since the underlying costs of these drugs remain high, and patients reach OOP caps very quickly with either oral or IV drugs. Methods for reducing the financial burden to the patient and health care system from these novel yet expensive therapies need to be explored. DisclosuresZafar:Novartis: Other: Spouse's Employment.
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