A 1 -A 3 1 8 tive. Results: A total of 1176 usable responses were obtained. Approximately 59% of respondents agreed that rescheduling would alter their pain management, 33% agreed that administrative burden would prevent them from prescribing C-II opioids and 24% agreed that ordering prescription pads will deter them from prescribing HCPs. Chi-square analyses indicated that physicians' medication prescribing for acute NCP was significantly associated with practice type (χ 2 = 71.11, p< 0.0001), race (χ 2 = 13.13, p= 0.001) and age (χ 2 = 8.50, p= 0.014). Prescribing for chronic NCP was significantly associated with practice type (χ 2 = 53.77, p< 0.0001). Overall, physicians were most likely to prescribe acetaminophen/codeine for acute NCP (33.56%) and tramadol for chronic NCP (40.43%) after rescheduling. ConClusions: After rescheduling, physicians were more likely to prescribe acetaminophen/codeine or tramadol over HCPs for NCP management. This may result in reduced efficacy, adverse events and drug-drug interactions associated treatment alternatives in addition to added clinical and economic burden. Future studies evaluating provider behaviors and NCP management outcomes are warranted.
A149Objectives: To understand why dronedarone failed to unseat amiodarone as the primary antiarrhythmic treatment of choice for persistent AF, thus uncovering the clinical outcome requirements for a future AF therapy to achieve optimal market access. MethOds: Review published HTA reports and clinical trial outcomes for dronedarone to assess market access outcomes and associated Payer rationale for decision-making. Interview ten (10) managed care medical directors and AF key opinion leaders (KOLs) in US and thirteen (13) ex-Payers and AF KOLs in Europe (mix of stakeholders encompassing France, Germany, Italy, Spain, and UK) for validation and gap filling. Results: Driven by benefits in all efficacy outcomes other than cardiovascular-related hospitalizations, Payers perceive amiodarone as more efficacious than dronedarone. The significant number of deaths during the highrisk PALLAS study crippled the safety image of dronedarone. Finally, a prohibitive price at launch contributed to a multiplicity of negative HTA assessments. In order to succeed where dronedarone failed and qualify as a step function increase over the standard-of-care amiodarone, Payers require at least: 40% reduction in AF recurrence; 30% relative risk reduction in hospitalizations compared to amiodarone; and fewer than 1% deaths as part of the clinical evidence package. Lower rates of bradyarrhythmia, liver toxicity, and no proarrhythmia will drive a favorable regulatory safety evaluation compared to amiodarone. cOnclusiOns: The sub-optimal market access and relatively low utilization of dronedarone resulted primarily from a failure to demonstrate an improvement in recurrence as compared to amiodarone, as well as a significant number of deaths during pivotal trials. Manufacturers considering development of novel antiarrhythmics should strive for equivalent efficacy but superior safety to amiodarone if a 40% reduction in recurrence is not clinically feasible.
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