368 Background: Multiple chemotherapy regimens are now available for the treatment of mPC. With these regimens median overall survival ranges between 6-11 months. Choice of regimen is often based on the patient’s performance status (PS) and toxicity profile of the regimen. Newer combinations may be associated with high financial costs. The objective of this study was to analyze the costs of first-line regimens to further aid in decision-making and develop a platform upon which to assess value. Methods: We calculated the monthly cost for individual standard regimens. These included gemcitabine (G), FOLFIRINOX (5-FU, irinotecan and oxaliplatin), and gemcitabine/nab-paclitaxel (GN-P). Furthermore, we evaluated other novel regimens. These included our institutional experience with dose-modified GN-P (dmG-NP) which will be presented at the ASCO GI conference. We additionally evaluated the cost of 3-weekly carboplatin/paclitaxel (CP) which formed the control arm of a phase II trial in mPC (NCT01280058). The results of this trial are to be presented as Late Breaking Abstract 19 at the upcoming ESMO conference. In addition to the cost of drugs, we included administration costs, and costs of toxicities (including growth factor support, blood product transfusion and hospitalization for toxicities). Costs for administration and management of adverse events were based on Medicare reimbursement rates for hospital and physician services. Drug costs were based on Medicare average sale prices (all 2014 US $). Results: The monthly cost of GN-P is $12,221. FOLFIRINOX costs $3.865 per month. G alone costs $1,363 per month. DmGN-P costs $6.716 per month. CP was the cheapest combination regimen ($2,154 per month) and in a recent phase II trial has been shown to have a similar efficacy to GN-P. Conclusions: Choice of chemotherapy regimen for mPC is usually based on tolerability and efficacy of the regimen individualized to patient’s PS. Healthcare systems have finite resources, thus, there is increasing emphasis on metrics to define value in healthcare These data provide useful financial information to incorporate into the decision-making process.
Application of adaptive design and decision making to a phase II trial of a phosphodiesterase inhibitor for the treatment of intermittent claudication