Abstract

8076 Background: FL in advanced stages is a life-threatening chronic disease. As recently demonstrated in the pivotal trial EORTC20981, RM significantly prolongs both progression free survival (PFS) and overall survival (OS) in relapsed/refractory FL patients responding to an induction treatment. Beyond these clinical benefits, the study objective was to assess, from the French Sickness Funds perspective, long-term costs and cost-effectiveness of RM after induction therapy versus current standard practice (observation). Methods: A lifetime transition model (30-years time horizon) with 3 health states (progression free, progressive disease and death) was developed comparing RM and observation (Obs). PFS and OS in the health states transition model were derived from the EORTC20981 trial with a median follow-up of 28 months. PFS and the OS benefits of RM therapy were conservatively assumed to last only 5 years. Standard French costs (2006 national tariffs) were applied to resources estimated from a prescription observational study, expert opinion and bibliography (in case of maintenance: acquisition and administration of RM, grade 3–4 adverse events, follow-up and in case of relapse: pre-treatment check- up, chemotherapy, radiotherapy, stem cell transplantation, adverse events, follow-up and supportive care). Costs were discounted at 3% and sensitivity analyses were performed. Results: RM is effective in the management of relapsed/resistant FL with more than one year of benefit in terms of survival. Patients receiving RM had a longer life expectancy than those with Obs (6.60 versus 5.41 years). Overall lifetime average costs were €71,314 and €62,251 respectively for RM and Obs. Incremental cost-effectiveness ratio (ICER) was €7,612 per life year gained, varying from €7,154 to €8,847 in one-way sensitivity analysis. This study did not include palliative care and productivity costs. As the relapse rate is lower in the RM group, those limitations are conservative. Conclusions: The economic assessment shows that RM is a cost-effective strategy in the management of relapsed/refractory FL in France with an ICER largely below the threshold commonly cited in such analysis. No significant financial relationships to disclose.

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