Immunotherapy – Clinical
E. Peyrilles1, I. Madelaine1, C. Thieblemont2, P. Brice2
1 Pharmacy Department, Saint-Louis Hospital, Public Hospitals of Paris (AP-HP), Paris, France, 2 Hematology Department, Saint-Louis Hospital, Public Hospitals of Paris (AP-HP), Paris, France
Introduction: In France, Nivolumab, registered for classical Hodgkin Lymphoma (HL) after failure from both autologous stem-cell transplantation and brentuximab vedotin is reimbursed into diagnosis-related group (DRG) tariffs. The study assesses the use in standard practice and efficacy of Nivolumab in HL and determines the economic impact of this use into a Paris hospital budget.
Methods: The data were collected from 03/2015 to 12/2017 from: Chimio® (software of chemotherapy prescription), Copilote® (software of management) and medical record systems Middlecare®. The cohort includes the patients with HL who received at least one Nivolumab dose for this indication under the nominative temporary authorization of use (ATU), authorized indication, or compassionate use in this period.
Results: 17 patients were treated with Nivolumab for HL. They received an average of 24.5 cycles [1–66]. The mean duration of treatment was at 12.3 months with 5 patients remaining under treatment. 12 patients (71%) stopped treatment after a median number of cycles of 14.4 [1–46]: 3 for complete response, 6 for progression. No unplanned hospitalization and no intensive care admission have been reported. No major adverse effects have been observed; only grade 1 asthenia, pain, hypothyroidism. From 03/2015 to 12/2016, 15 patients received a free treatment of Nivolumab (ATU or compassionate use) corresponding to 294 cycles and a cost of free treatment of €305,619 in 2015 and €578,645 in 2016. In 2017, 8 patients received payable Nivolumab (2 new patients) equivalent to €332,440 impacted on the hospital budget. The use of Nivolumab in hematology represents 12% in Nivolumab total cost of the hospital. The price of a Nivolumab cycle was between €1832 and €3435 versus €404 for the price of the DRG tariffs to an outpatient session of chemotherapy.
Discussion: In France, Nivolumab used in HL is one of first drugs in oncology no reimbursed in addition to DRG tariffs despite proven efficacy and access to market. Spending remains under control and was reduced in 2017 with only two new patients treated. Several reasons explain this number: fully treated cohort of patients, preferential use of Pembrolizumab (extensive indication, research trial cycle every 3 weeks, compassionate use). Now, Pembrolizumab has the same status as Nivolumab: no reimbursed in addition to DRG tariffs. The different statuses of these drugs make it difficult to estimate expenditures for the coming year.