Background and importance The US Food and Drug Administration (FDA) granted olaratumab (human anti-PDGFRα monoclonal antibody) fast track authorisation in November 2016 to treat advanced soft tissue sarcoma (STM). Also, the European Medicines Agency (EMA) allowed conditional marketing authorisation for this drug after the phase 1b/2 trial. In the post-authorisation phase III trial ANNOUNCE, data were limited because of the small number of patients included and the lack of confirmation of efficacy and clinical benefit. Consequently, the EMA banned the treatment of new patients with olaratumab.

Aim and objectives We studied the economic impact of olaratumab on the National Health Service (NHS) for our hospital patients, from its introduction in our country (November 2017) to the EMA ban (January 2019).

Material and methods A retrospective analysis was conducted. In our hospital 17 patients, 11 of which were women (64.7%), with a mean age of 54.7±24.5 years, were treated with olaratumab. Data (weight and doses prescribed) were extracted from our chemotherapy prescriptions and preparations database software. We selected patients treated with olaratumab.

Results An olaratumab vial cost €1375 (€2.75/mg). The recommended dose was 15 mg/kg on days 1+8 of each 21 day cycle. Between November 2017 and January 2019, in our hospital, 17 patients completed 79 total cycles for a total cost of €457 035.

The primary outcome of the authorisation study showed a better progression free survival (6.6 months). Only five of our patients exceeded this period and had to discontinued treatment because of progression of disease. The total cost of their therapy was €294 596 (48 total cycles for 5 patients). For the other 12 patients, the cost was €162 439 (31 total cycles). The average cost of administration to the NHS was €2815/patient.

Conclusion and relevance After conditional marketing authorisation, further research costs of the approved drug are necessarily at the expense of the NHS. This was the case for olaratumab, that resulted in it not being effective. For this reason, for fast track authorisation, the reimbursement price of the drugs should be taken into account in the post-authorisation costs. Furthermore, it is important to provide hospital monitoring of the clinical effects of the drug and consequent cost.

References and/or acknowledgements 1. 23 Gennaio 2019 EMA/27962/2019

2. ClinicalTrials.gov Identifier: NCT01185964

No conflict of interest.