PNS62 Project Orbis/Access Consortium - Are Quicker Regulatory Approvals Leading to Faster Reimbursement?

Abstract

Pharmaceutical companies often file for FDA approval before any ex-US regulatory agency. To facilitate earlier patient access with some of the world’s leading regulators, two initiatives aim to accelerate approvals with concurrent submissions, with Project Orbis (PO) for oncology and the Access Consortium (AC) for new substances, generics, biosimilars and complementary health products. With regulatory approvals being quicker, the aim of this research is to compare the speed of regulatory approvals and subsequent reimbursement recommendations for products receiving approvals under PO and AC vs European medicines agency (EMA) and EU3 HTA bodies (UK, France and Germany). Publicly approved drugs within select PO HTA markets (Australia, Canada, Switzerland, Singapore and Brazil) and the AC (Australia, Canada, Switzerland and Singapore) were tracked from regulatory to HTA approval from Jan 2019 to December 2020, using the respective regulatory and HTA websites. A total of 15 and 8 therapies were assessed by PO and AC, respectively, across oncology, cardiology and infectious diseases. Of the 23 therapies, 12 have also received approval by EMA. Majority (n=11/12) of therapies submitted data packages that included phase III and supporting trials for PO, AC and EMA submissions. Regulatory approvals for PO (n=4) and AC (n=8) were on an average 5.3 months and 4.4 months before EMA approvals, respectively. Of the 12 therapies, 8 were submitted to HTA bodies. Submissions that reached HTA/pending final decisions prior to EU3 through PO and AC were 75% (n=3/4) and 63% (n=5/8), respectively. Out of the 35 recommendations across HTA bodies for the 12 therapies, 16 were positive, 8 were negative, 11 were pending. Both PO and AC submissions were quicker to gain regulatory approval and subsequent HTA evaluation compared to those therapies that were approved through EMA.