PHP240 - HEALTH TECHNOLOGY ASSESSMENTS OF BEVACIZUMAB BIOSIMILARS: COULD A DEMONSTRATION OF COST-EFFECTIVENESS CHANGE THE RECOMMENDATION FOR REIMBURSEMENT VERSUS THE ORIGINATOR?

Abstract

To describe bevacizumab’s HTA assessment patterns in multiple countries and identify potential considerations for biosimilar coverage and reimbursement. The following HTA agencies were selected for this grey literature search; SMC in Scotland, NICE in England and Wales, CADTH/pCODR in Canada and HAS in France. HTA agency websites were searched for assessment reports for bevacizumab (Avastin®) in any treatment indication. These reports were retrieved and reviewed in full text to identify the drivers for coverage and reimbursement by indication. The HTA literature review covered a total of 33 single and multiple technology assessments in 6 indications across NICE (9), SMC (13), CADTH/PCODR (4) and HAS (7). Most of the reports by NICE and SMC did not recommend the reimbursement of bevacizumab (Avastin®). The primary reason was lack of demonstration of cost effectiveness due to insufficient supporting clinical evidence. CADTH/pCODR also raised concerns around clinical evidence but recommended the reimbursement of bevacizumab conditionally upon improvement of cost effectiveness through price negotiation at a provincial level. In France, the rationale for withdrawing coverage and reimbursement for bevacizumab in some indications was also the lack of clinical effectiveness and no cost effectiveness evaluations were conducted. In all 5 countries, HTA decisions for bevacizumab were not exclusively based on CEA. Other contributing factors were uncertainties around survival outcomes and applicability of studies to local clinical practice. As biosimilars are expected to have lower prices than originators, exploring the impact of a lower price on cost effectiveness is warranted. Development of HTA/modeling guidance for biosimilars seeking reimbursement in indications not reimbursed for the originator are needed and should consider that biosimilars may not have head to head data with the current standard of care but will need to leverage the originator clinical data in all indications, including the extrapolated ones.