PDG45 “the Domino Effect”: An International Comparison of Economic Evaluation Submission Sequences in Advanced Melanoma

Abstract

Pharmaceutical companies apply for reimbursement at different times in every country. The rationale for such practices resides in opaque profit-maximising launch strategies, influenced by factors like reference pricing. The objective was to identify sequences in the timing of drug economic evaluation submissions across the world. First, relevant economic evaluation bodies for medicines’ reimbursement, or lack thereof, were identified. Advanced melanoma was chosen as a recent therapy area with few drugs and homogeneous indications to validate our hypothesis before widening focus. Relevant databases were found and searched for the main treatments: nivolumab, pembrolizumab, ipilimumab, dabrafenib, trametinib, cobimetinib, vemurafenib, and their combinations. Submission dates were collected and ranked. Each country has its specific reimbursement process, with few countries leveraging economic evaluation. Those who do seldom share their conclusions. Even fewer publish details about the timelines of assessments, especially for older products. When they are available, methodological difficulties arise from interpreting the different types of dates published. Based on the data available, we estimated the months of submission for Canada, Brazil, England, France, Ireland, New Zealand, Norway and Romania. Submissions for treatments were made in a different sequence for all products and no trend can be identified, even for the same company, and some countries are not applied to. The main commonality is that England is generally one of the first submission countries. Pharmaceutical companies’ launch strategies seem to go beyond a set sequence. Sequences cannot be identified through economic submissions for advanced melanoma products. This reflects varied reimbursement practices but also a lack of transparency conceivably politics or resource-driven. The disparities between countries highlight the need for harmonisation that is an incentive for agencies to collaborate through organisations like EUnetHTA. Disclosing information used for decision making is key to involving more stakeholders like patients in HTA processes and improving accountability.