Harmonization of reimbursement and regulatory approval processes: a systematic review of international experiences

Abstract

A considerable degree of overlap exists between reimbursement and regulatory approval of health technologies, and harmonization of certain aspects is both possible and feasible. Various models to harmonization have been suggested in which a number of practical attempts have been drawn from. Based on a review of the literature, approaches can be categorized into those focused on reducing uncertainty and developing economies of scale in the evidentiary requirements; and/or aligning timeframes and logistical aspects of the review process. These strategies can further be classified based on the expected level of structural and organizational change required to implement them into the existing processes. Passive processes require less modification, whereas active processes are associated with greater restructuring. Attempts so far at harmonization have raised numerous legal and practical issues and these must be considered when introducing a more harmonized framework into the existing regulatory and reimbursement arrangements.

Can a Joint Assessment Provide Relevant Information for National/Local Relative Effectiveness Assessments? An In-Depth Comparison of Pazopanib Assessments

“…It is increasingly recognized that there is considerable scope for better, coordinated interactions between regulators and payers [29,31]. Although the end conclusion may differ, the examples above confirm the relevance of regulator-payer interaction because it is very likely that they face similar evidence dilemmas for the same compound.…”

“…Others from HTA organizations, however, argue that REA reports substantially differ [28] because of different decision criteria for licensing decisions and reimbursement/funding decisions. Possible differences are that HTA assessors always prefer comparative data [28], place more emphasis on clinically relevant outcomes and health-related QOL outcomes [1], perception of what is considered clinically relevant, stronger emphasis by HTA assessors on external validity of data, and, finally, a higher level of acceptance, by at least some HTA assessors, of modeling and observational data [29]. When comparing the pazopanib REA reports with the CHMP risk/ benefit assessment of pazopanib [30], some of these differences are confirmed.…”

Generating appropriate clinical data for value assessment of medical devices: what role does regulation play?

“…Regarding high-risk devices (class III and class IV), regulatory authorities require pre-clinical and clinical studies data generated from a well-controlled study environment, such as a randomized controlled trial. Relative efficacy with an active comparator is Generating appropriate clinical data for value assessment of MDs Review informahealthcare.com normally not considered, since placebo is often favored as the comparator [39].…”

Adaptive Approaches to Licensing, Health Technology Assessment, and Introduction of Drugs and Devices

“…These discussions could in theory be expanded to include other stakeholders, such as HTA/coverage bodies, clinicians and patients, though there are concerns about the capacity of HTA/coverage bodies to join a significant number of discussions of this kind-emphasizing the need to focus adaptive approaches as discussed previously. The challenges of systematically introducing the concerns of HTA/coverage bodies into discussions of this kind and reconciling differences in evidentiary standards (e.g., efficacy versus effectiveness) have already been documented in existing work on "joint scientific advice" (33), and will be amplified if these approaches are applied to more technologies.…”