Abstract
The need to optimize drug development and facilitate faster access for patients has ignited discussions around the importance of improving interactions between health technology assessment (HTA) bodies and regulatory agencies. In this study, we conducted a systematic review to examine processes, progress, outcomes, and challenges of harmonization/interaction initiatives between HTA bodies and regulatory agencies. MEDLINE, EMBASE, and the International Pharmaceutical s database were searched up to 21 October 2019. Searches for gray literature (working papers, commissioned reports, policy documents, etc.) were performed via Google scholar and several institutional websites. An online cross-sectional survey was also conducted among HTA (n = 22) and regulatory agencies (n = 6) across Europe to supplement the systematic review. Overall, we found that while there are areas of divergence, there has been progress over time in narrowing the gap in evidentiary requirements for HTA bodies and regulatory agencies. Most regulatory agencies (4/6; 67%) and half (11/22, 50%) of the HTA bodies reported having a formal link for “collaborating” with the other. Several mechanisms such as early tripartite dialogues, parallel submissions (reviews), adaptive licensing pathways, and postauthorization data generation have been explored as avenues for improving collaboration. A number of pilot initiatives have shown positive effects of these models to reduce the time between regulatory and HTA decisions, which may translate into faster access for patients to life-saving therapies. Thus, future approaches aimed at improving harmonization/interaction between HTA bodies and regulatory agencies should build on these existing models/mechanisms while examining their long-term impacts. Several barriers including legal, organizational, and resource-related factors were also identified, and these need to be addressed to achieve greater alignment in the current regulatory and reimbursement landscape.
Highlights
The transition of a product from benchside to clinical use involves several stages and engagements with different stakeholders [1]
Payers relying on the assistance of health technology assessment (HTA) bodies decide whether to reimburse a product based on its relative value under current clinical practice scenarios [6]
In the first search strategy (Strategy A), we looked for papers related to either HTA or regulatory [using the terms “drug approval” or “pharmaceutical regulation” or “drug legislation” or “pharmaceutical administration” or “European medicines agency (EMA)” or “food and drug administration (FDA)”] decision-making processes (Supplementary Table 1)
Summary
The transition of a product from benchside to clinical use involves several stages and engagements with different stakeholders [1]. Payers relying on the assistance of health technology assessment (HTA) bodies decide whether to reimburse a product based on its relative value under current clinical practice scenarios [6]. The value assessments usually focus on relative performance (such as relative safety, relative effectiveness, and cost effectiveness) of a technology against currently available clinical options. Unlike regulators who may accept short-term or surrogate outcomes, payers usually prefer long-term clinical outcomes [3, 7]. Their assessment may involve a broader perspective such as the consideration of the potential social, legal, ethical, and political impacts of adopting the new technology [8, 9]
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