Current update: July 2017

The Regulatory Interaction and Conditional Coverage Repository

The RICC Interest Group has developed the following repository of publically available information. The primary objective of this repository is to provide a regularly updated bibliography of peer-reviewed literature on the key topics in scope of the Interest Group, namely:

  • Adaptive pathways
  • Early dialogue / scientific advice involving both regulators and HTA bodies
  • HTA-Regulatory Interactions relating to evidence development
  • Managed entry agreements (focussed on outcomes-based agreements)
    • Performance-linked Risk Sharing Agreements (PBRSAs)
    • Coverage with evidence development (CED)
    • Conditional treatment continuation (CTC)
  • Post-marketing additional data collection

Repository Manager: Michelle Mujoomdar (CADTH)

Information Specialist: David Kaunelis (CADTH)

Detail of the literature search methodology

The literature search was performed by an information specialist. Published literature was identified by searching the following bibliographic database: MEDLINE (1946- ) with in-process records & daily updates via Ovid. The search strategy was comprised of both controlled vocabulary, such as the National Library of Medicine’s MeSH (Medical Subject Headings), and keywords. The main search parameters were health technology assessment and regulatory concepts. Additional terms specific to the RICC key topics were also included, such as: coverage with evidence development, scientific advice, adaptive licensing, adaptive pathways, managed entry and conditional approval. A search of specific agencies contributing to this work (TLV, PBAC, NICE, HAS, G-BA and ZIN) was also incorporated into the strategy. No methodological filters were applied to limit retrieval. Retrieval was limited to English-language citations, published from January 1, 2015 to the present. The initial search was completed on February 4, 2016. A monthly alert has been established to update the search results.