Current update: March 2016

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.

The literature search results were added to the existing HTA-Regulatory Interactions repository, that included peer-reviewed publications relating to HTA-Regulatory Interactions from 1999- October 2015.

Additional materials in the RICC repository

In addition to providing publications, the repository also provides a list of website links to government and non-government organisations whose activities are relevant to the above topics. At this stage, a simple title and hyperlink is provided although it is intended in the future that a short description will be developed for each of these links. While we endeavour to keep the list current and complete, the information has necessarily been compiled in a non-systematic fashion. If you are aware of activities that are relevant but have not been included in this list we would be grateful if you could let the repository manager know so that the appropriate information can be uploaded. If your organisation has been included on the list but you would prefer alternative information presented please also contact us.

Finally, the repository aims to include reports and materials developed by the RICC or from within HTAi that are related to the topics of interest. For example, summaries of HTAi conference panels.