logo-top-r-w
  • HOME
  • ABOUT MORSE
    • The Team
    • Strategic Partners
      • Lorraine Boyle
      • Dominika Dabrowski
      • Stephen Filbey
      • Brent Korte
    • Careers
  • SERVICES
    • Our Services
    • Strategic Advice
      • MORSE pCPA Assessment
      • MORSE HTA Strategic Advice
    • Analyses
    • Advisory Boards
      • MORSE Advisory Panel (MAP)
    • Training
      • RWE/Innovative Agreements
      • Private Payer
      • Negotiation Simulation
      • Reimbursement Training
    • Reports
      • Canadian Reimbursement and Forecasting Timelines Report (CRaFT)
      • Drugs for Rare Diseases Sub-Report
      • Oncology and Biosimilar Sub-Report
  • NEWS
    • MORSE Signals
    • MORSE Wire
    • Publications
    • What’s New
  • EVENTS
  • LINKS
  • CONTACT US
logo-top-c-r
logo-top-r-w
  • HOME
  • ABOUT MORSE
    • The Team
    • Strategic Partners
      • Lorraine Boyle
      • Dominika Dabrowski
      • Stephen Filbey
      • Brent Korte
    • Careers
  • SERVICES
    • Our Services
    • Strategic Advice
      • MORSE pCPA Assessment
      • MORSE HTA Strategic Advice
    • Analyses
    • Advisory Boards
      • MORSE Advisory Panel (MAP)
    • Training
      • RWE/Innovative Agreements
      • Private Payer
      • Negotiation Simulation
      • Reimbursement Training
    • Reports
      • Canadian Reimbursement and Forecasting Timelines Report (CRaFT)
      • Drugs for Rare Diseases Sub-Report
      • Oncology and Biosimilar Sub-Report
  • NEWS
    • MORSE Signals
    • MORSE Wire
    • Publications
    • What’s New
  • EVENTS
  • LINKS
  • CONTACT US

The End of Clinical Summaries?

April 4, 2022
-
Market Access News
-
Posted by MORSE - < 1 min read.

Recently announced changes to CADTH’s Reimbursement Review submission requirements, effective October 2022 necessitates completion of the Sponsor Summary of Clinical Evidence template. The new clinical evidence template is comprehensive, including but not limited to:

  • background information on the clinical condition, current treatment paradigm, unmet need, and place in therapy
  • methods and findings of a systematic literature search for clinical trials of the drug under review
  • summary of evidence from other studies, including observational real-world studies, that fill evidence gaps left by the clinical trials.

The completed template will not be publicly posted, but presents potential opportunities for industry including:

  • replacing the clinical summary with a comprehensive document that industry may be confident will be explicitly considered by CADTH
  • forward progress in the integration of real-world evidence in the reimbursement process, which may pave the way for future developments, such as outcomes-based agreements.

We would love to hear your thoughts in the comment section below!

 

Share
Tags
#Assessment
#Pharmaceutical
#Technology
CADTH
Clinical Evidence
health
HTA
Market Access
pCPA
pCPAO
Reimbursement
← PREVIOUS POST
MORSE Consulting Releases its pCPA Quarterly Update - Q1 2022
NEXT POST →
MORSE Consulting Releases its Fifth Annual pCPA Year in Review Infographic (2021 Edition)

Contact Us
MORSE Consulting Inc.
Toronto | Ottawa, Canada
+1-647-717-3179 (Toronto)
+1-613-864-8645 (Ottawa)
info@morseconsulting.ca
Social
Connect & Follow:

New Report

Newsletter – MORSE Signals
Sign up for our free e-mail newsletter service and receive timely and relevant updates related to the emerging developments in the Canadian pharmaceutical reimbursement landscape.

Sign Up
MORSE Consulting Inc. | Deciphering Canadian pharmaceutical market access signals to create reimbursement success.
© 2023 MORSE Consulting Inc. All rights reserved. | Site by Directica Media
The End of Clinical Summaries?