Pangaea Express: Revised Review Procedure from CADTH

March 5, 2016

For further information please contact Suzanne Solman, Director, The Pangaea Group

CADTH reached out in the fall asking for input into a new policy whereby confidential price submissions would no longer be accepted; all submitted prices would be made public and transparent.

After reviewing stakeholder submissions pro and con, CADTH has determined that all drug applications filed for review through either the CDR or pCODR process on or after April 1, 2016, will no longer accept confidential submitted prices. The submitted price will be disclosed in all applicable CDR and pCODR review reports, as well as CADTH Canadian Drug Expert Committee (CDEC) and CADTH pCODR Expert Review Committee (pERC) recommendation documents posted on the CADTH website

Companies that submit data with anticipated discounts (PLA or PCPA) will now have their data publically released. This should mean that all data submitted for review will be at the national ex-factory price.Also stated in their new recommendation framework, an unconditional negative recommendation arises in situations where there are concerns related to the clinical data only.

Fascinating…Absolutely fascinating!