REMINDER:
As announced last month, PDCI and its research partners are studying the private payer product listing agreement (PLA) landscape in Canada by surveying pharmaceutical manufacturers and private payers about their experiences and perspectives.  
The deadline to submit survey responses has been extended until May 15, 2020.

For more information about the survey please visit our website or contact Julia.Shen@pdci.ca to participate. 

CADTH Releases Pharmaceutical Reviews Update – Issue 15

CADTH’s Pharmaceutical Reviews Updates are used to communicate new CDR and pCODR drug review process updates to the public. PDCI has outlined below the key highlights from the most recent update. For more information, please consult the CADTH website.

1. COVID Update:

• CADTH has established a new website with information related to COVID-19 from CADTH and other respected organizations
• CADTH continues to operate virtually and stakeholders will be notified if there are any potential disruptions or delays to business activities. Please consult the questions and answers for more details.

2. CADTH Drug Review Procedures Consultations Postponed

• Consultations on aligned drug review process have been postponed due the the COVID-19 pandemic and stakeholders will be notified of new consultation time-frames. 

3. New Expert Review Committee for Plasma Protein Products

• CADTH and Canadian Blood Services (CBS) announced new members for the Expert Review Committee in the Interim Plasma Protein Product review process. Please refer to communication for details.

4.  Revised Procedure for the Sponsor Review of CADTH pCODR Reports

• Sponsors will now be provided with a copy of the complete CADTH Pharmacoeconomic Report in addition to the executive summary that will be posted on the CADTH website. The complete report will assist sponsors in validating the handling of non-disclosable information and identification of errors before they are posted on CADTH’s website.

5. Clarification of Requirements for Budget Impact Analysis (BIA)

• A minor adjustment to requirements emphasizes that sponsors are required to include copies of all pan-Canadian BIA supporting documentation as part of Category 1 requirements. 

6. Clarification of Stakeholder Feedback on pCODR Expert Review Committee Initial Recommendation

• The revised procedure now states: “Feedback must be provided in conformity with the templates provided on the CADTH website and should relate only to the pERC Initial Recommendation. Any commentary on the content of the CADTH clinical and pharmacoeconomic reports must be related to the pERC Initial Recommendation.”

7. Updated Fees for CADTH Pharmaceutical Reviews

• Fee Schedule for CADTH Pharmaceutical Reviews has been updated to include fee adjustments based on the Consumer Price Index.

8. Update to the Canadian Drug Expert Committee (CDEC) Meeting Schedule

• CDEC Meeting Schedule has been updated and can be found here. 

Contact Ara Salazar, Director of Market Access, to learn more about how these changes may affect your upcoming submissions.