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pCODR Update 52 (Update on Procedures for the CADTH Common Drug Review and pan-Canadian Oncology Drug Review: Mandatory Disclosure of a Submitted Drug Price)

Published on: February 25, 2016
Result type: News

Update on Procedures for the CADTH Common Drug Review and pan-Canadian Oncology Drug Review: Mandatory Disclosure of a Submitted Drug Price

In late September 2015, CADTH invited stakeholder comments and feedback on proposed revisions to the CADTH Common Drug Review (CDR) and pan-Canadian Oncology Drug Review (pCODR) procedures that would require a submitter/manufacturer to agree to the disclosure of a submitted price for a drug product undergoing a health technology assessment (HTA). Under these revised procedures, CADTH would no longer accept a confidential price, and a submitter/manufacturer would provide a submitted drug price that could be disclosed in the recommendation and reports.

We would like to thank all stakeholders who responded to the consultation. Feedback was received from five patient advocacy groups, nine pharmaceutical companies, two industry association groups, and one private payer association. Highlights of key comments received from stakeholders include the following:

  • A number of stakeholders stated their support of CADTH's commitment to enhance the transparency of both drug review programs with the proposal to have a disclosable drug price.
  • Stakeholders also offered some recommendations to support the principle of transparency — for example, requiring submitters/manufacturers to conduct their economic analyses using the market list price to enable the closest “apples to apples” comparison with currently reimbursed options. Other recommendations included clarifying that a negative recommendation should not be applied to situations where the only concern is related to price, but should instead be reserved for those products lacking clinical effectiveness and/or demonstrating clinical harms.
  • Some stakeholders wanted to keep prices confidential because of the competitive nature of the business; disclosure of a submitted drug price, in their opinion, could potentially lessen their ability to negotiate with payors.

CADTH and the jurisdictions that participate in the CDR and pCODR processes carefully considered the feedback from this consultation. We appreciate the thoughtful feedback received and recognize the importance of transparency within the HTA review process. Transparency helps reduce assumptions made by other stakeholders and eliminates confusion regarding the nature of the submitted price for the drug under review and its comparators. Payer negotiations function separately from CADTH’s work and assumptions related to non-transparent pricing should not be linked to the HTA review processes. As supported under our recommendation framework, an unconditional negative recommendation arises in situations where there are concerns related to the clinical data.

Revised Procedures for CDR and pCODR

In view of the above, for all drug applications filed for review through either the CDR or pCODR process on or after April 1, 2016, CADTH 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.

Revised CDR Documentation (for applications filed on or after April 1, 2016):

Applicants planning to file a submission or resubmission on or after April 1, 2016, should consult the following document:

Current CDR Templates (for applications filed before April 1, 2016):

Applicants planning to file a submission or resubmission before April 1, 2016, must use the following templates:

Revised CDR Templates (for applications filed on or after April 1, 2016):

Applicants planning to file a submission or resubmission on or after April 1, 2016, must use the following templates:

Revised pCODR Documentation and Templates: