1. 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:
- Summary of Revisions to the Procedure for the CADTH Common Drug Review and the Submission Guidelines for the CADTH Common Drug Review
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:
- Application Overview Template
- Commitment to Honour Submitted Price Letter
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:
2. Revised Procedure for Providing CADTH Review Team’s Responses
In CDR Update — Issue 111, CADTH invited stakeholder comments and feedback on a proposed revision to the Procedure for the CADTH Common Drug Review to provide manufacturers with the CDR review team’s responses to their comments. Feedback was generally supportive of CADTH’s proposal to provide manufacturers with the CDR review team’s responses to their comments on the draft clinical and pharmacoeconomic review reports.
Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, manufacturers will be sent the CDR review team’s responses to their comments eight business days prior to the CDEC meeting. CADTH will forward the CDR review team’s responses to the manufacturer for information only.
Table 1: Revisions to the Procedure for the CADTH Review Team’s Responses
|Procedure||Current Procedure||Revised Procedure|
The CDR review team’s responses are shared with CDEC; however, they are not distributed to the manufacturer.
CADTH forwards the CDR review team’s responses to the manufacturer for information.
3. Revised Procedure for Voluntary Withdrawal
In CDR Update — Issue 111, CADTH invited stakeholder comments and feedback on a proposed revision to the Procedure for the CADTH Common Drug Review to implement a revised deadline for voluntary withdrawal of five business days before the CDEC meeting.
There was acknowledgement from the majority of respondents that permitting voluntary withdrawal up until the day the CDEC Final Recommendation is issued represents a non-transparent and inefficient use of CADTH’s resources; however, there was concern regarding the proposed time frames for receiving the responses and the cut-off for voluntary withdrawal. In response to feedback from stakeholders, CADTH will revise the procedure to provide manufacturers with five business days to review the CADTH review team’s responses to their comments prior to the deadline for voluntary withdrawal from the CDR process.
Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, manufacturers will have until 4:00 p.m. ET three business days prior to the CDEC meeting to voluntarily withdraw from the CDR process (e.g., for a review targeting consideration at the April 20, 2016 CDEC meeting, a voluntary withdrawal would have to be received at CADTH by 4:00 p.m. EST on April 15, 2016).
Table 2: Revisions to the Procedure for Voluntary Withdrawal and CADTH Review Team’s Responses
|Procedure||Current Procedure||Revised Procedure|
An applicant may request that a submission or resubmission be withdrawn from the review process at any time up to the targeted date on which CADTH is scheduled to issue the notice of CDEC Final Recommendation.
An applicant may request voluntary withdrawal from the CDR review process at any time up until 4:00 p.m. ET three business days before the date on which CDEC is scheduled to deliberate on the submission or resubmission.
4. Revised Procedures for Category 2 Requirements
In accordance with the current Procedure for the CADTH Common Drug Review, CADTH will not issue the CDEC Final Recommendation in absence of complete category 2 requirements. Effective for all submissions and resubmissions targeting the April 2016 CDEC meeting and onward, CADTH will not issue the embargoed CDEC recommendation unless category 2 requirements have been filed. In addition, CADTH will no longer screen category 2 requirements for completeness; however, manufacturers are still required to file copies of category 2 requirements with CADTH. At the request of the CDR-participating drug plans, CADTH will support the drug plans by ensuring that they are provided with copies of category 2 requirements filed with CADTH prior to the targeted CDEC meeting (see also item 5 below).
Please consult the documents below for related revisions to the CDR procedure and submission guidelines:
- Revised Procedure for Screening CADTH CDR Applications
- Revised Submission Guidelines for Category 2 Requirements
Table 3: Summary of Revisions to the Procedure for Category 2 Requirements
|Procedure||Current Procedure||Revised Procedure|
Screening of Submissions and Resubmissions (sections 4.3 c and 4.4 c)
When not provided at the same time as category 1 requirements, category 2 requirements should be submitted at least 20 business days before the targeted CDEC meeting at which the submission or resubmission will be considered. Incomplete category 2 requirements will not preclude CDR reviews from being placed on the agenda of the targeted CDEC meeting; however, the CDEC Final Recommendation will not be issued until all category 2 requirements are complete.
When not provided at the same time as category 1 requirements, category 2 requirements should be filed at least 20 business days before the targeted CDEC meeting at which the submission or resubmission will be considered. Delayed filing of category 2 requirements will not preclude a CDR review from being placed on the agenda of the targeted CDEC meeting; however, the embargoed CDEC recommendation will not be issued until category 2 requirements are received.
Releasing the Embargoed CDEC Recommendation (section 8.2)
The embargoed CDEC recommendation will not be issued until category 2 requirements are received.
5. CADTH to Provide Drug Plans With Copies of CDR Submission or Resubmission Materials
CADTH has begun providing authorized recipients from the CDR-participating drug plans with copies of all category 1 and category 2 requirements prior to the targeted CDEC meeting at which the submission or resubmission is scheduled to be discussed. CADTH will provide copies of the category 1 and category 2 requirements to the CDR-participating drug plans to ensure that they have this information prior to the targeted CDEC meetings.
CADTH is updating stakeholders regarding this process change for information only. Manufacturers are still required to provide copies of their CDR submission or resubmission, including all drug plan–specific requirements, to the individual drug plans (i.e., CADTH is not providing the CDR category 1 and category 2 requirements on behalf of the manufacturer).
6. Password Protection on Confidential File Transfers
CADTH has added password protection when sending confidential files to manufacturers and other authorized recipients. Recipients will now be required to enter a password prior to accessing files. The following file transfers will be affected:
- Clinical and pharmacoeconomic review reports
- Embargoed CDEC recommendations
- CDEC Final Recommendations.
CADTH will assign a unique password for all CDR projects for which confidential files will be distributed. This password will be required in order to download all documents related to the corresponding project. Manufacturers will be provided with the password in the letter notifying them that the category 1 requirements have been accepted for review. Passwords for CDR reviews that are currently in progress will be provided to the recipient via email prior to the first file transfer that requires use of a password.
Any questions regarding password protection for confidential file transfers should be directed to email@example.com.
7. Total Email Attachments File Size Threshold
In cases where the current Submission Guidelines for the CADTH Common Drug Review indicate that specific outstanding, updated, or finalized category 1 requirements can be provided to CADTH by email to firstname.lastname@example.org, CADTH has revised the total email attachment(s) file size threshold from 10 MB to 20 MB.
If the total attachments file size for a single email exceeds 20 MB and consists of multiple documents, the documents can be divided among multiple emails as attachments. In cases where a single attachment’s file size exceeds the 20 MB threshold, the document will have to be provided to CADTH on a CD, DVD, or USB flash drive sent to the attention of CADTH’s Central Intake.
Please note that any CDR requirements sent to CADTH using the email@example.com email or received through Central Intake will be acknowledged with an email listing the names of the specific files received. This is in addition to the automatically generated response sent by the firstname.lastname@example.org email account. In cases where you have not received specific acknowledgement by the end of the next business day for any files sent by email to email@example.com, or after the expected day of receipt of files delivered to CADTH on a CD, DVD, or USB flash drive, please send a follow-up email to firstname.lastname@example.org.
The information above regarding the total email attachment(s) file size threshold, as well as specific acknowledgement of attachments received, also applies to any “additional information” requested by the assigned submission coordinator for a specific drug actively under review through the CDR process. In these cases, please follow up directly with the submission coordinator if you have not received acknowledgement of receipt within one business day of the anticipated date of receipt for the email, or CD, DVD, or USB flash drive.
8. Clarification: Requesting Health Canada Clinical Reviewer Report(s) From Health Canada
The filing of Health Canada Clinical Reviewer Report(s) is a category 1 CDR requirement (see also CDR Update – Issue 115). Should the report(s) not be available at the time of filing category 1 requirements, manufacturers are reminded that it is their responsibility to request, in writing, a copy of the report(s) from the appropriate Health Canada reviewing Bureau or Centre Director and to provide it to CADTH by email to email@example.com as soon as available (i.e., on the day of, or next business day after, receipt from Health Canada). The report(s) can be requested as soon as the Notice of Compliance or Notice of Compliance with conditions has been issued. In accordance with current guidelines, Health Canada aims to provide requested reviewer report(s) to sponsors within 30 calendar days from receipt of the request.