Common Drug Review Update — Issue 75

Confidentiality of Embargoed CEDAC Recommendations

CADTH would like to remind stakeholders that, in accordance with Figure 2 in theProcedure for Common Drug Review and with the CDR Confidentiality Guidelines, the Canadian Expert Drug Advisory Committee (CEDAC) Recommendations are to be held in confidence and not acted upon until after the Common Drug Review (CDR) Directorate has issued the Notice of Final Recommendation.

It has come to the attention of CADTH and the CDR-participating drug plans that embargoed recommendations have been made more broadly available during the embargo period. The intent of the embargo period* for CEDAC recommendations is to allow time for the manufacturers and the jurisdictions to consider the recommendations before they are made public. CADTH requests that stakeholders comply with the Procedure for Common Drug Review and the CDR Confidentiality Guidelines, and that distribution of the confidential, embargoed recommendations beyond the intent of the CDR procedure be discontinued. The jurisdictions and CDR are considering options to change the confidential embargo period in light of this activity.

* Embargo Period — refers to a period of time (ten [10] Business Days) following the issuance of the Recommendation and Reasons for Recommendation or such extended period of time as may be granted by CADTH (under section 8.5.1 or section 8.6.1) during which the Recommendation and Reasons for Recommendation are neither acted on by Drug Plans nor are they publicly available. During this period, the Manufacturer may submit a Request for Reconsideration or a Resubmission based on a Reduced Price, or the ACP or Drug Plans may submit a Request for Clarification.

Pilot Process for Filing Pre-submission Information — Effective Immediately

To help plan and resource Common Drug Review (CDR) reviews in a timely and efficient manner, CADTH is launching a pilot process to receive selected submission material prior to receiving complete submissions from manufacturers. The requested information is material that manufacturers have available and should be able to provide at the time they notify CADTH of pending submissions for patient input purposes (i.e., 10 days before filing the complete submission).

The following information should be provided in clearly labelled files in MS Word/searchable PDF format, by email to requests@cadth.ca (note that this information must still be included in the complete submission filed):

Cover letter indicating that the information is being submitted for the pre-submission pilot process. The letter should also list the information included, identify the contact person for the submission, and state the anticipated date on which the complete submission will be filed.
Product Monograph.
Common Technical Document — Clinical Overview (module 2.5); Clinical Summary (modules 2.7.1, 2.7.3, 2.7.4, 2.7.6). If these files are large, CADTH recommends zipping them.
Copies of articles of the key clinical studies (and their clinical study reports, if available).
Economic information — provide information using the following table format:

	Based on manufacturer’s pre-submission economic information	Provide comments or additional information
Treatment considered	Drug name Specify, if relevant: dose use (i.e., as monotherapy or in combination with other products [provide names]) other relevant information
Comparator(s)	List all of the comparators chosen for the economic analysis: indicate whether they are considered in combination with other treatments
Population modelled	Indicate the population modelled: indicate any subgroups considered
Key clinical trial data sources	List all of the data sources used for clinical inputs
Outcome measures	List all of the outcome measures considered in the economic evaluation or model: trial outcomes modelled outcomes (e.g., life-years, quality-adjusted life-years)
Study question	Include the study question
Type of economic evaluation	Identify the type of economic evaluation: cost-effectiveness analysis or cost-utility analysis or cost-minimization analysis
Perspective(s)	List all of the perspectives considered: government payer societal individual
Time horizon	Provide the time horizon

Note: The targeted timeframes for conducting reviews, as outlined in Figure 2 in theProcedure for Common Drug Review, will continue to be followed in the pilot project. Placement on the CEDAC agenda will be based on the date the submission is deemed complete.

The purpose of the pilot is to determine what information and timeframe for receipt of pre-submission material would assist in optimizing the resourcing and planning for CDR reviews. The pilot will be evaluated after sufficient experience has been gained with the process to perform an evaluation.

Changes to CDR Submission Guidelines for Manufacturers

The following changes and clarifications become effective immediately and will be reflected in upcoming revised versions of the Procedure for Common Drug Review and Common Drug Review Submission Guidelines for Manufacturers.

1. Letter Confirming Ability to Supply Changed to Category 2 requirement and Deadline for Category 2 Information Extended — Effective Immediately

CADTH has received feedback from manufacturers that submissions have been delayed due to the requirement to provide the Letter Confirming Ability to Supply and Drug Notification Form at the time of filing. Therefore, effective immediately, the Letter Confirming Ability to Supply becomes a Category 2 requirement and the deadline for Category 2 requirements is extended. All Category 2 requirements must be submitted to CADTH 20 business days prior to the targeted CEDAC meeting in order to be placed on the CEDAC agenda. The sections of the CDR Submission Guidelines for Manufacturers affected by these changes are listed in the table below.

Document	Location in CDR Submission Guidelines for Manufacturers
Letter Confirming Ability to Supply	Removed from Sections 4.2.1 (h) and 4.4.1 (h)
Letter Confirming Ability to Supply	Will be added to Sections 4.2.2 and 4.4.2
Deadline for Category 2 information	Sections 4.2, 4.3, and 4.4; Appendix 6 (c); Appendix 7 (a) and (b)

2. Clarification of Confidential Price

The definition of "Confidential Price” is clarified as follows:

Confidential Price — a price per unit that is submitted in confidence as part of the CDR Submission Requirements and to which the provisions of the CDR Confidentiality Guidelines apply. Following the release of a CEDAC recommendation to list or list with criteria, the submitted Confidential Price must be made available to all CDR participating drug plans, whether or not the CEDAC criteria is the same as the criteria requested by the manufacturer. A listed market price is not considered confidential.

In addition, the following criterion is being added to the CDR Submission Guidelines for Manufacturers:

Should issues arise regarding the submitted price, the CDR participating drug plans will consider next steps, including the option of submitting a Request for Advice to CEDAC about its Final Recommendation in light of the publicly available current market price. This could potentially result in a changed Final Recommendation.

Changes will be made in the following sections:

Section Heading	Location in CDR Submission Guidelines for Manufacturers
Pricing and Availability Information	Sections 4.2.1 (g), 4.3.1 (h), and 4.4.1(g)
Pricing Information	Section 5.2.1 (g)
Requirements for Resubmission based on Reduced Price during Embargo Period	Section 5.3 (a)

3. Budget Impact Model Required for Priority Review Requests Based on Cost Savings

To expedite the assessment of whether pre-Notice of Compliance (NOC) priority review submissions based on cost savings meet CDR criteria, the following additional information is now part of the Category 1 requirements:

Budget impact model (Excel spreadsheet), showing how the national cost savings is derived (in addition to the budget impact analyses for the participating drug plans)
Document explaining the national budget impact analysis and the assumptions on which it is based.

Personnel News

CADTH welcomes Chander Sehgal as the new Director, Common Drug Review (CDR) and Rapid Response.

Sandy Pagotto will continue as the Interim Director for CDR until further notice.

CADTH is streamlining the number of contacts for external requests and inquiries. Please note the following changes relating to the Common Drug Review:

Manufacturer notices of pending submissions, pre-submission material, and all CDR-related inquiries should be directed to requests@cadth.ca or 613-226-2553.

Requests for pre-submission meetings should be directed to meetingrequests@cadth.ca or 613-226-2553.

More information on advance notice of submissions and pre-submission meetings may be found on the Pre-submission Meetings page of the CADTH website.