Demystifying pCODR: Step 1- Pre-Submission Process

As appears on Impetus Digital.

Making the decision to launch a new prescription pharmaceutical product in Canada is often based on the likelihood of being able to secure the globally approved price through the PMPRB (Pharmaceutical Manufacturer’s Pricing Review Board) as well as prospective reimbursement through private and/ or public payers. If there appears to be a good estimated return on investment and a company decides to pursue the time, effort and financial resources to pursue public payer reimbursement, the next step will be to navigate through the CADTH (Canadian Agency for Drugs and Technologies in Health) submission process.

In the next series of Oncology and Market Access specific blogs, Impetus will seek to “demystify” the steps required for the pCODR (pan-Canadian Oncology Drug Review) submission process. It is a very lengthy and convoluted process, so “digging deep” and mapping out the requirements in distinct and digestible steps will be the objective of our upcoming posts.

Once a drug has been approved for sale by Health Canada and its reference price has been set by the PMPRB, the provinces, as a collective, will then conduct a “value for money” assessment of the new drug before deciding to add it to their public formulary through the pCODR process. This system applies to all provinces except for Quebec (see our recent blog that describes details pertaining to INESSS) and is used to review cancer drugs and can take 6 to 8 months to complete. The pCODR review does an analysis and recommendations for public funding and this is based on the drug’s effectiveness and cost. Ultimately, pCODR recommends which new cancer drugs should be covered in provincial public formularies.

Once the recommendations have been received by each provincial Minister of Health, each province will conduct their own drug reviews using their own expert committees. They will consider the drug’s clinical value, the impact on patients and society as a whole, and they will review the input provided by patients and clinicians as well as the pCODR recommendations. Getting a positive pCODR recommendation does not guarantee a provincial listing. Each province will enter into Product Listing Agreement (PLA) negotiations with the product manufacturer which will establish a confidential, lower, volume-based price for their public plan. The actual PLA negotiations are handled by an organization representing all Canadian provinces entitled the pan-Canadian Pharmaceutical Alliance (pCPA). Their role is to negotiate the best possible public formulary price in order to ensure country wide cost standardizations.

In our first blog focused on the pCODR submission process, we will unravel the steps required in the pCODR Pre-Submission Process.

Pre-Submission Information

It is recommended that a manufacturer provide their pre-submission information 4-6 months in advance of their actual pCODR submission or resubmission. This information needs to be submitted a minimum of 120 calendar days in advance. “Submitters” at this step can be the manufacturer themselves, a clinical based Tumour Group or the pCODR Provincial Advisory Board (PAG). At a minimum, the Submitters need to provide the following information: non-proprietary name of the drug, indication, reimbursement criteria, issued or anticipated date of Notice of Compliance (NOC), anticipated date of filing the pCODR submission/ resubmission, if there is an associated companion diagnostic, Health Canada review type and a list of the regulatory and reimbursement statuses based on the other countries where they product will be launched.

The Submitter will need to provide the above information in the “Pre-Submission Information Requirements Form” (see details below). Any missing information will need to be completed at the time of the actual Submission by the manufacturer and is a requirement before a “pre-submission meeting” is scheduled. If the Submitter is a Tumour Group, manufacturers will be notified and can assist the Submitter in collating and preparing the clinical and economic documents for the actual Submission. Submitters need to notify pCODR of any changes to the filing date that was posted on the Pre-Submission form by at least 5 business days. pCODR will then issue a “Pending Submission” notice about one month in advance of the anticipated filing date.

Pre-Submission Meeting

Submitters can request ONE meeting with pCODR to ask clarifying questions about their drug submission. These meetings do not normally exceed more than 1 hour in duration although can extend to 1.5 hours in extenuating circumstances. This should be done at least 4 months in advance of the anticipated filing date and can be done at the same time as filing their Pre-Submission Information. For “Anticipated Submission Meetings“, the Submitter can use the opportunity to introduce a new drug and seek advice on the submission requirements and the approaches that they should take on their economic evaluation. For “General pCODR Process Meetings“, which are normally only granted if the information cannot be conveyed via email or teleconference, Submitters can learn about the submission requirements and procedures if they are new at the process and do not have an upcoming submission within the next 4 months.

At least 5 days before the Pre-Submission meeting, the Submitter should provide an agenda for the Pre-Submission meeting, a list of confirmed attendees and the slides that will be presented. It is also highly recommended that Submitters provide additional information about their pipeline at this meeting, including new indications or new drugs, so pCODR can plan their review processes in advance. If the Submitter is a Tumour Group, a Pre-Submission meeting can be used to decide which pre-submission requirements can be waived and, in addition, it can be attended by the Tumour Group member who also represents the Provincial/ Ministry Tumour Group.

Garnering Advice

Impetus Digital can assist manufacturers in preparing for pCODR Pre-Submissions, leveraging the expertise of select stakeholders, to give timely and expert advice on best options to maneuver through the pCODR decision making process. Stakeholders can include ex-payers, health economic experts and physicians if required. Enrolled advisors can be engaged through a series of online touchpoints either in the form of web meetings or online asynchronous assignments delivered as web form questions, discussion forums or annotation exercises. Through the online engagements, manufacturers can vet the Clinical Overview section of their Pre-Submission and verify that the best trials are being cited and that the limitations of the trial designs are adequately expressed in order to pre-empt any concerns that may arise with pCODR. In addition, a virtual board that includes health economic experts can also assist with recommendations for the model parameters that should be incorporated in the Economic Overview section and the type of pharmacoeconomic evaluation that should be leveraged (ie. cost-utility analysis, cost-minimization analysis, etc.). Finally, they can also help to review pre-developed materials that may have already been created by global teams and give recommendations on how global clinical overviews and economic models should be tweaked in order to be accepted within the Canadian market. These experts may have participated in other company Pre-Submission meetings and can give “real world” expertise on what may or may not be acceptable to pCODR.

The virtual nature of the boards and working groups can help to increase the engagement rates of advisors who are often extremely busy and being utilized by multiple manufacturers for similar purposes. Also the assignments, which are compelling, relevant and timely, can give the advisors or steering committee members time to pause, reflect, process and review their colleague’s comments on their own time, allowing for more thoughtful and granular insights shared through the online forums. All of the assignments are created, programmed, project managed and reported out by Impetus and their technical team (market access subject matter experts) so the manufacturer’s workload is minimal and so are the costs when compared to more traditional in person consultancy meetings. Virtual advisory boards and working groups are excellent tools for manufacturers who need efficient ways to validate assumptions, content and models when submitting their Pre-Submission pCODR dossier.

Timelines

Prior to the anticipated final pCODR Submission, the final pre-planning dates should be considered:

• 9 months prior to the anticipated Submission date: recruit online advisory board and plan first touchpoint assignment
• 8 months prior to the anticipated Submission date: online touchpoint assignment live for advisor feedback, gather advice on clinical trial and economic model parameters and content of Pre-Submission
• 7 months prior to the anticipated Submission date: revise/ refine the pCODR Pre-Submission and vet internally for approval
• 6 months prior to the anticipated Submission date: file Pre-Submission and request Pre-Submission Meeting if required
• 4.5 months prior to the anticipated Submission date: finalize/ update the Pre-Submission form with any missing information and send pCODR the Pre-Submission Meeting agenda, confirmed meeting attendees, and the presentation slides
• 4 months prior to the anticipated Submission date: participate in the Pre-Submission meeting with pCODR and complete final Submission dossier
• 1.5 month prior to anticipated Submission date: notify pCODR of any filing date changes
• 1 month prior to anticipated Submission date: pCODR to issue a Pending Submissions notification to manufacturer

At Impetus Digital, we help pharmaceutical companies manage their advisory boards and steering committees through our Impetus InSite Platform. We increase the speed and quality of collaboration and outputs through asynchronous online assignments such as discussion forums and annotation exercises. We manage all the content development, project management, documentation and reports freeing up your team’s time to focus on their key priorities.

 The results are:

• 40% increase in speed to insight gathering and project completions
• 50% increase in quantity and quality of insights
• 75% decrease in costs versus in person consultancy meetings
• 90% customer engagement rates, a 30% increase versus in person consultancy meetings

To learn more about preparing for your next advisory board or steering committee, contact Natalie Yeadon or call her at 416-992-8557.

Appendix: Pre-Submission Forms

The following information should be included in all pCODR Pre-Submissions:

Online CADTH Collaboration Workspace

APPENDIX B: pCODR Pre-submission Information Requirements Form – Submissions

SUBMITTER/MANUFACTURER INFORMATION *Name of submitter/manufacturer:*Primary contact for submission: Provide name, title, email, phone number

*Back-up/secondary contact for submission: Provide name, title, email, phone number

DRUG INFORMATION*Name of drug (non-proprietary and brand):Is the brand name to be kept confidential until Notice of Compliance (NOC) or Notice of Compliance with conditions (NOC/c) is issued?

Yes ?        No ?   Not applicable ?

*Indication to be reviewed: State if the indication is approved or under review by Health Canada Dosing (schedule and duration) and route of administration: Available strengths:

*Requested reimbursement criteria:

A copy of the product monograph1 is included with this advance notification:   Yes ? No ?

Type of submission (check as appropriate): CADTH Common Drug Review (CDR) submission ? for a:

□ New drug

□ New indication

□ New combination product

□ Biosimilar

□ Subsequent entry non-biologic complex drug

 pan-Canadian Oncology Drug Review (pCODR) submission ? for a:

□ New drug

□ New indication

□ Biosimilar

COMPANION DIAGNOSTIC*Please indicate if there is a companion diagnostic test associated with the identification of the eligible patient population for the proposed drug submission:   Yes ? No ?HEALTH CANADA REVIEW TYPE*The drug is undergoing review by Health Canada through an expedited pathway:□ N/A (standard review pathway)

□ Priority review

□ Notice of Compliance with conditions (NOC/c) filed at the outset

□ Other expedited pathway (please specify)

KEY DATE INFORMATION (DAY-MONTH-YEAR)Date drug accepted for review by Health Canada: DD-MM-YYYY*Date of NOC (issued or anticipated): DD-MM-YYYY

*Anticipated date of filing this submission with CADTH: DD-MM-YYYY

• CANADIAN TRIALSList the Canadian trials evaluating the drug.
• Provide the total number of Canadian patients and the number of patients per province in trials.
• Provide the total number of Canadian patients and the number of patients per province acquiring the drug through Health Canada’s Special Access Program (SAP).
• CLINICAL OVERVIEWThis section should not exceed ONE page and should include:place in therapy (e.g., first-line, niche), current standard of care (including best supportive care), and description of jurisdictional differences
• a brief overview of key trials including outcomes, relevant data, trial design, limitations, mean number of treatment cycles per patient, doses used
• citations to main articles if clinical data are published.
• ECONOMIC OVERVIEWThis section should not exceed ONE page and should include:a brief overview, description of model parameters (outcomes, comparators and rationale for choice, doses [% intensity], dosing schedule, number of cycles, etc., as applicable)If possible, indicate if the anticipated pharmacoeconomic evaluation will be a cost-utility analysis, cost-minimization analysis, or other (please specify).
• a cost table for comparators
• high-level information on budget impact analyses highlighting differences for CADTH’s jurisdictional customers2 based on comparators or based on design of the program responsible for drug funding.
• INTERNATIONAL COMPARISONSProvide a summary of international guidelines.
• Provide in tabular format (one or two tables) a description of the regulatory and reimbursement status, i.e., under review/decision pending, rejected/approved. In the “Reimbursement Decision/Criteria” column, briefly describe the extent of coverage or reimbursement criteria. The following template may be used:

*Reimbursement and Regulatory Status of [Drug Name and Indication]

Region

DateRegulatory Decision/ IndicationDate

Reimbursement Decision/ Criteria

 

* Required Field that must be completed

1 Manufacturers are asked to provide a PDF copy of the current approved product monograph (not required for submissions filed on a pre-NOC basis, or if not yet available from Health Canada for submissions to be filed on a post-NOC basis).

2 The term “CADTH’s jurisdictional customers” refers to the federal, provincial, and territorial drug plans that participate in the CDR process and the federal drug plans, provincial and territorial Ministries of Health and provincial cancer agencies that participate in the pCODR process.

APPENDIX C: pCODR Pre-submission Information Requirements Form –Resubmissions

 SUBBMITTER/MANUFACTURER INFORMATION *Name of submitter/manufacturer:*Primary contact for resubmission: Provide name, title, email, phone number

*Back-up/secondary contact for resubmission: Provide name, title, email, phone number

 DRUG INFORMATION *Name of drug (non-proprietary and brand):*Indication to be reviewed: State if the indication is approved or under review by Health Canada

Dosing (schedule and duration) and route of administration:

Available strengths:

*Requested reimbursement criteria:

*Date of Notice of Compliance (NOC) or Notice of Compliance with conditions (NOC/c) (issued or anticipated):

*Anticipated resubmission filing date: DD-MM-YYYY

A copy of the most recently approved product monograph3 is included: Yes ? No ?

 COMPANION DIAGNOSTIC*Please indicate if there is a companion diagnostic test associated with the identification of the eligible patient population for the proposed drug submission:   Yes ? No ? HEALTH CANADA REVIEW TYPE*The drug is undergoing review by Health Canada through an expedited pathway:□ N/A (standard review pathway)

□ Priority review

□ Notice of Compliance with conditions (NOC/c) filed at the outset

□ Other expedited pathway (please specify)

 

• CANADIAN TRIALSList the Canadian trials evaluating the drug.
• Provide the total number of Canadian patients and the number of patients per province in trials.
• Provide the total number of Canadian patients and the number of patients per province acquiring the drug through Health Canada’s Special Access Program (SAP).
• RESUBMISSION INFORMATIONPrevious submitter/manufacturer:Indicate if it is the same or a different submitter/manufacturer who filed the original submission.

Rationale for the resubmission:

• Indicate if the reason for the resubmission is due to new clinical or new economic evidence.
• Identify reasons or points in the Canadian Drug Expert Committee (CDEC) or pCODR Expert Review Committee (pERC) recommendation, as applicable, that the new information addresses.
• NEW4  CLINICAL INFORMATIONThis section should not exceed ONE page and should include:a description of any new clinical information that was not available at the time of the last review by CADTH Common Drug Review (CDR) or pan-Canadian Oncology Drug Review (pCODR)
• details that address the following points, as relevant to the new clinical information available for the resubmission:place in therapy (e.g., first-line, niche), current standard of care (including best supportive care), description of jurisdictional differences
• a brief overview of key trials including outcomes, relevant data, trial design, limitations, mean number of treatment cycles per patient, doses used
• citations to main articles if clinical data are published.
• NEW2  ECONOMIC INFORMATIONThis section should not exceed ONE page and should include:a description of any new economic information that was not available at the time of the last review by CDR or pCODR
• details that address the following points, as relevant to the new economic information available for the resubmission:
• a brief overview, description of model parameters (outcomes, comparators and rationale for choice, doses [% intensity], dosing schedule, number of cycles, etc., as applicable)If possible, indicate if the anticipated pharmacoeconomic evaluation will be a cost-utility analysis, cost-minimization analysis, or other (please specify).
• a cost table for comparators
• high-level information on budget impact analyses highlighting differences for CADTH’s jurisdictional customers5 based on comparators or based on design of the program responsible for drug funding.
• INTERNATIONAL COMPARISONSProvide a summary of international guidelines. Identify any changes in guidelines since the last review by CDR or pCODR.
• Provide in tabular format (one or two tables) a description of the regulatory and reimbursement status, i.e., under review/decision pending, rejected/approved. In the “Reimbursement Decision/Criteria” column, briefly describe the extent of coverage or reimbursement criteria. The following template may be used:

Reimbursement and Regulatory Status of [Drug Name and Indication]

Region

DateRegulatory Decision/ IndicationDate

Reimbursement Decision/ Criteria

* Required Field that must be completed

2 The term “CADTH’s jurisdictional customers” refers to the federal, provincial, and territorial drug plans that participate in the CDR process and the federal drug plans, provincial and territorial Ministries of Health and provincial cancer agencies that participate in the pCODR process.

3 A copy of the product monograph is not required if the resubmission is based on new cost information only.

4 “New” clinical or economic information in accordance with the CDR or pCODR submission guidelines, as applicable; please review the appropriate document for how new clinical and economic information is defined.

5 The term “CADTH’s jurisdictional customers” refers to the federal, provincial, and territorial drug plans that participate in the CDR process and the federal drug plans, provincial and territorial Ministries of Health and provincial cancer agencies that participate in the pCODR process.