Subsequent Entry Biologic Template
for Submitting Patient Group Input to the CADTH
Common Drug Review
Section 1 — General Information
We recognize that patients have unique knowledge about what it is like to live with a specific disease or
medical condition. They can describe advantages and disadvantages of therapies, which may not be
reported in published literature. And they can tell us what they would most value from a new
treatment. This submission template has been created to help patient groups provide information for
the assessment of a subsequent entry biologic (SEB). It provides prompts/questions to draw out unique
patient knowledge to inform the CADTH Common Drug Review (CDR) team and the Canadian Drug
Expert Committee (CDEC).
Section 2 provides guidance to patient groups on how to complete this submission template.
Section 3 asks you for some background information about your patient group. Please be clear on the
approved indication for which you are providing input as SEBS may have approval for multiple
indications.
Sections 4 to 7 are the main part of the form for you to complete, describing the views and experiences
of patients and their caregivers.
Section 8 is for use by drug plans. CADTH reviewers and CDEC will not use this information.
We recognize that completing this template requires substantial resources and so we commit to making
all patient submissions available to all involved in the appraisal and decision-making process — the CDR
review team, CDEC members, and the CDR-participating publicly funded drug plans. Furthermore, our
posted CDR review reports and the CDEC Final Recommendation document will note how the
information from patient groups was considered in the review and in developing the recommendations.
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Section 2 — How to Complete This Submission Template
For more information on the CADTH Common Drug Review process for SEBs, see the CDR Update –
Issues 100 and 104. See the Health Canada website for a description of Subsequent Entry Biologics.
2.1 General Information
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This template is to be used by patient groups to submit patient group input for SEBs.
Please complete a different (separate) template for each indication.
Individual patients should contact a patient group that is representative of their condition to have their
input added to that of the patient group.
Please ensure that the input is in English, that it is succinct and clear, and in a ready-to-publish format.
Please use a minimum 11-point font in up to 6 pages. You may delete the instructions and examples under
each heading and also Sections 1 and 2 for more space. These are not part of the page count.
Patient input submissions must be provided as a Word document.
Use the “Submit” link in the table on the Patient Input page to file the submission.
The patient group input for a drug must be submitted by the deadline date posted on the Patient Input
page of the CADTH website to be used in the CDR process.
Privacy: The information provided in patient group input submissions to CADTH will be shared with CDR
reviewers, CDEC, and publicly funded drug plans that participate in the CDR process; and they may be included
in publicly available documents. All patient input submissions for a drug under review will be collated and
summarized in one document that will be posted as part of the CDR Clinical Review Report. All patient input
submissions for which permission to post has been granted will be posted in their entirety on the CADTH
website. Personal information will not be made publicly available.
Should you have any questions about completing this form, please contact CADTH by telephone at 613-2262553 or email requests@cadth.ca.
For information about the CDR process and CDEC see the CDR section on the CADTH website; for information
regarding patient input to CDR and CDEC, see the Patient Input section.
2.2 Information Gathering
Please briefly identify how the information to complete Sections 4 to 7 was obtained. Was it obtained,
for example, through personal experience, focus groups, one-to-one conversations with a number of
patients using the current therapy, printed sources? When available, indicate the number of patients or
caregivers that have been surveyed, interviewed, or contacted to provide information. (Note: If surveys
or interviews are used to collect information, the pan-Canadian Oncology Drug Review [pCODR]
document A Guide for Patient Advocacy Groups: How to provide patient and caregiver input for a pCODR
drug review is an excellent resource for conducting them, and collecting and reporting the findings.)
2.3 Providing Experiential Information
Throughout the template, prompts or examples are provided to help identify the type of information
that CADTH, CDEC, and participating drug plans will find most helpful in understanding the needs and
preferences of the majority of patients. Please describe any other relevant issues that are not captured
in the list of prompts or questions. Personal accounts and experiences that are representative of the
majority of the patient group are preferred. There is no need for patient groups to submit published
information, including information from the Internet or textbooks, as CADTH’s CDR review team and
CDEC have access to current scientific literature through the manufacturer’s submission and a rigorous,
independent literature search.
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Section 3 — Information About the Submitting Patient Group
Name of the drug
Indication of interest
Name of the patient group
Name of the primary contact for this submission:
Position or title with patient group
Email
Telephone number(s)
Name of author (if different)
Patient group’s contact information:
Email
Telephone
Address
Website
Permission is granted for CADTH to post this submission
□ Yes □ No
3.1 Submitting Patient Group
Please provide a brief overview of the patient group that is making the submission, including the purpose
or aim(s) of the patient group, its main activities, and an outline of the type of membership.
3.2 Conflict of Interest Declarations
CADTH requires that all participants in the CDR process disclose any conflicts of interest to ensure that
the objectivity and credibility of the CDR process is maintained. Patient groups must declare any potential
conflicts of interest that may influence or have the appearance of influencing the information submitted.
This information is requested for transparency — a declaration of conflict of interest does not prevent or
restrict the use of the patient input in the CDR process.
(Examples of conflicts of interest include, but are not limited to, financial support from the
pharmaceutical industry [e.g., educational or research grants, honorariums, gifts, and salary], as well as
affiliations or personal or commercial relationships with drug manufacturers or other interest groups.)
Please name all parties providing funding, not just the manufacturer of the drug under review.
a) We have the following declaration(s) of conflict of interest in respect of corporate members and joint
working, sponsorship, or funding arrangements:
b) We have the following declaration(s) of conflict of interest in respect of those playing a significant role
in compiling this submission:
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Section 4 — Disease/Condition and Current Treatment Information
4.1 Impact of Condition on Patients
What are the disease/condition-related symptoms and problems that impact the patients’ day-to-day life
and quality of life?
Examples of the type of information that could be included are:
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What aspects of this disease/condition are more important to control than others?
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How does this disease/condition affect day-to-day life?
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Are there activities that the patients are unable to do as a result of the disease/condition?
4.2 Patients’ Experiences with the Current Treatment
How well are patients managing their disease/condition with currently available treatments? This section
should focus on experiences with the originator (also, known as reference/brand name) product.
Examples of the type of information that could be included are:
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Are patients (all, most, some, or none) using the originator for the treatment of this condition? If not
what are they using?
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How effective are current treatments in controlling the common aspects of this disease/condition?
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Are there needs, experienced by some or many patients, which are not being met by the current
treatments? What are these needs?
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Do current treatments have adverse effects that are more difficult to tolerate than others? What are
they?
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Do patients have difficulty accessing current treatments because of costs (e.g., costs related to
travel, drug administration costs)?
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When offered, how do the patient assistance or support programs impact on the accessibility and
effectiveness of the treatment?
4.3 Impact on Caregivers
How does the disease/condition affect caregivers?
Examples of issues to consider:
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What challenges do family and friends who support a patient to manage the disease/condition face?
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What impact does the treatment have on the caregivers’ daily life (e.g., emotional/psychological
effects, fatigue, stress, physical challenges)?
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Section 5 — Information About the SEB Being Reviewed
5.1 What Are Patients’ Expectations for the SEB?
Examples of information that could be included are:
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What are the perceived advantages or disadvantages of the SEB?
Aspects of the patients’ disease/condition that it is hoped will be addressed?
Section 6 — Key Messages
Please provide the key points of your submission, in up to five bullet points.
Section 7 — Additional Information
Please provide any additional information that would be helpful to CADTH, CDEC, and participating drug
plans. This could include suggesting ways to improve the patient input process, indicating whether the
questions are clear, etc.
Section 8 — Comments on Potential Ways SEBs Can be Used
CDR reviewers and CDEC members will not review or use information in Section 8; however, drug
plans may consider this information in their decision-making.
Health Canada states that SEBs are new drugs that are not declared to be pharmaceutically or
therapeutically equivalent with their originator/reference products, and this should inform decisions
regarding interchangeability and substitutability. The authority to declare two products automatically
substitutable by a pharmacist does not rest with the federal government. Additionally, CADTH considers
the issue of interchangeability and substitutability of SEBs to be an implementation issue that is best
addressed by the CDR-participating drugs plans. See the Health Canada website for a description of SEBs.
Briefly provide your comments on the following scenarios or you may wish to provide other comments.
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The SEB will be used instead of the originator (reference/brand name) product with physician
approval before patient receives any treatments
The SEB would be replacing the originator product with physician approval once the patient has
been on the originator product for a period of time, i.e. a one time switch
The SEB will be used instead of the originator product without physician approval before patient
receives any treatments
The SEB would be replacing the originator product without physician approval once the patient has
been on the originator product for a period of time
Back and forth replacement between SEB and originator product without physician consent
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