Template for Patient Group Input

Template for Patient Group Input to CADTH Common Drug Review and pan-Canadian Oncology Drug Review

Name of the drug and indication Name of patient group Patient group website Author of submission Name of primary contact for this submission: Email Telephone number

About Your Patient Group We would like to learn about your patient group. In approximately 50 to 100 words, please: 1. Describe your organization’s mandate and members.

1 Information-Gathering CADTH is interested in hearing from patients and caregivers in this patient input submission.. We do hope to hear a range of experiences and perspectives. 2. Complete the table below to describe how your group obtained the information used to provide input.

Method Date In Canada Outside How Did you Find the Conducted Canada Respondents? First survey: # patients # with experience of drug under review # caregivers Interviews: # patients # with experience of drug under review # caregivers # others Other resources:

You are welcome to provide additional demographic details below, such as disease type, years of disease experience, or where in Canada patients live. Experiences With Current Treatments CADTH examines the clinical and cost-effectiveness of new drugs compared with currently available therapies. We want to better understand where current treatments meet the needs of patients and caregivers, and where they may fall short for different patients. We will use this information to evaluate how well the drug under review might address these gaps. We recommend that the maximum length for this section be approximately 300 to 1,000 words.

3. What therapies are patients using (past and present) to manage [this disease/type of cancer] and what advantages or disadvantages do these therapies have in controlling common aspects of the disease/type of cancer)?

4. If some symptoms are unresolved with current therapies, how do symptoms (some or all) affect the lives of patients and their families and/or caregivers?

5. Describe any side effects of the therapies that patients use to manage this disease/type of cancer and highlight the side effects that are the most difficult to tolerate or have the greatest impact to the patient and their families and/or caregivers?

6. Describe any hardships that patients and/or caregivers have in using or accessing current therapies.

3 Ideal Treatment Outcomes We’re interested in patients’ views on what outcomes we should consider when evaluating new therapies. We recommend that the maximum length for this section be approximately 300 to 500 words.

7. What would patients, their families, and caregivers like therapies for this disease/type of cancer to improve?

8. What improvements would be needed to offer patients more than what current treatments already provide?

9. What would it mean for the daily life and quality of life of patients, their families, and caregivers, if this treatment was able to achieve these outcomes? Experience With Drug Under Review CADTH has access to scientific literature and clinical studies. We’d like to hear from patients about their individual experiences with the new drug. This is important to help reviewers get a better understanding of how the drug under review meets the needs and preferences of those patients with the disease/cancer and its perceived advantages and disadvantages, and to learn how it has affected patients’ quality of life. We recommend that the maximum length for this section be approximately 300 to 1,000 words.

10. What positive and negative outcomes were experienced with the drug under review, as compared with previous therapies, and what was the impact on patients and their families and/or caregivers?

11. What side effects were experienced with the drug under review and how were they managed?

12. Was the drug easier to use than previous therapies, how so, and what is the impact of this for patients and their families and/or caregivers?

13. Has the drug under review met the overall expected outcomes (e.g., fewer side effects, better disease control, etc.)? If so, please explain how.

Anything Else? 14. Is there anything else, specifically related to this drug review, that CADTH reviewers or the expert committee should know? (Optional; maximum 200 words)

5 Appendix A: CADTH CDR and pCODR Patient Group Conflict of Interest Declarations

Name of patient group: ______

Name of drug and indication under review: ______

Conflict of Interest Declarations To maintain the objectivity and credibility of the CADTH Common Drug Review (CDR) and pan- Canadian Oncology Drug Review (pCODR) processes, all participants in the drug review processes must disclose any real, potential or perceived conflicts of interest. Patient groups must declare any real, potential or perceived conflicts of interest that may influence or have the appearance of influencing the information submitted. Conflict of interest declaration is requested for transparency — it does not negate or preclude the use of the patient group input. 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 affiliations or personal or commercial relationships with drug manufacturers or other interest groups.

Section A: Payment Received 1. Has this patient group received any payments over the previous two years from any company or organization that may have direct or indirect interest in the drug under review? □ Yes □ No If no, please go to Section B.

2. What form of payment did this patient group receive? (Check all that apply.) □ Operating □ Program funding (e.g., funds website) □ Royalties □ Research/educational grants □ Gifts □ Sponsorship of events □ Honorariums □ Other, please specify: ______

3. Please provide the names of companies and organizations and the amounts of the payments in the box below. Section B: Holdings or Other Interests 4. Has this patient group received, or is it in possession of, stocks or options of more than $10,000 (excluding mutual funds) for organizations that may have a direct or indirect interest in the drug under review? If yes, please list in the box below.

Section C: Affiliations, or Personal or Commercial Relationships

5. Does this patient group have personal or commercial relationships with either a drug or health technology manufacturer (including such manufacturer’s parent corporation, subsidiaries, affiliates, and associated corporations), or other interest groups? If yes, please provide the names of the companies and organizations and outline the nature of these relationships in the box below.

Section D: Contributors to the Patient Input Submission

6. Did you receive help from outside your organization to complete this template? If yes, please detail the help and who provided it.

7. Did you receive help from outside your organization to collect or analyze data used in this submission? If yes, please detail the help and who provided it.

I hereby certify that I have authority to disclose all relevant information with respect to any matter involving this patient group with a company, organization or entity that may place this patient group in a real, potential, or perceived conflict of interest situation.

Date: Name: ______Signature:______