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Patient Evidence Submissions

Ontario Guidelines for Patient Evidence Submissions

The purpose of the guidelines is to assist advocacy groups in making their submissions of patient evidence for a drug undergoing review.

Submissions are accepted only from organized advocacy groups registered with the Ministry at this time. Individual patients who wish to make a submission are encouraged to do so through one of the registered advocacy groups. The patient evidence submission form is available as PDF document to download and fill.

The following information must be identified at the beginning of the submission:

  • Date on which the submission was prepared
  • Drug and indication to which the submission pertains
  • Name of the author and the advocacy group
  • Contact information (mailing address, phone number and email address) of the author / advocacy group
  • Conflict of interest declaration. The author and the patient advocacy group must declare any potential conflicts of interest that may influence or have the appearance of influencing the information submitted. Examples of conflicts of interest include, but are not limited to, financial support from the pharmaceutical industry (such as educational/research grants, honoraria, gifts, and salary), as well as affiliations or personal/commercial relationships with drug manufacturers or other interest groups.
  • Confirmation of authorship. The author must confirm that the submission provided is entirely their own work and did not involve assistance or input from other interested parties (e.g. pharmaceutical companies).

The questions below outline the information that the OPDP is interested in receiving.

  • Impact of the disease/condition
    • What symptoms and problems do patients have as a result of the disease/condition?
    • How does the condition affect day-to-day life?  For example, are there activities that patients are not able to do as a result of the condition?
  • Treatment outcomes that matter most to patients
    • What are the most important aspects of the condition that patients would like to see addressed by treatments?
    • In terms of treatment efficacy and side effects, what are patients getting from existing therapies and what would patients like new therapies to do differently?
    • Are there other practical implications to be considered in determining the value of a treatment?  For example, how do treatments impact patients' or caregivers' daily routine or lifestyle? 
    • In addition to the drug cost, are there other financial implications to patients or caregivers (e.g. traveling cost, time away from work, drug disposal issues, drug administration supplies)?
  • If providing patient evidence on the specific drug under review
    • What positive and negative impacts does the drug have on the condition?
    • Which symptoms is the drug best or worst at treating?
    • What difference does the drug make to patients' long-term health and wellbeing?
    • What are the side effects of the drug; which ones are patients prepared to put up with, and which ones do they find unacceptable? 
    • How does the drug compared with other available treatments in terms of efficacy, side effects and other practical implications (e.g. administration, time, costs)?

The completed form must be sent in via email to PatientSubmission.OPDP@ontario.ca and must be received by midnight of the posted deadline date listed on the drug review schedule.

The information submitted by patient advocacy groups will be collated and presented to the Committee to Evaluate Drugs (CED) by the patient member during the discussion of the drug. Following its review, The CED makes recommendation to the Executive Office as to whether a drug product should be funded.  The CED discussion and the reasons for the funding decision are available from the EO Decisions and CED recommendations webpage. Find out more in the section on how drugs are approved.

See also:

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For More Information

Call ServiceOntario, Infoline at:
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TTY 1–800–387–5559.
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