Taking Action

15 January 2010

Canadian Agency for Drugs & Technologies in Health
#600 – 865 Carling Avenue
Ottawa, ON
K1S 5S8

Dear Sir or Madam:

Re: Consultations on Patient Input into the Common Drug Review

Thank you for inviting feedback on the Patient Input Template designed to incorporate patient input into the Common Drug Review (CDR) review process and the deliberations of the Canadian Expert Drug Advisory Committee (CEDAC). 

The Canadian Association of Wound Care (CAWC) believes that significant improvements to the health of Canadians can be achieved through improved wound care and prevention if we build on the solid foundation put into place by our volunteers and members over the past 15 years.  Our members and volunteers include for example physicians, nurses, wounds researchers, academics, chiropodists, occupational therapists, vascular surgeons, podiatrists, personal support workers and other health professionals but also patients and their families who are suffering from wounds or at high risk of preventable wounds. 

Wound healing efficacy is frequently a reflection of underlying health conditions, diseases or risk factors.  Acute wounds that result from surgery, radiation therapy, burns or trauma as well as preventable wounds like skin tears, diabetes foot ulcers, pressure ulcers and venous leg ulcers will heal if treated appropriately.  Pain management and other medications assist with recovery and are often critical to the quality of life of the patient.  Canadians with a chronic disease who self-manage with a variety of therapies including prescription medications are at high risk of preventable wounds.  Canadians with diabetes for example who can manage their blood glucose and blood pressure levels to recommended targets are less likely to develop preventable diabetes foot ulcers. 

Medication management therefore is one aspect of effective wound management and prevention.  CAWC believes we offer a unique perspective on the impact of prescription medication therapy on patients’ lives, and our contribution to this consultation is part of our efforts to achieve health systems change.  We are pleased to provide you with the following comments on the proposed CADTH/CDR Patient Input Template. 

  1. While this proposed patient input template is a step towards patient and public engagement in the CDR process, it is insufficient in terms of accountability, transparency and engagement.
    • There is no clear accountability back to the patient groups for ensuring their comments are considered appropriately in the deliberations on the final recommendation.
    • There is no independent appeal process that includes the right of appeal by Canadians directly impacted by the CEDAC final recommendation.
    • There is limited transparency for the public or patient groups to know which public, clinical and disease specific experts and/or research were included in the final recommendation.
    • There is no direct patient and public engagement by CADTH/CDR in this process.  Patient groups should be engaged, but the restriction on patient and public submissions must be addressed fully.
  2. While CADTH’s intention to improve patient and public engagement is welcome, the proposed template appears to have been developed without any patient or public involvement from the start of design and development.  We recommend that CADTH clearly demonstrates its interest in patient and public involvement from the beginning by engaging patient organizations in the development and refinement of, for example, the form for submitting patient input.  We encourage CADTH to translate some of the valuable insights in the UK NICE Patient Carer Organization template.
  3. The proposed process appears to provide patient organizations with an opportunity to submit comments during the development of the Review Protocol.  This process would be significantly enhanced if it included an opportunity for the patient organization to review the CEDAC recommendation and provide feedback on the recommendation during the embargoed period.  Patient organizations would then be assured that the final CEDAC recommendation going to participating drug plans accurately considered their feedback.  We recommend that CADTH/CDR implement this step.

  4. The purpose of the patient group input appears to be:  (a) identifying and incorporating outcome issues that are important to patients; and (b) providing information from the CEDAC public members during consideration of the final recommendation. 

    • Clarification about what actual weight will be given to the patient group input by CEDAC as part of the review of the economic, scientific and clinical evidence is required.  During CEDAC review, is the patient group input given equal weight or is it given a defined value in relation to any other evidence presented?  If it is not given a specific weighting, we recommend this be implemented and communicated publicly.
    • It appears that the CEDAC public members will present the information provided by the patient groups to the CEDAC members.  We recommend a conference call between the CEDAC public members and the originating patient group in advance be established to allow for clarification of any of the key points as well as increase confidence that the patient group’s input is appropriately positioned with CEDAC.
  5. Patient organizations providing information through the template need to be reassured that their submissions will not be marginalized as a result of a declaration of unrestricted educational grants support from the pharmaceutical industry.  To be reassured, patient organizations require clarification about whether the current CDR Conflict of Interest declaration is to be applied to this process.  As this declaration is currently written, it appears to be exclusionary and will prevent the majority of patient organizations from participating.  Many patient groups receive unrestricted educational grants from industry to invest in research or organize conferences.  Would they be ineligible to participate in the process as a result of obtaining an unrestricted educational grant from industry?  If the individual submitting on behalf of the patient group is also required to complete the declaration, would industry funding personally received by that individual prior to joining the patient group, prohibit the patient group’s participation in the process?  We recommend that CADTH provide clarification to these questions publicly on their website.
  6. The 15-day period for patient group review and submission will challenge many patient groups who rely on volunteers to provide expertise and advice.  Many do not have trained staff to undertake the research and writing of a submission.  Will CADTH provide funds that patient organizations may access in order to hire a researcher or writer to complete their submission within this 15-day timeline? Given the time frame, and without adequate support, CADTH may create an unintended consequence of forcing patient organizations to work more closely with the pharmaceutical companies in order to respond within the time frame.  We recommend therefore that the time frame be extended to 30 days, and that CADTH provide support either financially or through a dedicated staff resource within CADTH to assist patient organizations to develop submissions that are appropriate and relevant for the CDR/CEDAC deliberations.

Finally, we urge CADTH to examine and build from the UK experience in patient and public engagement.  In particular we encourage CADTH to consider the NICE Single Technology Assessment Process because they welcome submissions from health system organizations, patient carer organizations and professional organizations. 

From the patient perspective, the NICE process focuses first on the technology in question rather than putting it in the last section of the form.  Secondly, it asks about the implications to the patient if this treatment, therapy or technology was – or was not – available to patients through the National Health Service.  In our view, the NICE process demonstrates publicly that they value patient and public involvement as an important part of a timely review and evaluation process since they created the Patient and Public Involvement Program within their team.

The NICE Patient and Public Involvement Program supports appropriate involvement across their activities.  A Project Manager is assigned to each appraisal and supports patient and carer organizations throughout the process.  This support may include making it easier to attend workshops or meetings, giving advice on completing submissions, consultation responses or other documentation, as well as nominating experts.  The UK Patient and Public Involvement Program project manager also supports the lay members of the Appraisal Committee and supplies the patient organization with information to understand NICE guidance when finalized.

We recommend that a similar program be adopted by CADTH as a significant step towards greater patient and public involvement in the critical public policy discussions that not only inform CDR’s recommendations but also influence federal, provincial and territorial decisions about healthcare investments.

Thank you for this opportunity to provide our comments on the proposed CADTH/CDR patient input template.  If you would like clarification or have questions about any of our points, please contact me directly at 416-485-2292 or by email at .(JavaScript must be enabled to view this email address).

Sincerely yours,

Karen Philp
Chief Executive Officer