Introduction
The National Centre for Pharmacoeconomics (NCPE) performs detailed reviews of the clinical effectiveness and cost-effectiveness of new and existing drugs at the request of the Health Service Executive (HSE).
In 2016, the NCPE launched the Patient Organisation Submission of Evidence process. The purpose of this process is to supplement our health technology assessment (HTA) reports with information collected directly by patients, from patients, detailing real-life experiences of living with the disease in question and how the new treatment may address some of the challenges arising from the disease.
Review Process
Towards the end of 2017, the NCPE conducted a review of the Patient Organisation Submission of Evidence process, with input from engaged patient organisations, using a series of surveys with open and closed questions. We also received feedback on the previous submission of evidence template via participants in the pilot IPPOSI-led Patient Education Programme in Health Innovation. Based on the feedback provided, and following a review of the patient submission process in other jurisdictions, we identified a number of priority areas:
- Communication processes with submitting patient organisations
- Guidelines on how to complete a patient organisation submission template
- Language and tone of materials used throughout the submission process
We developed a new process around communicating with patient organisations, including the creation of a patient organisation database to allow the NCPE to notify interested organisations when a HTA in their area is being conducted. We also created new guidelines which detail the submission process in accessible language, and provide practical advice on how to complete the template and examples of previous submissions. Finally, we updated our Patient Organisation Submission of Evidence Template in response to detailed feedback we received from interested stakeholders, making it more concise while allowing for different scenarios to be described in more detail.
A four week public consultation process was subsequently launched by the NCPE on 29th March 2018 and closed on 30th April 2018. The primary objective of the process was to refine the proposed Patient Organisation Submission Process (POSP). We wanted to determine the views of relevant stakeholders and potential users of the updated documents, to ensure they were relevant, patient focused and user-friendly.
A number of patient organisations were contacted to highlight the public consultation process and invite feedback. The process was also highlighted via the NCPE website and via social media, using the NCPE Twitter account.
The public consultation utilised a questionnaire, which sought the views of stakeholders on 4 key documents that were identified by the NCPE as relevant for the POSP. These documents were:
- The patient organisation submission process overview
- The patient organisation database registration form
- The patient organisation submission of evidence template
- Guidance document on completing the patient organisation submission of evidence template
Respondents were asked to provide feedback giving special consideration to the following questions:
– Do you think all important areas have been covered?
– Is the language used appropriate and easily understood?
– Is the layout of the document clear and easy to follow?
Overview of Public Consultation Findings
A total of 14 submissions were received; 100% were submitted electronically via email.
The majority of submissions (72%) were from patient organisations and umbrella patient organisations. The remaining submissions were from individual patients in a personal capacity (14%) and from industry (14%).
A number of themes emerged from the qualitative analysis of the submissions. The new documents and processes were regarded as “patient friendly”, “well structured”, “clear and easy to follow”, “a positive transformation” and “will lead to more patient organisations engaging in the HTA process and improve the quality of evidence submitted”. The introduction of a patient organisation database was viewed as a welcome addition to the process by many respondents.
Several important issues were highlighted by respondents. These included the greater use of plain language, clarity around timelines, and details on how the patient submission template is used in the final HTA report. The need for training and education on the submission process/HTA process, and an improved notification and communication process with patient organisations on HTA outcomes, were emphasised by some respondents. The importance of having a dedicated contact person in the NCPE to support patient organisations, and the value of continuing to review and refine the POSP after implementation, were other issues highlighted by respondents.
Following the important and useful contributions from respondents to the public consultation, we made a number of amendments, particularly in relation to the submission of evidence template. In addition, terminology was simplified where necessary and a focus was made on the need for plain English.
Conclusion
The responses to our surveys and public consultation process acknowledged the proactive activities of the NCPE in terms of their efforts to develop the POSP, and identified opportunities to build on that progress.
The feedback and views of stakeholders, who engaged in the public consultation process, contributed to the update and development of the POSP, guidelines, a database registration form and the Patient Organisation Submission of Evidence Template. The final documents and processes have been agreed and implemented, and are now published on our website.
We would like to take this opportunity to sincerely thank everyone who provided feedback and contributed to the development of the Patient Organisation Submission Process in the NCPE.
September 2018
