Any internal HSE division or representative from industry can apply for a health technology assessment review by HTAG.
As we are a small unit, priority will be given to internal HSE requests, but we will attempt to facilitate all requests at the topic referral stage.
Excluding Circumstances - Article 57 of EU Council Directive 2014/24/EU
Please note that a company submitting a Horizon Scanning Form and who is subject to any one of the excluding circumstances contained in Article 57 of EU Directive 2014/24/EU will be deemed ineligible to be offered a mini HTA review.
The Process Steps
The horizon scanning, topic referral and mini HTA processes are explained in the following steps. (Download Process flow chart)
Step 1: Horizon Scanning
Horizon Scanning enables proactive planning and decision-making regarding the use and/or reimbursement of new medical devices. Horizon Scanning is intended to provide HTAG with a systematic process to identify and monitor medical devices that may be considered for reimbursement within the HSE.
HTAG will use Horizon Scanning to actively identify medical devices for which reimbursement applications are expected to be made between April 2018 and March 2019. The initial Horizon Scanning call will be targeted at industry and will open alongside the launch of the HTAG website. HTAG plan to hold a horizon scanning meeting in April 2018 and we request that companies submit the horizon scanning forms by the end of March 2018.
Companies are eligible to complete and submit the Horizon Scanning form if their medical device has a CE mark or is expected to have a CE mark within the following 12 months, and if they are in compliance with Article 57 of EU Council Directive 2014/24/EU. Once submitted, the Horizon Scanning Form will be logged on the HTAG Horizon Scanning database and an acknowledgement sent to the applicant. The purpose of this information is two-fold. First, HTAG will use this information to determine whether a medical device is relevant to the scope of HTAG. Companies will be notified as to the outcome of this assessment. Second, it will be used to inform HTAG’s future work plan, research activities and resource requirements.
Please note that completion and submission of the Horizon Scanning Form is a mandatory pre-requisite to be considered for inclusion in the HTAG topic referral process. Once the Horizon Scanning Form has been received and the medical device is deemed to be within the scope of HTAG’s remit, then such device will be eligible for inclusion in the HTAG topic referral process. The topic referral form will be made available on the HTAG website from April 2018.
Download and complete the Horizon Scanning Form
Once completed the Horizon Scanning Form should be emailed to firstname.lastname@example.org
Step 2: Topic Referral Process
Medical devices which have been submitted as part of the Horizon scanning process, and deemed suitable for review can proceed through the next stage of the HTAG process, Topic Referral, which will help HTAG prioritise which devices will be suitable for inclusion in the work programme for the following year.
Applicants who submit a Topic Referral Form must provide evidence to show that the device complies with minimum safety standards, that there is a clinician who supports the application and that the device is of potential benefit to patients. The supporting clinician must be a permanent consultant in a HSE funded hospital or equivalent (for example, GP, Specialist in Public Health Medicine etc.).
- On receipt of the Topic Referral Form, HTAG adds it to the Topics Referral Register and sends an acknowledgment to the Topic Referrer
- A screening report will be conducted by HTAG which will determine whether or not a Mini HTA should be conducted on the topic. If a Mini HTA is not recommended then HTAG will advise the Referrer as to the outcome of the topic screening process.
- Where the topic has successfully passed the screening stage, HTAG will issue a Mini HTA Application Form to Referrer which they will have to complete and submit to email@example.com
Step 3: Criteria for Screening Topics
The topic referral form seeks to capture information to answer the following screening questions. The answer must be yes to at least one of the points at 1 to 4 below:
- Is a clear additional health benefit to patients anticipated or evident from the use of this technology?
- Is the technology likely to have a major impact on HSE resources (consuming or releasing)?
- Is there potential for quality improvement from undertaking an assessment of this technology at this time?
- Are there likely to be sufficient published research findings available upon which to base a technology assessment?
Step 4: Mini HTA process
Once the Mini HTA Application Form has been submitted to the HTAG, the evidence for the medical device/technology provided on the application form will be assessed and evaluated.
- The first stage will be to review the evidence for effectiveness of the product submitted by the applicant. If there is evidence for effectiveness, then the mini HTA will proceed to review the evidence of cost-effectiveness contained in the mini HTA application.
- As part of an assessment of a mini HTA, HTAG may request additional information from the applicant during the review phase and may also be invited to attend a meeting of the Health Technology Assessment Expert Group (HTAEG) to discuss the application.
- Once HTAG has completed the mini HTA assessment, a report will be submitted to HTAEG for consideration at their next scheduled meeting and any necessary amendments and addendums will be incorporated. An Advice Note will then be compiled which the expert group will sign-off on and which HTAG will then communicate to the applicant. The Advice Note will be issued to HSE Procurement and any other relevant stakeholder and in due course it will be published on this site.
- The Advice Note is the final product within the Mini HTA process.