Health Technology Assessment, HTA 2011

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Published: 16 Sep 2011

Device Access

The major problem with the introduction of new Medical Devices is the need to prove not only clinical effectiveness but also economic benefits that will justify the change in process. As the figure below indicates there are a number of pressures on the sector from both economic and clinical outcomes whilst at the same time having to overcome established procedures or methods.

The figure used in the 2012 SMi Point-of-Care Testing (POCT) Diagnostics conference underlines the implementation issues not just for POCT tests but all Medical Devices.

In the case of diagnostics generally the position of HTA within the whole commercial environment is shown by the figure from the 2015 update of the ImmunoAssay Handbook provided by ABA.

In many ways the development of healthcare delivery can be linked to development of enabling technologies that achieve more extensive applications than considered possible at the first introduction of a technology or might even be the key component that allows the technology to be effective. A scheme is shown below contrasting Healthcare delivery with the development of computers.

A major consideration for introduction of new Medical devices depends upon assessing the impact and especially trying to determine unexpected consequences. The steps are well defined but in the excitement of a wonderful new technology attention is not always given to the detail required. The steps are as below.

  • Basis for Implementation & Quantification
  • What are the disadvantages of the device?
  • What are the NHS adoption issues?
  • Figures that can help quantify the market, its application and costs of use
    • Product Cost
    • Numbers of Patients & Usage
    • Treatment Pathway
    • Current & Changes if device used.
    • Social Care Costs current & if device used.
    • Etc. - including Unforeseen Consequences

The use of a Medical Device has to be seen in the broad context given above and what the goals in the use of the product by the user are as distinct from just the performance of the product as viewed by the supplier. These two perceptions have to be in tune and the differences can be seen below with the value dossier required shown next.

Hospital - Early discharge with primary care follow up, Fewer clinic visits.

Primary Care - GP or Home Monitoring, Pharmacy Potential for Screening & Monitoring with treatment changes.

Home & Self - use of District Nurse, etc. and self-monitoring with Telehealth.

Patient - Reduced clinic visits or hospitalisation, more convenience to suit the patient!

Value Dossier - Common Features to Assess & Evaluate

  • Innovation or Product Costs. Same data in all models.
  • Patient Pathway Costs - Current & New.
  • Financial Savings for NHS of Innovation.
  • QALY Value of innovation for longer term benefit (> 1 year).
  • Decision Tree Process to compare innovation impact.
  • Areas where data is still required & Unexpected Consequences.

The problems faced are illustrated by the findings from the Osprey report in considering the changes required for the introduction of Point-of-Care Testing (POCT) for diagnostics.

High Impact Process Changes from POC

  • Day cases treated as the normal route.
  • Improve access to diagnostic tests.
  • Reduce variation in discharges & stay.
  • Reduce variations in admissions.
  • Avoid unnecessary follow ups.
  • Increase reliability of interventions.
  • Systematic approach to long term conditions.
  • Reduce queues.
  • Optimise patient pathways.
  • Change of roles in line with pathways.

K Sylvester, Osprey Report.

Adams Business Associates has been at the forefront of the implementation of value based assessments for the introduction of new Medical Devices with over forty detailed economic assessments now carried out. Many of these have been used to support product approval submissions and guidance analysis for use by NICE in its various device programmes.

More information can be found here