Boosting clinical evidence with ODEP

Boosting clinical evidence with ODEP

The Orthopaedic Data Evaluation Panel (ODEP) is a UK initiative born out of a pressing need to establish a transparent, effective and powerful way of evaluating the long-term success rates of orthopaedic implants. Commissioned in 2002 following a meeting by the National Institute for Health Care Excellence (NICE), ODEP is hosted by the National Health Service (NHS) Supply Chain in the UK.

At their cores, both the NICE guidelines and the ODEP system are working to provide independent, unbiased classification of the long-term efficacy, confidence and cost-effectiveness of orthopaedic implants. Reduced revision rates, patient risks and unnecessary expenses are all targets hoped to be addressed. In brief, a benchmark was established that proposed all implants should, wherever possible, be able to last 10 years or more before revision (for any reason). [1] If a surgeon deems it necessary to use an implant without this rating, it must still have evidence of efficacy for three years or more.

With this in mind, the ODEP system provides a simple rating system for arthroplasty implants based on performance over time. Comprising both a numeric value that corresponds to how long the device has been implanted (in years) and an letter-based classification of the quality of the evidence (from A to C), the ratings [2] are as follows:

Implant duration

  • Pre-entry
  • 3, 5, 7 or 10 years

Evidence classification (for implants ≥ 10 years)

  • A: acceptable
  • B: reasonable
  • C: weak

Evidence classification (for implants < 10 years)

  • A: acceptable
  • B: weak

As an example, the top-rated 10A implant has a decade’s follow-up with evidence deemed acceptable. Note that there is no ‘C’ classification for implants younger than 10 years. Devices that do not meet the criteria above will not be used in the NHS unless as part of a clinical trial.

Dutch classification

Similar ratings systems are already rolling out across Europe, such as the hip system established by the Dutch Orthopaedic Association (NOV) [3], which was the subject of one of our previous blog posts.

Medical device companies

From an industry perspective, it is important to participate in ODEP ratings if manufacturers are to secure higher level classification of their product’s durability and long-term results. As new classifications come in, there may be severe limitations in the use of their existing products, in turn affecting both in-house success and the possible benefit to patients.

The current process requires implant companies register their device with ODEP, and submit data in support of the request for benchmark. Depending on the stage of both the implant and the data, this may be at one of five stages: pre-entry (yet to meet usage criteria), 3, 5, 7 or 10 years. While the implant time for each of the numbered categories is self explanatory, the pre-entry stage requires that test centres are identified, CE marks are obtained, and satisfactory success rates are shown, with all failures identified and discussed.

Future perspectives

To ensure that minimum risks are seen not only by patients, but also healthcare systems and device companies, post-market surveillance of devices is arguably the most important aspect of the early identification of implants causing concerns. [4] The UK is already well-established for data collection thanks to ODEP, NICE as well as national patients surveys (PROMS) and the National Joint Registry (NJR) – the largest orthopaedic registry in the world. [5] Other European initiatives will need to rely on similar systems.

If this data is harnessed to its full potential, better predictive power as to the use of certain types of implants would be easier to obtain. In addition, it will help in proper assessment of cost-effectiveness versus patient benefit. As an example, it has a role in ongoing debates surrounding the use of cemented or uncemented total hip replacements. 2009-2010 data by the NJR showed that while acetabular implants during that period were predominantly uncemented in nature (62%), only 7% of these implants had the top rating of 10A from ODEP.[6] This compares to 44% for cemented components. In addition, mean pricing for each approach was markedly different at £285 (cemented) and £511 (uncemented). While the intricate details of orthopaedic procedures are of course much more complex, it does mean that implant companies and healthcare professionals now have to be much more aware of the justifications behind each device use.

Impact

Times are clearly changing. Both the UK ODEP system and the NOV classification in the Netherlands are indicators that more widespread programs that focus on achieving the highest device ratings possible are likely to start filtering throughout Europe (and further). For the patient, this evolution will likely provide an almost ubiquitous improvement for care, although caution must always be used to ensure further revisions do not stifle device development or cause other unwanted negative effects.[4]

Device manufacturers will need to adapt in kind. On the one hand, the future of devices in development will benefit from collaboration more openly in clinical trials that can include companies, researchers, healthcare professionals and ratings bodies.[4] On the other hand, existing devices that were previously established may end up being classified as having evidence below acceptable levels (independent of their actual efficacy), thus requiring companies to replace with higher-rated revisions, to great cost. In these sorts of cases, healthcare providers may try to convince device companies and patients with these now de-validated devices to enter into a clinical trial (in which lower-rated devices can still be used), thus hopefully protecting future viability, as well as ensuring surgeons with device-specific skills can remain in practice.

Overall, the new ratings should offer a revolution for better long-term, cost-effective evidence for orthopaedic devices. Whether some companies will be able to keep up with the changes remains to be seen.

 

References

  1. National Institute for Health and Care Excellence. Selection of prostheses for primary total hip replacement. http://guidance.nice.org.uk/TA2 [Accessed October 2013]
  2. NHS Supply Chain. ODEP. http://www.supplychain.nhs.uk/odep/ [Accessed October 2013]
  3. Netherlands Orthopaedic Association. http://www.orthopeden.org [Accessed October 2013]
  4. MHRA Medical Devices Technology Forum. Orthopaedic workshop: joint replacement implants. Are we ensuring patient protection whilst facilitating the introduction of potentially beneficial technologies? (2011). http://www.mhra.gov.uk [Accessed October 2013]
  5. National Joint Registry. www.njrcentre.org.uk [Accessed October 2013]
  6. E J Griffiths, D Stevenson and M J Porteous. Cost savings of using a cemented total hip replacement. J Bone Joint Surg [Br] (2012); 94-B: 1032-5.

 

About Wesley Portegies

Wesley has over 10 years' experience as a marketing manager in the medical industry. He has successfully launched several products in the medical device market and has a great passion for sales and marketing.
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