By Andy Smallwood
In 2000, when NICE published its original Guidance relating to hip prostheses, they tasked NHS Purchasing and Supply Agency (PASA) with the collection and dissemination of claims made by companies as to how their prostheses compared with the benchmarks set out in their Guidance. Upon submission of the first set of data it was apparent that suppliers had differing views of what constituted evidence and the quality of submissions was generally poor. In response PASA created ODEP and worked with ABHI, BHS, MHRA and BOA to establish a common understanding of how prostheses could be compared to the benchmarks set out by NICE.
The key benchmark in the NICE Guidance was a failure rate of 10% or less at 10 years and prostheses that met this benchmark should be recommended for routine use in the NHS. In light of criticism relating to restriction of innovation several other developmental benchmarks were created that show the progress from entry to the market through to a 10A rating.
So how do Procurement use the benchmarks?
The number part of the rating represents the years of acceptable data submitted to ODEP.
The alpha part of the rating represents the quality of the data submitted (‘A’ being the best).
‘Pre-entry’ is the term used for prostheses that do not have enough data to support a 3 year rating and should only be used as part of an ongoing trial.
The rating is for the evidence submitted, not the product itself, and therefore a product may in theory move from pre-entry to 10A without progressing through the other benchmarks if further data is submitted.
Industry is required to submit data on a regular basis and ODEP review entries twice a year. A prosthesis that has not had data submitted for 5 years will be deemed ‘unacceptable’ and not recommended for use. In addition, prostheses that are not recorded as having an ODEP rating are also deemed ‘unacceptable’ and not recommended for use. If clinicians use or would like to use a prosthesis that falls in these ‘unacceptable’ categories then they should contact the supplier and encourage them to submit data in relation to the prosthesis’ performance.
ODEP would not recommend that the ratings be used as the sole measure of a product’s quality when scoring tenders as the ratings are fluid and may change twice a year. ODEP would also not recommend limiting use to 10A rated products as this would damage innovation in the industry. However, the ratings should be used as an aid to discussions with industry and clinicians on an ongoing basis to underpin evidence based procurement.
Should you wish to discuss ODEP from a procurement perspective, please call either Phil Lewis, ODEP member and facilitator or Andy Smallwood ODEP Founder and member. Both can be contacted via firstname.lastname@example.org