5 Implementation

5 Implementation

5.1 Section 7(6) of the National Institute for Health and Care Excellence (Constitution and Functions) and the Health and Social Care Information Centre (Functions) Regulations 2013 requires clinical commissioning groups, NHS England and, with respect to their public health functions, local authorities to comply with the recommendations in this appraisal within 3 months of its date of publication.

5.2 When NICE recommends a treatment 'as an option', the NHS must make sure it is available within the period set out in the paragraph above. This means that, if a patient has end-stage arthritis of the hip and the doctor responsible for their care thinks that total hip replacement or resurfacing arthroplasty is the right treatment, it should be available for use, in line with NICE's recommendations.

5.3 NICE has developed a costing statement explaining the resource impact of this guidance.to help organisations put this guidance into practice.

5.4 The Orthopaedic Data Evaluation Panel (ODEP) hosted and facilitated by the NHS Supply Chain, will provide information about revision rates for hip prostheses, enabling commissioners in the NHS to comply with this guidance. ODEP coordinates, receives and analyses submissions of long-term performance data from prosthesis manufacturers, used in the UK and internationally. Based on the quality and length of follow-up data, prostheses are rated as per the table below.

Benchmarks developed by ODEP

Pre-entry

Pre-entry A:

Product launched under Beyond Compliance.

Pre-entry B:

Products registered with the National Joint Registry. All primaries and revisions monitored via supplier feedback.

3 years

3A rating:

150 with minimum 3 years' follow‑up with actual revision rates of less than 3%. All deaths, loss to follow-up failures and indications for revisions recorded.

3B rating:

Data for a smaller cohort demonstrating less than 3% revision rates at 3 years, and patient time incidence rate (PTIR) or Kaplan–Maier survivorship data showing confidence limits on the data.

5 years

5A rating:

250 patients (with data from beyond the developing centre submitted) with minimum 5 years follow-up with actual revision rates of less than 5%. All deaths, loss to follow-up indications for revisions recorded.

5B rating:

Data for a smaller cohort demonstrating less than 5% revision rates at 5 years, and PTIR or Kaplan–Maier survivorship data showing confidence limits on the data.

7 years

7A rating:

350 patients (with data from beyond the developing centre submitted) with a minimum of 7 years follow-up with actual revision rates of less than 7%. All deaths, loss to follow-up, failures and indications for revisions recorded.

7B rating:

Data for a smaller cohort demonstrating 7% at 7 years, and PTIR or Kaplan–Maier survivorship data showing confidence limits on the data.

10 years

10A* rating:

500 patients (including 3 centres in cohort and including data from beyond the developing centres) with a minimum of 10 years' follow-up with actual revision rates of less than 5% at 10 years (that is, demonstrating survivorship of better than 95%). All deaths, loss to follow-up failures and indications for revision included in data.

10A rating:

500 patients (including 3 centres in cohort and including data from beyond the developing centres) with a minimum of 10 years' follow-up with a survivorship of better than 90%. All deaths, loss to follow-up, failures and indications for revision included in data.

10B rating:

Data for a smaller cohort demonstrating 10% at 10 years, and PTIR or Kaplan–Maier survivorship data showing confidence limits on the data.

5.5 Both strength of data and length of follow-up are considered when awarding a rating to individual stem and cup components. While the current A and B rating system is to be retained to support international users of the ratings, hip prostheses will need to track towards no more than a 5% revision rate over 10 years to achieve a 10A* rating in line with NICE guidance (implants with a 3A rating, followed by a 5A rating and with a less than 5% revision rate at 7 years are considered on track to meet the 10A* rating). All hip prostheses are expected to progress through benchmarks from pre-entry with, for example, a 5 year submission expected within 3 years following award of a 3-year benchmark. Failure to follow this progression will result in products being de-registered on the ODEP website. In addition, the option to show products at pre-entry following the Beyond Compliance Programme has been included with the introduction of a pre-entry 'A' benchmark.

5.6 When contracts for the purchase of prostheses exist and cannot be changed, the recommendation applies to all new contracts. However, commissioners should explore whether there is flexibility within such contracts to orientate their buying towards prostheses that meet the updated recommended revision rate standard.

  • National Institute for Health and Care Excellence (NICE)