The procedure is autologous chondrocyte implantation (ACI). The draft guidance recommends that ACI is used only in research, as more evidence is needed on how well it works in the long-term and its cost-effectiveness.
Cartilage is a smooth substance which covers the ends of the leg bones and the underside of the kneecap where they meet in the knee joint. Cartilage allows smooth movement and acts as a shock absorber. Cartilage contains cells called chondrocytes, which make collagen – a fibrous protein.
Cartilage damage can be caused directly from injury, for example from sports, or by arthritis, or suddenly for no apparent reason. People whose cartilage is damaged often experience knee pain, knee swelling, joint locking (this is when a joint becomes stuck in one position) and the 'giving way' of the joint. Cartilage has no blood and nerve supply, so if it becomes damaged it has a limited ability to repair itself.
ACI is a procedure where normal cartilage cells are collected from inside the knee and grown in a laboratory for several weeks to increase the numbers of the cells. Once they have grown, the cells are implanted into the damaged area of the knee and sealed by a layer of tissue.
Professor Carole Longson MBE, director of the NICE centre for health technology evaluation, said: “Knee cartilage damage can have a significant impact on a person’s life, employment and social activities. It’s estimated that every year in the UK, around 10,000 people need treatment for cartilage damage. Between 200 and 500 of these have cartilage defects suitable for autologous chondrocyte implantation.
“The independent Appraisal Committee considered the evidence available on ACI, which included evidence on the nature of knee cartilage damage, the views of people with the condition, those who represent them, and clinical experts. ACI is a promising technology, but there is insufficient long-term evidence to support a conclusion on the long-term effectiveness of its use. This lack of evidence meant that the Committee could not recommend ACI for routine use of NHS resources, but it wanted to encourage further research to generate more evidence on the effectiveness of the procedures considered.
“Therefore in this draft guidance, the committee recommends that ACI is used in the context of research which should include clinical trials and observational studies designed to measure its long-term benefits. We welcome comments on this draft recommendation as part of the consultation.”
This is draft guidance – NICE has not yet issued final guidance to the NHS.
Stakeholders, including the companies that market the procedures, healthcare professionals, patient groups and members of the public are now able to comment on this draft guidance. The consultation is open until 1 April 2015 and any comments received will be fully considered by the Committee. Until final guidance is issued to the NHS, NHS organisations should make decisions locally on the funding of specific treatments.
For more information call Dr Tonya Gillis at the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.
Notes to Editors
About the draft guidance
1. The draft guidance is available at http://www.nice.org.uk/guidance/indevelopment/gid-tag446 from Thursday 12 March.
2. The draft recommendation is:
• Autologous chondrocyte implantation is recommended only in research for repairing symptomatic articular cartilage defects of the knee. Research should include clinical trials and observational studies designed to measure its long-term benefits.
3. The ACI technologies considered in the appraisal are ChondroCelect (SOBi), MACI (Aastrom) and OsCell (Robert Jones and Agnes Hunt [RJAH] Orthopaedic Hospital).
4. ACI is not used on unstable or arthritic joints.
5. The Committee considered that there was no ICER available that included the assumptions that the Committee considered plausible, and that several key parameters in the Assessment Group’s model could not be populated with data available. Because of insufficient evidence on the long term effectiveness, the uncertainties in the economic modelling, and the fact that some more plausible assumptions in the modelling led to higher ICERs than the low base case ICERs from both the company and the Assessment Group model, the Committee could not justify recommending ACI for routine funding.
6. The list price of the ChondroCelect product is £18,301 for a vial containing 4 million cells in 0.4 ml implantation suspension (price excluding VAT; eMC Dictionary of Medicines and Devices Browser).
The MACI implant has a density of 500,000 to 1,000,000 cells per cm2, which the surgeon trims to the size and shape of the person’s cartilage lesion. The list price quoted in the submission for the MACI product is £16,226 per implant (price excluding VAT).
For both products, costs may vary in different settings because of negotiated procurement discounts.
The OsCell cultured chondrocytes are produced at an NHS facility under licence that allows the technology to be supplied to hospitals around the UK and in Norway for use in clinical trials only. OsCell cultured chondrocytes do not have a marketing authorisation, and are therefore not commercially available. The OsCell submission states that producing cells costs £4125 per patient.
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.