Autologous chondrocyte implantation in the knee assessed by IQWiG in Germany

03

Sep 2020

On behalf of the Federal Joint Committee (G-BA), the Institute for Quality and Efficiency in Health Care (IQWiG) investigated to what extent adults with symptomatic knee cartilage defect (but without advanced arthrosis) could benefit from autologous chondrocyte implantation (ACI) of different types: periosteal-covered (ACI-P), collagen-covered (ACI-C) or matrix-associated (M-ACI).

Cartilage tissue has a very limited ability to regenerate, and a cartilage defect is a risk factor for the development of osteoarthritis. In adults with cartilage defects that affect more than 50% of the cartilage depth or that extend to the underlying bones, ACI has been used for over 30 years. Compared to the two older methods, the ACI-C and the ACI-P, the M-ACI is the most commonly used technique today.

The ACI is a two-stage surgical method: On the first stage, the affected cartilage is removed, and the cartilage cells are cultivated to be reintroduced into the defect in the second step. The three different ACI procedures differ in terms of the reimplantation of the cultivated cells. In the M-ACI, the cultivated cartilage cells are fixed directly in a carrier matrix and inserted into the cartilage defect zone. In the two older methods, the grown cartilage cells are introduced into the cartilage defect in the form of a cell suspension and covered by the patient's periosteum (ACI-P) or a collagen membrane (ACI-C). In contrast to the M-ACI, in both methods, the cover must be fixed with seams and sealed watertight.

The study aimed to evaluate the benefit of the method of ACI (periosteal, collagen-covered, matrix-associated) compared to standard therapy in adult patients with the symptomatic defect of a circumscribed cartilage of the knee without advanced arthrosis concerning patient-relevant endpoints.

A systematic literature search was carried out in the databases MEDLINE and Cochrane Database of Systematic Reviews as well as on the websites of the National Institute for Health and Care Excellence (NICE) and the Agency for Healthcare Research and Quality (AHRQ). The search was limited to the publication date from January 2014. A systematic literature search for primary studies was carried out in the databases MEDLINE, Embase, and Cochrane Central Register of Controlled Trials.

Results – daily life activities:

  • 2 studies on M-ACI showed statistically significant difference in favor of the intervention (cod16HS13: mean difference [MD]: 6.32; 95% confidence interval [95% CI]: [1.33; 11.31]; MACI00206: MD: 11.40; 95% CI: [4.60; 18.20]). However, the threshold for clinical relevance (0.2) within the confidence interval is 1 of the two studies (cod16HS13: Hedges' g: 0.5; [95% CI]: [0.10; 0.90]; MACI00206 : Hedges' g: 0.55 [95% CI]: [0.21; 0.88]). Therefore, it remains unclear whether the effect for M-ACI reaches a clinically relevant range

Results – function:

  • The meta-analysis of the three studies on the M-ACI procedure showed a statistically significant difference in favor of the intervention. However, the threshold for clinical relevance (0.2) lies within the confidence interval of the pooled effect (Hedges' g: 0.44; [95% CI]: [0.03; 0.85]; p-value: 0.045). Therefore, it remains unclear whether the effect for M-ACI reaches a clinically relevant range

Results – treatment failure:

  • The Bentley study (2003) demonstrated a statistically significant difference in favor of ACI-C (OR: 0.17; [95% CI]: [0.07; 0.43]; p-value: <0.001)

Data on the outcomes "mortality", "pain", "symptoms", "algofunctional index", "serious adverse events", "discontinuation due to adverse events", "health-related quality of life" did not indicate a benefit or harm from the ACI compared to standard therapy.

Comments on the published preliminary report will be viewed after the deadline (27.07.2020). If they leave questions unanswered, the respondents will be invited to an oral discussion. The IQWiG will then prepare the final report.

The preliminary report in German can be found here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.

The latest related news

29

Nov 2022

On November 18, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) announced that sixteen applications for Innovation Funding of the new forms of care were accepted. These applications relate to the funding announcement of March 17, 2021. Most projects relate to interdisciplinary or cross-sectoral care and pathways.

Read more

24

Nov 2022

In November 2022, NHS Digital published a final summary of core changes from OPCS-4.9 to OPCS-4.10 to be introduced from April 01, 2023. OPCS-4 is a statistical classification for clinical coding of interventions and procedures undertaken within the NHS. It is updated every three years. A total of 236 new four-character codes will be implemented in OPCS-4.10. Key changes concern cardiovascular, gastrointestinal, endoscopy, ENT, nephrology and urology, neurology and neurosurgery, obstetrics and gynecology, orthopedic, and breast surgery fields.

Read more

23

Nov 2022

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 21738 of November 4, 2022, Tuscany Regional Healthcare has published assessments of three medical devices in the orthopedics, surgical procedures, and peripheral vascular areas.

Read more

22

Nov 2022

On October 27, 2022, the BfArM (Federal Institute for Drugs and Medical Devices) published the final version of the 2023 OPS procedure coding classification. The OPS, together with the ICD-10-GM (International Statistical Classification of Diseases and Related Health Problems, 10th revision, German Modification), forms the basis for the reimbursement systems in outpatient and inpatient care in Germany.

Read more

18

Nov 2022

On October 28, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) reported that 231 applications were received for innovation funding of healthcare research projects.

Read more