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Updates of previous evaluations of individual medical procedures by Austrian Ludwig Boltzmann Institute
In August 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI-HTA) published updated evaluations of medical procedures previously assessed. Technologies that were revised are The Barricaid® device for annulus Fibrosus Repair after lumbar discectomy, single-step scaffold-based treatment (AMIC) and two-step scaffold-based treatment (MACI), radiofrequency denervation, and electrical stimulation of the hypoglossal nerve.
The Austrian Ministry of Health receives every year proposals for reimbursement of new medical interventions. LBI is responsible for the evaluation of the efficacy and safety of these interventions, suggested being included in the MEL (German for individual medical services) catalog. The interventions to be evaluated by LBI-HTA are decided by the Ministry of Health. The assessments are based on systematic reviews for each intervention and a summary of the scientific evidence according to the GRADE scheme.
First, the report “Annulus Fibrosus Repair after lumbar discectomy” is updated. This report is the first update of the systematic review “Implantation einer lumbalen Bandscheibenring-Teilendoprothese (Barricaid®)” conducted in 2013. For this update, report results from two RCTs and two observational studies on annular closure devices were available. After the evaluation of the newly available evidence, the inclusion in the hospital benefit catalog is not recommended for the closure of an annular defect after discectomy using the Barricaid® device.
“Single-/two-step scaffold-based cartilage repair in the knee and ankle joint” report has also been updated. The systematic review “Single-step scaffold-based cartilage repair in the knee” was performed by the Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA) on behalf of the Austrian Ministry of Health in 2016. The evidence included in the 2016 report was not sufficient to conclude that the single-step matrix-assisted cartilage repair combined with MFx (AMIC) was more effective and safer than MFx. No evidence was available to compare AMIC with the (matrix-assisted) autologous chondrocyte implantation. Therefore, it was concluded in the report that the inclusion of the single-step matrix-assisted cartilage repair combined with MFx (AMIC) was currently not recommended for inclusion in the Austrian hospital benefit catalog. At this point in time, the single-step repair (AMIC) of cartilage defects or osteochondritis dissecans (OCD) or (osteo)chondral lesions in the knee or ankle joint is not reimbursed by the Austrian health care system. In 2019 for the new report, a systematic review focuses on the treatment of chondral and osteochondral lesions in the knee and ankle joint was carried out. The authors concluded that due to inconsistent outcome reporting, AMIC and MACI are currently not recommended for the inclusion in the Austrian hospital benefit catalog. The authors recommend a re-evaluation for AMIC not before 2022 since there are still ongoing RCTs. For MACI a reassessment might be reasonable not before 2021, as the technique seems to be promising compared to MFx.
“Radiofrequency denervation for lumbar and cervical facet joint pain“ report received an update as well. In 2016, a systematic review evaluating the clinical effectiveness and safety of radiofrequency denervation (RFD) for sacroiliac and facet joint pain in patients with chronic low back pain was published by LBI-HTA on request of the Austrian Federal Ministry of Health. The available evidence included in the 2016 report was not sufficient to prove that the assessed technology of radiofrequency denervation in adult patients with chronic low back pain who had a positive response to diagnostic block is more effective than, and as safe as, the comparator(s) (placebo/sham intervention or conventional treatment). Therefore, the inclusion in the catalog of benefits was not recommended, but a re-evaluation in 2019 was suggested. In 2019, a reassessment of RFD for the treatment of lumbar facet joint pain and evaluation of RFD for the treatment of cervical facet joint pain was additionally included. The 2019 report concludes that the inclusion into the hospital benefit catalog is currently not recommended and a re-evaluation is proposed for 2023.
The last update is about the upper airway stimulation for moderate-to-severe sleep apnea. In 2016, the efficacy and safety of electrical stimulation of the hypoglossal nerve in moderate to severe obstructive sleep apnea (OSA) were evaluated in a systematic review. The evidence available at the time of the 2016 systematic review did not allow conclusions to be drawn as to whether the treatment was more effective than the standard of care. Therefore the inclusion in the catalog of benefits was not recommended, but a re-evaluation in 2018 was suggested. This updated report of 2019 concluded that the current evidence is still not sufficient to prove that hypoglossal nerve stimulation for treating moderate to severe OSA is more effective and equally safe compared to “no treatment.” The inclusion in the catalog of benefits is currently not recommended. A re-evaluation is recommended in 2021 as it can be expected that results from new prospective controlled trials will be available.
See the all decision support documents in German and/or English here.
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