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Food for Thought: Future Benefit Assessment of Medtech in Germany

Germany´s Law on the Stabilization and Structural Reform of the Statutory Health Insurance (Versorgungsstrukturgesetz) came into effect January 1st, 2012. For medtech companies it is important that the law introduces a novel instrument of the statutory healthcare system’s Joint Federal Committee G-BA for the assessment of innovative medical technologies. This novelty – the so-called “trial provision” for innovative medtech methods – has the advantage of not summarily excluding methods whose benefit is not immediately clear.

Dr Rainer Hess, Chairman of G-BA, in January detailed the plans of G-BA for the assessment of innovative medical technologies: “We are not assessing medicinal products, such as pacemakers or endo-prostheses,” he said during the recent MedInform conference “Versorgungsstrukturgesetz 2012” hosted by BVMed, the German Medical Technology Association. “We are evaluating medical diagnostic and therapeutic procedures in which medical devices may play a role.”

The trial provision, he added, would offer the opportunity to conduct representative studies of novel procedures, if adequate evidence is not available and novel studies are not to be expected.

Hess said G-BA will expect the demonstration of an additional benefit as compared to existing methods.  To determine this additional benefit, G-BA will lay out study requirements in a guideline and assign an institute with conducting the study. Manufacturers will have to contribute financially to the study – otherwise the device can be excluded from reimbursement.

Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) will then furnish a scientific opinion. Finally, G-BA will host a hearing, including experts, and subsequently make a decision about reimbursement.

Assessment can be demanded by the manufacturers but also from a statutory health insurance company.

Further information can be found at the webseite of BVMed – The German Medical Technology Association

Company News: Curetis AG Initiates Prospective Clinical Trial for Rapid Pneumonia Diagnostics

Curetis AG, an innovative molecular diagnostics company focusing on the development and commercialization of in-vitro diagnostic products for infectious diseases, today announced the start of a prospective clinical trial of its Unyvero™ System and the Unyvero™ P50 Pneumonia Cartridge in the European Union.

The prospective, international, multicenter trial will enroll up to 1,000 hospitalized patients suspected with a lower respiratory tract infection. Patient samples such as sputa, aspirates or bronchial lavages will be pre-processed by the Unyvero™ Lysator and transferred to the Unyvero™ P50 Pneumonia cartridge, which is analyzed by the Unyvero™ Analyzer.

Primary endpoint of the study will be assay performance defined as clinical sensitivity and specificity compared to today’s diagnostics standard of care, microbiology culture. Trial sites include the University Hospital Tuebingen, Germany, the Heart and Diabetes Center Bad Oeynhausen, Germany, the Hospital Clinic of Barcelona in Spain, the Erasme Hospital in Brussels/Belgium, and the University Hospital Jena, Germany. Principal investigator is Prof. Dr. Ingo B. Autenrieth of the University Hospital Tuebingen. Interim topline data are expected for spring 2012.

Innovation Radar: How to Detect Increased Risk for Renal Manifestations in SLE (lupus) patients

Patients suffering from the autoimmune disease systemic lupus erythematosus (SLE) develop autoantibodies to chromatin and often to neutrophil proteins as well. As immune complexes of these antibodies can be deposited in kidneys, they contribute to the frequent and dangerous organ manifestation of lupus nephritis.

Recent studies suggest that neutrophil extracellular traps (NETs) might act as a source of autoantigens. NETs consist of chromatin as well as granule proteins and play an important role in immune defense after their release from neutrophils to sites of infection. Degradation of NETs is mainly promoted by DNase1 digestion which is impaired in a subset of SLE patients. A strong correlation between NET degradation status and lupus nephritis, e.g. glomerulonephritis, has been shown and therefore offers a new diagnostic method for detecting an increased risk of SLE patients to develop renal manifestations.

Based on these observations, scientists of the German Max Planck Society (MPG) have developed a technology for the assessment of an increased risk in SLE patients for developing renal manifestations – a finding that is not achieved by determination of anti-dsDNA antibody titers.

The technology measures a NET-degradation status upon incubation with a sample of body fluid (e.g. blood or serum) from a SLE patient, whereby a poor NET-degradation corresponds to a higher probability of developing renal manifestations. Protocols for obtaining NETs from healthy donors as well as preparing NETs artificially are provided. Degradation status is assessed by determination of released/present NET-component(s) (e.g. neutrophil elastase) after incubation with a sample from a patient and either by comparison with the results obtained from a healthy donor or a control sample (buffer). Determination of NET-degradation can be achieved by the use of fluorescence spectrometry, ELISA or EIA. An international patent application has been filed.

The technology is available for licensing via Max Planck Innovation.

 

Innovation Radar: Starving Cells Improves Chemotherapy

A few days of fasting may delay tumor progression and improve chemotherapy, a new study in mice reports. The findings indicate that fasting prior to chemotherapy treatment protects animals – and possibly humans – against the side effects of treatment. Here, Valter Longo and colleagues show in mice that fasting for 2 days in the absence of other treatments can delay the progression of different types of cancer, and may in some cases be just as effective as toxic chemotherapy drugs. However, the combination of fasting and chemotherapy appears to be more effective at making normal cells stronger (more able to resist damage from chemotherapeutic drugs) than either alone. In fact, combined fasting and chemotherapy promoted long-term, cancer-free survival in up to 40 percent of mice with neuroblastomas. Although clinical trials testing the effect of fasting in cancer treatment are still in early stages, these studies suggest that fasting cycles have the potential to boost the efficacy of chemotherapy. The results are particularly relevant for advanced-stage patients for whom standard treatment is ineffective.

The research is published in this week’s Science Translational Medicine (Sci. Transl. Med. DOI: 10.1126/scitranslmed.3003293)

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