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
The human genome of newborns contains an unexpectedly low number of mutations, writes Joachim Müller-Jung in Frankfurter Allgemeine Zeitung (FAZ). Contrary to earlier estimates of 100-200 mutations generated in the germ cells of parents, the number is only about 60. Results come from sequencing the entire genomes of two families with one child each. The results have implications for understanding human evolution and genetics.
Sonja Kastilian, also in FAZ, features a preliminary report of IQWiG, Germany’s watchdog agency appraising drugs and treatments for quality and cost effectiveness, on the benefits of HPV testing of women as a screening for ovarian cancer. IQWiG set out to compare DNA tests for HPV with common pap smear tests and reported that the HPV tests leas to an earlier diagnosis and better follow-up examinations, regardlesss of whether it is applied alone or in combination with the conventional test. A final decision on whether the test is to be reimbursed by Germany’s statutory healthcare system is expected for 2012. In 2006, the Joint Federal Committee (G-BA), the body in charge, had voted against reimbursement for cost reasons. Kastilian also points out that HPV vaccination rates at present are below 30% in young women in Germany, in contrast to up to 81% in the UK, Portugal, and Australia. Reason has been an unduly discussion in German media about potential risks, high costs and lack of efficacy.
Uta Neubauer in Neue Zürcher Zeitung (NZZ) reports on novel approaches to use cold plasma to disinfect wounds, hands, and food. A method and device developed by the German Max Planck Institute for Extraterrestrial Physics has already demonstrated safety and efficacy in treating wounds and disinfecting hands. At present, it is under investigation for the treatment of foods, e.g. food additives and berries.
Sven Titz, also in NZZ, deals with latest insights into the physics of the water surface. Using vibration spectroscopy, physicists of the University of Southern California at Los Angeles found that the surface is made up basically by -OH groups of the water molecules sticking out from the liquid. The discovery will lead to better understanding solubility of molecules in water.
Forbes this week introduces two innovations in optics. Jennifer Hicks writes about the “socialization of the microscope” by a technology that allows the display of microscopic images on an extremely large multitouch screen, just like an oversized iPad. Thereby, groups of students, pathologists or researchers can focus on tiny details by touching, gesturing, and zooming in and out. A video of the microscope at work can be found here.
Californian-based start-up Lytro has unveiled a camera that can take pictures without focusing, writes Tomio Geron in Forbes. Instead, focusing on any point of interest in the photo is done once the image is loaded on a computer. The consumer camera is based on the light field technology invented by Stanford University researchers. The camera is fitted with special lenses and a sensor that captures every ray of light hitting it, regardless of whether it is from the fore- or the background, and records its individual color, intensity and direction. The camera therefore also can be used to generate 3D-pictures. Examples can be found here.
The Economist this week introduces an intelligent drug delivery approach using nanoparticles. It can be used to deliver anti-cancer chemotherapeutic drugs and makes use of the blood-clotting mechanism: first, nano-sized golden rods are injected into the blood stream. They fit into the unusual pores common in capillaries nourishing tumors and thereby mark tumor sites. Once they are in place, the tumor site is treated with laser light bursts. Their energy is absorbed by the gold and converted to heat destroying the capillaries so that the body’s coagulation system is triggered to repair the damage. This is when the second nanoparticles come into play. They carry the chemotherapeutics together with a fibrin-binding protein fragment and are designed to release the drug upon fibrin-binding only. The treatment strategy therefore delivers the drug exactly to the site the coagulation system is active, that is, at the tumor. The method developed at the Massachusetts Institute of Technology (MIT) has proven safety and efficacy in mice and will be tested in humans soon.
Researchers from the University of Rochester have come up with just another idea to release drugs on target, the New Scientistreports. They found that nanocarbon tubes containing aqueous solutions can be made to pop open by heating them from the outside with infrared lasers. Patients could be administered nanocontainers carrying drugs to deliver it to a desired target where the drug then is released by laser light.
And finally, Die Welt this week deals with wrinkles and high tech attempts to avoid or get rid of them. Clinical studies in people with an average age of 87 prove that vitamin A1 (retinol) is useful to smooth skin. Also, light from LEDs is able to remove a water film caging the skin’s elastic fibers so that they become rigid. The method is best applied by pre-treating the skin with green tee polyphenols to deactivate free radicals generated by the LEDs. Moreover, scientists from Hamburg-based Skin Investigation and Technology SIT found out that eating one bar of dark chocolate a day also leads to a 34% improvement of skin elasticity after 6 months. Further attempts to eliminate wrinkles are being made by using signaling peptides activating collagen-producing cells and by polymers carrying nanoparticles that are injected between outer and inner skin layers. The resulting films disperse the compression forces within the skin, thereby “ironing” it from inside.
