Nephrology and Urology

In August 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (magnetic resonance therapy for knee osteoarthritis, laparoscopic removal of uterine fibroids with power morcellation, hysteroscopic mechanical tissue removal for uterine fibroids), and six new Medtech Innovation Briefings (PLASMA system with button electrode, Immunoscore, MMprofiler, Patient Status Engine, lung texture analysis, Colli-Pee). Also, five clinical guidelines were published.

In August 2021, 22 Russian clinical guidelines in the fields of ENT, cardiovascular, obstetrics and gynecology, orthopedics and others, were released. Furthermore, the order on the approval of the standard of medical care for adults with urolithiasis disease entered into force.

The HTA body of the Tuscany Regional Healthcare issues two types of documents: HTA forms and motivational forms. With a regional decree 14763 of August 25, 2021, Tuscany Regional Healthcare has published assessments of thirteen medical devices of various therapeutic areas, including devices belonging to the obstetrics and gynecology field, as well as gastroenterology, urology, cardiovascular, endoscopy, spine, peripheral vascular, and other fields of care.

In July 2021, 31 clinical guidelines were released in Russia: irritable bowel syndrome, rectal prolapse, chronic kidney disease, and others. Furthermore, the orders on the approval of the several standards of medical care entered into force, including standards for the provision of medical care for adults with acute ST-elevation myocardial infarction, hemorrhoids, and anal fistula.

For the first time in three years, the Institute for Quality and Efficiency in Health Care (IQWiG) received data within the framework of the early benefit assessment of new examination and treatment methods (NUB) with high-risk medical devices according to §137h of Social Code Book (SGB) V. This involves seven invasive therapeutic cardiovascular, pulmonary, neurological, gastrointestinal, and urological procedures.

On January 28, 2021, the Innovation Committee at the Federal Joint Committee (G-BA) published the first overview of the 28 innovative projects on new forms of medical care that will be funded. The projects concerning the technologies belonging to the cardiovascular, eHealth, orthopedic, neurology, nephrology, and other technology groups received funding.

On January 29, 2021, the Institute for the Hospital Remuneration System (InEK) has published the List of the requests for innovation funding (NUB) that were submitted by the hospitals in 2020. The medical technologies belonging to the cardiovascular, ENT, eHealth, gastrointestinal, neuromodulation, neurovascular, orthopedic, and other technology groups obtained positive status 1.

The German Society for Neurology (DGN) has released a new version of the S1 guideline "Diagnostics and therapy of neurogenic bladder disorders." It is valid until January 2025.

On March 13, 2020, the Institute for Quality and Efficiency in Health Care (IQWiG) announced that the new HTA reports would concern cystitis, heart disease in children, social isolation, as well as vitamin B12 / vitamin D deficiency in the elderly, and the Feldenkrais Method in treatment of mobility disorders.

In October 2019, the Agency for Health Quality and Assessment of Catalonia (AQuAS) has released an assessment report regarding the evaluation strategies to prevent urinary tract infections associated with urethral/urinary catheters in critical patients in Intensive Care Units. The evidence is not conclusive, but there is scientific evidence that aims for the introduction of review measures for the indication of indwelling urethral/urinary catheters, its use in decubitus, and without kinking.

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including nephrology and urology technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for nephrology and urology devices in Europe.

The report presents a summary of the reimbursement situation for lithotripsy for kidney stones in Europe. The following types of procedure are considered: extracorporeal shock wave therapy; intracorporeal (endoscopic) lithotripsy with different type of energy used. The analysis covers procedure coding, payment mechanism, reimbursement tariffs and policy restrictions in 11 EU countries including Austria, Belgium, Denmark, England, France, Germany, Italy, the Netherlands, Norway, Sweden and Switzerland. It is also possible to add analysis in the Czech Republic, Finland, Hungary, Romania, Russia and Turkey.