Cancer

On July 01, 2021, NHS England published an update of the Specialized Services Policy Pipeline (covering March 21, 2021 - June 21, 2021). One new Clinical Commissioning Policy related to radiotherapy was published. Three new policies were added to the work program; however, all related to pharmaceuticals only. The status of ongoing policies was updated as well.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on July 1, 2021. Three biomarker tests in breast cancer, a number of services related to cryopreservation of egg and sperm cells in young cancer patients, new services dedicated to prenatal testing of the fetal rhesus factor, services concerning the delivery of brachytherapy in prostate cancer were introduced.

In June 2021, the National Institute for Health Research (NIHR) in England released six MedTech-related reports in its Health Technology Assessment (HTA) Journal, which concerned tibial nerve stimulation for urinary incontinence treatment, imaging in ophthalmology, in-vitro diagnostics, and eHealth. HTA Journal publishes research reports on the effectiveness, costs, and broader impact of health technologies for those who use, manage, and provide care in the NHS, and informs National Institute for Health and Care Excellence (NICE) guidance.

On July 1, 2021, the updated version of the Swiss Services Ordinance (KLV/OPre) came into force. The changes concern the List of explicitly evaluated services (Annex 1 of KLV/OPre), the List of medical aids (Annex 2 of KLV/OPre), and the List of Analyses (Annex 3 of KLV/OPre).

The National Institute for Health and Care Excellence (NICE) is currently developing health technology assessments concerning in-vitro diagnostics in its Diagnostic Guidance and Medtech Innovation Briefing programs. As of June 08, 2021, there are ten ongoing assessments.

In May 2021, the Agency for Health Quality and Assessment of Catalonia (AQuAS) published a report on next-generation sequencing (NGS) for molecular diagnosis and selection of therapeutic targets in oncological diseases. The studies identified present favorable results on the diagnostic efficacy of the NGS-based gene panels; the evidence on the clinical effectiveness of NGS panels remains limited. The authors emphasize the need for further studies.

In May 2021, two clinical guidelines on male infertility and female cystitis were released in Russia. 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 laryngopharyngeal cancer retroperitoneal sarcomas, endometrial cancer, and uterine sarcomas, etc.

In April 2021, the National Institute for Health and Care Excellence (NICE) published three new Interventional Procedure Guidance (repetitive short-pulse transscleral cyclophotocoagulation for glaucoma, deep brain stimulation for chronic, severe, treatment-resistant obsessive-compulsive disorder in adults, and Melphalan chemosaturation for primary or metastatic cancer in the liver) and two Medtech Innovation Briefings (microINR for anticoagulation therapy and RenalSense Clarity RMS for acute kidney injury), and two clinical guidelines (for atrial fibrillation and chronic pain in over 16s).

In April 2021, the Austrian Institute for Health Technology Assessment (AIHTA) initiated several new research projects. The projects are related to IVD tests for early detection of colon cancer, telemedical care in diabetes field, health apps, screening methods, consequences of coronavirus pandemic, and other topics.

In late April and early May 2021, three more health apps were introduced in the Directory of digital health applications (DiGAs) at the Federal Office for Drugs and Medical Devices (BfArM) and thus became reimbursable. These apps can be prescribed by physicians and psychotherapists and will be reimbursed by health insurers. In total, fifteen health apps are now available at the DiGA Directory.

On April 20, 2021, the Dutch Healthcare Institute (ZIN) published an annual report on the progress of the conditional reimbursement program. In 2020, there were 13 ongoing projects under the program, six of which concerned medical technologies. Furthermore, in 2020, percutaneous transforaminal endoscopic discectomy for the treatment of lumbosacral radicular syndrome in lumbar disc herniation was included in the basic insurance package as regular care.

The revised EBM (German Uniform Evaluation Standard) catalog came into force on April 1, 2021. Two new EBM codes for IVD tests were introduced, and reimbursement conditions for two IVD tests were amended.