HTA

On February 4, 2021, the guide on dossier submission to the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) for the inclusion of the device in the List of Reimbursable Products and Services (LPPR) was published in English. Furthermore, the guide was recently updated with the information dedicated to the technologies falling within the scope of artificial intelligence.

In January 2021, the National Institute for Health and Care Excellence (NICE) published two new interventional procedure guidance (self-expanding implant insertion into the intersphincteric space for faecal incontinence and minimally invasive radical hysterectomy for early stage cervical cancer), two new medical technologies guidance (the PLASMA system for transurethral resection and haemostasis of the prostate, and the VAC Veraflo Therapy system for acute infected or chronic wounds), and six Medtech innovation briefings (Optilume for anterior urethral strictures, AI in mammography, AI for analyzing chest CT images, AcQMap for mapping the heart atria to target ablation treatment, and others). Also, two clinical guidelines were updated.

On December 30, 2020, the French National Authority for Health (HAS) published a report "Economic evaluation of telemonitoring to inform public decision-making", based on the systematic literature review. According to the results of the review, telemonitoring can be considered as a way to improve the organization of care and reduce care costs.

In December 2020, the National Institute for Health and Care Excellence (NICE) published one new medical technologies guidance (Zio XT for detecting cardiac arrhythmias), three Medtech innovation briefings (ReStore Soft Exo-Suit for gait rehabilitation, Cytosponge for detecting abnormal cells in the esophagus, and Evoke Spinal Cord Stimulator for managing chronic neuropathic or ischemic pain). Also, nine clinical guidance documents were updated.

On December 31, 2020, the French National Authority for Health (HAS) published a methodological guide clarifying aspects related to the organizational impact of health technologies under the evaluation. As the organizational impact can be documented when submitting an evaluation file for a drug, medical device, or a procedure, the guide aims to define the types of organizational impact and to propose criteria to measure these effects.

MTRC maintains two subscription services with a focus on all published, initiated or ongoing HTA and reimbursement reports and decisions for medical devices, procedures and IVD tests. HTA Alerts is a global service and covers 56 organizations from 24 countries. Reimbursement Alerts is focused on 14 key European countries. All alerts are tailed to the technologies of interest for each client. First EU issues of both newsletters are available for download free-of-charge.

On October 09, 2020, the National Institute for Health and Care Excellence (NICE) launched a public consultation on proposals for changing how it selects the topics for medicines, medical devices, and diagnostics guidance development. The consultation closes on November 19, 2020.

On October 15, 2020, the French National Authority for Health (HAS) published the report “New techniques of bariatric surgery: identification, the status of advancement and opportunities to evaluate,” in which they outlined three techniques currently diffusing in France (SADI-Sleeve, Endosleeve, and Sleeve Gastrectomy with Transit Bipartition). All three methods are the subject of ongoing clinical studies, and the evaluation will be initiated at the end of these studies.

MTRC has started a subscription service with email alerts about initiated, published and ongoing health technology assessments of pharmaceuticals, gene and cell therapies, as well as vaccines from 56 HTA organizations globally (24 countries).

In August 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA26 “Surgical procedures for treatment of obesity.” The key question of the assessment is bariatric surgery for the treatment of adults with obesity.

At the end of July 2020, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA27 “Comparative effectiveness of surgical techniques and devices for the treatment of benign prostatic hyperplasia (BPH).”

In July 2020, the network of European HTA agencies, EUnetHTA, announced a final project plan of the project OTCA25 “Stereotactic Body Radiation Therapy (SBRT) for lung, prostate, and liver cancer.”