The 2021 list of medical technologies approved for innovation funding (NUB) released in Germany

08

Feb 2021

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.

Out of 818 submitted technologies, 213 (26%) received the positive status 1, which means that the suggested procedure or medical device met the NUB criteria, so now the hospitals can negotiate the innovation funding for these technologies with the sickness funds.

Furthermore, 36 (4%) technologies received differentiated status, which means that status 1 can be granted only under certain conditions.

The full list of medical technologies (n=78, excluding pharmaceuticals), which obtained status 1, is provided below. The technologies are listed according to the number of received applications for funding. The technologies with differentiated status were not included in the list.

  1. Insertion of coated (covered) stents with a bioactive surface for peripheral vessels
  2. Covered endoprosthesis with a bioactive surface for dialysis shunt revision
  3. Ascites treatment using a fully implantable pump
  4. External stabilization scaffold for anastomosis of an AV shunt as part of shunt surgery
  5. Endovascular system of an internal AV shunt using magnetically guided radiofrequency energy
  6. Hemodynamically effective implant for the endovascular treatment of intracranial aneurysms and brain-supplying neck vessels
  7. Intra-aneurysmal hemodynamically effective implant for endovascular treatment of intracranial aneurysms
  8. Flow-reducing wire mesh in the coronary sinus
  9. Removable, ultra-soft microcoils for intracranial therapy of vascular malformations and aneurysms
  10. The intra-aortic catheter with paracorporeal membrane pump for circulatory support of the left ventricle
  11. Gastric pacemaker implantation
  12. Extra-corporeal neurostimulation system for the peripheral nervous system
  13. Percutaneous transluminal insertion of an atrial septal implant for the treatment of heart failure
  14. Transfer of virus-specific donor immune cells after allogeneic stem cell transplantation
  15. Therapy of scoliosis using magnetically controlled rods
  16. Focal photodynamic therapy with padeliporfin for the treatment of localized prostate cancer
  17. Transcatheter implantation of an interatrial shunt device for the treatment of heart failure
  18. Endovascular implantation of an extra-corporeal centrifugal pump for circulatory support
  19. Mesenchymal stem cells
  20. Transapical mitral valve reconstruction by implantation of neochordae (PTFE)
  21. Vertebral bodies growth modulation technique
  22. Temporomandibular joint endoprosthesis (total replacement)
  23. Endovascular mitral valve annuloplasty with an annuloplasty band
  24. Administration of CAR-T cells for the treatment of hematological diseases
  25. Minimally invasive LV-reconstruction with a myocardial anchoring system
  26. Intra-aortal balloon occlusion with extra-corporeal circulation
  27. Catheter-based implant for the treatment of left ventricular cardiac motility disorders
  28. Insertion of coated (covered) stents with a bioactive surface for peripheral and other vessels
  29. Wireless left ventricular cardiac pacing system for cardiac resynchronization therapy
  30. Implantation of growing heart valves
  31. Therapy of scoliosis using a screw and rod system that grows with the patient
  32. Endo-Exo-Prostheses
  33. Replacement of the pulmonary trunk or parts of the aorta with an acellular allograft
  34. Percutaneous transluminal implantation of an interatrial shunt for the treatment of heart failure with preserved or reduced left ventricular ejection fraction
  35. Forming of a sleeve stomach (sleeve resection), endoscopic
  36. Endovascular forming of a peripheral AV fistula via direct current
  37. Radioligand therapy with Actinium-225-PSMA-ligands
  38. Insertion of coated (covered) stents with a bioactive surface for intraabdominal, cranial, or peripheral vessels
  39. Implant for direct acoustic stimulation of the cochlea (DACI)
  40. Apicoaortal valve-carrying conduit
  41. Insertion of coated (covered) stents with a bioactive surface for visceral and supra-aortic vessels
  42. Acoustic neurinoma surgery with simultaneous cochlear implantation
  43. Endovascular implantation of a stent-graft with valve element for tricuspid valve regurgitation
  44. Fetoscopic drainage therapy
  45. Radioimmunotherapy with anti-CD19, anti-CD45, and anti-CD66 antibodies
  46. Epiretinal retinal prosthesis
  47. Endovascular mitral valve annuloplasty with seam anchoring
  48. Fetoscopic tracheal balloon occlusion in diaphragmatic hernia and premature bladder rupture
  49. Intracavitary radiotherapy with Iodine-125
  50. Lutetium-177- or Yttrium-90-pentixafor therapy
  51. Pulmonary arterial banding, telemetrically adjustable
  52. Closure of umbilical cord and intrafetal vessels by percutaneous ultrasound-controlled radiofrequency ablation or fetoscopic laser ablation
  53. Boston keratoprosthesis
  54. Fetoscopic opening of narrowed semilunar valves and the foramen ovale
  55. Auditory brainstem implant
  56. Fetoscopic therapy of fetal supraventricular tachycardia and larynx or trachea occlusion
  57. Thyroplasty implant with the possibility of postoperative adjustment of vocal fold position
  58. Keratoprosthesis, biologically coated
  59. Growth endoprosthesis
  60. Continuous amniotic infusion using the subcutaneously implanted port system
  61. Radionuclide therapy with lutetium-177-bisphosphonate in bone metastases of prostate cancer
  62. Uterine shield closure after fetoscopic interventions
  63. Allogenic hepatocytes transplantation
  64. Artificial larynx after total laryngectomy
  65. Percutaneous-transthoracic tricuspid valve replacement
  66. Uterus transplantation
  67. Auditory middle brain implant
  68. Percutaneous caval valve stent placement
  69. Radionuclide therapy with Iodine-131-azetidinylamide in metastatic adrenal carcinoma
  70. Subretinal active implant
  71. Autologous matrix-induced hepatocytes transplantation
  72. Treatment of fatal epidermolysis bullosa junctionalis (M. Herlitz type) by transplantation of haploidentical bone marrow and skin of the same donor
  73. Treatment of children with rhabdomyosarcomas of the bladder/prostate/rectum / perineal region with organ-preserving surgery and interstitial HDR brachytherapy
  74. Joint transplants with thin-layered, fresh, living, allogeneic cartilage or bone material
  75. Gene therapy with autologous CD34+ enriched cells with ARSAGs for the treatment of metachromatic leukodystrophy
  76. Combined renal and stem cell transplantation (living donation)
  77. Radionuclide therapy with Iodine-131-metomidate
  78. Complete face transplantation

Four new technologies (percutaneous transluminal implantation of an interatrial shunt for the treatment of heart failure with preserved or reduced left ventricular ejection fraction, endovascular implantation of a stent-graft with valve element for tricuspid valve regurgitation, thyroplasty implant with the possibility of postoperative adjustment of vocal fold position, gene therapy with autologous CD34+ enriched cells with ARSAGs for the treatment of metachromatic leukodystrophy) received status 1 in comparison with the 2020 list.

The full details in German can be found here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news).

Not ready for a subscription service? Subscribe to our free-of-charge newsletter delivered every second week to get updates about key reimbursement developments in Europe (10-12 news every two weeks). First EU issues of both newsletters are available for download free-of-charge.

The latest related news

18

May 2022

On April 19, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) has informed of the favorable results of the scientific evaluation of the G-BA Innovation Fund performed by the economic research center Prognos AG.

Read more

16

May 2022

The French National Authority for Health (HAS) released new recommendations about add-on reimbursement of medical devices and medical aids from the meetings of the National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) in April 2022. Thirty recommendations were published in relation to the registration, modification of registration conditions, and renewal of registration for devices in the List of reimbursable products and services (LPPR). Opinions concern cardiovascular and peripheral vascular, orthopedic, neurovascular, and neuromodulation and other devices, as well as medical aids.

Read more

11

May 2022

On April 4, 2022, the Innovation Committee at the Federal Joint Committee (G-BA) published the decisions, which recommended the transfer to standard care for two completed projects. The projects relate to the management of rare diseases and the strengthening of the regional healthcare structures and processes.

Read more

06

May 2022

In Q1 of 2022, Health Technology Wales (HTW) published one MedTech-related guidance on transcranial magnetic stimulation in depression treatment. A total of eleven Topic Exploration Reports (TERs) were released in Q1. Based on the TERs conclusions, HTW's Assessment Group decided to proceed with developing an Evidence Appraisal Report (EAR) and Guidance on one topic only - radiofrequency renal denervation for the treatment of resistant hypertension.

Read more

05

May 2022

In March and April 2022, 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, thirty-three health apps are now available at the DiGA Directory.

Read more