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Five digital solutions approved for temporary reimbursement in Germany – Up to 2000 €/year in reimbursement
09 Nov 2020

Germany has launched a reimbursement process for digital solutions focused on the patient and with regulatory class I or IIa according to the MDR. If you are interested to learn more about the process, these recorded webinars may be of interest:

Currently there are five digital health solutions that have been approved for temporary reimbursement. This means that they are in the process to develop additional evidence before the final negotiation about the pricing with the insurance companies.

Company

Disease area

Monthly reimbursement *

Kalmeda

H93.1 Tinnitus

38,99 €

Somnio

F51.0 Nonorganic insomnia

164,67 €

Velibra

F40.01 Agoraphobia with panic attacks
F40.1 Social phobias
F41.0 Panic disorder
F41.1 Generalized anxiety disorder

158,67 €

Vivira

M16.0 Primary coxarthrosis, bilateral*
M16.1 Other primary coxarthrosis
M16.2 Coxarthrosis resulting from dysplasia, bilateral

79,99 €

zanadio

E66 Obesity

166,67 €

* some of the prices have more details to the pricing. This is a simplified overview for comparison. For full details: https://diga.bfarm.de/de/verzeichnis

The prices are rather attractive for digital solutions. It will be interesting to see that the final prices will be after the trial period.

Below is a list of evidence the companies refer to in their applications. While reviewing the evidence, one should have in mind that they are all in the process of establishing additional evidence during this temporary reimbursement period of 1 year.

Kalmeda

  • Andersson G, Cuijpers P, Carlbring P, Heleen R, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatr; 2014 Oct 13(3):288-95.
  • Brüggemann P, Szczepek A, Rose M, McKenna L, Olze H und Mazurek B. Impact of Multiplie Factors on the Degree of Tinnitus Distress. Frontiers in Systems Neuroscience 2016 Jun 29; 10: 341.
  • Cima RFF, Mazurek B, Haider H, Kikidis D, Lapira A, Norena, A. A multidisciplinary European guideline for tinnitus: diagnostics, assessment, and treatment. 2019 Mar 19; HNO 67: 10–42.
  • Cima RFF, Andersson G, Schmidt C, Henry, J. Cognitive-behavioral treatments for tinnitus: a review of literatur. Journal of the American Academy of Audiology. 2014 Mar; 25 (1): 9-61. Cima RFF, Maes I, Joore M, Scheyen D, El Refaie A, Baguely D et al. Specialised treatment based on cognitive behaviour therapy versus usual care for tinnitus: a randomised controlled trial. Lancet. 2012 May 26;379(9830):1951-9.
  • Hesser H, Westin VZ, Andersson G. Acceptance as a mediator in internet-delivered acceptance and commitment therapy and cognitive behavior therapy for tinnitus. J Behav Med. 2014 Aug; 37(4):756-67.
  • Hölzel B, Brähler C, editors. Achtsamkeit. München: Barth; 2015 Kreuzer P, Vielsmeier V und Langguth B, Chronic Tinnitus, an interdisciplinary Challenge. Deutsches Ärzteblatt; 2013 Apr 19. 110 (16): 278-284.
  • Storch M, Krause F. Selbstmanagement-ressourcenorientiert. 5th ed. Bern: Huber; 2014.
  • Weise C, Kleinstäuber M, Andersson G. Internet-Delivered Cognitive-Behavior Therapy for Tinnitus: A Randomized Controlled Trial. Psychosomatische Medizin. 2016 May;78(4):501-10.
  • Wengenroth M. Akzeptanz- und Commitmenttherapie. 2nd ed. Weinheim: Beltz; 2017.

Somnio

  • Riemann D, Baum E, Cohrs S, Crönlein T, Hajak G, Hertenstein E, et al. S3-Leitlinie Nicht erholsamer Schlaf/ Schlafstörungen. Somnologie. 2017 Mar 27;21(1):2–44.
  • Zachariae R, Lyby MS, Ritterband LM, O’Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016;30:1–10.
  • Ye Y, Zhang Y, Chen J, Liu J, Li X, Liu Y, et al. Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-i) Improves Comorbid Anxiety and Depression—A Meta-Analysis of Randomized Controlled Trials. Courvoisier DS, editor. PLoS One. 2015 Nov 18;10(11):e0142258.
  • van Straten A, van der Zweerde T, Kleiboer A, Cuijpers P, Morin CM, Lancee J. Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. Sleep Med Rev. 2018 Apr;38:3–16.
  • Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Heal Psychol. 2006;25(1):3–14.
  • Harvey AG. A cognitive model of insomnia. J Cogn Psychother. 2002;18(3):281–8.
  • Harvey AG, Bélanger L, Talbot L, Eidelman P, Beaulieu-Bonneau S, Fortier-Brochu E, et al. Comparative efficacy of behavior therapy, cognitive therapy, and cognitive behavior therapy for chronic insomnia: A randomized controlled trial. J Consult Clin Psychol. 2014;82(4):670–83.
  • Harvey AG, Sharpley AL, Ree MJ, Stinson K, Clark DM. An open trial of cognitive therapy for chronic insomnia. Behav Res Ther. 2007;45(10):2491–501.
  • Tang N, Harvey A. Correcting distorted perception of sleep in insomnia: a novel behavioural experiment? Behav Res Ther. 2004;42:27–39.
  • Eidelman P, Talbot L, Ivers H, Bélanger L, Morin CM, Harvey AG. Change in dysfunctional beliefs about sleep in behavior therapy, cognitive therapy, and cognitive-behavioral therapy for insomnia. Behav Ther. 2016;47(1):102–15.
  • Jacobson E. Progressive muscle relaxation. J Abnorm Psychol. 1938;75(1):18.
  • Buysse DJ, Germain A, Moul DE, Franzen PL, Brar LK, Fletcher ME, et al. Efficacy of brief behavioral treatment for chronic insomnia in older adults. Arch Intern Med. 2011.
  • Backhaus J, Hohagen F, Voderholzer U, Riemann D. Long-term effectiveness of a short-term cognitivebehavioral group treatment for primary insomnia. Eur Arch Psychiatry Clin Neurosci. 2001 Mar 21;251(1):35–41.
  • Ho FY-Y, Chung K-F, Yeung W-F, Ng TH, Kwan K-S, Yung K-P, et al. Self-help cognitive-behavioral therapy for insomnia: A meta-analysis of randomized controlled trials. Sleep Med Rev. 2015 Feb;19:17–28
  • Irish LA, Kline CE, Gunn HE, Buysse DJ, Hall MH. The role of sleep hygiene in promoting public health: A review of empirical evidence. Sleep Medicine Reviews. 2015.
  • Miller CB, Espie CA, Epstein DR, Friedman L, Morin CM, Pigeon WR, et al. The evidence base of sleep restriction therapy for treating insomnia disorder. Sleep Medicine Reviews. 2014.
  • Morgenthaler T, Kramer M, Alessi C, Friedman L, Boehlecke B, Brown T, et al. Practice parameters for the psychological and behavioral treatment of insomnia: An update. An American Academy of Sleep Medicine Report. Sleep. 2006.

Velibra

 

Vivira

  • Bundesärztekammer (BÄK), Kassenärztliche Bundesvereinigung (KBV), Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) (2017). Nationale Versorgungsleitlinie Nichtspezifischer Kreuzschmerz – Langfassung, 2. Auflage. Version 1.
  • S2k-Leitlinie Koxarthrose AWMF-Registernummer: 033-001 Stand: 08.07.2019.
  • S2k-Leitlinie Gonarthrose AWMF-Registernummer: 033-004 Stand: 30.11.2017.
  • Grifka, J. & Kuster, M. (2011). Orthopädie und Unfallchirurgie. Berlin, Germany: Springer.
  • Hayden, J. A., van Tulder, M. W., Malmivaara, A., & Koes, B. W. (2005). Exercise therapy for treatment of nonspecific low back pain. The Cochrane database of systematic reviews, (3), CD000335.
  • Reimers, N. & Reimers, C. (2012). Sportliches Training bei Lumbalgien, Kox- und Gonarthrose sowie Fibromyalgie-Syndrom: Effekt auf die Schmerzen - Eine Literaturübersicht. Aktuelle Rheumatologie, 37(03), 174–188.
  • Fransen, M., McConnell, S., Hernandez-Molina, G., & Reichenbach, S. (2014). Exercise for osteoarthritis of the hip. The Cochrane database of systematic reviews, (4), CD007912.
  • Fransen, M., McConnell, S., Harmer, A. R., Van der Esch, M., Simic, M., & Bennell, K. L. (2015). Exercise for osteoarthritis of the knee: a Cochrane systematic review. British journal of sports medicine, 49(24), 1554–1557.
  • Anwer, S., Alghadir, A., & Brismée, J. M. (2016). Effect of Home Exercise Program in Patients With Knee Osteoarthritis: A Systematic Review and Meta-analysis. Journal of geriatric physical therapy (2001), 39(1), 38–48.
  • van Middelkoop, M., Rubinstein, S. M., Kuijpers, T., Verhagen, A. P., Ostelo, R., Koes, B. W., & van Tulder, M. W. (2011). A systematic review on the effectiveness of physical and rehabilitation interventions for chronic nonspecific low back pain. European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 20(1), 19–39.
  • Garber, C. E., Blissmer, B., Deschenes, M. R., Franklin, B. A., Lamonte, M. J., Lee, I. M., Nieman, D. C., Swain, D. P., & American College of Sports Medicine (2011). American College of Sports Medicine position stand. Quantity and quality of exercise for developing and maintaining cardiorespiratory, musculoskeletal, and neuromotor fitness in apparently healthy adults: guidance for prescribing exercise. Medicine and science in sports and exercise, 43(7), 1334–1359.
  • Byström, M. G., Rasmussen-Barr, E., & Grooten, W. J. (2013). Motor control exercises reduces pain and disability in chronic and recurrent low back pain: a meta-analysis. Spine, 38(6), E350–E358.
  • Klingenberg, M. (2019). Return-to-Sport: Funktionelles Training nach Sportverletzungen (2. Aufl.). München, Deutschland: Richard Pflaum Vlg GmbH.
  • Wainner, R. S., Whitman, J. M., Cleland, J. A., & Flynn, T. W. (2007). Regional interdependence: a musculoskeletal examination model whose time has come. The Journal of orthopaedic and sports physical therapy, 37(11), 658–660.
  • Reiman, M. P., Weisbach, P. C., & Glynn, P. E. (2009). The hips influence on low back pain: a distal link to a proximal problem. Journal of sport rehabilitation, 18(1), 24–32.
  • Sueki, D. G., Cleland, J. A., & Wainner, R. S. (2013). A regional interdependence model of musculoskeletal dysfunction: research, mechanisms, and clinical implications. The Journal of manual & manipulative therapy, 21(2), 90–102.
  • Karandikar, N., & Vargas, O. O. (2011). Kinetic chains: a review of the concept and its clinical applications. PM & R : the journal of injury, function, and rehabilitation, 3(8), 739–745.
  • Dischiavi, S. L., Wright, A. A., Hegedus, E. J., & Bleakley, C. M. (2018). Biotensegrity and myofascial chains: A global approach to an integrated kinetic chain. Medical hypotheses, 110, 90–96.
  • Pschyrembel, W. (2017). Pschyrembel Klinisches Wörterbuch (German Edition) (267. Aufl.). Berlin, New York: De Gruyter.

Zanadio

  • Alberga AS, Goldfield GS, Kenny GP, Hadjiyannakis S, Phillips P, Prud´homme D, et al. Healthy eating, aerobic and resistance training in youth (HEARTY): Study rationale, design and methods. Contemp Clin Trials 2012: 33, 839-847. doi: 10.1016/j.cct.2012.04.004
  • Allen, J.K., Stephens, J., Dennison Himmelfarb, C.J., Stewart, K.J. & Hauck, S. (2013). Randomized Controlled Pilot Study Testing Use of Smartphone Technology for Obesity Treatment. J Obes. 2013 Dec 10; doi: 10.1155/2013/151597
  • Bechthold A. Wissenschaftliche Stellungnahme der DGE. Ernaehrungs Umschau international. 2014; 1. https://www.ernaehrungs-umschau.de/fileadmin/Ernaehrungs-Umschau/pdfs/pdf_20  14/01_14/EU01_2014_M014_M023_-_002d_011d.qxd.pdf
  • Becker S, Zipfel S, Teufel M. Psychotherapie der Adipositas: Interdisziplinäre Diagnostik und differenzielle Therapie. Kohlhammer Verlag; 2015.
  • Benecke A. Verhaltenstherapie der Adipositas. In: Herpertz S., Zwaan M., Zipfel S. (eds) Handbuch Essstörungen und Adipositas. Springer, Berlin, Heidelberg; 2015.
  • Buchholz D, Erickson N, Meteling-Eeken M, Ohlrich S. Der Nutrition Care Process  und eine standardisierte Sprache in der Diätetik – Status Quo, Implikationen & Perspektiven. Ernährungs-Umschau. 2012; 10: S. 586–593. EU10_2012_586_593.pdf
  • Conn VS, Hafdahl AR, Mehr DR. Interventions to Increase Physical Activity Among Healthy Adults: Meta-Analysis of Outcomes. Am J Public Health. 2011; 101 (4): S.751–758. doi: 10.2105/AJPH.2010.194381.
  • Cooper Z, Fairburn CG, Hawker DM. Kognitive Verhaltenstherapie bei Adipositas: ein Manual in neun Behandlungsmodulen; mit 7 Tabellen; mit CD-ROM Informations-und Arbeitsblätter für Patienten. Schattauer Verlag; 2008.
  • Dennison L, Morrison L, Conway G, Yardley L. Opportunities and Challenges for Smartphone Applications in Supporting Health Behavior Change: Qualitative Study. J Med Internet Res. 2013; 15 (4). doi: 10.2196/jmir.2583.
  • Friedmann K. Trainingslehre. Sporttheorie für die Schule. Pfullingen: Promos Verlag GmbH; 2008.
  • Gemeinsame Empfehlungen zur Förderung und Durchführung von Patientenschulungen für behandlungsbedürftige adipöse Erwachsene auf der Grundlage von § 43 Abs. 1 Nr. 2 SGB V https://www.gkv-spitzenverband.de/media/dokumente/krankenversicherung_1/rehabilitation/patientenschulung/2020_01_30_Reha_GE_Patientenschulungen_adipoese_Erwachsene.pdf
  • Gomez-Marcos MA, Patino-Alonso MC, Recio-Rodriguez JI, Agudo-Conde C, Romaguera-Bosch, M, Magdalena-Gonzalez O, et al. Short- and long-term effectiveness of a smartphone application for improving measures of adiposity: A randomized clinical trial – EVIDENT II study. Eur J Cardiovasc Nurs. 2018; 17(6): 552-562. doi: 10.1177/1474515118761870 
  • Göhner W, Schlatterer M, Seelig H, Frey I, Berg A, Fuchs R. Two-year follow-up of an interdisciplinary cognitive-behavioral intervention program or obese adults. J Psychol. 2012;146(4):371-91. Abgerufen von: http://www.ncbi.nlm.nih.gov/pubmed/22808686.
  • Halle, M. Bewegungstherapie bei Adipositas, metabolischem Syndrom und Typ-2-Diabetes. Praktische Tipps. Springer Medizinverlag GmbH, 12, 312-322. 2017.
  • Hauner H, Bechthold B, Boeing H, Brönstrup A, Buyken A, Leschik-Bonnet E, et al. Kohlenhydratzufuhr und Prävention ausgewählter ernährungsmitbedingter Krankheiten. In: Evidenzbasierte Leitlinie der Deutschen Gesellschaft für Ernährung e. V. Carbohydrate intake and prevention of nutrition-related diseases
  • Evidence-based guideline of the German Nutrition Society. Dtsch Med Wochenschr 2012; 137(08): 389-393. DOI: 10.1055/s-0031-1298916
  • Hauner, H. Möglichkeiten der Adipositasbehandlung. Internist 52, 374–382; 2011.https://doi.org/10.1007/s00108-010-2707-1
  • Hauner H, Berg A, Bischoff SC, Colombo-Benkmann M, Ellrott T, Heintze C, Kanthak U, Kunze D, Stephan N, Teufel M, Wabitsch M, Wirth A: Interdisziplinäre Leitlinie der Qualität S3 zur «Prävention und Therapie der Adipositas». Version 2.0, 2014 (1. Aktualisierung, 2011- 2013). www.awmf.org/leitlinien/detail/ll/050-001. Html
  • Hernández-Reyes A, Cámara-Martos F, Recio G, Molina-Luque, R, Romero-Saldaña M, Rojas RM. Push Notifications From a Mobile App to Improve the Body Composition of Overweight or Obese Women: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020; 8(2). doi: 10.2196/13747.
  • Konsensuspapier 2018: Quantitative Empfehlung zur Zuckerzufuhr in Deutschland Deutsche Adipositas-Gesellschaft e.V. (DAG) Deutsche Diabetes Gesellschaft e.V. (DDG)
  • Deutsche Gesellschaft für Ernährung e.V. (DGE) https://www.dge.de/fileadmin/public/doc/ws/stellungnahme/Konsensuspapier_Zucker_DAG_DDG_DGE_2018.pdf
  • Krämer L, Fuchs, R. Barrieren und Barrierenmanagement im Prozess der Sportteilnahme. Zeitschrift für Gesundheitspsychologie. 2010; 18(4): 170-182.
  • Lagerstrom D, Haas U, Kuhn D, Laque M, Berg A. M.O.B.i.L.i.S. Interdisziplinäres  Schulungsprogramm zur Therapie der Adipositas und assoziierter Risikofaktoren. Norderstedt: BoD-Books on Demand; 2018.
  • Messerli-Bürgy N, & Munsch S. Adipositas. Lehrbuch der Verhaltenstherapie, Band 2. Springer, Berlin, Heidelberg, 2018. 319-332.
  • Meyhöfer, Svenja, et al. "Konservative Therapie der Adipositas." Somnologie 22.2(2018): 106-111.
  • Michie S, Johnston M, Richardson M, Abraham C. The Behavior Change Technique Taxonomy (v1) of 93 Hierarchically Clustered Techniques: Building an International Consensus for the Reporting of Behavior Change Interventions. Ann behav med. 2013; 46: S. 81–95. https://doi.org/10.1007/s12160-013-9486-6
  • Munsch S, Hilbert A. Übergewicht und Adipositas. Vol. 59. Hogrefe Verlag, 2011 Petridou A, Siopi A, Mougios V. Exercise in the management of obesity. Metabolism. 2019; 92: 163-169. https://doi.org/10.1016/j.metabol.2018.10.009
  • Sheeran P, Milne S, Webb TL, Gollwitzer PM. Implementation, intentions and health behavior. Predicting health behavior. 2005; 276-323. Sigal RJ, Alberga AS, Goldfield GS, Prud´homme D, Hadjiyannakis S, Gougeon R,
  • Phillips P, et al. Effects of Aerobic Training, Resistance Training, or Both on Percentage Body Fat and Cardiometabolic Risk Markers in Obese Adolescents. The Healthy Eating Aerobic and Resistance Training in Youth Randomized Clinical Trial. JAMA Pediatrics. 2014 Nov; 68(11):1006-14. doi: 10.1001/jamapediatrics.2014.1392
  • Stiefelhagen, Peter. "So gelingt es Ihren Patienten, dauerhaft abzunehmen "MMWFortschritte der Medizin 160.16 (2018): 19-19.
  • Teufel M, Becker S, Rieber N, Stephan K, Zipfel S. Psychotherapie und Adipositas :Strategien, Herausforderungen und Chancen [Psychotherapy and obesity: strategies, challenges and possibilities]. Nervenarzt. 2011;82(9):1133-1139. doi:10.1007/s00115-010-32302
  • Türk Y, Theel W, Kateleyn MJ, Franssen FME, Hiemstra PS, Rudolphus A, et al. High intensity training in obesity: A Meta-analysis. Obesity Science & Practice. 2017; 258-271. doi: 10.1002/osp4.109
  • Vandelanotte C, Van Itallie A, Brown W, Mummery WK, Duncan MJ. Every Step Counts: Understanding the Success of Implementing the 10,000 Steps Project. Information Technology Based Methods for Health Behaviours. 2020; 15-21. doi:10.3233/SHTI200003.
  • Verband der Diätassistenten- Deutscher Bundesverband e. V. (VDD) (Hrsg.): Manual für den German- Nutrition Care Process (G- NCP). 1. Auflage. Pabst Science Publishers, Lengerich 2015,
  • Wolfram G, Bechthold A, Boeing H, Ellinger S, Hauner H, Kroke A, et al. Evidence-Based Guideline of the German Nutrition Society: Fat Intake and Prevention of Selected Nutrition-Related Diseases. Ann Nutr Metab. 2015; 67:141-204. doi: 10.1159/0004372

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Five digital solutions approved for temporary reimbursement in Germany – Up to 2000 €/year in reimbursement | Synergus

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