For 2 out of 3 DiGAs, no positive healthcare effect could be proven so far
The DiGA directory currently lists 31 applications (22.03.2022), of which the largest percentage deals with neurotic, stress, and somatoform disorders (14.6 %). On 6 March, the newest DiGA „Meine Tinnitus App - Das digitale Tinnitus Counseling“ was added to the directory. DiGAs are provided by a total of 23 companies, with GAIA AG and GET.ON Institut für Online Gesundheitstrainings GmbH being the top performers each with four digital health apps. To be included in the DiGA directory, manufacturers must specify the positive healthcare effect the digital application is intended to lead to. With 71%, a large proportion of DiGAs aim to create a medical benefit for the patient (see figure 1).
More information is available at in our German speaking sites.
The Hospital Structure Act (KHSG) of 01.01.2016 is the legal basis for the conclusion of quality contracts in which the aim is to test "the extent to which a further improvement in the provision of inpatient treatment services can be achieved, in particular through the agreement of incentives as well as higher-value quality requirements" (Section 110a (1) SGB V).
In August 2019, the “Gesetz für mehr Sicherheit in der Arzneimittelversorgung“ (GSAV) came into force. The law aims to improve the quality and safety of medicines. The contents of the GSAV also affect the supply of biotechnologically produced drugs, known as biologics. The Federal Joint Committee (G-BA) was instructed to regulate notes on the interchangeability of biologics with their biological reference drugs (so-called biosimilars) at the pharmacy level. The aut-idem regulation is thus to be extended to biologics. Previously, this regulation was not permissible, as biosimilars are not generics of biologics. Due to the complex manufacturing process, biosimilars and biologics are not completely identical. By August 2022 at the latest, the G-BA should have regulated more details on interchangeability at the pharmacy level.
Real World Evidence, Evidence Generation
A brief video summary of our latest study using a Discrete Choice Experiment (DCE); health services research:
Use our smart tools to efficiently enter the German speaking (D-A-CH) market.
Introduce and keep competitive prices.
Modern ways to generate evidence.
Prevalence of #atopicdermatitis (AD) is estimated to be 2.19% in Germany, which translates to 1.53 million adults with AD in Germany. This is the result of an analysis of @LinkCareGmbH and Lilly for a Module 3 in the #AMNOG process for #Baricitinib #GBA https://t.co/BwAI5G5D2n— LinkCare GmbH (@LinkCareGmbH) February 16, 2021
Hat Deutschland im internationalen Vergleich eine höhere Sterblichkeit bei #Sepsis und septischem Schock? In unserer neuen #Metanalyse ergaben sich keine Anhaltspunkte für eine erhöhte Sterblichkeit in Deutschland. https://t.co/YqQ1BrOPNq @Anaesthesisten @sepsisdialog @UKJ_Jena— LinkCare GmbH (@LinkCareGmbH) February 11, 2021
Given a choice, which treatment options, oral or topical, would patients with peripheral polyneuropathic pain choose? Find out in the infographic of our latest publication. https://t.co/drzdF88l0J #polyneuropathicpain #discretechoiceexperiment #topicaltherapy #healtheconomics pic.twitter.com/cU46NmpilX— LinkCare GmbH (@LinkCareGmbH) January 11, 2021
On 30.10. we presented our #epidemiology analysis of residual excessive daytime sleepiness (#EDS) at the #DGSM. Important findings: we have to assume that at least 34k patients in GER with #OSA and #CPAP therapy also have EDS. Every 2nd is unemployable and with psych. comorbidity— LinkCare GmbH (@LinkCareGmbH) November 1, 2020
What may be relevant clinical differences in the prescription of #opioids for #chronic #backpain? we showed in coop. with an academic industry partnership at the Congress for #healthcareresearch #Versorgungsforschung that co-medication plays a major role. https://t.co/r49PXnTSPF— LinkCare GmbH (@LinkCareGmbH) October 3, 2020
#Evaluation und Evidenzanforderungen für #DiGA: positiver Versorgungseffekt (pVE), was ist das und was Sie beachten sollten haben wir in unserem Blog für Sie zusammengefasst #appsaufrezept #medicalapp #DiGAV #Nutzenbewertung @bfarm_de @DigitalVersorgt https://t.co/XpyaXVXyJT— LinkCare GmbH (@LinkCareGmbH) June 18, 2020