In-vitro diagnostics

11

Nov 2019

On the 19th of September 2019, the Federal Joint Committee (G-BA) concluded on the possible applications and limits of non-invasive molecular genetic tests (NIPT) at the expense of the statutory health insurance (SHI). The decision provides that a NIPT can be used in justified individual cases and after medical consultation. Read more

17

Oct 2019

The insurance company AOK Saxony-Anhalt concluded that patients are much less frequently prescribed an antibiotic after the examination via a rapid test for a bacterial cause of the infection. In more than 40% of the tested patients, the doctors waived the antibiotics prescription. Read more

10

Oct 2019

The fee negotiations for the coming year are over - the National Association of Statutory Health Insurance Physicians (KBV) and the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) agreed on an increase in the monetary conversion factor for all medical and psychotherapeutic services in the amount of 1.52 percent. GKV-Spitzenverband and KBV have also agreed to sponsor the video consultations. Read more

03

Oct 2019

In order to diagnose pre-eclampsia in pregnancy, two new markers were included in the EBM catalog in early October 2019. The statutory health insurances then will take over the costs for the determination of the PIGF concentration and the sFlt-1 / PIGF quotient. In addition, another tumor marker for ovarian cancer will be included in the EBM. Read more

27

Sep 2019

In August 2019, the Norwegian Institute of Public Health (NIPH) has released a single technology assessment report for molecular profiling panel – Prosigna aimed to investigate its prognostic accuracy, clinical and cost-effectiveness in patients with breast cancer. It was outlined that it is uncertain to what extent Prosigna contributes prognostic information that turns into better clinical results; conclusions about the cost-effectiveness of Prosigna cannot be made due to the lack of existing information. Read more

20

Sep 2019

In mid-August 2019, the network of European HTA agencies, EUnetHTA, announced the final plan of the project OTCA22 “Clinical utility of Point-of-care Tests (POCT) D-Dimer and Troponin.” Read more

06

Sep 2019

The seminar includes overview of topics of reimbursement, funding, payment mechanisms for IVD tests in hospital, day case and out-patient settings, health technology assessment, innovation funding, role of clinical and economic evidence, stakeholder engagement. Data from 10 EU countries are used. The seminar is available as a pre-recorded on-demand webinar or full presentation in Acrobat PDF. Read more

04

Sep 2019

Laboratory examinations that can predict whether a patient will receive therapeutic benefits from “personalized” drug treatment or from so-called "molecular companions diagnostics" can be promptly and flexibly reimbursed using the new specific procedure from July 1, 2019. Read more

30

Aug 2019

Educational modules include an overview of key stakeholders, money flow, payment model for IVD tests in the ambulatory sector, the process of creation of reimbursement for novel IVD tests. Overviews are available for France, Germany, Italy, Switzerland. Overviews are available as presentations in Acrobat PDF. Read more

30

Aug 2019

In late July 2019, the report of the project OTJA10, titled “Stool DNA testing for early detection of colorectal cancer” was published on the website of the European Network for HTA (EUnetHTA). Read more

22

Aug 2019

With the preventive program for pregnant women, "Hello Baby," premature births and infection-related birth complications should be minimized. Now, the program has been established nationwide: 60 health insurance companies offer to their approximately 6.5 million insured since July 1, 2019, the additional tests contained therein. Read more

16

Aug 2019

The HTA center of Swedish Västra Götaland region has published a report for gene expression profiles to guide adjuvant chemotherapy in luminal, HER2-negative breast cancer. It was concluded that withholding adjuvant chemotherapy in breast cancer patients with intermediate clinical risk of recurrence and low/intermediate risk according to a gene expression assay, compared with providing chemotherapy, probably results in little or no difference in overall survival within nine years and can probably not exclude a small increased risk of recurrence. Read more