Regular and abbreviated early benefit assessments – Is this the end of orphan drug privileges?
This is the first article in a series about maybe the most important topic influencing market access in Germany: HTAs or early
Tag: G-BA
The G-BA increases the fees for consultations
Manufacturers of drugs or medical devices can apply for a consultation meeting with the G-BA before submitting a dossier. This consultation offers
Prof. Dr. Karl Lauterbach is the new German health minister
On 6 December 2021, Prof. Dr. Karl Lauterbach was announced as the new German health minister. This might mean quite a lot
New government coalition plans AMNOG, pricing and other reforms
The new government in Germany is formed as a coalition of the three parties, SDP, FDP and the Green Party. At the
The G-BA specifies QA requirements for cell and gene therapies in Germany
In the previous assessments of Kymriah, Yescarta, Tecartus, and Zolgensma, the G-BA had defined specific QA requirements for the use of these
G-BA assessment of orphan drug gene therapies, Zolgensma and Libmeldy
The gene therapies Zolgensma and Libmeldy, both, are targeting very rare, severe, genetic diseases in children. The G-BA has now assessed the
Why did the G-BA assess Trimbow now?
Trimbow was launched onto the German market in 2017. So why did the G-BA assess its benefit now? You likely know that
Change in morbidity factor means more GPs are needed in Germany
Identifying amount of required healthcare The G-BA developed the needs planning directive (German: Bedarfsplanungs-Richtlinie) to give national rules on “how much” SHI-funded
Who are the members of the G-BA?
The G-BA has 13 voting members forming the so-called plenum. The representatives of care providers are only entitled to vote on topics
Three new methods were added to the catalogue of SHI funds
Before a new diagnostic and treatment method can be offered and reimbursed in the outpatient sector, two important steps need to be