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
Category: News and updates
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
Reimbursement price and discounts – Drug prices in Germany
You might be familiar with the price negotiations to derive the reimbursement price, but this does not always reflect the final, real-world
Another reimbursement restriction in Germany
Most medicines are reimbursed at 100% from the day of launch in Germany, i.e. coverage by SHI funds is granted with the marketing authorization
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
Pricing of generics in Germany: Are there any rules?
The process of determining the reimbursed price of a product with a new chemical entity is clearly defined and follows specific steps.
Wound treatment: bandage material or other products – an important difference for reimbursement
Wound treatment materials and products are considered medical devices. The GVWG (§31 (1a) SGB V) from 2 December 2020 introduced a new
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
Are lifestyle drugs reimbursed in Germany?
Drugs that primarily aim to increase the quality of life are so-called “lifestyle” drugs. These are not covered by the SHI funds