German system of innovation funding (NUB) has changed in 2016.
For the first-time applicants for devices of class risk IIb and III, the national policy-maker Federal Joint Committee (G-BA) may consider "benefit assessment". Benefit assessment includes rapid health technology assessment by G-BA in collaboration with Institute for Quality and Efficiency in Health Care (IQWiG). This framework is functioning in accordance with the §137h for the German Security Code V.
There are three possible outcomes of the assessment:
- Benefit is proven: in this case technology can be funded within statutory health insurance
- Potential benefit is established: technology shall be studied with the framework of government-cosponsored study to provide definite answer about value of a technology (framework according to the §137e SGB V)
- No benefit and no potential benefit is established: technology shall be excluded from provision within statutory health insurance
In March 2017, G-BA has released information about outcomes of benefit assessment of two technologies:
- Catheter-based lung denervation system for COPD, manufactured by Holaira
- High-intensity focused ultrasound (HIFU), manufactured by Haifu
No benefit was found for lung denervation and HIFU in five indications:
- Endometriosis of the uterus
- Not surgically treatable, malignant neoplasms of the pancreas
- Not surgically treatable primary malignant neoplasm of bone and articular cartilage
- Not surgically treatable secondary malignant neoplasm of bone and bone marrow
- Not surgically treatable secondary malignant neoplasm of liver and intrahepatic bile ducts
Potential benefit was established in relation to HIFU in two indications:
- Leiomyomas of uterus
- Non-operable liver cell carcinoma
Technologies with no benefit will be likely excluded from provision within statutory health insurance and HIFU in two indications should be enrolled into government-cosponsored study (§137e SGB V framework).
Read full press-release in German here.