Did you know that some hospital methods are not covered by SHI funds?
In Germany, non-drug interventions are assessed as methods. Methods and medical devices that are used in hospitals can be offered and are reimbursed by the SHI funds unless they have explicitly been excluded from reimbursement by the G-BA. These excluded methods are listed in the so-called “Directive hospital treatment methods“.
In order to decide whether a method should be excluded, the G-BA assesses if a method has a benefit. If the G-BA sees no benefit (yet), it will be determined whether the method has the potential of showing a benefit. In that case, testing studies (“Erprobungsstudien”) will be conducted.
The G-BA has now published their method assessment for allogeneic SCT with in vitro preparation of the transplant in ALL and AML, as well as allogeneic SCT in T-cell NHL.
Decision for SCT in NHL
The G-BA specified that allogeneic SCT in NHL should be EXCLUDED from reimbursement in the following condition:
- Adults with
- peripheral T-cell lymphoma, not further specified (PTCL-NOS),
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma,
- in first-line treatment
- where systemic induction therapy achieved a partial or complete remission
- in whom autologous stem cells can be obtained in sufficient quantities and who can be transplanted autologously.
The decision was based on the AATT study as well as DGHO and ESMO clinical guidelines. The G-BA concluded that the method does not offer a benefit and also does not show the potential of a required treatment alternative.
Thus, from now, the method can no longer be covered by SHI funds.
Decision for SCT in ALL and AML
In a search conducted in September 2020, the G-BA identified two relevant studies: NCT02345850 (study 1) and NCT03970096 (study 2). Both of these are relevant for the German hospital context, but their results are not available yet. Results for study 1 are expected in September 2021, while study 2 is planned to be completed by August 2024. Therefore, the G-BA decided to suspend the method assessment again until 31 December 2025.
However, the G-BA will continue to conduct regular literature searches. If further relevant studies are identified and suitable data become available, the assessment may be re-started at an earlier time point.