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 and applicable from market entry onwards. In general, this coverage is granted for the full patient population covered by the license. There is no restriction on the patient population for reimbursement.
However, there are some exceptions: SHI funds do not cover OTC or lifestyle products. In addition, when products are considered to not be economical, the G-BA can
- exclude products from reimbursement or
- restrict the reimbursement to specific patients.
This happens very rarely.
The G-BA issues a binding regulation, the so-called drug directive (German: Arzneimittel-Richtlinie). This directive describes how to prescribe the product and in which situations it is reimbursed. Until now, a reimbursement restriction was applied to only three products that were previously assessed through an early G-BA benefit assessment: alirocumab, evolocumab, and inclisiran. All three of them are indicated for the treatment of hypercholesterolemia or mixed dyslipidemia.
Reimbursement restriction of Febuxostat in Germany
Now, on 18 Aug 2022, the G-BA added another reimbursement restriction.
But this still is not for a G-BA assessed drug, so the above still holds true.
Drugs containing febuxostat for the treatment of chronic hyperuricaemia, which can lead to gout attacks, can now only be prescribed in certain exceptional cases.
According to current studies, the use of allopurinol to avoid complications from elevated uric acid levels is just as effective, but cheaper. A cost comparison (as of 1 June 2022) showed that the annual therapy costs of febuxostat are significantly higher than those of allopurinol.
Therefore, febuxostat can now only be used in patients
- with an intolerance or at high risk of intolerance to allopurinol or
- in whom an individually optimized therapy with allopurinol was unsuccessful.
The G-BA will regularly review the price development of both drugs and, if necessary, adjust the prescription restriction accordingly.
The G-BA maintains this most up-to-date list of all restrictions and exclusions of prescriptions (Drug directive, Appendix III).