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 two products that were previously assessed through an early G-BA benefit assessment: alirocumab, and evolocumab, both indicated for the treatment of hypercholesterolemia or mixed dyslipidemia.
Reimbursement restriction of Inclisiran in Germany
Now, the G-BA added another drug to these restrictions: the lipid-lowering drug Inclisiran. The benefit assessment from July 2021 of Inclisiran for the treatment of primary hypercholesterolemia or mixed dyslipidemia showed no additional benefit. The G-BA, therefore, assessed the economics of prescribing the drug. Its annual therapy costs are currently €5,464 to 8,058, while the appropriate comparator therapy costs from €69 to 2,593.
Consequently and consistent with alirocumab, and evolocumab, the G-BA restricted prescriptions and reimbursement for Inclisiran to a specific group of patients.
Inclisiran is reimbursed only for patients with heterozygous hypercholesterolemia or mixed dyslipidemia
- for whom all therapeutic alternatives have been exhausted and
- for whom, as a last resort, only regular LDL apharesis or monoclonal antibodies could be considered.
- with a proven vascular disease (e.g. coronary heart disease, manifest circulatory disorders) in combination with other risk factors for cardiovascular events such as diabetes mellitus or impaired kidney function or a confirmed familial heterozygous hypercholesterolemia, taking into account the overall risk of familial predisposition.
The G-BA maintains this most up-to-date list of all restrictions and exclusions of prescriptions (Drug directive, Appendix III).