On 16 Aug 2019, the GSAV came into force. This new law also included legislation with the aim to increase the market share of biosimilars in Germany, through
- automatic substitution by pharmacies
- rebate contracts for generics.
The first item means that pharmacies will have to automatically substitute biologics with biosimilars when filling a patient’s prescription.
Following the publication of the law, the G-BA had three years to develop a directive with details for this automatic substitution. Therefore, the G-BA held a hearing with all stakeholders on 13 July 2022. However, there wasn’t much consensus amongst all participants.
Stakeholder positions
GKV-SV
As expected, the payers, i.e. the GKV-SV are supportive of the automatic substitution.
Clinicians, pharmacists and the pharmaceutical industry
On the other hand, clinicians, pharmacists and the pharmaceutical industry are all against this regulation. They foresee possible problems in the safety of the therapies, and the nocebo effect.
The groups against the regulation point out that biosimilars are not generics. They are “only” very similar to the originator product and are comparable in clinically relevant parameters, such as efficacy.
If the pharmacy substitutes a product, the clinician could not follow the possible treatment effects, since they would not know which product the pharmacy dispensed to the patient in the end. The existing infrastructure is insufficient to follow the prescription.
In addition, there also was the risk of the nocebo effect. Studies have shown that patients judge the efficacy or side effects of a treatment subjectively different, if they become aware that they received a different product for financial reasons.
The opposing groups consider the new regulation unnecessary, since biosimilars already have a high market share, as soon as they become available. There was no need for political pressure to increase this.
German Health Minister
The German Health Minister, Karl Lauterbach, has not taken a clear position on the issue. However, last month, he said that there were good arguments for and against the planned substitution. The final decision would have to be made on the basis of scientific findings, but the available study data is currently sparse.
His gut feeling was “that greater trust can be established if this decision is ultimately made by clinicians, and not in pharmacies”.
Next steps
Despite some stakeholders considering the regulation unnecessary, the substitution was included in previously agreed legislation. Therefore, the G-BA will now develop their first draft and share it with the BMG.
However, there is the possibility that the G-BA will conclude that it is not possible to introduce the automatic substitution. Two compromises have been proposed:
- There is the possibility to restrict the substitution to laboratory preparations only, i.e. primarily oncologicals and parenterals. This would have the advantage that these drugs are used under close medical supervision only anyway. Therefore, the prescribing clinician would be informed about the substitution, even to the level of the batch number of the preparation.
- Another possible compromise could be a phased implementation: From August, for example, only two or three active ingredients would be included in the automatic substitution whose originator has been patent-free for a long time and for which there is already sufficient data on its interchangeability.
Further reading related to biosimilars in Germany
- Switching between original biologics and biosimilars in Germany
- Regular and abbreviated early benefit assessments – Is this the end of orphan drug privileges?
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