In November 2018, the German Health Ministry tabled the draft GSAV (Gesetzes für mehr Sicherheit in der Arzneimittelversor-gung) bill, which translates to the ‘law for more safety in the supply of pharmaceuticals’. The law aims to provide a legal framework for the automatic substitution of biosimilars at the level of the pharmacist in Germany, among other elements. The goal is to drive the increased adoption of biosimilars, due to the huge potential for cost savings. As few EU countries currently have pharmacist biosimilar substitution, this would represent a significant change in practice, particularly for Germany.

What is the current proposition and how might this work in practice?

Negotiations between the Bundestag and Health Ministry on the GSAV are ongoing, but the current proposal focuses on the development of two substitution lists – a physician and a pharmacist list. The physician substitution list would contain information on how to switch to biosimilars, whilst the separate pharmacist substitution list would dictate which biosimilars were eligible for substitution at the pharmacy level.

The responsibilities for developing and defining the physician and a pharmacist lists would be tasked to the G-BA, as the G-BA is already responsible for defining the active substances for which reference price groups (Festbetragsgruppe) can be determined. A transition period of 3 years has been proposed to ensure physicians and patients are comfortable with the changes, reflected in the second draft of the GSAV approved by the German cabinet in January 2019.

What are the implications and what does this mean in practice?

There is still significant uncertainty over the exact practical details of the GSAV, including its draft guidance on biosimilar interchangeability. Specifically, the length of the transition period is still under debate, whilst further discussions are ongoing as to whether there should be separate physician and pharmacist biosimilar substitution lists, or a single unified list for both physicians and pharmacists.

One of the major challenges with the proposed approach is that the G-BA’s remit will now be extended to potentially include economic considerations, in order to determine which molecules will be eligible for substitution. Neither the Paul-Ehrlich-Institut or the Drug Commission of the German Medical Association (AkdÄ) specify molecules more suitable for substitution in their current guidance on biosimilars. The current AkdÄ guidance in fact states that automatic substitution independent of the medical prescription should be refused in Germany. The G-BA therefore has no scientific basis or clinical results to add some molecules to the substitution list(s) but not others. If the G-BA only allowed certain molecules to be substituted by the pharmacist, it would be interesting to see the clinical and/or economic rationale for their decisions, which would be at odds with publications from other German institutes.

The other outstanding issues are the role the physician plays in treatment decisions and whether automatic substitution would apply to both treatment-naïve and existing patients. German doctors are largely conservative and prefer to continue their patients on the same biological products where possible. This is particularly true of existing patients, and physicians hope that ultimately automatic substitution will only be introduced for treatment-naïve patients, with an additional control for existing patients. Under the existing ‘Aut idem’ regulation (which allows the automatic substitution of ‘bio-identicals’ manufactured by the same supplier and on the same production line), a physician can tick a box on the prescription to forbid the pharmacist from substituting for a cheaper alternative. It is probable that this mechanism will be applied if automatic substitution is introduced more widely, which should help address physician concerns in making treatment choices.

In summary, it is highly probable that pharmacy-level automatic biosimilar substitution in Germany will become a reality in the next three years. Whilst the exact details as to how this will work in practice remain under discussion, potential outcomes range from a significant shift in the German biosimilar market, to simply another tool which only impacts a few molecules. Regional biosimilar quotas have been increasingly effective in increasing biosimilar market share, and as such there may be limited scope for the GSAV to drive this further when it is introduced. As such, whether the Health Ministry will achieve its aim of achieving greater adoption of biosimilars in future remains to be seen. However, the impact on other European markets will be interesting to observe. If Germany can successfully implement a pharmacy level substitution policy and reduce costs, there may be significant interest and demand from other EU countries to implement similar policies, notably Norway and Finland to help manage their healthcare budgets.