Quotas improve biosimilar use in Germany

Biosimilares/Investigación | Posted 17/07/2020 post-comment0 Post your comment

An assessment of the role of cost control measures on biological drugs in Germany finds that quotas for biosimilars are in some cases associated with increased use and are overall more effective than priority prescribing [1].


Germany has a biologicals market worth Euros 8.2 billion, according to 2015 data. Germany also has a significant market for biosimilars, with one of the world’s highest rates of biosimilar uptake.

This has been achieved through various initiatives, including policies addressing the prices of biological (such as reference pricing and tendering) and policies addressing their use (such as physician incentives).

Germany has also implemented cost control measures, such as minimum quotas for biosimilars, priority prescribing schemes, and policies to substitute originator biologicals for biosimilars. However, the effectiveness of these policies is little understood.

A recent study [1] investigated regional variation in the use of such cost control measures in Germany, and the associations of different cost control measures with the numbers of biosimilar prescriptions issued by physicians.

The researchers collected data on the cost control measures implemented by German physician associations and national claims data from statutory health insurance between 2009 and 2015. Using this data, they identified the average associations between cost control measures and biosimilar use.

The analysis included three types of biological drugs: erythropoiesis-stimulating substances, which stimulate the production of red blood cells to treat anaemia; filgrastim, which increases neutrophil count and is often used in patients receiving chemotherapy; and somatropin, which is recombinant human growth hormone. For these three drugs, they identified 44 individual cost control measures, which were either biosimilar quotas, priority prescribing, or a combination of the two.

There was significant regional variation in biosimilar share and the use of cost control measures. The percentage of patients being treated with a biological drug was much higher (by up to 16 times) in specialist practices than in general practice, which is often the case for biological drugs, which are used to treat complex and often chronic conditions.

On average, when biosimilar quotas were used, the share of biosimilar use was significantly higher for regular prescribers of biologic drugs. For erythropoiesis-stimulating substances, biosimilar quotas were associated with a significant increase in biosimilar share for regularly prescribing GPs. For filgrastim, quotas were associated with an increase in biosimilar share across all specialists. For somatropin, cost control measures were not associated with biosimilar share at all.

The authors say this is likely due to higher uncertainty regarding the efficacy of somatotropin biosimilars, and the competitive market for biosimilars. Only one somatotropin biosimilar is available in Germany, compared to five biosimilars for erythropoiesis-stimulating substances and seven filgrastim biosimilars.

Other associations with biosimilar share included group practice status, which was associated with increased biosimilar share. There was also a positive association between the number of patients in a practice, as well as the number of patients being treated with with a biological, and biosimilar share. Finally, physicians who prescribed more expensive biologicals had, on average, a lower biosimilar share.

Overall, the findings suggest that the use of quotas for biosimilars is more effective than priority prescribing measures. The authors do, however, say that the implementation of these measures differs by region, which leads to variability in biosimilar uptake levels across Germany.

Despite the variability, the authors conclude that biosimilar quotas are a ‘vital tool’ to increase biosimilar uptake. They further recommend that specialist prescribers be supported to increase their confidence in switching to biosimilars, as this could improve the effectiveness of cost control measures like quotas and thereby increase savings for the healthcare system.

Conflict of interest statement
One of the authors of the paper [1] was later employed by an association of health insurers in Germany. The remaining authors declared no competing interests.

Editor’s comment
Readers interested to learn more about the biosimilar market in Germany are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:

Regional management of biosimilars in Germany

Biosimilars in Germany: guidance of the Drug Commission of the German Medical Association

Germany wants to increase biosimilars penetration

Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.

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1. Blankart KE, Arndt F. Physician-level cost control measures and regional variation of biosimilar utilization in Germany. Int J Environ Res Public Health. 2020;17(11)4113.  

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