Report: Germany Has Not Fully Realized Its Biosimilar Potential

Investigators have concluded that fully realizing the cost-saving potential of biosimilars could “release enormous resources” for other uses in the German health care system. Their analysis also found that although “Germany takes a leading role in the amount of biosimilar prescriptions” in the European Union, the nation could realize much greater savings in the cost of cancer care by expanding its use of biosimilars.

Germany’s advancements in biosimilar uptake and its drug price management have been held up as potential models for the United States. Germany has achieved relatively greater savings on biologics through pricing restrictions, negotiations with drug manufacturers, and robust biosimilar competition.

In Germany as elsewhere, improved understanding of cancer biology has led to advanced treatments. However, costly drugs still have driven up health expenditures. The authors argued that additional cost savings from biosimilars could “offset financing of new innovative therapies,” such as chimeric antigen receptor T-cell therapy, which in the United States can cost well over $400,000 a year, and other targeted therapies.

The investigators quantified the potential savings on cancer drugs in Germany by examining costs in specific disease indications for each of 3 biologics: rituximab, trastuzumab, and granulocyte colony-stimulating factors (G-CSFs; filgrastim and pegfilgrastim). They calculated the cost savings associated with treating all newly eligible patients with a biosimilar rather than a reference biologic for 1 year using existing health economic analyses, estimates of annual cancer incidence in Germany, pharmacy wholesale prices, and current market share.

The biosimilars analyzed in this study already have sizable market share in Germany: in 2019, “61.8% of trastuzumab prescriptions, 79.1% of rituximab prescriptions, 35.5% of pegfilgrastim and 76.7% of filgrastim defined daily doses were biosimilars,” the authors wrote

Still, they calculated potential annual cost savings of $5.75 million for rituximab, $112.12 million to $140.88 million for trastuzumab, and $65.93 million for pegfilgrastim. Filgrastim, already at 82% market share, generated $47.35 million in savings in 2018, according to the authors.

Rituximab

For rituximab, calculations were based on the potential use of biosimilars for follicular lymphoma. There are about 3100 new cases of follicular lymphoma in Germany every year, of which approximately 70% will be treated with rituximab during the course of the disease. The annual cost of the reference product (Mabthera, Roche) is $38.59 million, and the cost of the 2 currently available biosimilars (Rixathon and Truxima) was an estimated $32.84 million by the authors, a savings of $5.75 million.

Trastuzumab

The authors drew from multiple estimates of the number of patients with HER2-positive breast cancer receiving trastuzumab yearly in the (neo-)adjuvant and metastatic setting, from which they determined the range was 6985 to 12,250 patients. Based on these figures, annual savings of $112.12 million to $140.88 million were projected “if all patients received the least expensive trastuzumab biosimilar compared to the original drug.”

There are currently 5 trastuzumab biosimilars on the market in Germany, the least expensive of which is Pfizer’s Trazimera, “with costs 10.8% below that of the reference biologic,” Roche’s Herceptin.

G-CSFs (Filgrastim and Pegfilgrastim)

Filgrastim and pegfilgrastim are indicated for prevention of neutropenia. Because filgrastim already has 82% market share, the authors were able to estimate the actual cost savings in Germany during 2018. The total cost of filgrastim use was $127.40 million, and the authors estimated “without biosimilar usage and implementation of fixed reference pricing due to significant biosimilar penetration,” costs would have been $174.75 million, a savings of $47.35 million.

Total annual costs for pegfilgrastim were $245.91 million in 2018, and the authors estimated the cost would have been $179.99 million if biosimilars had been prescribed exclusively, saving $65.93 million. The first pegfilgrastim biosimilar authorized in Europe became available in Germany in October 2018 and reached market share of 22% in June of 2019.

Cost Savings Could Be Reallocated “to Facilitate Optimal Patient Treatment”

The investigators recommended that cost savings from the use of biosimilars be used to improve treatment for patients, for example, to “improve access to care in underserved areas” and “offset financing of new innovative therapies.”

They see additional positives to increasing biosimilar use, arguing that more biosimilar manufacturers means “stronger competition between suppliers” and, globally, “the presence of multiple biosimilar manufacturers ensures the security of supplies.” Plus, “biosimilars contribute to lower prices of the drug group including the reference product, thus further relieving the financial burden on the health care system.”

The authors pointed out that some of their savings projections may be underestimates, because “due to individual discount agreements, the actual costs for biosimilars may be lower.” Additionally, they cautioned that the numbers of patients they used in their calculations are based on estimates and that inpatients were not considered in their analyses.

From their results, the investigators concluded, “the adoption of biosimilars has the potential to improve sustainability of health care in oncology, which is particularly important as the incidence of cancer increases worldwide.”

They also noted that in Germany, classes of biosimilars not included in the study have substantial room for growth. Insulin lispro and insulin glargine biosimilars have just 3.3% and 11.5% of their respective markets in Germany, the authors said.

Reference

Hübel K, Kron F, Lux MP. Biosimilars in oncology: effects on economy and therapeutic innovations. Eur J Cancer. Published online September 17, 2020. doi:10.1016/j.ejca.2020.07.037