With the introduction of biologics (also called biopharmaceuticals), the drug treatment of rheumatoid arthritis (RA) and numerous other diseases has changed fundamentally over the past decade. Biologics now offer a broader spectrum of treatment options that contribute to positively influencing disease processes and sustainably supporting patients' quality of life.

> Biologics are biotechnologically produced medicines; they are produced in genetically modified organisms. The active ingredients consist of proteins (including monoclonal antibodies) and nucleic acids, the production of which requires particularly high technological effort.
There are currently 92 biologic active ingredients on the market in Germany. These account for approximately 15 percent of pharmaceutical expenditures in statutory health insurance (SHI), amounting to €4.6 billion in 2009 (valued at pharmacy selling prices/AVP; source: NVI, INSIGHT Health). Immunological diseases such as rheumatoid arthritis, along with metabolic diseases, infections, and diseases in the fields of oncology, central nervous system, hematology, and others, represent a key indication.
Growing importance
of biologics
The following section examines in more detail the nine biologics used in the treatment of rheumatoid arthritis (see Table 1). 309,000 statutory health insurance prescriptions for over 82,000 patients resulted in gross expenditures of almost €1 billion (AVP) in 2009. With an increase of 25.3 percent, these preparations are a driver of pharmaceutical expenditures in the statutory health insurance system (see Table 1). TNF-alpha blockers such as adalimumab and etanercept play a key role.
The pharmaceutical expenditure for the biologics supply of RA patients is also remarkable because, for example, for the two substances adalimumab and etanercept, at just under 63 euros, it is more than 26 times higher than the daily therapy costs for treatment with the established generic basic therapy (methotrexate) (according to AVP; source: INSIGHT Health).

Increasing patient numbers
The number of patients treated with RA biologics has risen steadily in recent years. According to calculations by INSIGHT Health, approximately 82,000 patients were treated with these antirheumatic drugs in the statutory health insurance system in 2009, compared to just 49,000 in 2007 (see Figure 1). Thus, the number increased by an average of over 16,500 patients annually. This corresponds to an average annual increase of 29.5 percent.
More than two-thirds of biologic prescriptions are issued by internists and their subgroups; together with outpatient clinics, dermatologists, and general practitioners, they accounted for over 90 percent of statutory health insurance prescriptions for biologics in 2009. Other specialist groups play a negligible role in this context (see Figure 2).
There have been several new approvals in the recent past: The active ingredient tocilizumab has been approved since February 2009. The active ingredients golimumab and certolizumab pegol followed in October 2009. Approximately one in thirty patients treated with the biologics described above received at least one of these newly approved drugs in 2009. Recent figures show that this proportion has more than doubled in the first half of 2010.

Cost neutrality taking into account follow-up costs?
Biopharmaceuticals will continue to gain importance in the future, and not only in the treatment of rheumatoid arthritis. Approximately one in four newly approved active ingredients is a biopharmaceutical. The question of the financial viability of innovative therapies by statutory health insurance will therefore become even more of a focus in the future – especially given the frequent additive use of newly approved biologics in combination with conventional medicines. However, in an overall health economic analysis, the increased pharmaceutical expenditure should also be offset by the savings from avoided inpatient stays and other follow-up costs.
The German Rheumatism Research Center Berlin (DRFZ) concludes that the overall social costs have hardly changed. Further studies on this topic – also in light of the often-discussed costs of pharmaceutical innovations – are desirable.

by: Christian Bensing and
Dr. André Kleinfeld*