The drug therapy for type 2 diabetes mellitus has changed in recent years. Significant increases in expenditure, driven primarily by more modern therapeutic approaches such as DPP-IV inhibitors, were recorded continuously. In 2011, every second euro of oral antidiabetics (OADs) was spent on DPP-IV inhibitors. But market growth could stall.

>> Diabetes mellitus type 2 is one of the most common chronic diseases in Germany. According to the 2011 Drug Atlas, there are currently 4.6 million type 2 diabetics. However, these numbers are subject to uncertainty because the estimates of the prevalence of diabetes and its growth rates in Germany vary significantly. Older figures from the 1998 Federal Health Survey, which show the overall prevalence of diabetes at 4.7 percent for men and 5.6 percent for women, are now viewed as an underestimate. Other figures, such as those from the Diabetes Atlas IDF 2010 or calculations based on routine data from individual health insurance companies, are significantly higher. It therefore remains to be seen what the results of the new survey by the Robert Koch Institute will be (Study on the Health of Adults in Germany - DEGS).
However, reliable and current data is available on prescriptions of antidiabetic drugs. The GKV market for oral antidiabetic drugs (OAD) will be examined below. The analyzes presented partly take up analysis findings that were already published in 2009 in the “Monitor Healthcare Research” (cf. Bensing/Kleinfeld: The importance of oral antidiabetics is increasing, in: Monitor Healthcare Research, No. 02/2009, p. 10f.)
Slowed increase in spending
In 2011, oral antidiabetic drugs worth 644 million euros (valued at pharmacy sales prices without deducting discounts and additional payments) were used for diabetes therapy within statutory health insurance. This corresponds to an increase of 3.7 percent compared to 2010. This means that the increase in expenditure in 2011 reached the lowest value in the last five years examined. The number of statutory health insurance prescriptions for OAD even fell by 2.6 percent in 2011 - to 17.3 million prescriptions billed (Fig. 1).
Different classes of active ingredients are used for the drug therapy of type 2 diabetes. The DPP-IV inhibitors now have the greatest economic relevance, accounting for 54.2 percent of expenditure (Fig. 2). This group of active ingredients has only been established on the market since 2007, and has also been available in a fixed combination with metformin since 2008. This increase in importance in terms of sales occurs relatively evenly at the expense of the other OADs, with the exception of the special situation of glitazones.
Slump in sales for Glitazone
Glitazone's drop in sales from 18.0 percent in 2010 to 4.2 percent in 2011 is considerable. This goes back to the exclusion of regulations at the expense of the GKV decided by the G-BA in mid-2010 (decision published: Federal Gazette No. 175 (p. 3855) of November 18, 2010). The G-BA assumes that the possible harm, for example in the form of heart failure and bone fractures, outweighs the benefit because alternative treatments are available. In 2011, biguanide antidiabetics with metformin accounted for 23.3 percent of sales, and the alternative sulfonylureas accounted for 11.0 percent. On the prescription side, the high status of biguanide antidiabetics is clearly evident. These currently make up 60.5 percent of OAD prescriptions (Fig. 3).
The reason for this can be stated that metformin is the antidiabetic drug of first choice. This is based in particular on the proven effectiveness in terms of metabolic control and the low influence on weight and hypoglycemia rate (see Drug Commission of the German Medical Association. Recommendations for antihyperglycemic therapy for type 2 diabetes mellitus. 2nd ed. Berlin. 2009). If there is metformin intolerance, sulfonylurea therapy should be carried out according to the guidelines. If there is simultaneous sulfonylurea intolerance, alpha-glucosidase inhibitors or DPP-IV inhibitors should be used.
The question remains exciting about the future development of the OAD market and especially the DPP-IV inhibitor segment. In its most recent decision of March 29, the G-BA assessed the additional benefit of the active ingredient linagliptin (“Trajenta”) from Boehringer Ingelheim as not proven due to an incompletely submitted dossier. As part of the early benefit assessment, the manufacturer chose an appropriate comparator therapy other than the proposed one in its benefit dossier. The pharmaceutical company has the opportunity to submit a revised dossier one year after publication of the decision (see interview starting on page 20) and thereby initiate a new benefit assessment of the active ingredient. <<
by: Christian Bensing
Dr. Andre Kleinfeld