According to a survey by INSIGHT Health, the German market for narcotic analgesics (N02A) had a spending volume of 900 million euros in 2008. This results in medication expenses of 10.91 euros per German citizen. In terms of data, there are clear differences between the federal states in terms of care. Discount contracts are becoming increasingly important in this fast-growing market.

>> In Germany, around one in four patients comes to the general practitioner's practice because of pain (see Guideline Group Hesse: General Practitioner Guidelines for Pain, 2008). The pain shown can often not be assigned to a clear clinical picture. If a pain-related diagnosis is made, strong analgesics are increasingly used, especially if the symptoms are severe. In Germany in 2007, around 310,000 tumor patients needed strong analgesics (see Häussler, Bertram et al.: Medicines Atlas 2008, p. 246).

Sales of narcotic analgesics are growing steadily

Narcotic (BTM) analgesics such as fentanyl, morphine or oxycodone are of particular importance: for this classification alone, according to the INSIGHT Health survey, the sales volume for 2008 according to the selling prices of the pharmaceutical companies (ApU, formerly: HAP) was 621 million euros in the outpatient area. This pain market has more than doubled since 2002.
Significant increases were also recorded on the sales side. The standard units dispensed - defined as the product of the number of packs multiplied by the amount of content (e.g. number of tablets, patches) - rose from 110 million to 233 million standard units in the same period.
This increased consumption of strong analgesics must also be seen in the context of the fact that the (pain therapeutic) care of cancer patients has increasingly shifted from inpatient to outpatient care in recent years (cf. Häussler, Bertram et al.: Medicinal Atlas 2008, p. 118).
Compared to BTM analgesics, sales (according to ApU) of prescription analgesics (N02B1) have declined slightly in recent years: While in 2005 sales of prescription analgesics according to N02B1 amounted to 310 million euros, this value shrank to 277 million euros in 2008 ( see Fig. 1).
However, the number of tablets, patches and the like increased from 1,291 to 1,501 standard units over the same period. This is related to the generic competitive situation that is quite pronounced in this segment.

Fentanyl is by far the biggest seller
BTM analgesic

The top-selling active ingredient of the approved BTM analgesics is fentanyl, a synthetic opioid that is primarily used in cancer therapy in Germany. Fentanyl gained fame particularly through its transdermal dosage form (patches).
For patients with swallowing disorders, such transdermal therapy can be an alternative to oral medication with few side effects (see Hessen Guideline Group: General Practitioner Guideline for Pain, 2008). This is one of the reasons why fentanyl has always seen significant increases in sales and volumes in the past. However, due to some restrictions, such a dosage form is not recommended for all diagnoses and only after the patient has been informed in detail about the application and effect of the patches. Ultimately, this is also why general practitioner guidelines on pain therapy usually recommend oral medication. In 2008, the active ingredient fentanyl achieved around 251 million euros in wholesale sales including direct business (according to ApU). This corresponds to 24.3 million standard units. This means that in 2008 around 40.5 % of sales, but only 10.4 % of the units in the BTM analgesics market, were accounted for by fentanyl (see Fig. 2).

Morphine and oxycodone: top-selling substances

At the level of standard units delivered, substances such as morphine and oxycodone are the most commonly used BTM analgesics in Germany. In 2008, around 75 million standard units of morphine were distributed via wholesalers. For oxycodone it was 59 million standard units. In 2008, 30.4 million standard units of the innovative combination of oxycodone and naloxone, which has been used for pain patients since 2006, were sold.
BTM analgesics by federal state: Regional differences, especially when comparing expenditure

According to a survey by INSIGHT Health, outpatient BTM analgesic care in Germany had an expenditure volume of 900 million euros in 2008, valued at current pharmacy sales prices.
This results in expenses of 10.91 euros for BTM analgesics per German citizen. A comparison of the federal states shows that spending varies significantly between regions. In Bavaria, the lowest amounts are spent per citizen (8.41 euros), whereas in Mecklenburg-Western Pomerania the expenditure per resident is more than twice as high at 18.01 euros. What is particularly striking is the significantly lower fluctuation range in terms of sales figures per inhabitant: in the federal states with high per capita expenditure on BTM analgesics, on average, not necessarily significantly more units of analgesics are issued, but more expensive ones. The national average in 2008 was around 75.5 standard units of BTM analgesics per 1,000 inhabitants. While this value in Bavaria was 62.7, for Mecklenburg-Western Pomerania there are 100.7 standard units per 1,000 inhabitants (see Fig. 3).

BTM analgesics under discount agreement
Discount agreements between health insurance companies and the pharmaceutical industry do not stop at BTM analgesics. 27.6 % of the BTM regulations are now discounted within the GKV (basis: YTD 11/2008).
A year earlier, this was only 7.7 % of the corresponding statutory health insurance regulations. For fentanyl, the proportion of discounted prescriptions is highest at 46.0 % (YTD 11/2007: 12.7 %). Further relevant discount agreements exist for the BTM analgesics substances oxycodone and morphine.
An increasing number of discount contracts can be expected for 2009. For example, fentanyl is a significant part of the most recent DAK rebate tender, which ended on January 12, 2009. In the prescription analgesics segment (N02B1), 61.4 % of all prescriptions are already discounted today (as of YTD 11/2008) (see Fig. 4).
If one looks at the limits of the outlined growth in discounted regulations, the aut-idem quota must be considered as an essential parameter. This is the proportion of aut idem prescriptions that are crossed, i.e. that exclude substitution. Aut-idem regulations therefore limit the effect of discount agreements. According to INSIGHT Health, the 2008 Aut-idem rate of BTM analgesics was 27.4 %, well above the average Aut-idem rate of 14.4 %. Further differentiation by substance shows that the aut-idem rates of fentanyl (27.1 %), morphine (30.1 %) and oxycodone (28.6 %) are consistently at a high level. In contrast, other prescription analgesics (N02B1) with an aut-idem proportion of 14.0 % are even slightly below the average of all prescriptions (see Fig. 5).

Conclusion
As mentioned at the beginning, pain is usually a symptom and rarely a diagnosis (as with chronic pain). Therefore, the definition of the so-called pain market already represents a challenge. Given the numerous gaps in knowledge in the area of pain care and, not least, the high economic importance of the pain market, there is still a broad field of activity for health services research with many exciting questions.
In this article, the market was narrowed down to outpatient drug supply with BTM analgesics. This shows that innovations in terms of new substances and dosage forms are drivers of the pain market, as Professor Dr. Ludwig remarks in an interview with “Monitor Healthcare Research” (see p. 6 ff.).
However, these have different market access in the respective regions of Germany, which requires further differentiated analysis by healthcare research, for example in the context of population structure, inpatient versus outpatient care situation and the health insurance or cost provider structure. In addition, market parameters such as discount agreements and aut-idem quotas shape the scope of health insurance companies and drug manufacturers. It will be important to see how the future of the pain market shapes up with regard to the changes expected as part of the healthcare reform. <<

by: Christian Bensing*