Numbers and data on discount contracts: What do we know and what don't we?

With the GKV Competition Strengthening Act (GKV-WSG), the discount regulation in the area of drug supply was brought into focus on April 1, 2007 and an obligation to sell discounted products in pharmacies was introduced. The legal framework has existed in its current form for over 3 years, apart from the expansion of the selection of medicines through the new framework agreement on the supply of medicines in 2008. At the beginning of the discount agreement era (April 2007), there were 2,924 agreements for 18,954 products in accordance with Section 130a Paragraph 8 SGB V, whose partners were 241 health insurance companies and 70 pharmaceutical companies. There are now 11,936 discount agreements for 31,587 active forms of trading, in which 169 health insurance companies and 138 pharmaceutical companies were involved (March 2010).

>> The instrument of drug discount contracts was introduced by the legislature into the statutory health insurance (GKV) system with the aim of reducing or curbing rising drug expenditure. Such discount agreements are contractual agreements between pharmaceutical companies and health insurance companies about the exclusive supply of individual drugs from the manufacturer to those with health insurance, in which the price of the drug is then reduced through reimbursements.
It all started with the Contribution Rate Guarantee Act, which came into force on January 1, 2003. The pharmaceutical industry was obliged to provide a collective discount in the form of discounts on medicines that are supplied at the expense of the GKV. Medicines from a fixed price group according to Section 35 or Section 35a SGB V are not affected by this regulation. The pharmacies pay the deductions amounting to 6 % of the manufacturer's retail price to the health insurance companies and are subsequently reimbursed by the manufacturer. Since 2003, health insurance companies have been able to conclude fund-specific discount contracts with manufacturers in accordance with Section 130a Paragraph 8 SGB V.
When the law to improve the cost-effectiveness of drug supply (AVWG, May 1, 2006) came into force, the existing regulations were expanded to the extent that service providers such as doctors could also be involved. However, without targeted support for prescribing and dispensing discounted preparations, health insurance companies had little influence on sales volumes. It was only with the GKV Competition Strengthening Act (GKV-WSG) that came into force on April 1, 2007 that the path was paved significantly for health insurance companies to be able to conclude discount agreements with pharmaceutical manufacturers more effectively than before. The existing aut-idem regulation for drug supply (distribution of the prescribed drug or one of the three cheapest comparison preparations by pharmacies) was modified for this purpose. Since then, pharmacies have had to give preference to a group of comparable medicines for which there are discount agreements with the respective health insurance companies, unless the doctor has excluded the exchange using an aut-idem cross on the prescription. The aut-idem regulation applies as before April 1, 2007 if there is no discount agreement, the discounted medication is not available or urgent delivery of a medication is required. Pharmaceutical concerns can also be a reason for a different approach. With the new framework agreement on the supply of pharmaceuticals in accordance with Section 129 Para. 2 SGB V, which came into force on April 1, 2008, the selection of drugs was also expanded to include areas in which the Federal Joint Committee (G-BA) did not provide any information on the interchangeability of dosage forms within the meaning of Aut idem regulation has been in place (Pharmatrix, 2008).
Discount contracts: “A (never-ending) story”
On April 1, 2007, drug discount agreements became effective at many statutory health insurance companies, and the drug market changed fundamentally. Over time, the number of contracts continued to increase significantly. In December 2008, 215 health insurance companies concluded a total of 5,777 discount agreements with 116 pharmaceutical companies in accordance with Section 130a Paragraph 8 SGB V, which corresponds to an increase of 80.9 % compared to the same month of the previous year (December 2007) (Table 1). In the following year, in December there were 9,339 discount contracts between 184 health insurance companies and 141 companies, 61.7 % more than in the previous year. If you look at the discounts at the level of the pharmaceutical central number (PZN), which also clearly identifies the different potencies and packaging sizes of a drug, the result for December 2009 is an unmanageable total of 2.6 million, which is an increase of 24.2 % corresponds to the same month last year and more than doubles compared to the level in December 2007.
Discount contracts can be divided into active ingredient contracts, i.e. discount contracts for individual (patent-free) active ingredients, into portfolio contracts, i.e. discount contracts for the entire range of a pharmaceutical company, and into original contracts or supply contracts with discount agreements for individual original preparations. In this context, for example, the discount agreements with manufacturers of short-acting insulin analogues to reduce the costs to the level of human insulin should be mentioned. Since September 29, 2006, short-acting insulin analogues for the treatment of type 2 diabetes mellitus (insulin aspart, insulin glulisine, insulin lispro) cannot be prescribed, with exceptions, as long as they are associated with additional costs compared to short-acting human insulin (G-BA, 2006 ). However, through discount agreements between health insurance companies and manufacturers on price equivalence, some of which came into effect almost immediately after the decision came into force in October (i.e. before the active ingredient and portfolio contracts since April 1, 2007), in many cases the insured were able to continue using short-acting analogue insulins be supplied.
While the replacement funds tend towards portfolio contracts, the AOKen tend to have active ingredient contracts (Schumacher et al., 2009). Overall, the AOK can without a doubt be described as a pioneer in pharmaceutical discount agreements. Its first season began on April 1, 2007 with agreements on 42 active ingredients. As evaluations in this regard showed, the contracts sometimes differed greatly between the individual AOKs. In addition, extremely short contract periods were revealed (Hoffmann et al., 2009). The shortest term for the stomach medication omeprazole within the second contract season in the example of AOK Bayern was only 2 months (Table 2). At times, up to 36 different medications containing this active ingredient were discounted from various manufacturers (Table 2).
A large number of contracts with different manufacturers and the sometimes short terms can mean frequent changes of medication, especially for chronically ill people who are on long-term medication. As far as this point is concerned, the AOK contracts from the third season onwards point in the right direction with only one manufacturer per active ingredient and area lot and at least a two-year term.
Legal disputes were a constant companion of the discount agreements. For example, at the end of February 2008, the Baden-Württemberg State Social Court temporarily stopped negotiations between the AOK community and various pharmaceutical companies in an urgent procedure. The starting point were disagreements between the AOK and the public procurement chamber of the Düsseldorf district government and the federal government. They prohibited the AOK from entering into discount agreements because medium-sized pharmaceutical companies were exposed to competitive disadvantages. The AOK previously won a case in the first instance at the Stuttgart Social Court, but the Düsseldorf Public Procurement Chamber lodged an objection and new negotiations took place. The Public Procurement Chamber was able to prevail (decisions dated February 27, 2008 Ref. L5 KR 507/08 ER-B and L5 KR 6123/07 ER-B) and brought about an end to the ongoing contract negotiations. The AOK was accused of a lack of transparency and violations of the principle of equal treatment.
New discrepancies arose with the introduction of the active ingredient-related discount contracts of the third AOK season from June 1, 2009. This time it was about the interpretation of the terms “identical pack size” and “same indication area”. According to the legal regulations, the medicine dispensed must be identical to that prescribed in terms of potency and packaging size, approved for the same indication area and have the same or interchangeable dosage form (Pharmatrix, 2008). In order to achieve a high proportion of discounted preparations, the AOK tried to interpret the terms “same indication area” and “identical pack size” as broadly as possible. Many generics do not have the full range of indications as the original product, which has become off-patent. While the report by the lawyer Dierks (2009), commissioned by the pharmaceutical industry, comes to the conclusion that an obligation to substitute only exists if the drug to be dispensed is approved in all areas of application of the prescribed drug, the interpretation of the Almost as expected, the report commissioned by AOK was different: According to the current state of science, it can be assumed that generics have the same safety profile and the same effectiveness in all of the areas of application for which the reference drug has been approved. Therefore, in terms of liability law, there is nothing to be said against selling a generic drug, even if there is no approval for certain indications compared to the prescribed preparation (Ehlers et al., 2009). However, such an exchange can unsettle the patient, as the package insert may neither list his illness nor the relevant dosage instructions.
The term “identical pack size” has also been controversial since 2009. The background at the time was the AOK discount agreements for omeprazole with the company KSK-Pharma AG for pack sizes of 15, 28, 56 and 98 pieces, which deviate from the standard number of pieces (20, 50, 100 pieces). This is apparently the reason why the AOK now takes the position with regard to the “identical pack size” according to the law that all packs with the same N standardization (N1, N2 or N3 correspond to small, medium or large pack sizes) are viewed as identical regardless of the number of items contained in the medication pack.
A legal report commissioned by the AOK comes to the same conclusion (Kingreen, 2009). Since, in the case of the active ingredient Omeprazole, N3 packs with a content of 56 capsules up to the usual 100 capsules are available on the market, an exchange based on the standard size and not the number of units can mean that a patient can take a preparation based on the discount agreements in the pharmacy I was given 56 capsules even though the doctor “meant” 100 capsules. The AOK interpretation not only caused a lack of understanding among the pharmaceutical industry (Pro Generika, 2009), but especially among pharmacies. On March 15, 2010, the latter in the state of Baden-Württemberg even received “serial threatening letters” from the AOK based there, in which the pharmacies demanded immediate, complete substitution (Apotheker Zeitung, 2010).
Ultimately, the points mentioned above have not been clearly clarified to this day. The example of Spectrum|K, a joint venture between company health insurance companies, showed that there is a different way to do it, which specified exact pack sizes (with information on the number of units) when tendering. In addition, drugs with critical bioequivalence, such as antiepileptic drugs, were not included in the Spectrum|K contracts. However, a “discount ranking” caused a lot of discussion, according to which Spectrum|K requires pharmacists to follow a certain order when dispensing up to four discount partners per active ingredient in order to achieve maximum savings from the discount contracts (apotheke adhoc, 2010a ).
There is no end to the discount agreements in sight. As of March 1, 2010, the discount agreements for 52 active ingredients negotiated by SpektrumK for 80 health insurance funds with 7 million insured persons were launched, and the Techniker Krankenkasse concluded discount agreements for 89 active ingredients on April 1, 2010. At the same time, the fourth season of the AOK discount agreements started for a further 80 medicinal products, with the fifth season scheduled to follow in October (apotheke adhoc, 2010b). The chief negotiator of the AOK discount agreements, Christopher Hermann, deputy chairman of the AOK Baden-Württemberg, never tires of emphasizing the success of the pharmaceutical discount agreements and cites enormous, ever-increasing savings potential. He expects a savings volume of one billion euros by the end of 2010 (AOK BV, 2010), a sum that unfortunately cannot be verified, especially not as net savings after all transaction costs have been deducted.
Studies on discount contracts
There are now a number of studies on the effects of discount agreements, some of which differ considerably in their results and their interpretation. The following statements should make this clear: On the one hand, patients do not accept that the health insurance company has any influence on the prescribed preparations (Gröber-Grätz & Gulich, 2010) and after switching to discounted medicines, almost half of the patients complain about undesirable effects (Neises et al., 2009). On the other hand, however, the majority of insured people welcome the fact that health insurance companies conclude discount agreements with drug manufacturers and there are no problems with switching to discount drugs (WIdO, 2009). A total of 89.5 % respondents would like to keep their usual medication (Gröber-Grätz & Gulich, 2010). At the same time, for 86.9 % of those surveyed, the manufacturer of the medication does not play a role as long as the quality is good (WIdO, 2009).
How can such differences be explained? First of all, you have to ask yourself who benefits from such results. The last cited survey of 2,025 insured persons, from which the conclusion was drawn that they generally rated the discount contracts positively, comes from the documents for the AOK press conference on May 6, 2009 at the start of the third season of the discount contracts. However, a full-text publication with a more detailed description of the methodology and further results is not available, which is why it is not possible to critically assess the study. Interestingly, there was a preview of exactly this survey in WIdOmonitor 2/2008 with the following wording: “The next WIdOmonitor examines the perception and acceptance of drug discount contracts among those insured by statutory health insurance.” In fact, the survey in question was not published at all; Next issue with “Expectations of the statutory health insurance after the introduction of the health fund”. For the marketing of the fourth season of the AOK discount contracts, the results of a survey of almost 6,000 insured people from AOK Baden-Württemberg were again presented selectively (Herrmann, 2010; Rottschäfer, 2010). This would be the largest survey conducted to date on patients' views on discount contracts - will we ever be able to expect a full-text publication on this? Such studies, which are clearly driven by interests and carried out exclusively for marketing purposes, the results of which are used selectively and whose use was previously the “privilege” of pharmaceutical companies, are no longer a foreign concept among health insurance companies (Hoffmann & Glaeske, 2009). We consider this to be an extremely worrying development!
The other study cited above was published in the “Pharmazeutische Zeitung” in autumn 2009 under the title “Do discount agreements make you sick?” According to this study, 49 % of the 135 patients surveyed in doctors' practices or pharmacies whose medication was changed due to discount contracts complained about side effects, one in four even complained about severe side effects (Neises et al., 2009). Although published, important methodological information is also missing from this study, for example: How were practices/pharmacies selected? How were the patients recruited? How high was the response? And who sponsored the study? The first author has also held a Stada endowed professorship since 2003 and is therefore (co-)financed by one of the largest generic drug manufacturers. Even if the study authors make the absolutely supportable demand that the instrument of discount agreements must be critically examined, the results regarding side effects do not necessarily seem plausible. After all, generics have to prove their bioequivalence during approval and often even come from the same “machine” as the original. In the other study, which was not necessarily positive for discount contracts, the questions were chosen rather poorly. Or would you answer the question: “Do you want to keep your usual medication?” with “not applicable”? As expected, 89.5 % respondents also chose “apply”.
Conclusion
Above all, these studies underline a well-known point in survey research: people often do not have a preconceived opinion on a topic before the survey, but rather they “react” (Noelle-Neumann & Petersen, 2000). According to two surveys carried out in spring 2008, 62 % and 60 % of those with statutory health insurance were aware of discount contracts (Leutgeb et al., 2009; Pfannkuche et al., 2008). According to the survey quoted at the press conference for the third season, only 32 % of AOK insured people were informed about discount contracts (WIdO, 2009). Having heard of it does not mean being able to fully assess the background and effects of this instrument.
Although almost two thirds of the respondents in the study by Leutgeb et al. (2009) knew about discount contracts, only a third (34 %) knew that health insurance companies had a contract with a specific manufacturer. Hardly any more agreed with the statement that the effect of the medication being replaced is identical (41 %). The results of the Bertelsmann Health Monitor also point in the same direction, according to which the majority of respondents did not give a clear assessment of discount contracts: 34 % answered “partly/partly” and a further 19 % answered “don’t know” (Pfannkuche et al., 2008 ). The question formulation would be all the more important if reactions are generated on topics on which one does not have a clear opinion or about which one does not know much.
This certainly explains some of the differences between studies. On the other hand, strong opinions cannot be shaken by tendentious questions. If someone thinks football is terrible, you couldn't elicit a "I think it's good" with a question: "What do you think of football, an extremely entertaining outdoor sport that millions of Germans are already enthusiastic about?" never thought about it.
Not black or white,
but above all not evidence-based
According to the AOK, discount contracts significantly reduce the burden on statutory health insurance, they are a long-term, proven model of success, are accepted by everyone involved and also promote a variety of offers and competition (Rottschäfer, 2010)! According to the Federal Ministry of Health, competition in turn should create more responsiveness to needs, more quality, more efficiency, lower costs and less bureaucracy. Busse (2009) rightly asks at this point how evidence-based such statements or the corresponding interventions are?
With regard to the discount contracts, the existing cross-sectional studies without a control group are not suitable for deriving statements about the patient-relevant benefits or harms of this intervention, the extent of which those affected cannot even estimate themselves. Ideally, randomized controlled studies with control regions, but also prospective cohort studies with before-and-after comparisons would be conceivable. However, such studies have not been carried out.
Due to the lack of high-quality studies, an IQWiG benefit assessment for discount contracts would come to the conclusion that there is no evidence of the benefit of discount contracts and no additional benefit compared to conventional care. Discount contracts would consequently have to be deleted from the GKV's catalog of services. So why doesn't health policy question its own reform measures just as rigorously as, for example, new medicines (Busse, 2009)? Why are effectiveness, safety and pharmaceutical quality required for the approval of medicines - quite rightly in order to protect patients from ineffective or even harmful drugs - while health policy interventions are introduced as mass experiments?
If discount agreements were medicines, they wouldn't even be approved. On the one hand, with the establishment of IQWiG, among other things, the focus is increasingly being placed on quality and evidence-based healthcare. On the other hand, at the system level, interventions are introduced and, above all, continued almost at will without any evidence. There are also no “termination criteria” as in clinical studies. There is also no provision for continuous adaptation based on the available studies, as is usual with guidelines, for example.
Policy follow-up research is urgently needed. Health services research offers a corresponding methodological instrument (Glaeske et al., 2009). Health policy is often expert opinion and therefore evidence of the lowest level, which also does not critically question its own approach. Methodologically high-quality studies in the sense of a hurdle that can be overcome as a “proof of principle” are of course expensive and delay the introduction of a health policy intervention. But this also applies to medications. Why is there a double standard here? The introduction of discount contracts and other competitive elements in healthcare appears to be a prioritization of economic aspects over quality aspects. But even for these cost savings that are repeatedly touted, there is no reliable data available. <<