>> As the name of the law suggests, the biggest role in the GSAV is played by the safety of medicines, a health policy consequence of the scandals surrounding counterfeit or contaminated medicines in recent years. Also prominent is the mandatory introduction of electronic prescriptions, which is now legally stipulated. The new law also contains new regulations on the handling of imported drugs, new therapies and the care of hemophilia patients (see Fig. 1). As a result, the measures affect numerous people involved in the supply of medicines and ultimately also the patients. The regulations are intended not only to make medicines safer, but also to improve patient care.
Imported medicines are medicines imported from abroad that, due to the price difference in the European Union, can be sold to pharmacies more cheaply than those produced directly in the country (see vdek, 2019). Patent-protected medicines in particular have a significant price difference, so that in this segment the sale of an imported medicine can make a contribution to fulfilling economic reserves. According to Section 129 SGB V, the framework agreement for drug supply, pharmacies were previously obliged to fulfill an import quota of 5% per health insurance company and quarter. An imported medicine had to be sold if the selling price relevant to the insured was at least 15 percent or at least 15 euros lower than the price of the reference medicine (cf. AOK Bundesverband, 2016). The new framework agreement, which has been in force since July 1, 2019, provides for the following grading for medicines without a discount agreement before the GSAV comes into force: The sale of a low-cost imported medicine is relevant if there is a price difference of at least 15% for a selling price of up to and including 100 euros, and for a selling price of over 100 euros up to and including 300 euros, there is a price difference of at least 15 euros and with a selling price over 300 euros there is a price difference of at least 5% to the reference medicinal product. With these regulations, Section 13 paragraph 5 of the framework agreement sets a savings target of 2%. In the MAT (Moving Annual Total) May 2019, imported medicines account for around 20 million prescriptions, a share of 2.9% of all packs dispensed in the GKV's entire finished medicines market. This means they represent sales of 3.25 billion euros (according to AVP) in the same period under review. This corresponds to a sales share of 7.8% in the overall market (source: NVI, INSIGHT Health). While the debates and statements on the GSAV were still about the complete abolition of the import support clause, the current resolution provides for differentiated regulations and excludes biopharmaceuticals and cytostatic preparations. In addition, according to the law, the National Association of Statutory Health Insurance Funds must submit a report on the effects to the Federal Ministry of Health by the end of 2021, on the basis of which the current regulations will be reviewed, evaluated and, if necessary, decided on whether to continue them.
Similar to the import support clause, a controversial debate also arose around the automatic substitution of certain biologics in pharmacies. The proposal to exchange biosimilars in the same way as generics in the future was followed by requests for changes from various players in the health system. In a hearing of the professional associations, only the GKV voted for the substitution. The current version of the GSAV postpones the exchange by three years. However, one year after the law comes into force, the G-BA should specify in the guidelines according to Section 92 Paragraph 1 instructions for medical prescriptions on the interchangeability of biological reference medicinal products with essentially the same biotechnologically produced biological medicinal products, taking into account their therapeutic comparability. Information on the interchangeability of biological reference medicinal products by pharmacies will follow no later than three years after it comes into force. What is crucial for the definition and therefore the supply is the interchangeability with regard to a specific reference medicinal product. This means that automatic substitution can be limited to adequate treatment alternatives. But for now, with this transitional regulation, treatment sovereignty remains with the doctors.
Based purely on the number of biosimilars currently available on the German market, the future regulations of the GSAV only affect a very small part of the biopharmaceuticals market. Because of a total of 153 biotechnologically produced active ingredients (excluding vaccines, test diagnostics, radiopharmaceuticals), there are only biosimilars for 13 active ingredients - currently 38 preparations in total. Based on regulations in the GKV, the biosimilar share of the entire biosimilar-capable market is 12.3% (MAT May 2019). The proportion of interchangeable biosimilars, i.e. bioidenticals (definition according to the framework agreement according to Section 129 Paragraph 2 SGB V, Annex 1), is significantly lower at 3.7%. An example of the market shifts between originals, biosimilars and bioidenticals is shown in Figure 2 for the active ingredient infliximab. As expected, the prescription share of the original Remicade is falling steadily, with an increasing share of biosimilars up to 70.8% in the 1st quarter of 2019. At the same time, the two bioidenticals Remsima and Inflectra dominate with increasing shares of all infliximab prescriptions, but are continuously losing in relation to all biosimilars . The biosimilar Flixabi in particular has seen increasing prescriptions in the last four quarters. And the latest biosimilar Zessly is also slowly arriving on the market (source: NVI-Plus, INSIGHT Health).
In order to be able to better assess what effects the automatic substitution of biosimilars will have in pharmacies, the provisions of the G-BA on the interchangeability of biological reference medicinal products, also taking into account their therapeutic comparability as mentioned, must be awaited. In its statement on the GSAV from April 2019, the committee itself welcomed the planned strengthening of the exchange of biological medicines. The G-BA also formulated the option of obtaining information from the BfArM or the Paul Ehrlich Institute in order to implement the regulatory mandate and in particular to assess therapeutic comparability. It therefore remains to be seen whether the period of one or three years provided for in the law is sufficient for an assessment.
Patients with hemophilia now have a longer life expectancy thanks to good treatment options
close to the population average. In Germany, around 5,000 to 6,000 patients are affected by
mophilia A or B affected. In addition to the clotting factor preparations obtained from blood donations, genetically engineered alternatives are also available (see PEI 2019).
With the GSAV, the previous exception to the pharmacy sales channel, i.e. direct sales by the manufacturer to doctors and hospitals, is withdrawn for the group of genetically engineered drugs. The processes are thus adapted to the regulations for other biologics. However, they explicitly do not affect the emergency supplies that medical facilities specializing in hemophilia are allowed to keep on their premises and provide to patients or health care facilities. The GSAV wants to create price transparency in the hemophilia market by obtaining the manufacturer's sales prices, taking into account the quantities supplied, which both the pharmaceutical company and the billing health insurance companies transmit to the GKV-SV. With this information, after a plausibility check, the manufacturer's selling price is adopted or set by the GKV-SV.
However, the distribution channel via the pharmacy creates new reporting obligations for them. In the case of hemophilia preparations, the name and further details of the medication dispensed as well as the patient's master data must be sent from the pharmacy to the German Hemophilia Center. In the past, this was done by the treating doctor. For the newly defined distribution channel, the expanded documentation requirement for all specific drugs approved for hemophilia therapy is intended to ensure more security and transparency in supply. So that the long-term effectiveness and safety of the therapy can be better assessed, the medical reporting requirement and correspondingly the German hemophilia register at the Paul Ehrlich Institute will be expanded (see DAZ, 2019).
With regard to compatible solutions, the struggle between the actors over entire chapters, individual sections and details in the GSAV was great until it was passed. Dates stipulated in the law until certain requirements and deadlines have to be implemented appear to have created room for compromises throughout the entire process. The most famous quote in this context, “Patients must be able to rely on the fact that medications heal and do not harm them,” comes from Jens Spahn. And despite numerous points of criticism, Martin Litsch (Chairman of the AOK Federal Association) also found: “The law is absolutely the right step and contains many good regulations to improve the safety of medicines.” The next few months will show how the contents are implemented in practice and what concrete steps are necessary for this. <<
Author: Kathrin Pieloth*
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