The Standing Committee on Vaccination (STIKO) at the Robert Koch Institute (RKI) is responsible in Germany for issuing vaccination recommendations based on scientific standards. When vaccinations are administered accordingly, they make a significant contribution to the prevention of more than 25 infectious diseases. STIKO's vaccination schedule, published annually, provides a quick overview of which vaccinations are recommended for whom and when. STIKO distinguishes between standard, booster, and indicated vaccinations, as well as other vaccinations. The basic immunizations that should be administered in childhood include vaccinations against the classic childhood diseases measles, mumps, and rubella (MMR) and meningococcal C. These also include vaccinations against hepatitis B, pneumococcus, rotavirus, and varicella, and, since 2007, against human papillomavirus (HPV) for the prevention of cervical cancer. In addition, the STIKO recommends annual influenza vaccination with an antigen combination recommended by the WHO for people over 60 years of age, pregnant women and chronically ill people.
Vaccine supply
Since July 1, 2008, the Federal Joint Committee (G-BA) has regulated which vaccinations are reimbursed by health insurance funds in its vaccination guidelines, based on the recommendations of the Standing Committee on Vaccination (STIKO). All insured persons are entitled to this benefit, which also includes catch-up vaccinations and completing vaccination series. So-called private travel vaccinations are not reimbursed, except to prevent the introduction of a communicable disease into the Federal Republic of Germany (see the Federal Joint Committee's guidelines on vaccinations pursuant to Section 20d Paragraph 1 of the German Social Code, Book V, dated February 14, 2015). Many health insurance funds include vaccinations in bonus programs to encourage their members' preventive health efforts and reward their completion with cash or in-kind bonuses.
In the tightly oligopolized vaccine market, shared by only a few manufacturers, security of supply is repeatedly threatened by supply disruptions.
Shortages are being questioned. Even in September of this year, there were shortages, particularly of combination vaccines containing pertussis components. To be able to track supply bottlenecks for human vaccines at any time, the Paul Ehrlich Institute has been providing a tabular overview on its website since October 9, 2015, including possible vaccine alternatives and recommendations for action. In the entire vaccine market, only twelve manufacturers (excluding parallel importers) had more than one prescription in 2014 (compared to 15 manufacturers in 2010). The top five manufacturers together held a market share (based on revenue per unit) of 81.1 percent in 2014 (source: regioMA, INSIGHT Health).
Similar to the pharmaceutical sector, vaccines are also tendered via discount contracts. Health insurance funds almost exclusively publish tenders for seasonal anti-flu vaccines, which are intended to ensure the supply for insured members of various funds in specific regions. Recently, at the 5th German Influenza Congress, Eberhard Mehl, Managing Director of the German Association of General Practitioners, questioned "whether it is necessary to conclude discount contracts for vaccines in this manner, as they lead to an artificial shortage."„
The legislature has already reacted: The German Health Insurance Financial Structure and Quality Development Act (FQWG), passed by the German Bundestag on June 5, 2014, requires health insurance funds to conclude contracts with at least two pharmaceutical companies per healthcare region. Since January 1, 2013, a total of 13 tenders for seasonal influenza vaccines have been published on TED (Tenders Electronic Daily). Discount rates (based on defined daily therapy doses) for influenza vaccines were 12.5 percent in the second half of 2013 and fell to 6.1 percent in the same period of 2014 (Source: NVI-KT, INSIGHT Health).
In addition to the tender for influenza vaccines, AOK Hessen and AOK Niedersachsen issued a tender for HPV vaccines in 2014, which was recently cancelled because manufacturers refused to participate. Furthermore, Baden-Württemberg is the only German state that, in addition to its exclusive supply of influenza vaccines, issued tenders for other vaccines. However, since January 2015, vaccines against tick-borne encephalitis (TBE), Tdap-IPV (tetanus, diphtheria, pertussis, and polio), Tdap-IPV-Hib (with Haemophilus influenzae type b), meningococcal C, MMR, and varicella have no longer been subject to discount agreements (see Baden-Württemberg Association of Statutory Health Insurance Physicians).
Good measles vaccination status
Over the past five years, statutory health insurance (SHI) prescriptions for measles vaccine combinations have ranged between 1.45 million and 1.65 million doses. It is evident that combination vaccines are used significantly more often: for example, the MMR trivalent vaccine accounted for 60.8 percent of prescriptions in 2015. The quadrivalent combination, which includes immunization against varicella (chickenpox), accounted for 38.8 percent. With a prescription share of only 0.4 percent, the monovalent measles vaccine is now negligible in the SHI market.
According to the current vaccination schedule of the Standing Committee on Vaccination (STIKO) dated August 24, 2015, two doses of the primary measles vaccination are recommended, to be administered between the 11th and 14th month and between the 15th and 23rd month of life. Based on these recommendations and compared with actual consumption, an analysis by the IGES Institute concludes that, purely mathematically, the demand for MMR and varicella vaccines for infants and toddlers was met in 2013 (see Drug Atlas 2014). Data collected by the Robert Koch Institute (RKI) on children at the time of school enrollment also show vaccination rates that are almost sufficient to meet demand. The rate for the first measles vaccination increased from 92.5 percent in 2003 to 96.7 percent in 2013. As in previous years, Germany thus achieved the WHO target of at least 95 percent for the first measles vaccination. Although the rate for the second measles vaccination also increased during the period in question, it only reached 92.6 percent. This means that Germany's rate for the second measles vaccination is still below the 95 percent target for elimination. An increase in prescribed vaccine doses in the first three quarters of 2015 may bring us closer to the goal of elimination. While the average number of prescriptions covered by statutory health insurance has remained at 442,631 vaccine units per quarter since 2013, the total number of vaccinations from January to September already exceeds the total for 2014 (see Figure 1). A possible – though not necessarily causal – connection to the increased incidence of measles and the subsequent public debates could exist and have influenced vaccination behavior.
TBE vaccination achieved
High-risk regions
Differences in vaccination needs and recommendations become particularly clear when looking at the regional aspects of TBE vaccination. While in Bavaria and Baden-Württemberg, ten TBE vaccination units were administered per 100 people with statutory health insurance in 2014, the rate in the northern German states is reduced to one prescription per 100 people with statutory health insurance (see Fig. 2). This corresponds to the RKI's recommendation to vaccinate individuals with increased exposure in high-risk regions such as Baden-Württemberg, Bavaria, Hesse, Rhineland-Palatinate, Saarland, Saxony, and Thuringia.
Fewer flu vaccinations
The influenza vaccination recommended by the Standing Committee on Vaccination (STIKO) should be administered annually to at-risk groups. Nevertheless, the multi-year trend shows a downward trend. While prescriptions totaled 16 million doses in 2010, they fell to 13.1 million doses in 2014 (source: regioMA, INSIGHT Health). These figures also reflect the results of the needs assessment and supply analysis of influenza vaccines conducted by the IGES Institute. A comparison with the number of standard vaccinations recommended by STIKO for the respective age groups revealed a need for approximately 20.3 million doses of seasonal influenza vaccine in 2013. The 13.4 million doses prescribed in the same year, however, were significantly below the calculated need (see Drug Atlas 2014).
In addition to declining prescriptions for influenza vaccines, significant regional differences are evident between the former East and West German states (see Fig. 3). To compensate for the differing age structures of the 17 regional associations of statutory health insurance physicians (KVs), prescriptions are considered in relation to the number of individuals over 60 years of age covered by statutory health insurance, regardless of vaccination recommendations for other risk groups. In 2014, the figures varied from just under 0.5 vaccine units in Rhineland-Palatinate to one vaccine unit in Brandenburg, Saxony-Anhalt, and Mecklenburg-Western Pomerania. Thus, in some of the former East German states, twice as many influenza vaccine units were prescribed as, for example, in the KVs of Bavaria and Baden-Württemberg.
Conclusion
The G-BA's vaccination guidelines ensure that the statutory health insurance (GKV) services cover the independent recommendations of the STIKO (Standing Committee on Vaccination), thereby directly translating scientifically sound findings into healthcare practice. This analysis also shows that vaccination coverage in Germany is at a stable and high level. However, it also highlights areas where there is still room for improvement. In addition to the challenges of complying with the WHO elimination programs, regional differences in healthcare provision are also evident. Significant variations in vaccination behavior between the former East and West Germany suggest differing levels of willingness to be vaccinated. This could potentially be improved through more intensive public education. To sustainably increase vaccination rates in the population without restricting patients' autonomy through mandatory vaccination, more in-depth counseling by health insurance companies and treating physicians would be a possible approach.

Authors:
Kathrin Pieloth, Jana Heiler

Citation information: doi: 10.24945/MVF.06.15.1866-0533.1929