|Implemented in this survey?|
To reduce the incidence of cervical cancer, a vaccination against the Human Papilloma Virus (HPV) has been included into the benefit basket of German statutory sickness funds for girls between 12 and 17 years of age in the spring of 2007. Recently, a discussion about the efficiency of HPV vaccination has been developing.
Worldwide, cervical cancer (cancer of the cervix) is the second or third most common cancer among women with an estimated 500,000 new cases and almost 260,000 deaths in 2005 (WHO 2006). In Germany, there are about 6,500 new cases each year, which corresponds to 3.2% of all cancer incidents and 1.8% of all cancer related deaths among women (RKI 2006).
Since 1970, a pap smear is part of the annual cancer prevention program of statutory sickness funds. Since then, the prevalence of cervical cancer among German women has been decreasing. In Germany, it is the currently the 10th most common cancer among women. In a European comparison that means a place in the middle field (RKI 2006). The incidence of cervical cancer in Germany is 10.8 new cases per 100,000 women (according to the Globocan 2002 database).
Cervical cancer is in the large majority of cases caused by some genotypes of the Human Papilloma Virus (HPV). Among the high-risk types of HPV are HPV 16 and 18 (RKI 2007, 98). They are the main targets of the existing HPV vaccines, the first of which (Gardasil) has been approved for the German market in September 2006.
About 70% of women are at some point of their lives infected with HPV. In the majority of cases (70-90%), the infection is defeated by the immune system and vanishes without causing harm. If a HPV infection turns chronical, however, there is a possibility for it developing into cervical cancer (RKI 2007, 98).
There is no data on the prevalence of HPV infections in Germany (RKI 2007, 98). A recent US-American study concludes that about 1.5% of women between 14 and 59 years of age are infected with HPV 16 and 0.8% with HPV 18 (Dunne 2007).
To further reduce the incidence of cervical cancer, the immunization against HPV has been included into the benefit basket of German statutory sickness funds for girls between 12 and 17 years of age.
There has been a large information campaign in the media targeting mothers, stating that HPV vaccination is a possibility to protect their daughters from cervical cancer. The inclusion of the vaccine into the benefit basket means that immunization is free of charge for girls between the ages of 12 and 17. In some federal states, there have been initiatives to vaccinate all girls in this age group at school. Some statutory sickness funds cover the immunization for women until the age of 26, since the vaccines have been approved for women up to this age.
Mainly girls between the ages of 12 and 17 years, pharmaceutical companies that produce HPV vaccines, sickness funds
|Medienpräsenz||sehr gering||sehr hoch|
After HPV vaccination was initially greeted by mainly positive reactions in Germany, recently criticism regarding its efficiency and safety is finding broader resonance in the media.
Immunization is not compulsory in Germany, but the Standing Vaccination Committee (STIKO) gives recommendations on vaccinations. STIKO is the major federal commission concerned with vaccination issues. Its responsibilities include issuing advice regarding vaccination practices. They issue a yearly immunization reference guide entitled "Empfehlungen der Staendigen Impfkommission" (Recommendation of the Standing Vaccination Commission). Each year are the new immunization schedule, references and resource information in regard to the schedule, and standards for administration of vaccines (Schutzimpfungen) are announced. The immunization scheldule, changes to immunization recommendations as well as justifications and comments are disseminated via an epidemiological newsletter ("Epidemiologisches Bulletin") (for English information on the STIKO see www.rki.de).
The STIKO meets at least twice a year. It consists of 17 honorary members selected by the Minister of Health in consultation with professional societies. Members include experts in virology, microbiology, immunology, infection control, paediatric, and other clinical practice. There is also a representative from the statutory insurance companies.
The "Statutory Health Insurance Competition Strengthening Act" (SHI-CSA), which came into force in April 2007 (see report "Health care reform in Germany: Not the big bang" 8/2006), commits the statutory sickness funds to automatically include all vaccinations recommended by the STIKO into the benefit basket. Based on the STIKO recommendation, the Federal Joint Committee of service providers and statutory sickness funds ("Gemeinsamer Bundesausschuss" G-BA), the paramount decision-making body of the self-government, decides within three months about the inclusion of a vaccination into the SHI benefit basket. Only in well-founded exceptional cases can the G-BA come to a conclusion not in line with STIKO recommendations. Prior to the SHI-CSA, immunizations were optional, non-statutory benefits covered by the sickness funds.
In March 2007, the STIKO published a recommendation on HPV vaccination stating that all girls between the ages of 12 and 17 years should be immunized. It further recommended that vaccination would be most effective following a structured approach including all relevant actors, in order to guarantee immunization of as many youth as possible before their first sexual intercourse.
Half a year before this recommendation was issued, Gardasil (produced by Sanofi/Merck) was the first HPV vaccine to be approved for the German market, Cervarix (produced by GlaxoSmithKline) followed in September 2007. The vaccination is costly: The three necessary doses of Gardasil are sold to statutory sickness funds at 465 Euro (currently about USD 680), a much higher price than in other countries (in the US, Gardasil sells for USD 360).
|Implemented in this survey?|
HPV vaccination is currently on the health policy agenda of many countries, although there is no official supranational initiative on this matter. There have been similar developments in other countries (e.g. see HPM reports from Canada, New Zealand, Switzerland and California).
Screenings come first
The European Commission argues that HPV vaccination does not give 100% protection against cervical cancer, while countries that have organized cervical cancer screening programs have substantially reduced cervical cancer incidence and deaths. Therefore, HPV vaccination is not a replacement for routine cervical screening. Since HPV vaccines will not provide protection against all HPV types, nor against existing HPV infections, the European Commission recommends that authorities carry out population-wide, quality assured cervical screening by pap smear (according to the EU guidelines) before introducing HPV vaccination into the population.
The scientific community and physicians are divided on the HPV vaccination.
A recent Health Technology Assessment on HPV vaccines by the Austrian Ludwig Boltzmann Institute comes to the conclusion that a strategy of immunizing 12-year-old girls in addition to screening leads to 9-10% fewer cervix carcinoma cases during 2008 and 2060 and 11-13% fewer fatal cases. The reduction is delayed and initially small increasing continuously until 2060. The calculated cost-effectiveness predicts a discounted cost efficiency ratio of 64,000 Euro per life year gained (public payer perspective) or 50,000 Euro (societal perspective). The calculated costs of such an immunization program correspond to roughly 5% to 10% of the Austrian budget for prevention, leading to fewer resources for other measures. Based on these results the authors recommend an improvement of screening as the first policy option. Vaccination is only recommended under improved cost-effectiveness due to a lower vaccine price. (LBI 2007)
Criticism concerning transparency of STIKO recommendations
Sickness funds fear triplication of costs for immunization
In October 2006, statutory sickness funds published a joint position paper regarding the "Statutory Health Insurance Competition Strengthening Act" (SHI-CSA). Among other points, they criticized the upcoming obligation for sickness funds to automatically include STIKO recommendations into the benefit basket. They warned that a complete realization of STIKO recommendations would lead to a triplication of the costs that had so far been covered by the sickness funds in the field of immunization - adding up to 1.6 billion Euro in additional costs for the sickness funds. Furthermore, the position paper mentioned a close connection between the STIKO and the pharmaceutical industry and stated that in the past in some cases STIKO recommendations had later to be revoked because of new findings regarding health risks related to immunizations.
However, the sickness funds have not protested the inclusion of HPV vaccination into the benefit basket for girls between 12 and 17 years of age. A number of them even offer reimbursement for women up to the age of 26.
How transparent and independent are STIKO recommendations?
A too close connection between the STIKO and the pharmaceutical industry has also been implied by the Green party in parliament. As an opposition party it has entered an official question addressed at the federal government in October 2007, criticizing a lack of transparency regarding decisions of the STIKO and possible connections of its member to the pharmaceutical industry. Since vaccinations recommended by the STIKO are now paid for by the members of statutory health insurance, the Green party called for increased transperancy. In its response, the government coalition of CDU and SPD rejected the idea of insufficient transparency in the work processes of the STIKO. However, the government also decided to have members of the STIKO publish possible conflicting interests on the internet, beginning by the end of 2007.
The quick recommendation of the STIKO for HPV vaccination has also contributed to a public discussion regarding STIKO's independence. One information discussed in the media was the fact that former STIKO chairman Heinz-Josef Schmitt was awarded and accepted a 10,000 Euro award in 2006 for his efforts to promote immunization as an effective means of prevention. The award was paid for by Sanofi Pasteur, producers of Gardasil. In September 2007, Schmitt left the STIKO to work for Novartis Vaccines and Diagnostics (Berndt 2007; Goerlitz 2007).
|Professional association of gynecologists||sehr unterstützend||stark dagegen|
|German association for gynecology and obstetrics (DGGG)||sehr unterstützend||stark dagegen|
|Federal association of women's health centers||sehr unterstützend||stark dagegen|
|Physicians for an individual decision on vaccination||sehr unterstützend||stark dagegen|
|Statutory sickness funds||sehr unterstützend||stark dagegen|
|Private sickness funds||sehr unterstützend||stark dagegen|
|German Cancer Research Center||sehr unterstützend||stark dagegen|
|Social Science Research Center Berlin (WZB), Rolf Rosenbrock||sehr unterstützend||stark dagegen|
|German Cancer Association (Deutsche Krebsgesellschaft e.V. - financed by pharmaceutical industry)||sehr unterstützend||stark dagegen|
|Privatwirtschaft, privater Sektor|
|Pharmaceutical companies||sehr unterstützend||stark dagegen|
No legislation necessary. Since the new SHI-CSA recommendations of the STIKO are automatically included into the benefit basket of the statutory sickness funds.
|Professional association of gynecologists||sehr groß||kein|
|German association for gynecology and obstetrics (DGGG)||sehr groß||kein|
|Federal association of women's health centers||sehr groß||kein|
|Physicians for an individual decision on vaccination||sehr groß||kein|
|Statutory sickness funds||sehr groß||kein|
|Private sickness funds||sehr groß||kein|
|German Cancer Research Center||sehr groß||kein|
|Social Science Research Center Berlin (WZB), Rolf Rosenbrock||sehr groß||kein|
|German Cancer Association (Deutsche Krebsgesellschaft e.V. - financed by pharmaceutical industry)||sehr groß||kein|
|Privatwirtschaft, privater Sektor|
|Pharmaceutical companies||sehr groß||kein|
No official evaluation is planned.
There is an ongoing debate about the effectiveness, efficiency and safety of HPV vaccination. The effects of this policy are therefore difficult to assess at this point in time. Further clinical studies will make an assessment of outcome and costs more reliable.
A call for more comprehensive screening
In any case, HPV vaccination has to be seen as one part of public health strategies against cervical cancer. It is important to prevent a negative effect on screening efforts, which have already proven to be effective. Currently, only 50% of women take part in cervical cancer screening (Rosenbrock 2007). To expand screening efforts to reach as many women as posible would at any rate be a positive step to reduce the incidence of cervical cancer .
|Qualität||kaum Einfluss||starker Einfluss|
|Gerechtigkeit||System weniger gerecht||System gerechter|
|Kosteneffizienz||sehr gering||sehr hoch|
The inclusion of HPV vaccination into the SHI benefit basket has no major impact on the quality of health care services or the level of equity. Its cost efficiency is disputed: The supporters of HPV vaccination predict a high cost efficiency as a result of effective prevention of cases of cervical cancer. Opponents point to open questions regarding long-term efficacy and criticize the high price of the vaccine. Some of them predict a high negative influence of HPV vaccination in regard to cost efficiency.
Reviewer: Sophia Schlette