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HPV vaccination in Germany

Country: 
Germany
Partner Institute: 
Bertelsmann Stiftung, Gtersloh
Survey no: 
(10)2007
Author(s): 
Blum, Kerstin
Health Policy Issues: 
Public Health, Prevention, Pharmaceutical Policy, Benefit Basket, Access
Current Process Stages
Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no yes yes no no
Featured in half-yearly report: Health Policy Developments 10

Abstract

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.

Purpose of health policy or idea

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.

Main points

Main objectives

  • reduce the incidence of HPV infection
  • reduce the incidence of cervical cancer

Type of incentives

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.

Groups affected

Mainly girls between the ages of 12 and 17 years, pharmaceutical companies that produce HPV vaccines, sickness funds

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Characteristics of this policy

Degree of Innovation traditional neutral innovative
Degree of Controversy consensual controversial highly controversial
Structural or Systemic Impact marginal neutral fundamental
Public Visibility very low high very high
Transferability strongly system-dependent system-neutral system-neutral

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.

Political and economic background

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.  

Supply-driven recommendation?

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). 

Purpose and process analysis

Current Process Stages

Idea Pilot Policy Paper Legislation Implementation Evaluation Change
Implemented in this survey? no no no yes yes no no

Origins of health policy idea

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.

Initiators of idea/main actors

  • Providers: Providers are divided: Those who believe HPV vaccination to be a good means to fight cervical cancer, those who criticize its very quick approval for reimbursement on a slim data base, and those who believe the money should better be spent on screening.
  • Payers: For sickness funds, the inclusion of HV vaccination into the benefit basket means high costs. Still, many of them have been quick to advertize that they cover HPV vaccinations, partly even beyond the age groups of the STIKO recommendation, in order to attract new members to their fund.
  • Scientific Community: Like providers, the scientific community is divided when it comes to the benefit of HPV vaccination in comparison to an improved screening. Both sides however share the conviction that the vaccine is currently sold at a too high price.
  • Private Sector or Industry: Pharmaceutical companies producing vaccines against HPV naturally have a strong interest in promoting its widespread use.

Stakeholder positions

The scientific community and physicians are divided on the HPV vaccination.

  • Some believe HPV vaccination to be a major step in the fight against cervical cancer. They are convinced by clinical studies showing very good results of Gardasil and Cervarix for immunization against HPV. (Many unanimously positive articles in German on HPV vaccination can be found at www.aerztezeitung.de
  • Others do not oppose the HPV vaccination but believe that the STIKO recommendation is based on too little data (Berndt 2007). The long term efficacy of the vaccination is still unclear, as is the need for a booster vaccination. No final judgement on the cost-effectiveness of the vaccination can therefore be made.  
  • A third group opposes the vaccination as too expensive, and argues that the number of cases of cervical cancer that can be prevented through widespread immunization is too small in relation to the costs - even if no booster shot is necessary. Furthermore, opponents fear that HPV vaccination might reduce the awareness of of the ongoing need for preventive screening among women. Some think that vaccination against some types of HPV might lead to an increase in cervical disease from other types. (e.g. Rosenbrock 2007; Berndt 2008)

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).     

Actors and positions

Description of actors and their positions
Providers
Professional association of gynecologistsvery supportivevery supportive strongly opposed
German association for gynecology and obstetrics (DGGG)very supportivevery supportive strongly opposed
Federal association of women's health centersvery supportiveopposed strongly opposed
Physicians for an individual decision on vaccinationvery supportivestrongly opposed strongly opposed
Payers
Statutory sickness fundsvery supportiveneutral strongly opposed
Private sickness fundsvery supportiveneutral strongly opposed
Scientific Community
German Cancer Research Centervery supportivevery supportive strongly opposed
Social Science Research Center Berlin (WZB), Rolf Rosenbrockvery supportiveopposed strongly opposed
German Cancer Association (Deutsche Krebsgesellschaft e.V. - financed by pharmaceutical industry)very supportivevery supportive strongly opposed
Private Sector or Industry
Pharmaceutical companiesvery supportivevery supportive strongly opposed

Influences in policy making and legislation

No legislation necessary. Since the new SHI-CSA recommendations of the STIKO are automatically included into the benefit basket of the statutory sickness funds.  

Actors and influence

Description of actors and their influence

Providers
Professional association of gynecologistsvery strongstrong none
German association for gynecology and obstetrics (DGGG)very strongstrong none
Federal association of women's health centersvery strongweak none
Physicians for an individual decision on vaccinationvery strongneutral none
Payers
Statutory sickness fundsvery strongvery strong none
Private sickness fundsvery strongvery strong none
Scientific Community
German Cancer Research Centervery strongstrong none
Social Science Research Center Berlin (WZB), Rolf Rosenbrockvery strongstrong none
German Cancer Association (Deutsche Krebsgesellschaft e.V. - financed by pharmaceutical industry)very strongstrong none
Private Sector or Industry
Pharmaceutical companiesvery strongvery strong none
Professional association of gynecologists, German association for gynecology and obstetrics (DGGG), German Cancer Research Center, German Cancer Association (Deutsche Krebsgesellschaft e.V. - financed by pharmaceutical industry)Pharmaceutical companiesStatutory sickness funds, Private sickness fundsFederal association of women's health centersSocial Science Research Center Berlin (WZB), Rolf RosenbrockPhysicians for an individual decision on vaccination

Positions and Influences at a glance

Graphical actors vs. influence map representing the above actors vs. influences table.

Monitoring and evaluation

No official evaluation is planned.

Expected outcome

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 .

Impact of this policy

Quality of Health Care Services marginal marginal fundamental
Level of Equity system less equitable neutral system more equitable
Cost Efficiency very low high very high

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.

References

Sources of Information

  • Arbyn, M., A. Raifu, P Autier and J Ferlay. Burden of cervical cancer in Europe: estimates for 2004. Ann Onc 2007.
  • Berndt, Christina. "Impfung gegen Gebärmutterhalskrebs. Voreilige Vorsorge." Süddeutsche Zeitung. 6 October 2007.
  • Die Gesetzlichen Krankenkassen. "Gemeinsame Stellungnahme zum Entwurf eines GKV-Wettbewerbsstärkungsgesetzes." Bundestags-Drucksache 16/3100. 24.10.2006.
  • Dunne, Eileen F. et al. "Prevalence of HPV Infection Among Females in the United States." JAMA - Journal of the American Medical Association. 2007;297:813-819. http://jama.ama-assn.org/cgi/content/abstract/297/8/813
  • Gesellschaft der epidemiologischen Krebsregister in Deutschland e.V./Robert Koch Institut. "Krebs in Deutschland. Häufigkeiten und Trends." Saarbrücken 2006.
  • Görlitzer, K.P. "Impfkommission im Interessenkonflikt." taz - die tageszeitung. 16 November 2007.
  • Radel, Inga. "HPV-Impfung - Durchbruch in der Krebsprävention oder überschätzt?" dpa 21.12.2007. www.krankenkassen.de/dpa/126360.html.
  • Robert Koch Institut. "Epidemiologisches Bulletin. Aktuelle Daten und Informationen zu Infektionskrankheiten und Public Health."No. 12, March 2007.
  • Rosenbrock, Rolf. "HPV-Impfung - Durchbruch in der Krebsprävention?" March 2007. www.forum-gesundheitspolitik.de. 
  • Hirte, Martin. "Die HPV-Impfung." Ärtze für individuelle Impfentscheidung e.V. www.individuelle-impfentscheide.de/index.php?option=com_content&task=view&id=23&Itemid=1. Herdecke 2007.
  • WHO. Comprehensive cervical cancer control: a guide to essential practice. 2006.

Author/s and/or contributors to this survey

Blum, Kerstin

 

Reviewer: Sophia Schlette

www.hpm.org/en/About_Us/About_the_project/Project_team.html

 

Suggested citation for this online article

Blum, Kerstin. "HPV vaccination in Germany". Health Policy Monitor, January 2008. Available at http://www.hpm.org/survey/de/b10/1