sou · GYB339 · 2010-06-01 00:00:00 — En generell modell för samhällsekonomisk analys av nationella vaccinationsprogram bör utvecklas i internationellt samarbete. får i uppdrag att i samråd med bl.a. Statens bered- ning för medicinsk utvärdering inleda ett arbete med att ta fram en sådan modell. Skolhälsovården ska även utföra barnvaccinationer i de delar som berör skolbarn. Lokal eller regional samverkan mellan barn- och skolhälsovård bör ske när det finns synergieffekter. Förhållandet mellan vaccinationsprogram och läkemedelsförmån Vacciner av det slag som avses i den föreslagna lagen om nationella vaccinationsprogram, dvs. vacciner som är avsedda att mer än kortvarigt förebygga sjukdom i hela eller delar av befolkningen, ska inte kunna komma i fråga för läkemedelsförmåner. Det är billigare, både för staten och för allmänheten, att erbjuda sådana vaccina- tioner i nationella vaccinationsprogram. Denna form är också väsentligt bättre ägnad att uppnå en hög vaccinationstäckning än subventioner inom systemet med läkemedelsförmåner. Upphandling och finansiering av vacciner som används i nationella vaccinationsprogram Vacciner som används i nationella vaccinationsprogram ska upp- handlas centralt i nationella upphandlingar och finansieras av staten. Upphandlingen kan ske endera i en myndighets egen regi eller på uppdrag av en myndighet. Staten genom ska ta ett centralt ansvar för saklig information till allmänheten om vacciner och vaccinationer och i samråd med andra berörda myndigheter och offentliga organ utarbeta en modern kommunikationsstrategi för nationella vaccina- tionsprogram. Inga förstärkningar eller andra förändringar förslås när det gäller information till personal i hälso- och sjukvården. Ett hälsodataregister för vaccinationer Ett hälsodataregister för vaccinationer införs i vilket vårdgivarna ska registrera alla vaccinationer som ingår i nationella vaccina- tionsprogram. Registreringsplikten föreslås utvidgas till att omfatta alla vaccinationer som ges i . föreslås bli personuppgiftsansvarig för registret. Förslagen leder till ett tydligare författningsreglerat ansvar för olika offentliga aktörer, tydliga författningsreglerade förutsättningar för nya vacciner i vaccinationsprogrammen och ett ökat inflytande för riksdag och regering vid utformning av nationella vaccinations- program. Kostnadskonsekvenserna är svåra att kvantifiera. De samlade kostnadsökningarna för det allmänna kan beräknas till mellan tre och jämfört med nuvarande situation. Drygt hälften av kostnadsökningen avser det föreslagna hälsodataregistret för vaccinationer. Detta innebär en avsevärd och nödvändig ambi- tionshöljning och kvalitetsförbättring i ett nationellt perspektiv, snarare än i förväg kalkylerbara besparingar i de statliga myndig- heterna. Kostnadsbesparingarna kan bedömas bli i enbart barnvaccinationsprogrammet. Huvuddelen av denna besparing förväntas uppstå i form av billigare vacciner genom nationella vaccinupphandlingar. De samlade vaccinkostnaderna kan alltså förväntas sjunka jäm- fört med om förslagen inte genomförs. Effekten uppnås, förutom genom lägre vaccinpriser, även genom en väsentligt kostnads- effektivare upphandlingsverksamhet med en högre kvalitet än vad som varit möjlig att nå. The Government decided on 30 October 2008 to appoint an Inquiry Chair with a remit to analyse, in view of ongoing develop- ment in the area of vaccines, what measures may need to be taken with regard to regulations, decision-making processes, decision- making criteria, forms of funding and follow-up systems for vacci- nations offered and reimbursed by society. Such vaccinations may, for example, form part of the public childhood vaccination pro- gramme or be reimbursed under the pharmaceutical benefits scheme, i.e. through prescriptions dispensed in pharmacies. With regard to criteria for vaccination programmes, the Inquiry is to consider in particular whether there is a need to improve the usability of health-economic analyses as a basis for decisions in the area of vaccines. The Inquiry is to identify changes in the world at large which have taken place or are in progress in the area of vaccination and assess how these affect the national vaccination programmes and the pharmaceutical benefits scheme. In addition, a number of other issues linked to vaccination programmes are to be elucidated, such as information provided to individuals, the relationship between vaccination programmes and pharmaceutical benefits, funding issues and overall responsibility for vaccinations given in vaccina- tion programmes. In the part relating to follow-up and evaluation of vaccinations, the Inquiry Chair is to consider whether a vaccina- tion register under the Registers Act should be intro- duced. The term vaccines is used below to mean medicinal products for human use which prevent infectious diseases by inducing endoge- nous production of antibodies or other protective mechanisms (immunisation). A closer definition of such vaccines is contained in Pharmacopoeia, which has been com- piled in accordance with on the Elaboration of a European Pharmacopoeia from 1975. Terminology and regulation of vaccination programmes The term public vaccination programme is generally used to mean the childhood vaccination programme. This is intended for the whole population by being offered to all citizens in childhood according to a specified schedule. The childhood vaccination pro- gramme is now based on regulations and therefore has to be followed by the care providers. The term targeted vaccination programmes usually means vacci- nations offered to individuals who have what are known as high- risk diseases, for example cardiovascular diseases, diabetes etc. These vaccination programmes are not specified in regulations but are based on recommendations from . Such recommendations have been issued, for instance, for influenza, pneumococcal infections, tuberculosis, diphtheria and tetanus. Recommendations issued by an authority, in contrast to regulations, do not require any statutory authorisation, and compliance with them by care providers is voluntary. The term national vaccination programmes appears to be used as a collective designation for the childhood vaccination programme and the targeted vaccination programmes which are offered both to children and to adults in groups at risk. is the central gov- ernment administrative and supervisory agency for activities relating to health care and social services. The right of to issue regulations on vaccinations binding on the health care system is based on the powers granted to it under the Communicable Diseases Act and the Communicable Diseases Ordinance. These powers are kept very general in both statutory instruments and signify that the Government or, on the authority of the Government, , may issue the further regulations required for appropriate protection against communicable diseases and for the protection of individuals. The currently applicable childhood vaccination programme is shown in Table 1. Table 1 The Swedish childhood vaccination programme in spring * Haemophilus influenzae type b ** Human papillomavirus The most recently added vaccinations relate to vaccination against pneumococcal infection, applicable from 1 January 2009, and against human papillomavirus (HPV), which is due to begin in 2010. continuously monitors the development of the vaccines market and examines whether a vaccine should be included in the childhood vaccination programme, and if so at what age and how many doses are to be given. The examination takes place on the basis of a number of grounds of assessment or criteria. The following factors are valued prior to decisions on vaccination regulations: 1.The burden of the disease the vaccine is intended to protect against. Both the number of cases of disease and the seriousness of the disease in individual cases are assessed. 2.Risks and gains associated with the vaccination, for example how effective the vaccine is. 3.Any risks or gains for persons other than the target group for vaccination. 4.Public acceptance of the vaccine. 5.The risk of side-effects, which must be weighed up against the threat of disease. 6.The relationship to existing vaccination programmes as a new vaccine may affect the efficacy of those used previously. 8.Financial aspects, i.e. the cost of the vaccination in relation to the gains from reduced disease burden. According to the factors indicated should be valued in a weighted assessment as they may affect one another. The systematic approach to assessment has been devised by and is not governed by statutory instrument, even in the agencys own internal provisions. Government agencies other than also have important roles to play in connection with vaccination programmes. ease Control (SMI) is the national expert agency in the area of protection against communicable diseases. Its principal task is to monitor the epidemiological situation with regard to communicable diseases among humans and to promote protection against such diseases. SMI is also required to follow and analyse the immunity situation in selected population groups after vaccination programmes have been carried out and propose vaccinations. is responsible for the approval and control of medicinal products, natural remedies and devices. When a medicinal product has been approved, the has important key tasks in safety surveillance, among other areas. Vaccines under the pharmaceutical benefits scheme The costs of medicinal products and certain other products are reimbursed in under the pharmaceutical benefits scheme.1 It has also been possible for the cost of vaccines to be reimbursed under the scheme since 2002 if they fulfil the statutory require- ments laid down for such reimbursement. This reimbursement entails the individual paying a patient cost, on a reducing scale for each repeat prescription over a twelve-month period. The maxi- mum charge over the period is 800. The Dental and prepares cases relating to pharmaceutical benefits etc. on application from anyone who markets a medicinal product. Decisions are taken by . For reimbursement to be possible, it is required that 1.the costs of use of the medicinal product, having regard to the provisions of Section 2 of the Health and Act, appear reasonable on the basis of , humanitarian and economic principles and 2.that there are no other available medicinal products or methods of treatment which are found to be significantly more suitable for the purpose. Three cases concerning pharmaceutical benefits for vaccines have been considered to date, of which two relate to HPV vaccines and one relates to vaccine against rotavirus infection. Both the HPV vaccines are included in the pharmaceutical benefits scheme. The application relating to rotavirus vaccine was rejected. There are important differences between vaccines given under vaccination programmes and vaccines funded from the pharmaceu- tical benefits scheme. The latter must be prescribed by a doctor. The vaccine then has to be collected from a pharmacy by the indi- vidual and kept at a carefully controlled refrigerator temperature at home. It may otherwise be destroyed. The vaccination must be car- ried out by qualified personnel at a health care centre or other facility. In addition there is the patient cost, which can amount to a maximum of 800, and costs of visits to doctors and to health care centres. 1 Under the Act (2002:160) on Pharmaceutical Benefits etc. Vaccines offered for example in the childhood vaccination pro- gramme are not dispensed on prescription. They are prescribed directly by the nurse who out the vaccination and are free of charge for the individual. The county councils are responsible for health care in their area in . Like the municipalities, the county councils are governed by elected political assemblies. The municipalities are responsible for most other community services provided locally, for example schools, social care for the elderly and disabled, municipal clean- sing, emergency services, supply of housing etc. Childhood vaccinations, according to regulations, are given in the county councils child health care service and at school. The tasks of the child health care service, which is aimed at pre-school age children, are principally performed in child health care centres (BVC). The school health service is operated by school nurses and school doctors under the responsibility of the municipalities for school health care laid down in the Schools Act. This activity forms an integral part of municipal school administration and in practice is undertaken in the schools. Vaccination activity in the child and school health service is more precisely defined in regulations on childhood vaccinations.2 Several new vaccines have been introduced onto the market in the past ten years. It is characteristic of these that they are not, like previous vaccines, intended to control widespread, severe child- hood or common diseases such as measles, smallpox or polio. The distinctive feature of the new vaccines is instead that they counter- act either 2 2006:22, as amended by SOFS 2008:7 and SOFS 2008:31. severe diseases with few cases or diseases which are rarely severe but which affect large numbers of people. Vaccine against pneumococcal infection is an example of a vaccine against a severe infection which affects fewer than 100 children annually in . The vaccine against human papillomavirus (HPV) can be classified in the same category. Vaccinations against shingles and rotavirus are examples of vac- cines against diseases which affect many people, but which are gen- erally uncomplicated and virtually never prove fatal or lead to severe persistent complications. The new vaccines are therefore not obvious cases for introduction into public vaccination programmes in the same way as the older ones. The new vaccines are also sub- stantially more expensive than the older ones. This in any case applies, as for medicinal products in general, to the first few years following introduction. No wave of new vaccines can be expected in the short or medium terms. This in any case applies to vaccines which may become relevant for introduction into European vaccination pro- grammes. Extensive research is in progress in the area of vaccines and research breakthr0ughs can occur rapidly. However, there is a high failure rate in clinical testing of vaccines. It is therefore very difficult to assess how the development of vaccines will proceed in the future. The vaccine market is highly concentrated and is dominated by two large manufacturers. Another three manufacturers each have mar- ket shares of between 5 and 16 per cent of the world market. The barriers to entry are significant, with high investment costs for production facilities. Clinical studies are conducted in substantially larger populations and take longer than for medicinal products in general. The structure of the vaccines market can therefore be expected to persist. It should also be noted that the vaccine market exhibits several known risk factors for the formation of cartels. Attention should be paid to the risk of tendering cartels in particu- lar in the procurement of vaccines. Research, development and manufacturing take place principally in Europe and the . There are vaccine manufacturers in , but they are not expected to be able to offer any competi- tion on market in the foreseeable future. The individual product markets for vaccines are more concen- trated than the market at large. With the exception of the market for influenza vaccine, there are rarely more than two competing vaccines to choose between. In several cases there is only one vac- cine on the market. This applies for example to Hib vaccine, which is included in the childhood vaccination programme.3 The vaccines used in the childhood vaccination programme, or given following recommen- dations, not sold through pharmacies. They are procured directly by county councils and municipalities from the manufacturers and are distributed through wholesalers, for example SBL Vaccines. Vaccines which are issued on prescription and which are included in the pharmaceutical benefits scheme are distributed by the pharmacies and dispensed on prescription. A sale price of just over 100 per dose applies to the two vaccines now included in the pharmaceutical benefits scheme. The same type of vaccine is included in the childhood vaccination programme and has been procured for the needs of the whole country for this purpose at a preliminary price of around per dose. However, an appeal has been lodged against this procurement. There are no combined statistics on actual prices and volumes for vaccines used in the childhood vaccination programme or offered in accordance with recommendations. On the other hand, figures are available on the number of packs sold and the pharmacy purchasing price (AIP). The costs of vaccine use in the childhood vaccination pro- gramme alone, measured in terms of AIP, total just over million per year. Large discounts are, however, applied, primarily for those vaccines which are used over a long period. Figures for the average level of discount on childhood vaccines in relation to AIP range between 30 per cent (according to the county councils) and 50 per cent (according to the industry). At a level of discount of 30 per cent, the cost of childhood vaccines can thus be calcu- lated at between and 250 million per year. Around a hundred public vaccine procurements have been con- ducted in the past ten years. There are wide variations between the procurements in several dimensions. Both the combined volume and the number of types of vaccine vary widely. A number of dif- ferent constellations occur on the purchasing side, from individual smaller municipalities to larger forms of procurement cooperation between several county councils and municipalities. The smallest procurement relates to around a thousand doses of childhood vac- cine for a small municipality at such a low cost that the vaccines could easily have been procured directly. The largest procurement to date is the national procurement of pandemic vaccine against influenza A H1N1 (swine flu). The quality of tendering docu- mentation and other documents, for example specifications, is highly variable. The general impression is that much procurement documentation is formulated in such a way that the opportunities for competition which nevertheless exist are not exploited in an appropriate . Information to the public on vaccinations The judgement of the Inquiry is that the information provided by is objective and easy to assimilate. On the other hand, it is not entirely easy to find. In practice it is necessary to go directly to the agencies websites and search for the information there. The county councils provide vir- tually no general information at all on vaccines and vaccinations. Anyone searching for vaccine information on the Internet with- out preconceptions will not, however, find entry points to objec- tive information from government agencies among the first hun- dred hits. This is shown to be the case by the systematic searches using Google conducted by the Inquiry. Instead there are links to many websites where non-objective information on vaccines is dis- seminated. A Google search on the Swedish term svininfluensa (swine flu) in October 2009 led into an information corridor of heavily distorted information, which in many cases was calculated to deter the public from vaccination. and have confirmed that dis- torted, non-objective and scaremongering information was a great problem in the initial stage of pandemic vaccination. lesson learnt is that such disinformation can now spread very quickly through new social media and blogs. This does not only apply to pandemic vaccination. Experience from the childhood vaccination programme is similar. This is a new phenomenon. Blogging and the social media have developed in recent years and their use is increasing sharply, particularly in older age groups. Follow-up and evaluation of vaccinations Monitoring of a vaccination programme traditionally rests on four pillars: 1.Monitoring of the diseases the programme is intended to con- trol (epidemiological monitoring). 2.Monitoring of vaccination coverage. 3.Follow-up of side-effects. 4.Sero-epidemiological studies, which are intended to assess the immunity situation in the population. is responsible for compiling and analysing data on the coverage of vaccines and for evaluations of the immunity situation. Analytical data are com- piled in different ways in different parts of the country. Three county councils, those of , and , and the child health care service in register vaccines through the SMI vaccination register (Svevac). Other county councils apply manual systems with forms, which are filled in by each child health care centre every year. The diseases covered by the childhood vaccination programme are notifiable under the Communicable Diseases Act. However, in the case of pneumococcal infections and Hib only serious cases of disease are notified. Reported cases of disease can be compared with the number of vaccinations against the disease. In addition, special studies are conducted to gauge the immunity situation. is responsible for the reporting of side-effects. Holders of authorisation for the marketing of medicinal products for humans have to notify side-effects which come to their knowledge. Since 2009 it has also been possible for individuals to report a side-effect directly to the The reports are registered for statistical purposes and research in the side-effects register (), which is now a health data register. Current evaluation routines are judged by the government agencies affected to be inadequate. Reliable data are lacking on which individuals have been vaccinated in defined target groups, when they have been vaccinated and with what vaccine. Data are compiled in different ways in different parts of the country. When vaccination coverage falls, as happened when incorrect and mis- leading rumours were spread about side-effects of the measles vac- cine in the early 2000s, it is crucially important to know exactly where in the county council and why this happens, so that it is pos- sible to intervene. It is not possible to obtain such detailed statis- tics without effective computer-based follow-up systems. Immu- nity studies at present are conducted in statistical selections of the population without taking account of whether the individuals in the selection have been vaccinated or not. is it possible to quickly test different hypotheses, i.e. to confirm or refute claims on side-effects of vaccines. It took several years, for example, before the link between MMR vaccination and autism could be disproven through extensive multi-year follow-up studies.4 It would have been possible to obtain the necessary infor- mation far more quickly with a vaccination register capable of being matched with other health data registers. register of medici- nal products provides good options for various follow-ups for other medicinal products. However, only those vaccines for which prescriptions are issued are included in the register of medicinal products. This means that the options for follow-up are considera- bly poorer for vaccines than for medicinal products in general. The Inquirys considerations and proposals It has been stated in the introduction that the terminology relating to vaccination programmes is not entirely clear. National vaccina- tion programmes are understood to be both the public childhood 4 MMR vaccine is a combination vaccine against measles, mumps and rubella. Vaccinationer till barn – Skyddseffekter och biverkningar (Vaccinations for children – Protec- tive effects and side-effects), () 2009.