Rapid Responses to:
|
|
Rapid
Responses: Rapid Responses published:
-
![[Read
Rapid Response]](bmj%20hep%20B2_files/sectionDOWN.gif)
Economics of hepatitis B vaccination
- Peter M B English (5 November 2004)
-
-
Correction
- Peter M B English (8 November 2004)
-
-
Universal immunisation with hepatitis B in the UK is not
cost beneficial
- Jacob M. Puliyel, S. Hydros, V Sreenivas (28 November 2004)
-
-
The economics of Hepatitis B immunization
- John B. March (29 November 2004)
-
-
Improving targeted hepatitis B vaccination.
- Vivian D. Hope, Ruth Gilbert, Helen Munro, Fortune Ncube, and O. Noel Gill. (29 November 2004)
-
-
Hepatitis B vaccination policy
- M Adekoyejo Balogun, Susan J.M. Hahne, Mary E. Ramsay, W. John Edmunds (29 November 2004)
-
-
Hepatitis B: how to manipulate the media machine
- Marc Girard (30 November 2004)
-
-
Policy aims of hepatitis B vaccination should be clear
- J. Claire Cameron, Sharon J. Hutchison, Lesley A. Wallace, David J. Goldberg, and Syed Ahmed (17 December 2004)
-
-
How should healthy hepatitis B carrier should be managed
effictively?
- Ashraf Ahmed Zada, P.O.Box 112 (1 January 2005)
|
|
|||
|
Peter M B English, CCDC Surrey and Sussex HPU, KT22 8BZ
Send response to journal:
|
The health economics of vaccination against hepatitis B are changing, and the introduction of universal hepatitis B vaccination certainly merits further consideration. As Dr Beeching states, the cost of vaccines is falling. The UK recently introduced a "five-in-one" or pentavalent vaccination to the routine paediatric schedule; in many other countries a "hexavalent" vaccine is used, similar to the UK's new vaccine, but including also hepatitis B. The additional cost of using the hexavalent, rather than the pentavalent vaccine would depend on the price that DH could negotiate with the manufacturers. Indeed, we have seen a trend for manufacturers to reduce the number of lines they produce, focussing on producing more compound vaccines (such as diphtheria, tetanus, and inactivated polio vaccine that we now use routinely where we would previously have used separate single-component vaccines) that are very widely used: if this were to apply with the paediatric vaccines, it might cost no more to use the hepatitis B vaccine. The programme cost would certainly be far lower than for a programme using separate hepatitis B vaccine. The cost per person vaccinated of targeted vaccination is, of course, very much higher than when a universal vaccination programme is in place. As a consultant in communicable disease control (CCDC), I am regularly involved in "incidents" involving actual or potential exposure to hepatitis B. A typical incident (that I was not involved in) was reported at a recent conference (Turbitt, D et al. Use of post-exposure prophylaxis for HIV in children following needlestick injury. 2004. Five Nations Health Protection Conference. http://www.5nations.org.uk/). I had planned to analyse and publish the costs of a recent incident, but due to concerns about confidentiality did not do so. The incident I'd hoped to write up generated a great deal of anxiety, and required hundreds of hours of professionals' time (teachers, primary care, clinicians, health protection professionals, LEA managers). I would have been somewhat surprised if the cost of time, travel and meetings expenses alone had come to much less than �1.5k ($2.8k; �2.1k), and it might have been considerably higher. At that time my unit covered a population of 1M, and we have a similar incident most years. Assuming that similarly expensive incidents occur at the same rate across the country, then the UK would be spending about �670k ($1.2M, �953) per year on such incidents. That said, the prevalence of hepatitis B in the UK is still low at present (although with increasing international travel, and continuing migration, it may not remain so). And the benefits of introducing a universal vaccination programme would not be seen immediately: it would take years for the number of cases of hepatitis B virus related hepatocellular carcinoma to fall, for example. There are about 695,500 births per year in the UK (http://www.statistics.gov.uk/cci/nugget.asp?id=761). If the marginal programme cost of a hexavalent vaccine were �5, it would therefore cost under �3.5m ($6.5m; �5m) to use it instead of the pentavalent vaccine - considerably less than the annual NHS costs for hepatitis B virus related hepatocellular carcinoma alone as quoted by Dr Beeching (�26m-�375m; $48m- 686m; �37m-538m). The latest minutes of the Joint Committee on Vaccination and Immunisation (JCVI), referring to hepatitis B, state only that �Progress in this area had slowed during the re-organisation of the Department. However, it is hoped that the work needed to take this issue forward could now be carried out. A JCVI Hepatitis B sub-group meeting is also needed.� (http://www.advisorybodies.doh.gov.uk/jcvi/mins040604.htm.) I hope that the committee will give further consideration to recommending universal immunisation against hepatitis B in the UK. Competing interests: I have received funding to attend scientific conferences and consultancy fees from various vaccine manufacturers |
|||
|
|
|||
|
Peter M B English, CCDC Surrey and Sussex HPU, Leatherhead KT22 8BZ
Send response to journal:
|
In my previous � and rather-too-rapid � response I estimated the marginal cost of a universal vaccination programme that includes hepatitis B vaccine as �under �3.5m� (695,500 births x �5). I omitted to factor in the three doses that are required, which would bring the cost to approximately �10m ($19m; �15). This is, of course, still lower than the costs for hepatitis B virus related hepatocellular carcinoma alone as quoted by Dr Beeching (�26m-�375m; $48m-686m; �37m-538m); but it would be many years before vaccination would have a major impact on the incidence of this condition, so we should perhaps discount these cost savings; and we will still have to deal with the consequences of hepatitis B in e.g. people who were born, and infected, in other countries. It is considerably less than the time and meetings costs to the of dealing with hepatitis B- related community incidents that I estimated. Of course, hepatitis B incurs many other costs that I did not attempt to include, hence my interest in seeing a full economic evaluation. Competing interests: I have received funding to attend scientific conferences and consultancy fees from various vaccine manufacturers |
|||
|
|
|||
|
Jacob M. Puliyel, onsultant Pediatrician West Middlesex University Hospital, TW7 6AF, S. Hydros, V Sreenivas
Send response to journal:
|
Nicholas J Beeching has succinctly summarized the situation with regards hepatitis B in the UK (1). It is however unclear how he arrived at the conclusion that universal immunization should be preferred in Britain. We have serious concerns about this. An assessment of the data provided, shows an unfavourable cost: benefit ratio. The annotation has drawn heavily on one reference (2). In this paper we will also rely on the same source for most of our calculations, so it is not just a matter of using one reference against another, to arrive at slightly different conclusions. We are told that 430 persons develop hepatitis B related carcinoma in the UK each year and that Hepatitis B costs the NHS �26m-�375m per year (UK � = US $ 1.8).(1) The reference quoted by the author (2) elaborates how this wide range of costs has been arrived at. The lower-limit figure was based on an eight year study in Tayside, Scotland. It projects the resources consumed each year, by the 45,700 people, with diagnosed chronic hepatitis B in all of the UK. The costs for treating patient with chronic hepatitis B in Germany or the USA are very different. The upper-limit figure �375m, is the cost of treating all the hepatitis B cases in the UK, at the German rate! Obviously the figure of �26 m is a more realistic estimate of costs in the UK and will be used in this letter. In his rapid response, Peter MB English calculates that using a hexavalent vaccine that includes hepatitis B (at a marginal programme cost of �5/dose of hepatitis B) to immunise the UK birth cohort of 695,500 each year, would result in an additional bill of only �10m. Does this prove that universal immunization is more cost beneficial? To evaluate this, it is important to look at the proportion of �hepatitis B related problems� that can be prevented by universal immunization in the UK. There 7500 new cases of chronic infection with hepatitis B virus in the UK who are consuming these resources but only 4% of these are from among persons born in the UK(2). The remainder are immigrants who have been infected overseas and cannot be helped by the programme of universal immunization in the UK. Thus universal immunization can bring about only a cost reduction of 4% of the total expenditure of �26m. This works out to be a saving of �1m per year. Most hepatitis B infection in the UK occurs in adolescence and it is several years afterwards, that they develop cirrhosis and hepatocellular carcinoma. With a neonatal immunization programme the benefit may be seen more than 40 years later.(3) Using a conservative discounting rate of 3% (4) the discounting factor for 40 years is 0.2. If the benefit is discounted, this works out to savings of � 0.2m per year . The cost savings through universal immunization with Hepatitis B vaccine is there for not � 375m nor even � 26m but � 0.2m per year and it is against this, that the cost of immunization must be compared. This is of course only an economic argument. The decision to go for universal immunisation need not be based on economic arguments. Italy undertook universal immunization although a cost effectiveness assessment performed by Demicheli and Jefferson showed an unfavourable cost-benefit ratio.(5) We also know from literature that the phenomenon of ignoring cost benefit analysis is not of recent origin. George Bernard Shaw in the preface of The Doctor�s Dilemma (6) under the subheading The Perils of Inoculation wrote a follows: �Suppose it were ascertained that every child in the world could be rendered absolutely immune from all disease during its entire life by taking half an ounce of radium to every pint of its milk. The world would be none the healthier, because not even a Crown Prince - no, not even the son of a Chicago Meat King, could afford the treatment. Yet it is doubtful whether doctors would refrain from prescribing it on that ground. The recklessness with which they now recommend wintering in Egypt or at Davos to people who cannot afford to go to Cornwall, and the orders given for champagne jelly and old port in households where such luxuries must obviously be acquired at the cost of stinting necessaries, often make one wonder whether it is possible for a man to go through a medical training and retain a spark of common sense� References 1. Beeching NJ Hepatitis B infections BMJ 2004; 329: 1059-1060 2. Foundation for Liver Research. Hepatitis B: out of the shadows. London, Foundation for Liver Research, 2004. www.ucl.ac.uk/liver- research/hepatitis-report.pdf (accessed 18 November 2004) 3. Acharya AK, Murray CJL. Rethinking discounting of health benefits in cost effectiveness analysis. http://www.sussex.ac.uk/Units/economics/dp/arnab1.pdf accessed on 18/11/2004) 4. Evans D Hurley B. The application of economic evaluation in the Health Sector. The state of art. The Journal of International Development 1995;7:503-24 5. Demicheli V, Jefferson TO. Cost-benefit analysis of the introduction of mass vaccination against hepatitis B in Italy. J Public Health Med. 1992;14:367-75. 6. Shaw GB. The Doctor�s Dilemma. London Penguin Books 1957 pp33 puliyel@vsnl.com Competing interests: None declared |
|||
|
|
|||
|
John B. March, Principal Research Scientist Moredun Research Institute, Penicuik, Midlothian EH26 0PZ, UK
Send response to journal:
|
Universal hepatitis B immunization makes no medical or economic sense at all in the UK unless to boost drug company profits through increased vaccine sales. Bearing in mind the 55 million plus population of the UK, an incidence of some 4500 acute cases of hepatitis B infections a year represents a tiny proportion (0.008%). Furthermore, with the requirement for 3 immunizations to confer adequate immunity and the relatively low duration of immunity (10 years maximum), what possible justification can there be for universal immunization of children? Particularly pre-school children. Pre-adolescent children are hardly at a high risk of hepatitis B infection from intravenous drug use and/or unprotected sex. By the time they are potentially at risk, any immunity engendered by childhood vaccination will almost certainly have disappeared. Is it being suggested that all children should be vaccinated to develop herd immunity to potentially protect a tiny number of high risk individuals, who through their own actions, bring this particular infection upon themselves? If the Department of Health was unable to sell the MMR 'herd immunity' vaccination campaign to a sizeable proportion of parents who were unwilling to have their children vaccinated against a disease which actually affects children (indiscriminately), I would anticipate that selling this particular vaccination campaign to the general public is doomed to failure. What are the benefits to the vaccinates? By all means promote universal hepatitis B vaccination; but do this where it is required and where it makes economic sense to the country as a whole (i.e. the Developing World), rather than where it only makes economic sense to those who produce and promote the vaccines. Competing interests: JB March has developed a low cost bacteriophage-based Hepatisis B vaccine and received commercial funding for this work. |
|||
|
|
|||
|
Vivian D. Hope, Surveillance Co-ordinator/Research Fellow Health Protection Agency Centre for Infections, 61 Colindale Avenue, London NW9 5EQ, Ruth Gilbert, Helen Munro, Fortune Ncube, and O. Noel Gill.
Send response to journal:
|
EDITOR--Beeching (1) in relation to the United Kingdom's strategy of targeting hepatitis B vaccination at various high-risk groups states that "This has generally failed", before going on to consider uptake among a number of these groups. In relation to three of these groups - injecting drug users, men who have sex with men (MSM), and prisoners - he selectively quotes data that misrepresents the current situation. Whilst previously levels of vaccine uptake have been low, recent efforts to increase vaccination rates among these groups have led to substantial improvements. Data from the national Unlinked Anonymous Prevalence Monitoring Programme Survey of injecting drug users has shown a marked increase in the proportion of injecting drug users in contact with drug services who have received one or more doses of the hepatitis B vaccine from only 25% in 1998 to 50% in 2003 (2). This increase followed the allocation of extra funding for vaccination of injecting drug users in 1999 (3). Since 2001, the Prison Service has also provided funding for a hepatitis B vaccination programme, initially in 42 prisons and subsequently extended to include all reception prisons and young offender institutions. In 2003, 17% (range 0-94%) of new receptions received at least one dose of vaccine within one month of arriving in prison. A total 14,163 prisoners received at least one dose of vaccine and 26,265 doses were administered (4). As part of the national strategy for sexual health and HIV (5), ?1m was secured for the provision of hepatitis B vaccine to GUM clinics in England. Data for 2003, indicated that 85% of susceptible MSM were vaccinated against hepatitis B at first attendance with only 7% refusing vaccination and 46% of those beginning a course received three doses at the same clinic (6). While the debate continues on whether universal hepatitis B immunisation for either infants or adolescents is needed in the UK, vaccination of high-risk groups will still be required for the medium term. The data we have presented above shows that with concerted efforts the uptake of targeted vaccination can be improved considerably. 1. Nicholas J Beeching. Hepatitis B infections. Editorial. BMJ 2004 329: 1059-1060. 2. Health Protection Agency,
SCIEH, National Public Health Service
for Wales, CDSC Northern Ireland, CRDHB, and the UASSG. Shooting Up;
Infections among injecting drug users in the United Kingdom 2003.
London:
Health Protection Agency, October 2004 (ISBN: 0 901144 64 9). Available
at
3. NHS Executive. Drug Misuse Special Allocation: 1999/2000 Funding and Guidance on the Modernisation Fund Element. HSC 1999/036. 4. Gilbert RL, Costella A, Piper M and Gill ON (2004). Increasing hepatitis B vaccine coverage in prisons in England and Wales. Commun Dis Public Health, in press. 5. The National strategy for sexual health and HIV implementation plan. London: Department of Health, 2002. 6. Health Protection Agency. 2004. The HepB3 study: hepatitis B vaccine uptake in men who have sex with men (MSM) attending a GUM clinic in England as first time attendees. CDR Weekly; 14(40). Competing interests: None declared |
|||
|
|
|||
|
M Adekoyejo Balogun, Clinical Scientist Health Protection Agency, Centre for Infections, 61 Colindale Avenue, London NW9 5EQ, Susan J.M. Hahne, Mary E. Ramsay, W. John Edmunds
Send response to journal:
|
Dear Editor, Beeching suggests that universal hepatitis B vaccination should replace the current selective programme in the UK.(1) Although correctly pointing out that selective vaccination needs to continue for some time, he fails to explain that universal vaccination can not have any discernable impact on the UK burden of disease related to chronic hepatitis B. Infections preventable by vaccinating UK residents contribute less than four percent of all new chronic infections, with the vast majority arising from immigration of carriers.(2) A reduction in the UK burden of chronic hepatitis B will therefore require long-term efforts to vaccinate infants and children in high prevalence countries.(3) Although universal infant vaccination might prevent more infections than the current selective programme in the UK, the additional benefits would be small and take many years to accrue. Based on the age distribution of cases currently reported, 20 years of universal infant vaccination could prevent 10% of acute hepatitis B infections. Adolescent vaccination should have a more rapid impact - based on the same assumptions, 50% of cases could be prevented in 20 years. We believe that similar coverage is achievable now by targeting resources in certain settings.(4) Although recognised infection in children is rare, the incidence of hepatitis B infection is higher in children from certain ethnic minorities.(5) Universal infant immunisation in parts of the country with a high proportion of ethnic minorities is therefore likely to be more cost -effective than a national programme. Antenatal screening and vaccination of high-risk infants would need to continue, however, since preventing perinatal transmission requires a first dose of vaccine to be given within 12 hours of birth. To ensure children at highest risk are protected, selective vaccination of children arriving in the UK from countries without universal programmes would also be required. References 1. Beeching N. Hepatitis B infections: Universal immunisation should be preferred in Britain. British Medical Journal 2004; 329:1059-1060. 2. Hahne S, Ramsay M, Balogun K, Edmunds WJ, Mortimer P. Incidence and routes of transmission of hepatitis B virus in England and Wales, 1995 -2000: Implications for immunisation policy. Journal of Clinical Virology 2004; 29: 211-20. 3. Gay NJ, Edmunds WJ. Developed countries could pay for hepatitis B vaccination in developing countries. British Medical Journal 1998; 316: 1457. 4. Hutchinson SJ, Wadd S, Taylor A, et al. Sudden rise in uptake of hepatitis B vaccination among injecting drug users associated with a universal vaccine programme in prisons. Vaccine 2004, 23: 210-214. 5. Hahne S, Ramsay M, Soldan K, Balogun K, Mortimer P. Hepatitis B incidence among South Asian children in England and Wales: implications for immunisation policy. Archives of Disease in Childhood 2003; 88: 1082- 3. Competing interests: None to declare M. Adekoyejo Balogun, Clinical Scientist Susan J.M. Hahne, Specialist Registrar Mary E. Ramsay, Consultant Epidemiologist W. John Edmunds, Head of the Modelling and Economics Unit Contact details Authors 1, 3 and 4 Health Protection Agency Centre for Infections 61 Colindale Avenue London NW9 5EQ Tel: 020 8200 6868 Email for correspondence: koye.balogun@hpa.org.uk Author 2 Health Protection Agency North East London Health Protection Unit 78-79 Leadenhall Street London, EC3A 3DH Tel: 0207 220 4500 Competing interests: None declared |
|||
|
|
|||
|
Marc Girard, Consultant 1 bd de la Republique - 78000 Versailles (France)
Send response to journal:
|
As a medical expert witness involved in a number of judiciary cases on hepatitis B vaccine (HBV), I spent thousands of hours with an unique opportunity to make a thorough inventory of the evidence supporting universal immunisation in low-endemic countries, which proved to be nonexistent. Quite often in my reports, I opposed the BMJ's invigorating irony on how pharmaceutical communication may "manipulate the media machine" (1996; 313: 825) to the depressing naivety of French doctors, and ascribed this contrast to a traditional superiority of British training in clinical research, statistics and epidemiology. But even in France and within less than two months, the champions of universal vaccination have been shattered by a accumulation of catastrophic news including: the confirmation that the figures of viral contaminations had been grossly exaggerated (by more than a 1000-fold factor), a case/control study showing a 3-fold increase in the risk of post-vaccinal multiple sclerosis (MS) [1], the statistics of health insurance showing a burst in neuro- muscular diseases [2], and the first official admission of a sharp increase in paediatric MS of very early onset (even in neonatal age). For deprived they are of their longstanding argument that any controversy on the benefit/risk ratio of this vaccination would be a new French paradox (Hernans et al study being performed upon British data), French "experts" have now an opportunity to claim that even British "experts" came over to the necessity of universal immunisation. This admirable timing may be related to the fact that on both sides of the Channel, "experts" have the same links with manufacturers, the same contempt of EBM requirements regarding the validation of their sources and the same propensity to ignore all of those likely to ruin their claims, as exemplified by Beeching's editorial (6 Nov, 2004: 1059-60) which remains completely silent on: 1) the strong evidence showing that HBV is remarkable by the frequency, the severity and the variety of its complications [2], 2) increasing evidence supporting doubts on the duration of immunity given [3], 3) examples like the French one demonstrating that universal scheme failed to reduce HB incidence risk populations (see http://www.rolandsimion.org for additional relevant references). Moreover, it maintains the nonsense of recommending vaccination of autochthonous population to avoid a disease in immigrants. Finally, it bypasses the democratic debate on imposing the unusual toxicity of this vaccine to a large population to protect a narrow subpopulation of people who deliberately adopt risky behaviours. [1] Hernan M, Jick S, Olek M, Jick H. Recombinant hepatitis B vaccine and the risk of multiple sclerosis. A prospective study. Neurology 2004; 63: 838-42 [2] Girard M. Autoimmune hazards of hepatitis B vaccine. Autoimmunity Reviews (in press) [3] Petersen KM, Bulkow LR, McMahon BJ et al. Duration of hepatitis B immunity in low risk children receiving hepatitis B vaccinations from birth. Pediatr Infect Dis J 2004; 23:650-5 Competing interests: Dr Girard works as an independent consultant for pharmaceutical industry, including vaccine manufacturers and a number of their competitors. |
|||
|
|
|||
|
J. Claire Cameron, Epidemiologist (Immunisation) Health Protection Scotland, Clifton House, Clifton Place, Glasgow G3 7LN, Sharon J. Hutchison, Lesley A. Wallace, David J. Goldberg, and Syed Ahmed
Send response to journal:
|
As highlighted by Aggarwal and Ranjan, the UK remains one of the few countires worldwide which has, thus far, chosen not to embark on a programme of universal hepatitis B immunisation (1). The accompanying editorial (2) points out that past strategies for targeting high risk groups have largely failed to provide adequate coverage, and proposes universal immunisation to overcome this. Universal adolescent HepB immunisation is feasible and high uptake rates can be achieved; a pilot study in Glasgow has demonstrated uptake rates of 89% for at least two doses and 80% for three doses, figures which are similar to other vaccines offered in the school setting (3). Such a programme would be essential if the UK policy aim was to protect all individuals before they embarked on high risk activities, and not only those at highest risk, which in the UK is currently injecting drug users (IDUs). However, if the major aim was to improve the original goal of achieving adequate coverage in high-risk groups, other strategies may involve vaccination of fewer individuals and be more cost effective. For example, recent figures from Scotland provide evidence that implementing HepB vaccination for all prison inmates can boost vaccine coverage among IDUs to acceptable levels. HepB vaccine uptake among community-recruited IDUs in Glasgow has increased dramatically since the implementation of this initiative in April 1999. Figures increased from 15% in January-March 1999 to 52% in 2001-2, 56% of whom had been vaccinated in prison (4). Therefore, the policy aims must be clear when discussing HepB vaccine policy options, and the interventions chosen accordingly. 1. Aggarwal R, Ranjan P. Preventing and treating hepatitis B infection. BMJ 2004;329:1080-1086. 2. Beeching NJ. Hepatitis B infections. Universal immunisation should be preferred in Britain. BMJ 2004;329:1059-1061. 3. Bramley JC, Wallace LA, Ahmed S, Duff R, Carman WF, Cameron SO, et al. Universal hepatitis B vaccination of UK adolescents: a feasibility and acceptability study. Communicable Disease and Public Health 2002;5(4):318- 320. 4. Hutchison SJ, Wadd S, Taylor A, Bird SM, Mitchell A, Morrison DS, et al. Sudden rise in uptake of hepatitis B vaccination among injecting drug users associated with a universal vaccine programme in prisons. Vaccine 2004;23:210-214. Competing interests: Health Protection Scotland has received funding for research and conference attendance from pharmaceutical companies. |
|||
|
|
|||
|
Ashraf Ahmed Zada, Specialist Registrar Family Medicine Dubai, UAE, P.O.Box 112
Send response to journal:
|
We are having quite good No. of healthy carrier with Hepatitis B e Ag negative and Hepatitis B e Ab positive with normal LFT and normal USS scan. Do they need to be referred for interferon treaatment? Competing interests: None declared |
|||