Selective testing for hepatitis A IgG may be cost effective in vaccination candidates? Dr. Fiona Wallace

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1 Selective testing for hepatitis A IgG may be cost effective in vaccination candidates? Dr. Fiona Wallace Northern European Conference on Travel Medicine 5, Bergen, June 2014

2 Acknowledgements and Declarations Dr. Kate Templeton BSc Hons, FRCPath, PhD Dr. Michael Jones MBChB, FRCP, FFTM RCPS Ann Walker (BSc Hons) No conflicts of interests to declare.

3 is the commonest cause of viral hepatitis worldwide (1.4 million cases annually) Five types of hepatitis (A, B, C, D, E) Transmission: faecal-oral/close human contact Clinical disease spectrum Asymptomatic self limiting gastroenteritis fulminant hepatic failure Increasing severity with increasing age Supportive treatment only No chronic disease state Acute infection confers lifelong immunity Vaccine preventable disease World Health Organization, Factsheet N0328

4 vaccination Inactivated vaccine Two doses confer long term immunity in 90-95% of recipients Vaccine well tolerated. Repeated vaccination has no adverse effects. THE UK guidelines recommend pre-exposure vaccine in: individuals at high risk of exposure to, or complications from the disease. Pre-vaccination screening: UK guidelines - No comment CDC recommends depending on local vaccination cost and seroprevalence. Guidance for the Prevention and Control of Infection. Health Protection Agency World Health Organization, Factsheet N0328 Centres for Disease Control. Sexually transmitted disease Guidelines Vaccine preventable STD s. Department of Health. Immunisation against Infectious Diseases. Chapter 17. Accessed online May 2014

5 Epidemiology: In areas with low prevalence: majority of the population is nonimmune Outbreaks and infections are typically concentrated in specific at risk groups Non-immune individuals travelling to areas of high endemnicity Intravenous drug misuse (IVDU) Men who have sex men (MSM) Immunocompromised People living in regions with poor sanitation/lack of access to safe water Accessed May 2014

6 Rationale & aims Eligible hepatitis A vaccination Current model Screen for immunity non-immune Targeted vaccination Proposed model Empirically vaccinate for No previous cost analysis studies in our area Is pre-vaccination screening for hepatitis A, compared with empirical vaccination, cost effective in our population, NHS Lothian, Scotland. Is pre-vaccination screening for hepatitis A cost effective in individuals eligible for hepatitis A & B vaccination

7 Methods A retrospective search identified all patients who had hepatitis A IgG (HAV IgG) serology tested in the 1 year data collection from April 2008-April 2009 The presence of detectable HAV IgG was used as a marker of immunity Further data obtained for a proportion of specimens Total vaccination cost - British National Formulary, Screening cost 2013 NHS Lothian laboratory cost (minimum cost, including overheads) Further search of all hepatitis A IgG requests to see if additionally screened for past hepatitis B exposure. (hep B core IgG, hep B surface antigen)

8 Results 2367 specimens identified. 95 excluded as duplicate entries Vaccine Product Total cost of Course (BNF Oct 2013) 2272 specimens eligible (Single dose followed by booster 6-12 months) Havrix Avaxim screening and B screening TEST Minimum cost (including overheads) IgG included in analysis for hepatitis A cost effectiveness 50 specimens excluded (Age <16) 2272 specimens searched for screening for hepatitis B immunity 1191 (54%) HAV IgG positive (immune) 1029 (46%) HAV IgG negative (non-immune) 1488 specimens further data collected 959 specimens identified as screened for hepatitis A and hepatitis B

9 Results: cost analysis ,00 Comparison of the cost of empirical vaccination compared with routine screening and targeted vaccination , , , , , , , , ,40 0,00 Havrix Avaxim Empirical Vaccination Screen and targeted vaccination Screening and targeted vaccination was cheaper than targeted vaccination resulting in a saving of

10 Results: Reason for hepatitis A IgG request 1 % 1 % 1 % 0 % 0 % 0 % 0 % Indication for HAV IgG request 2220 specimens Further data collected on 1488 specimens (67%) 3 % 3 % 4 % 5 % 7 % 11 % 17 % 26 % 20 % Unknown MSM IVDA Sexual contact Immunocompromised Travel Abnormal LFT Hepatitis C +ve Other Haemophilia Hepatitis B Contact Acute IVF treatment Transplant patient Adverse reaction to vaccine

11 Results: immunity by test subgroup Percentage of positive HAV IgG tests by test reason IVDA MSM Sexual contact Unknown Immunocompromised Travel 0 % 10 % 20 % 30 % 40 % 50 % 60 % 70 % 80 % 90 % 100 % HAV IgG +Ve HAV IgG -ve Over 70% of requests in the travel subgroup were immune to hepatitis A Possible selection bias by clinicians

12 Results: Cost analysis by subgroup (Havrix ) Indication for vaccination Number in group Empirical vaccination (Havrix ) Screen & targeted vaccination (Havrix ) Saving screen and vaccinate Unknown , , , IVDU , , , MSM , , , Immunocompromised 99 4, , , Travel 69 3, , , Sexual contact 159 7, , , Indication for vaccination Number in group Empirical vaccination (Havrix ) Screen and targeted vaccination (Havrix ) Saving with screen and vaccinate Unknown 100 4, , , IVDU 100 4, , MSM 100 4, , Immunocompromised 100 4, , , Travel 100 4, , , Sexual contact 100 4, , Screening and targeted vaccination is cost effective among all subgroups, however, the saving is particularly marked in those requiring vaccination for travel.

13 Cost per 100 people Comparison of cost (per 100 people) for screening with targeted vaccination versus empirical vaccination 5 000, , , , , , , , , , , , , , , , , , , , ,00 500,00 0,00 Unknown IVDU MSM Immunocompromised Travel Sexual contact Population group Empirical vaccination (Havrix) Screen and targeted vaccination (Havrix) In the travel population pre-vaccination screening results in a saving of 1928 per 100 patients

14 Individuals screened for hepatitis A & B immunity 42% of samples were also screened for hepatitis B immunity of which 88% have no evidence of hepatitis B 959/2272 (42%) screened for hepatitis A& B Significant cross over between those requiring hepatitis A and hepatitis B vaccination Current method Proposed method Availability of a combined (hepatitis A and hepatitis B) vaccine Safe to vaccinate individuals who are immune or have previously been vaccinated for hepatitis A Hepatitis B non-immune and Hepatitis A non immune Screen for and B immunity Hepatitis B immune, non-immune immune, Hepatitis B non-immune Hepatitis B non-immune Screen for hepatitis B immunity Hepatitis B immune Combined vaccination (Twinrix ) vaccination (Havrix ) Hepatitis B vaccination (Engerix ) Combined vaccination Hepatitis B & A (Twinrix ) Screen for immunity vaccination (Havrix )

15 Number of people Summary of evidence of past hepatitis B, in those screened for hepatitis A and B Evidence of past HBV 12 % Results: Hepatitis A and B No evidence past HBV 88 % From the 2272 specimens (including age <16) screened for hepatitis A 959 (42%) were also screened for Hepatitis B 843 (88%) have no evidence of previous hepatitis B 367 (44%) of these have immunity to hepatitis A suitable for engerix 116 (12%) are immune to hepatitis B 66 are additionally immune to hepatitis A no vaccination required (6% of total) Summary of results for hepatitis A & B serology No evidence of past HBV HAV immune 66 HAV non-immune 50 Evidence of past HBV

16 90 000,00 Comparison of screening and vaccination options for individuals eligible for hepatitis A and B vaccination , , , , , , , , , ,00 0,00 Current method: Screen for hepatitis A&B Proposed method: Screen for hepatitis B only initially Screening for both hepatitis A and B then offering targeted vaccination is more cost effective than screening for hepatitis B initially and empirically using twinrix in those who do not have evidence of past hepatitis B. Twinrix course costs 83.28, compared with Engerix 38.97

17 Limitations Limitations: Limited cost analysis study for example did not include cost involved in vaccine administration, number of clinic visits. Retrospective study so the criteria for pre-vaccination screening were not absolute. Particularly relevant in the travel subgroup.

18 Summary In our population: Pre-vaccination screening for HAV IgG is more cost effective than empirical vaccination for hepatitis A The greatest saving is in patient groups with high HAV IgG prevalence including travel In those requiring hepatitis A and B vaccination Pre- vaccination screening for hepatitis A and B and targeted vaccination is more cost effective than screening for hepatitis B initially and empirically using twinrix in non immune individuals and only offering hepatitis A screening in those immune to hepatitis B. Conclusion: Pre-vaccination should therefore be specifically considered in individuals where there is a high clinical suspicion of previous hepatitis A exposure. Born or resident in a country with a high prevalence of hepatitis A History of jaundice Adults born prior to World War II QUESTIONS?

19 References World Health Organization, Factsheet N WHO positions paper on hepatitis A vaccines. July Accessed May Guidance for the Prevention and Control of Infection. Health Protection Agency. Available online at: Department of Health. Immunisation against Infectious Diseases. Chapter 17. Accessed online 25 th May 2014 at Department of Health. Immunisation against Infectious Diseases. Chapter 18. Accessed online 25 th May 2014 at: Routine childhood immunisation schedule. Health Protection Agency. Available at:

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