The HPV Immunisation Programme in NZ. Chris Millar Senior Advisor Immunisation Ministry of Health

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The HPV Immunisation Programme in NZ Chris Millar Senior Advisor Immunisation Ministry of Health chris_millar@moh.govt.nz 4 September 2015

Background of NZ s HPV Immunisation Programme Aim: To protect young women from Human Papillomavirus (HPV) infections and the risk of developing cervical cancer later in life. HPVs: small, non-enveloped DNA viruses from the Papillomavirus family about 150 different HPV serotypes infecting squamous epithelium at different sites, eg palmar, plantar or anogenital > 40 HPV types can infect the anogenital tract.

HPV types causal link to cancer high risk types:16, 18, 31, 33, 45, 52 and 58 (16 and 18 associated with cervical cancer) low-risk types include 6, 11, 40, 42, 43, 44, 54, 61, 70, 72, 81 and 89, (6 and 11 associated with genital) Data from the US cancer registry indicates that HPV is linked to: 99.7% of cervical cancers 50 % of vulvar cancers 65 % of vaginal cancers 35 % of penile cancers 95 % of anal cancers 60 % of oropharyngeal cancers

Perinatal transmission can cause laryngeal infection in infants - recurrent respiratory papillomatosis (rare) Infection results from skin-to-skin contact with a person with HPV infection. Data from the NZ Youth 2012 survey suggests that approximately: 8 percent of New Zealand adolescents may have had sexual intercourse before the age of 13 years. 24 percent by 15 years 46 percent by age 17 years and 17 percent of sexually active students don t use a condom or other contraception.

NZ HPV Immunisation programme 1 September 2008 - Commenced HPV immunisation catch-up programme for young women born in 1990 and 1991. Secondary schools and GPs 2009 - catch-up programme extended to include girls born from 1992-1996. 31 Dec 2010 - catch-up programme completed. 2010 School Immunisation Programme for girls in school year 8 (age range 11-13 years) as part of National Immunisation schedule - also available from general practices for girls aged 12 to 19 years

National Immunisation Register (NIR) NIR: computerised information system; has collected childhood immunisation since 2005 & and since July 2014 some adult immunisation information. Purpose: to facilitate immunisation delivery and provide an accurate record of an individual s immunisation history. Provides: an accurate record of immunisation coverage rates regionally & nationally enabling programme planning to target populations with the lowest immunisation rates. Assists: to improve its immunisation rates and improve the delivery of immunisations across the primary, community and secondary health sector. Access: authorised health professionals; non-identifiable information for research; parents can request record of child s immunisations.

HPV Immunisation Programme Vaccines approved for use and available in NZ : HPV4, Gardasil, (biocsl/msd) contains HPV types : 16 & 18 causes 70 % of cervical cancers 6 & 11 causes 90% of genital warts Funded for: - girls and young women aged under 20 years individuals under 26 years with confirmed HIV infections for use in transplant patients HPV2 vaccine (Cervarix, GSK) -contains HPV types 16 & 18 (not funded)

Effectiveness: Ali, H. et al (2013). - Collated genital wart data from eight sexual health services from 2004 to 2011 Large study 85 770 Australian born patients seen for the first time at sexual health services 9.0% (7686) were found to have genital warts. Large declines in number of women diagnosed with genital warts occurred under 21 year olds: 11.5% in 2007 to 0.85% in 2011 (P<0.001) 21-30 year old: 11.3% in 2007 to 3.1% in 2011 (P<0.001) Concluded: The significant declines in the proportion of young women with genital warts and the absence of genital warts in vaccinated women in 2011 suggests that the human papillomavirus vaccine has a high efficacy outside of the trial setting. Large declines in diagnoses of genital warts in heterosexual men.

Crowe et al (2014) looked at the effectiveness of the vaccine on cervical abnormalities Women eligible for free vaccination (aged 12-26 years in 2007) and attending for their first cervical smear test between April 2007 and March 2011. o high grade cervical abnormalities with confirmed histology (n=1062) o other cases - women with any other abnormality at cytology or histology (n=10,887). o controls were women with normal cytology (n=96,404). Concluded: The quadrivalent HPV vaccine conferred statistically significant protection against cervical abnormalities in young women who had not started screening before the implementation of the vaccination programme in Queensland, Australia.

Smith et al (2015) study assessed the impact of the qhpv vaccine and Ontario s grade 8 qhpv vaccination program on cervical dysplasia and anogenital warts girls in grade 8 before (2005/2006 2006/2007) and after (2007/2008 2008/2009) program implementation. 131,781 ineligible and 128,712 eligible girls (n = 260,493). Identified 2436 cases of dysplasia and 400 cases of anogenital warts. Vaccination reduced the incidence of dysplasia by: 5.70 per 1000 girls (95% CI 29.91 to 21.50), corresponding to a relative reduction of 44% (RR 0.56; 95% CI 0.36 to 0.87). Concluded: the effectiveness of HPV on cervical lesion showed - vaccination significantly reduced the incidence of dysplasia by 5.70 per 1000 girls (ie, a 44 percent reduction).

NZ s HPV Immunisation Coverage 2011-2014 the HPV immunisation coverage ranged in mid to high 50 s 90 Percentage Coverage for Maori and Pacific 2010-2014 (Report run date: 13 January 2015) 80 70 60 50 40 30 Māori Pacific Total 20 10 0 2010 2011 2012 2013 2014 Coverage for 12 year old girls immunised in 2014 as at 30 June 2015 reached 60%

How does this compare to other countries Country HPV Coverage for girls 2014 New Zealand 60 Canada 70.2 Australia 73 UK 85.9

Revitalising the HPV Immunisation Programme Up until December 2014, the targets for 12-year-old girls were: Dose one 70 % Dose two 65% Dose three 60% 1 January 2015, agreed HPV fully immunised (dose three) target was 75% by December 2017. Incremental increases: Dec 2015 65% Dec 2016 70% Dec 2017 75%

The Ministry recommends applying GAVI immunisation objectives to the current Programme, as follows Objective Ownership Shared responsibility and partnership Equity Integration Sustainability Innovation Description All providers and the wider health sector recognise the importance of the Programme and work collectively to achieve agreed targets. The Ministry, the National Screening Unit (NSU) and DHBs, as partners and customers, respect the role of primary health care providers and the community itself in increasing coverage, and actively look for opportunities to improve the Programme. The Programme deliverables are fair and just; in particular for vulnerable populations such as Māori, Pacific peoples and lowincome groups. The Programme is integrated with other programmes on the Schedule in order to achieve better outcomes for young women and improve the efficiency of SBIP delivery. The Programme continues to receive funding and remains a government priority. The Programme undergoes continuous improvement, with an aim to increase coverage rates and quality.

Use of Ministry s four-point action plan to activate change Underlying principles of action plan: trusting relationships with parents more functional relationships between SBIP and general practice teams better quality processes, based on the Plan, Do, Check, Act cycle recognising the role of the community.

Timeline Year Action GP s SBIP DHB s 2015 2017 2015 2017 Recall 14 year olds who are unimmunised or incomplete olds Notify GP s 12 year old girls who choose GP to vaccinate instead of SBIP 2015 Achieve 65% fully immunised for HPV 2016 Achieve 70% fully immunised for HPV 2017 Achieve 75% fully immunised for HPV 2017 Offer HPV in School Year 7 with Tdap

Future Possible Options Closer working relationship with NSU to achieve Parliamentary recommendations June 2015 Implementing 2 dose HPV immunisation schedule for girls aged under 15 years Including boys in HPV programme - New NIR Primary HPV testing for women (self sampling, test interpretation less subjective, 5 year smears, potentially more cost effective). Consultation paper available in October on nsu.govt.nz

Current age in 2015 of girls offered vaccination from 2008-2015 Current Age in 2015: 30 25 20 15 Current Age in 2015 10 5 HPV Scheduled Programme 2010 2015 > Catch up programme 2008 2010 0 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002

Early (anecdotal) evidence from 6 monthly independent monitoring reports (Smith, M. 2015) 2.5% Cytologically detected HSIL in 20-24 years olds between Jan 2013 Dec 2014 show reducing trend. Possible associated with early Vaccination effects. 2.0% 1.5% 1.0% 0.5% 0.0% <20 20 24 25 29 30 34 35 39 40 44 45 49 50 54 55 59 60 64 65 69 70+ All ages Jan Jun 2013 Jul Dec 2013 Jan Jun 2014 Jul Dec 2014

Longer term trends in the proportion of total satisfactory samples reported as HSIL (July 2008 December 2014), selected age groups (Smith,M. 2015) 2.5% 2.0% 1.5% 1.0% 0.5% 0.0% Jul Dec 2008 Jan Jun 2009 Jul Dec 2009 Jan Jun 2010 Jul Dec 2010 Jan Jun 2011 Jul Dec 2011 Jan Jun 2012 Jul Dec 2012 Jan Jun 2013 Jul Dec 2013 Jan Jun Jul Dec 2014 2014 <20 20 24 25 29 30 34 35 39 All ages

Clark TC, Fleming T, Bullen P, et al. 2013. Youth 12 Overview: The health and wellbeing of New Zealand secondary school students in 2012. URL: https://cdn.auckland.ac.nz/assets/fmhs/faculty/ahrg/docs/2012-overview.pdf (accessed 24 October 2013). Centers for Disease Control and Prevention. 2012. Human papillomavirus-associated cancers United States, 2004 2008. Morbidity and Mortality Weekly Report 61(15). URL: www.cdc.gov/mmwr/preview/mmwrhtml/mm6115a2.htm (accessed 3 September 2013). Ali,H.et al (2013).Genital warts in young Australians five years into national human papillomavirus vaccination programme: national surveillance data. BMJ 2013;346:f2032 doi: 10.1136/bmj.f2032 (Published 19 April 2013) Crowe, E. et al(2014). Effectiveness of quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalities: case-control study nested within a population based screening programme in Australia. BMJ 2014;348:g1458 doi: 10.1136/bmj.g1458 (Published 4 March 2014) Smith,L. (2015). The Early Benefits of Human Papillomavirus Vaccination on Cervical Dysplasia and Anogenital Warts. PEDIATRICS Volume 135, number 5, May 2015