o 2-yearly (Pap test) o 18 to 69 years 1 o Registry reminder

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1 Invasive cervical cancer cases per 100,000 Main changes from Dec 2017 The Renewed National Cervical Screening Program The Big Picture Brisbane 22 nd April 2017 Ian Hammond National Cervical Screening Program: Department of Health Australia School of Women s and Infants Health: University of Western Australia Now Pap smear 2 yearly Start 18 years End 69 years Reminders Dec 2017 Cervical Screening Test (oncogenic HPV test) 5 yearly Start 25 years End years Invitations/Reminders Self-collection Topics for today Cervical screening in Australia Rationale for Change: The Renewal The test, the age range and the interval National Cervical Screening Policies NCSP policy Self-Collection policy Transitioning women to new program policy The National Cancer Screening Register Quality and Safety 1991 NCSP Policy: o 2-yearly (Pap test) o 18 to 69 years 1 o Registry reminder Participation: 2 2-yearly 58% 5-yearly 83% 2 50% reduction in incidence & deaths Opportunistic screening Introduction of the National Cervical Screening Program Organised screening Organised screening: Plateau phase 1 NHMRC Australia, Guidelines for Cervical Screening Australian Institute of Health and Welfare 2014, Why Renewal of the NCSP New knowledge on the development of cervical cancer. New evidence for cervical cancer prevention and screening New technologies liquid-based technology computer assisted image analysis HPV tests National HPV Vaccination Program (girls) National HPV Vaccination Program (girls + boys) Current NCSP is intensive compared to other countries Cervical Cancer in Australia Incidence and mortality rates of cervical cancer: selected countries-2012 Country Incidence per 100,000 women Mortality per 100,000 women Sweden United Kingdom USA Canada Australia New Zealand Finland Source: GLOBOCAN

2 Renewal of the NCSP What: is the aim of the Renewal Ensure the success of the program continues All women, HPV vaccinated and unvaccinated George Papanicolaou Pap test developed Diagnosis of uterine cancer by the vaginal smear American Cancer Society Pap smear is a valuable test Access to a cervical screening program based on current evidence and best practice. Harald zur Hausen 1982 Demonstrated that HPV was the cause of cervical cancer 2008 Nobel Prize in Medicine Ian Frazer AC Developed the first vaccine for HPV 2007/2013 National HPV Vaccination Program girls/boys HPV Normal Add HPV (30% incidence) 98% over 5 years Development of cervical cancer due to HPV infection Cancer Prevent HPV infection (Vaccine) 5 weeks LSIL 2% in 5 years HSIL years Detect/Treat HPV/CIN PAP smear, HPV testing destructive therapy E1-7, L1,2 E6, E7 E6, E7 2

3 Discounted lifetime cost ($) Discounted lifetime cost ($) Options for Screening Approaches Cost-effectiveness plane Evaluated Safety Effectiveness Cost effectiveness in both unvaccinated and cohorts offered HPV vaccination 132 screening algorithms Supplementary analysis: screening end age 65 or 70 years Decreasing LYS/QALYS Decreases life years and increases costs Decreases costs but also decreases life years (disinvestment) Increasing costs Unlikely to be cost-effective WTP ratio ` Current practice Decreasing costs ` Likely to be costeffective Increasing LYS/QALYS Both life years and cost saving Lew JB*, Simms K,* Smith M, Kang YK, Xu X, Caruana M, Walker R and Canfell K. (*Joint first authors) National Cervical Screening Program Renewal: Effectiveness modelling and economic evaluation in the Australian setting (Assessment Report). MSAC Application No November Results: Unvaccinated cohorts Results: Cohorts offered vaccination Cost-effectiveness plane showing current practice and potential screening scenarios with life-years as an outcome unvaccinated cohort Cost-effectiveness plane showing current practice and potential screening scenarios with life-years as an outcome cohort offered vaccination at age 12 years $400 $380 $360 $340 Current practice Conventional cytology Manually-read LBC Image-read LBC Co-testing No genotyping Genotyping $340 $320 $300 $280 Current practice Conventional cytology Manually-read LBC Image-read LBC Co-testing No genotyping Genotyping $320 $260 $300 $240 $280 $220 $260 $240 $200 $220 $180 $ Discounted life-years (years) $ Discounted life-years (years) Lew JB*, Simms K,* Smith M, Kang YK, Xu X, Caruana M, Walker R and Canfell K. (*Joint first authors) National Cervical Screening Program Renewal: Effectiveness modelling and economic evaluation in the Australian setting (Assessment Report). MSAC Application No November Lew JB*, Simms K,* Smith M, Kang YK, Xu X, Caruana M, Walker R and Canfell K. (*Joint first authors) National Cervical Screening Program Renewal: Effectiveness modelling and economic evaluation in the Australian setting (Assessment Report). MSAC Application No November MSAC Recommendations Cervical Screening Test (CST) HPV test with partial genotyping (16/18) Reflex Liquid Based Cytology (LBC) triage Five year screening interval Start at age 25 years Exit at years All sexually active women-hpv vaccinated or not Self collection: never-screened and under-screened Invitation & reminders to screen: National Register 3

4 Renewal: the bottom line Primary HPV screening program will lead to: Up to 30% Fewer cases of cervical cancer Fewer deaths from cervical cancer NCSP Policy Objectives (i) Reduce the mortality and morbidity attributable to cervical cancer Maximise the proportion of women, yrs, who are screened every 5 years Minimise the harms of cervical screening NCSP Policy Objectives (ii) Provide cervical screening that is equitable, accessible and appropriate to Australian women Provide safe and effective services in accordance with the NCSP Quality Framework Provide quality program management, monitoring, evaluation and accountability NCSP: 1 st Dec 2017 New - screening test HPV New - screening interval 5 years New - starting age 25 years New - finishing age 74 years New - self-collection New - National Cancer Screening Register NEW CHALLENGES Possible concerns The test: Oncogenic HPV NAT The age range: years The interval: 5 years HPV Nucleic Acid Testing More sensitive than cytology Earlier detection of high grade lesions Prevents more cervical cancer + Potential to reduce invasive adenocarcinoma Allows for individual risk based assessment Partial genotyping improves risk stratification A negative oncogenic HPV test is protective for at least 5 years 4

5 HPV NAT (Nucleic Acid Testing) Which tests will be used in the renewed NCSP?? HPV-NAT: NPAAC Draft Requirements Equipment (Assay) Human papillomavirus (HPV)-based primary screening with reflex liquid-based cytology Open platform testing based on criteria rather than a tender process National Pathology Accreditation Advisory Council (NPAAC) Requirements for Laboratories Reporting Cervical Screening Tests Draft requirements released on Friday October 14th, 2016 Courtesy: Dr David Hawkes (VCS) Must satisfy Meijer Criteria (sensitivity, specificity, reproducibility) Must be validated for primary population based screening Must contain a control to monitor inhibition and/or assay failure Must contain a control for cellularity to detect inadequate or empty cell samples Courtesy: Dr David Hawkes (VCS) Summary All HPV tests satisfying the NPAAC Draft Requirements are sensitive and specific enough to detect clinically relevant infections The quality of HPV testing as part of the NCSP is maintained through QAP, QC and population based positivity NPAAC: 2000 per month HPV test minimum Why has the recommended age for commencing screening been raised to 25 years? Is it safe? Courtesy: Dr David Hawkes (VCS) Three-year average cervical cancer incidence (with 95% CIs), by all ages and histological type, Three-year average cervical cancer incidence (with 95% CIs), by age and histological type, M.Smith, K. Canfell: Med J Aust 2016; 205(8): M.Smith, K. Canfell: Med J Aust 2016; 205(8):

6 Safety of not screening women < 25 years Three-year average cervical cancer incidence (with 95% CIs), by age and histological type, years of screening women under 25 years of age no impact on incidence of cervical cancer in this age group Systematic literature review No evidence for screening effectiveness in other countries Very low incidence of cervical cancer in these women Expected to decline further due to HPV vaccination M.Smith, K. Canfell: Med J Aust 2016; 205(8): IARC recommendation Do not screen women under age 25 years Older women Benefits of screening outweigh harms for 25 to 69 yo 70 to 74 yo are recommended to have an exit HPV test before leaving the cervical screening program. Older women, who are regular screeners will have a protective effect. Women > 69 years of age who have never screened or are lapsed screeners should be screened if they request a test. Why has the screening interval been extended from two years to five years? Is it safe? Primary HPV screening Longitudinal results for screen-negative women Primary HPV screening: Pooled data on invasive cervical cancer outcomes from four European trials - 176,000 women At longer intervals] HPVbased screening provides 60 70% greater protection against Cytology invasive cervical carcinomas compared with cytology Low risk HPV Cytology HPV Copyright 2008 BMJ Publishing Group Ltd. Dillner, J. et al. Joint European Cohort Analysis. BMJ 2008;337:a1754 Effectiveness and Safety Ronco et al, Lancet

7 What does this mean for you? What sample should you collect for a cervical screening test? Liquid based cervical specimen only Conventional Pap smear no longer accepted!! Laboratories will provide detailed instructions appropriate consumables so that the sample satisfies requirements both of the HPV test and LBC, should this be required. What does this mean for women? Will still need a speculum vaginal examination Will be invited to have a screening test every 5 years A sample will be taken from her cervix and sent to lab If cytology needed no additional visit to GP/provider Women will receive results from their GP/provider active communication Test results: kept by National Cancer Screening Registry What should you expect from the lab report? An overall cervical screening risk assessment Low risk Higher risk Intermediate risk A statement of test(s) performed and the results HPV test result including any LBC result A recommendation for follow-up/action Taking account of screening history and clinical notes Cervical Screening Test Women s Risk Based Assessment Low risk HPV not detected ACTION: REPEAT CST in 5 YEARS Higher risk HPV (16/18) detected (with any LBC result) OR HPV (not 16/18) detected (with LBC: phsil, HSIL or any glandular abnormality) ACTION: REFER for COLPOSCOPY Normal endocervical cells Expert colposcopy referral is necessary Abnormal endocervical cells Cervical Screening Test Women s Risk Based Assessment Intermediate risk (risk is determined by combined HPV and LBC result) HPV (not 16/18) detected (with LBC negative or plsil/lsil) ACTION: Follow-up HPV test in 12 months 7

8 Follow up of Intermediate risk women after initial cervical screening test result Women at Intermediate risk Follow-up HPV test in 12 months At follow-up 12 month test HPV detected (any type) with any LBC result (= persistent HPV infection) ACTION: REFER for COLPOSCOPY At follow-up 12 month test HPV not detected ACTION: REPEAT CST in 5 YEARS Self-collection pathway Self-collection for cervical screening 80% cervical cancer occurs in women never screened or under-screened (VCCR 2012) MSAC recommendation Self collection of vaginal sample for HPV test Under screened and never screened women only Facilitated by nurse or medical practitioner Carried out at the practice not at home Or on behalf of a medical practitioner Who also offers routine cervical screening 8

9 Transition to the renewed NCSP Women already participating in program >23yr and <70yr at last test Will be invited to screen when due for next test <23yrs at last negative test Will be advised test not needed until age 25 Will be invited at that time Overdue by < 2 years and >25yr age Advised overdue and reminded to screen Overdue by 2years and >30 yr age Invited to screen and advised re self-collect option 70yr and <75yr invited to have exit screening test Renewal NCSP Steering Committee for the Renewal Implementation Project (SCRIP) Implementation Project Plan MBS items National Cancer Screening Register Workforce + Practice Change Quality and Safety Communication, Education and Information National Cancer Screening Register National Cancer Screening Register Linked to HPV register Used to issue invitations/reminders Full history from vaccination-diagnosis Colposcopy and pathology data Monitoring and service improvement One woman = One record Quality and Safety QSMC Quality and Safety Monitoring Committee Chair: Professor David Roder Protocols for monitoring the NCSP Quality Framework Principles of quality control Program standards Colposcopy standards Education and Training National Prescribing Service On line education modules Practical training modules Train the Trainer module (For all CST providers) Cancer Council Australia On line education clinical scenarios (For GPs, O&G specialists, Nurses and others) Department of Health Australia Cancer screening website, Publications for all 9

10 The 2016 Guidelines Endorsed by NHMRC 9 th June 2005 Implemented 3 rd July 2006 Renewal NCSP Concerned about Renewal? Primary HPV screening program will lead to: Until 1 st Dec 2017 Business as usual! Up to 30% Fewer cases of cervical cancer Fewer deaths from cervical cancer Questions? - Panel discussion Further information: Cervicalrenewal@health.gov.au 10