1. Cervical Screening Guidelines - for now and the future - Meg McLachlin, MD, FRCPC

2. Faculty/Presenter Disclosure Faculty: Dr. C. McLachlin Program: 51 st Annual Scientific Assembly Relationships with commercial interests: –None

3. Disclosure of Commercial Support This program has received financial support from no one in the form of nothing This program has received in-kind support from no one in the form of nothing. Potential for conflict(s) of interest: –none

4. Mitigating Potential Bias None identified

6. Cervical Screening Guidelines - for now and the future Status of Cervical Screening in Ontario Guidelines – Context, Start, Stop and Interval Future Directions –Role of HPV testing

7. Available at www.cancercare.on.ca/ pcs/screening/ cervscreening/OCSP/

8. Incidence rates, by age group, 1981-2007 Cancer Care Ontario (Ontario Cancer Registry, 2010).

9. Cervical Screening Participation Rate Ontario Cancer Plan target 2010: 85%

10. Ontario Cervical Screening Program Report (2003–2008) Other Key Messages  Quality of Screening Unsatisfactory Pap test rate (0.5%) is much lower than in many other jurisdictions > most likely due to Ontario’s predominant use of liquid-based cytology.  Screening History In 2008, 37.9% of women (20-69 yrs) diagnosed with cervical cancer had not had a Pap test six months to 10 years before their diagnosis date.

11. What has changed? - Recognition of the potential harms of overscreening - especially in young women - Emerging evidence regarding the role of primary HPV testing

12. Potential Harms of Screening Adolescents High rates of low-grade, mostly transient abnormalities 90% will clear infection within 2 years Unnecessary anxiety from detection and treatment Treatment linked to adverse future pregnancy outcomes No protective effect with screening

14. Screening Initiation Start screening at age 21 for women who are or ever have been sexually active women Sexual activity includes intercourse, as well as digital or oral sexual activity involving the genital area with a partner of either gender. Women who are not sexually active by 21 years of age should delay cervical cancer screening until sexually active. Regardless of sexual activity, there is no evidence to support screening women under 21 years of age.

15. Screening Interval Cytology screening every 3 years No incremental benefit of annual cytology screening over triennial for the average risk population Any visual cervical abnormalities and/or abnormal symptoms must be investigated regardless of cytology findings

17. Screening Cessation Stop screening at age 70 if adequate and negative screening history (3 or more negative tests in past 10 years) Low incidence in women with negative history Potential discomfort of procedure Difficulties visualizing squamocolumnar junction Aligns with most Canadian provinces

18. Ontario GYN Cytology Volumes 39% drop in overall volume Data from Cytobase

19. NLNSONMNSKABBC Age to Start 20 + SA21 or within 3yr SA (earlier) 21 or later 21 or within 3yr SA (later) 21 or within 3yr SA IntervalAnnual X3 Q 3 yr Annual X3 Q 2 yr Q 3yr Q 2yr X3 Q 3 yr Annual x3 Q 3 yr Annual x3 Q 2 yr Age to Stop > 69 yr75 yr> 70 yr>69 yr Screening Recommendations SA – sexually active Aug 2013

20. Follow-up of Abnormal Cytology No change from previous guidelines ASCUS/ LSIL ASC-H, HSIL, Atypical Glandular Cells > Colp

21. Amendments to the Schedule of Benefits for Physician Services The cervical screening fee code (G365) has been amended to reflect CCO’s new guidelines Routine cervical screening is insured once every 33 months Payment rules for G394 (additional) have been amended to allow payment for:  follow-up of abnormal pap smear; or  inadequate pap smear; or  annually in a patient who is immunocompromised, or  a patient with a history of oncogenic HPV-typing; or  the patient is a member of a vulnerable group

22. Cervical Transformation Zone

23. Transformation Zone Women whose cervical cytology is satisfactory for evaluation and negative for intraepithelial lesion or malignancy but transformation zone components are lacking should be retested at their regular screening interval. Absence of T- zone components alone does not require earlier re-screening. Women with abnormal cervical cytology should be managed as per guidelines regardless of the presence or absence of T zone components. If cytology is normal, screening should be done every 3 years. The absence of T zone is NOT a reason to repeat a Pap test earlier than the recommended interval.

24. Endometrial Cells

25. Benign Endometrial Cells BEC in pre-menopausal women who are asymptomatic require no action BEC in post-menopausal women require investigation, including adequate endometrial tissue sampling any woman with abnormal vaginal bleeding requires investigation, which should include endometrial tissue sampling Recommendation: Endometrial cells in Pap tests from premenopausal women who are asymptomatic require no action. Postmenopausal women and/or women with abnormal vaginal bleeding require investigation including adequate endometrial tissue sampling.

27. E Franco, National Symposium on Infectious Agents & Cancer Toronto, March 11, 2010

28. Positive Negative High risk HPV DNA testing Repeat HPV DNA at X year intervals Positive Colposcopy Repeat hrHPV testing at 12 months Positive Negative Cytology Negative Cervical Sample (Pap) adapted from Cuzick et al. 2008 Primary Cervical Screening with HPV testing

29. Organizing the Program 1º HPV screening must be implemented only within an organized program OCSP organization underway Prescribed registry status Data collection – Cytobase and health claims data Patient correspondence

30. Evidence: Correspondence Recalls and reminders increase screening attendance and are cost-effective Correspondence on abnormal test results may increase follow-up adherence Follow-up rates increase with personalized reminders 30

31. Timelines & Status Overview 31 Category Type OCSPTimelinesStatus Privacy Notice Notice Women age 21-69 with a current Result Aug 15, 2013COMPLETE Invitation Women age 30-69Nov 2013In progress Invitation Reminder Invitation remindersNov 2013In progress Recall Women age 21-69 due for screening Oct 2013In progress Recall ReminderRecall remindersOct 2013In progress Result Notification Normal ResultNormal Pap test resultsSept 19, 2013On Target Unsatisfactory Result Unsatisfactory Pap test results Sept 19, 2013On Target Abnormal Result Abnormal Pap test results Sept 19, 2013On Target Abnormal Follow- up (Reminder) Abnormal follow-upNov 2013In progress