“ Cost-Effectiveness of USING HPV DNA TESTING IN cervical cancer screening in Peru ”

1. “Cost-Effectiveness of USING HPV DNA TESTING IN cervical cancerscreening in Peru” Beatriz Paulina Ayala Quintanilla & WinWah Copenhagen,14th June 2011

2. CONTENTS • INTRODUCTION • OBJECTIVE • METHODOLOGY • RESULTS • CONCLUSIONS • RECOMMENDATIONS

3. INTRODUCTION • Cervical cancer is approximately 10% of the global burden of cancer and is the second most common cancer affecting women. • (1.4 million prevalent cases, 529 409 new cases and 273 000 deaths worldwide.)

4. TYPES OF CERVICAL CANCER 90% (85–90%) are cervical carcinomas (squamous cell carcinomas); 5 to 9 % are adenocarcinoma; the rest are small cell carcinoma and cervical sarcoma; 90-95% of squamous cell carcinomas of the cervix contain the human papilloma virus DNA.

5. 150 (200) related viruses types and 40 HPV types are sexually transmitted; 15 high-risk HPV types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82), Types 16 and 18 are responsible of 70% of cervical cancer cases HPV prevalence among peruvian women with normal PAP: 7.5 %. Prevalence (%) of HPV 16 and/or HPV 18 among women with normal PAP: 3.8% and cancer cases: 68.3% HUMAN PAPILLOMA VIRUS

6. HUMAN PAPILLOMA VIRUS INFECTION 91% (70%) of HPV infections regressed spontaneously within 2 years, whereas the regression rate is 100% for HPV-negative women; Persistent infections and precancerous lesions are established within 1-5-10 years. Precursor lesions may progress to cancer over a period of 3-5 -20 years.

7. RATES OF CANCER IN WOMEN WHO, 2008

8. INCIDENCE AND MORTALITY RATE OF CERVICAL CANCER IN SOUTHAMERICA WHO, 2010 WHO, 2010

9. INCIDENCE AND MORTALITY RATE OF CANCER AMONG WOMEN IN PERU WHO, 2010 WHO, 2010

10. INCIDENCE AND MORTALITY RATES OF CERVICAL CANCER IN PERU

11. Place: Peru Sociodemographics Indicators Population: 27 836000 (Female 13878000) GDP per capita: $ 4477 HDI: 0.723, Rank of 63 out of 169 Population living in urban areas: 73% Life expentancy at birth (years): 73 (Female 71) Literacy rate: 87.9% Total expediture on health as % of GDP: 4.3 • HealthIndicators • Crudebirthrate: 21.3 (birth per 1000 population): • Crudedeathrate: 5.4 • (death per 1000 population) • Total fertility rate: 2.5 • (live births per women) • Infant mortality rate: 21 • (per 1000 births) • Maternal mortality rate: 240 (per 100 000 births) • Pap smear positive: 6.9%

12. OBJECTIVE To assess the cost-effectiveness of using HPV DNA testing in cervical cancerscreening in Peru.

13. METHODOLOGY • Selected Population of Peru • 25to 49 years old: 3 839 000 • Cervical cancer screening: 30.9 / 42.9% • Model: • Decision Analytic Model: Decision Tree • Screening Alternatives • Standard Screening • First screening and regular screening every 3 years: PAP smear and Visual Inspection with Acid acetic (VIA) • New Screening Method • First screening: PAP smear and HPV DNA testing (HC II) • Regular screening every 3 years: Pap smear and HPV DNA testing (HC II)

14. NEW SCREENING METHOD

15. STANDARD SCREENING

16. TWO SCREENING METHODS

17. METHODOLOGY • Model Parameter • Natural History of cervical cancer

18. METHODOLOGY • Model Parameter • Test Characteristic • Pap • Sensitivity (+): 63% (55.4, 60, 74) • Specifity (-): 94% (83.3, 87, 96.8) • VIA • Sensitivity: 76% (70.4, 71, 66-96) • Specifity: 81% (74, 77.6, 64 to 98) • HPV DNA testing (HC II) • Sensitivity: 83 (86, 88, 89.5, 95) • Specifity: 93 (86, 87.5, 95) • Pap + VIA • Sensitivity: 96 • Specifity: 82 • Pap + HPV DNA testing (HC II) • Sensitivity: 99.2 (94) • Specifity: 87.3 (93)

19. METHODOLOGY • Model Assumptions: • The coverage rate was assumed to be 35% (population: 1 343 650 women); • All women started in health state; • All cases of CIN occur in presence of high-risk HPV infection; • The program routinely screened every 3 years; • Biopsy confirmed CINI was treated and cured, and followed-up every 6 months for 1 year and then yearly; • Biopsy-confirmed CINII/III was treated, cured and followed-up every 6 months for 2 years; • Cancer was detected in the first stage so It was treated and cured; • Cost of the program and its implementation was not considered.

20. METHODOLOGY • Cost-effectiveness evaluation • We compared the different strategies in terms of cost and effectiveness • Cost Data • We analyzed mainly direct life time costs for screening procedures, treatment of CIN I, CIN II/III (cold-knife conization), and treatment of cervical cancer (local cancer); • Indirect life time cost referred to expenses for patient time and transport; • Cancer treatment related costs included staff, surgical procedures and medical treatments; • Cost of the program and its implementation was not considered; • All cost was calculated in US dollars.

21. METHODOLOGY • Effectiveness was measured by: • The number of CIN II/III and cancer cases detected (or the number of missed CIN II/III or cancer) between two strategies. • Analysis • ICER • Incremental cost-effectiveness ratio • ICER Threshold • $25 000 to $50 000 • WHO: < GDP per capita (Very cost-effective); 1-3 x GDP per capita (cost-effective); > 3 x GDP per capita (not cost-effective)

22. RESULTS: INDIVIDUAL LIFETIME COST EVALUATION *Lifetimecostfrom 25 to 49 yearsold

23. RESULTS: LIFETIME COST EVALUATION PER WOMEN *Lifetimecostfrom 25 to 49 yearsold

24. RESULTS: LIFETIME COST* *Lifetimecostfrom 25 to 49 yearsold

25. RESULTS: INCIDENCE OF CERVICAL CANCER *per 100 000 women

26. RESULTS: COST EFECTIVENESS ANALYSIS

27. COST EFECTIVENESS ANALYSIS COST EFECTIVENESS ANALYSIS • The incremental cost of detecting an additional CIN I+ as a consequence of adding HPV DNA testing (HC II) in the National Screening programme is as follow: • The incremental cost-effectiveness ratio (ICER) is $3168 per additional CIN I+ case detected. • The incremental cost-effectiveness ratio (ICER) is $3168 per additional CIN II/III + case detected. • The incremental cost-effectiveness ratio (ICER) is $6465 per additional Cancer case detected.

28. LIMITATIONS • The model is based on assumptions that may not fully reflect the clinical complexity of screening and treatment of cervical cancer. • Data were combined from multiple data sources that varied in study design and entry criteria.

29. CONCLUSIONS • First screening with HPV-DNA testing (HC II) instead of VIA increase detection of CIN I, CIN II/III and Cancer cases in Peru; • Using HPV DNA testing in combination with Pap smear in the National Cervical Screening program is safe, effective, very cost-effective for detection of CIN I and CIN II/III and cost-effective for cancer cases.

30. RECOMMENDATIONS • We recommend the use of HPV DNA testing and Pap Smear in the first screening of the National Cervical Screening Program.

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