HPV vaccine introduction and implementation Experience from Sri Lanka Dr. Deepa Gamage Consultant Medical Epidemiologist Epidemiology Unit Ministry of Health Sri Lanka
Presentation outline Evidence generation and decision making process for HPV vaccine introduction Vaccine procurement process Vaccine implementation preparatory activities Implementation, coverage and AEFI monitoring
HPV vaccine introduction: evidence for decision Large scale community based Burden study conducted to identify country specific burden on; HPV prevalence and specific genotype among normal women and cancer patients HPV risk attribution in developing cervical cancers Cost estimation for cervical cancer screening : existing national Pap smear screening programme Cervical cancer management cost incurring to the government at each stage of cervical cancer Gamage D. Rajapaksa L, Abeysinghe M.R.N., and De Silva A., Prevalence of carcinogenic Human Papilloma Virus infection and burden of cervical cancer attributable to it in the district of Gampaha, Sri Lanka, 2012UNFPA, Epidemiology Unit, ISBN 978-955-8375-06-8
HPV vaccine introduction: evidence for decision Reviewed existing cervical cancer burden using routine data; Indoor mortality & morbidity data Population based cancer registry data National Cancer Control Programme data Cervical Cancer incidence was around 850-1000 cases per year, majority were at advanced stages of disease at the time of detection
HPV vaccine introduction: evidence for decision.. Cost incurred by the government in pre-cancer detection and cervical cancer management evaluated at different scenarios : based on baseline findings of costing study Cervical cancer screening cost for; Single screening at Call - recall method screening (at least twice in life time) Maximum expected recall of 5 yearly screening Cervical cancer management cost at each stage of the disease in government institutions were assessed
HPV vaccine introduction: evidence for decision.. Cost estimation done for different vaccination options Below 13 years vs Above 13 years Programe mode vs Routine vaccination School based vs community based Reviewed other country experiences global, and in the region Bhutan : team visited for experience sharing
Road map in decision making for HPV vaccine introduction Discussed evidence based results at National Immunization Summits: 2010 and 2015 on HPV and cervical cancer burden, risk attribution in developing cervical cancer, cost effectiveness in different preventive strategies 2010 Summit : HPV was not considered as country priority due to high vaccine price 2015 Summit: An expert working group was appointed to review feasibility of HPV vaccine implementation
Cost to access : HPV Vaccine price (GAVI price) Sri Lanka has access to GAVI price Bivalent HPV vaccine : US$ 4.6 (for 5 years) Quadrivalent HPV vaccine : US$ 4.5 (for 10 years) Total cost for HPV vaccines is 230 million Sri Lankan Rupees Pentavalant vaccine (reintroduction) from 2010 MMR vaccine from 2011 Introduction of IPV vaccine in 2015 Propose d HPV vaccine from 2016 Note: Year 2015-2016 are estimates
Road map in decision for HPV vaccine introduction Expert working group on HPV vaccination Reviewed all existing evidence and recommendations to Advisory Committee on Communicable Diseases (NITAG) ACCD (NITAG) decided HPV vaccine introduction
Road map in decision for HPV vaccine introduction further decided : vaccine type, schedule and implementation strategies Quadrivalent vaccine 2 dose schedule at 0 and 6 months Target population : as girls in Grade 6 (10-11 years) Country wide introduction (National) Mode of introduction as a School based programme and to follow up with if any drop-outs at community clinics Government procurement procedure : GAVI contributed 50% of vaccine cost for the initiation year
Vaccine implementation preparatory activities Government assured funding for the implementation by incorporating HPV in to the National Immunization Programme, through School Medical Inspection programme Partner organizations supported the preparatory work GAVI, UNICEF, WHO All preparatory work including advocacy and training are organized and conducted by the National Immunization Programme, Ministry of Health, in line with the programme requirements
Communications in advocacy Basic 5 points expected 1. What is cervix and what is cervical cancer 2. HPV causes majority of cervical cancer 3. Preventable, safe, effective HPV vaccine is available which prevents 70% of cervical cancer but needs to continue pap smear screening at 35 years for women 4. HPV vaccine is given to girls at Grade 6 in schools (10-11 year old girls) or at Community level immunization clinics, if missed in the school 5. 2 doses are required for complete protection, 2 nd dose 6 months after the 1 st dose
Implementation School based vaccine implementation by field level public health staff : started in October 2017 School based health programme: school medical inspection in Grade 1,4, 7, 10 HPV vaccination for girls in Grade 6 Coverage will be monitored for the completion of 2 nd dose of HPV vaccine AEFI will be closely monitored : by integrating in to existing vaccine safety monitoring programme 1 st dose vaccination in October-November: all districts conducted, & coverage achieved 75-100% at district level 77% (20/26) of districts achieved above 80% coverage