ADDRESSING MDR-TB: The PHILIPPINE EXPERIENCE For the APEC Conference on Prevention, Control and Care of MDR-TB And Supply of 2nd Line Anti-TB Drugs Taiwan, June 29, 2016 ROSALIND G. VIANZON, MD, MPH Division Chief, IDPCD Disease Prevention and Control Bureau Department of Health Philippines

Philippines 2014 - Impact Indicators Incidence Prevalence Mortality 288/100,000 290,000 Filipinos 417/100,000 410,000 Filipinos 10/100,000 10,000 Filipinos

30 countries with High TB Burden Each list contains 30 countries (top 20 in terms of absolute numbers of cases plus 10 countries with the most severe burden in terms of case rates per capita (not part of top 20) and meet minimum threshold of absolute numbers of cases (10 000 per year for TB, and 1000 per year for TB/HIV and MDR-TB). Each list accounts for 85–89% of the global burden.

Global Burden of MDR-TB Est. Deaths from MDR-TB 190,000 >50% Missing DR-TB Cases Treatment Success Rate 50%

Global Burden of MDR-TB Estimated MDR-TB Cases New TB Cases: 3.3% Previously Treated TB Cases: 20% Estimated New MDR-TB Cases Worldwide 480,000 Mortality 190,000 Estimated MDR-TB Cases among Notified TB Cases 300,000 RR/MDR-TB Notified 123,000 (41%) RR/MDR-TB Enrolled 111,000 Treatment Success Rate 50% Source: WHO Global TB Report 2015

How Big is the MDR TB Burden in the Philippines? Drug Resistance Survey % of Notified Cases with MDR-TB 2004 2012 Among New TB cases 4% 2% Among Re-treatment TB cases 21%

How Big is the MDR TB Burden? Drug Resistance Survey % of Notified Cases with MDR-TB 2004 2012 Among New TB cases 4% 2% Among Re-treatment TB cases 21% 2015 notified New TB cases 2015 notified Re-treatment TB cases 28,404 5,419 5,965

How Big is the MDR TB Burden? Drug Resistance Survey % of Notified Cases with MDR-TB 2004 2012 Among New TB cases 4% 2% Among Re-treatment TB cases 21% 2015 notified New TB cases 2015 notified Re-treatment TB cases 11,384 MDR-TB 28,404 5,419 5,965

National TB Control Program Case detection rate: > 90% Success rate: > 90% Localized implementation of TB Monitor health system performance Engage both public & private health care providers Promote and strengthen positive behavior of the community Secure adequate funding and improve allocation and efficiency of fund utilization Certify and accredit TB care providers Regulate and make available quality TB diagnostic tests and drugs Address MDR-TB, TB/HIV, and needs of vulnerable population Detect and Treat 19,500 MDR-TB Cases (2010-2016) MDR-TB Notification of 62% Treatment Success of 75% 2010 – 2016 Philippine Plan of Action to Control Tuberculosis. Department of Health, Philippines

PhilPACT Objectives Strategies Reduce local variation in TB control program performance Localize implementation of TB control Monitor health system performance Scale up and sustain coverage of DOTS implementation 3. Engage both public and private health care providers Promote and strengthen positive behaviour of the communities Address MDR-TB, TB/HIV, and needs of vulnerable population Ensure provision of quality TB services Regulate and make available quality TB diagnostic tests and drugs 7. Certify and accredit TB care providers Reduce out-of-pocket expenses related to TB care Secure adequate funding and improve allocation and efficiency of fund utilization

Trend of Enrollment and Treatment Success Rates 9-MTR OR ETAP Food Pckg NTPMO iDOTS ComPCare MAIP Xpert MTB/RIF test TSR 41% TSR 49% SRDR TSR 46% Started in the private sector in NCR Expansion outside NCR TSR 64% TSR 57% In 1999, a non-government organization (Tropical Disease Foundation), started providing diagnostic and treatment services to DR-TB patients. This was continued through a Green Light Commitee-approved DOTS-Plus Pilot Project. In 2003, the Global Fund to Fight against AIDS, Tuberculosis and Malaria initiated giving financial support to the country to expand services to DR-TB patients. In 2007, there were 3 PMDT treatment facilities, all located in the National Capital Region.  In 2008, the number of DR-TB cases increased as compared to the previous years. This may be attributed to the expansion  of DR-TB services.  A PMDT treatment facility (Eversley Childs Sanitarium Treatment Center, Cebu) outside the National Capital Region was established. In the same year, the Department of Health (DOH) issued Administrative Order 2008-0018 "Guidelines for the Implementation of the Programmatic Management of Drug Resistant Tuberculosis (PMDT). This paved the way for mainstreaming PMDT to other regions of the country. Treatment Success Rate was 64%. In 2009, the treatment success rate was 57%.  In 2010, there were more DR-TB cases and again, the increased in enrollment was mainly due to continuous expansion of DR-TB services. In April, 2010, PMDT management was transferred from a private sector to a government institution (Lung Center of the Philippines). Treatment regimen was revised from individualized to standardized treatment regimen (Standard Regimen Drug Resistant/SRDR). TSR was low at 46% due to increase in the lost to follow-up rate. In 2011, there was a dramatic increased in the number of enrolled DR-TB but the TSR was only 41%. In the last quarter of 2011, rapid molecular diagnostic tool (Xpert MTB/RIF test) was adopted by the program initially to 16 sites. There was an improvement of the TSR in 2012 but still below the global TSR of 50%. Various initiatives were introduced and implemented to overcome the challenge of poor treatment success rate due to increase in the lost to follow-up such as the Milestone Achievement Incentive Package (MAIP) in 2013 wherein, enrolled DR-TB patients were provided financial support (total amount of P20,000) for good compliance to treatment.  In 2014, integration of PMDT services into the basic DOTS services of health facilities with community based PMDT care was piloted in the National Capital Region. In the same year, PMDT has been integrated within the NTP at the national, regional and provincial/city levels and services have been expanded to all the 18 regions of the country. In 2015, together with partners, initiated the 9-month treatment regimen operational research in selected PMDT treatment facilities. This aims to test the country-specific operational feasibility, and to measure the effectiveness and safety of a shorter, 9-month MDT-TB regimen in the Philippines. Other initiatives to ensure treatment compliance of DR-TB patients are: Enhance Treatment Allowance Package (ETAP) – this is basically enhancing the financial scheme being provided by increasing the amount from P75.00 to P150.00 and is being done on a front-loading scheme to avoid out-of-pocket expense from the patients. Food package – on top of the treatment allowance, the program is also providing food package worth P100.00

Cascade for PMDT Care 88% of identified has been enrolled – 578 not enrolled For every 15 tested, 1 positive

Trend of Treatment Outcome of Patients under PMDT, 1999 to 2012

Analyzing Case Notification PhilPACT Target: 62% No access to health care Access to health facilities, but don't go Undiagnosed cases Presenting to health facilities, but undiagnosed All TB cases Diagnosed by public or private providers, but not notified Systematic screening for active TB is predominantly provider-initiated. It may target people who do not seek health care because they do not have or recognize symptoms, because they do not perceive that they have a health problem that warrants medical attention, because there are barriers to accessing care, or for other reasons. It may also target people seeking health care who do or do not have symptoms or signs compatible with TB and who may not be identified by “passive case-finding” as possibly having TB. People seeking care who may be eligible for TB screening include people with medical conditions that constitute risk factors for TB (such as people living with HIV and people with diabetes mellitus) who may seek care for reasons other than symptoms compatible with TB Poor or no access to health care – delay in diagnosing TB and initiating appropriate treatment Increse sensitivity of current case-finding approach by expanding current definition of TB symptomatics from 2 wks symtoms to any period of symptoms and signs, and we would like to see how many additional TB cases are idendified and see if this new approach is cost effective, affordable, acceptable and feasible and to get more beneficial than doing harm such as putting false positives on unnessary treatment. (potential benefits and harms of screening) Target three different groups of people (missed, delayed or problems with access to high-quality care) Who seek health care with or without symptoms and signs compatible with TB Who do not seek care because they do not perceive that they have a health problem that warrents medical attention Who do not seek care because barriers such as financial/geographicial or cultureal barries, which make it difficult to access health care - Barriers to early case detection may occur at each step, and the poorest people are at highest risk of not completing, or delaying, each step. They have the least access to high-quality services, and face the highest costs from illness and for health care.24 Screening groups who have limited access to health care may help reduce delays. However, other interventions to improve health-seeking and access may be equally or more relevant and cost effective, depending on the local situation. Diagnosed but not notified cases Diagnosed by NTP or collaborating providers Recorded in NTP notification data Notified cases

Findings (Joint Program Review March 2016) Implementation and scaling-up of PMDT depends heavily on external funding and project-hired staff Gap between diagnosis v.s. notified v.s. treatment cohorts are wide Low Treatment Success on MDRTB is due to High Lost to follow-up Current regimen for pre-XDR-TB and XDR-TB do not include new anti-TB drugs (Bedaquiline and Delamanid)

Burdens of MDR-TB On Service Delivery: - Complexity on the needed preparations and high cost of expanding PMDT services - Limiting the capacity of DOTS facilities; capable only for basic TB services On Health Systems: - More expensive - More workload for the health workforce

Burdens of MDR-TB On Patients: - Onset of ADRs - Long treatment duration - Absence from work - Far from the family

Tropical Disease Foundation Most frequent self-reported reasons for stopping treatment among LTFU patients (based on qualitative analysis) Tupasi, et. al, LTFU Study 2014 Tropical Disease Foundation

NTP’s Actions to “Unburden” MDR-TB Pillar 1: Integrated, Patient-Centered Care and Prevention Service Delivery : Expand PMDT services: i-DOTS with CompCare Decentralize services -closer to patients and family - Lessen travel time; no need for re-location Strengthen capability of HCWs; upgraded facilities Provide Nurses “AIDERs” based at GIDA areas Patient Support Group (KAP) per Satellite/Tx Center Use RMDT (Xpert MTB/RIF test); includes Sm-CXR+ Conduct Contact Tracing strategies Offer PICT to enrolled DR-TB patients 15y/o &above

Integrated DOTS (i-DOTS) Hospital: DOTS Center Identification & referral of presumptive DR-TB DSSM RHU: DOTS Center Identification & referral of presumptive DR-TB DSSM Treatment: continuation RHU: iDOTS Center Screening & sputum collection DSSM Treatment: initiation, intensive, continuation, post RHU: DOTS Center Identification & referral of presumptive DR-TB DSSM Treatment: continuation RHU: iDOTS Center Screening & sputum collection DSSM Treatment: initiation, intensive, continuation, post RHU: DOTS Center Identification & referral of presumptive DR-TB DSSM Treatment: continuation RHU: PMDT STC Screening & sputum collection DSSM & GX Treatment: initiation, intensive, continuation, post RHU: DOTS Center Identification & referral of presumptive DR-TB DSSM Treatment: continuation Hospital: Laboratory DSSM GX TBC and DST Hospital: PMDT TC Screening & sputum collection Treatment: initiation, intensive, continuation, post

Community – Based DOT for PMDT Community Treatment Partners Key Components iDOTS FACILITY Community Treatment Partners i-DOTS Staff DR – TB Patient

NTP’s Actions to “Unburden” PMDT Pillar 2: Bold Policies and Supportive Systems Needed Resources (Human and Monetary) TB Law RA.10767”Comprehensive Tuberculosis Elimination Plan Act” - mandatory reporting of TB cases PMDT sub-plan under the NSP (PhilPACT) Includes workforce-specific needs, budget, fund source Private Sector support – PMDT policies in CPGs of MDs Decentralized TB services to reduce costs (already in 18 reg) Priority on available domestic funds for sustainable services Initiative to advocate with new National Leadership to expand current insurance financing scheme (TB OPB Pckge)

NTP’s Actions to “Unburden” PMDT Pillar 2: Bold Policies and Supportive Systems DOMESTIC (GOVERNMENT) EXTERNAL RESOURCE (GFATM) Consumables Needed; Microscopy supplies, CXR films, Xpert cartridges Equipment needed: Microscopes, some CXR machines Xpert units First line anti-TB drugs; IPT for Children and PLHIVs Second-line anti-TB drugs; Ancillary drugs Entire drug chain processes Mainly on procurement; partly on distribution/delivery to periphery 60-70% of Program budget on logistics (primarily drugs) 70-75% of Project budget on PMDT implementation NTP - biggest budget amongst the Infectious Disease Programs GF-TB Project has the biggest budget amongst the 3 GF Projects

NTP’s Actions to “Unburden” PMDT Pillar 3: Intensified Research and Innovation Patient Condition Conduct researches to address patient issues: - Long treatment duration (e.g. 9-MTR) - ADRs (e.g. new treatment regimens?) Assess/Evaluate incentives - Milestone Incentive Package

Basic Lessons Learnt Prevent DR-TB generation Sustain GOOD basic DOTS Prevent DR-TB transmission Expand to Patient-centered DOTS

Let us all support the NTP; Let’s contribute to the economy! TB/DR-TB is a socio economic disease. It contributes to the country’s economic burden It affects the economically-productive age group; Our economic workforce. A well-planned and effective National TB Program, the NTP, can help sustain the growing economy of the country. Let us all support the NTP; Let’s contribute to the economy!

Thank You…