Is the private sector prepared to engage in MDR-TB management?

Findings from the Philippines

Tauhid Islam WHO/WPRO

PPM and PMDT: The Philippines Why PPM-PMDT? Assessments Finding way forward!

The Philippines: The pioneer country in conceptualizing PPM model

• 1993: PhilCAT • 1995: PPM DOTS project • 1999: PPM DOTS-Plus • 2003: DoH adopted PPM strategy • 2004: Operational guidelines • 2010: PhilPACT 2010-16 • 2011: 12% contribution to total

notifications of new TB cases • 2012: 24% contribution to total

notifications of new TB cases • 2013:

– 171 (26%) public hospital, – 157 (24%) private hospitals engaged, – 8513 private practitioners trained on

DOTS

The Philippines: Commendable progress in PMDT scale up

526 566

1953 2056

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1000

1500

2000

2500

01 02 03 04 05 06 07 08 09 10 11 12N

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Yearly enrolled• Good progress has been achieved in case finding and the scaling up against their targets

• The enrolment increased four times in 2011 compared to 2010

• Programme covers all 17 regions

• 45 treatment and satellite treatment centers

• 18 culture, 3 DST and 20 GeneXpert

Why PPM-PMDT? The same onion model applies!

• Despite progress, the number of MDR-TB cases notified in 2011 represents 19% of estimated caseload (among notified) of the Philippines.

Estimated MDR-TB among notified are within NTP network

1. Recorded in notification data

2. NTP or collaborating providers but not reported

3. Public or private but not notified

4. Present to health facilities but not diagnosed

Moving towards outside NTP network

1. Recorded in notification data

2. NTP or collaborating providers but not reported

3. Public or private but not notified

4. Present to health facilities but not diagnosed

Opening the PANDORA BOX Major challenge!

And opportunity to strengthen the system Specialized

Hospital

Specialist doctors

Specialized lab

Difficult patients

Long duration of Tx ADR

Availability of QA drugs

Catastrophic expenditure

A story line

Pharmacy Traditional healer

Private hospital

Private practitioners NGO FBO

Public health center/DOTS

Public hospital/DOTS

Public hospital

A story line

Private Specialist TB

doctor

Private Hospital

Public PMDT centres

A story line

Private laboratory

Public laboratory

A story line

Private market drugs

NTP drugs

PPM-PMDT Is it the same modality as PPM DOTS??

• The strategic information is

crucial for – understanding where the 'missing

MDR-TB cases' are being diagnosed and treated,

– assessing the quality of private sector MDR diagnosis and care, and

– developing appropriate mechanism. • Detailed assessment should

include the following sectors – Private physicians – Hospitals – Laboratory – Drug market

1 A survey among specialist private practitioners

on

the practise in dealing with MDR-TB suspects and patients in the

Philippines

Methodology • A pre-tested short questionnaire survey • Pulmonologists and infectious disease (ID) specialists who

are active members of two medical societies in the Philippines were approached – PTSI: Philippines Tuberculosis Society Inc – PSMID: Philippines society for Microbiology and Infectious

Disease • The questions were either emailed to respondents, or

provided in hard copies during a meeting and a national convention.

• The questions were sent to a total of 220 members of the two societies

• The survey yielded 152 respondents (69%) response rate

Findings

• 87% (132) encountered at least one highly suspected or laboratory-confirmed MDR-TB patients in their practice in the last 12 months.

• The average number of MDR-TB patients seen was 6 in the last 12 months.

• 86% specialist practitioners referred their MDR-TB patients to other facilities or physicians

• Among those who referred their cases, 33% specified that they referred them to NTP approved sites (either MDR-TB and/or DOTS facilities)

• 11% (15) managed themselves.

2 An assessment of

The potential role of the private sector in managing MDR-TB in the

Philippines

Study preparation: Involving all stakeholders

Methodology

• Semi-structured questionnaires

• Trained field interviewers (6 pulmonologists)

• One-on-one interviews with the study subjects

Study population: response rate

Geographic involvement of study population

Hospitals

87% 96%

47% 46%

13% 4% 53% 54%

0%

20%

40%

60%

80%

100%

Free TB dxcs Free TB drugs Free MDR-TB dxcs Free MDR-TBdrugs

% h

ospi

tals

Aware Not aware

Anti-TB drugs in hospital pharmacies (n=72)

Anti-TB drugs No. pharmacies

Single: H, R, Z, E 33 (46%)

FDC: HRZE 62 (89%)

HRE, HRZ 30-55 (42%-76%)

HR 31 (43%)

Fluoroquinolones

Ofloxacin 35 (49%)

Levofloxacin 35 (49%)

Ciprofloxacin 33 (46%)

Moxifloxacin 31 (43%)

Injectables

Streptomycin 39 (54%)

Amikacin 56 (78%)

Kanamycin 0

Capreomycin 0

Group 5 drugs

Clofazimine 0

Clarithromycin 69 (96%)

CoAmoxiclav 72 (100%)

Imipenem/Meropenem 55 (76%)

Linezolid 31 (43%)

Oral b-static SLDs

Ethionamide, Cycloserine, PAS

0

Treatment rate among MDs who saw TB/MDR-TB patients

Private Practitioners

Use of standard regimens for TB

82%

18%

Standard Regimen:2HRZE/4HR

72%

28%

Standard Regimen:2HRZES/HRZE/5HREOther regimens

New cases (n=108) Previously treated cases (n=86)

Regimens for chronic TB cases 20 regimens by 21 MDs

11. 2HRZES/HRZE/5HRE (2) 12. 2HRZES/HRZE/6HRE 13. 2HRZES/4-6HRZE/HR 14. HRZE/HRE + S, Lfx 15. HRZE + 1 wk Cfx or Mfx 16. HRZE + any FQ (Ofx, Lfx, Mfx) 17. 3HRZES + 1 mo Lfx (sometimes) 18. 2HRZESFq/HRZEFq/5HRE 19 2HRZESCfx/HRZECfx/3HRECfx+2HRE 20. HRZE initially. If resistant + 2-3 S and/or Cfx until end of treatment

Regimens for DR-TB suspects (9 regimens by 21 MDs) HRZE(S) + FQ + Cla

Regimens for MDR-TB patients 6 regimens for 6 MDs

1. HRZES Lfx 18-24 mos 2. HRZES Ofx/Lfx/Mfx 2 mos after (-) 3. HZES Lfx Till CD4 ct normal 4. 2HRZES Cfx/10HRZE Cfx 12 mos

(Amikacin sometimes) 5. HRZES Cfx (Amikacin) 24 mos 6. HRZE Cfx/Mfx Cla 12 mos Injectable: 2-6 mos

Practices: • Ambulatory in all 6 • No treatment partner in 4 • Family member in 3, volunteer,

public HW

Private laboratories Procedure No. (%)

laboratories Method

Smear microscopy 14 (100%) Kinyoun’s (8) Zhiel Neelsen (7) Fluorescence (3)

Culture 14 (100%) Solid (13) Liquid (12)

DST 12 (86%) MGIT (8) Conventional (5)

Molecular techniques 4 Xpert MTB/RIF (3) Line probe assay (HAIN test) -1

Q to MDs. Are you interested and willing to (further) collaborate with gov’t for MDR-TB control?

Q to Hospitals and Labs. Are you interested and willing to (further)

collaborate with the gov’t for TB/ MDR-TB control?

55% 45%

Hospitals for MDR-TB (n=58) Willing Unwilling

Laboratories (n=14): 100% willing to collaborate for both TB and MDR-TB control

Possible areas of collaboration with Hospitals (n=64),

MDs (n=102) and Laboratories (n=14)

Area for collaboration Hospitals No. (%)

MDs No. (%)

Labs No. (%)

1. Training 59 (95%) 75 (74%) 11 (79%)

2. Becoming a DOTS/MDR-TB referring hospital 54 (92%) 77 (76%) -

3. Becoming a facility for TB laboratory tests 49 (78%) N/A -

4. Establishment of a DOTS facility 42 (76%)* 4 (4%) -

5. Becoming a facility for DR-TB laboratory tests 63 (43%) N/A 12 (86%)

6. Establishment of an MDR-TB facility (or as MD) 24 (38%) 3 (3%) -

7. Advocacy 23 (36%) 81 (79%) 13 (93%)

8. Research 12 (19%) 53 (52%) 14 (100%)

3 Market size and utilization of TB Drugs

in the Philippines

NTP driven procurement Procurement year and equivalent cohort year* 2007 2008 2009 2010 2011

Cat I & III Kits

GDF 130,784 64,408

Local Procurement 114,544 256,810 378,000 228,157

Total 130,784 178,952 256,810 378,000 228,157

Corresponding notified new and relapse cases* 139,603 146,565 166,323 195,560 203,826

Difference -8,819 32,387 90,487 182,440 24,331

Cat II Kits

GDF 3,205

Local Procurement 16,372

Total - 3,205 - 16,372 - Corresponding notified retreatment cases* 6,289 6,602 8,066 10,528 13,103

Difference -6,289 -3,397 -8,066 5,844 -13,103 Total cost (USD in millions) 2.3 5.5 12 13 5.5

Private sector Anti TB drug sales

0

20,000,000

40,000,000

60,000,000

80,000,000

100,000,000

120,000,000

2007 2008 2009 2010 201121

22

23

24

25

26

Mill

ions

Dosage unit Sales in USD

Private sector Anti TB drug sales

2007 2008 2009 2010 2011

4FDC (J04A5) 39,021,040 41,895,860 46,120,220 42,456,960 43,103,500

Number of new TB patients can be treated

77,423 249,380 274,525 252,720 256,568

• Standard treatment regimen: • 4 FDC : 2 FDC = 1 : 2

• Private sale: • 4 FDC: 2 FDC = 5: 1 • Indicates drugs may not be used

as per standard treatment regimen

Second line drugs (Source: FDA database)

Gr Description Drugs availability Products

registered

2 Injectable Kanamycin Yes 2

Amikacin Yes 36

Capreomycin Yes 3

3 Fluroquinolone Moxifloxacin Yes 9

Levofloxacin Yes 120

4 Oral bacteriostatic Cycloserine Yes 1

Ethionamide No NA

Protionamide No NA

PAS No NA

Terizidone No NA

5 Unclear Linezolid Yes 4

TB drug sales in the Philippines (2007-2011)

• An enormous amount of TB drugs are channelled through the private drug market: – Enough to treat 250,000 TB Patients annually

assuming compliance with international regimens – Combining public and private sales in 2011, TB

cases could be treated which is 2.5 times higher – Indicating severe under reporting and/or misuse

of drugs • Not all second line drugs are available in the private

market and it is impossible to describe an adequate private sector MDR-TB regimen

Finding Way forward Stakeholders meeting

Is the private sector prepared to engage in MDR-TB management?

Hospital Private Practitioners

Private laboratories

Focus group discussion

Reality Quality

Regulate

Engage

• Mandatory notification • Accreditation • Minimum set of quality

criteria • Regulation of drug sales

• Information directory • Insurance packages • Training curricula • Involve academia and medical

associations in advocacy plan

Framework

To PPM Subgroup In this era of new drugs and diagnostics

• Revitalize PPM-PMDT task force

Acknowledgments • Technical Working Group

– Proponent: WHO-Western Pacific Region (WPR) in collaboration with the National TB Program (NTP), DOH, Phil., National TB Reference Lab (NTRL), WHO-Phil.

– Study Team: – Dr. Camilo Roa – Dr. Maridel Borja – Dr. Ma. Imelda Quelapio – Dr. Tauhid Islam – Dr.Kitty van Weezenbeek

– Advisory Group: – Dr. Jubert Benedicto – Dr. Lalaine Mortera – Dr. Roentgene Solante

– Consultant-Interviewers – Dr. Shane C. Boiser – Dr. Chariza Halun – Dr. Lerma Malabag – Dr. Jennifer S. San Luis – Dr. Andre Tanque – Dr. Ma. Philina P. Villamor – Ms. Alma Palparan

Acknowledgments – Partners

– Phil Coalition against Tuberculosis (PhilCAT)

– Phil College of Chest Physicians (PCCP)

– Phil. Society for Microbiology & Infectious Diseases (PSMID)

– Phil Tuberculosis Society, Inc. (PTSI)

– Research Team – Jundelle Romulo – Gilbert Madriaga – Kevin Borja – Ruby Lamac – Chris Mercado

– Admin staff: – Reissie Francisco

• Study participants – 76 hospitals, 118 Medical Doctors, and 14 laboratories

Thank YOU

Salamat Po