IPAQT - Initiative for Promoting Affordable & Quality TB Tests - 2nd May 2014 6th Global Laboratory Initiative (GLI) Partners Meeting
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IPAQT – Initiative for Promoting Affordable &
Quality TB Tests
2nd May 2014
6th Global Laboratory Initiative (GLI) Partners Meeting
|1
TB diagnosis in India is characterized by private sector
dominance despite a strong national TB programme.....
Although, the government
India suffers from the highest
program (RTNCP) tests ~7.9M …the private sector is usually
TB samples for free mainly the first point of contact for
TB burden in the world
through sputum smears majority of TB suspects
annually…
Breakdown of TB cases1 TB samples tested by RNTCP2 Break-up of TB suspects by sectors3
In millions
India Public sector Private sector
20% 7.9
40% 60%
0.1
Rest of
the World Sputum Smear Culture/ LPA/ GX
80%
Total TB patient in India = 2.3M
SOURCE: 1. www.who.int/tb/data; RNTCP TB India Report 2011; 2. RNTCP Anuual report 2012; 3. Analysis conducted by Shekhar Menon and
Minal Madhavankandi (IIMB) and CHAI |2
Private healthcare market is complex and layered
Qualified doctor Qualified lab Qualified pharmacy
Unqualified doctor Unqualified lab Unqualified pharmacy
• An average TB patient is diagnosed with TB after a delay of 2
months; seen by 3 healthcare providers before diagnosis
• Nearly 50% seek private/informal healthcare
• Even the really poor prefer private healthcare
*Jishnu Das et al. MAQARI Project. |3
Diagnostic market is extremely cluttered
Exact number
and distribution
is not known Large lab networks (all accredited)
• 5 lab chains with pan-India presence (SRL, Dr Lal Pathlabs,
Thyrocare, Metropolis, Quest India)
Only 400 of • Can perform sophisticated tests including culture and NAATs
>40,000
labs have any Regional lab networks (mostly accredited)
form • Strong presence in a limited geographic region through
of accreditation collection centers
• Can perform sophisticated tests including culture and
NAATs
Small local labs (not accredited)
• Usually single-owner run, and tend
not to have automated systems
• Most do not have any MD or PhD
level lab professionals
• May account for the majority of lab
testing in India (these labs are close
to care providers/patients)
• Highly fragmented and unregulated
• Cannot offer sophisticated tests
• Can offer rapid diagnostics and
simpler tests
|4
Market inefficiencies imply that poor testing practices abound
Too many intermediaries in Quality diagnostics are Higher commercial
the value chain expensive incentives on poor tests
Ex-factory price (x) Price of WHO-approved tests in Intermediary margins for TB tests1
private sector1 $15.0
Taxes & transport charges (1.3x)
$52
Distributor margins (1.9x) Smear $2
$7.0
$5.5
Reference lab margins (2.5x) Hain $58 $4.6
$0.8 $0.6
GeneXpert $64
Franchisee lab margins (2.9x)
Lab Network
MGIT + DST $73 margins margins
Provider margins (3.3x)
Sputum smear
Patient price Average monthly Household Serology
income of TB patients2 In-house PCR
Breakdown of TB tests in the private sector (2011)2
Smear
microscopy, Hain LPA, 0%
26% Annual TB tests in the private
Serology, sector (2011) = 11.5 million*
TB-Gold, 2% 52%
Culture, 10%
PCR, 10%
SOURCE: 1.Discussions with manufacturers (Cepheid), distributors (LabIndia, Biomerieux) and labs; 2.CHAI and IIMB student analysis
NOTE: *Does not include TST and Chest X-ray |5
A sustainable market-based solution was required to address
the motivations of diverse stakeholders….
Diagnostics Manufacturers Private Laboratories
CHALLENGE
Goal: Maximizing ROI Goal: Maximizing ROI
Unable to generate volumes and tap Not eligible for lower public sector
the huge potential of the Indian pricing
private market
Unable to individually negotiate
competitive prices with
manufacturers
IPAQT structure
RNTCP and NGOs
SOLUTION
Goal: Improving public health
TB Programme and NGOs eligible for the public sector pricing
|6
IPAQT was aimed at creating a win-win-win for all stakeholders…
RNTCP Access to data on
positive cases in the
Access to private sector for
HBDC Pricing treatment follow-up
IPAQT Charter
Hain
GenoType
CHAI
Private labs Patient
Access to quality Access to
tests at lower price affordable quality
Lower Investment in diagnostics
machines as well as Linkage to better
reagents/cartridges treatment through
Higher volumes
public sector
| 77
…by establishing key guiding principles
Key guiding principles of IPAQT – to be followed by all IPAQT labs
Use of only high-quality Affordable price to Linking diagnosis to
TB tests patients treatment
Only WHO/ RNTCP- Partner labs to charge the Partner labs to notify all the
approved tests to be patients below a ceiling price positive cases to RNTCP
included in IPAQT
All member labs to undergo
Market price
periodic EQA
$67
Only accredited labs to join $58 IPAQT ceiling
price
$33
$27
$18 $15
GX Hain LPA MGIT
|8All stakeholders in the value chain agreed to drop their margins
- translating into lower prices for the TB patient
Xpert MTB/ RIF $67
- 50%
Pricing in the private sector
Pricing through IPAQT $33.3
$19.1
Although the per unit returns are lower, all the players could
(29%) make higher aggregate returns on basis of higher volumes
$10.0 $10.2 $10.9
(30%) (15%) $9.7 (16%) $8.6 $8.6
$6.4
(14%) $6.4 (13%) $3.9 (13%) $3.9
(19%) $2.6 (19%)
(8%) (12%) (12%)
Ex-factory price Transport + Distributor Reference lab Franchisee lab Provider Patient price
taxes1 margins margins* margins** incentives**
Hain Genotype $58.2
- 53%
$27.3
$24.2
(42%)
$14.8
$12.2 (25%) $8.7
$8.7
(45%) $6.9 (15%)
(15%) $3.6 $3.6
$1.8 $1.0 (25%)
(3%) (4%) (13%) (13%)
Distributor price* Transport + Reference lab Franchisee lab Provider Patient price
taxes margins** margins*** incentives***
NOTE: 1. New price calculation accounts for a 5% error rate and assumes 80% utilization, advance payment and an outright equipment
purchase model; *Calculated as a percentage of patient price minus franchisee lab margins and provider incentives; ** Calculated as |9
percentage of patient price 1 USD =53.5The Initiative has met with some initial success
..with about 3000 franchisee labs and
Number of member labs under IPAQT
collection centers
64
54 15
49
9
6
14
36 10 11
7
10 10 10
5
20
2 8
3
4 23 24 25
16
11
Q 1(Feb-Mar Q 2 (Apr-Jun Q 3 (Jul-Sep Q 4 (Oct-Dec Q 1 (Jan-Feb Number of districts
2013) 2013) 2013) 2013) 2014) covered so far: 390
(60% of total)
"Labs members but not yet ordered tests" Both GX and Hain
IPAQT Labs with Hain installations only IPAQT Labs with GX installations only
Total no. of IPAQT lab partners
| 10…. there has been a commensurate increase in the number of
tests as well
IPAQT tests YTD cumulative totals IPAQT labs have ordered ~4500 tests
(GX+LPA) per month in the past quarter1
26,240
73% increase in GX
Total tests in year 1 = 28,474 orders in the last quarter
Total tests in Q 1 of year 2 = 12,838
(13% of year 2 target)
15,130 15,072
13,344
11,200
8,160
5,430
4,704
1,000 1,344
Q1 2013 Q2 2013 Q3 2013 Q4 2013 Q1 2014
GeneXpert Hain LPA
NOTE: 1. Month-on-month orders in appendix
| 11While partner labs have led to over 8,000 positive notifications
to RNTCP…
Notification of TB+ by Active IPAQT Labs TB positive cases captured by GxAlert2
Notification supported by other organization Number of member labs where Gx Alert is
Manual/paper based notification installed = 14
Email notification Total TB + Cases : 2,970
34 8,2612 DS TB cases
929 Rif+ TB cases
8
734
(25%)
7,320
25
2,236
(75%)
Labs that No. of patients notified till
are notifying now (Feb13 - Mar14)
NOTE: 1 Data received from labs is non standardized with respect to time period; a few labs have not been able to share the data till now; 2
GxAlert Data | 12….but significant challenges to further scale up remain
CHAI’s market assessment reveals that ~ Private labs and providers make
85 % of the providers are not aware higher margins on sub-optimal tests
about molecular tests such as IGRAs and in-house PCRs
TB tests awareness among providers
TB Gold 13 Base: All providers = 1,244 Intermediary margins on TB tests2
NAAT (In house PCR) 16 Figures in $11
percentages $8
TB DST 25
$7
Serological Tests 40 $4 $4 $4 $5
$3 $3 $3
Culture 42 $2 $2
Tuberculin Skin Test 63
Reference lab Collection Provider
Smear Microscopy 82
center
Chest X-Ray
TB Gold In-House PCR GeneXpert Hain LPA
91
0 20 40 60 80 100 High up-front capital costs remain a
Providers ordering IGRA based test barrier to adoption by labs
strongly believe that these tests are valid
for diagnosing active TB
SOURCE: 1.TB Diagnostic in India’s private sector survey : Conducted in Feb 20132. 2.Information from IPAQT labs
| 13Linkages to treatment need to be ensured….
Quality of data recorded by labs is usually not WHO State team of Bihar exemplifies a
uniform for State TB team to follow up with successful post-diagnosis follow up of MDR
patients patients
• In Bihar, 5 out of 6 private sector labs that are
Neither
address
offering GeneXpert testing are under the IPAQT
details nor umbrella
contact
number of • WHO State consultants and state TB authorities in
patients Bihar carried out a rigorous following-up exercise
on every MDR TB patient tested through a private
sector GeneXpert installation
• During the first quarter of 2014, a total of 188
samples were tested on GeneXpert by partner
IPAQT labs in Bihar
No Address;
Incomplete • This led to a total of 26 MTB+ Rif – cases, and 13
information
MTB+ Rif+ (MDR) cases being diagnosed from Jan
2014 until March end 2014
• All MDR cases have been followed up by State TB
team and those opting for public sector
treatment have been initiated on DOTS plus
treatment
| 14.....and potential risks mitigated through collaborative actions
and support
Collaborative action by diagnostic manufacturers and CHAI has led to dramatic price
reductions under IPAQT….
Price reduction Labs can charge
under IPAQT as per their will
$67
>$33
$40 Price reduction
under IPAQT $33
$24.5
$ 19
Before Under Cepheid’s new Before Under Expected price to
IPAQT IPAQT market price IPAQT IPAQT be paid by
patient
Landing cost of GX cartridge to Labs Price paid by Patient for test
No. of GX tests
Under IPAQT, accredited labs have been encouraged to promote
26,240
WHO approved tests, notify patients to RNTCP, and adhere to globally
accepted testing practices. Any reduction in commercial pricing for
500 non-IPAQT labs can have an adverse effect on the holistic change to
TB testing practices IPAQT is bringing about
Before Under IPAQT
IPAQT (Till Mar 14)
Exchange rate 1 USD : Rs 60 | 15Interventions such as subsidies to labs can drive penetration of
latest diagnostic tools even to the bottom of income pyramid
Xpert MTB/ RIF $67
50%
Pricing in the private sector1
Pricing through IPAQT1
$33.3
Although the per unit returns are lower, all the players could
$19.1 make higher aggregate returns on basis of higher volumes
(29%)
$10.0
$10.2 $10.9
(30%) $9.7 $8.6
(15%) $6.4 (16%) $8.6
(14%) $6.4 (13%) (13%)
(19%) $2.6 $3.9 $3.9
(19%)
(8%) (12%) (12%)
Ex-factory price Transport + Distributor Reference lab Franchisee lab Provider Patient price
taxes margins margins* margins** incentives**
Monthly Income profile of TB patients2
Before IPAQT : Assuming a patient is willing to pay up to half
Household income a month’s household income for a TB test; at the premium
>$201 0.7% price of $64, only 3.7% of market would be available
Household income
$161-200 3.0% Under IPAQT: Applying similar affordability assumption;
at the price of $33, ~15%of market would be available
Household income $80-
160 8.2%
After Subsidy : If volume-based subsidy
Household incomeTHANK YOU
| 17APPENDIX
| 18Distribution of test results captured by GxAlert (As of 2014)
The following graph provides the distribution of Genexpert test results by result type (as of
April 2014)
Genexpert Test results
Total no. of tests – 9,825 ; No. of GxAlert installed - 14
1% 3%
1%
8%
MTB-
MTB+ Rif-
21% MTB+ Rif+
MTB+ Rif?
66% Invalid
Errors
| 19Data from follow-up exercise conducted by WHO consultants &
State TB Machinery in Bihar
CBNAAT Site Total Pulmonary Extra MTB Detected Rifampicin MTB Detected Rifampicin
Samples (Sputum) Pulmonary Sensitive Resistant
Tested
Central 32 7 25 Pulmonary- 1 ( 14.28 %) Pulmonary- 1
Diagnostics (21.87 %) (75.82 %) Extra Pulmonary- 2 ( 8 %) ( 14.28 %)
Patna Extra Pulmonary- 1
( 4 %)
Sen Labs 26 20 6 Pulmonary- 4 ( 20 %) Pulmonary- 2
Patna (76.92 %) (23.07 %) Extra Pulmonary- 2 ( 33.33 %) ( 10 %)
Extra Pulmonary- 0
( 0 %)
Geeta 44 32 12 Pulmonary- 2 Pulmonary- 5
Molecular (72.72 %) (27.27 %) ( 6.25 %) ( 15.62 %)
Darbhanga Extra Pulmonary- 2 Extra Pulmonary- 1
( 16.66%) ( 8.33%)
Maurya Labs 58 37 21 Pulmonary- 5 (13.51 %) Pulmonary- 2
Purnia (63.79 %) (36.20 %) Extra Pulmonary- 3 (14.28 %) (5.04 %)
Extra Pulmonary- 1
(4.76%)
Boyd labs 28 15 13 Pulmonary- 2 (13. 33 %) Pulmonary- 0
Bhagalpur (53.57 %) (46.42 %) Extra Pulmonary- 3 ( 23.07 %) ( 0 %)
Extra Pulmonary- 0
(0 %)
Total 188 111 77 Pulmonary- 14 ( 7.65 %) Pulmonary- 10
(59.04 %) (40.95 %) Extra Pulmonary- 12 (15.58 %) ( 5.31 %)
Extra Pulmonary- 3
(1.60%)
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