CASE STUDY

Catalyzing the market foraccurate tuberculosis testing inIndia’s extensive private sectorthrough IPAQT

THEORY OF CHANGEImproving access to high-quality TB diagnosticsreduces morbidity, mortality, and drug resistancerates. In a developing country with a high TB burdenand high utilization of private sector laboratories,discounted prices for WHO-endorsed tests in theprivate sector, combined with increased awareness oftest benefits, will result in sustained private sectoruptake of high-quality diagnostics at improved patientpricing levels.

IMPACTCHAI catalyzed the creation of IPAQT, a consortium ofaccredited private sector laboratories that offer WHO-endorsed tests to patients at or below a ceiling pricein exchange for improved pricing from suppliers fortest equipment and reagents. Since 2013, IPAQT hasgenerated accurate diagnoses for more than 290,000individuals suspected of TB at a comparable price tonon-WHO-endorsed tests that may not have providedaccurate diagnosis. The model also pilotedapproaches to improve linkage with public sectortreatment, facilitating government notification ofmore than 20,000 confirmed TB patients.

KEY PARTNERS•Bill & Melinda Gates Foundation•DFID•McGill International TB Centre•Private sector laboratories and manufacturers

CLINTON HEALTH ACCESS INITIATIVE: CATALYZING INDIA’S PRIVATE SECTOR MARKET FOR ACCURATE TB TESTING | JUNE 2016APPROACHThe IPAQT business model aimed to address key systemicweaknesses in order to boost the uptake of quality TBtests. The cornerstone of the IPAQT strategy wasadoption of a low-margin, high-volume mass marketmodel that aligned the interests of test suppliers, privatelaboratories, and patients. The suppliers and laboratoriesmaintained profit margins once uptake of accurate andvalidated tests was achieved; in turn, patients and thepublic health system received better tests and,ultimately, better health outcomes. The model waspredicated on three prongs.

Ensure access to high-quality diagnostics at low pricesfor patients and laboratoriesFirst, CHAI worked with manufacturers of WHO-validatedtests to extend negotiated public-sector pricing forquality equipment and reagents to partnering privatesector laboratories at 30-50% less than existingcommercial rates. CHAI then brought together aconsortium of private sector laboratories, called IPAQT,providing them access to the improved supplier pricingon the condition that they pass on the benefit of thispricing to patients. The ceiling price – the maximum pricetesting centers could charge patients – was determinedthrough analysis of operating costs and negotiationsbetween CHAI and partnering laboratories. This processreduced the average price to patients in the privatesector for WHO endorsed TB tests to the level of sub-optimal serological TB tests available in the market:•GeneXpert – from US$67 to US$33•Hain Line Probe Assay – from US$58 to US$27•MGIT Liquid Culture – from US$18 to US$15IPAQT membership was open to any privately owned,quality standard accredited laboratory offering TBdiagnostic services, provided they agreed to offer tests topatients at or below the negotiated ceiling price. Thesepartners also had to abide by two additional conditions:(i) discontinue use of non-validated and low-quality TBtests in lieu of accurate, WHO-endorsed tests, and (ii)notify government of all positively diagnosed TB cases.

Establish sustainable market pricing by growingprocurement volumesIPAQT was launched in March 2013 with five large privatelaboratories. However, most private sector doctors wereunaware of the benefits and availability of WHO-validated TB tests. CHAI recognized the need for acoordinated medical education effort to increase testdemand. CHAI proceeded to conduct medical educationseminars in collaboration with private laboratories andlarge healthcare providers to promote adoption of WHO-issued diagnostic guidelines. These seminars havereached 8,000 private doctors in more than 40 cities as ofApril 2016.Furthermore, rigorous in-clinic sensitizations similar tothose used by pharmaceutical representatives werepiloted in five cities. An on-the-ground team ofrepresentatives educated private doctors and assistedpartner laboratories with patient notification. CHAIpiloted this approach, called “Demand Generation andNotification Efforts” (DENOTE), in September 2014. Theresulting increase in private sector doctors’ awareness ofvalidated TB testing has led to more test prescriptions forIPAQT partner laboratories.

Increase and streamline notification of results betweenthe public and private sector systemsDENOTE representatives also assisted IPAQT partnerlaboratories in ensuring that the RNTCP is notified ofdiagnosed patients through an automated internet-basedsystem. This information enables the RNTCP to follow-upon privately diagnosed TB patients who otherwise wouldbe missed by the government program in order to linkthem to appropriate treatment. In cities where DENOTEfield officers are not present, CHAI linked private labs andpublic sector district TB officers through remote trainingand support.

IMPACTIPAQT has transformed the private sector market forvalidated TB testing in India. Highlights of its impact onpatients, partnering laboratories, manufacturers, andIndia’s greater health system include:

FIGURE 1. WITH A SECURED DISCOUNT OF 30-50%,WHO-ENDORSED TEST ORDERS IN THE PRIVATESECTOR INCREASED BY FIVE TIMES SINCE 2013

CLINTON HEALTH ACCESS INITIATIVE: CATALYZING INDIA’S PRIVATE SECTOR MARKET FOR ACCURATE TB TESTING | JUNE 2016Lower costs and improved access to quality tests forpatients – As of May 2016, IPAQT has provided access toaccurate and rapid diagnosis for over 290,000 individualssuspected of TB, resulting in substantial out-of-pocketsavings. A McGill University analysis of private sectorpatient pricing for GeneXpert tests in 12 high-burdencountries found pricing to be the lowest in IPAQT partnerlaboratories.7 Further, while it is dificult to quantify thedegree of improved health outcomes due to issues ofpatient data confidentiality, many of the estimated 32%of patients diagnosed as TB positive, and 25% of the drug-resistant TB positive, may have gone undiagnosed withnonstandard tests. It can be inferred that improvedaccess to high quality diagnostics has led to improvedhealth outcomes for the 290,000 presumptive cases thataccessed IPAQT services.

Fostered access to quality tests in the private sector –IPAQT has built significant inroads in the private sector.Starting with only five partner laboratories in March2013, the consortium has grown to 121 partnerlaboratories as of May 2016. These partner labs cater toover 5,500 sample collection centers, which providecoverage to more than 85% of Indian districts. Growthopporunties remain: the private sector consists ofapproximately 300 to 400 accredited labs, andapproximately 100,000 private unaccredited laboratoriesoverall.8

Greater health systems impact – Private laboratories’RNTCP notifications for positive TB cases grew from 1,444cases in 2014 to more than 20,000 cases in the selectedfive cities within a year of DENOTE’s launch. Nationalpolicy has also been updated to reflect that TB patientsdiagnosed via a calibrated GeneXpert in the privatesector can begin treatment in the public sector withoutthe need for additional confirmatory public-sectortesting.

LIMITATIONS AND LESSONS LEARNEDThe IPAQT model establishes that existing marketdynamics in the private sector can be leveraged to createa sustainable public health impact through innovativeapproaches to service delivery. With the promise of truepoint-of-care molecular testing and further reductions inprice in the future, such approaches may yield evengreater impact.IPAQT has demonstrated that access pricing in the privatesector should be complemented with targeted demand-generation activities to educate doctors and testprescribers. Both DENOTE field officer outreach andmedical education seminars led to increased awarenessof quality TB diagnostics within the provider community.However, it should be noted that these interventions areresource-intensive and the continued sustainability ofdemand-generation activities must be considered.The IPAQT model does not rely on a direct financialsupport mechanism for laboratories or patients, which isconsidered a strength of the approach. However, theunderlying costs and economics of other market contextsshould be studied carefully before employing the IPAQTmodel to ensure that it is the right fit.

FUTURE OUTLOOKTo reinforce demand, CHAI is exploring the limited-timeoffer of vouchers redeemable for free or discounted testsavailable through IPAQT to select healthcare providers.This initiative will gather data to understand the impactof pricing on prescription behavior change and uptakerates.CHAI is also exploring the model’s applications in otherdisease areas in India, and globally in other high-burdencountries with large private sectors.1 World Health Organization Global Tuberculosis Report, 2015http://www.who.int/tb/publications/global_report/en/2 TB India 2007: RNTCP Status Reporthttp://tbcindia.nic.in/WriteReadData/l892s/8838543515TB%20India%202007.pdf3 Kapoor SK, Raman AV, Sachdeva KS, Satyanarayana S (2012) How Did the TBPatients Reach DOTS Services in Delhi? A Study of Patient Treatment SeekingBehavior. PLoS ONE 7(8): e42458. doi:10.1371/journal.pone.00424584 Sreeramareddy CT, Panduru KV, Menten J, Van den Ende J (2009) Time delaysin diagnosis of pulmonary tuberculosis: a systematic review of literature. BMCInfect Dis 9: 91. 1471-2334-9-91 [pii];10.1186/1471-2334-9-915 Uplekar MW (2003) Public-private mix for DOTS: demanding, but delay willonly hamper TB control. Int J Tuberc Lung Dis 7: 1113–11146 Pai M. Promoting Affordable and Quality Tuberculosis Testing in India. Journalof Laboratory Physicians. 2013;5(1):1-4. doi:10.4103/0974-2727.115895.7 Puri L et al. Lancet Global Health, 20168 Chaudhury A. Manual of Commercial Methods in Clinical MicrobiologyInternational Edition John Wiley & Sons Inc. 2016

About the Clinton Health Access InitiativeIn 2002, the Clinton Health Access Initiative (CHAI) began as theClinton HIV/AIDS Initiative to address the HIV/AIDS crisis in thedeveloping world. Taking the lead from governments and workingwith partners, CHAI now works to improve markets for lifesavingmedicines and diagnostics, lower the costs of treatments, andexpand access to life-saving technologies — creating asustainable model that can be owned and maintained bygovernments.To learn more about CHAI, please visit