Prices analysis of essential HIVCD4 and VL technologies

Teri Roberts & Cara Kosack

Diagnostics Network

30 September 2014

What do lab-based viral load tests cost?- Reagents and consumables

Manufacturingcost1

Supplier quotedprice (incoterm)2

Lowest CHAInegotiated in-country price3

Price survey across6 countries4

$1.61 - $6.77 $11 (CPT) - $25(Exworks/CPT)

$10.50 (Kenya, CIF) $18.62 - $36.38

1Estimated by Cambridge Consultants (MSF commissioned study); reagents only (consumables adds only a small amount)2Putting HIV Treatment to the Test (http://msfaccess.org/content/putting-hiv-treatment-test); lowest quoted price3ASLM meeting 2013: “Consultation on Viral Load Monitoring for African HIV Treatment Programmes”4All costs for point of use from national programmes (Kenya, Thailand) or MSF sites (Lesotho, Malawi, Swaziland,Zimbabwe)

Account forsome profitanddistributioncosts

Account forsomedistributioncosts

Account forsomedistributionand othercosts e.g.tax

Estimated manufacturing costs ofexemplar lab and POC products (1mil/yr)

Reagent costs Moulding costs Reagentcontainer costs

Final assemblycosts

Total withoutintellectual

property costs

LAB-BASED TESTS (COMMERCIALLY AVAILABLE)

Abbott RealTime HIV-1assay

$2.38 $0.02 $0.07 $0.06 $2.52

Roche CAP/CTM HIV-1assay

$4.37 $0.07 $0.03 $0.04 $4.51

BioMerieux NucliSensEasyQ HIV-1 assay

$1.23 $0.00 $0.35 $0.04 $1.61

Cavidi ExaVir Load assay $2.49 $0.00 $0.22 $0.05 $2.76

POINT-OF-CARE TESTS (NOT YET MARKET LAUNCHED)

Alere Q HIV Test $1.56 $4.01 $0.00 $1.50 $7.07

DRW SAMBA test $1.62 $3.29 $0.00 $1.50 $6.41

Wave80 EOSCAPE-HIVtest

$1.56 $3.50 $0.00 $0.00 $5.06

Lumora “BART” test $1.62 $0.00 $1.27 $0.95 $3.84

Moulding costs for POC POC = x2

Breakdown of average comprehensivecosts from 6 country survey

Comprehensive test cost range: $24.90 - $44.07 of that reagents and consumables range from $18.62 - $36.38

Modelling the effect of throughput onviral load cost per test

Using the instrument at <50% capacity means up to double the cost per testMay mean that larger instruments will have to remain centralized for now

Sample pooling as a cost reductionstrategy

Efficiency expressed as cost savings:

• Example of Thyolo District

– Population: 620,000

– HIV prevalence: 14,5%

– # VL tests needed/year: 23,000

– Price per VL test: $24

• Total cost/year = 23,000 x $24 = $552,000

– Efficiency at 1,000 cps/mL = 28,6% => $157,800 saved

– Efficiency at 5,000 cps/mL = 51,4% => $283,700 saved

Sample 1500 µL

100 µL

Pool 500 µL

Viral loadtesting

100 µL100 µL

100 µL

100 µL

Sample 2500 µL

Sample 3500 µL

Sample 4500 µL

Sample 5500 µL

What to do with pooledresults?1. Pooled VL result < threshold=> no further testing2. Pooled VL result > threshold=> further testing

©G

iulio

Do

nin

i/U

NIT

AID

Task shifting sample collection as acost reduction strategy

In Malawi, MSF has previously validated the use of fingerprick DBS, prepared by lab techsand lay workers, on the bioMerieux NucliSENS EasyQ HIV-1 platform (RNA-specific) Now finishing a study to show whether it is possible to task-shift to lay workers

© Giulio Donini / UNITAID

Task shifting point-of-care testing as acost reduction strategy

In Malawi, MSF is investigating whether point-of-care testing can be task-shifted to layworkers (PIMA, SAMBA)

In Swaziland, MSF has set up “mini-labs” at clinics, where phlebotomists have beentrained to perform point-of-care testing (RDTs, PIMA, HemoCue, Reflotron)

© Giulio Donini / UNITAID © Giulio Donini / UNITAID

Future directions to reduce costs• Use negotiating power through mechanisms such as pooled

procurement to bring down prices large volume procurers suchas the Global Fund, PEPFAR, and countries like South Africa, can dothis right now

• Higher demand for testing will promote competition and bringdown extraneous costs such as in-country maintenance (typicallyabout 20% in RLS compared with 10% in rich countries)

• Use instruments at maximal capacity• Other cost reducing strategies may include:

– Replacing CD4 testing for treatment monitoring with viral load testingin stable patients

– Sample pooling– Task shifting sample acquisition and point-of-care testing to lay

workers

Want to know more?www.msfaccess.org/undetectable

Thank you

Acknowledgements:Professor Bruce Larson and Bryan Patenaude from Boston University for creating the costing models and undertakingthe data analysisUNITAID as co-fundersMSF colleagues, PLWHA, Ministries of Health and Laboratories with which we work