expanding access to diagnostics - who...sources: chai eid forecasting model (2014), chai country...

Expanding Access to Diagnostics: Initiatives impacting the rate of scale-up

April 9, 2015

Index

1 Introduction

2 Access to EID

3 Access to CD4

4 Access to VL

5 Conclusions

3

Introduction

1

CHAI operates programs in twenty-five countries around the world

CHAI’s major programs include HIV, TB, Malaria, Child and Maternal Health, and Health Financing.

CHAI’s Approach to Diagnostics Access

Demand

Pre & post market technical and business support to limited manufacturers by providing technical advice on device design as well as market & regulatory intelligence

Promote private sector investments by preparing business cases and articulating market size, segments and need

More effective technologies at affordable prices

Market efficiency, transparency and predictability

25 countries

Supply

Planning effective market entry by advising on regulatory approval, market selection, and relevant performance evaluations to reduce uncertainty, time and cost for introducing products

Ensure and sustain rational adoption and scale up of existing and new diagnostics by supporting policy and implementation strategy development, site selection, budget planning, etc.

Strengthen the laboratory system by improving the procurement and supply chain, sample transportation, etc. Strengthen linkage to care by supporting the adoption of data management solutions and patient tracking systems

Partners are joining together under the DAI 90-90-90 goals to stem the tide of the HIV epidemic

70%

Children with HIV diagnosed

7

Access to EID

2

Partners are redoubling funding and efforts to reduce new pediatric infections and mortality

These efforts will require strong partnership and careful coordination among key stakeholders to collectively expand best practices and facilitate innovation.

Access to Early Infant Diagnosis (EID) testing across countries in Sub-Saharan Africa and Asia is limited

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Pat

ien

t C

ove

rage

Access to EID Testing

Sources: CHAI EID Forecasting Model (2014), CHAI country service statistics (2014), UNAIDS World AIDS Day 2014 data table, UNICEF Children and AIDS Stocktaking Reports, Global Plan. Note that for some countries demand may be underestimated due to reporting convention of only accounting for children tested before <2 months.

The average patient coverage across Global Plan countries remains under 50%.

Results delivery and

linkage to treatment

Countries need to overcome a number of barriers to meet the first 90 for EID

Commodity security

Availability of cost-effective

POC technologies

Need for improved service delivery

models

Sample transportation

70%

We are here . . . . . . we want to get here

90% 45%

2

3 4

5

Main Bottlenecks to

Extending Access

1



To improve access to EID, innovative solutions and systems strengthening will be required to strengthen service delivery models and lab systems

Results delivery and

linkage to treatment

Commodity security

Availability of cost-effective

POC technologies

Need for improved service delivery

models

Partners are engaging in numerous demand-side efforts to accelerate access and improve care models

On-going and Planned

Interventions

5 2

3

1 Scale-up of results

delivery and patient tracking systems

(SMS printers, LIMS, and mHealth

solutions

4

Introduction of alternative

testing strategies (e.g. testing at

birth and outside PMTCT)

Introduction and scale-up of new

quantification and forecasting tools

(e.g. ForLABS)

11

Introduction and scale-up of POC

EID


1


costing and partner

coordination

In 2015, a number of partner and MOH efforts will center on the uptake of POC EID and implementation of alternative testing strategies

1

6 week visit

2

Sample collection

3

Laboratory Testing

4

Result received

Continuum of Care

5

Follow-up appointment

Conventional testing: Multi-week testing and results delivery process

The adoption of POC EID and availability of EID testing outside of PMTCT bear the potential to identify more exposed infants and strengthen linkages to care.

POC: Potential for same-day testing and results delivery

6

ART initiation

1

6 week visit

2

Laboratory Testing

2

ART initiation

13

Access to CD4

3

CD4 testing will be required to support initiation in the medium-term

• CD4 testing will continue to be used for initiation, Pre-ART monitoring, and screening for susceptibility to opportunistic infections

• On-site access to testing remains critical for improving the linkage to care

• The scale-up of both conventional CD4 testing and POC has significantly improved the availability of onsite access to testing

• Still, most health centers—whether with low or high-patient volumes—continue to have poor access

Note: These figures represent on-site access to testing based on estimated Pre-ART patient volumes in the seven UNITAID POC grant countries (Kenya, Uganda, Tanzania, Zimbabwe, Mozambique, Malawi, and Ethiopia).

17%

43%

40%

Percent of Pre-ART Patients with On-site Access to Testing

On-site accessto POC

On-site accessto conventional

No on-siteaccess

• Ethiopia

• Kenya

• Uganda

• Tanzania

• Mozambique

• Malawi

• Zimbabwe

Through support for POC, access to on-site CD4 testing has increased significantly in 12 countries supported by UNITAID, DFID, UNICEF, and CHAI

PIMA Roll-out: progress and impact

• India

• Lesotho

• South Africa

• Swaziland

• Zambia

POC CD4 Testing Sites

POC CD4 Testing Volumes

On-Site CD4 Access

1,194

2012 2014

1,683

1.15m 1.5m

51% 73%

Lack of clarity in policy about utility

of CD4 post-test and treat

Despite notable advances, significant access barriers to CD4 access remain that limit linkages to care and treatment

Commodity security and distribution

Prioritization of limited

funds


Utilization of lab equipment

70%


90% 36%*

2

3 4

5

Main Bottlenecks to

Scale Up

1

Patients with HIV initiated on treatment

Patients with HIV initiated on treatment

*Note: This estimate uses UNAIDS data from 2013 for the number of persons living with HIV and the number of persons on treatment in low and middle income countries.

Lack of clarity in policy about utility

of CD4 post-test and treat

Commodity security and distribution

Clinical demand

Sample Transportation

(ST)

Partners are engaging in numerous demand-side efforts to improve access

On-going and Planned

Interventions

5 2

3

1

Policy support to disseminate WHO recommendations

4

Scale up of POC devices and

implementation of integrated ST

systems

Introduction and scale-up of new

quantification and forecasting tools

(e.g. ForLABS)

17

Training and mentorship of

healthcare workers

Utilization of lab equipment

1

Implementing connectivity solutions and optimize site

selection

One example of support is CHAI’s work (supported by UNITAID) to assist MOHs in the selection, placement, and deployment of new POC technologies

Sele

ct p

rod

uct

s fo

r

Pilo

t/sc

ale

-up

Se

lect

pro

du

cts

for

eva

luat

ion

Site selection tool

Product selection

18

Convene TWG

Conduct evaluations

Review product information

Convene TWG Review evaluation

results

Pilot/Scale-up

Product selection

19

Access to VL

4

-

500 000

1 000 000

1 500 000

2 000 000

2 500 000

3 000 000

3 500 000

4 000 000

Viral load coverage remains very low outside of a handful of countries

tests

- Testing volume (demand) and unmet need, 2014 -

Demand (tests run)

Unmet Need

Sub-Saharan Africa represents an estimated 95% of the total VL volumes in low and middle-income countries today, with 75% of global volumes coming from South Africa.

Countries are currently at various stages of VL implementation

Considering plans for public scale-up.

Feasibility analysis on VL (assessment, costing, TWGs)

Piloting VL or recently rolled out a VL program. (initial funds secured, start up phase)

Well established VL program Scaling-up to improve access

VL Scale Up

South Africa

Kenya

Tanzania

Zambia

Rwanda

Nigeria

Malawi

Brazil China

Swaziland Uganda

Ethiopia

Cameroon

Mali

Mozambique

Zimbabwe

1

2

3

4

Botswana

Thailand

Lesotho

Cote d’Ivoire

Namibia

Cambodia

Planning

Country challenges with viral load implementation

Demand generation

Lab capacity

Funding

Test cost

70%


90% 30%

2

3 4

5

Main Bottlenecks to

Scale Up

1

Patients on ART who are virologically

suppressed

Patients on ART who are virologically

suppressed

Update'Session:'Development'of'Country'Specific'Viral'Load'Implementation'Plans'!

November'29'&'30,'2014'International'Convention'Center'

Cape'Town,'South'Africa'!Background'!Following!the!launch!of!the!Technical!and!Operational!Considerations!for!Scaling8Up!HIV!Viral!Load!Testing!in!Melbourne!at! the! International!AIDS!Society! conference,! the! first! group!of! countries!met! in!Ethiopia!with!Diagnostics!Access!Initiative!(DAI)!members!to!initiate!development!of!viral!load!implementation!plans.!This!group!will!be!meeting!with!new!or!second!group!of!countries!yet!to!develop!their!plans!to!share!their!drafts,!experiences!and!best!practices!just!

before!ASLM!2014!kicks!off.!!!This!is!a!plausible!first!step!in!the!development!of!viral!load!implementation!plans!and!a!great!example!of!south8to8south!collaboration.!Strong!partnership!between!the!ministries!of!health,!partners!and!donors!in!developing!country!specific!plan!and!led!by!the!ministry!of!health!is!key!to!successful!program!implementation!and!sustainability.!

!Meeting'Objectives'

· To!provide!country!updates!on!the!status!of!their!viral!load!implementation!plans!

· Share!best!practices!on!viral!load!implementation!planning!

· Sensitize!countries!yet!to!develop!their!plans!on!the!value!of!viral!load!implementation!plans!

· To!update!countries!on!the!status!of!tools!required!to!successfully!implement!viral!load!programs!

Expected'outcomes'

· Fostered!south8to8south!collaboration!amongst!countries!

· Sensitized!“new!or!second!group!countries”!on!the!value!of!viral!load!implementation!plans!!

· Updated!status!of!viral!load!implementation!tool!kit!and!request!for!feedback!!!!

''''''''''

''''''

'''''''

Planning

Demand generation

Lab capacity

Funding

DAI partners are collaborating to support VL implementation in countries

Main Bottlenecks to

Scale Up

5 2

3

1

A multi-partner Viral Load Implementation Task Force has been:

Helping countries develop VL

implementation plans and budget

4

Identifying funding gaps and

assist with efficient design

Providing training and best practices

on VL use and interpretation

23

Helping build sample referral and other lab

systems

Test cost

1

Kenya Demand

generation drivers

Clinician education

Patient education

Early adopter countries such as Kenya and Malawi demonstrate that awareness and capacity building around VL testing is critical

• DAI partners are developing tools to help countries increase demand for viral load and to educate patients and clinicians on the use of viral load

• Other efforts needed

• Lack of effective dissemination and translation of the VL guidelines into easy to access and understand job aids

• Awareness campaigns for patients on the benefits of VL testing and its difference from CD4

Challenge

Solutions

After a slow start, testing volumes increased from 50k to 250k in one year after Kenya implemented demand generation activities (algorithm change, clinician and patient education)

5X

After the successes of the global access pricing agreement, DAI continues to support countries in scaling up their VL program

Facilitate knowledge and best practices sharing between all global, regional and in-country stakeholders

Support the integration of EID and VL

Drive and coordinate the implementation of VL scale up in individual countries

2

3

4

Support countries develop country specific viral load implementation plans

1

Create tools to help countries overcome non-price barriers to the scale up (e.g. demand generation – clinician and patient education, sample referral, adherence counseling, M&E, costing etc.

5

0.0

2.0

4.0

6.0

8.0

10.0

12.0

14.0

16.0

2015 2016 2017 2018

What share will VL POC have of the total market?

Partners and governments are also working to determine the appropriate balance between POC and lab-based testing

AlereQ

Cepheid GeneXpert

Samba 2

Growth Drivers for VL POC versus Conventional Testing

• Affordability

• Product performance versus conventional testing using plasma and DBS sample collection

• Ability of countries to use existing POC testing networks to drive scale-up

• Setting of intended use

• Potential future evidence on the impact of POC VL on patient outcomes

• Existing in-country networks and preferences

While countries have yet to publicize detailed plans regarding POC VL scale-up, there will likely be some portion of the testing need that cannot be met by conventional VL. Still,

POC VL will need to compete on price and utility.

Northwestern Savanna Wave80 iQuum

?

27

Conclusions

5

Conclusions

• Partners are working towards a more concerted and harmonized effort to enable a more cost effective and higher pace scale up of testing

• Countries need to build a framework of processes around the technologies adopted to enable a more sustainable growth and linkage to treatment

• Manufacturer support to countries is key to enable a more rational introduction and scale up of testing platforms and service support models that maximize utilization

• Countries have the resources and capacity to expand access and meet the forecasted testing volumes

• Without more integrated diagnostics and treatment systems, investments will not result in adequate patient impact

expanding access to diagnostics - who...sources: chai eid forecasting model (2014), chai country...

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