Global Drug Facility: New Strategies to Address Common TB Challenges

Joël Keravec

GDF Special Adviser

and

Kaspars Lunte

Team Leader MDR-TB supplies, GDF

29 May 2013

Wolfheze 2013 Meeting

1

What is the Global Drug Facility?

2

An initiative of the Stop TB Partnership (2001), mainly funded by Usaid and CIDA, hosted in WHO and managed by

the Stop TB Partnership secretariat

An operating mechanism to support the Stop TB Strategy: • expanding access to quality-assured first (FLD) and

second-line TB drugs (SLD) and diagnostics, • contributing to the development of sustainable

procurement and supply management for countries in need

GDF began supplying FLDs in 2001, and in 2008 added the supply of SLDs, pediatric TB medicines and diagnostics and is a major source for GeneXpert

What is GDF Mandate today?

3

GDF is more than a traditional procurement mechanism – it is a one-stop access for provision of medicines and diagnostics through:

• Emergency one year grants - bridge TB program gaps for FLDs

• Grants for FLDs to continue for 1 more year to allow for proper phase-out

• Grants for SLDs: under discussion with Donors

• Direct procurement (DP) – TB program buys FLDs, SLDs, Diagnostics through GDF

• In-country technical assistance in procurement and supply chain management

SLD $85,291,452

58

74

16

FLD

MDR

New Diag

Value of Orders Placed 2012 (mUSD)

GDF Quality Assurance Policy

Prequalification criteria for manufacturers and medicines:

Finished Pharmaceutical Product (FPP) is authorized by the relevant national Medicines Regulatory Authority (NMRA) in the country of use;

AND

1. Product is pre-qualified by WHO under the WHO PQP; OR

2. Product is approved by an SRA; OR

3. Product is found acceptable through a quality risk/benefit assessment process involving an Expert Review Panel (ERP). Time limited approval for 12 months pending WHO PQP or SRA approval

GDF Quality Assurance Policy

The GDF product catalogue includes details of all the drugs that GDF procures, including price range and highest available price (to be used for planning purposes).

For most products, GDF has multiple suppliers and cheaper prices may be available during quotation, in addition to consolidation of orders and staircase pricing.

You can browse the catalogue online http://stoptb.org/gdf/drugsupply/pc2.asp

List of Products Available:

– Diagnostics and laboratory technology

– Medical devices (Auto disable syringes)

– Pharmaceuticals (Anti-tuberculosis medicines, WFI)

GDF product catalogue

10990 12420

19605

29537

45212

0

5000

10000

15000

20000

25000

30000

35000

40000

45000

50000

2009 2010 2011 2012 2013*

+53%

* Estimated, based on constant 2012 value and 15675 DR-TB treatments planned for India Note: Method 6 months intensive phase injectables up to 2011, 8 months from 2012

SLD Patient treatments supplied by GDF and current projections for 2013

$7.890,60

$6.746,40

$5.822,21

$0,00

$1.000,00

$2.000,00

$3.000,00

$4.000,00

$5.000,00

$6.000,00

$7.000,00

$8.000,00

$9.000,00

TOTAL COST PER PATIENT FOR 24 months:

2011/2013 Cost of treatment 12 Cm Pto Cs Mxf PAS/ 12 Pto Cs Mfx PAS

2011 USD Drug Breakout for 12 Cm Pto Cs Mxf PAS/ 12 Pto Cs Mfx PAS

2013 USD Drug Breakout for 12 Cm Pto Cs Mxf PAS/ 12 Pto Cs Mfx PAS same suppliers than 2011

2013 USD Drug Breakout for 12 Cm Pto Cs Mxf PAS/ 12 Pto Cs Mfx PAS best prices

- 26.2 %

- 14.5 %

GDF Impact on SLD Dynamics: 2011 vs. 2013 treatment cost comparison / High end regimen

$2.069,90

$1.816,20

$1.516,51

$0,00

$500,00

$1.000,00

$1.500,00

$2.000,00

$2.500,00

TOTAL COST PER PATIENT FOR 24 months:

2011/2013 Cost of treatment 8 Am Eto Cs Lfx/ 16 Eto Cs Lfx

2011 USD Drug Breakout for 8 Am Eto Cs Lfx/ 16 Eto Cs Lfx

2013 USD Drug Breakout for 8 Am Eto Cs Lfx/ 16 Eto Cs Lfx same suppliers than 2011

2013 USD Drug Breakout for 8 Am Eto Cs Lfx/ 16 Eto Cs Lfx best prices

- 26.7 %

- 12.3 %

GDF Impact on SLD Dynamics: 2011 vs. 2013 treatment cost comparison / Low end regimen

• Group 5 Medicines now available through:

– Linezolid

– Clofazimine

– Imipinem /cilastatin

• Rifabutin currently being added to GDF catalogue

• Partial regimens now available to countries

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Update on specific medicines

Manufacturers eligible 2009

Manufacturers eligible

2013

% change Agreements w. manufacturers

2013

Special supply agreements

2013

10 24 X 2,4 19 1

Items available 2009

Items available 2013

% change

17 53 X 3,12

Summary of GDF achievements to strengthen manufacturers base – 2009 vs 2013

GDF procurement process is only a small share of the overall procurement system

NTP Procurement & Funding planning 12 to 24 months

75%

NTP Procurement

planning

GDF Supply Chain

GDF supply chain = 1/4 From 1 to 12 months

25%

If Drugs in stock + immediate payment

If late payment, delayed PO =>

production

Current TB Supply Chain Process

NTP surveillance data collection: enrollment rates, etc

NTP assess stocks & shelf life

NTP calculates theoretical drugs requirements

NTP funding plan & request

NTP Final Drug Quantification + Payment Mechanism

Product is dispatched

Order is placed and Payment received

Order is processed by manufacturer

Product is manufactured

Product is inspected

Country receives product

Limited quantities of medicines are available in the Strategic Revolving Stock for emergencies

~6 months

Current TB Supply Chain Process

Independent Study on stock-outs

Preliminary Results

14

0 10 20 30 40

50 43

27

7 3 3 10

7

Percentage of Countries with Stock outs per Cause

Independent Study on stock-outs

Preliminary Results

15

0

5

10

15

20

2007 2008 2009 2010 2011

2012

2 1

20

11 11

2

Number of Countries with Stock outs per Year

Rationale for GDF New Strategic Future Direction

• Aim at zero tolerance for stock-outs in countries to re-shape operations

• Continue to further shape the market for more affordable prices with no compromise on the international quality standards for TB drugs

• Build on lessons learnt from the past and regular market dynamics research

• Incorporate new TB drugs and diagnostics within GDF platform

• Promote innovative tools for forecasting, M&E to countries and leverage communication/collaborative actions with partners for improved planning

• Mobilize and catalyze partners expertise, including in country technical assistance programs to improve service delivery and data management

• Foster countries shared responsibility, accountability and sustainability for supply chain systems strengthening, regulatory aspects and rational use

• Work closer and focus on country needs and feedback to improve operations

1.Redefinition of operations based on evidences / assessment of limitations from current model and lessons learned:

- Problems increased when switching from grants to DP

- Operations too focused / dependent on financial model vs logistics

- Lack of in country information sharing / coordination / collaborative actions

- Need to re-shape current GDF structure and operations - => on-going merging FLDs/SLDs/Diagnostics procurement + new products inclusion (bedaquiline)

- => closer country support implemented / new Regional Officers / new tools

- => bring new skills for increased delivery capacity / stockpile management and logistics support

- => increase suppliers basis / improve current suppliers relationships and strategic management

- New communication strategy and plan for countries/civil society/partners

2.Zero tolerance for TB Drugs stock-outs and overstock risks

=> pro-active actions/planning to improve forecasts and supply chains

=> Build a new model with more synergetic approach with GF for global delivery + leveraging partners competencies and in country presence

Rationale for the new GDF operation model and strategy

• As recommended during last GF MDAG Meeting, SLDs market should not be further fragmented among key stakeholders

• An expansion on GDF UNITAID funded SLD stockpile with GF support would allow us to respond immediately – one year time extension of current stockpile conceded but yet too small to

address current needs = > scale-up

– On-going negotiations with key partners / donors (Unitaid, GF, Usaid, CIDA) for extending stockpile to FLDs

• Currently GDF delivers emergency SLDs in around 30 days from this stockpile as documented and revised by external auditors

• Recurrent financial issues need to be offset by a new mechanism like the proposed Flexible Procurement Fund

How can GDF and its partners move forward together?

Source web report : 2007-2012 http://gva1swamphion/sree/Reports?op=vs&path=/WHO_HQ_Reports/G1/PROD/INT/Shared/Delivery_dashboard_order_placed_to_delivery_rev1&userid=GDF_ro&password=gdfread1

Fig X

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SLDs

GDF delivers emergency orders from SLD stockpile in 33-50 days

• Early warning system for stock-outs –

- capture key data and information which define stock data, treatment plans, and medicines used

- work closely with countries to ensure pro-active actions between partners to mitigate risks of stock-outs (procurement date, regional overview of stocks …)

- piloted with SIAPS (Systems for Improved Access to Pharmaceuticals and Services)/MSH in some Africa countries

• GDF with smaller HQ staff will build more on more local presence with RSOs in the regions + improved liaison with WHO Offices, rGLCs, in country partners, civil society and donors supported projects for more pro-active and cost-effective interventions with countries/NTPs

Strategic interventions & new tools

to avoid stockouts

• New Forecasting Tools: GDF and its partners are developing new forecasting systems to quantify needs for the coming years and these systems are continuously being improved upon, esp. for SLDs

• Promoting M&E systems inter-operability for better data exchange and SLDs consumption at country and global level

• Information sharing: information on demand side is being provided to manufacturers to expand the basis of QA drugs suppliers, increase competition, and help them plan in terms of production capacity with advanced purchased commitments building up strategic stockpiles

Strategic interventions & new tools to avoid

stockouts

Expected Impact

GDF is working with partners / donors to develop:

(1) Global Strategic stockpile

(2) Flexible Procurement Fund

Greatly reduce lead times Avoid unnecessary drug stockouts due to financial delays/barriers Maintain quality and supplier base for the FLD and SLD market Sustain, then further reduce prices, gradually Contribute to better global forecast of FLDs and SLDs – with partners

s

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New initiatives

Detailing 2 new initiatives

to address upcoming challenges

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GDF would build on the

existing stockpile for

SLDs (30 days delivery),

Flexibly manage supply

of FLDs and SLDs

Stabilize SLD market

(e.g. APIs and prices)

Larger stockpile would

require at least 300 000

FLD and up to 16 000

SLD patient treatments

FPF would mitigate funding delays on the demand side

Ensure procurement volume commitment to suppliers Increase availability of medicines Reduce threat of stock outs Promote efficiency of the reordering process Stimulate interest for manufacturers Bridging gaps caused by funding delays from GF to countries

“production to order”

to a

“production to stock”

paradigm

allowing building of stocks

in anticipation of firm

orders with significant

lower lead times

The Global Strategic Stockpile (GSS)

The Flexible Procurement Fund: GDF manufacturers will shift from a

With donors support, GDF is willing to shift to a

new operational paradigm

Translate the key data of # of months of stock on hand into the country classification:

• Reaching 8 months or Less than 8 months : Red alert (urgent imminent risk of shortage: immediate action taking for new drugs supply)

• Between 8 and 12 months: orange alert (action taking is required to ensure next supply will meet current needs, and revising stock levels is urgently needed)

• 12 months or more supply : green light situation - smooth supply guaranteed for more than 1 year

New Tools and Monitoring Model for Countries

GDF services and procurement model

will have market shaping effect

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• Procurement: transparent, competitive, award splitting to retain suppliers for IQA products

• Promotion of larger IQA API pool (via USAID/PQM & WHO)

• Global mechanism for harmonization of SLD supply with actual and planned PMDT scale-up

• Procurement to stockpile: guaranteed volumes to suppliers through Global Strategic Stockpile

• Streamlined fast payment through Flexible Procurement Fund

• Reduced lead times of procurement and delivery cycles

Expected outcomes of GDF´s future strategy direction if supported by donors and partners

GDF will…

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… offer quicker response time for medicines/diagnostics … reshape operations, work on new financial strategies (service fee)

… be able to place orders in advance of payment by NTPs stockpile and flexible fund will jointly promote the quick and reliable handling of offers

… have direct access to a sufficient number of QA suppliers for all GDF products and will pro-actively perform shared forecasting based on reliable information from GDF clients

… offer even better prices for SLDs and will better impact the market by procuring and delivering low-cost high quality products

… contribute to better availability of APIs + longer shelf life for FPP + climatic zone 4 compliance (FLDs)

… collect and connect critical data to disseminate to stakeholders on pending stock-out situations … catalyze more synergetic interventions with partners to unblock supply barriers and avoid in country stock-outs

Is any EURO country eligible to procure small quantities of quality

assured SL TB drugs from GDF?

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Provided that:

– Payment is ensured

– No registration or any other importation bottlenecks exist

– Tender process possible through IDA on behalf of GDF

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Yes, we can: GDF is ready!

Thank You for your attention

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