Improving Access for Quality-Assured TB

Medicines + Diagnostics

Andrea de Lucia

GDF

NTP Manager Meeting, Nairobi. 14-16 October 2013

1

Update on GDF &

New Strategic Direction

Outline

• GDF key achievements since 2001

• Demand side: Changes in GDF services

• Supply side: What is the current procurement situation and what are its challenges?

• Looking forward: New Strategic Framework

• Technical Assistance: Regional focus and new tools

2

Outline

Key achievements

3

Total Patient Treatments Supplied 2001-2012

First Line Drugs

4

Live Report June 2013 http://gva1swamphion/sree/Reports?op=vs&path=/WHO_HQ_Reports/G1/PROD/INT/Shared/FLD_Patient_Treatments_supplied_and_dashboards+rev4&userid=GDF_ro&password=gdfread1

Total Patient Treatments Supplied 2001 - 2013

Second Line Drugs

Live Report June 2013 http://gva1swamphion/sree/Reports?op=vs&path=/WHO_HQ_Reports/G1/PROD/INT/Shared/FLD_Patient_Treatments_supplied_and_dashboards+rev4&userid=GDF_ro&password=gdfread1

*

June 2013

SLD $85,291,452

Scale-Up of MDR-TB treatment supply with GDF

medicines over the years

Scale-Up of MDR-TB treatment supply over the years

Report Date:

Tue Aug 27 2013

Note: Method 6 months intensive phase injectables up to 2011, 8 months from 2012

SLD $85,291,452

58

74

16

FLD

MDR

New Diag

Value of Orders Placed 2012 (mUSD)

89 M in 2013 till June 2013

GDF's current procurement services

8

GDF procurement services

9

• Grants of in-kind donations are now the exception rather than the rule:

•FLD Grants for 1 year to allow for proper phase-in of other donor funding or in cases of emergencies (no more 3 year grants)

•Current call for 1 year grants open until 28 October 2013

• SLD Grants under discussion with donors

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

First-line drugs portfolio

10

10 one-year term agreements with suppliers, covering 31 products: o 9 Fixed-Doses Combinations, blister & loose o 3 paediatric, Fixed-Doses Combinations, blister o 5 single dose formulations, blister o 2 paediatric single dose formulations, blister o 1 injectable, vial o 3 medical devices o 8 patient kits

Increased number of suppliers vs 2011, with shelf-life ranging from 2 to 5 years – Current INH shortage: new API sources identified, some current orders may be

impacted: staggered delivery extra transport costs. IDA to contact clients.

Products with

No. of products

4 suppliers 4

3 suppliers 5

2 suppliers 11

1 supplier 11

GDF Second & Third-line drugs portfolio

11

17 one-year term agreements with suppliers, covering 27 products:

o 5 Floroquinolones, blister

o 8 Bacteriostatics, blister, strips, sachet, container

o 4 Injectables, vial, ampoule

o 10 Third line drugs, blister and vials.

Up to 37% price reduction negotiated on Cycloserine

Up to 27% price reduction on treatment regimens supplied (2013 vs 2012)

SLD supplier base twice as big as in 2009

Number of SLD products available 3x higher vs 2009

No risk

Medium Risk

High Risk

Demand: Low Medium High Very High

Terizidone

Capreomycin

Kanamycin

Amikacin

Cycloserine Ethionamide/ Prothionamide

Levofloxacin

Moxifloxacin

PAS Acid

PAS Sodium

API risk: monopoly, quality or capacity of API

More than 2 suppliers for each FPP

1 supplier for FPP

SLD supply vulnerabilities: demand versus risk

• Group 5 Medicines now available:

– Linezolid (ERP approved until May 2014, no objection needs to be sought)

– Clofazimin (off label use)

• Belaquoline will be added to GDF catalogue in 2014

• Partial regimens now available to countries

13

Update on specific SLD medicines

GDF engagement with Diagnostics Supply Overview

and programmatic support to MDR-TB scale-up

1. Standard Diagnostics / Microscopy • Provided to GDF clients using own funding

• GDF Diagnostic Kits (LED Microscope, Equipment / Start-Up, Consumables,

Sputum Containers)

2. GeneXpert (Cepheid Inc.)

• TB REACH Initiative / GDF, financed by CIDA

• Rollout to TB REACH Grantees since mid 2011

• TBXpert Project, UNITAID financed

Consortium among seven partners incl. GDF

2013 – 2015

• Direct Procurement open to all through TBREACH/GDF (more information on TBREACH website)

3. Expandx-TB Project, UNITAID financed, providing New Diagnostics for MDR-

TB - Executed by GLI, FIND, GDF – 2009/2014 • Support to patients follow-up through conventional diagnostics (Solid and liquid cultures – FLDs-

SLDs

14

GeneXpert TB REACH / GDF

• TB REACH /GDF: largest GeneXpert pooled procurement

mechanism

• Approx. 300 machines and 500,000 cartridges ordered in

21 months for delivery to 35 countries (June 2013)

• Value of orders placed: 10.3 million USD

• GeneXpert procured at 25 % of the market price.

• Cartridges <USD 10

• Median Order lead time: 55 days

• TA provided by TB REACH / GDF

15

New Diagnostics

Quality Assurance

• Countries must immediately visually inspect their consignments upon arrival at central warehouse (issue a clean report of findings)

• Statue of limitations for quality complaints to GDF.

• Encourage countries to test quality of drugs at each level of distribution.

16

Quality Assurance

GDF New Strategic Plan

17

Rationale for GDF New Strategic Future Direction

• Build on lessons learnt from the past procurement experience

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

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

• 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

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

• Technical Assistance: – Regional Support Officer for Francophone Africa (Libreville, Gabon)

– Increased technical assistance missions & regional workshops in 2014

– New tools: revised 1st line Drug Calculation Sheet, QuantTB for 2nd line drugs

• Development of an Early Warning System (EWS) for anti-TB medicines: currently AFRO and EMRO

• Creation of 1st line stockpile

• Increase in 2nd line stockpile

• Creation of a Flexible Procurement Fund (FPF): allow for advance order placement while disbursement ongoing

19

Key Aspects

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 From 2 to >12 months

Request of quotation to delivery

If Drugs in stock + immediate payment

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

Current GDF Supply Chain Process

Product is distributed

Central an peripheral storage

Hospitals

Clinics

Patients

~6 months

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 Pile for emergencies

Supply Chain Process with FPF and SRS

SRS Lead Time = 55 days

FPF (unknown time)

Technical Assistance: Early Warning System

23

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

GDF will…

24

… offer quicker response time for medicines/diagnostics

… be able to place orders in advance of payment by NTPs stockpile and flexible fund will jointly promote a quick response

… have 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

… collect and connect critical data to disseminate to stakeholders on pending stock-out situations

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

… catalyze more synergetic interventions with partners to unblock supply barriers and avoid in country stock-outs