Transcript Patients - Roll Back Malaria

Affordable Medicines Facility - malaria
Agenda
Background
Summary of Achievements to date
–AMFm Technical Design
–Ensuring that AMFm will work
Requested Board Action
–Proposed Decision Points
–Management of AMFm
Next steps
2
Rationale for the AMFm: to increase the availability of ACTs and
substitute artemisinin monotherapies across all sectors
2006 Antimalarial Treatment Volumes (Million)
100%
~400
~150
Total = ~550
Other
Chloroquine (CQ)
80
SulfadoxinePyrimethamine (SP)
Chloroquine (CQ)
60
40
ACTs
20
Sulfadoxine-Pyrimethamine (SP)
Artemisinin monotherapies
0
Private
ACTs
Public
Note: Other category includes Mefloquine, Amodiaquine and others. ACT data based on WHO estimates and manufacturer interviews.
Source: Biosynthetic Artemisinin Roll-Out Strategy, BCG/Institute for OneWorld Health, WHO, Dalberg.
3
ACT prices are relatively high and affordable to only few in the private
sector - major barrier to usage
Average Prices (USD)
10.0
8.0
8.0
6.5
6.0
4.0
2.0
0.0
Range
(USD)
ACT
6-10
Artemisinin
monotherapies
5-8
0.5
0.3
SulfadoxinePyrimethamine
(Generic)
0.4-0.7
Chloroquine
(Generic)
0.2-0.4
Note: Ranges indicate variance across countries and products excluding outliers; N (observations): (ACT, 222); (AMT, 227) ; (CQ, 37) ; (SP, 118).
Source: Dalberg field research (Kenya, Uganda, BF, Cameroon), Observations by World Bank and Research International (Nigeria). Smaller pricing
observations were also performed in Ghana, Rwanda, Burundi, Niger and Zambia), but due to low n not included. Sulfadoxine-Pyrimethamine and Chloroquine
data complemented with HAI and IOM observations
4
Objective and design principles (endorsed by Board in May)
Objective: Increase overall use of ACTs
AMFm design principles
• Promote the use of ACTs and drive
mono-therapies and ineffective drugs
from the market by:
• Pricing & availability – to all sectors and countries
–Reducing end-user prices to an
affordable level
–Introducing supporting interventions
including those for proper use of ACTs
• Management – small secretariat
• Eligibility – standards for products, suppliers, buyers
• Importance of in-country supporting activities to
ensure responsible introduction and use
• Monitoring & evaluation - linked to RBM Strategic
Targets for 2015
5
Agenda
Background
Summary of Achievements to date
–AMFm Technical Design
–Ensuring that AMFm will work
Requested Board Action
–Proposed Decision Points
–Management of AMFm
Next steps
6
The AMFm will offer ACTs to first-line buyers at a similar price range
as CQ and SP through existing channels (illustrative)
Co-payment
Multiple eligible ACT
Manufacturers
National
distributors
Private Buyers
(e.g. National
Wholesalers)
NGO Buyers
(e.g. PSI, MSF)
AMFm
Public Buyers
(e.g. Ministry of
Health)
E.g. Central
medical stores
Distributors
Medicines
Money
Information
Retailers, private
clinics and public
providers
Patients
Supporting
interventions
7
Impact of AMFm on prices at each level of the supply chain
(illustrative example)
Future, with co-payment
Current
Manufacturers
(MSP reduced to USD
1 for all buyers)
Manufacturers
USD 4-5
Private buyers
USD 5-6
Retailers / providers
USD 6-10
Patients
USD 1
Public buyers
Free /
fee
Public providers
Free /
fee
Patients
USD 0.05
Private buyers
USD 0.2-0.4
Retailers / providers
USD 0.2-0.5, for
majority of
patients
Patients
USD 0.95
AMFm
USD 0.05
Public buyers
Free /
fee
Public providers
Free /
fee
Patients
8
Ensuring that the AMFm will work
Examples of key issues
Approach
•Will the co-payment be passed through to
the patient?
•Ex-ante analysis
•Will it reach the poor?
•Eligibility criteria
•Will it increase resistance?
•Supporting
interventions
•Is it a subsidy for manufacturers?
•Piloting
•What is the opportunity cost?
•What is the cost-effectiveness?
•How will drug quality and safety be
assured?
•Conceptual evolution
from “Global ACT
Subsidy” to AMFm
9
Illustration – will the co-payment passed through to the patient?
Ex-ante analysis
Piloting
Eligibility criteria
• Detailed
analysis of
existing
markets for
other
essential
medicines,
e.g., low-cost
antimalarials
CQ, SP
• Research on the
impact of Global
Fund financed
programs that are
selling subsidized
ACTs through
private-sector
pharmacies in
Senegal (IRD)
• Introduction of
subsidized ACTs in
Tanzania (Clinton
Foundation)
• Baseline research in
Uganda (Medicines
for Malaria Ventures)
• Buyer eligibility
criteria
Supporting
interventions
• Wholesaler
incentives and
pricing / price
control
mechanisms
• Public
information
• M&E, operational
research
10
Evolution from ”Global ACT Subsidy” to AMFm
•
•
•
•
CORE AMFm FUNCTIONS
(Executed by Facility)
Negotiation of terms for low-cost antimalarials
Processing co-payments for low-cost products
purchased by first line buyers
Setting prices and terms for international distribution
Transparent sharing of information and forecasts
ELIGIBILITY CRITERIA / REQUIREMENTS
(Set by Facility)
• ACT treatment requirements
• Buyer eligibility requirements
• Country preparedness requirements
PARTNER / SUPPORTING INTERVENTIONS
(Monitored or coordinated by Facility)
• National policy and regulatory • Provider training
preparedness
• National monitoring and quality
• Wholesaler incentives and
preparedness (resistance
pricing / margin control
monitoring, pharmacovigilance,
mechanisms
and quality surveillance)
• Public education and
awareness (IEC)
11
Estimated impact and funding requirements
Expected impact
Global
ACT Subsidy
Funding
(USD Million)
AMFm
Funding
(USD Millions)
• Reduce retail prices from
current level of USD 6-10 to
USD 0.20-0.50 for majority of
patients
300
• Increase demand from current
level of 100 million treatment
courses per year to 360
million
200
• Shift most purchases away
from ineffective medicines and
possibly eliminate the market
for artemisinin monotherapies
• Save 174,000-300,000 lives
per year, in a fully-funded
scenario
287
264
282
289
274
250
150
100
Org costs
Supporting
interventions
Medicines
and
International
Distribution
50
0
Year 1
Year 2
Year 3
Year 4
Year 5
12
Update on Tanzania’s Pilot ACT Subsidy
Project
Roll Back Malaria Partnership 13th Board Meeting
29 November 2007
13
Today’s presentation
Background and context
Results to date
Implications and Next Steps
14
The pilot project is being led by the Ministry of Health and Social Welfare
and implemented by PSI – Tanzania and the Clinton Foundation
• Lead partners: TFDA and NMCP
• Manage relations with local government
• Conduct dispenser training
Tanzania Pilot
ACT Subsidy
Project
• Implement in-country social marketing and repackaging
• Build on lessons learned from ACT repackaging/subsidy
experiences in other countries
• Manage procurement of drugs and
implementation of supporting interventions
• Lead communication to global partners
15
The project aims to answer three key questions through a design which
varies interventions across districts
Key questions:
1. What is the final price paid by patients for subsidized drugs?
2. What is the effect of a package of accompanying interventions (e.g., SRP, repackaging, social marketing) on
end-user price and uptake?
3. What is the impact of the subsidy on the purchase and use of ACTs compared to other anti-malarials?
Supporting interventions
OTC
M&E
Shinyanga Rural
Serves as a control
Maswa
Explores effects of a
subsidy without SRP
Kongwa
Explores effects of a
subsidy with SRP
Subsidy
Status
Repackag- Social
Marketing
ing
SRP

    
     
SRP ranges
from US$0.25
to $1.00
based on
dose
16
Subsidized ACTs are distributed to retailers through two commonly used
channels– via a regional distributor or directly to shops
Novartis
ACTs procured
at public sector
price
Clinton Foundation
ACTs sold to
wholesaler at
90% subsidy
Wholesaler
Maswa District
Regional
Stock Point
“Direct”
Kongwa District
Regional
Distributor
“Indirect”
Trucks/bikes deliver
direct to shops
Regional
Distributor
“Indirect”
Regional
Stock Point
“Direct”
Shops pick up drugs
from distributors
Drug
Shops
Trucks/bikes deliver
direct to shops
Drug
Shops
17
Today’s presentation
Background and context
Results to date
Implications and next steps
18
There are inherent limitations to this study and caution should be taken
in interpreting and applying its findings
Limitation
Description
Preliminary data
• Initial data was collected one month after distribution of
subsidized ACTs began. Experience has shown it takes time for a
market to adjust to a new product
Limited scope
• The study was designed to examine price and volume in drug
shops. Some other important questions such as impact on total
anti-malarial access in the district cannot be answered
• Study is conducted in 3 rural districts of Tanzania. Conditions vary
widely across sub-Saharan Africa
Formal v. informal sector
Potential study biases
• ACTs are being distributed only through – and data collected at –
rural drug shops, which are an important source of malaria
treatment in Tanzania, but are more formal and less pervasive
than general stores.
• There is the potential for the Hawthorne effect (behavior is altered
due to the knowledge of being studied) and social desirability
bias. The study was designed to deliberately minimize these
biases
19
Subsidized ACTs have quickly gained market share, appearing to displace
sales of both SP and AQ for adults…
Products purchased in Kongwa and Maswa: August vs. November
% of adult exit interview customers purchasing anti-malarials
100% =
Other
Quinine
323
231
3%
4%
Subsidized ACT
26%
Amodiaquine
(AQ)
25%
1%
12%
SP
Other ACT +
2%
artemisinin
monotherapy
65%
4%
55%
2%
August
(pre-subsidy)
November
20
… with higher uptake for children under 5 seeming to cause significant
displacement of AQ
Products purchased in Kongwa and Maswa: August vs. November
% of exit interviews purchasing for an anti-malarial for a child under 5
100% =
Other
Quinine
44
58
2%
2%
40%
3%
89%
Amodiaquine
(AQ)
SP
Subsidized ACT
47%
7%
August
(pre-subsidy)
10%
November
21
While a greater proportion of subsidized ACTs were purchased for
children, adults continue to be overrepresented compared to estimated
fever incidence
Intended recipient of exit interview
purchases by age group
100% =
608
676*
Comparison of subsidized ACT purchases
versus fever incidence by age group
90
~ 2.1 million
41%
66%
Adult
79%
83%
23%
9%
5-15
Under 5
7%
3%
14%
14%
August
Exit
Interviews
November
Exit
Interviews
36%
26%
November
ACT
Purchases
2002 census
adjusted by fever
incidence
22
Price paid for subsidized ACTs is in line with other commonly-available
anti-malarials, with no variation in pricing behavior observed between
shops regardless of location
Mean and standard deviation of price paid
% of adult exit interviews buying a full dose of an anti-malarial
$3.00
$2.50
US Dollars
$2.00
$1.50
$1.00
$0.50
$0.00
ACT Maswa
ACT Kongwa
SP
AQ
Art.
Monotherapy
(only 3 observations)
In both districts, 100% of
customers paid the same
price
In the price intervention
district, consumers paid
exactly the SRP (~US$1)
23
Prices paid for subsidized ACTs compare favorably with common
alternatives in Maswa, but the SRP appears to have inflated prices in
Kongwa
Price paid for subsidized ACTs compared to most common alternative
Median price (US$)
Maswa
Adult
Kongwa
Child < 5
Adult*
$1.00
$0.67
$0.50
$0.42
$0.42
$0.17
SP
Subsidized
ACT
AQ
Subsidized
ACT
* Insufficient observations of AQ or alternatives for children under 5 to enable comparison
SP
Subsidized
ACT
24
Among similarly-priced products, shopkeeper recommendation plays an
important role in determining consumer choice
Reasons for buying each drug
% of 443 exit interview customers buying anti-malarials
Shopkeeper recommendation
Subsidized
ACT
Any SP
Any AQ
Prescribed
51
22
28
13
42
40
12
Previous
use Most
effective
1
12
16
25
Price
8
4
7
9
25
Consumers interviewed continue to be skewed towards the wealthier
quintiles and wealthier individuals appear to buy subsidized ACTs more
often than others
Socioeconomic status of consumers by district
% of customers buying anti-malarials or anti-pyretics
Maswa (n = 322)
Kongwa (n = 128)
Shinyanga (n = 219)
Total (n = 670)
72%
66%
61%
47%
41%
29%
23%
13%
11%
23%
10%
4%
Quintiles 1 & 2
“Poorest & Poor”
Quintile 3
“Neither rich
nor poor”
Quintiles 4 & 5
“Rich & Richest”
26
Today’s presentation
Background and context
Results to date
Implications and next steps
27
These preliminary findings highlight potential important lessons and areas
for further exploration
Area
Implication
Pricing
• The subsidy has been passed through to consumers, with retail
prices generally at or below those for alternatives. The SRP can
serve as an effective ceiling, but can perversely inflate prices
Uptake and displacement
• Stocking of subsidized ACTs by storeowners has occurred rapidly,
though it has been lower in more remote areas
• It appears that the subsidized ACT is displacing AQ, and to some
part SP
Socioeconomic status
Access for children U5
• Continuing lack of consumers from lowest SES quintiles in private
sector drugstores  need to explore treatment-seeking of this
group from other outlets
• Uptake of subsidized ACTs has been higher among children, but,
in general, drug shops seem not to be the preferred access point
for caregivers of children under 5  data and other studies
indicate that they seem to be served by public/NGO health
facilities
28
While the pilot provides important information, we must move rapidly to
large-scale implementation to increase access to ACTs
• Close to half of Tanzanians access malaria treatment through the private sector and are
currently using inappropriate or ineffective treatments due to high price of ACTs
• A pilot has been launched in Tanzania to help determine how this challenge can be best
addressed, including subsidizing ACTs and implementing supporting interventions
• Preliminary data suggests that the subsidy is being passed through to patients in rural
areas and that uptake of subsidized ACTs by both consumers and retailers has been
rapid
• However, low numbers of poorer individuals and children under five seeking treatment
at the targeted drugstores is a potential cause for concern, and additional efforts to
increase points of access for these groups should be explored
• Tanzania is firmly committed to expanding access to ACTs through all sectors and
supports global and national initiatives to accomplish this goal
29
Providing a subsidized ACT through the
private sector
Ministry of Health Uganda
Medicines for Malaria Venture Pilot
Contents
• The pilot
• Baseline findings
• Next steps
MoH-MMV pilot to provide a subsidized ACT
through private sector
SUDAN
• Total population in study
areas: 3 million
• Different transmission
settings (high / medium)
• 6 intervention and 2 control
districts
• Baseline data in study
district powered to test
different interventions
Moyo
Kitgu
m
Yumb
Arue
a
DEMOCRATIC
REPUBLIC CONGO
Adjuma
ni
Kotido
Pader
Gulu
Morot
o
Lir
a
Neb
bi
Apa
c
Masin
di
Hoim
a
Fort Portal
Kabaro
le
Kase
se
Kyenjoj
o
Kamwen
ge
Bushen
yi
Mbarara
Rukungi
ri
Kanun
Ntunga
gu
mo
Kaba
Kisorle
o
Kibog
a
Kibaa
le
Mubend
e
Mpig
Sembab
i
ule
Masa
ka
Nakapiripirit
Kmaid
o
Soro
ti
Katakw
i
Kum Bu
ke
i
Sironk
Pallis
de
o
Kamul
Kalir a
a Mle
Kngai
o
Butal
eja Toror
Igan
Luwero
Bugi
ga
Jinja
o
ri
Busi
Mayu
Mukon
a
ge
KAMPALA
o
KENYA
Wakiso
Nakasong
ola
Kalang
ala
Rak
ai
TANZANIA
RWANDA
= 6 Intervention districts
= 2 control districts
Most children continue to be treated
with ineffective drugs
(despite free Coartem at formal health facilities)
Proportion of under 5s, with fever in last 2 weeks, in rural
areas who received
Any antimalarial: Less than 30%
50
50
46,5
38,9
40
40
28,9
30
%
24,4
20,1
%
31,5
30
20
ACT: Less than 4%
20
5,5
10
10
3,2
6,6
3,8
3,5
5,1
0
0
Kamuli (N=711)
Kamuli (N=711)
24 hrs from onset of fever
Pallisa (578)
Soroti (545)
48 hrs from onset of fever
Source: MoH-MMV household surveys
Within 24 hours
Pallisa (N=578)
Within 48 hours
Soroti (N=545)
Over 60% of people from the lowest
economic quintiles get antimalarials from the
private sector
Source of antimalarials for children under 5s
by socio-economic quintiles
Govt health
facility
CMD
Highest quintile (n=159)
Fourth quintile (n=181)
Private disp.
/ clinic
Drug shop
Middle quintile (n=89)
Second quintile (n=165)
Pharmacy
Lowest quintile (n=111)
Other
0% 20% 40% 60% 80% 100
%
Source: MoH-MMV household surveys
Only a quarter of all outlets provide ACTs
largely due to the prohibitive price
Outlets providing antimalarials in study districts
Stores
(unlicensed)
Market
Public sector
NGO
Priv. Disp
ACTs
available but
frequent
stock-outs
CDD
Pharmacy
Drug shops
(licensed)
431 outlets identified in 3 districts using census approach in enumeration areas in 3 districts
Source: MoH-MMV supply side survey
Urgent need to close the private sector
access gap
• Private sector is an integral part of the antimalarial landscape
• Must engage to provide effective and affordable
treatment through outlets close to communities
• Will complement public sector delivery
• AMFm provides the framework to address key constraints
limiting access
Key elements of the pilot
• Finding innovative solutions for underserved areas
• Aligning incentives with the existing supply chain to maximize
availability
• Promoting a distinct product offering (repackaged Coartem)
with clear user instructions
• Testing different approaches
– packaging, pricing, promotional intensity
• Training to ensure correct dispensing
• Strong monitoring and evaluation
Launch 2Q 2008
MoH-MMV pilot is generating valuable data
for AMFm
• Baseline data provided insight for AMFm design issues
• Operational research will inform the roll-out of the AMFm on a
regular basis with emphasis on
– ensuring correct dispensing and use of ACTs through the
private sector
– uptake and impact of subsidized drug by socio-economic
groups
– displacement of ineffective drugs
– reaching underserved communities
Communities and
patients need the AMFm
Agenda
Background
Summary of Achievements to date
–AMFm Technical Design
–Ensuring that AMFm will work
Requested Board Action
–Proposed Decision Points
–Management of AMFm
Next steps
40
Partners must address challenges from announcement to launch of AMFm
Five implementation challenges
Challenge 1. Ensuring quality assurance, pharmaco-vigilance, strengthening
treatment practices (maximize points of access, diagnostics, mono-therapies),
local manufacturing
Challenge 2. In-country supporting interventions, particularly around patient
information, education, retail price setting, communication and country level
monitoring
Challenge 3. Developing and agreeing a business plan for AMFm management
Challenge 4. Supplier sourcing and forecasting
Challenge 5. Resource mobilization
41
Proposed Terms of Reference for Reconfigured AMFm Task Force
Roles and
Responsibilities
Membership
Ways of Working
Timeline
• Address outstanding questions from partners around each of the five implementation
challenges
• Work with Global Fund as it performs its due diligence to develop a business plan for
submission at the April Board meeting
• Develop work plans and identify resources needed to prepare for launch of AMFm
• Organize two consultations with endemic country civil society, private sector and
government representatives (one in West Africa and one in East Africa, countries TBD)
• Representation: WHO, UNICEF, World Bank, Gates, Global Fund, UNITAID, CHAI
MMV, Industry, Endemic Countries (2), UNF, NGO, bi-lateral
• Co-chairs: RBM Executive Director, DFID
• Action-oriented with emphasis on timely deliverables of good quality
• Sub-groups will be formed to address specific issues; sub-group membership will not be
confined to membership of the AMFm Task Force. Membership will depend on
willingness and ability to make a clear contribution
• Role for RBM working groups on several issues, in particular key role for the
Harmonization Working Group (needs assessment and planning for technical
assistance) and the PSM Working Group (local manufacturing and forecasting)
• December 2007 – April 2008
• Review and update terms of reference after the Global Fund Board decision
42
Proposed decision points
(1) Endorses the design of the AMFm as outlined in the executive summary of the technical design
submitted by the AMFm Taskforce.
(2) Declares its support for the creation of an Affordable Medicines Facility for malaria (AMFm) to be
implemented in accordance with the agreed technical design, noting that a launch is contingent upon
resolution of five implementation challenges in the following areas: (i) pharmaceutical standards and
treatment guidelines, (ii) supporting interventions, (iii) developing and agreeing a business plan for
managing the AMFm, (iv) supplier sourcing and forecasting, (v) resource mobilization.
(3) Invites the Global Fund to Fight AIDS, Tuberculosis and Malaria to consider taking on full
responsibility as AMFm manager at its earliest convenience, for the implementation of this facility in
accordance with the agreed design principles.
(4) Expresses its gratitude to the co-chairs, secretariat, including advisers, members of the RBM
AMFm Taskforce and other resource persons for having successfully achieved their mandate.
(5) Decides to re-configure the AMFm Task Force to address the implementation challenges in a
timely manner, in accordance with the terms of reference attached here.
(6) Encourages interested donors to hold consultations with the Task Force to secure financing for
the AMFm.
43
Agenda
Background
Summary of Achievements to date
–AMFm Technical Design
–Ensuring that AMFm will work
Questions & Answer session
Requested Board Action
–Proposed Decision Points
–Management of AMFm
Next steps
44
Next steps
• December 2007: First meeting of the AMFm Task Force to develop
work plan
• April 2008: Expected acceptance by GFATM to take on the
management of the AMFm
45
BACK-UP
46
Some issues still require consensus – no pure technical answer
• Over-the-counter status
• Use of diagnostics
• Banning mono-therapies
• Drug quality standards
• Negotiation framework to set subsidy levels
47