Transcript Diapositive 1

Access to essential medicines
for asthma
WHO Technical Briefing Seminar on Essential Medicines
& Health Products, Nov. 2013
Christophe Perrin, Pharmacist, MPH – IUATLD (The Union)
Asthma - Global Context
• Most common chronic disease among
children
• 235 million people worldwide suffer
from asthma
• One of the chronic respiratory
diseases (with Chronic Obstructive
Pulmonary Disease) considered as a
priority target by WHO NCD Global
Action Plan, 2013
• Asthma often goes undiagnosed, untreated or poorly treated
• Effective medicines are available
• Unfortunately, for many people with asthma – particularly the
poor – these medicines are too costly or not available at all
Effective medicines available
• Asthma and COPD inhaled medicines on the current 18th WHO
Essential Medicines List, April 2013:
 Inhaled salbutamol (100μg/puff)
 Inhaled beclometasone (50 & 100μg/puff)
 Inhaled budesonide (100 & 200μg/puff)
 Inhaled ipratropium (20μg/puff)
• So far, no combined inhaler (corticosteroid + bronchodilator) on
the WHO EML
Effective medicines available
• Quality-assured single & combined inhalers on the market with
registrations in stringent regulated countries:
- from innovator companies: e.g. GlaxoSmithKline, Astra
Zeneca, Chiesi
• Quality-assured single inhalers on the market with registrations
in stringent regulated countries:
- from generic companies: e.g. Cipla, Aldo-Union, Teva, Meda
Pharma
• Quality-assured single inhalers on the market assessed by the
Asthma Drug Facility:
- from generic companies: e.g. Beximco
+ few more companies manufacturing inhalers at unknown quality
standards
Challenges for management of asthma
in poor countries
• High cost of essential asthma medicines, particularly
inhaled corticosteroids unaffordable to most patients
→ to buy one beclometasone HFA 100mcg inhaler, a patient spends:
- over 5 days wages in Ethiopia
- over 8 days wages in Malawi
- almost 14 days wages in Madagascar
(Note: a person with severe asthma needs approx. 16 inhalers per year)
Sources: The Union and The University of Auckland, NZ in ‘Global Asthma Report’ The Union, ISAAC,
2011 ; Mendis, 2007
• Non-essential asthma medicines often available at very
high cost: accessible to a minority of wealthy patients /
health insurance holders
Challenges for management of asthma
in poor countries
• Lack of demand at country level:
 Lack of political will to:
− provide affordable essential medicines
− make asthma guidelines available or implement them
 Difficult to identify appropriate NCD focal points
 Few countries have inhaled corticosteroids on the national
EML & treatment guidelines
 Few medical professionals understand the essential role of
inhaled corticosteroids in asthma management, prescribing the
reliever medication alone
 Health services are often not organised for long-term chronic
care; health workers are not trained in asthma care
 Patient education is mostly absent or inappropriate
Challenges for management of asthma
in poor countries
• Failure of market to encourage rational procurement and meet patient
needs:
 Non-essential medicines are pushed by pharmaceutical companies
and specialist physicians; brand loyalty to innovator products can
override evidence-based decision-making.
 Many national procurement systems have restrictions about using
pooled procurement mechanisms like ADF:
− They prefer to negotiate prices directly with suppliers
− Tenders often only open to locally represented suppliers
− Incentives can jeopardise rational procurement
 Few funds exist for purchasing essential medicines at national and
international levels:
− The Global Fund will not continue funding country implementation
of WHO’s Practical Approach to Lung health
− Lack of governmental funds for NCDs
Despite availability of effective asthma
medicines
• For countries and for patients, costs increase when
asthma is not treated or incorrectly treated.
There are unnecessary expenses of emergency visits,
hospitalisations, and ineffective and inappropriate medicines
Despite availability of effective asthma
medicines
Male asthma mortality/100.000 in 2010
Source: Global burden of Disease Study 2010
• Despite a decrease of mortality rates since 1990, asthma still
kills in 2013; especially in low and middle income countries
(80% of asthma deaths) Source: Braman, 2006
What can be done?
WHO NCD GAP - Global target, nber 9:
80% availability of affordable basic technologies &
essential medicines, including generics, in both
public & private facilities
Providing access to affordable quality-assured essential asthma medicines
A practical solution at The Union:
Asthma Drug Facility (ADF)
• From 2008 till 2013
(currently transfers under study
to another agency)
• Provides affordable access
to quality-assured, essential
asthma medicines for low- and
middle-income countries
• Promotes a quality improvement
package for the diagnosis,
treatment and management of asthma
How did the ADF work?
• Unlike TB and HIV essential medicines, asthma inhalers are
not part of the WHO Prequalification Programme
• ADF organised “qualification” of manufacturers and products,
using a Quality Assurance system based on WHO norms and
standards.
• Contracts with these selected manufacturers for qualified
products and proposes these products to countries,
organisations, programmes
• Countries purchase at affordable prices
• Training materials and information system for following patient
progress
ADF Product Prices 2011-13
Product
Primary Supplier
(Country)
Price per unit FCA
(USD)
Beximco
(Bangladesh)
1.28
Salbutamol 100µg/puff
200 doses, HFA inhaler*
GSK Export
(UK)
1.08
Budesonide 200µg/puff
200 doses, HFA inhaler*
Cipla/Medispray
(India)
2.60
Fluticasone 125µg/puff
120 doses, HFA inhaler
Cipla/Goa
(India)
2.50
Beclometasone 100µg/puff
200 doses, HFA inhaler*
*On the 18th WHO Essential Medicines List, April 2013
Reduction in annual costs for a patient with
severe asthma when medicines purchased
through ADF
(in Euros, based on 2009/2013 ADF prices)
90
80
83
79
70
62
60
50
48
40
36
In 2009, national
procurement
40
35
33
In 2010, ADF
procurement
30
20
In 2012, ADF
procurement
10
0
BENIN
SALVADOR
SUDAN
Other contributions of ADF
• Pilot project in Benin with positive outcomes to be published soon:
- improvement of patient care (i.e. less emergency visits and
admissions)
- sustainable supply of inhalers and related devices (peak-flow meters,
spacers) between 2009 and 2013, after an initial donation of The Union
to set up a revolving fund mechanism
• After ADF initiation in 2008, set-up in 2011 of tiered price policy for
asthma inhalers by innovator companies, such as GSK, in several
African countries
• Dialogue initiated with WHO Prequalification Programme about the
possibility to include asthma inhalers in their Expression of Interest:
- assessing the quality of inhalers is indeed complex:
. combination of devices (canister, valve & actuator), active
pharmaceutical ingredients and a propellant
. need for equivalence studies between generic and innovator products
Conclusions
• Actions needed to improve access to asthma quality-assured
essential medicines:
- improve coherence between in-country treatment guidelines and
national EML vs. WHO recommendations
- training of health workers to efficient asthma care
- patient empowerment
- encouragement of LMICs to demand affordable and qualityassured essential medicines for NCDs, also to allocate budget for
them
- mechanism(s) to enhance offer of affordable inhalers to the
poorest patients (ADF-like mechanism, PAHO Strategic Fund)
- reference list of quality-assured inhalers compliant to WHO
standards
Publications of interest
Global Asthma Report 2011
www.globalasthmareport.org
Z. Ud-Din Babar. The availability, Pricing and affordability of three
essential asthma medicines in 52 low and middle income countries.
PharmacoEconomics, Oct 2013
http://www.globalasthmanetwork.org/news/medicines.php
Global Atlas of Asthma 2013
http://biblioms.dyndns.org/Global%20Atlas%20of%20Asthma.pdf