for asthma WHO Technical Briefing Seminar on Essential Medicines amp Health Products Nov 2013 Christophe Perrin Pharmacist MPH IUATLD The Union Asthma Global ID: 630553
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Slide1
Access to essential medicines for asthma
WHO Technical Briefing Seminar on Essential Medicines & Health Products, Nov. 2013Christophe Perrin, Pharmacist, MPH – IUATLD (The Union)Slide2
Asthma
- Global ContextMost 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
allSlide3
Asthma and COPD inhaled medicines on the current 18
th WHO Essential Medicines List, April 2013:Inhaled salbutamol (100μg/puff)Inhaled beclometasone (50 & 100μg/puff)Inhaled budesonide (100 & 200μg/puff)Inhaled ipratropium (20
μg/puff)
So far, no combined inhaler (corticosteroid + bronchodilator) on the WHO EML
Effective medicines availableSlide4
Quality-assured single & combined inhalers on the market with registrations in stringent regulated countries:
- from innovator companies: e.g. GlaxoSmithKline, Astra Zeneca, ChiesiQuality-assured single inhalers on the market with registrations in stringent regulated countries: - from generic companies: e.g. Cipla, Aldo-Union, Teva, Meda PharmaQuality-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
Effective medicines availableSlide5
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 Slide6
Lack of demand at country level:
Lack of political will to:provide affordable essential medicinesmake asthma guidelines available or implement themDifficult to identify appropriate NCD focal pointsFew countries have inhaled corticosteroids on the national EML & treatment guidelinesFew medical professionals understand the essential role of inhaled corticosteroids in asthma management, prescribing the reliever medication aloneHealth services are often not organised for long-term chronic care; health workers are not trained in asthma carePatient education is mostly absent or inappropriateChallenges for management of asthma in poor countries Slide7
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 suppliersTenders often only open to locally represented suppliersIncentives 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 healthLack of governmental funds for NCDsChallenges for management of asthma in poor countries Slide8
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 medicinesSlide9
Despite availability of effective asthma medicines
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
Male asthma mortality/100.000 in 2010
Source: Global burden of Disease Study 2010Slide10
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 facilitiesProviding access to affordable quality-assured essential asthma medicinesSlide11
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 countriesPromotes a quality improvement package for the diagnosis, treatment and management of asthmaA
practical
solution
at
The
Union:
Asthma
Drug
Facility (ADF) Slide12
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, programmesCountries purchase at affordable prices Training materials and information system for following patient progressHow
did the
ADF
work
?Slide13
ADF Product
Prices 2011-13Product Primary Supplier
(Country)
Price
per unit FCA (USD)
Beclometasone
100µg/puff 200 doses, HFA inhaler*
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
*
On the 18
th
WHO Essential Medicines List, April 2013Slide14
Reduction
in annual costs for a patient with severe asthma when medicines purchased
through
ADF
(in Euros,
based
on 2009/2013 ADF
prices
)Slide15
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 mechanismAfter ADF initiation in 2008, set-up in 2011 of tiered price policy for asthma inhalers by innovator companies, such as GSK, in several African countriesDialogue 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 productsSlide16
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 quality-assured 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 standardsSlide17
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