Access to essential medicines for asthma

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)

2. 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

3. 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) • Inhaledipratropium(20μg/puff) • So far, no combined inhaler (corticosteroid + bronchodilator) on the WHO EML

4. 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, MedaPharma • 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

5. 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

6. 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

7. 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

8. 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

9. 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

10. 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 Providingaccess to affordablequality-assured essential asthmamedicines

11. A practicalsolution at The Union: Asthma DrugFacility (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

12. Howdidthe 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

13. ADF Product Prices 2011-13 *On the 18th WHO Essential Medicines List, April 2013

14. Reduction in annualcosts for a patient withsevereasthmawhenmedicinespurchasedthrough ADF(in Euros, based on 2009/2013 ADF prices)

15. 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

16. 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 standards

17. 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