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

• 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

Effective medicines available

• 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

Challenges for management of asthma in poor countries

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

• 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 2010Source: Global burden of Disease Study 2010

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

• 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

A practical solution at The Union: Asthma Drug Facility (ADF)

• 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

How did the ADF work?

ADF Product Prices 2011-13

Product Primary Supplier(Country)

Price per unit FCA (USD)

Beclometasone 100µg/puff 200 doses, HFA inhaler*

Beximco(Bangladesh)

1.28

Salbutamol 100µg/puff200 doses, HFA inhaler*

GSK Export(UK)

1.08

Budesonide 200µg/puff 200 doses, HFA inhaler*

Cipla/Medispray(India)

2.60

Fluticasone 125µg/puff120 doses, HFA inhaler

Cipla/Goa (India)

2.50

*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)

BENIN SALVADOR SUDAN0

10

20

30

40

50

60

70

80

90

7983

62

48

3540

3633

In 2009, national procurement

In 2010, ADF procurement

In 2012, ADF procurement

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 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

Publications of interest

Global Asthma Report 2011www.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 2013http://www.globalasthmanetwork.org/news/medicines.php

Global Atlas of Asthma 2013http://biblioms.dyndns.org/Global%20Atlas%20of%20Asthma.pdf