The Challenges of Asthma (PartII)

7/27/2019 The Challenges of Asthma (PartII)

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Asthma Drug Facility 2005-2013:

achievements and lessons learnt for J2J

Karen Bissell, DrPH, MADepartment of Lung Health and NCDs and Department of

Research

International Union Against Tuberculosis and Lung Disease


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Asthma Drug Facility

Provides affordable access to quality-assured,

essential asthma medicines for low- and middle-

income countries

Promotes a quality improvement package for thediagnosis, treatment and management of asthma


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ADF mechanism

Procurement strategies: Kept prices down by running

limited competitive process. Pooled procurement. Clients

paid in advance.

Health service strengthening:Unions guidelines and

training materials for standardised mgt of asthma, including

an information system for monitoring outcomes and

improving service. Tracking reduction in emergency visits and

hospitalisations shows health and financial benefits of

appropriate care & medicines.

Quality assurance: Based on WHO norms &

standards. Inhalers not part of WHOprequalification programme, so ADF organised

qualification of manufacturers, sites and products.

Contracts are for qualified product/site pairs.


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Achievements:

procurement and prices

Established a strong Quality Assurance system based on

WHO norms and standards. Transparency: info aboutqualification and tender process, prices and medicines

sources on website.

ADF qualification process proved that generic single

inhalers not yet registered in strictly regulated countrieswere up to WHO quality standards and this contributed to

improved access to inhalers in LMICs.

Undertook 3 rounds of product and site

qualification and 2 restricted tenders(ADF closed prior to start of 3rd tender).

ADF has shown what can be done with

very few human and financial resources,

and minimal bureaucracy.


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Achievements:

procurement and prices

The companies stayed with ADF for 3 consecutive bi-yearly

Expressions of Interest and kept renewing theircommitment, despite small orders.

Retained same prices for 2009-2010 and 2011-2012

contract extensions

Prices decreased between both tenders - 1st 2009, 2nd 2011.

3rd tender (due August 2013) was cancelled.

An innovator company, GSK, also became a supplier.

ADF has challenged big pharmas pricing policies. Since

2012, innovator companies have a tiered price system in

most African countries. Prices are higher than ADFs, but

lower than before for innovator products.


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Around 50% and higher reductions in annual

costs for a patient with severe asthma when

medicines purchased through ADF(in Euros, based on 2009/2012 ADF prices)

7983

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4036

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BENIN SALVADOR SUDAN

In 2009, national

procurement

In 2010, ADFprocurement

In 2012, ADF

procurement


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Sabir Nazar for The Union


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Achievements:

clients progress

Countries that purchased

Africa: Benin (5 inhaler orders + 2 medical device orders),Burundi (1 inhaler order + 1 medical device), Kenya, Sudan (2

inhaler orders)

Central America: El Salvador, Honduras

Asia Pacific: Vietnam, Vanuatu Countries that cancelled orders early 2012, after budget

restrictions at The Global Fund

Burkina Faso, Guinea Conakry

Pilot projects

- improvement of patient care (i.e. less emergency visits and

admissions) eg Benin, Sudan, El Salvador

- sustainable supply of inhalers and related devices

- innovative financing: revolving fund mechanisms in Benin, Sudan


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Achievements:

new clients

Contact with new potential clients that were not dependent on

international funds European NGOs working in Egypt, Laos, Morocco

International NGOs, such as MSF

NTP / MoH of DRC, Kyrgyzstan, Mali, Nepal

UN agencies, such as UNRWA ADF has accompanied some of these potential clients for up to 2

years, providing technical support, regulatory insight, financial

information for their fundraising activities necessary before they can

place their first order; contacts in Laos and Morocco would have

been ready to order late 2013

Entities from some 30 LMICs sought support from ADF and

confirmed their desperate need to access affordable quality-assured

inhalers - reasons why they did not yet place firm orders are

covered in our lessons learnt


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Achievements:

policy and advocacy Contact with GARD, WHO NCD department, Global Fund

(ADF mechanism was announced as compliant with GF QAand procurement policies in 2010), Stop TB dept, WHO

prequalification programme, FIRS, ERS, GINA, ISAAC, UN

Environment Programme, World Asthma Meeting, many

conferences

ADF/Union invited to UN meetings in lead-up to UN High-

Level Meeting on NCD Prevention and Control 2011

ADF/Union made submissions to UN consultation on

Global Monitoring Framework for NCDs and WHO Global

Action Plan, May 2013

Contributed to success at getting

asthma and chronic respiratory disease

specified, and access to essential

medicines and technologies included.


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WHO Essential Medicines MonitorAugust 2011

ADF contributed to the NCD

Alliance Briefing paper on Access

to Essential Medicines, 2011

ADF was a core contributor to Global Asthma

Report 2011 (Union/ISAAC), presented at UN

High Level Meeting on NCDs

www.globalasthmareport.org


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Achievements:

policy and advocacy

ADF & University of Auckland conducted research into availability, prices

and affordability of essential asthma medicines. Worked with volunteerdata collectors in 52 countries. Published in Pharmacoeconomics

- Availability was particularly poor for corticosteroids, and worse in national

procurement centres and main hospitals.

- The surveyed strength of beclometasone was only on the EML of 10 countries.

- Considerable variability was found in pricing and affordability across countries.

- Procurement systems appeared largely inefficient when ADF prices were applied

as reference prices.

- Some countries appear to be subsidising asthma medicines, making them free or

less expensive for patients, while others are applying very high margins,

significantly increasing price for patients unless reimbursement system exists.- Health systems and patients are paying more than necessary for asthma

medicines, which are unaffordable for many patients in many countries.

ADF prices are being used as references prices (ICS price much lower

than Management Sciences for Healths IRP supposedly a reference for

efficient procurement)

E i l M di i


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Essential Medicines:Pricing, Availability andAffordability

The Union and The

University of Auckland, NZ

in

Global Asthma ReportThe Union, ISAAC, 2011


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Achievements:

policy and advocacy

ADF model has attracted attention of those wanting toincrease access to other NCD medicines. Requests for

advice from those working specifically in diabetes, mental

health and from others working on NCD movement.

Global Asthma Network (Formed by the former

ISAAC research network and The Union) hasadopted ADF-inspired targets, messages and

activities.

More info during plenary of

Prof Innes Asher on 2nd Nov.


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Lessons learnt:

establishment of mechanism

TB and asthma are VERY different contexts. GDF model

needed significant adaptation; expectations needed to bevery different, given countries realities and no funding.

Procurement of medicines and devices that are not pre-

qualified by WHO is a VERY different undertaking.

Having an in-house pharmacist, experienced in qualityassurance and international procurement, LMIC field

conditions and well-networked with others working on

access to essential medicines, is indispensible - from the

outset of any such mechanism.

Wide consultation with pharmacist essential medicine

experts is indispensible for such initiatives.

We aimed to be self-sustaining, while keeping prices as low

as possible. We did not manage to find external funding.

L l t


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Lessons learnt:

guidelines and actors

Almost all countries have no national programme and no

national information system for asthma.

Many have no real national consensus, and/or

implemented guidelines, strategy or dedicated budget.

Some countries follow guidelines that are more for HICs.

Essential Medicines Lists (EMLs) often not include inhaled

corticosteroids; if they do, often not updated to include

latest HFA strengths (HFA propellants replaced CFCs);some include very expensive medicines.

Difficult to identify appropriate people in country: varied

configuration of actors expert in and/or influential in

decisions and policy related to asthma. Not like TB.

L l t


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Lessons learnt:

health services

Few medical professionals understand the essential role of

inhaled corticosteroids in asthma management, prescribingthe reliever medication alone.

Services are often not organised for long-term chronic care

and health workers are not trained in asthma care

Patient education is often absent or inappropriate. It proved hard to get outcomes for cohorts of patients.

Many patients appear lost to follow-up . Likely that they

dont attend follow-up because they are well now they

have medicines and self-management plan?


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Lessons learnt:

procurement

Market doesnt encourage rational procurement.

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


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Conclusions and future

ADF has proved its possible to help LMICs to purchase quality-

assured essential asthma medicines at affordable prices.

It has influenced international market prices and contributed to

price reductions.

It has catalysed change in several countries asthma

management, created case studies, shared knowledge & tools. It has brought international attention to LMIC challenges and

solutions for access to essential medicines for asthma, NCDs.

Significant obstacles are still stalling country progress in

establishing asthma care and procuring essential medicines.

LMICs should be encouraged to demand affordable and quality-

assured essential medicines for NCDs and allocate budget for

them .

The Union will try to transfer some of the functions of the ADF to

another agency.


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Asthma contacts

[email protected]@theunion.org

www.globaladf.org

www.theunion.org

www.globalasthmanetwork.org

The Challenges of Asthma (PartII)

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