Asthma Drug Facility 2005-2013: achievements and lessons learnt for J2J

Karen Bissell, DrPH, MA
Department of Lung Health and NCDs and Department of Research International Union Against Tuberculosis and Lung Disease

Asthma Drug Facility
• Provides affordable access to quality-assured, essential asthma medicines for low- and middleincome countries • Promotes a quality improvement package for the diagnosis, treatment and management of asthma

ADF mechanism
Quality assurance: Based on WHO norms & standards. Inhalers not part of WHO prequalification programme, so ADF organised qualification of manufacturers, sites and products. Contracts are for qualified product/site pairs.

Procurement strategies: Kept prices down by running limited competitive process. Pooled procurement. Clients paid in advance. Health service strengthening: Union’s 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.

Achievements: procurement and prices
• Established a strong Quality Assurance system based on WHO norms and standards. Transparency: info about qualification and tender process, prices and medicines sources on website. • ADF qualification process proved that generic single inhalers not yet registered in strictly regulated countries were 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.

Achievements: procurement and prices
• The companies stayed with ADF for 3 consecutive bi-yearly Expressions of Interest and kept renewing their commitment, 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 pharma’s 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.

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)
90 80 70 62 60 50 40 30 20 10 0 BENIN SALVADOR SUDAN In 2012, ADF procurement 48 36 40 35 33 In 2010, ADF procurement In 2009, national procurement 79 83

© Sabir Nazar for The Union

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

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

Achievements: policy and advocacy
• Contact with GARD, WHO NCD department, Global Fund (ADF mechanism was announced as compliant with GF QA and 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 HighLevel 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.

ADF was a core contributor to Global Asthma Report 2011 (Union/ISAAC), presented at UN High Level Meeting on NCDs
www.globalasthmareport.org

WHO Essential Medicines Monitor August 2011

ADF contributed to the ‘NCD Alliance’ Briefing paper on Access to Essential Medicines, 2011

Achievements: policy and advocacy
• ADF & University of Auckland conducted research into availability, prices and affordability of essential asthma medicines. Worked with volunteer data 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 Health’s IRP – supposedly a reference for efficient procurement)

Essential Medicines: Pricing, Availability and Affordability

The Union and The University of Auckland, NZ in ‘Global Asthma Report’ The Union, ISAAC, 2011

Achievements: policy and advocacy
• Global Asthma Network (Formed by the former

ISAAC research network and The Union) has adopted ADF-inspired targets, messages and activities. More info during plenary of Prof Innes Asher on 2nd Nov.

• ADF model has attracted attention of those wanting to increase access to other NCD medicines. Requests for advice from those working specifically in diabetes, mental health and from others working on NCD movement.

Lessons learnt: establishment of mechanism
• TB and asthma are VERY different contexts. GDF model needed significant adaptation; expectations needed to be very different, given countries’ realities and no funding. • Procurement of medicines and devices that are not prequalified by WHO is a VERY different undertaking. • Having an in-house pharmacist, experienced in quality assurance 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.

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.

Lessons learnt: health services
• Few medical professionals understand the essential role of inhaled corticosteroids in asthma management, prescribing the 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 don’t attend follow-up because they are well now they have medicines and self-management plan?

Lessons learnt: procurement
• Market doesn’t encourage rational procurement. • Non-essential medicines are pushed by pharmaceutical companies and specialist physicians. • Brand loyalty to innovator products can override evidencebased 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

Conclusions and future
• ADF has proved it’s possible to help LMICs to purchase qualityassured 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 qualityassured 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.

Asthma contacts

adf@theunion.org kbissell@theunion.org www.globaladf.org www.theunion.org www.globalasthmanetwork.org

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