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Open Letter

A novel initiative to improve access to medicines for control of non-communicable diseases in low-and middle- income countries

[version 1; peer review: 2 approved with reservations]
PUBLISHED 23 Feb 2018
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Abstract

The global burden of non-communicable diseases (NCDs) is growing, and access to prevention and treatment strategies remain limited, especially for those in low- and middle-income countries (LMICs).
Novel approaches are needed to improve access and affordability of medicines that can treat NCDs in LMICs. An integrated approach including differential pricing, health systems strengthening, improved supply chain management and greater affordability can improve access to innovative branded medicines for NCDs.
While differential pricing has several advantages for improving the affordability of NCD medicines in LMICs, it can’t overcome all access barriers as a standalone approach.  An integrated approach to health systems strengthening, supply chain management and affordability are needed to overcome key challenges in getting medicines for NCD to patients in LMICs.
The Access and Affordability Initiative (AAI) is a public private partnership aiming to improve access to and availability of essential medicines for the treatment of NCDs and strengthening of health systems. Through this novel initiative a prospective cohort of patients with hypertension and diabetes were followed in Ghana and the Philippines to examine the effect of differential pricing on access to treatment of hypertension and diabetes.

Keywords

Hypertension, Diabetes, Ghana, Differential Pricing, LMIC, Non-Communicable Diseases, Universal Health Coverage

Introduction

Burden of non-communicable diseases

Non-communicable diseases (NCDs), especially cardiovascular diseases, diabetes, and cancer, have emerged as the leading cause of premature deaths globally. Eighty-six per cent of these deaths are estimated to occur in low-and middle-income countries (LMIC), where they pose a serious public health threat1. The increase in the prevalence of NCDs is largely due to demographic changes from population growth and ageing. The epidemiologic transition in LMICs, characterized by a growth in the burden of disease from infectious diseases to NCDs, has largely been driven by a number of factors, including the consumption of processed foods high in fat, salt and sugar, a decrease in physical activity with sedentary lifestyles, obesity and a rise in the use of tobacco and alcohol2.

Access and affordability of medicines for NCDs in LMICs

For many patients, the high cost of medicines constitutes a major barrier to access innovative patented medicines, but also to the World Health Organization (WHO) list of essential medicines, 92% of which are off-patent3. As the prevention and control of NCDs often requires life-long treatments, novel initiatives, which improve access and affordability, are needed. Health financing reforms and enhanced normative guidance are required for current financing strategies, such as health insurance (with or without co-payment), out-of-pocket expenditure, financing pools and pre-payment, in order to enhance patient access to medicines and overall health outcomes. Essential medicines used to treat NCDs tend to have limited availability and affordability, especially in public sector settings in LMICs, thus negatively impacting control of NCDs46. Approximately 90% of individuals in LMICs are estimated to use their own funds to purchase medicines, resulting in out-of-pocket expenditures for medicines being the highest expenditure after food, resulting in challenges with affordability, posing major burdens on government budgets5. A significant proportion of morbidity and mortality due to NCDs can be prevented if medicines are made accessible and affordable6.

The lack of available data on pharmaceutical expenditure, specifically on the types of medicines procured or sold, public and private sector spending, and the degree of access by key population subgroups was recently highlighted by an article in the Lancet7. It recommended that Governments and health systems create and maintain information systems for routine monitoring of data bearing on the affordability of essential medicines, as well as price and availability, in the public and private sectors7. The aim of this paper is to discuss differential pricing for the treatment of NCDs, as a financing scheme to help achieve Universal Health Care.

Health financing: Differential pricing

Differential pricing is one of the approaches to achieve the goal of Universal Health Care (UHC). UHC is defined as the ability to access quality, needed health services, while ensuring that the use of these services does not expose the user to financial hardship. UHC is now a Sustainable Development Goal (SDG) goal: “Achieve UHC, including financial risk protection, access to quality essential health care services and access to safe, effective, quality and affordable essential medicines and vaccines for all.” The concept of UHC ensures a “system-wide effective coverage combined with universal financial protection,” thus avoiding exorbitant out-of-pocket costs8. Out-of-pocket financing for chronic disorders poses a real barrier to increasing access to medicines for poor populations9.

Differential pricing, an approach used to price medicines based on the purchasing power of payers in different socioeconomic segments, within countries or between countries, has been shown to be beneficial and lead to improvement of access and affordability10,11. Thus far, the use of differential pricing has generally been limited to vaccines, contraceptives, antimalarials and antiretrovirals in the context of the Global Fund and Global Alliance for Vaccine Initiative, where price reductions were achieved through such strategies as high-volume purchasing, reliable and adequate financing, public advocacy, negotiation, and market competition12,13. Some of the challenges in the roll out of differential pricing stand out, as this approach doesn’t completely address non-price barriers to access, such as challenges related to regulation and weak supply chain and health systems. With regards to supply chain challenges, frequent stockouts, inability to forecast accurately, inefficient distribution systems, or leakage of medicines for private resale, can all impact access9. Therefore in order to improve access and affordability using differential pricing as a financing scheme, it is important that an integrated approach be utilized which includes robust partnerships between multiple stakeholders (governments, donors, biopharmaceutical companies, UN agencies, non-governmental organizations), as well as targeted efforts to strengthen supply chain and health systems.

Key international commitments recognize the need for improvement in access and affordability for essential medicines

The WHO Global Action Plan for the Prevention and Control of non-communicable diseases was endorsed by the 66th World Health Assembly to strengthen national efforts to address the burden of NCDs1. The goal of the WHO Global Action Plan is to improve availability of essential medicines in both public and private facilities and reduce premature mortality from non-communicable diseases by 25% by the year 20251. In 2015, NCDs were included in the SDGs, thus recognizing NCDs as a challenge for sustainable development (SDG target number 3).

One of the objectives of the WHO Global Action Plan is to “Implement other cost-effective interventions and policy options to strengthen and orient health systems to address non-communicable diseases and risk factors through people-centered health care and universal health coverage”13. Through differential pricing, the cost of medicines in populations with limited access in LMICs can become more affordable and, when coupled with needed health system improvements, has the potential to dramatically increase access to medicines for specific conditions among lower income segments of the population.

These key commitments on the part of the international community are critical in helping achieve improved access for patients living with NCDs in LMICs.

The WHO recently launched the #beatNCDS campaign, which aims to assist countries to achieve nine global voluntary NCD targets to reduce premature deaths from cancers, heart and lung diseases, and diabetes by 25% by 2025. In order to successfully achieve these goals, it is essential that access to medicines be improved by health financing reforms.

Study: Access and Affordability Initiative

The Access and Affordability Initiative (AAI) is a multilateral collaboration between multiple stakeholders with the aim of improving access to and availability of essential medicines for the treatment of NCDs and strengthening of health systems. It brings together four major biopharmaceutical companies – Merck, Sharp and Dohme Corp. (MSD), a subsidiary of Merck & Co., Inc., Kenilworth, N.J., U.S.A., Novartis, Pfizer and Sanofi – and the Bill & Melinda Gates Foundation, who have initiated a public private partnership with the Ministries of Health in Ghana and the Philippines. AAI is one of the initiatives supporting Access Accelerated, a global partnership of a coalition of biopharmaceutical companies to address the barriers to access for NCDs in LMICs. Access Accelerated was launched at the World Economic Forum’s Annual Meeting in Davos by twenty-two leading biopharmaceutical companies to advance access to NCD prevention and care in low and lower-middle income countries14.

Through this novel initiative a prospective cohort of patients with hypertension and diabetes were followed in Ghana and the Philippines at multiple sites, allowing these countries, with the support of the Ministry of Health, as well as academic institutions, to study the effect of within-country differential pricing of innovative medicines and health systems strengthening on access to innovative medicines, clinical outcomes, including disease control, complications and adherence, for diabetes and hypertension. Health system strengthening activities included the development of clinical guidelines, training on supply chain and clinical management, strengthening of supply chain management. Each of the participating companies independently and made decisions involving the AAI. The initiative will provide a unique opportunity to determine whether this type of public private collaboration can improve access to affordable medicines in the developing world and thereby help to achieve SDG3. Additional evidence will be needed to determine the generalizability of such an intervention in other LMIC to tackle the issue of access to treatment.

The AAI study will help provide essential data on access to medicines, affordability of treatment, clinical outcomes, as well as out-of-pocket expenditure by rural and urban populations in both Ghana and the Philippines. This information system will be shared with the respective Ministries of Health in both countries and will assist in providing important policy recommendations to these respective Ministries.

Conclusions

Given the growing cost to the health system of poorly managed NCDs and of the limited availability of financial resources, targeted, cost-effective interventions are needed. Additional evidence will be required to examine the ability to implement differential pricing as a means to improve access to and affordability of medicines for the treatment of NCDs in a variety of contexts. “To explore viable health financing mechanisms and innovative economic tools supported by evidence” is a policy recommendation in the updated WHO Global Action Plan for the Prevention and Control of NCDs15.

The AAI presents one example of such an exploration through differential pricing of innovative medicines for the control of NCDs, coupled with health systems strengthening and may reveal an innovative means to improve access to critically needed medicines and thereby help curb the disturbing trends of excess morbidity and mortality from NCDs in LMICs.

Disclaimer

The views expressed in this article are those of the authors. Publication in Gates Open Research does not imply endorsement by the Gates Foundation.

Data availability

No data are associated with this article.

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VERSION 2 PUBLISHED 23 Feb 2018
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how to cite this article
Mobula LM, Sarfo S, Arthur L et al. A novel initiative to improve access to medicines for control of non-communicable diseases in low-and middle- income countries [version 1; peer review: 2 approved with reservations] Gates Open Res 2018, 2:12 (https://doi.org/10.12688/gatesopenres.12798.1)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Open Peer Review

Current Reviewer Status: ?
Key to Reviewer Statuses VIEW
ApprovedThe paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approvedFundamental flaws in the paper seriously undermine the findings and conclusions
Version 1
VERSION 1
PUBLISHED 23 Feb 2018
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Reviewer Report 04 May 2018
Alessandra Ferrario, Department of Population Medicine, Harvard Pilgrim Health Care Institute, Harvard Medical School, Boston, MA, USA 
Approved with Reservations
VIEWS 16
Thank you for giving me the opportunity to review this article describing the Access and Affordability Initiative (AAI), a public-private partnership to improve affordability and availability of medicines for non-communicable diseases (NCD) in Ghana and the Philippines.

... Continue reading
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HOW TO CITE THIS REPORT
Ferrario A. Reviewer Report For: A novel initiative to improve access to medicines for control of non-communicable diseases in low-and middle- income countries [version 1; peer review: 2 approved with reservations]. Gates Open Res 2018, 2:12 (https://doi.org/10.21956/gatesopenres.13859.r26350)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 13 Mar 2018
David J. Heller, Arnhold Institute for Global Health, Department of Medicine/Health System Design & Global Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA 
Approved with Reservations
VIEWS 22
This article is a welcome addition to the under-studied field of non-communicable disease (NCD) policy. It both outlines several solutions to the problem of NCD medication access, and describes an example organization working in this domain. However, I feel the ... Continue reading
CITE
CITE
HOW TO CITE THIS REPORT
Heller DJ. Reviewer Report For: A novel initiative to improve access to medicines for control of non-communicable diseases in low-and middle- income countries [version 1; peer review: 2 approved with reservations]. Gates Open Res 2018, 2:12 (https://doi.org/10.21956/gatesopenres.13859.r26268)
NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article.

Comments on this article Comments (0)

Version 2
VERSION 2 PUBLISHED 23 Feb 2018
Comment
Alongside their report, reviewers assign a status to the article:
Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested
Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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