Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data

doi:10.1016/S0140-6736(15)00469-9

The Lancet

Volume 387, Issue 10013, 2–8 January 2016, Pages 61-69

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https://doi.org/10.1016/S0140-6736(15)00469-9 Get rights and content

Summary

Background

WHO has targeted that medicines to prevent recurrent cardiovascular disease be available in 80% of communities and used by 50% of eligible individuals by 2025. We have previously reported that use of these medicines is very low, but now aim to assess how such low use relates to their lack of availability or poor affordability.

Methods

We analysed information about availability and costs of cardiovascular disease medicines (aspirin, β blockers, angiotensin-converting enzyme inhibitors, and statins) in pharmacies gathered from 596 communities in 18 countries participating in the Prospective Urban Rural Epidemiology (PURE) study. Medicines were considered available if present at the pharmacy when surveyed, and affordable if their combined cost was less than 20% of household capacity-to-pay. We compared results from high-income, upper middle-income, lower middle-income, and low-income countries. Data from India were presented separately given its large, generic pharmaceutical industry.

Findings

Communities were recruited between Jan 1, 2003, and Dec 31, 2013. All four cardiovascular disease medicines were available in 61 (95%) of 64 urban and 27 (90%) of 30 rural communities in high-income countries, 53 (80%) of 66 urban and 43 (73%) of 59 rural communities in upper middle-income countries, 69 (62%) of 111 urban and 42 (37%) of 114 rural communities in lower middle-income countries, eight (25%) of 32 urban and one (3%) of 30 rural communities in low-income countries (excluding India), and 34 (89%) of 38 urban and 42 (81%) of 52 rural communities in India. The four cardiovascular disease medicines were potentially unaffordable for 0·14% of households in high-income countries (14 of 9934 households), 25% of upper middle-income countries (6299 of 24 776), 33% of lower middle-income countries (13 253 of 40 023), 60% of low-income countries (excluding India; 1976 of 3312), and 59% households in India (9939 of 16 874). In low-income and middle-income countries, patients with previous cardiovascular disease were less likely to use all four medicines if fewer than four were available (odds ratio [OR] 0·16, 95% CI 0·04–0·57). In communities in which all four medicines were available, patients were less likely to use medicines if the household potentially could not afford them (0·16, 0·04–0·55).

Interpretation

Secondary prevention medicines are unavailable and unaffordable for a large proportion of communities and households in upper middle-income, lower middle-income, and low-income countries, which have very low use of these medicines. Improvements to the availability and affordability of key medicines is likely to enhance their use and help towards achieving WHO's targets of 50% use of key medicines by 2025.

Funding

Population Health Research Institute, the Canadian Institutes of Health Research, Heart and Stroke Foundation of Ontario, AstraZeneca (Canada), Sanofi-Aventis (France and Canada), Boehringer Ingelheim (Germany and Canada), Servier, GlaxoSmithKline, Novartis, King Pharma, and national or local organisations in participating countries.

Introduction

17 million people are estimated to die of cardiovascular diseases worldwide every year.¹ About 20% occur in those with known vascular disease.² Many of these deaths could be avoided if the use³ of proven medicines among patients with vascular disease (secondary prevention) were increased. Clinical guidelines recommend the use of four medicines for the secondary prevention of cardiovascular disease: aspirin, β blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin-II receptor blockers (ARBs), and statins.⁴ However, in a previous report from the Prospective Urban Rural Epidemiology (PURE) study, only 25% of patients with established cardiovascular disease were taking aspirin, 17% β blockers, 20% ACE inhibitors or ARBs, and 15% statins. In high-income countries, 11% of eligible patients were not taking any of these medicines, compared with 80% in low-income countries.³

Research in context

Evidence before this study

We searched the PubMed database for articles about the availability and affordability of medicines for the secondary prevention of cardiovascular disease in countries at various stages of economic development published before May 1, 2014, without language restrictions. Our search terms included “availability”, “affordability”, “secondary prevention”, “CVD medicines or drugs”, “low-income countries”, and “middle-income countries”. We excluded studies that did not provide data for at least one of the four medicines recommended for the secondary prevention of cardiovascular disease (aspirin, β blockers, angiotensin-converting enzyme inhibitors or angiotensin-II receptor blockers, or statins), or a measure of affordability for the medicines.

We identified five reports that used different methods to measure the availability and affordability of different medicines for cardiovascular disease. Only one report considered the availability and affordability of the four medicines recommended by clinical guidelines. That report included data from five low-income and middle-income countries, and as a measure for affordability used the number of days wages it would cost the lowest paid government worker to purchase 1 month of treatment. Affordability varied by country; however, in view of the method used, the number of days wages that made treatment unaffordable (ie, a cutoff point to determine affordability) could not be determined. Additionally, information about the use of these medicines in the communities described was not collected and therefore the effects of little availability and affordability on use could not be deduced.

Added value of this study

To our knowledge, our study is the first to describe the availability and affordability of the four medicines recommended for the secondary prevention of cardiovascular disease in high-income, upper middle-income, lower middle-income, and low-income countries. It is also the first to relate these factors to medicine use. Our results suggest that the availability and affordability of these medicines is low in low-income and middle-income countries, which correlates with low rates of use. In India, these medicines are available in most communities given the large production of generic-brand medicines in the country. However, they remain unaffordable for large proportions of the community.

Implications of all the available evidence

Clinical guidelines recommend the use of four medicines for the secondary prevention of cardiovascular disease. However, the medicines remain unavailable and unaffordable for large proportions of communities in low-income and middle-income countries. Although our results show substantially lower use of key medicines when they are not available or unaffordable, it does not automatically mean that improving availability or affordability by themselves will increase their use. Additional research on how additional factors might further affect use of these medicines is needed (eg, access to health-care providers and attitudes to prevention on the part of both physicians and patients). Research on this topic is especially scarce in low-income and middle-income countries. Strategies to make proven medicines more available and affordable are crucially needed to increase their use in low-income and middle-income countries where the burden of cardiovascular disease is growing.

WHO's Global Action Plan has set a goal to achieve 50% use of medicines recommended for the prevention of cardiovascular disease worldwide by 2025.⁵ To reach this goal, these medicines need to be made widely available and affordable.

In this Article, we aim to document the availability of aspirin, β blockers, ACE inhibitors, and statins in community pharmacies and assess their affordability at different country incomes. We then relate availability and affordability of medicines to their use in patients with cardiovascular disease from 18 countries.

Section snippets

Study design and participants

We did a post-hoc analysis of the PURE study, using data from 94 919 households with reported household incomes from 596 communities in 18 countries and 7013 people with cardiovascular disease. Individuals in households that reported or did not report income were generally similar (appendix).

Countries were selected to ensure a range of economic development, and the feasibility to collect high-quality data and complete long-term follow-up.⁶ In every country chosen, communities were selected from

Results

Recruitment of participants began in January, 2003, with most recruitment completed between 2005 and 2009.⁹ Data for 94 919 eligible households' incomes were collected between Jan 1, 2003, and Dec 31, 2013, and for medicine costs were collected between Jan 1, 2009, and Dec 31, 2013. The analyses include three high-income countries (Sweden, United Arab Emirates, and Canada; 94 communities, 9934 households), seven upper middle-income countries (Poland, Turkey, Chile, Malaysia, South Africa,

Discussion

The availability and affordability of the four medicines recommended for the secondary prevention of cardiovascular disease greatly varies across the different country income groups. These medicines were more commonly available and affordable in high-income countries, less so in upper middle-income countries and lower middle-income countries, and least available and affordable in low-income countries (excluding India). Medicines were widely available in India, however, they were not affordable,

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For this analysis, we used data from the Prospective Urban Rural Epidemiology (PURE)-China cohort study, which enrolled adults aged 35–70 years from 115 urban and rural areas in 12 provinces in China between Jan 1, 2005, and Dec 31, 2009. Final follow-up was on Aug 30, 2021. Indicators of socioeconomic status were education, occupation, and household wealth; these individual indicators were also used to create an integrated socioeconomic-status index via latent class analysis. Standard questionnaires administered by trained researchers were used to obtain baseline data and were supplemeted by physical measurements. The primary outcomes were all-cause mortality, cardiovascular-disease mortality, non-cardiovascular-disease mortality, major cardiovascular disease, and cardiovascular-disease admission to hospital. Hazard ratios (HRs) and average marginal effects were used to assess the association between the primary outcomes and socioeconomic status.
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^†: See appendix for the full list of study investigators

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ArticlesAvailability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data

Summary

Background

Methods

Findings

Interpretation

Funding

Introduction

Section snippets

Study design and participants

Results

Discussion

Lancet

Lancet

Health Policy

Lancet

Global atlas on cardiovascular disease prevention and control

Incidence and 30-day case fatality for acute myocardial infarction in england in 2010: national-linked database study

Eur J Public Health

AHA/ACCF secondary prevention and risk reduction therapy for patients with coronary and other atherosclerotic vascular disease: 2011 update: a guideline from the American Heart Association and American College of Cardiology Foundation

Circulation

Global action plan for the prevention and control of noncommunicable diseases 2013–2020

The prospective urban rural epidemiology (PURE) study: examining the impact of societal influences on chronic noncommunicable diseases in low-, middle-, and high-income countries

Am Heart J

Prospective urban rural epidemiology (PURE) study: baseline characteristics of the household sample and comparative analyses with national data in 17 countries

Am Heart J

Association of urinary sodium and potassium excretion with blood pressure

N Engl J Med

Articles
Availability and affordability of cardiovascular disease medicines and their effect on use in high-income, middle-income, and low-income countries: an analysis of the PURE study data