Globally, cardiovascular diseases (CVD) continue to be the leading cause of mortality, accounting for estimated 17.6 million deaths (i.e., 31% of all deaths) annually [1]. Low- and middle-income countries (LMICs) are most affected and account for over 80% of global CVD mortality [2]. This increasing disease risk is driven by rising levels of lifestyle-related risk factors and the inability of healthcare systems to provide adequate CVD risk prevention, early detection and treatment [2].

In 2012, the United Nations (UN) member states adopted a global commitment to reduce premature non-communicable diseases (NCDs) burden by a third by the year 2030 [3]. Subsequently, various international agencies have promulgated these goals in their agendas, including the World Health Organization (WHO)’s 2013–2020 Global Action Plan [4], World Heart Federation (WHF)’s 25 × 25 vision [5], and UN 2030 Sustainable Development Goals [3]. However, to achieve these goals, equitable and affordable access to essential medicines (EMs) and technologies for managing CVD is critical. A 2001 resolution (WHA 54.11) by the member states of the WHO called for a methodology to monitor medicine prices to improve access. In response, the WHO/Health Action International (WHO/HAI) methodology was developed in 2003 to monitor medicine availability, consumer prices and affordability in a reproducible way, allowing international comparisons over time [6]. Realizing that medicine availability and affordability are key components of patient access, the WHO medium term strategic plan 2008–2013 defines a) global and national targets of 80% for availability for EMs in health facilities in all sectors; and that b) no patient should pay more than four times the international reference price (IRP) for a given medicine [7]. While governments should be procuring medicines on the international market as close to IRPs, private-sector patient prices have to take into account additional costs (such as taxes, tariffs, margins) in the pharmaceutical supply chain [7].

Mozambique – a low-income, sub-Saharan African country – faces a high NCD burden that accounts for 28% deaths, of which 12% are due to CVDs [8]. Mozambique is one of the poorest countries worldwide [9], less urbanized than other countries in Southern Africa [10, 11, 12] and highly dependent on donor aid to implement its key health programs [13] and research. Patients predominantly seek subsidized healthcare in the public sector, wherein hospital pharmacies dispense medicines at a charge of 5MTs (0.08$) per prescription. However, these public-sector health facilities are over-burdened due to high caseload, limited resources and infrastructure, poor management, and inefficient medicine supply. This often forces patients, especially those in urban areas, to seek healthcare in the private sector through out-of-pocket (OPP) payments. Although NCDs are now included in several important government documents such as the Government Five Year Plan (2015–2019) and the Health Sector Strategic Plan (PESS 2014–2019), and, a Policy framework for inter-sectorial prevention and control of NCDs was included in the Government of Mozambique 2017–2020 United Nation Development Assistance Framework (UNDAF), very little survey data exists to provide a baseline measure of access to essential CVD medicines and diagnostics in Mozambique.

Multiple surveys have highlighted variations in medicine availability and prices across regions, therapeutic categories, and health sectors. An analysis of surveys conducted during 2008–2015 found that very few medicines met WHO’s 80% availability target in LMICs [14]. However, such available data from over 100 other surveys provide a limited perspective in terms of CVD medicines access. The most commonly surveyed medicine basket includes a limited number of essential CVD medicines and thus offers a limited perspective on access to CVD treatments. Furthermore, there is a lack of data on access to CV diagnostics in Mozambique. This information would be invaluable to guide decisions and policies aimed at addressing the unique CVD profile in LMICs, that is often linked to poverty and/or to uncontrolled endemic infections [8]. Therefore, we conducted a representative survey and evaluated access (i.e., availability, prices and affordability) to a comprehensive list of essential CV medicines and diagnostics needed to treat patients with CVD.

To our best knowledge, this is the first study to evaluate availability and affordability of both essential diagnostics and medicines needed to treat CVD in Mozambique. Overall, we found that availability of essential cardiovascular diagnostics and medicines in both the public and the private sector are low and do not meet WHO’s 80% availability target. While the availability of core EMs (medicines, identified by the WHO/HAI methodology, as indicators of medicine access situation) was just above 50% in both public and private sectors, the mean availability of CVD EMs was even lower, at <25%. The mean availability of CVD EMs was lower in the public hospitals compared to the private sector, thereby compromising the benefit of affordability offered by government subsidized healthcare. For medicines not available in the public sector, patients would have to spend between 3–100% of their monthly wage (approximately 1–30 work days) to purchase a month’s supply of a medicine. Risk monitoring (including lipid profile, fasting blood sugar, and proteinuria) for individuals with low CVD risk would cost USD 4.44, that is, equivalent 2 days’ wages.

These results reveal lower availability of medicines compared to that reported from urban areas in Cameroon (36.4 to 59.1%) [23] and from Nepal (around 50%) [19]. Regarding affordability, the cost of managing individuals with high cardiovascular risk was comparable to that found in Cameroon (USD 28.8 to 34.2 in Mozambique versus 30.7 in Cameroon); however, medicines were less affordable in Mozambique compared to Nepal where on average, the lowest-paid worker would spend 1.03 (public-sector) and 1.26 (private-sector) days’ wages to purchase a monthly supply [19].

Our comprehensive list of survey medicines and diagnostics has the potential to be upscaled, with adaptation as per a given country’s CVD profile, and to inform decision making for improving access to CVD care. This modified list of survey medicine addresses the needs for endemic CVD related to poverty affecting predominantly children and young adults (such as uncorrected congenital heart diseases, rheumatic heart disease, neglected cardiomyopathies, nutritional and infectious diseases), and women of reproductive age [8, 20, 21]. Its use shows low availability of paediatric formulations and safe drugs for peripartum period and reveals how unaffordable the CVD management is in this resource poor setting.

The present study was performed in Maputo City, the economic center of Mozambique, where referral hospitals with the highest concentration of specialized health services countrywide (including cardiac catheterization and open heart surgery at Hospital Central de Maputo) and the highest availability of drugs are found [22]. As such, we believe that our results represent the best case scenario, and CV medicines and diagnostics are less available and affordable in the rest the country [23].

Medicine availability was higher in the private retail pharmacies when compared to public facilities, and originator brands were only found in the private sector, where patients would need to pay out-of-pocket (OOP) more than four times the maximum acceptable IRP according to the WHO [7]. This represents a high burden of health expenditure in the household’s budget, as previously reported in a national census [24]. Interestingly, among essential CVD medicines, the MPR for the MSG was even higher than that for LPG, suggesting that costlier brands of generic medicines are probably more prescribed and/or dispensed than available cheaper generics, potentially resulting in speculation by retailers based on demand. The limited availability of EMs in the public-sector hospitals in LMICs is usually caused by deficiencies of the supply chain, suboptimal coordination in the distribution chain and inadequate funding; however, it may also be driven by the belief that cheaper means lower quality, leading to consumer’s preference for higher priced medicines [25]. Indeed, a high proportion of lay people, doctors and pharmacists have negative perceptions regarding the quality, efficacy and safety of generic medicines, which are deemed as of inferior quality than branded medicines [26].

While understanding that private-sector prices have to take into account additional costs (such as taxes, tariffs, margins) in the pharmaceutical supply chain [7] compared to prices in the public sector, the differences we found represent an uneven application of statutory profit and cost ceilings (against the local law that stablishes profit mark-ups) and suggests poor local market control by the regulatory bodies. An earlier economic evaluation of medicines price in urban Mozambique comparing the lowest priced version of drugs in both sectors had concluded that local mark-ups determine a large proportion of the final price of medicines sold and showed a clear segmentation of the market [22]; in Maputo low-cost retailers acted in peripheral neighborhoods while in central Maputo pharmacies prices are higher, with price discrimination depending on the aspect and location of the pharmacy, as well as the social class and purchase capacity of customers [22].

The present study also found that the mean availability of diagnostic tests and devices in the day of survey was much higher in private (89.5% and 91.7%) than public hospitals (55.6% and 58.3%), respectively. Among public hospitals, where patients do not pay for diagnostics, we have found that less than 35% had some essential tests such as troponin, natremia, kalemia, ECG and echocardiogram available at the time of visit and none had LDL-Cholesterol and HbgA1C tests available. In private sector, where the availability was high (above 90% for both tests and devices), high prices were charged.

To purchase a monthly supply of most CVD EMs or to perform an annual risk monitoring without purchasing any medicine, a lowest paid unskilled worker would have to spend more than one day’s wage per month. The expenditure would increase substantially with increased complexity of evaluations and treatments, reaching more than 15 days’ wage per month if secondary prevention was needed, much higher than what is reported elsewhere [27].

Low availability, high prices and poor affordability represent major barriers to access to medicines [28, 29, 30, 31], a major component of access to health care. Surveys deployed worldwide have highlighted disparities in drug availability and prices by region, therapeutic category and sector [30, 32]. By including a comprehensive range of evidence-based CVD medicines (including paediatric formulations) the present study brings a more complete evaluation of access to essential CVD medicines in the targeted setting. The addition of basic diagnostic tests and devices, constitutes a scaling up of this standard methodology that can be used for comparisons between regions and countries, and will hopefully promote equitable CVD care. Even so, some limitations of our study should be acknowledged. Firstly, availability and prices were evaluated for the tailored list of medicines that was generated for this study, and comparisons with previous studies should take this into account. Secondly, the variations of availability that occur over time are not captured with this methodology, which used data referring to the day of survey. Finally, for the affordability analysis, one should consider that the lowest paid government worker earns more than the minimum wage in the general population, and thus our results may in fact be a conservative measure of affordability. Nevertheless, we purposefully used this standardized WHO/HAI methodology to allow for future comparisons within the same country, as well as with other countries.