Indicator 3.b.3 Proportion of health facilities that have a core set of relevant essential medicines available and affordable on a sustainable basis

Indicator 3.b.3: Proportion of health facilities that have a core set of relevant essential medicines available and affordable on a sustainable basis

Target 3.b: Support the research and development of vaccines and medicines for the communicable and non‑communicable diseases that primarily affect developing countries, provide access to affordable essential medicines and vaccines, in accordance with the Doha Declaration on the TRIPS Agreement and Public Health, which affirms the right of developing countries to use to the full the provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights regarding flexibilities to protect public health, and, in particular, provide access to medicines for all

World Health Organization (WHO)

Definition:

Proportion of health facilities that have a core set of relevant essential medicines available and affordable on a sustainable basis.

The indicator is a multidimensional index reported as a proportion (%) of health facilities that have a defined core set of quality-assured medicines that are available and affordable relative to the total number of surveyed health facilities at national level.

Concepts:

Indicator 3.b.3 is defined as the “Proportion of health facilities that have a core set of relevant essential medicines available and affordable on a sustainable basis”.This indicator is based on the proportion of facilities (pharmacies, hospitals, clinics,primary care centers, public/private, etc.) where core essential medicines from the identified set are available for purchase and their prices are affordable, compared to the total number of facilities surveyed.

There are several core concepts that are used for measuring indicator 3.b.3:

1. Availability of medicine
2. Affordability of medicine

→to define affordability, additional concepts are used:

• Daily dose treatment of the medicine
• National poverty line
• Wage of the lowest paid unskilled government worker

1. Core set of relevant essential medicines (defined on a global level)

→to apply a core set of relevant essential medicines defined on a global level to all countries, an additional concept is used:

• global burden of disease

1)A medicine is available in a facility when it is found in this facility by the interviewer on the day of data collection. Availability is measured as a binary variable with 1=medicine is available and 0=otherwise.

2) A medicine is affordable when no extra daily wages (EDW) are needed for the lowest paid unskilled government sector worker (LPGW wage) to purchase a monthly dose treatment of this medicine after fulfilling basic needs represented by the national poverty line (NPL). Affordability is measured as a ratio of 1) the sum of the NPL and the price per daily dose of treatment of the medicine (DDD), over 2) the LPGW salary. This measures the number of extra daily wages needed to cover the cost of the medicines in the core set and that can vary between 0 and infinity.

2.a) Daily dose of treatment (DDD) is an average maintenance dose per day for a medicine used for its main indication in adults.² DDDs allow comparisons of medicine use despite differences in strength, quantity or pack size.

2.b) National poverty line (NLP) is the benchmark for estimating poverty indicators that are consistent with the country's specific economic and social circumstances. NPLs reflect local perceptions of the level and composition of consumption or income needed to be non-poor.

2.c) Wage of the lowest paid unskilled government worker (LPGW is a minimum living wage that employees are entitled to receive to ensure overcome of poverty and reduction of inequalities.

In other words, affordability of a medicine identifies how many (if any) extra daily wages are needed for an individual who earns the LPGW wage to be able to purchase a medicine. The computed EDW ratio aims to indicate whether the LPGW wage is enough for the individual who earns the lowest possible income to cover 1) the daily expenditures for food and non-food items used to define (relative or absolute) poverty using national standards (NPL) and 2) the daily needs for a medicine (DDD). This ratio then requires transformation into a binary variable where medicine is affordable when zero extra daily wages are required to purchase it and not affordable otherwise.

3)The core set of relevant essential medicines is a list of 32 tracer essential medicines for acute and chronic, communicable and non-communicable diseases in the primary health care setting.

This basket of medicines has been selected from the 2017 WHO Model List of Essential Medicines and used in primary health care. By definition, essential medicines are those that satisfy the priority health care needs of the population and are selected for inclusion on the Model List based on due consideration of disease prevalence, evidence of efficacy and safety, and consideration of cost and cost-effectiveness.

These medicines are listed in table 1 of Annex 1, where a detailed justification for including each medicine is also provided, as well as online references for the relevant treatment guidelines and sections in the WHO List of Essential Medicines.

This list of medicines is intended as a global reference. However, to address regional and country specificities in terms of medicine needs, the medicines in this basket are weighted according to the regional burden of disease.

3.a) The global burden of disease is an assessment of the health of the world's population. More specifically, disease burden provides information on the global and regional estimates of premature mortality, disability and loss of health for causes. The summary measure used to give an indication of the burden of disease is the disability adjusted life years (DALYs), which represent a person’s loss of the equivalent of one year of full health. This metric incorporates years of life lost due to death and years of life lost through living in states of less than full health (or disability).

The indicator relies on three data sources that have been used by countries to collect information on medicine prices and availability:

1. Health Action International Project supported by the WHO [HAI/WHO]
2. The Service Availability and Readiness Assessment survey [SARA]
3. The WHO Medicines Price and Availability Monitoring mobile application [EMP MedMon]

Health Action International Project supported by WHO [HAI/WHO] provides data from national and sub-national surveys that have used the WHO/HAI methodology, Measuring Medicine Prices, Availability and Affordability and Price Components. The database is available at the following link: http://haiweb.org/what-we-do/price-availability-affordability/price-availability-data/

The Service Availability and Readiness Assessment [SARA] is a health facility assessment tool designed to assess and monitor availability and readiness of the services provided in the health sector and to generate evidence to support the planning and managing of a health system.

The WHO Medicines Price and Availability Monitoring mobile application [EMP MedMon] can be considered as an updated version of the HAI/WHO tool for collecting data on medicine prices and availability. This data collection tool was created based on the two previously mentioned existing and well-established methodologies. This application is used at facility level to collect information on availability and price of the agreed-upon core basket of medicines.

The EMP MedMon is easier to use, faster to conduct and consumes much fewer resources for collecting data. It also allows for a modular approach to defining the basket, which is highly useful and convenient for the purposes of this indicator.

In order to compute historical data points prior to 2018, data from HAI/WHO is used. To compute current and future data points, SARA and EMP MedMon are recommended

SARA, HAI/WHO, EMP MedMon: Data is collected by the countries’ Ministries of Health (MOH), often with the support of the WHO country office. Data is then validated by MoH-based statisticians and shared with WHO by request.

1. On basket of tracer essential medicines:
   1. Although it is possible to regularly monitor all 400+ medicines on the current WHO Model List of Essential Medicines, indicator 3.b.3 requires a specific subset of this list. Over the years, several baskets of medicines have been defined for different purposes and used to conduct data collection and monitor price and availability. This core set of medicines does not replace the other existing baskets, and WHO teams and partners are encouraged and committed to continue ad hoc monitoring through other existing channels. Throughout the process of identifying the core set of medicines, one area of focus has been to balance the selection of the tracer medicines for primary health care with the size of the basket itself. The proposed basket represents a balanced approach to allow that relevant tracer medicines for primary health care are monitored yet ensuring a practical and feasible data collection and analysis. The 32 medicines listed in the basket are meant to be indicative of the access to medicines for primary health care but do not serve as a complete or exhaustive list.
   2. As mentioned above, each medicine in the basket is weighted according to the regional Disability Adjusted Life Years (DALYs) for relevant disease from the WHO Global health estimates. Regional estimates are less sensitive to country-by-country variability of data quality, they sufficiently illustrate the disease distribution across countries in the region and work well due simplicity and comparability. Hence, regional weights for medicines are used to establish the associated country weights. However, this diminishes the specificity of the basket to the national context.
2. On the measurement of medicines’ availability:
   1. The proposed approach for measuring the availability of medicines is based on the presence of the medicine on the day that the interviewer visits the facility and does not account for temporary and/or planned stock outs. The 32 medicines identified for the analysis should always be available in the facilities considering that in some (mainly rural) areas, the facility may be very difficult to reach and individuals may not have resources to travel on a daily basis. Moreover, in this proposed methodology the price of the medicine does not take into consideration the so-called indirect costs, which normally include transportation and other costs to reach the facility. Thus, the proposed measure for availability presents some limitations.

Furthermore, given the data collection occurs at the facility level and does not monitor quantities of any given medicine, an overall analysis of the available medicines compared to the national needs is not possible.

1. On the measurement of medicines’ affordability:
   1. Affordability of a medicine is often measured as the capacity of the population of a given country to pay for this medicine either ex-ante (usually based on income) or ex-post (usually based on reported expenditures). The latter would mainly require data collected at the individual level and from household surveys. However, information on medicine expenditures in these surveys is not always collected and when collected, is not done so consistently and regularly across the countries. In addition, there is usually a large amount of missing data.

The ex-ante approach is suggested for the purposes of this indicator as it is measured at the facility level. Ex-ante analysis requires identifying a reference person or group of people for the measurement. The lowest paid unskilled government worker is suggested to serve as the reference for this indicator. In other words, if a medicine is identified as being affordable for the individual who receives the LPGW wage, it will most likely be affordable for all other individuals affiliated with that economic group and higher. This obviously does not account for people employed in the unofficial labour market.

The proposed methodology is an adjusted HAI/WHO methodology. The HAI/WHO approach suggests computing the affordability of medicine prices as the number of daily wages that are required for the lowest paid unskilled government worker (LPGW) to purchase a daily dose of a medicine (DDD). This approach is straightforward and also refers to the capacity of the reference individual to pay for the medicines. However, no threshold was identified to distinguish the maximum number of daily wages that an individual must spend on a medicine in order to still be able to afford it.

• 1. Information on minimum LPGW wage is available by the International Labour Organization (ILO) for 155 countries. When information is missing or when information has not been updated recently, the alternative measure suggested is to be taken from the World Development Indicators data on “minimum wage for a 19-year old worker or an apprentice”, which is often used as an alternative in ILO reports.
  2. The proposed indicator, being measured at the facility level, does not account for potential reimbursement schemes/insurance coverage present at the national level. Information about insurance or other forms of cost-coverage schemes at the national level is not readily available and would require standardization to allow for comparison across countries and income levels of the population. However, as demonstrated by the OECD in its Health at a Glance report in 2015, in 31 high- and middle-income countries the out-of-pocket (OOP) expenditures on pharmaceuticals as a share of all OOP on health varies from 64 to 16%.

Moreover, there are other SDG indicators, such as 3.8.1 and 3.8.2 that capture coverage of essential health services as well as financial protection from health expenditures net of reimbursement, including expenditures for medicines.

1. Other dimensions on access to medicines (quality)
   1. The quality of the product is another equally important dimension of access to medicines. Currently, there is no systematic and publicly available data collection on quality of a single medicine or in a single country. WHO has, however, contributed to enhanced access to quality health products through different programmes such as regulatory systems strengthening and prequalification.

A national regulatory authority (NRA) plays a key role in assuring the quality, safety, and efficacy of medical products until they reach the patient/consumer, as well as ensuring the relevance and accuracy of product information. Hence, stable, well-functioning and integrated regulatory systems are an essential component of a health system and contribute to better public health outcomes. NRA maturity and WHO prequalification of medicines can be considered as a proxy for ensuring that medicines in a country are of assured quality. The NRA maturity level is assessed using the WHO National Regulatory Authority Global Benchmarking Tool (WHO NRA GBT). After the evaluations, countries are assigned one of five levels of maturity, with a score of maturity level three representing the minimum acceptable regulatory capacity and maturity level five representing the highest level of functioning.

The importance of transparency and the disclosure of the results of assessments amongst regulators (from ML 3 up) are taken into consideration. However, the information on country-specific NRA maturity level is not currently publicly available and WHO is working to address this limitation through recent discussions on WHO Listed Authorities (WLA).

1. Other comments:
   1. The “sustainability” dimension in this indicator can be measured only when more than one-time series of computations is available for a specific country so that a trend (tendency of a series of data points to move in a certain direction over time) can be identified.

The proposed methodology takes advantage of recognized standards and data collection methods, proposing a recombination of dimensions to allow measurement of affordability of a core set of relevant essential medicines for communicable and non-communicable diseases.

The index is computed as a ratio of the health facilities with available and affordable medicines for primary health care over the total number of the surveyed health facilities:

${SDG}_{3.b.3}=\frac{Facilities\mathrm{\ }with\mathrm{\ }available\mathrm{\ }and\mathrm{\ }affordable\mathrm{\ }basket\mathrm{\ }of\mathrm{\ }medicines\mathrm{\ }\left(n\right)}{Surveyed\mathrm{\ }Facilities\mathrm{\ }\left(n\right)}$

For this indicator, the following variables are considered for a multidimensional understanding of the components of access to medicines:

• A core set of relevant essential medicines for primary healthcare
• Regional burden of disease
• Availability of a medicine
• Price of a medicine
• Treatment courses for each medicine (number of units per treatment & duration of treatment)
• National poverty line and lowest-paid unskilled government worker (LPGW) wage
• Proxy for quality of the core set of relevant essential medicines.

The index is measured for each facility separately. Then a proportion of facilities that have accessible medicines is computed. The following steps must be taken to compute the index at the facility level:

1. Review and selection of the core basket of medicines for primary health care
2. Estimate weights for the defined medicines based on regional burden of disease
3. Measure the two dimensions of the access to medicine
   • • • 1. Availability
         2. Affordability
4. Combine the two dimensions on availability and affordability (access to medicines)
5. Apply weights to the medicine in the basket according to the regional prevalence of the diseases that are cured, treated, and controlled by these medicines
6. Identify whether a facility has a core set of relevant essential medicines available and affordable

The next two steps are calculated at the country level across all the surveyed facilities:

1. Calculate the indicator as the proportion of facilities with accessible medicines in the country
2. Consideration of the quality of the accessible medicines in the country using a proxy

Below is a more detailed procedure of the index computation.

Step 1: Review and selection of the core basket of medicines for primary health care

For some of the disease categories captured by the proposed basket of medicines, a therapeutic category of medicine has been specified (e.g. statins, beta blockers, corticosteroids, etc.) and a specific medicine must be identified for monitoring. For example, beclomethasone is used to treat non-communicable respiratory disease and if it is not supplied in a particular country for some policy or market reason, an alternative corticosteroid inhaler must be included in the analysis. In other cases, more than one medicine should be included in the basket per disease category. This will require a preliminary review of the basket before starting the data collection process.

Step 2: Estimate weights for the defined medicines based on regional burden of disease

The following points must be considered when computing medicines’ weights:

1. Equal weights are assigned to medicines that are used to treat, cure, and control the same disease(s) (e.g. gliclazide (or other sulfonylurea), metformin and insulin regular are assigned equal weights according to the diabetes disease burden).
2. For a medicine indicated for multiple diseases, DALYs values for each disease are summed.
3. For a medicine used for treating conditions for children (four medicines from the list) sum of DALYs is computed for males and females at the age between 0 and 14 years.
4. For some of the medicines which cannot be assigned to a specific disease (e.g. paracetamol) the weight is computed as $\frac{1}{T}$ (where T is a total number of medicines in the surveyed basket) assuming equal use of the medicine relative to other medicines in the core list.
5. For medicines not in the list but “suggested for monitoring” by the country, weight is computed as $0.5*\frac{1}{T}\mathrm{\ }$ assuming a minor relevance of these medicines for this indicator and to avoid major issues in inter-country comparison.

To estimate the weight for each medicine, the following steps have to be undertaken:

• 1. Assign each medicine in the basket to one or several disease(s) that are treated/cured/controlled by that medicine (Annex 1 table 2)
  2. Assign to each disease the corresponding DALYs^[1] (if several diseases are treated with the same medicine, compute sum of these DALYs accordingly) [${\mathrm{\ }DALYs}_{Mi}$ ]
  3. Compute total sum of the DALYs per medicine [ ${\sum _{i=1}^{32}DALYs}_{Mi}$ ]
  4. Compute weight of each medicine as a proportion of the medicine specific DALYs to the total sum of DALYs in the basket [$\mathrm{\ }{W}_{Mi}$ ]:

$W_{Mi}=\frac{{DALYs}_{Mi}}{{\sum _{i=1}^{32}DALYs}_{Mi}}$

As an example, the weights computed across regions for year 2015 are represented in Annex 2 table 2.1 and 2.2.

Step 3: Measure the two dimensions of access to medicine

Availability and affordability of medicines must be measured and transformed (when necessary) into the format of a binary variable.

1. Availability is measured as a binary variable coded as “1” when the medicine is in the facility on the day of the survey and coded as “0” otherwise. This approach is currently used in the HAI/WHO methodology.^[2]
2. Affordability is computed following these steps:

3.1 Compute daily price per dose of treatment for each medicine (price per DDD) in the selected basket of medicines

WHO treatment guidelines provide the needed information to compute DDD.

DDD of a medicine is defined using the following formula:

$price\mathrm{\ }per\mathrm{\ }DDD=\frac{Medicine\mathrm{\ }price\mathrm{\ }\left(month\right)*Units\mathrm{\ }per\mathrm{\ }treatment\left(month\right)}{365/12}$

where:

• Units per treatments are tablets/vials or other forms that are needed for an individual with the average severity of the disease per one course of treatment of a duration of one month (365 days per year / 12 months per year = 30.42 days given 30 or 31 day per month), and
• Medicine prices are calculated per unit (per tablet/vial/other form) requiring adjustments for gram or milligram according to the potency.

This ratio varies between “0” and infinity and is measured in local currency units per day [LCU/d].

Information on the number of units per treatment is specified in Annex 3. The price per DDD can be measured in per day or per month.

3.2 Define National poverty line (NPL) and minimum wage of the LPGW for the analysed country

National poverty line (NLP): countries periodically recalculate and update their poverty lines based on new survey data and publish this information in their national reports on poverty. To adjust the latest available NPLs to the relevant year of analysis (when needed) information on the Consumer Price Index (CPI) in the analysed country has to be used to account for deflation/inflation.

National poverty reports consistently provide information on the NPLs in local currency units but often refer to different recall periods from country to country (NPL can be measured per day, per month or per year). For consistency, NPL has to be adjusted to be measured per day [LCU/d].

The wage of the lowest paid unskilled government worker (LPGW): is estimated and published in the ILOSTAT database. For countries with the latest available data collected in a year different from the year of analysis, LPGW wage is actualised using the CPI conversion factor.

ILO provides information on the minimum LPGW wages in local currency units per month. LPGW wage has to be adjusted to be measured per day as well [LCU/d].

The NPL and LPGW wage can be measured in per day or per month.

3.3 Compute extra daily wages (EDW)

First, the LPGW wage is compared to the NPL and if it is lower, medicine is considered unaffordable. In this case, only medicines with a price equal to zero will be considered affordable.

Next, the affordability is measured via the number of extra daily wages (EDW) that are needed for the LPGW to pay for one-month course of treatment using the formula below. In particular, the number of extra daily wages can be computed using the following formula:

$Extra\mathrm{\ }daily\mathrm{\ }wages\mathrm{\ }\left(EDW\right)=\mathrm{\ }\frac{NPL+price\mathrm{\ }per\mathrm{\ }DDD}{daily\mathrm{\ }wage\mathrm{\ }of\mathrm{\ }LPGW}$

3.4 Transform EDW variable into a binary format

Following the definition, medicine is considered to be affordable when the sum of NPL and price of a daily dose of the treatment is equal to or less than the minimum daily wage of the LPGW:

$\left\{\mathrm{\ }\begin{array}{c}if\mathrm{\ }EDW\mathrm{\ }\le 1,\mathrm{\ }\mathrm{\ }affordability=1,\\ otherwise,\mathrm{\ }\mathrm{\ }affordability=0\end{array}\right)$

Hence, the affordability of medicines is also measured as a binary variable that is coded as “1” when the medicine is affordable and “0” otherwise.

When the price of the medicine is 0, there is no need for the above-mentioned computations and the medicine is considered affordable (i.e. “1”). If all medicines in the country are provided free of charge, all medicines are directly marked as affordable and further computation of the index depends on the availability of these medicines.

Step 4: Combine the two dimensions on availability and affordability (access to medicines)

In this step, the two dimensions of access to medicines (availability and affordability) are combined into a multidimensional index.

The construction of a multidimensional index is based on the union identification approach^[3] proposed by S. Alkire and G. Robles.

The combination of the dimensions of medicines can be built in matrix form:

$g_{ij}^o=\mathrm{\ }\left[\begin{array}{ccc}{x}_{11}& \dots & x_{1d}\\ \dots & \dots & \dots \\ x_{n1}& \dots & x_{nd}\end{array}\right]$

This matrix contains performance for n objects of analysis (specified in rows) in d dimensions (specified in columns). The performance of any object $\mathrm{i}$ in all $\mathrm{d}$ dimensions is represented by the d-dimensional vector ${\mathrm{x}}_{\mathrm{i}.}$ for all $\mathrm{i}=1,\dots ,\mathrm{\ }\mathrm{n}$. The performance in any dimension $\mathrm{j}$ for all $\mathrm{n}$ objects are represented by the n-dimensional vector ${\mathrm{x}}_{.\mathrm{j}}$ for all $\mathrm{j}=1,\dots ,\mathrm{d}$. Overall, an index should be computed via two main steps: identification and aggregation. An example of how to combine the 2 dimensions can be found in Annex 4.

Step 5: Apply weights to the medicine in the basket according to the regional prevalence of the diseases that are cured/treated/controlled by these medicines

After identifying the access variable, medicines in the basket have to be weighted according to the prevalence of the disease(s) that these medicines are used to cure/treat/control using the weights identified in step 2 and provided in Annex 2, tables 2.1 and 2.2. This is performed by multiplying the access variable with the medicine weights:

Figure 1. Achievement matrix of weighted access to medicine

Step 6: Identify whether a facility has a core set of relevant essential medicines available and affordable

The following computations must be undertaken in this step:

6.1 Calculate proportion of medicines that are accessible (both available and affordable) in each facility

Because medicines are weighted, the proportion is computed as a weighted sum of medicines that are both available and affordable (accessible) in each facility using the following formula:

$Access=\mathrm{\ }\sum _{i=1}^n{w}_{mi}$

This variable is then transformed into a percentage and varies from 0 to 100.

The computed number of accessible medicines accounts for the importance of the analysed medicines in the country. In particular, if a medicine with a higher weight (for example hypertension) is not accessible, the index will be sensitive to this and will demonstrate the lack of access. On the contrary, if a medicine has a low weight (i.e. approaching zero, such as antimalarial medication in a non-endemic country) and is not accessible, the index will not be affected.

6.2 Mark facilities that have 80% or more of available and affordable medicines

The computed variable “access” is then transformed into the binary format identifying facilities that have the core basket of essential medicines available and affordable versus facilities that do not. A threshold of 80% is applied in order to transform the “access” variable into a binary format. In particular, at least 80% of all the medicines surveyed in a facility have to be both available and affordable. The transformation is made using the following formula:

$\left\{\begin{array}{c}if\mathrm{\ }{Access}_{{facility}_i}\ge 80\%\mathrm{\ }Facility=1,\\ 0\\ otherwise,\mathrm{\ }Facility=0\end{array}\right)$

This threshold is agreed upon and adopted by the WHO Global Action Plan on Non-Communicable Diseases and used as a reference in this proposed methodology.

Step 7: Calculate the indicator as the proportion of facilities with accessible medicines in the country

The proportion of facilities that have reached the 80% threshold is calculated out of the total number of surveyed facilities in a selected country using the following formula:

${SDG}_{3.b.3}=\frac{Facilities\mathrm{\ }with\mathrm{\ }available\mathrm{\ }and\mathrm{\ }affordable\mathrm{\ }basket\mathrm{\ }of\mathrm{\ }medicines\mathrm{\ }\left(n\right)}{Surveyed\mathrm{\ }Facilities\mathrm{\ }\left(n\right)}$

The computed indicator is a proportion that will then be converted into a percentage between 0-100%.

Step 8: Consideration of quality of the accessible medicines in the country using a proxy

The country level of medicine regulatory capacity assessed using the WHO NRA GBT is used as a proxy of the quality of the accessible medicines. The countries with a WHO Listed Authority (WLA corresponding to maturity level 3 and above) will be flagged to indicate the assured quality component.

2019-01-01

World Health Organization (WHO)

3.b.1- Proportion of the target population covered by all vaccines included in their national programme

3.b.2- Total net official development assistance to medical research and basic health sectors

3.8.1-Coverage of essential health services (defined as the average coverage of essential services based on tracer interventions that include reproductive, maternal, new born and child health, infectious diseases, non-communicable diseases and service capacity and access, among the general and the most disadvantaged population)

3.8.2-Proportion of population with large household expenditures on health as a share of total household expenditure or income

3