The state of pharmacoeconomic evaluation studies in

Kenya and an analysis of their influence on medicine

selection and utilisation: A review

by

GAKUU Esbon Mwangi

Thesis submitted in partial fulfilment of the requirements for the degree of

Master of Science in Public Health

Health Systems & Disease Control

Antwerpen-Belgium, June 2020

Disclaimer: This dissertation was written as part of the Master of Science of Public Health's
curriculum at the Institute of Tropical Medicine (ITM). It has not been subjected to peer review. The
views expressed in this document are those of the author and do not necessarily reflect those of the
ITM or any other party. Possible inaccuracies, factual errors and acknowledgement of due credit to
the work of others, are the sole responsibility of the author.

ii
Acknowledgements
I would like to express my deepest gratitude and appreciation to the following;

To the Belgian Directorate-General for Development Co-operation (DGD) for the scholarship grant,

To the entire ITM establishment for a wonderful and intellectually enriching experience,

To my coach, Gareth White, for his invaluable guidance and contribution,

To my classmates, for their companionship and peer-learning, and

To my family, for their moral support.

I am forever grateful.

iii
Summary
Background: Pharmacoeconomics is the field of study that evaluates the behaviour or welfare of
individuals, firms, and markets relevant to the use of pharmaceutical products, services, and
programs. The use of reliable, timely pharmacoeconomic evaluation data assists policymakers in the
allocation of scarce healthcare resource and act as a guide to the health sector in implementing
effective measures towards a sustainable and highly efficient healthcare system. There is very little
information about the cost and cost-effectiveness of many health services and interventions in
Kenya, including pharmaceuticals. Besides, economic analysis input has been infrequently used for
resource allocation in national strategic planning and decision making. There is currently no study
that has attempted to systematically analyse the number and quality of pharmacoeconomic studies
conducted in Kenya.

Aim of the study: The study aimed at conducting a systematic review and evaluating the volume and
quality of published pharmacoeconomic studies articles undertaken in Kenya and their impact on
selection and rational use of medicines in the country.

Methods: We conducted a comprehensive literature search using PubMed, Google Scholar and
other sources to identify published pharmacoeconomic studies on Kenya. Articles were included if
they were conducted in Kenya, were original economic research articles and compared a
pharmaceutical intervention to another pharmaceutical intervention, treatment modality, or no
treatment as the control or comparator. Each article in the final sample was assessed using the 24-
item Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist.

Results: The study's final sample consisted of 15 pharmacoeconomic studies that satisfied the
eligibility criteria. The 15 articles were published in 13 different journals of which none were
published in Kenya. Thirteen (86.7%) of the selected articles stated economic evaluation as either
the main objective or one of the main objectives. Two studies' (13.3%) main objective was clinical
outcomes with economic outcomes stated as secondary or minor objectives. Ten (66.7%) of the
studies were full economic evaluations involving either cost-effectiveness, cost-benefit or cost-utility
analysis with five studies (33.3%) utilising a cost of illness approach. The CHEERS checklist scores
were used to determine and compare the quality of the economic evaluation studies. The mean
CHEERS quality scores (expressed as a percentage) of the 15 economic evaluation studies was
78.33% (SD 14.67) and ranged from a minimum of 45% to a maximum of 94%. The quality of articles
was significantly related (p < 0.05) to the geographic location covered in the study (multinational =
higher), type of data used in the analysis (secondary = higher), and method of economic analysis
(economic evaluations = higher). The quality of articles was not statistically related (p > 0.05) to the

iv
type of publication, country of residence of the lead author, or the primary objective of the
economic analysis. Apart from HIV/AIDS and immunisation of childhood illnesses, there was little
evidence of the impact of pharmacoeconomic evaluation studies to inform therapeutic decision
making and medicine selection in Kenya.

Conclusions: The state of Pharmacoeconomic analysis in Kenya is still in its infancy, and the number
of such studies is still scarce and limited. On average, the published articles assessed were of good
quality. Still, some studies were found to be of very inferior quality, signalling the need for more
capacity building on the conduct of such studies in Kenya. This study forms the basis for further
research using more rigorous and comprehensive systematic review to draw together, appraise and
evaluate all known pharmacoeconomic research conducted in Kenya. There is great potential for
growth and improvement of the role that pharmacoeconomic evaluation studies can play in shaping
medicine use policy decisions in Kenya.

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Table of Contents
ACKNOWLEDGEMENTS .......................................................................................................................................................... III

SUMMARY ............................................................................................................................................................................... IV

TABLE OF CONTEN TS ............................................................................................................................................................. VI

LIST OF TABL ES...................................................................................................................................................................... VIII

LIST OF FIGURES.................................................................................................................................................................... VIII

LIST OF ABBREVIATIONS ........................................................................................................................................................IX

1 INTRODUCTION ..............................................................................................................................................................1

1.1 BACKGROUND...........................................................................................................................................................1
1.2 ESSENTIAL MEDICINES CONCEPT.................................................................................................................................2
1.3 STUDY RATIONALE.....................................................................................................................................................3

2 AIM AN D OBJECTIVES ...................................................................................................................................................4

2.1 AIM OF S TUDY: .........................................................................................................................................................4

2.2 SPECIFIC O BJECTIVES:................................................................................................................................................4

3 METHODS ........................................................................................................................................................................5

3.1 STUDY SETTING .........................................................................................................................................................5

3.1.1 Access to medical products, vaccines, and technology ...........................................................................5
3.2 STUDY DESIGN...........................................................................................................................................................6
3.3 SEARCH STRATEGY ....................................................................................................................................................6
3.4 STUDY SELECTION AND ELIGIBILITY CRITERIA ...............................................................................................................7
3.4.1 Study Selection ................................................................................................................................................7
3.4.2 Inclusion Criteria .............................................................................................................................................8
3.4.3 Exclusion Criteria ............................................................................................................................................8
3.5 DATA EXTRACTION AND QUALITY ASSESSMENT ...........................................................................................................8
3.5.1 Characteristics of the selected econo mic evaluation studies .................................................................8
3.5.2 Quality assessment of the selected economic evaluation studies .........................................................8
3.5.3 Statistical Analyses.........................................................................................................................................9

4 FINDIN GS ...................................................................................................................................................................... 10

4.1 SEARCH RESULTS .................................................................................................................................................... 10

4.2 GENERAL CHARACTERISTICS OF THE SELECTED ECONOMIC EVALUATION STUDIES ........................................................ 11
4.2.1 Authors' and journals' characteristics ..................................................................................................... 14
4.2.2 Study methods and data characteristics ................................................................................................. 14
4.2.3 Disease characteristics ............................................................................................................................... 14

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 4.2.4 Geographical lo cation and coverage ....................................................................................................... 14
4.2.5 Sources of funding ....................................................................................................................................... 14
4.2.6 Other characteristics................................................................................................................................... 15
4.3 ECONOMIC CHARACTERISTICS OF THE SELECTED ECONOMIC EVALUATION STUDIES ..................................................... 15
4.3.1 Study perspective ........................................................................................................................................ 15
4.3.2 Methods of economic analyses ................................................................................................................. 15
4.4 QUALITY ASSESSMENT OF THE SELECTED ECONOMIC EVALUATION STUDIES ................................................................ 15

5 DISCUSSION ................................................................................................................................................................. 19

5.1 GENERAL CHARACTERISTICS OF THE SELECTED ECONOMIC EVALUATION STUDIES ........................................................ 19

5.2 QUALITY OF ECONOMIC EVALUATION ...................................................................................................................... 20
5.3 I MPACT OF COST-EFFECTIVENESS STUDIES ON MEDICINES SELECTION......................................................................... 20
5.4 STRENGTHS & LIMITATIONS .................................................................................................................................... 23

6 RECOMMENDATIONS ................................................................................................................................................ 24

7 BIBLIOGRAPHIC REFERENCES ................................................................................................................................... 25

8 ANNEXES....................................................................................................................................................................... 29

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List of Tables
TABLE 1-PUBMED SEARCH STRATEGY .............................................................................................................................................7
TABLE 2-STUDY RESULTS- KEY SUMMARY CHARACTERISTICS OF SELECTED ARTICLES ON PE IN KENYA INCLUDED IN THIS REVIEW
(N=15) ............................................................................................................................................................................ 11
TABLE 3-GENERAL I NFORMATION AND ECONOMIC DATA OF THE INCLUDED PAPERS REPRESENTED AS NUMBERS(PERCENTAGES) ...... 13
TABLE 4- SUMMARY STATISTICS OF CHEERS CHECKLIST SCORES ................................................................................................... 16

List of Figures
FIGURE 1. FLOWCHART OF ARTICLE SELECTION THROUGH THE DIFFERENT PHASES OF THE SYSTEMATIC REVIEW ................................ 10
FIGURE 2 - NUMBER OF PHARMACOECONOMIC ARTICLES PUBLISHED ON KENYA, 1988-2019 (N=15) .......................................... 15
FIGURE 3- QUALITY OF ARTICLES AS ASSESSED USING THE 24-ITEM CHEERS CHECKLIST................................................................. 17
FIGURE 4 - DISTRIBUTION OF STUDIES IN CHEERS QUALITY QUARTILES. ........................................................................................ 18

viii
List of abbreviations
AL Artemether Lumefantrine

ARV Antiretroviral Drugs

CBA Cost-Benefit Analysis

CEA Cost-Effectiveness Analysis

CHEERS Consolidated Health Economic Evaluation Reporting Standards

CUA Cost-Utility Analysis

DHA-PQP Dihydroartemesinin-Piperaquine

EML Essential Medicines List

GDP Gross Domestic Product

Hib Haemophilus Influenza type B

HPV Human Papilloma Virus

ICER Incremental Cost-Effectiveness Ratio

ISPOR International Society of Pharmacoeconomic and Outcome Research

IMCi Integrated Management of Childhood Illnesses

Kes Kenya Shillings

LPV/r Ritonavir boosted Lopinavir

MeSH Medical Subject Heading

PE Pharmacoeconomics

PRISMA Preferred Reporting Items of Systematic Reviews and Meta-Analyses

RCT Randomized Controlled Trial

USD United States Dollar

WHO World Health Organization

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1 Introduction
1.1 Background

Pharmaceuticals are a vital healthcare resource used to prevent, cure, and mitigate or alter the
course of a disease. Health systems in both developed and developing countries face a significant
challenge in increasing expenditure on medicines. Over time, economic evaluation of
pharmaceutical interventions has grown into a substantial body of work, and its contribution to
medical decision-making is increasingly being recognised [1].

Pharmacoeconomics(PE) is the field of study that evaluates the behaviour or welfare of individuals,
firms, and markets relevant to the use of pharmaceutical products, services, and programs [2]. PE
makes use of descriptive and analytic techniques that evaluate pharmaceutical interventions,
spanning from individual patients to the healthcare system as a whole . The use of reliable, timely
pharmacoeconomic evaluation data assists policymakers in the allocation of scarce healthcare
resource[3] and act as a guide to the health sector in implementing effective measures towards a
sustainable and highly efficient healthcare system[4]. They also ensure transparency in formulary
decision-making[5].

The concepts of PE were introduced in Western countries in the 1970s. Formal PE guidelines were
first established in Australia and Canada [6,7]. Currently, PE is a well-established field in high-income
countries and is utilised to make informed choices for pharmaceutical interventions. For example,
the United Kingdom's National Institute of Clinical Excellence (NICE) and the Canadian Agency for
Drugs and Technology in Health (CADTH) are examples of public institutions set up for
pharmacoeconomic evaluation of pharmaceutical interventions and technologies. In well-resourced
countries, the field of PE employs the use of several pharmaco-regulatory tools to regulate complex
pharmaceutical markets within the broader healthcare system. Some of these tools include a well-
established health technology assessment framework in which pharmacoeconomic activities are
nested, reference pricing for pharmaceuticals, treatment/therapeutic classes for medicines and
prescription audits[8].

In contrast, application of pharmacoeconomic evaluation studies in developing countries is minimal ,

and many such countries have yet to integrate PE within their healthcare decision-making structures
to understand and manage healthcare costs, access and quality. There is a raging debate on the role
of PE in medicine selection and prioritisation in most developing countries whose pharmaceutical
systems are less formalised with little capacity to assess costs and outcomes. Babar and Scahill[9]

1
have argued that the utility of PE for selection of pharmaceuticals for national essential medicines
lists depends on factors such as health system performance and design, the state of the
pharmaceutical industry in the country, and the country's total pharmaceutical expenditure. The
authors assert that it may not be necessary for low-income countries to utilise sophisticated cost-
effectiveness strategies for inclusion of medicines into the national essential medicine lists and a
medicine pricing policy and generic substitutions may suffice.

However, this stand on PE in developing countries has been refuted by several leading PE experts. In
their paper, "Pharmacoeconomics and developing nations(2012)" [10], L. Villa and G. Krepnek
disprove the idea that PE is a low utility, high-cost intervention for promoting better allocation of
resources and improved clinical decisions in the low-income countries. While they acknowledge
potential barriers to implementation of PE within these countries, the authors argue that PE
presents an important opportunity that can assist in the assessment of the consequences or
outcomes and costs of pharmacotherapies and pharmaceutical services even in low and middle-
income countries.

Within the African continent, several studies have evaluated the quality of pharmacoeconomic
studies in Egypt, Nigeria, South Africa, Tanzania and Zimbabwe[11–15]. These studies showed that
the quality of some pharmacoeconomic evaluation research studies was poor. However, little is
currently known about the extent and quality of economic studies carried out in Kenya. To enhance
the decision-making process in Kenya, high quality and well-designed pharmacoeconomic studies
are a necessity. A first step in improving study quality is to review and evaluate the current
published PE studies conducted in Kenya.

1.2 Essential medicines Concept

In developing countries, medicines may represent as much as 40% of the total health budget and still
leave swathes of the population without access to even the most basic essential medicines. In
addition, as much as 70% of the pharmaceuticals in the world are duplicative or non-essential,
offering minimal marginal advantage over other cheaper and readily available medicines[16]. In such
a context, it is extremely difficult for prescribers and health decision-makers to find all the relevant,
up-to-date information and use it to compare pharmaceutical alternatives and finally make a
rational choice. Hence the development of the essential medicines concept; the use of a limited
number of essential medicines in a defined geographical setting.

The essential medicines concept was developed by the World Health Organization (WHO) following
the 28th World Health Assembly. The WHO defined essential medicines as medicines that are
indispensable for primary healthcare and satisfy the priority health needs of the population[17]. The

2
first WHO model list of essential medicines was developed in 1977 and was intended to be a guide
for the development of country-specific and institutional essential medicines lists (EML). Ever since
the WHO model list has undergone revision every two years to keep it current. Many developing
nations adopted and customised the WHO model list to their particular needs. Countries were
encouraged to periodically update the essential medicines list to ensure they were relevant to the
prevalent health needs of the majority of the population and ensured equitable access to essential
medicines at a cost that the countries could sustainably afford. Ever since, the essential medicines
concept has been accepted worldwide and has proven to be one of the most cost-effective
strategies in healthcare. As of 2015, at least 156 countries(80% of UN member states) have adopted
national essential medicines list modelled on the WHO list[18].

1.3 Study Rationale

There is very little information about the cost and cost-effectiveness of many health services and
interventions in Kenya, including pharmaceuticals. Moreover, where it is available, economic
analysis input is infrequently used for resource allocation in national strategic planning and decision
making. If Kenya is to utilise PE data to supplement other pharmaceutical cost-containment
measures such as pricing decisions, a review of the published literature is paramount to provide the
available evidence to guide policymakers in making rational and evidence-based choices. After a
detailed search, no other systematic review of the literature on PE in Kenya was found at the time of
data collection and writing this thesis from February to May 2020. Consequently, this study aims to
describe the quantity and quality of PE studies on Kenya that have been published and their impact
on the selection of essential medicines.

3
2 Aim and Objectives
2.1 Aim of Study:

The aim of the study was to identify and describe the state of pharmacoeconomic research related
to Kenya and its contribution to setting of pharmaceutical policy. The present study aims at
conducting a systematic review and evaluating the volume and quality of published PE studies
articles undertaken in Kenya and their impact on selection and rational use of medicines in the
country.

2.2 Specific Objectives:

The specific objectives of the study were:

1. To describe the characteristics and quality of pharmacoeconomic evaluation studies related

to Kenya.

2. To assess the influence of the pharmacoeconomic evaluation studies conducted in Kenya on

the selection and utilisation of medicines.

4
3 Methods
3.1 Study Setting

Kenya is located in Eastern Africa and is bordered by Tanzania, Uganda, Ethiopia, South Sudan, and
Somalia. It is categorised as a lower-middle-income country with a total population of approximately
47.6 million (2019)[19], a GDP per capita of US$1710 (2018) and a per capita expenditure on health
of US$66 (2016)[20]. The total health expenditure (THE) in Kenya was USD 3.5 billion in 2015/16
financial year and accounted for 5.2% of the GDP. Out of pocket (OOP) expenses accounted for
26.1% of THE [21]. The healthcare system is dominated by a tax-funded public sector, a rapidly
growing private sector and a mushrooming unregulated informal health sector.

3.1.1 Access to medical products, vaccines, and technology

Access to health care in Kenya has been recognised as a fundamental human right in the country's
constitution[22]. Medicines form a critical component of the right to health.

Following the promulgation of the new constitution in 2010, the Ministry of Health developed the
Kenya National Pharmaceutical Policy whose main objective was to ensure "universal access to
quality essential medicines, essential health technologies and pharmaceutical services in Kenya"[23].

In 2016, total pharmaceutical expenditure accounted for 36.64% of the total health expenditure in
Kenya, resulting in per-capita pharmaceutical spending of US$ 9.9. Total Government expenditure
on pharmaceuticals represented 9.03 % of the total expenditure on pharmaceuticals with donations
accounting for 27.3% and private expenditure contributing 66.67% of the total pharmaceutical
spending[24].

Patients have access to medicines through community pharmacies and hospitals, either as inpatients
or outpatients. The medicines supply chain comprises of three principal participants: manufacturers
(originators and generics), wholesalers and dispensing pharmacies.

With regards to the pricing of pharmaceuticals in Kenya, there are currently no legal provisions on
the pricing of pharmaceuticals as price controls were abolished in 1994. The basic underlying
expectation was that this liberal pharmaceutical pricing regulation would encourage stiff completion
amongst suppliers resulting in highly competitive consumer prices. Besides, the government levied
no taxes on imported pharmaceutical ingredients, or on imported finished pharmaceutical products.
The effect of these policy changes was the lowering of entry barriers into pharmaceutical
distribution and retailing. However, studies done over the years have demonstrated high and

5
extremely variable prices of medicines in Kenya, which have had a significant impact on financial
access to equitable health care in Kenya.

Kenya was the first country to adopt the WHO EML developing its first essential medicines list in
1981. Ever since, five other revisions of the EML were conducted in 1993, 2003, 2010, 2016 and
2019[25]. The rationale for the inclusion of medicines in the list has primarily been based upon the
efficacy, safety, quality and the cost-effectiveness of the medicines.

3.2 Study design

This study employed a systematised review design. This type of study incorporates some elements of
a full-fledged systematic review but does not draw upon the full resources of a systematic review
such as having more than one reviewer and searching and cataloguing data from all known sources.
While the output of such a review process involves many elements of a systematic review, it does
not possess the comprehensiveness and robustness that characterises a systematic review. A
systematised review can then be used as a starting point in conducting a fully-funded systematic
review research project.

This study involved systematically searching for, and collecting all known and available PE studies
conducted in Kenya. The selected studies were then appraised in line with the consolidated health
economic evaluation reporting standards (CHEERS) guidelines for economic evaluations. This was
followed by a synthesis of the literature to describe the state of PE research in Kenya.

3.3 Search Strategy

A comprehensive literature search was conducted between February and May 2020 to identify
published pharmacoeconomic studies on Kenya in the following databases; PubMed, EMBASE,
ISPOR, Cochrane Library, Google Scholar, The International Network of Agencies for Health
Technology Assessment, African Journals Online (AJOL), African Index Medicus and the East African
Literature on Health Sciences Databases.

In PubMed, a string combining MeSH terms and free text with the Boolean operators "AND" and
"OR" was developed (see Table 1). The search engine strategy was adapted to carry out an optimal
literature search in other databases.

6
Table 1-PubMed Search strategy

No Search Query Results

1. economics/ or "costs and cost analysis"/ or "cost allocation"/ or cost- 978,457

benefit analysis/ or "cost control"/ or "cost of illness"/

2. Quality-adjusted-life-year* or Disability-adjusted-life-Year* 20,137

3. Cost* or economic* or pharmacoeconomic* 1,278,696

4. (QALY or ((cost* or economic*) AND (minimi* or utility* or evaluat* or 911,667

review* or outcome* or analys* or effect* or benefit)))

5. (DALY or ((cost* or economic*) AND (minimi* or utility* or evaluat* or 920,987

review* or outcome* or analys* or effect* or benefit)))

6. “Medicine*”/ or “pharmaceutical*”/ 5,749,328

7. 1 or 2 or 3 or 4 or 5 AND 6 323,917

8. Kenya 29,843

9. 7 AND 8 1,382

10. Limit 9 to the English Language 1,382

Key:
/= Indexing term
ti , a b  = terms in either ti tle or a bstract field

3.4 Study selection and Eligibility criteria

3.4.1 Study Selection

Screening all identified studies was done independently and at two different stages. First, titles and
abstracts of the articles were reviewed during the primary screening of the initial search results.
Duplicates were removed. The articles were then examined to determine which ones met the
inclusion and exclusion criteria. Second, all identified relevant articles obtained during the primary
screening were selected for further review of the content of the full text.

7
3.4.2 Inclusion Criteria

Studies were included in the review if;

 They were original economic research articles, addressing at least one or more health-
related problem.

 The intervention included comparing a pharmaceutical to another pharmaceutical,

treatment modality, or no treatment as the control or comparator.

 The studies included had a statement or word in the title, abstract or keywords that
indicated that an economic (including cost) analysis was conducted.

 They were conducted in Kenya or, if multiple countries were included, Kenya was one of the
countries in which the interventions were carried out.

3.4.3 Exclusion Criteria

Studies were excluded if;

 The costs and outcomes of the intervention were not considered and compared.

 The articles were treatment guidelines, expert opinions, narrative reviews, letters, editorials
and studies whose full texts could not be accessed.

3.5 Data extraction and Quality Assessment

3.5.1 Characteristics of the selected economic evaluation studies

Key characteristics of the selected pharmacoeconomic evaluations were identified and extracted
into a pre-designed data collection form (table 2 and 3). The data collection form included two
sections. First, the form collected general information such as the name of the lead author(s), year
of publication, population intervention, and comparator(s). Second, the form collected economic
analysis information which included study perspective, study design, time horizon, discount rate,
study model and primary outcomes and results of the study.

Descriptive statistics were calculated for these variables as outlined in section 3.5.3 below.

3.5.2 Quality assessment of the selected economic evaluation studies

Quality assessment of each of the identified articles was performed in line with the 24-item
Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist[26] (see annexe
1). The CHEERS checklist was developed for better reporting of economic evaluations and was used
to assess the level of completeness of the selected pharmacoeconomic studies.

8
Each criteria item was scored using three scoring points; articles fully meeting a criterion were
assigned one-point (1) for that criteria, partial points (0.5) were awarded if the study did not
completely fulfil the criteria, and no points (0) were awarded if the item was missing. The total
scores for each article were then summed out of 21 for study-based(n=6) and 24 (n=9) for model-
based studies. The scores were then converted to percentages for comparison.

Given the absence of a widely accepted method for quality appraisal of economic evaluations, set
categories were based on published literature.[27,28] Studies scoring 85% or higher were deemed to
be of "excellent" quality, studies scoring between 70-<85% of "very good" quality, studies scoring
55-<70% were rated to have "good" quality and studies scoring below 55% were classified as "poor"
quality.

3.5.3 Statistical Analyses

Descriptive statistics were calculated and reported for all variables. To determine if there were
significant differences in the mean quality of articles by various categorical groups, independent t-
tests and ANOVAs were used. Data analyses were conducted using the R package version 4.0.1. An
alpha level of 5% was used for statistical significance (p < 0.05).

9
4 Findings
4.1 Search results

PRISMA guidelines[29] were followed in the study selection process (Figure 1). Database searches
identified 1,382 studies after the initial screening process, and an additional 27 records were
identified through screening of references and grey literature. Following a preliminary review of the
titles and abstracts, 745 were excluded as they were not economic evaluations comparing
pharmaceutical interventions, 138 were duplicate articles, and 392 did not include Kenya in their
analysis. The next phase was to locate the full-text articles of the remaining 134 articles and assess
the articles to determine if they met the study criteria. After reviewing the full articles, 67 were
excluded as they did not include costs among the outcomes, 34 were not conducted in Kenya, 8
were narrative reviews, 3 were treatment and costing guidelines for pharmaceutical interventions ,
and 7 were communication articles from international non-governmental organisations and national
health bodies. The study's final sample consisted of 15 pharmacoeconomic studies that satisfied the
eligibility criteria. Eight of the studies were full economic evaluations whereas seven used a cost of
illness approach (figure 1).[30,31,40–44,32–39]

Articles identified through database searching

Identification

(1382)
Additional articles identified through other
PubMed (n= 1118) sources
Cochrane(n = 36)
(n=27)
ISPOR (n= 8)
Others (n=220)

Articles identified by database searches (n=1409)

Screening

Excluded after titles and abstracts review

(n=1275)
 Non-Pharmacoeconomic evaluation
(n=745)

Full-text articles assessed for  Duplicate articles (n=138)

Eligibility

eligibility (n=134)  Study did not include Kenya (n=392)

Excluded according to the inclusion

criteria after screening the entire article
(n=119)
 Cost not considered (n=67)
 Not conducted in Kenya (n=34)
Included

Studies included in final analysis (n=15)

 Economic Evaluations (n=8)  Reviews(n=8), guidelines(n=3),
communications(n=7)
 Cost Analyses (n= 7)

Figure 1. Flowchart of article selection through the different phases of the systematic review

10
4.2 General characteristics of the selected economic evaluation studies

Table 2-Study Results- Key summary characteristics of selected Articles on PE in Kenya included in this review (n=15)

First Author, Year Disease/Condition Study Study Outcome Intervention vs Comparator Main results/outcome CHEERS
Investigated Perspec Design, measures checklist
tive Model score (%);
Quality
rating
Mi chelle Atieno O. Cancer Pa ti ent Cos t of Cos ts Des criptive cross-sectional hospital s tudy Chemotherapy treatment alone cost an average of 64; Good
Il l ness (n=412) compa ring $1364.3 per pa tient; surgery cos ts a n a verage of
2016[39]
s urgery, chemotherapy a nd palliative ca re for $1265.6, ra di otherapy cost $1175.1. Combi nation
ca ncer. of a l l three cost on a verage $3291.8.
Boul anger VLL. Va ri ous Childhood Pa ti ent/ Cos t of Cos ts Compa red the cost of drugs prescribed vs the The a verage cost of drugs prescribed per child was 62; Good
i l lnesses Hos pital Il l ness cos t of medicines had the children been $0.44.
1999[41]
/cl i nic ma naged a ccording to IMCI guidelines
The cos t of drugs had the same children been
ma naged with the recommended IMCI guidelines
ra nged from $0.16-0.39 per child.
Pul l an RL. 2019.[36] Soi l-transmitted Pa yer RCT Cos ts Cl us ter RCT comparing a nnual vs biannual Community-wide treatment was more effective i n 86;
Hel minths in a l bendazole treatment of s chool-going children reduci ng hookworm prevalence and intensity tha n Excel l ent
chi l dren s chool-based treatment.

The economic cost of community-wide drug

a dministration ranged from $0.68-0.87 per
trea tment.
Ki t N Si mpson. HIV Soci etal CEA, QALY Es ti mate the ICER of switching to an LPV/r- LPV/r ICER for Kenya was $1483 per QALY 88;
2011[30] Ma rkov ba s ed regimen Vs remaining on a failed ARV compa red to $1673/QALY for Uganda. Excel l ent
Model regi men or discontinuing all ARV drugs.
Di s continuation of ARV reduces costs and benefits
proportionally.
Nya wa lo JO. Ti nea Ca pitis Pa yer Cos t of Cos ts s i ngle-dose vs intermittent Griseofulvin The i ntermittent regimens were found to be very 45; Poor
Il l ness trea tment regimens for ti nea i nfected children cos t-effective.
1988;[38]
(n=3788)
Akumu AO.2007 [43] Pneumonia and Soci etal CEA, DALY A model developed to follow the Kenyan 2004 The cos ts per discounted DALY US$ 38 (95%, CI: 90;
Meni ngitis i n Ma rkov bi rth cohort until death, wi th and without Hib 26–63) a nd per discounted death a verted were Excel l ent
Chi l dren Model va cci ne. US$ 1197 (95% CI: 814–2021)

11
Ki a tpongsan Huma n Soci etal CEA ICER A model developed to follow the course of At a wi llingness-to-pay threshold of three ti mes 88;
Pa pi llomavirus cervi ca l ca ncer with a nd without Human per-ca pita GDP, the thresholds of added costs Excel l ent
S.2014.[33]
Pa pi llomavirus (HPV) Vaccine. a s sociated with HPV va ccine were $23.4, $12.6 and
$38.4 per va cci nated girl for the base case, worst-
ca s e a nd best-case s cenarios, respectively.
Okel l LC.2014.[37] Ma l a ria Pa yer CEA, ICER Model -based CEA Comparing a rtemether- Loca l ly optimised treatment policy i s highly cost- 94;
Deci sion l umefantrine (AL) vs effective for reducing clinical malaria burden. Excel l ent
Model di hydroartemisinin-piperaquine (DHA–PQP) i n
4 Afri ca n countries, including Kenya.
Mercy G. Mugo. Contra ceptives Pa yer, CEA Cos ts , Da ta from a region in central Kenya utilised to Fa mily planning provision s ystems found in the 69; Good
2017.[34] Soci etal ICER conduct a cost-effectiveness analysis of family s tudy a rea a re cost-effective.
pl a nning s ervice provision alternatives.
Temperley M. Ma l a ria Pa yer, CEA Cos ts , CEA Compa red the costs of a dministration of IPT a dministered by teachers is a cost-effective 90;
2008[44] Soci etal a nti malarial drugs to school-going children by s chool-based malaria i ntervention. Excel l ent
tea chers vs health workers administration.
Va n Gorkom. Tuberculosis Pa ti ent, CEA Cos t, CEA To compa re the cost-effectiveness and total Enti re a bandonment of T i s the cheapest a t HIV 56; Good
1996[42] Pa yer cos t of three strategies i n which preva lence of over 65% a nd would cost a n extra
Thi a cetazone(T) is replaced with US$160 000 to TB progra mme per year.
etha mbutol (E).
Joha nnes Pfeil. Ma l a ria Hea lthc CEA DALY Ma rkov model comparing the economic va lue In l ow-to-moderate transmission s ettings, 1st Li ne 85; Very
2015[31] a re of pos ttreatment prophylaxis of DHA-PQP Vs trea tment with DHA-P was highly cost-effective Good
Sys tem AL i n pa ediatric malaria patients. wi th a n ICER of US$5 (95% CI = −76 to 196) per
DALY a verted.
In moderate-to-high tra nsmission settings, DHAP
trea tment led to cost s aving of US$1.09 (95% CI =
−0.88 to 3.85) a nd a verted
0.05 (95% CI = −0.08 to 0.22) DALYs per child per
yea r.
Ca rl a Guerri ero. Pos t-s urgical Pa yer CEA Cos t per A decision tree model evaluating the cost- The i ncremental cost per l ife s aved is $87 for 92;
2010[40] Bl eeding l i fe saved, effectiveness of provi ding Tranexamic Acid Kenya a nd $93 for Ta nzania. In Botswana a nd Excel l ent
ICER (TXA) Vs No TXA i n post-surgery bl eeding South Afri ca, TXA a dministration not life-saving but
i s highly cost-savi ng.
Sung Eun Choi. Ma l a ria Soci etal CEA DALY Model comparing four malaria In a ll simulated countries, cotrimoxazole (CTX) was 90;
2017[32] pha rmacological treatment strategies the preferred strategy, with ICER ra nging from Excel l ent
cos t-saving to $3.9 per DALY a verted.
Ja cqueline E. Ta te. Rota vi rus Soci etal CEA DALY Model comparing Routine Rotavirus Routi ne rotavirus vaccine would avert 2467 deaths 77; Very
2009[35] va cci nation vs no va ccination (55%), 5724 hos pitalisations (65%), and 852,589 Good
cl i nic visits (59%) and would save 58 DALY per 1000
chi l dren annually.

12
Table 3-General Information and Economic data of the included papers represented as numbers(Percentages)

Characteristic/Parameter N (%) CHEERS Average P-Value*

Score(%)
Country in which the journal is based
Kenya 0 (0) 0
Outside Kenya 15 (100) 78.3
Type of Publication
Medical 11 (73.3) 78.2 0.96
Non-Medical 4 (26.7) 78.6
Country of residence of the lead author
Kenya 6 (40) 74.6 0.49
Other 9 (60) 80.8
Geographic location covered in the study
Kenya 9(60) 71 0.008
Multinational 6 (40) 89.2
Primary source of funding
Private non-profit Organisation 9 (60) 78.2
Government 2 (13.3) 83.3 -
Pharmaceutical Industry 1 (6.7) 88
Not listed 3 (20) 72.3
Study Perspective
Government/Private 4 (26.7) 78.6
Patient 2 (13.3) 63.1 -
Societal 6 (40) 83.4
Health systems 3 (20) 78.1
Type of data used
Primary 7 (46.7) 80.4 0.015
Secondary 8 (53.3) 87.8
Method of economic evaluation
Cost analysis 5 (33.3) 62.7 0.020
Economic Evaluations(CEA and CBA) 10 (66.7) 86.2
Was economic analysis the primary objective?
Yes 13 (86.7) 81 0.42
No 2 (13.3) 61.2
Study Design
Experimental/Trial design 8 (53.3) 68.75 0.006
Modelling 7 (46.7) 89.3
*Independent Sample t-test, P-values <0.05 are statistically significant

13
4.2.1 Authors' and journals' characteristics

The 15 articles were published in 13 different journals of which none were published in Kenya.
Eleven articles (73.3%) were published in medical journals with and 4 (26.7%) published in non-
medical journals. The journals with the most publications were The Bulletin of The World Health
Organization (n=2)[41,43] and Malaria Journal (n=2)[32,44]. At the time the studies were published,
6 of the lead authors (40%) were Kenyans and affiliated with institutions in Kenya, and the other 9 of
the articles (60%) were non-Kenyan residents and affiliated with institutions outside of Kenya.

4.2.2 Study methods and data characteristics

Five studies (33.3%) were retrospective studies, seven (46.7%) adopted a modelling technique, and
three (20%) were randomised controlled trials. Seven (46.7%) of the selected studies collected
primary data, and 8 (53.3%) utilised secondary data sources.

4.2.3 Disease characteristics

Each of the assessed articles investigated only one disease or condition with malaria (n=4) being the
most investigated disease. Other diseases/conditions investigated in the assessed articles included;
Tuberculosis (n=1), HIV (n=1), human papillomavirus (n=1), neoplasms (n=1), childhood illnesses
(n=1), rotavirus (n=1), fungal infections (n=1), soil-transmitted helminths (n=1), pneumonia (n=1),
family planning (n=1) and post-surgical bleeding(n=1)(see Table 2). In addition, five of the studies
used vaccines as an intervention with the other ten articles comparing medicines with other
medicines or other interventions.

4.2.4 Geographical location and coverage

Nine (60%) of the studies were conducted solely in Kenya with the other six comparing
pharmaceutical interventions in Kenya with other countries. Of the nine studies done in Kenya, only
one adopted a national approach. Eight of the exclusively Kenya studies focused on a sub-national
sample and were limited in geographic scope. The six multinational studies compared interventions
in Kenya with interventions in other sub-Saharan countries.

4.2.5 Sources of funding

Private non-profit organisations were the primary funders (n=9; 60%) of most of the selected
studies. Two studies (13.3%) identified governmental bodies as the source of funds for the research,
one (6.7%) was funded by a multinational pharmaceutical company. Three articles (20%) did not
indicate their source of funding.

14
4.2.6 Other characteristics

The earliest study was published in 1988 and the latest study in 2019. Two articles were each
published in 2014 and 2017, respectively (figure 2).

Number of Pharmacoeconomic Articles Published on Kenya, 1988-2019 (n=15)

2 2
Number

1 1 1 1 1 1 1 1 1 1 1

1988 1996 1999 2007 2008 2009 2010 2011 2014 2015 2016 2017 2019
Year of Publication

Figure 2 - Number of Pharmacoeconomic articles published on Kenya, 1988-2019 (n=15)

4.3 Economic characteristics of the selected economic evaluation studies

4.3.1 Study perspective

The societal (n = 6) and government/private payer (n = 4) perspectives were the most common s tudy
perspectives. Three studies adopted a health system perspective , and two studies utilised the
patient perspective when evaluating the economic costs.

4.3.2 Methods of economic analyses

Thirteen (86.7%) of the selected articles stated economic evaluation as either the main objective or
one of the main objectives. Two studies' (13.3%) main objective was clinical outcomes with
economic outcomes stated as secondary or minor objectives.

Ten (66.7%) of the studies were full economic evaluations involving either cost-effectiveness, cost-
benefit or cost-utility analysis with five studies (33.3%) utilising a cost of illness approach.

4.4 Quality assessment of the selected economic evaluation studies

The CHEERS checklist scores were used to determine and compare the quality of the economic
evaluation studies. The mean CHEERS quality scores (expressed as a percentage) of the 15 economic
evaluation studies was 78.33% (SD 14.67) and ranged from a minimum of 45% to a maximum of
94%. (Table 4)

15
Table 4- Summary statistics of CHEERS Checklist scores

Statistic Value

Mean 78.33%

Standard Error 3.79%

Standard Deviation 14.67

Median 86%

Range 49%

Minimum 45%

Maximum 94%

Averages of the 24 criteria items in the CHEERS checklist for all the articles was computed ( fig 3), and
the results indicate the studies scored highly in many of the criteria. However, the abstracts score
was very low (36.7%), indicating that many articles had incomplete data summarised in their
abstracts. The score for heterogeneity and uncertainty, which are measures of methodological
assumptions and variability respectively, were deemed of average quality.

16
 Quality of Assessed Articles per item on the CHEERS Checklist, n=15

CONFLICTS OF INTEREST 63.3

SOURCE OF FUNDING 83.3

STUDY FINDINGS, LIMITATIONS, GENERALISABILITY AND
CURRENT KNOWLEDGE
83.3

CHARACTERISING HETEROGENEITY 63.3

CHARACTERISING UNCERTAINTY 62.5

INCREMENTAL COSTS AND OUTCOMES 83.3

STUDY PARAMETERS 76.7

ANALYTICAL METHODS 77.8

ASSUMPTIONS 94.4

CHOICE OF MODEL 83.3

ChEERS Checklist Criteria

CURRENCY, PRICE DATE, AND CONVERSION 86.7

ESTIMATING RESOURCES AND COSTS 76.4

MEASUREMENT AND VALUATION OF PREFERENCE BASED
OUTCOMES
90.0

MEASUREMENT OF EFFECTIVENESS 81.9

CHOICE OF HEALTH OUTCOME 93.3

DISCOUNT RATE 66.7

TIME HORIZON 76.7

COMPARATORS 96.7

STUDY PERSPECTIVE 66.7

SETTING AND LOCATION 83.3

TARGET POPULATION AND SUBGROUPS 93.3

BACKGROUND AND OBJECTIVES 90.0

ABSTRACT 36.7

TITLE 83.3

0.0 20.0 40.0 60.0 80.0 100.0

Average Score

Figure 3- Quality of articles as assessed using the 24-item CHEERS checklist

17
Eight articles (53.3%) were of excellent quality (score of <86%), two articles (13.3%) were of very
good quality (score >70% and <85%), four (26.7%) were of good quality (score >55% and <69%) and
one (6.7%) was of poor quality (<54%)(Fig 4).

8
8
7
Number of Studies

6
5

4
4
3

2
2
1
1
0
Excellent Very Good Good Poor
CHEERS Checklist Quality Quartiles

Figure 4 - Distribution of studies in CHEERS quality quartiles.

The quality of articles was significantly related (p < 0.05) to the geographic location covered in the
study (multinational = higher), type of data used in the analysis (secondary = higher), and method of
economic analysis (economic evaluations = higher). The quality of articles was not statistically
related (p > 0.05) to the type of publication, country of residence of the lead author, or the primary
objective of the economic analysis. The numbers of articles per category were not large enough to
conduct statistical comparisons on the country of residence of the primary author (Table 2)

18
5 Discussion
5.1 General characteristics of the selected economic evaluation studies

This study summarised the characteristics and quality of published pharmacoeconomic studies
conducted in Kenya that were available online. The absolute number of pharmacoeconomic articles
published on Kenya between 1988 and 2019 is small (n=15), and even fewer studies are full
economic evaluations(n=10). This is similar to other systematic reviews of pharmacoeconomic
studies from Zimbabwe (n=26)[15], India (n=29)[45] and Bangladesh(n=12)[46]. The small number of
such studies indicates that PE is still in its infancy in Kenya. Previous studies have reported that many
developing countries lack sound economic evaluation data[47]. Several plausible reasons can explain
the low number of economic evaluations in Kenya: lack of appreciation of economic evaluations by
health professionals and the health system in general; misconceptions about economic evaluations;
inadequate expertise in economic evaluation; high costs involved in conducting health economic
evaluations and insufficient government funding for health economic evaluation and outcomes
research.

None of the study articles was published in Kenyan-based journals (n=0). This finding is consistent
with other pharmacoeconomic systematic reviews on Nigeria[12], Zimbabwe[15] and South
Africa[13], which demonstrated that most of the articles in those countries were published in
international journals.

Consistent with results from several reviews, this review showed that most of the articles were
published in medical journals (73.3%). Systematic reviews conducted for Nigeria[12] and
Zimbabwe[15] found that 70% and 73% of the pharmacoeconomic evaluations were published in
medical journals, respectively.

Whereas this study did not suggest a significant difference in the quality of studies published in
medical journals compared to non-medical journals, Maria-Florencia Hutter et al[48] has shown that
the type of journal in which the economic assessments were reported is correlated with the criteria
for methodological quality and reporting. Jefferson et al.[49] found that medical journals tended to
have lower publication standards for health economic studies than well -established health economic
journals and appeared to have weaker publication requirements for health economic studies than
well-established health economic journals. As a result, authors were more likely to publish in
medical journals than in more rigorous health economics and pharmacoeconomic journals. Studies

19
conducted by Hansel JO et al.[50] in 2008 and Neumann PJ et al[51] in 2009 provided further
evidence of the disparity in the publication of health economic studies and the underlying factors .

5.2 Quality of economic evaluation

All considered, the quality of the articles was very good, with a mean CHEERS quality score of
78.33% (SD 14.67). The analysis of the selected pharmacoeconomic studies indicated that there
were multiple flaws in the design, analysis and reporting of the fi ndings.

The economic evaluation perspective is an important issue which defines the cost and outcome
metrics of the interventions under investigation in a study. One study, Michelle Atieno et al[39] did
not explicitly state the study perspective adopted.

Sources of data for costs and outcome were mentioned in all articles but lacked a detailed
description of how the data was collected. All studies used the United States Dollar (USD) as the
reference currency with conversions conducted based on the prevailing exchange rate at the time of
the study. Some studies used the US dollar rate, without considering the variation in purchasing
power between Kenya, the United States of America and the other comparator countries for multi-
country studies. Purchasing Power Parity adjusted dollar rate needs to be applied instead of a simple
dollar exchange rate.

To validate study results, it is good practice for researchers to conduct sensitivity analyses to explore
potential cost-effectiveness under varying operational, epidemiologic and clinical settings. This was
observed in all but two studies[39,41] which conducted sensitivity analyses to examine the impact of
various health states and operational conditions on the cost-effectiveness. Sensitivity analysis can
either be univariate (one-way) or multivariate (multi-way). With univariate analysis, each uncertain
component of the evaluation is varied individually across a plausible range of values. In contrast, the
others retain their base-case specifications, to establish the impact of each component on the
results. Multivariate sensitivity analysis involves varying two or more inputs at the same time and
studying the effect on outcomes[52]. For better validation of the result, multivariate sensitivity
analyses should be carried out and the results triangulated by comparing with other similar
studies[53]. Most studies (n=10) conducted univariate sensitivity on select parameters, e.g. changing
the cost per averted deaths, mortality rate, discount rate or foreign exchange rate. Only three
studies[37,42,43] carried out multivariate sensitivity analyses.

5.3 Impact of cost-effectiveness studies on medicines selection

Kenya developed its first essential medicines list (EML) in 1981, which was modelled along the WHO
EML. Ever since, five other revisions of the EML were conducted in 1993, 2003, 2010, 2016 and

20
2019[25]. Until 2010, the responsibility of developing and revising the Kenya EML was not clearly
defined, and neither was the process well outlined. Moreover, there were no standard operating
procedures to review the EML, and the process was done in an ad hoc manner. Since 2010, the
National Medicines and Therapeutic Committee was mandated to lead the review and revision of
future editions of the Kenya EML guided by feedback from stakeholders, changes in the WHO Model
lists and results of other health research[54].

Analysis of the EML revision procedures and the application of cost-effectiveness studies yielded
varying results. No information was available on the process of development of the 1981 Kenya EML.
The 1981 Kenya EML was reviewed in 1993, twelve years after its development. The composition of
the team charged with updating the essential medicines list was made up of clinicians, clinical
pharmacists and nursing professional with no mention of professional with a health economics
background. While it is stated that the team focused on costs and prioritisation of medicines that
would benefit a majority of the population, there is no mention of cost-effectiveness comparisons
and studies being utilised in the selection process[55]. The 2010, 2016 and 2019 Kenya EMLs lists
among their criteria for inclusion, comparative cost-benefit and cost-effectiveness ratios, but there
was no evidence of the application of economic evaluation studies in the selection and decision-
making process.

Besides the EML, Kenya has developed treatment guidelines and protocols for management of major
diseases and conditions and relies on advice from international bodies such as the WHO and also
local institutions and locally generated research findings. Major diseases such as tuberculosis, HIV,
malaria and childhood illnesses have their own stand-alone treatment guidelines with
recommended pharmacological therapeutic options. This study evaluated the impact of PE research
on the various guidelines’ recommendations and successive revisions.

The fifteen assessed articles were economic evaluation of eleven diseases and condition s with
malaria (n=4) being the most investigated disease. Other diseases/conditions investigated in the
assessed articles included; Tuberculosis (n=1), HIV (n=1), human papillomavirus (n=1), cancer (n=1),
childhood illnesses (n=1), rotavirus (n=1), fungal infections (n=1), soil-transmitted helminths (n=1),
pneumonia (n=1), family planning (n=1) and post-surgical bleeding(n=1). Of the interventions
evaluated, five of the studies used vaccines as the intervention with the other ten articles comparing
medicines with other medicines or other interventions.

In terms of disease impact, HIV/AIDS is the leading cause of illness in Kenya accounting for 15.63% of
the total Disability Adjusted Life Years (DALY) in 2017[56] with the most affected age group being
the economically productive 15-65 years of age. This study found only one PE study on HIV/AIDS[30],

21
which evaluated the economics of switching HIV/AIDS patients from a failing antiretroviral (ARV)
regimen to a superior regimen. The 2011 modelling study conducted in both Kenya and Uganda
demonstrated that there would be an improvement of 20 months in average survival for the base
model and an Incremental Cost-Effectiveness Ratio (ICER) of $1483 per DALY averted for Kenya if
HIV/AIDS patient were switched to the superior ARV regimen. It is a generally agreed concept that
interventions which avert one DALY for less than the local per capita gross domestic product (GDP)
are considered very cost-effective, interventions that cost less than three times local GDP per DALY
averted are still considered cost-effective, and those that are above this threshold are considered
not to be cost–effective[57]. According to The World Bank, Kenya’s per capita GDP was $972 in
2011, making this ARV switch cost-effective.

In 2014, the WHO revised its 2013 ARV recommendations advocating for early ARV switch from first-
line ARV regimens to more superior second-line ARV regimens for adults and adolescents[58]. Two
years later, Kenya revised its ARV guidelines, adopting the same recommendations[59]. It is
therefore plausible to deduce that this pharmacoeconomic study could have contributed to
changing the HIV/AIDS treatment guidelines in Kenya.

Malaria poses a significant public health problem in Kenya and accounted for 1.63% of total DALYs in
2017[56]. This review identified four articles on malaria with three articles comparing different
malaria medicine options and one article comparing malaria medicine delivery mode. In 2006, Kenya
abandoned the use of sulphadoxine-pyrimethamine as its first-line therapy in treatment of malaria
and adopted the use of artemisinin combination therapies with artemether-lumefantrine being the
preferred medicine[60]. Since then, the guidelines have been revised three times but the first-line
recommendations for malaria treatment have remained the same. This indicates that the assessed
articles had a minimal role in shaping malaria medicine use policy in Kenya.

The 2009 study by Jacqueline Tate et al[35] showed that rotavirus vaccine administered to children
under five years was very cost-effective, especially in low-income countries where rotavirus
associated diarrhoea disease and mortality is rampant. In the same year, the WHO recommended all
countries to roll-out rotavirus immunisation programs[61]. Rotavirus vaccine was introduced in
Kenya in July 2014 as part of the expanded programme for immunisation and has since been
administered to infants as oral doses at ages 6 and 10 weeks[62]. One can therefore infer that the
economic evaluation study by Jacqueline Tate et al. had a significant impact on the WHO
recommendation on rotavirus vaccine and later incorporation of the vaccine into the Kenyan
immunisation programme.

22
5.4 Strengths & Limitations

One of the key strengths of this study is that it took on a ‘systematic review’ approach and was
successful at conducting a relatively robust search and catalogue PE studies in Kenya. The appraisal
of the identified studies provides a relatively good description of the state of Pharmacoeconomics
studies in Kenya and their application. This study can form the basis for a more thorough and
comprehensive systematic study on the topic.

There were a number of limitations that were identified during the execution of this study. First, the
results of this study are representative of, and based on articles published in online journals.
Unpublished or written, but non-electronically available, grey literature were not included due to
time and geographical constraints. Articles published in hard-print journals and not indexed in the
major medical and other online databases were also not included in this study.

Second, since the systematic review process was performed solely by the author of this report,
selection and information biases cannot be ruled out. There may be other sources of papers from
the research that were not included, which could have provided additional studies for inclusion in
this review.

Many of the studies(n=7) were model-based, and therefore many of the results relied on simulations
of effects of possible interventions and not on real clinical applications. Moreover, the methodology
section of some studies did not clearly explain what was done, making it challenging to categorise
and code them; other readers may categorise them differently.

Finally, the quality ratings were subjective, and the papers could be judged differently by other
readers and researchers. Also, using different scoring systems such at the Quality of Health
Economic Studies checklist would yield different ratings and scores.

23
6 Recommendations
The general finding of this study is that very little pharmacoeconomic research has been carried out
in Kenya, as evidenced by the scarcity of literature in this area. As the pharmaceutical market in
Kenya evolves and policies change, more substantial amounts and rigorous pharmacoeconomic
research may be needed. While the overall quality of the assessed articles was deemed to be good,
there were a few articles whose quality was below average. This could point to insufficient
awareness and expertise in the conduct of health economics evaluations wi thin the healthcare
industry in Kenya. There is need for enhanced capacity building through short-courses, seminars and
curriculum inclusion of health economic studies.

The study findings indicate that utilisation of cost-effectiveness studies on the selection of medicines
for inclusion into essential medicines list and treatment guidelines in Kenya is inconsistent. The
utilisation of pharmacoeconomic research can be incorporated onto the current arsenal of
pharmaceutical regulatory frameworks which include generic substitutions. The need for
pharmaceutical economic evaluation is crucial, particularly in developing countries such as Kenya, as
this enables decision-makers to distribute scarce resources in a more rational evidence-based
manner. As Kenya embarks on the process of institutionalising economic evaluations and health
technology assessment for decision making and priority setting, it can borrow lessons from countries
with a similar socio-economic profile which has been successful in deploying these technologies to
inform health decisions. Ghana and The Phillipines have demonstrated some level of success in this
utilising cost-effectiveness studies to compare new drugs with standard treatments for inclusion into
their medicine formularies and reimbursement[63].

With ever-increasing demands for healthcare for the growing and ageing Kenyan population, there is
a widening gap between available and required resources for healthcare. Economic evaluation of
pharmaceuticals has the potential to reduce this gap and to contribute to cost-effective healthcare
delivery in Kenya. Systematic reviews are useful as instruments to provide information and assess
the practice of economic evaluation in any field of health. This study forms the basis for further
research using more rigorous and comprehensive systematic review to draw together, appraise and
evaluate all known pharmacoeconomic research conducted in Kenya.

24
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8 Annexes
Annexe 1- Quality Assessment Checklist used in the analysis.

Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Wholly adapted from Husereau D, Drummond M et al[26]

Item Section Item Questions

no
Title & Abstract Description Score
1 Title Identify the study as an economic evaluation or use more specific terms such as “cost-
effectiveness analysis”, and describe the interventions compared.
2 Abstract Were the perspective of the analysis (societal, third-party payer, etc.) and reasons for
its selection stated?
Introduction
3 Background and Objectives Provide an explicit statement of the broader context for the study
Methods
4 Target Population and Describe characteristics of the base case population and subgroups analysed,
subgroups including why they were chosen.
5 Setting and Location State relevant aspects of the system(s) in which the decision(s) need(s) to be made.
6 Study Perspective Describe the perspective of the study and relate this to the costs being evaluated.
7 Comparators Describe the interventions or strategies being compared and state why they were
chosen.
8 Time Horizon State the time horizon(s) over which costs and consequences are being evaluated and
say why appropriate.
9 Discount Rate Report the choice of discount rate(s) used for costs and outcomes and say why
appropriate.
10 Choice of Health Outcome Describe what outcomes were used as the measure(s) of benefit in the evaluation and
their relevance for the type of analysis performed.

29
11a Measurement of Single study-based estimates: Describe fully the design features of the single
effectiveness effectiveness study and why the single study was a sufficient source of clinical
effectiveness data.
11b Synthesis-based estimates: Describe fully the methods used for identification of
included studies and synthesis of clinical effectiveness data. denominator displayed in
a clear, transparent manner?
12 Measurement and valuation If applicable, describe the population and methods used to elicit preferences for
of preference based outcomes.
outcomes
13a Estimating resources and Single study-based economic evaluation: Describe approaches used to estimate
costs resource use associated with the alternative interventions. Describe primary or
secondary research methods for valuing each resource item in terms of its unit cost.
Describe any adjustments made to approximate to opportunity costs.
13b Model-based economic evaluation: Describe approaches and data sources used to
estimate resource use associated with model health states. Describe primary or
secondary research methods for valuing each resource item in terms of its unit cost.
Describe any adjustments made to approximate to opportunity costs.
14 Currency, price date, and Report the dates of the estimated resource quantities and unit costs. Describe
conversion methods for adjusting estimated unit costs to the year of reported costs if necessary.
Describe methods for converting costs into a common currency base and the
exchange rate.
15 Choice of model Describe and give reasons for the specific type of decision-analytical model used.
Providing a figure to show model structure is strongly recommended. analytical model
used. Providing a figure to show model structure is strongly recommended.
16 Assumptions Describe all structural or other assumptions underpinning the decision-analytical
model.
17 Analytical methods Describe all analytical methods supporting the evaluation. This
could include methods for dealing with skewed, missing, or censored data;
extrapolation methods; methods for pooling data; approaches to validate or make
adjustments (such as half cycle corrections) to a model; and methods for handling
population heterogeneity and uncertainty.

30
 Results
18 Study Parameters Report the values, ranges, references, and, if used, probability
distributions for all parameters. Report reasons or sources for distributions used to
represent uncertainty where appropriate. Providing a table to show the input values is
strongly recommended.
19 Incremental Costs and For each intervention, report mean values for the main categories of estimated costs
Outcomes and outcomes of interest, as well as mean differences between the comparator
groups. If applicable, report incremental cost-effectiveness ratios.
20a Characterising Uncertainty Single study-based economic evaluation: Describe the effects of sampling uncertainty
for the estimated incremental cost and incremental effectiveness parameters,
together with the impact of methodological assumptions (such as discount rate, study
perspective).
20b Model-based economic evaluation: Describe the effects on the results of uncertainty
for all input parameters, and uncertainty related to the structure of the model and
assumptions.
21 Characterising If applicable, report differences in costs, outcomes, or cost-effectiveness that can be
Heterogeneity explained by variations between subgroups of patients with different baseline
characteristics or other observed variability in effects that are not reducible by more
information.
Discussion
22 Study findings, limitations, Summarise key study findings and describe how they support the conclusions
generalisability and current reached. Discuss limitations and the generalisability of the findings and how the
knowledge findings fit with current knowledge
Other
23 Source of funding Describe how the study was funded and the role of the funder in the identification,
design, conduct, and reporting of the analysis. Describe other non-monetary sources
of support.
24 Conflicts of interest Describe any potential for conflict of interest of study contributors in accordance with
journal policy. In the absence of a journal policy, we recommend authors comply with
International Committee of Medical Journal Editors recommendations.

31