A STUDY ON PHARMACOECONOMIC EVALUATION AND
OUTCOME MEASURES OF ANTI DIABETIC AGENTS
Introduction
All over the world patients are affected by high price of medicines. Economics is the science
of scarcity and choice. Economics is the skill that we all use on a daily basis in our everyday
lives. Health economics is basically economics applied to healthcare and it is most commonly
used to help decision makers make difficult choices. This is the field which:
 Analyses the supply and demand for healthcare
 Provides a structure for understanding decisions and their consequences.
Pharmacoeconomics adopts and applies the principles and methodologies of health
economics to the field of pharmaceuticals and pharmaceutical policy.
Pharmacoeconomics can be defined as the branch of the economics that uses cost-benefit,
cost-effectiveness, cost-minimization, cost-of-illness and cost-utility analyses to compare
pharmaceutical products and treatment strategies.
Cost-Benefit Analysis: Cost benefit studies provide the most direct comparisons of costs with
benefit; but they can also be most controversial. All outcomes are valued in dollars, thus the
study asks whether the dollar value of benefit is larger than the dollar value of the costs. Cost
benefit studies may place dollar values on medical care costs saved, in addition to days off
from work, days of reduced productivity at work because of illness. It is appreciated that
while the costs of specific treatment are easy to obtain (drug costs) that of the consequences
(eventual therapy, support costs) are variable and difficult to estimate.
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Cost-Effectiveness Analysis: Cost effectiveness is broadly used term inside and outside the
healthcare community. The costs of treatment to achieve specific therapeutic objectives are
assessed30. In pharmacoeconomics, these studies measure dollars spent per outcome
achieved, in which the outcomes (i.e. Effectiveness) are measured in natural units.
Cost Minimization Analysis: Cost minimization studies compare two or more treatment
options that achieve the same or a defined minimum outcome, (costs of alternative equivalent
treatments).
Cost-of-Illness Analysis: Cost of illness studies measure the lifetime cost for an incident case
of a condition (i.e cost over a lifetime for individuals with a condition, even if the condition is
not lifelong).
Cost Utility Analysis: Cost utility studies are a specific type cost effectiveness analysis in
which two interventions are compared on preferences for different health states. The health
states are measured by morbidity & mortality. Morbidity is defined based on quality of life
measures and for cost utility studies, morbidity is combined with mortality to create a QALY.
The outcome of treatment is measured in terms of quality of life, willingness to pay or patient
preference for one treatment over another. Although this appears to be an index of consumer
satisfaction, choices are influenced by several factors. Attempts at defining outcome in terms
of quality of life per additional year of life (QALYs) may be suitable in measuring the effect
of treatment of a fatal disease.
Pharmacoeconomics is the application of economic analysis to the use of pharmaceutical
products, services and programs, with frequently focuses on the cost (inputs) and
consequences (outcomes) of that use. Research that identifies measure and compares the
costs (resources consumed) and the economic, Clinical and Humanistic outcomes of diseases,
drug therapies and programmes directed to the diseases. In 1978 Mc Ghan, Rowland &
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Bootman, from the university of Minnesota , introduced the concepts of cost-benefit & costeffectiveness analyses. The team pharmacoeconomics was used on a public forum for the first
time in 1986 by Townsed. The health care system is clearly in state of rapid revolution.
Traditional approaches to healthcare decisions will no longer suffice; therefore, new tools
will be needed. Medical, ethical and societal concerns about costs, access and quality of care
are causing healthcare practitioners to consider a more comprehensive model for medical
decision making. Diabetes Mellitus is a major health problem. It is a chronic illness, which in
most cases is treated for life, hence the cost associated with it is enormous. Few data exists as
regard its cost to the patient and the society in developing countries. Such costs, if available,
are useful tools in policy formulations, decision taking and motivation for adherence to
preventive measures by the populace. Recently throughout the globe many people have
become more cost oriented, especially in terms of medical care. Therefore, estimation of cost,
of any new treatment has become more significant. As the medical care costs keep on
increasing, therefore more efforts is made to figure out the economic effects associated with
progression of diseases and their treatment. DM is the commonest form of the disease across
the globe, in developing states like India being at the top of this epidemic. Recent studies,
showed approximately 285 million people worldwide in the age group of 20-79 years were
diabetic in the year 2010, and by the year 2030, 438 million people, above 30 years of age are
expected to have diabetes. The DM will be more in developing countries. DM is one of
world’s leading causes of morbidity and death. Individuals who are diagnosed with diabetes
mellitus are more prone to cardiovascular problems than their counterpart without diabetes
mellitus. Increasing in health care cost is a foremost concern in the developing nations,
hence, it has increased individual economic burden.
Drug use evaluation is one of the important services provided by pharmacists. Ideally, that
value should be translated into patient and financial outcomes. Apart from concentrating on
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inappropriately prescribed therapy and overprescribing, drug use evaluation focuses on the
most cost-effective therapy. A high degree of sophistication is required in order to make such
determination fairly, considering patient factors, disease factors, and other issues.
Patients are affected by high cost of drugs though the symptoms improve.
The cost can be measured in following ways:
 Cost / unit
 Cost / treatment
 Cost / person
 Cost / person / year
 Cost / case prevented
 Cost / life saved
 Cost / DALY (disability-adjusted life year)
The fundamental component of a pharmacoeconomic study is outcomes or benefits. The
expected benefits might be measured in:
 “Natural” units e.g. years of life saved, strokes prevented, and peptic ulcers healed
etc.
 “Utility” units - Utility is an economist’s word for satisfaction, or sense of well being,
and is an attempt to evaluate the quality of a state of health, and not just its quantity.
Utility estimates can be obtained through direct measurement (using techniques such
as time trade off or standard gambles, or by imputing them from the literature or
expert opinion. They are often informed by measures of quality of life in different
disease states.
Perspective is the key point that is to be considered for any economic evaluation. Here it is
mandatory from whose point of view the evaluation should be considered, from health care
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perspectives involve (direct cost) or societal perspective (involves indirect cost). How much a
drug cost depends on your point of view? From: Patient’s perspective: out-of-pocket expenses are cost.
 Societal perspective: It is the most comprehensive, as it includes all cost and benefit
irrespective of who pays and who benefits, but often more limited perspectives are
adopted.
Application of economic evaluation methods to healthcare products and services, especially
pharmaceuticals, might increase their acceptance by healthcare professionals and society.
Need for study: Pharmacoeconomics serves as a link between medicine and market economy.
It is a subdivision of health economics and results from that discipline coming of age through
consolidation to diversification. Health Economics, as a branch of economics is itself
relatively young. Basically the pharmacoeconomics is needful in following manner, in
Government- Determining program benefits and prices paid. In Private Sector- Designing
insurance benefit coverage. In industry- Deciding among specific research and development
alternatives. Its offers reliable and meaningful information and serves as a tool for decision
making in the choice of therapeutic approach. The aim is to maximize health benefit for the
community to be delivered considering the existing limited financial resources.
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Objectives:
Primary objective:
 To
evaluate
oral
hypoglycemic
agents
vs
insulin
analogues
based
on
pharmacoeconomic study and its outcome results
Secondary objectives:
 To prepare patient data collection form, and feedback questionnaires
 To document the treatment of type 2 DM which the in-patients will receive during
their study period at wards of CSI Holdsworth memorial (Mission) hospital Mysore,
Karnataka.
 To calculate and record various treatment-related expenses incurred such as: Cost of
oral-hypoglycemic agents, Cost of Insulin, laboratory charges, hospitalization
charges, and any other miscellaneous expenses.
 To apply cost analysis and find out the treatment with maximum benefit.
 Explain pharmacoeconomics & prescription cost
 To analyze and evaluate cost of drug therapy & beneficence
 Discuss the significance of pharmacoeconomics in various strata of society
 Explain drug compliance, adherence and therapeutic failure
 Discuss consequences of non compliance
 To find the patient demographics of diabetic population
 To assess their adherence to therapy and Quality of health care
 To analyze their clinical data with ongoing therapy
 To study the prescribing pattern of the Antidiabetic drugs
 To compare the cost and benefits among each drug used for treatment
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Methodology:
Study site: This study will be conducted in the CSI Holdsworth Memorial (Mission) Hospital
Mysore, Karnataka
Study Period: This study will be conducted over a period of 6 months from September 2019
to March 2020
Study Design: The study will be performed as a Prospective method to analyze the
pharmacoeconomics of drugs prescribed widely for their cost minimization and cost
effectiveness, in management of diabetes mellitus.
Study Approval: Approval awaited from the Institutional Ethics Committee of Farooqia
College of Pharmacy, Mysore
Study Materials: Data entry form, Patient medical records,
Study Analysis: Evaluate Patient data collection forms followed by a graphical representation
of the data, Feedbacks of Doctors/Patients/Other Health Care Professionals
STUDY CRITERIA:
Patient Inclusion Criteria:
 Patients older than 18 years of age and either Genders
 Patients using Insulin as their regular medication
 Patients admitted and diagnosed with Type 2 Diabetic Mellitus
 Patients willing to participate in the study
 Patients having good orientation and ability to communicate verbally
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Patient Exclusion Criteria:
 Patient who are not willing to give the informed consent.
 Pregnant and lactating women
 Complicated patients
 Bed ridden patients
 Mentally unstable patients
Study procedure:
 To prepare patient data collection form, and feedback questionnaires
 All the needful and applicable information are collected in a distinctive data entry
form
 The following data will be noted and recorded from the case notes; demographic data,
date of visits, fasting blood glucose level at first and subsequent visits, blood pressure
at each visit, concurrent illness (s), number of visits and prescribed anti-diabetic drugs
as well as duration of therapy.
 The costs for personnel, drugs, transportation and diagnostic tests will be noted and
recorded.
 To calculate the personnel costs for physicians, pharmacists and nurses.
 Drug costs will be obtained from the pharmacy department of the hospital and the cost
per defined daily dose (DDD) will be calculated taking the duration of therapy into
consideration.
 The cost of diagnostic tests was obtained from the laboratory of the hospital.
 All these costs will be added up for each patient and for all the patients to obtain the
total. The average cost per patient will be then calculated and recorded.
 Periodically thanking Doctors Pharmacists and Nurses
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Literature Review:
Suleiman IA et al. conducted a study on “Pharmacoeconomic Evaluation of Anti-Diabetic
Therapy in A Nigerian Tertiary Health Institution.”It is a retrospective study and involved
using 277 prescriptions from randomly selected 37 case notes of diabetic patients conducted
in the Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, Olabisi
Onabanjo University. The aim was to determine the cost of illness to the patient and society
at large. It’s conclude that the cost associated with diabetes is enormous. Adequate
consideration for cost implication of chosen therapy is indispensable. Economic evaluation of
therapy should be encouraged to ensure improved cost effectiveness and efficiency in
management. Regularly up-dated drug formulary and evidence-based standard treatment
guidelines would ensure better choice of therapeutic options. More importantly, a concerted
effort is needed to reduce the incidence of diabetes mellitus in the society.
Abdelaziz MSL et al.conducted a study on “Pharmacoeconomic evaluation of oralhypoglycemic agents at hospital in Bangalore.”A prospective observational study was
conducted at St. Martha’s Hospital in Bangalore for 9 months. Its aimed to conduct
Pharmacoeconomic evaluation of oral-hypoglycemic agents using cost effectiveness analysis.
It conclude that, combination of metformin + glimipiride was found to be the most cost
effective drug for the treatment of type-2 diabetes mellitus with an average total direct cot of
Rs.6267.11, average benefit of 82.52 units reduction in RBS value and average cost
effectiveness ratio of Rs.75.94/unit RBS value reduction compared to all other regimens
prescribed. However, the differences in the costs between the treatment regimens were not
statistically significant.
Shah Jainam V et al. conducted a study on “Pharmacoeconomic Evaluation, Cost
Minimization Analysis of Anti-Diabetic Therapy in Gujarat.” This study was conducted in
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Department of Pharmacology and Clinical Pharmacy, K. B. Institute of Pharmaceutical
Education and Research (KBIPER), Gandhinagar, Gujarat, India. It is aim to analyze clinical
information for most commonly and most costly prescribed drug molecule. It is concludes
that cheaper drugs can be prescribed to patients reducing the health-economic burden on
diabetic patients.
Tamilselvan T et al. conducted a study on “Pharmacoeconomical Evaluation Of Oral
Hypoglycemic Agents for Type-2 Diabetes Mellitus in a Multispeciality Hospital.”This is a
Prospective Cost Effective Study was conducted for 6 months in both inpatients and
outpatients of Cardiology, General Medicine and Nephrology Departments with Type 2
Diabetes Mellitus in a 300 bedded multispecialty hospital located at Elayampalayam.The
objective of the study was to determine the cost effective drug among oral hypoglycemic
agents utilized in a multispeciality hospital to treat type-2 diabetes mellitus. Its conclude that
economic evaluation of therapy should be encouraged to ensure cost effective therapy for
diabetic patients and for the initial treatment of Type 2 Diabetes Mellitus, Metformin may be
considered as cost-effective monotherapy.
Sri Lakshmi G et al. conducted a study on “Pharmacoeconomics: An Overview.” This study
was conducted in Department of Pharmaceutics, ST. Mary’s Group of Institutions Guntur
(Dt),
Andhra
Pradesh,
India.
This
article
provides
a
brief
overview
about
pharmacoeconomics, its utility with respect to the Indian pharmaceutical industry, and the
expanding insurance system in India. Its conclude that Pharmacoeconomic evidences can be
utilized to support decisions on licensing, pricing, reimbursement, and maintenance of
formulary procedure of pharmaceuticals. For the insurance companies to give better facility
at minimum cost, India must develop the platform for pharmacoeconomics with a validating
methodology and appropriate training. The role of clinical pharmacists including Pharm D
graduates are expected to be more beneficial than the conventional pharmacists, as they will
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be able to apply the principles of economics in daily basis practice in community and hospital
pharmacy.
Soniya Scaria et al. conducted a study on “Pharmacoeconomics: Principles, Methods and
Indian Scenario.” This study was conducted in Department of Pharmacy Practice, Nazareth
College of Pharmacy. It is conclude that pharmacoeconomics evaluation has become an
important area of interest to find the optimal therapy at the lowest price as healthcare
resources are not easily accessible and affordable to many patients. Numerous drug
alternatives and empowered consumers also fuel the need for economic evaluations of
pharmaceutical products. In a country like India the PE can help the poor and middle class
Indians to obtain well health care services because many households are below poverty line,
unaffordable for private health care.
Zohour Anouassi conducted a study on “Cost Benefit Analysis: Prevention Of Diabetes
Type 2 Using Insulin.”This study was a Cost-benefit analysis was conducted in a societal
prospective in Paris Sorbonne University Abu Dhabi. This study only catalogues what other
studies have analysed over the years in other countries. It is conclude that there is a rising
prevalence of diabetes of 19.3% of the total population of UAE in 2015 of whom a good
percentage of the population is still undiagnosed. However, it is worth noting that the data on
the cost implication of diabetes in the UAE is scarce.
Sri Swetha Meka et al. conducted a study on “Cost Minimization and Effectiveness of
AntiDiabetic Drugs in the Treatment of Patients with Diabetes Mellitus in a Secondary Care
Hospital.” It’s a prospective study was conducted in Department of Pharmacy Practice,
Vinayaka Mission’s College of Pharmacy, Salem- 8, India. The main objective of the study is
to assess the cost minimization and cost effectiveness of Antidiabetic drugs (Insulin,
Metformin, glibinclamide) in the treatment of patient with Diabetes Mellitus (both type 1 and
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2) from the prescriptions. The result showed that, the mean cost of prescription for one day
was Rs. 11.40 and if alternative used Rs. 6.07 and mean cost of prescription for total time
period during hospitalization was Rs. 180.69 and if alternative brands used Rs.112.98. Thus,
cost minimization was achieved with the use of alternatives without alteration in the effect of
the drugs for the indicated condition.
Giwa Abdulganiyu et al. conducted a study on “Cost-Effectiveness Analysis Of AntiDiabetic Therapy
In A University Teaching Hospital.”A retrospective review of selected
case-notes was conducted in the Department of Clinical Pharmacy and Pharmacy Pharmacy
Practice, Faculty of Pharmaceutical Sciences, University of Ilorin, Ilorin, Nigeria.The aim
was to conduct cost-effectiveness analysis of anti-diabetic therapy in a University Teaching
Hospital. The result’s shows that Glibenclamide (N1.76/unit of effectiveness) which was
more cost-effective than chlopropamide (N2.97/unit of effectiveness) in the management of
moderate hyperglycemia in non-obese Type II Diabetes Mellitus was more frequently
prescribed (81.5%). Glibenclamide + Metformin (N7.63/unit of effectiveness) which was
more frequently prescribed (92.5%) was not necessarily more cost-effective than
Chlopropamide + Metformin (N9.76/unit of effectiveness) in the management of moderate
hyperglycemia in obese Type II Diabetes- Mellitus. Biphasic Isophane Insulin (N12.65/unit
of effectiveness) which was more cost-effective than soluble insulin + insulin zinc
(N30.37/unit of effectiveness) in the management of serve hyperglycemia in non-obese Type
II Diabetes Mellitus was less frequently prescribed (42.3%). Biphasic Isophane Insulin +
Metformin (N15.91/unit of effectiveness) which was more cost-effective than soluble insulin
+ insulin zinc + metformin (N34.45/ unit of effectiveness) in the management of severe
hyperglycemia in obese Type II Diabetes Mellitus patients was less frequently prescribed
(25%).
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Ipek Ozer Stillman et al. conducted a study on “Cost-utility analysis of memantine extended
release added to cholinesterase inhibitors compared to cholinesterase inhibitor monotherapy
for the treatment of moderate-to-severe dementia of the Alzheimer’s type in the US.” This
cost-effectivenessstudy was conducted inJersey City, NJ, USA. The main objective of this
study was to evaluates the cost-effectiveness of memantine extended release (ER) as an addon therapy to acetylcholinesterase inhibitor (AChEI) [combination therapy] for treatment of
patients with moderateto-severe Alzheimer’s disease (AD) from both a healthcare payer and a
societal perspective over 3 years when compared to AChEI monotherapy in the US. Its
conclude that combination therapy for patients with moderate-to-severe AD is a costeffective treatment compared to AChEI monotherapy in the US.
References:
1. Suleiman IA, Fadeke OF, Okubanjo OO. Pharmacoeconomic Evaluation of AntiDiabetic Therapy in A Nigerian Tertiary Health Institution. Annals of African
Medicine 2006; 5(3): 132-137.
2. Abdelaziz MSL, Shobha Rani H, Ravindranath S et al. Pharmacoeconomic evaluation
of oral-hypoglycemic agents at hospital in Bangalore. IOSR Journal of Pharmacy and
Biological Sciences 2015; 10(5): 46-50.
3. Shah Jainam V, Patni Kalyani N, Deshpande Shrikalp S. Pharmacoeconomic
Evaluation,
Cost
Minimization
Analysis
of
Anti-Diabetic
Therapy
in
Gujarat. International Journal of Medical Research & Health Sciences 2016; 5(3):
34-43.
4. Tamilselvan T, Kumutha T, Amrita Lekshmi V et al. Pharmacoeconomical Evaluation
Of Oral Hypoglycemic Agents For Type-2 Diabetes Mellitus In A Multispeciality
Hospital. International Journal of Pharmaceutical Sciences and Research 2017; 8(5):
2320-5148.
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5. Sri Lakshmi G, Sai Shankar K, Desu Prasanna Kumar et al. Pharmacoeconomics: An
Overview. Universal Journal of Pharmacy 2018; 7(3): 1-7.
6. Soniya Scaria, Remya Raju, Sijimol Joseph et al. Pharmacoeconomics: Principles,
Methods and Indian Scenario. International Journal of Pharmaceutical Sciences
Review and Research 2015; 34(1): 37-46.
7. Zohour Anouassi . Cost benefit analysis: Prevention of Diabetes TYPE 2 using insulin
. PSUAD Economic Report 2017;1-19.
8. Sri Swetha Meka, Arul B, Jaykar B. Cost Minimization and Effectiveness of
AntiDiabetic Drugs in the Treatment of Patients with Diabetes Mellitus in a
Secondary Care Hospital. International Journal of Scientific Research and
Review 2018; 7(11): 378-382.
9. Giwa Abdulganiyu, Tayo Fola. Cost-Effectiveness Analysis Of Anti-Diabetic
Therapy In A University Teaching Hospital. International Journal of Pharma
Sciences and Research 2014; 5(3):82-91.
10. Ipek Ozer Stillman, Catherine Saint-Laurent Thibault, Stephanie Chen et al. Costutility analysis of memantine extended release added to cholinesterase inhibitors
compared to cholinesterase inhibitor monotherapy for the treatment of moderate- to
severe dementia of the Alzheimer’s type in the US. Journal of Medical
Economics 2015; 18(11): 930-943.
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1
Signature of
Candidate
MUHAMMAD HASHIR VK
SEPIDEH HABIBOLLAHI NAJAFABADI
HISANA MOOSA
2
Remarks of Guide
3
Name and
Designationof
Guide
4
Signature of Guide
5
Head of the
Department
6
Signature of HOD
Dr. Umesh,PHARM D
Dr. MAHENDRA KUMAR BETUR JAYAPPA, M PHARM, PhD
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