Добавил:
Sekretar
kiopkiopkiop18@yandex.ru
t.me/Prokururor I Вовсе не секретарь, но почту проверяю
Опубликованный материал нарушает ваши авторские права? Сообщите нам.
Вуз:
Предмет:
Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5990_Библиотеки_им_академика_М_И_Перельмана.pdf
313Pharmacoeconomics
Cost of drugs: It is the total resources spent in making the
drug or drug preparation.
Price: It is the amount a customer pays for a product or
service.
Opportunity cost: This is defined as the benefit foregone
when choosing one therapeutic alternative over another. Costs
are measured by economic methods to evaluate the actual cost
of using resources in one way about another.
Incremental analysis: This decision-making technique is
used in business to determine the true cost difference between
alternatives. It is a fact that treatment exists in most therapeutic
fields, even if this treatment is limited to providing the best
supportive care. Economic evaluations assess the costs and
benefits of a new intervention over and above what is currently
provided.
Quality adjusted life year (QALY): QALY attempts to
integrate both quality and quantity of life. For example, if a
treatment increases one’s life expectancy by 2 years, but adverse
effects decrease his quality of life by 25%, the net gain is 2 ×
0.75 = 1.5 QALYs.
Setting: The context in which the intervention will occur.
Perspective: The different viewpoints from which health
benefits and costs can be assessed (e.g. patient, provider, payer,
society in general).
Time horizon: It is the duration over which costs and
outcomes (i.e., benefits) are calculated in an economic analysis.
Costs: Cost refer to the monetary component of the economic
analysis. It can be divided into direct, indirect medical, and
non-medical costs, and intangible costs.
Outcomes: Outcomes also called ‘benefits’ or ‘consequences’,
are the expected healthcare or humanistic results from
intervention.
Willingness to pay (WTP): It is the process in which
individuals are asked the maximum they are willing to pay, in
monetary terms, to achieve a given benefit of an intervention/
service.
314 Social Pharmacy
Discounting: Method used to account for individuals’ time
preference. Most individuals have a positive rate of time
preference whereby benefits are preferred sooner rather than
later, and costs incurred later rather than sooner.
Modeling: Decision analyses from economic evaluations can
be operationalized through modeling processes such as
decision trees or simulation models.
Sensitivity analysis: It is a means of representing uncer-
tainty in the results of economic evaluations. The four main
types of sensitivity analyses are: (i) One-way simple sensitivity
analysis, (ii) multi-way sensitivity analysis, (iii) threshold
sensitivity analysis, and (iv) probabilistic sensitivity analysis
Methods of Pharmacoeconomic Evaluation
There are four methods of pharmacoeconomic evaluation
(Fig. 6.1). They are as follows:
1. Cost-minimization analysis (CMA)
2. Cost-effectiveness analysis (CEA)
3. Cost-benefit analysis (CBA)
4. Cost-utility analysis (CUA)
The ultimate objective of all four methods is to compare the
cost and outcome of alternative regimens, ideally by generating
a single index or cost-outcome ratio.
The nature of outcome measurement is the all-important
factor determining both the level of complexity and sophisti-
cation as well as the reliability and validity of a comparison of
alternative regimens.
Fig. 6.1: Methods of pharmacoeconomic evaluation
315Pharmacoeconomics
1. Cost-minimization analysis (CMA)
Cost-minimization analysis is the simplest method to compare
drugs that have the same clinical outcomes (i.e. efficacy and
safety). In such a case, the decision simply revolves around
the costs. CMA is a tool used in pharmacoeconomics and is
applied when comparing multiple drugs of equal efficacy and
equal tolerability.
It compares the costs of therapeutically equivalent drugs to
identify the least expensive drug, e.g. generic preparation
versus brand leader.
Employing CMA is appropriate when comparing two or
more therapeutically equivalent agents or alternate dosing
regimens of the same agent.
Applications: CMA shows the cost savings of one treatment
program over another. It aids in the selection of pharmaceu-
ticals for inclusion in the formulary.
2. Cost-effectiveness analysis (CEA)
CEA is the most commonly applied form of economic analysis,
especially in drug therapy. CEA evaluates multiple drug
treatments for the same condition, e.g. prolongation of life,
duration of treatment required, mortality rate, etc. It compares
the costs of two or more alternative interventions versus the
outcome of the effectiveness of the drug treatment, e.g.
prolongation of life, duration of treatment required, mortality
rate, etc. The results of a CEA are expressed as cost/outcome
for both therapies. It does not allow comparisons to be made
between two different areas of medicine with different
outcomes.
Cost-effectiveness ratio = Cost/effectiveness
Drug intervention with lower CER is preferred.
Cost of drug A – Cost of drug B
Incremental cost effective ratio
Benefits of dru
g
A – Benefits of dru
g
B
Applications: CEA is useful in comparing cost with health
outcomes for individual patients. CEA also assists a decision-
maker in identifying a preferred choice among possible
alternatives.
316 Social Pharmacy
3. Cost-utility analysis (CUA)
Cost-utility analysis refers to a particular form of CEA where
the outcomes are measured in terms of quality-adjusted life
years (QALY) gained. QALYs combine changes in quantity and
quality of life (QOL; mortality and morbidity) into one
composite measure which is independent of program or
disease. CUA is a type of evaluation in which drugs/
interventions with different outcomes can be compared. In this
evaluation, costs are measured in monetary terms and outcome
is expressed in terms of patient preferences or quality of life.
CUA is a suitable method to compare programs and treatment
alternatives that increase life expectancy with serious side
effects (e.g., cancer chemotherapy), and cause reductions in
morbidity (e.g. treatment of arthritis).
Applications: CUA compares treatment programmes with
different outcomes and various health programs. CUA can
compare cost, quality, and the number of patient-years.
4. Cost-benefit analysis (CBA)
CBA is a basic tool that permits the identification, measurement,
and comparison of the benefits and costs of a program or a
treatment alternative. In this technique, the costs and benefits
are assigned a monetary value. If the B:C (benefit: cost) ratio
equals 1, the benefits equal the cost. The benefits realized by
the program or treatment alternative are equivalent to the cost
of providing it. If the B:C ratio is less than 1, the program or
treatment is not economically beneficial. CBA should be
employed when comparing treatment alternatives in which the
costs and benefits do not occur simultaneously. Hence, different
interventions can be compared based on cost-benefit ratios. In
CBA the common denominator for conversion is money.
CBA also can be used when comparing programs with
different objectives because all benefits are converted into
rupees or dollars and to evaluate a single program or compare
multiple programs. This method of evaluation is well-
established in the insurance industry.
Applications: CBA is used mainly at the macro level for
policy decisions on healthcare programs.
317Pharmacoeconomics
Table 6.1: Appropriate methods for comparison of therapies
Therapies compared Appropriate method
Similar therapies produce essentially Cost minimization analysis
identical outcomes (CMA)
Different therapies resulting in clini- Cost-effectiveness analysis
cally different patient outcomes (CEA)
Similar therapies affecting quality Cost-utility analysis (CUA)
of life or patient preference for
treatment
Comparison of different interven- Cost-benefit analysis (CBA)
tions with different outcomes
Variables in pharmacoeconomic studies: Variables in
pharmacoeconomic studies are summarized in Table 6.2.
Table 6.2: Variables in pharmacoeconomic studies
Input/ Output/ Aim
investment benefit
Cost minimization Cost Therapeutic equi- Efficiency
valence
Cost-effectiveness Cost Health outcomes Cost minimization
(effectiveness given adequate
units) resources
Cost-benefit Cost Cost for health Optimized benefit
outcomes given limited
resources
Cost-utility Cost Health outcomes HrQoL gains
adjusted for HrQoL*
* HrQoL means health-related quality of life
The pharmacoeconomic evaluation tools are compared in
Table 6.3.
Limitations of Pharmacoeconomic Evaluations
a. Sometimes choice of the drugs is dictated by the avail-
ability.
b. Drugs are prescribed under promotional pressurizing
activities of marketing executives of pharmaceutical firms.
c. For chronic diseases, bioavailability consideration may
have an upper hand over Pharmacoeconomics.
318 Social Pharmacy
These limitations can be overcome by:
a. Creating awareness of concepts and rules of pharmaco-
economics in physicians (prescribers).
b. Sensitizing students of health sciences on pharmaco-
economics.
c. Procurement/purchase of drugs directly from the
pharmaceutical manufacturer.
Healthcare Costs
Total costs: The sum of all costs defined by research design
(perspective).
Direct medical costs: Direct medical costs is the amount that
is paid for specified health resources and services–physician
visit, medications, lab investigations, and hospitalization.
Direct non-medical costs: Direct non-medical costs are the
costs necessary to enable an individual to receive medical care
like lodging, special diet, transportation, and lost work time
(important to employers).
Table 6.3: Comparison of pharmacoeconomic evaluation tools
Evaluation method Description Objective
COI (cost of illness) Identification and esti- To estimate the finan-
mation of the total cost cial burden of a parti-
of a particular disease cular disease
CMA (cost minimi- Comparison of multiple To select the most eco-
zation analysis) drugs having the same nomical (least costly)
efficacy and tolerability treatment
CBA (cost benefit Computing a net gain To identify the cost
analysis) benefit of a particular benefits of any parti-
program or treatment cular program or
treatment
CEA (cost effective- Comparison of cost of To evaluate the cost of
ness analysis) more than one treat- multiple drug treat-
ment alternatives ments
CUA (cost utility Identification and To evaluate the conse-
analysis) comparison of the cost quences of treatment
of more than one treat- alternatives in terms
ment alternatives of quantity and
quality of life
319Pharmacoeconomics
Cost of illness analysis (COI): It includes sums of all costs
of a disease. COI uses data on the epidemiology of the disease,
its treatments, and outcomes and sums everything in costs.
COI is used to identify and set priorities for policy-making
Financial costs that fall on health services include drug
acquisition costs, days in the hospital, etc.
Healthcare costs are usually subdivided as follows:
1a. Variable costs: Costs, which vary immediately accord-
ing to the number of patients treated (e.g. drug acqui-
sition costs, costs of other consumables such as needles
and syringes)
1b. Fixed costs: Costs which do not vary with the number
of patients treated, at least in the short term, usually
one year (e.g. capital costs of building or equipment;
staff salaries).
2. Other financial costs: Financial costs which fall outside
the health services (e.g. prescription charges or other
treatment expenses incurred by the patient; cost of
patient’s and/or carer’s travel to and from hospital,
costs of providing social services, loss of productivity).
3. Intangible costs: Costs, which are difficult to measure
financially (e.g. pain, anxiety, and loss of energy; time
given up by voluntary carers).
4. Direct costs: Expenditure that can be identified and
allocated to a particular cost object in an economically
feasible manner is termed a direct cost.
5. Indirect costs: All the costs that are not tied to a
particular cost object, i.e. it is difficult to trace the cost
to a single product, is termed indirect cost.
6. Overheads: Examples of overhead costs include
salaries, maintenance, and production expenses.
Importance of Pharmacoeconomics
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. Pharmacoeconomics evaluation is critical to
320 Social Pharmacy
insurance companies. Numerous drug alternatives and
empowered consumers also fuel the need for economic
evaluations of pharmaceutical products.
1. It aids in clinical drug therapy evaluation, clinical
pharmacy service evaluation, and policy decision-making.
2. It helps the practitioners and administrators to make
decisions regarding their products and services.
3. It is a powerful tool to aid in effective formulary manage-
ment, individual patient treatment, medication policy, and
resource allocation.
4. It aids in making decisions on the selection of pharma-
ceuticals and medical devices.
5. Helps to decrease the concern for patients, healthcare
professionals, and the public.
6. Helps to find the optimal therapy at the lowest price.
7. In industry, it aids in the selection of specific research and
development options.
8. PE is used to determine program benefits and costs in the
public sector.
9. In the private sector, it is used to create insurance benefit
coverage.
10. Pharmacoeconomics combines the objectives of both
clinics and payers by estimating the value of patient
outcomes for the expenditure spent on medications and
other healthcare services.
11. PE is very useful in the formulation of the Essential Drug
List (EDL).
In the Indian scenario, pharmacoeconomics can help the poor
and middle-class populations obtain reasonable and affordable
healthcare services because many households are below the
poverty line and cannot afford costly private healthcare. Costs
of medicines are also increasing constantly.
Pharmacoeconomics evaluation can help to find the optimal
therapy at the lowest price. It can also help in health policy
decision-making and can be adopted by healthcare
professionals such as policymakers, primary healthcare
providers, healthcare administrators, and health managers.
321Pharmacoeconomics
REVISION QUESTIONS
Long Answer Questions (10 Marks)
1. What is pharmacoeconomics? Write components of
pharmacoeconomics.
2. Describe the importance of pharmacoeconomics.
3. Discuss the methods of pharmacoeconomic evaluation.
Short Answer Questions (5 Marks)
1. Write a note on healthcare costs.
2. Write a note on cost-effectiveness analysis (CEA).
3. Write a note on cost-benefit analysis (CBA).
4. Write a note on variables in PE studies.
5. Define QALY, opportunity cost, discounting, and WTP.
Very Short Answers Questions (2 Marks)
1. Define mental health.
2. Who coined the term pharmacoeconomics?
3. What is Quality Adjusted Life Year (QALY)?
4. What is Direct Medical Costs and Direct Non-Medical
Costs?
5. Define efficiency and incremental analysis.
Multiple Choice Questions [answers are in bold]
1. Which of the following statements represents the best
definition of pharmacoeconomics?
a. Description and analysis of the costs of drug therapy
to healthcare systems and society
b. Process of identifying, measuring, and comparing
costs, risks, and benefits of programs, services, or
therapies and determining which of several alter-
natives produces the best health outcomes for the
resources invested
c. Studies that attempt to identify, measure, and evaluate
the results of healthcare services in general
d. Application of economics to pharmacy
322 Social Pharmacy
2. In cost-effectiveness analyses, which of the following
statements regarding the decision is true?
a. The highest effect is used to determine cost-effective-
ness
b. It is a subjective judgment made by the decision-
maker to determine cost-effectiveness
c. The lowest ICER is used to determine cost-effective-
ness
d. Cost-effectiveness analyses depend upon the purchas-
ing capacity of consumers
3. A full economic evaluation includes:
a. A comparison of two or more alternatives in terms of
costs and consequences
b. An analysis of two or more alternatives in terms of
consequences
c. A comparison of two or more alternatives in terms of
cost
d. None of the above.
4. All of the following statements are general characteristics
of cost-effectiveness analyses (CEAs) except which one?
a. Costs are measured in economic terms and the
outcome is measured in natural units.
b. Ratios of costs to effects are used to make judgments
on cost-effectiveness.
c. Uses the human capital approach to place a dollar
value on outcomes
d. None of the above
5. Which one is not the method of pharmacoeconomic
evaluation:
a. Cost-minimization analysis (CMA)
b. Cost-effectiveness analysis (CEA)
c. Cost-benefit analysis (CBA)
d. Cost-utility analysis (CUA)
e. Cost-reduction analysis (CRA
6. Which government agency in India controls the prices of
pharmaceutical drugs?
a. National Pharmaceutical Pricing Authority (NPPA)
b. Ministry of Health and Family Welfare