Department of Pharmacology, SJTPC, Rajkot

GUIDED BY:

Mr. ASHISH KYADA

JAY RAJA

Department of Pharmacology, SJTPC, Rajkot

1.INTRODUCTION:

NEED FOR PHARMACOECONOMICS:

Department of Pharmacology, SJTPC, Rajkot

Over the past few years, the study of PE has experienced an extraordinary boom within the health care sectors.

Why?

Initially the decisions regarding the use of medical intervention was based on clinical safety, efficacy, and quality of the intervention used (old paradigm). But this scenario was suddenly changed into a different setting which mainly concerned about the cost of the intervention (new paradigm).

Department of Pharmacology, SJTPC, Rajkot

Desires and needs are infinite but resources are limited.

Thus, health economists are trying to find out the best way to allocate these resources appropriately in order to maximize the overall health of the population.

Pharmacoeconomics act as a tool that aids in decision-making for choosing an economic, safe, efficacious drugs using the combination of cost (resources used) and consequences (clinical, economic, humanistic). Pharmacoeconomics has been defined as the description and analysis of the costs of drug therapy to health care systems and society.

Department of Pharmacology, SJTPC, Rajkot

Questions that pharmacoeconomics may help to address are as follows:

Which drugs should be included in hospital formulary? Which is the ideal drug for a particular patient? Which is the ideal drug for pharmaceutical manufacturers to develop? Which drug delivary system is the best for the hospital? How do two clinical pharmacy services compare? What is the cost per quality adjusted year of life extended by a drug? Will patients quality of life be improved by a particular drug therapy decision? What is the best drug for particular disease?

Department of Pharmacology, SJTPC, Rajkot

For better scenario:

understanding

consider

one
Department of Pharmacology, SJTPC, Rajkot

Suppose, you are a clinical pharmacist, member Pharmacy and Therapeutic Committee at hospital, and have been given responsibility evaluate a new beta blocker product for addition the hospital drug formulary.

of a to to

In clinical setting:
The consideration must be given to; Therapeutic effectiveness of the agent for patient subpopulation, Impact of therapeutic agent cost or impact on pharmacy budget, Quality of life.

Department of Pharmacology, SJTPC, Rajkot

In industrial setting:
The consideration must be given to; All the criteria which are having impact on clinical setting, Competition with other companies and impact of drug in market

2.TYPES OF PHARMACOECONOMIC EVALUATIONS:

Cost-Minimization Analysis (CMA): Cost-Effectiveness Analysis (CEA):
Department of Pharmacology, SJTPC, Rajkot

Cost-Utility Analysis (CUA):

Cost-Benefit Analysis (CBA): Cost-of-Illness Evaluation (CIE): Cost-Consequences Analysis (CCA):

2.1) Cost-Minimization Analysis (CMA):

When two or more drugs or alternative therapies have demonstrated equivalent outcomes, then only costs of these alternatives need to be compared, such analysis is referred as CMA. Example-1: CARBOPLATIN & CISPLATIN (In the treatment of ovarian cancer) Example-2: Comparision of two prescription, one of which consist of Generic company product while other is Brand leader. (Molpara and Crocin)

Department of Pharmacology, SJTPC, Rajkot

LIMITATION:
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Outcomes must be equivalent for analysis.

2.2) Cost-Effectiveness Analysis (CEA):

It is a technique used to aid in decision-making between alternatives; when the costs are measured in monetary terms (Rupees) but the outcomes are measured in natural unit changes in health (life years increased or number of side effects decreased). Additional benefit is worth even if the cost is more.

Department of Pharmacology, SJTPC, Rajkot

There can be 9 possibilities when comparing two different drugs or program or intervention:

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Adopt: More effective, less cost A: At least as effective at less cost B: More effective at same cost C: More effective, more cost D: Less effective and less costly (reduction in cost is more than the reduction in effect)

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Department of Pharmacology, SJTPC, Rajkot

Alternative with lower cost to effectiveness ratio is considered as preferable. Most studies using CEA have been performed using,
1) ACER (Average Cost-Effectiveness Ratio) ACER=Total cost/Total effectiveness
Department of Pharmacology, SJTPC, Rajkot

2) ICER (Incremental Cost-Effectiveness Ratio) ICER= Diff. in cost/Diff. in benefits

ICER=

Cost A Cost B Effect A Effect B

In other words, ICER means: Added cost per additional effect gained for one alternative (eg, new drug A ) as compared to another (eg, old drug B).
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How CEA can be used in deciding Costeffectiveness in a pharmacy setting:

Example 1:
Department of Pharmacology, SJTPC, Rajkot

Comparison of four lipid lowering agent/program: No drug treatments or dietary modifications-No Pharmacological program Drug-A Drug-B Drug-C (1) Drug-C (2)

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Four measures of effectiveness: i) Changes in total cholesterol level ii) HDL iii) LDL iv) Triglycerides

Department of Pharmacology, SJTPC, Rajkot

Now, any one effectiveness is considered as common:

Assume decreased total cholesterol level as the most clinical outcome. Then, a decision could be made based on drug costs and total cholesterol level.

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Example 2: (More detailed)

Deep

Vein Thrombosis:
Department of Pharmacology, SJTPC, Rajkot

Venous thromboembolism (VTE) comprises both; deep vein thrombosis (DVT) and pulmonary embolism (PE). VTE is responsible for appx. 2,50,000 hospitalization in US each year. 20% of people with accute PE present with sudden death, 30% of people with VTE syndromes die within 30 days. Direct costs of VTE reaches appx. 3-4 billion dollars annualy.

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Depending on treatment for VTE, there are additional costs potentially associated with therapeutic monitoring. Furthermore, management of potential side effects of anticoagulants, including bleeding and heparin induced thrombocytopenia (HIT) are very expensive. Cost related to long-term complications of VTE, including clot recurrence and post thrombotic syndrome. A recent cost-effective analysis determined that use of Fondaparinux for initial DVT therapy may offer substantial cost savings relative to Enoxaparin.

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Department of Pharmacology, SJTPC, Rajkot

TABLE-1
MODEL
INPUTS FOR RATES OF VENOUS THROMBOEMBOLISM MAJOR BLEEDING, AND

(VTE)

RECURRENCE,

HEPARIN-INDUCED

THROMBOCYTOPENIA,AND ASSOCIATED COSTS PER EVENT.

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Department of Pharmacology, SJTPC, Rajkot

TABLE: 2
RESULTS OF BASE-CARE COST-EFFECTIVE ANALYSIS OF FONDAPARINUX VERSUS ENOXAPARIN FOR TREATMENT OF DEEP VEIN THROMBOSIS (DVT)

Department of Pharmacology, SJTPC, Rajkot

From these data it is concluded that Fanoparinux offers greater advantage in DVT compared to other agents.

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LIMITATIONS:

All years of life are valued equally without considering QUALITY (Full functional state)of life.
Department of Pharmacology, SJTPC, Rajkot

CEA can measure effectiveness.

only

one

measure

of

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2.3) Cost-Utility Analysis (CUA): It is considered to be an extension of costeffectiveness analysis.

Department of Pharmacology, SJTPC, Rajkot

The main advantage of CUA as compared to traditional CEA is that it can combine more than one measure of effectiveness or both measures of morbidity and mortality into a single measure. In CUA, both quality and quantity of life often measured from patients perspective are merged into a single unit by calculating utility/preference for the alternatives and then calculating qualityadjusted life year (QALY).

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QALY is not a well defined fixed unit, it changes from study to study. Example:
Department of Pharmacology, SJTPC, Rajkot

With Treatment (X drug)

Estimated Survival=10 years

Without Treatment
Estimated Survival=5 years

Estimated Quality of life=0.7 years Estimated Quality of life=0.5 years QALY=10*0.7=7 Years QALY=5*0.5=2.5 Years

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QALY gain from treatment 7-2.5=4.5 Years

Department of Pharmacology, SJTPC, Rajkot

To achieve QALY total ` 18,000 need to be spend. Therefore, per year ` 4,000 is the cost of X drug. Now, drug X is compared with drug Y, in terms of total cost and QALY gained from the treatment.

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LIMITATION:
Department of Pharmacology, SJTPC, Rajkot

The only limitation of CUA is that it should not be applied when single intermediate outcome is enough to measure effectiveness of therapy. Example: Restricted days due to disability.

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2.4) Cost-Benefit Analysis (CBA):

It compares the total costs of each alternative to resultant outcome/benefits of the intervention measured in monetary units i.e., Cost-Benefit Ratio: Total cost/Benefit Benefits are measured using contingent valuation or willingness to pay method (WTP). WTP measures an individuals desirability or utility (Preference) for a program by determining how much money he/she is willing to pay in order to gain improved health.

Department of Pharmacology, SJTPC, Rajkot

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Example: The value of a new antidepressant, Moclobemide, in comparison to TCAs (Amitryptiline, Imipramine, etc.) which have equivalent efficacy but a higher incidence of adverse events.

Department of Pharmacology, SJTPC, Rajkot

LIMITATION: CBA is difficult to perform because it requires both cost and benefits to be measured in monetary terms

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2.5) Cost-of-Illness Evaluation (CIE):

Cost-of-illness studies are evaluation of new therapies.

important

to

PE
Department of Pharmacology, SJTPC, Rajkot

By evaluating the humanistic impact of disease and resources used in treating a condition prior to discovery of a new intervention, the pharmacoeconomist can effectively establish a baseline for comparison.

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2.6) Cost-Consequences Analysis (CCA):

A cost-consequence analysis has been defined as one in which costs and effects are calculated but not aggregated into quality life adjusted years or cost-effectiveness ratios.

Department of Pharmacology, SJTPC, Rajkot

In simple words, this type of analysis comprises a listing of all relevant costs and outcomes of drug therapy or healthcare intervention including direct medical costs, direct non-medical costs, indirect costs, clinical outcomes, utility impacts, and quality of life impacts.

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It provides most comprehensive presentation of information describing the value of an intervention and has an advantage of being more readily understandable and more likely to be applied by healthcare decision-makers. In this application, weigh of different costs and benefits is left to each decision-maker.

Department of Pharmacology, SJTPC, Rajkot

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LIMITATIONS: A possible drawback for disaggregated presentation of health outcomes is that decisions made at the individual decision-makers level might not be made in patients or societys best interests. Another potential drawback of cost-consequence analysis is that all of the data are not always of comparable quality.

Department of Pharmacology, SJTPC, Rajkot

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3. TYPES OF INPUTS AND OUTPUTS IN PHARMACOECOMONIC STUDIES:

Inputs:
Department of Pharmacology, SJTPC, Rajkot

Healthcare Sector (C1): Cost of providing care by the program (i.e. organizing and operating costs within the health sector). It also include continuing care (Hospitalization). Patient and Family (C2): Out of pocket cost, co-payment cost, cost due to time spent in treatment/unemployement. External costs (C3): This category includes all resources consumed in other sectors (Other than healthcare sector for e.g., Volunteer sector, Kitchen, Caregiver sector (nurses) etc..)

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 Outputs:

Economic outcome: Reduction in resources use or savings, this may occur to health sector (S1), patient and family sector (S2), non-health sector (S3). Clinical outcome/Physical effects: E: Physical effects in natural units for e.g., number of lives saved, number of deaths prevent, number of disability days reduced. H: Humanistic outcome. V: Changes in health related quality of life measures (HRQOL) and other values. U: QALY (Quality adjusted life-years) based on valuation of health state preferences W: Willingness to pay or Contingent valuation W: Global willingness to pay

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Department of Pharmacology, SJTPC, Rajkot

4. EQUATIONS FOR PHARMACOECONOMIC EVALUATIONS

Cost-Minimization Analysis (CMA): (C1-S1) Or (C1+C2+C3)-(S1+S2+S3)

Cost-Effectiveness Analysis (CEA): (C1-S1)/E; [(C1+C2+C3)-(S1+S2+S3)]/E

Department of Pharmacology, SJTPC, Rajkot

Cost-Utilization Analysis (CUA): (C1-S1)/U; [(C1+C2+C3)]/U Cost-Benefit Analysis (CBA): (W)-(C1+C2+C3); [(W+V+S1+S2+S3)-(C1+C2+C3)]

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Department of Pharmacology, SJTPC, Rajkot

Sincere Thanx to,

Dr. Manish Rachchh, Dr. Rina Gokani, Mr. Pinakin Jadav, &

Department of Pharmacology, SJTPC, Rajkot

Mr. Ashish Kyada

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RNDr. Marta Megyesiov

I have finished my presentation you can get up!!!

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Department of Pharmacology, SJTPC, Rajkot