Pharmacoeconomic Evaluation of Conservative and Interventional Management in patients with Coronary Artery Disease: Real World Data

 

Krupanidhi Karunanithi1, Aditya. J2, Angaleshwari. M3, Anna Joseph4, P. Sharmila Nirojini5*

1Assistant professor, Emergency Medicine Department, Swamy Vivekanadha Medical College Hospital and Research Institute.

2Pharm D Intern, Swamy Vivekanandha College of Pharmacy, Namakkal, Tamil Nadu, India.

(Affiliated to the Dr. M.G.R. Medical University)

3Pharm D Intern, Swamy Vivekanandha College of Pharmacy, Namakkal,

Tamil Nadu, India. (Affiliated to the Dr. M.G.R. Medical University)

4Pharm D Intern, Swamy Vivekanandha College of Pharmacy, Namakkal,

Tamil Nadu, India. (Affiliated to the Dr. M.G.R. Medical University)

5Professor and HOD, Department of Pharmacy Practice,

Swamy Vivekanandha College of Pharmacy, Namakkal, Tamil Nadu, India

(Affiliated to the Dr. M.G.R. Medical University)

*Corresponding Author E-mail: sharmilapractice@gmail.com

 

ABSTRACT:

Objectives: The study tackles evaluating and comparing the cost-effectiveness of Conservative and Interventional Management in patients with CAD from the payer’s perspective concerning real-world data. Methodology: The pharmacoeconomic analysis consisted of an ICER calculation quadrant and a decision tree that reflected the most economically advantageous course of treatment, whether it be conservative or interventional. The costs for the interventional and conservative therapy were taken from The Government of Tamil Nadu, the Chief Minister's Comprehensive Health Insurance Scheme, and the Pharmacy of the multispecialty hospital, and the SF-36 Questionnaire was used to measure patients' health-related quality of life. Result: 126 patients were included. The SF-36 score 1 and 3 QoL comparison between conservative and interventional management had a high level of significance (p values = 0.00349 and 0.0035, respectively). When comparing the costs of conservative and interventional management, the results were extremely significant (p-value 0.001). For patients receiving interventional management, the average medical expense is higher (Rs 1, 41, 784 vs. Rs 38, 388). Patients with CAD receiving conservative therapy had an average HRQol score that was higher (52.32 vs. 39.64). The overall ICER of conservative versus interventional management in terms of life years saved was Rs 8,154. Conclusion: CAD patients receiving Interventional management has higher average medical cost than conservative management.  CAD patients receiving conservative management had a higher average HRQol. ICER of conservative versus interventional management in all age groups was Rs 8,154/life years saved. Conservative management was more Cost- Effective than interventional.

 

KEYWORDS: Pharmacoeconomic Evaluation, Coronary Artery Disease, Conservative and Interventional Management, Cost, QOL.

 

 


 

 

 

INTRODUCTION: 

Coronary artery disease (CAD) is an atherosclerotic pathological disorder that may or may not be symptomatic3. CAD harms the human population globally4. By making therapeutic changes in lifestyle and using effective medications, secondary prevention of CAD may lower mortality, avoid recurrent cardiovascular events, and enhance the QoL5.

The prevalence of acute coronary syndrome and ST-elevation myocardial infarction is now the highest in India (MI). It has been recognised to be the primary contributor to the global burden of disease and is the third biggest contributor to years of disability-adjusted life4. 3.8million men and 3.4million women die each year from coronary heart disease, which is currently the leading cause of death worldwide1. In India, coronary artery disease has become a major public health concern. One of the main factors contributing to death and disease in this nation is CAD.  It also results in a significant financial burden.6

 

High blood pressure, diabetes, smoking, being postmenopausal for women and older than 45 for men are the main risk factors for coronary artery disease as well as high LDL cholesterol, low HDL cholesterol, high blood pressure, family history, and obesity.9 Diabetics have a CAD prevalence of 21.4%, while non-diabetics have a prevalence of 11%. Rural areas of the country have a CAD prevalence that is almost half that of urban areas6. When considering the risk factors men and women are both at risk. It has been demonstrated that a 1mg/dl rise in HDL levels reduces the risk of coronary disease by 3% in women and 2% in men. Smokers experience a twofold increase in IHD-related mortality and morbidity as compared to non-smokers. Endothelial dysfunction is induced by hypertension. In 75-80% of diabetic people, cardiovascular disease (CHD) is the primary cause of mortality, and of these deaths, 75% are attributable to CHD. A higher body mass index (BMI) in children has been linked to an increased risk of coronary heart disease (CHD) in adults7. Annual deaths from cardiovascular disease account for about 30% of all deaths worldwide.10

 

Angioplasties are the primary management method used in CAD because they can: improve blood flow via the obstructed artery, reduce angina, improves one's capacity for exercise, and lowers the chance of having a heart attack, Carotid endarterectomy: opening of neck arteries to reduce the risk of stroke8. PCI eases angina and lowers myocardial ischemia in individuals who have stable ischemic heart disease (SIHD), but there hasn't been any evidence of a survival advantage from this procedure in randomized trials. While PCI decreases the composite of recurrent death plus MI in patients with non-ST-segment elevation myocardial infarction (MI) and increases longevity for patients with acute ST-segment elevation myocardial infarction (MI), respectively3. Vascular grafts known as coronary artery bypass grafts are used to overcome coronary blood vessel blockages. The 5-year and 10-year survival rates after CABG are approximately 85% and 70%, respectively. For up to 10-15 years, CABG typically improves or eliminates angina, and it may also lower the chance of suffering a heart attack8.

 

To evaluate the health care costs and health outcomes of different approaches to treatment in the presence of scarce resources in terms of both their cost and consequences, economic modeling, is frequently used in the economic analysis of pharmaceuticals (cost-effectiveness analysis, cost-utility analysis, cost-benefit analysis, and budget impact analysis)9. Pharmacoeconomics focuses on the application of techniques for economic evaluation of health care programmes to interventions involving pharmaceutical products7. In pharmacoeconomics, decisions are made between options when resources are scarce, as they are in India, our country.8 For the most effective distribution of healthcare funds, pharmacoeconomics provides methods for evaluating the health benefits and financial costs of medical products in a systematic way10. A drug's value for the price the pharmaceutical company sets can be assessed using a cost-effectiveness analysis to examine whether branded medications are priced in line with their therapeutic benefits. It is typically accomplished by determining an incremental cost-effectiveness ratio (ICER), which is defined as the relationship between the estimated quality-adjusted life-years (QALYs) acquired through a course of treatment and the price charged for the drug treatment plus or minus any cost offsets. QALYs, or quality-adjusted life years, are frequently employed as a measure when interventions are utilized to enhance health outcomes. This measurement adds a quality-of-life index to the number of years added to a person's life through medical intervention. Interventions are deemed cost-effective if their cost per QALY does not exceed predetermined amount, the latter of which is influenced by the decision-financial maker's constraints11. The quality of life (QoL) of a person is defined by the World Health Organization as "the perception of his position in life within the cultural context and values he lives as well as in relation to his goals, expectations, standards, and concerns."3 For research evaluating the effectiveness of healthcare, analysing the effects of sickness, and conducting cost-effectiveness evaluations, HRQOL is acknowledged as a crucial health outcome.2 For example, the SF-36 (Medical Outcomes Study Short Form Health Survey), EQ-5D (Euro Qol), and WHOQOL (The World Health Organisation Quality of Life) are just a few of the evaluation tools available to measure health-related quality of life.5 The crucial premise of this strategy is that none of the variables is exogenous and is not affected by the analysis. While the presumption might be true for data on a drug's efficacy, it is undoubtedly insufficient when taking into account aspects that influence pharmaceutical prices12.

 

 

Cost-benefit analysis (CBA) compares an action's benefits with costs to determine whether a project or policy is socially desirable. The goal of using CBA in treatment decisions- or policy-making is to make sure that resources are distributed effectively, hence enhancing societal welfare13. CBA results that are calculated for each patient may be applied to the entire population being studied, making it easier to compare the effectiveness of various programs14. When the clinical efficacy of the alternative therapies is the same as that of the medication therapy, cost-minimization or cost-identification is an analytical procedure used in pharmacoeconomics to analyze the cost of pharmacological treatment15. Cost-utility analysis (CUA) compares the incremental cost of a program from a specific perspective to the incremental benefit in health measured in quality-adjusted life years (QALYs)16.

 

The decision analysis tree outlines and quantifies the outcomes of two or more options for a decision to be made. It helps to quantify and compare various health strategies, including drug therapy in terms of cost or health outcomes. A Markov chain is a series of events where the probability of one event happening depends on the probability of the previous occurrence17. Models are frequently the only reliable source of rapid, flexible, reasonably priced information on illness care strategies' clinical, financial, and humanistic effects18. Pharmacoeconomic models are used by following the guidelines for economic analysis that have been published, such as using comparators that are relevant to the local area, discounting to present value, rigorous sensitivity analysis, and the right health utility values19.

 

The input correlation with different methodologies revealed that, for the most part, the ideal decision was made using the same criteria as in the independent scenario. However, introducing input correlations resulted in a dramatic change in the value of additional information. The outcomes were consistent across dependency patterns and mostly depended on the correlation's strength, as determined by the linear correlation coefficient20. Transparency rarely even has face validity; from the viewpoint of the subject matter expert, the simplifications that modelers must make frequently leave more problems unanswered. Modelers can alert users to flaws in their models through transparency; however, this can be done by simply outlining the model's restrictions, which does not bring us any closer to actual accuracy21.

 

MATERIALS AND METHODS:

Study Population- Patients from a Multispecialty Tertiary Care Teaching Hospital with Coronary Artery Disease between the ages of 20 and 90 have participated in this prospective comparative cost-effective study. Data were gathered over six months. After patients were screened, 126 patients were selected based on inclusion and exclusion criteria and with the patient’s consent, data were gathered using a specifically created data input form.

 

Inclusion Criteria- Age group 20- 90 years, Both Male and Female patients, Coronary Artery Disease patients, Patients who are treated with Conservative and Interventional Management.                                

 

Exclusion Criteria- Age less than 20 and more than 90 years, Pregnant and Lactating Women, Pediatrics, Self-finance patients, Chronic CAD patients who cannot undergo Interventional Management, Patients who are not willing to participate.

 

Patient’s case report, Designed data entry form, ECG report, ECHO report, Medication chart, Cost per unit details from Pharmacy, Patient and Patient's caretaker interview were utilized and the collected data was analyzed will Independent and Paired Student- t test to compare the cost-effectiveness of Conservative and Interventional Management by using Microsoft Excel 2007.

 

Then Quality Adjusted Life Years were estimated using

 

QALY = No. of years patients with disease x HRQoL score

The formula used to determine Incremental Cost Effectiveness Ratio (ICER)

 

ICER= (Cost of A- Cost of B)/ (Effect of A- Effect of B)

Here, A- Interventional management, B- Conservative management

 

A report was created after the data was evaluated using the ICER Quadrant plane.

 

The software Tree Age Pro Healthcare 2022 R2.1 was used to create the decision tree model for clinical decision analysis. It served as the study's conceptual underpinning for the assessments and the pharmacoeconomic decision-making process.

 

Statistical Analysis- P 0.05 was taken into consideration as statistically significant P0.05 was regarded as statistically significant when performing the analysis applying the Independent and Paired Student-T Test by SPSS Version 22.0.

 

 

 


RESULTS:

Table 1: Data of Study Population

S. No

Demographic details

Conservative No of Patient (N= 56)

Percentage (%)

Interventional No of Patient (N= 70)

Percentage (%)

1.

Age

25-35 years

01

1.78

00

0

36-45 years

08

14.28

06

8.57

46-55 years

09

16.07

15

1.42

56-65 years

18

32.14

20

28.57

66-75 years

16

28.57

20

28.57

76-85 years

04

7.14

09

12.85

Age in years

(mean ± SD)

59.75

61.66

2.

Gender

 

No Of Patients (N= 56)

Percentage (%)

No Of Patients (N= 70)

Percentage (%)

Male

32

57.14

42

60

Female

24

42.85

28

40

3.

BMI Category

(N= 126)

Underweight

6

4.76

Normal

61

48.41

Overweight

49

38.88

Obese

13

10.31

BMI (mean ± SD)

23.55

25.91

4.

Ejection Fraction

(N= 126)

Low

84

66.66

Possible Heart Failure

42

33.33

5.

Incidence

(N= 126)

Cardiac diseases

20

15.87

Cardiac Diseases with Co- Morbidities

106

84.12

6.

Co- Morbidities

(N= 106)

Hypertension

74

69.81

Diabetes Mellitus

63

59.43

Respiratory Disorders

11

10.37

Renal Disorders

11

10.37

Cardiovascular Disorders

4

3.77

Lipid Disorders

5

4.71

Seizure

1

0.94

Sleep Disorders

1

0.94

Cancer

1

0.94

Thyroid Disorders

5

4.71

Hepatitis

1

0.94

Psychiatric Disorders

2

1.88

Secondary Infections

3

2.83

Anemia

1

0.94

7.

Treatment

(N= 126)

Conservative

56

44.44

Interventional

70

55.56

8.

Procedure

(N= 70)

 

Number Of Patients

Percentage (%)

PCI

68

93.15

CABG

5

6.84

9.

Average Length Of Stay

Conservative Therapy Subjects

3.63

Interventional Therapy Subjects

3.84

10.

Average No. Of Medication Prescribed

Conservative Therapy Subjects

14.41

Interventional Therapy Subjects

23.4

11.

Type Of Therapy

 

Number Of Drugs In Conservative Treatment

Number Of Drugs In Interventional Treatment

Monotherapy

68

82

Dual Drug Combination

36

39

Triple Drug Combination

7

6

12.

Average Cost Of Therapy

Therapy

Average Cost

Conservative Therapy (n = 56)

38,388.44

Interventional Therapy (n=70)

1,41,784.088

13.

Average Quality Of Life (Sf-36 Score) Of Therapy

 

SCORE 1

SCORE 2

SCORE 3

Conservative

35.17

43.75

52.32

Interventional

26.14

33.35

39.64


The average patient score in conservative management was observed to have increased in the third evaluation (52.32142857 9.86) when compared to the first (35.17857143 8.94). According to the statistical analysis (p-value = 0.00349), there is a highly significant difference between the scores before and during the patient's continuous treatment. As for interventional management, it was found to have increased in the third evaluation when compared to the first (26.14285714 4.59). As for the statistical analysis, there is a significant difference between the patient's scores before and after their current treatment (p-value = 0.0035).

 

Using the Independent Student T Test to assess treatment costs, it was discovered that the Conservative option's average cost (38388.44 16747.14) was lower than the Interventional Management's (141784.0882 19716.29). According to the statistical study, there is a highly significant difference in the prices of conservative and interventional management (p-value = 0.001).

 

ICER Calculation

ICER = Cost of Interventional- Conservative / Effect of Interventional- Conservative

ICER = (1, 41, 784. 088 – 38,388.44)/ (39.64 - 52.32)

ICER = (1, 03, 395)/ (-12.68) = (- 8,154.17)

 

Patients receiving interventional management incur higher medical costs on average (Rs 1,41, 784 vs Rs 38, 388 for Conservative management). The majority of CAD patients receiving conservative therapy had higher average HRQol scores (52.32 versus 39.64) (Table 2).

 

Table 2: ICER Parameters for Conservative and Interventional Management

ICER Parameters

Conservative

Interventional

Score 1

35.17 ± 8.94

26.14 ±  4.59

Score 3

52.32 ± 9.86

39.64 ± 5.40

P Value

0.00349

0.0035

Average Cost (Rs)

38,388.44 ± 16747.14

1,41,784.088 ± 19716.29

P Value

<0.001

 

The overall ICER of conservative versus interventional therapy in patients was Rs 8,154.17 in terms of life years saved. Contrary to widespread assumption, conservative management in our study seemed to be more cost-effective (Figure. 1).

 

 

Figure 1: ICER Quadrant

Model Outcome:

Outcomes from a decision tree model developed with TreeAge Pro Healthcare 2022 R2.1 include the following. (Figure. 2).

 

 

Figure 2: Structure of the Decision Tree

 

The triangles indicate results or the endpoint, and the square stands for options or decisions. So "conservative management" and "interventional management" are possibilities. With each scenario, the patient experiences a chain of events that either results in recovery or complications that are followed by death. Cost and effectiveness varied depending on the payoff and QALY for the "conservative management" and "interventional management" options. According to the decision tree analysis results, conservative treatment is preferable to interventional management in terms of payoff and QALY.

 

The graph (Figure 3) demonstrates that conservative management was found to be cost-effective.

 

 

Figure 3: Graph Demonstrating Cost- Effectiveness

 

Cost-Effectiveness Rankings Report:

ICER values and incremental cost and effectiveness values were generated using the TreeAge Pro Healthcare 2022 R2.1 application (Figure 4).

 

Figure 4: ICER Calculation using software

The ICER value determined manually using a formula and the value generated by the application were nearly identical. The correlation of the ICER results can be used to make significant choices.

 

DISCUSSION:

The study included 126 individuals, with 58.73% being between the ages of 56 and 75. Our study primarily focused on the cost-effectiveness of treatment alternatives from the payer's perspective by integrating the cost and quality of life, followed by the correlation of ICER that could assist with major decision-making. The dominant treatment option in the ICER decision matrix is believed to be the one that is less expensive and more effective. According to the Tree Age CE Rankings data, dominating is a treatment choice with a high cost and vice versa. Our research found that CAD patients who receive interventional care have a higher average medical cost (Rs 1, 41, 784 versus Rs 38,388 for conservative management).

 

CONCLUSION:

While analyzing the cost-effectiveness of both treatment options for CAD patients using TreeAgePro2.1 healthcare and the ICER quadrant, assuming from the payers' perspective because household, out-of-pocket expenditure accounts for 85% of overall health expenditure. Conservatively managed CAD patients had a higher average HRQoL. In all age categories and both genders, the ICER of conservative versus interventional management was Rs 8,154.17 per life year saved. Regardless of age, gender, BMI, or co-morbidities, conservative therapy appeared to be more cost-effective than interventional management.

 

Ethical Approval- The study protocol was approved by the Institutional Ethical Committee (IEC) of Vivekanandha Medical Care Hospital, Elayampalayam (Ref.No.EC/NEW/INIT/2021/1811 dated 17/09/2022). Before enrolling in the study, individuals were made aware of it and required to sign a written consent form in both Tamil and English.

 

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Received on 12.05.2023            Modified on 14.11.2023

Accepted on 16.03.2024           © RJPT All right reserved

Research J. Pharm. and Tech 2024; 17(5):2133-2138.

DOI: 10.52711/0974-360X.2024.00337