COST VARIATION ANALYSIS OF ANTIHYPERTENSIVE DRUGS AVAILABLE IN INDIAN MARKET: AN ECONOMIC PERSPECTIVE

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IJPSR (2016), Vol. 7, Issue 5 (Research Article) Received on 03 December, 2015; received in revised form, 14 January, 2016; accepted, 07 February, 2016; published 01 May, 2016 COST VARIATION ANALYSIS OF ANTIHYPERTENSIVE DRUGS AVAILABLE IN INDIAN MARKET: AN ECONOMIC PERSPECTIVE Laxminarayana Kamath * and G. R. Satish Department of Pharmacology, Bangalore Medical College and Research Institute, K R Road, Bangalore, Karnataka, India Key words: Cost-analysis, Antihypertensive, Percentage cost variation, Brands Correspondence to Author: Laxminarayana Kamath Assistant Professor, Department of Pharmacology, Bangalore Medical College and Research Institute, K R Road, Bangalore, Karnataka 560002, India E-mail: koteshwarkamath@yahoo.com ABSTRACT: Aim: To analyze the percentage cost variations among different brands of the commonly prescribed anti hypertensive drugs. Materials and Methods: The cost of different brands of commonly used antihypertensive drugs was sorted out by referring latest CIMS, MIMS, Drugs Monitor and IDR. The cost of 10 dosage forms (Tablets / capsules) in INR of each brand, Cost Ratio and Percentage Cost Variation were calculated. Results: The percentage variation in the cost was above 100% with most of the commonly used antihypertensive drugs like Amlodipine (2.5 mg) 1040.58%, Atenolol (50 mg) 564.10%, Telmisartan (40 mg) 542.22% and Ramipril (10 mg) 478.39%. Among the combination therapy Atenolol + Hydrochlorothiazide (50 + 12.5 mg) 504.82%, Amlodipine + Atenolol (5 + 50 mg) 437.86% and Lisinopril + Hydrochlorothiazide (5 + 12.5 mg) 403.33% variation Conclusion: Hypertension is the most common cardiovascular disease and drugs are to be prescribed for prolonged period. If a costly brand is prescribed, the patients have to pay more money unnecessarily for their treatment. The costly brand of same generic drug is proved to be in no way superior to its economically cheaper counterpart. Ideally, therefore, the drugs should be prescribed in generic to save the patient's money and to enhance the compliance. INTRODUCTION: Hypertension is one of the major causes of morbidity, mortality and needs lifelong treatment. It is a major risk factor for cardiovascular disease. Worldwide nearly 1 billion adults (more than a quarter of world s population) had hypertension in 2010 and this is predicted to increase 1.56 billion by 2025. Hypertension is fast gaining the status of a potential epidemic in India. Prevalence of hypertension in India is reported to vary from 17 21%. The situation is more alarming as hypertension attributes for nearly 10% of all deaths. 1-3 QUICK RESPONSE CODE DOI: 10.13040/IJPSR.0975-8232.7(5).2050-56 Article can be accessed online on: www.ijpsr.com DOI link: http://dx.doi.org/10.13040/ijpsr.0975-8232.7 (5).2050-56 Pharmaco-economics plays an important role in practice of medicine in developing countries. Cost of drugs is an important factor influencing compliance with treatment of disease and also constitutes an essential part of rational drug prescription. Pharmaceutical Industry has many branded formulation of the same drug with large difference in selling price. In India, most of the drugs are available in brands and these are also prescribed by clinician mostly in brand name. This may affect the patient's finance adversely if costly brand is prescribed specially in diseases like hypertension which need treatment for longer duration. 4 Very few studies are available in Indian scenario, which compare the cost of drugs of different brands. Therefore, we decided to carry out the International Journal of Pharmaceutical Sciences and Research 2050

study which compares the cost of different brands of drugs used for the treatment of one of the most common disorder, hypertension. The study here focuses on cost-effectiveness analysis on different available brands of antihypertensive drugs in India. MATERIALS AND METHODS: Cost of a particular antihypertensive drug (cost per 10 tablets/capsules) in the same strength and dosage forms being manufactured by different companies was obtained from latest Current Index of Medical Specialties October - December 2015, 5 Indian Drug Review (IDR) 2015, 6 Monthly Index of Medical Specialties November 2015, 7 Drugs monitor 2015. 8 as they are readily available source of drug information and are updated regularly. The cost was also crosschecked at pharmacy (retail drug store). Cost ratio between the maximum and minimum cost of the same drug manufactured by different pharmaceutical companies was calculated as follows: Cost ratio= Maximum cost / Minimum cost Percentage cost variation was calculated as follows: % cost variation = (Max cost - Min cost) 100 Min cost The drug formulation being manufactured by only one company was excluded. RESULTS: The prices of commonly used antihypertensive drugs (23 single + 15 combination preparations) manufactured by different pharmaceutical companies were analyzed. Table 1 shows percentage cost variation of 23 commonly used antihypertensive drugs used as a single drug therapy. TABLE 1: PERCENTAGE COST VARIATION OF COMMONLY USED ANTIHYPERTENSIVE DRUGS AS A SINGLE DRUG THERAPY Drug Dosage form Minimum cost(inr) Max cost(inr) cost ratio % Cost variation Calcium Channel Blockers Amlodipine 2.5mg Tablet 7.54 86 11.41 1040.58 Amlodipine 5mg Tablet 5.71 44 7.71 670.58 Clinidipine 5mg Tablet 25 42 1.68 68.00 Nifidepine 10mg SR-Tablet 11.33 14.2 1.25 25.33 Beta Blockers Atenolol 50mg Tablet 5.71 37.92 6.64 564.10 Atenolol 25mg Tablet 4.14 27.07 6.54 553.86 Labetalol 100mg Tablet 29.57 110 3.72 272.00 Metoprolol 25mg Tablet 12 37 3.08 208.33 Metoprolol 50mg Tablet 18.5 55.97 3.03 202.54 Carvedilol 12.5mg Tablet 30 66 2.20 120.00 Metoprolol25mg ER-Tablet 21 45.35 2.16 115.95 Metoprolol25mg ER-Tablet 31.5 62.95 2.00 99.84 Carvedilol 25mg Tablet 52 100 1.92 92.31 Nebivolol 5mg Tablet 52 81.5 1.57 56.73 ACE inhibitors Ramipril 10mg Tablet 31 179.3 5.78 478.39 Ramipril 5mg Tablet 45 123.9 2.75 175.33 Enalapril 2.5mg Tablet 8.8 22.6 2.57 156.82 Enalapril 5mg Tablet 15 36.84 2.46 145.60 Lisinopril 5mg Tablet 25.1 53.24 2.12 112.11 Drug Dosage form Minimum cost(inr) Max cost(inr) cost ratio % Cost variation Lisinopril 10mg Tablet 43.45 73.7 1.70 69.62 ARB'S Telmisartan 40mg Tablet 18 115.6 6.42 542.22 Telmisartan 80mg Tablet 25.5 160 6.27 527.45 Losartan 25mg Tablet 12 45.1 3.76 275.83 Losartan 50mg Tablet 24.5 68.5 2.80 179.59 Olmesartan 20mg Tablet 49 135 2.76 175.51 Olmesartan 40mg Tablet 79 144.6 1.83 83.04 Valsartan 80mg Capsule 69 85.79 1.24 24.33 Candesartan 4mg Tablet 28.48 34.95 1.23 22.72 Miscellaneous Chlorthalidone 12.5mg Tablet 13.25 49 3.70 269.81 Torsemide 10mg Tablet 19.5 55 2.82 182.05 Metolazone 5mg Tablet 90.5 187.9 2.08 107.62 Hydrochlorothiazide 12.5mg Tablet 6 9.53 1.59 58.83 Hydrochlorothiazide 25mg Tablet 11 16.51 1.50 50.09 Prazosin 2.5mg Tablet 72 99 1.38 37.50 Prazosin 5mg Tablet 130 163.5 1.26 25.77 Methyldopa 250mg Tablet 21.77 24.14 1.11 10.89 International Journal of Pharmaceutical Sciences and Research 2051

Overall Amlodipine (2.5 mg) shows maximum price variation of 1040.58 %, while methyldopa (250 mg) shows minimum variation of 10.89 %. The maximum and minimum percentage price variation respectively for CCBs: Amlodipine (2.5 mg) 1040.58% and nifedipine (10 mg) 25.33%, ACE inhibitors: Ramipril (10 mg) 478.39% and lisinopril (10 mg) 69.62%, ARBs: Telmisartan (40 mg) 542.22% and candesartan (4 mg) 22.72%, beta blockers: Atenolol (50 mg) 564.10% and nebivolol (5 mg) 56.73% etc. Table 2 shows percentage cost variation of 15 commonly used antihypertensive drug combination. Overall Atenolol + Hydrochlorothiazide (50 + 12.5 mg) combination shows maximum variation of 504.82%, Amlodipine + Atenolol (5 + 50 mg) 437.86%, Lisinopril + Hydrochlorothiazide (5 + 12.5 mg) 403.33%, Ramipril + Amlodipine (2.5 + 5 mg) 328.57% and Amlodipine + Losartan (5 + 50 mg) shows variation of 265.38% etc. TABLE 2: PERCENTAGE COST VARIATION IN COMBINATION OF ANTIHYPERTENSIVE DRUGS Drug Dosage form Min cost(inr) Max cost(inr) Cost ratio % Cost variation Atenolol 50mg + Hydrochlorothiazide 12.5mg Tablet 8.3 50.2 6.05 504.82 Amlodipine 5mg + Atenolol 50mg Tablet 10.3 55.4 5.38 437.86 Lisinopril 5mg + Hydrochlorothiazide 12.5mg Tablet 15 75.5 5.03 403.33 Ramipril 2.5mg + Amlodipine 5mg Capsule 28 120 4.29 328.57 Amlodipine 5mg + Losartan 50mg Tablet 20.8 76 3.65 265.38 Amlodipine 5mg + Lisinopril 5mg Tablet 32 110.4 3.45 245.00 Telmisartan 40mg + Hydrochlorothiazide 12.5mg Tablet 32 98.5 3.08 207.81 Amlodipine 5mg + Telmisartan 40mg Tablet 38.25 90 2.35 135.29 Telmisartan 40mg + Amlodipine 5mg Tablet 39.2 91 2.32 132.14 Ramipril 2.5mg + Hydrochlorothazide 2.5mg Tablet 43.86 92 2.10 109.76 Nebivolol 5mg + Hydrochlorothiazide 12.5mg Tablet 57 108 1.89 89.47 Temisartan 40mg + Amlodipine 5mg + Hydrochlorothiazide 12.5mg Tablet 55 104 1.89 89.09 Amlodipine 2.5mg + Metoprolol 25mg ER-Tablet 41 67 1.63 63.41 Telmisartan 40mg + Ramipril 2.5mg Tablet 69.95 111.5 1.59 59.40 Atenolol 50mg + Nifedepine 20mg Capsule 23 35 1.52 52.17 FIG. 1: COST DIFFERENCE [MIN AND MAX] COMMONLY USED ANTIHYPERTENSIVE DRUGS USED AS A SINGLE DRUG THERAPY International Journal of Pharmaceutical Sciences and Research 2052

FIG.2: COST RATIO OF COMMONLY USED ANTIHYPERTENSIVE DRUGS USED AS A SINGLE DRUG THERAPY FIG. 3: PERCENTAGE COST VARIATION OF COMMONLY USED ANTIHYPERTENSIVE DRUGS USED AS A SINGLE DRUG THERAPY FIG. 4: COST DIFFERENCE [MINIMUM AND MAXIMUM] IN COMBINATION OF ANTIHYPERTENSIVE DRUGS International Journal of Pharmaceutical Sciences and Research 2053

FIG.5: COST RATIO IN COMBINATION OF ANTIHYPERTENSIVE DRUGS FIG. 6: PERCENTAGE COST VARIATION IN COMBINATION OF ANTIHYPERTENSIVE DRUGS DISCUSSION: Our study findings showed a very high fluctuation in the minimum and maximum price of antihypertensive agents (Fig. 1&4) which is being manufactured by several companies across the different brands. The cost ratio was also observed to be very high (Fig. 2&5). The percentage variation in the cost was above 100% with most of the commonly used antihypertensive drugs (Fig. 3) and also with combination of antihypertensive drugs (Fig. 6). A Similar study done by Karve AV et al at Mumbai also showed significant higher price variations in different brands of the same antihypertensive drug. 9 Other similar studies on oral anti-diabetic drugs, antidepressants, antibiotics, anti-epileptics also found similar results. 10-13 India is known to export medicines to various countries at low cost, but faces the challenge of access to affordable and quality medicines for its own population. The Indian market has over 100,000 formulations and there is no system of registration of Medicines. More than one company sells a particular drug under different brand names apart from the innovator company. This situation has led to greater price variation among drugs International Journal of Pharmaceutical Sciences and Research 2054

marketed. These wide variations in the prices of different formulations of the same drug have severe economic implications in India. Unlike developed countries, people in developing countries pay the cost of medicines out-of-pocket. In India, more than 80% health financing is borne by patients. 14-16 Patients have to pay more unnecessarily if costly brands are prescribed. The costly brand of same generic drug is scientifically proved to be in no way superior to its economically cheaper counterpart. 4 Many poor people frequently face a choice between buying medicines or buying food or other necessities due to limited resources and high pricing of drug. So medicine prices do matter. Ideally the drugs of cheaper brands should be prescribed to save the patient's money and to enhance the compliance. In India, doctors have less awareness in the cost difference of different brands of the same drug. It is felt that physicians could provide better services and reduce costs of drugs if information about drug prices was readily available. Studies have shown that providing a manual of comparative drug prices annotated with prescribing advice to physicians reduced their patients drug expense especially in a diseases like hypertension which needs long term treatment. 17 Rational prescribing involves selecting the cost effective treatment. There is a need for concerted action from regulatory authorities, doctors, pharmacists and general public at large to address this issue of antihypertensive drugs price variation. The excess profit margins presently being shared by pharmaceutical traders must be passed on to consumers which is a feasible and economically viable. Drug price control order (DPCO) is an order issued by the government to fix prices of drug. Once medicine is brought under DPCO, it cannot be sold at a price higher than that fixed by the government (DPCO). Out of 509 drugs under price control, we found that only eight antihypertensive drugs amlodipine, atenolol, enalapril, losartan, methyldopa, nifedipine, hydrochlorothiazide were included in the DPCO list 2015. 18, 19 We found in our study, price variation with above drugs even though the price is less than the ceiling price quoted by DPCO. Also none of the combinations of antihypertensive drugs are included in DPCO list 2015. Many hypertensive patients need combination drug therapy during the course of the disease. Hence, it is desired that the Government should bring all lifesaving drugs and combinations under price control. Government of India has opened few generic drug stores in some states that sell generic medicines manufactured by public sector companies. 20 The quality of generic medicines available on these stores at cheaper rates should be tested and compared with popular branded drugs and results should be widely published. Studies involving comparative evaluation on quality of branded and their generic counterpart may be made mandatory for the generic manufacturer and their reports should be made public to promote generic use and prescription. CONCLUSION: Our study findings show a wide variation in the prices of different brands of same antihypertensive drugs in India (Table 1 and 2). There is a strong need to create awareness about this huge price variation among the general public, health care providers, health care payers, government agencies, policy makers, pharmacists for appropriate intervention to reduce economic burden on patients as well as the healthcare system. Results of our study make the prescriber informed about various brands and their price variations. So the prescriber can chose the cost effective antihypertensive agents for a patient to achieve rational prescribing. Financial support and sponsorship: Nil. Conflicts of Interest: There are no conflicts of interest. Ethical committee approval: Not Required. ACKNOWLEDGEMENT: None REFERENCES: 1. Park K. Park s textbook of preventive and social medicine. 23rded.Jabalpur. M/s Banarasidas Bhanot Publishers 2015; 372-375. International Journal of Pharmaceutical Sciences and Research 2055

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