Title: Author:

Cost-effective analysis of the combination therapies, Losartan + Hydrochlorothiazide and Bisoprolol + Hydrochlorothiazide for Hypertension Inolino, Emilyn Aira A. Mahinay, Desteen Abegail F. Maosa, Jose Marlo B.

Co-Author: Aya-ay, Adorico, Ph.D. Salva, Edna Pasicolan, Vivien Leigh Introduction: Medicines can be expensive and often make up a large portion of any family's health care budget. And the burden can be even greater for people in poor countries, where the cost of vital medicines can push them into poverty (Hoban, 2010). This problem is further escalated by the fact that more people worldwide are being diagnosed with diseases such as diabetes and hypertension that could entail treatment that could last a lifetime. As the costs of our treatment continue to rise, many of our patients find themselves in a dilemma, forcing them to budget tightly their medication expenses. Hypertension is an especially difficult condition because it is common for physicians to test several different medications before finding the one optimal for our patient (Weber, M.D. 2008). This could lead our patient being unable to reach our treatment goal leading to increased treatment cost and eventually poor and inadequate blood pressure control. Fixed-dose combination treatments offer several potential benefits, including simplification of the treatment regimen, convenience, and more importantly decreased cost (Jennifer Frank MD, Journal of the American Academy of Family Physicians, 2008). Overall, 20% of the worlds adult population has hypertension. In the United States, approximately 50 million are afflicted with this disease. Although breakthroughs in our field has managed to enable effective management of hypertension among at risk and afflicted individuals, 30% of adults are unaware that they have hypertension. Even among individuals that have been diagnosed with hypertension, 40% are not r\eceiving treatment and a further 67% do not attain the treatment goal of reducing the patients blood pressure to less than

140/80 mm Hg (Kamran Riaz, MD, Medscape, 2011). Hypertension is one of the most common diseases worldwide. It is a very important public health challenge due to its associated morbidity and mortality. Its cost to society is great. According to the government, nearly eight million adult Filipinos suffer from hypertension and its cardiovascular complications. Of these, tens and thousands are unnecessarily disabled and/or die prematurely from it. Hypertension and the complications it cause is the Top 2 cause of mortality here in the Philippines, second only to heart diseases (Department of Health, 2009). Of all age groups, the elderly are the ones most at risk of hypertension. The prevalence of hypertension dramatically increases in patients older than 60 years. In most countries, 50% of people older than 60 years have hypertension (Kamran Riaz, MD, Medscape, 2011). As mentioned earlier, 67% of patients do not attain the treatment goal of less than 140/80 mm Hg. We currently have about 125 antihypertensive drugs available. Most of them are very effective drugs. Yet, we struggle to control our patients blood pressure. The problem lays in the stepped care approach in the treating hypertension. This concepts states that in the treatment of chronic illnesses, we give patients as few drugs as possible at the lowest doses possible, increasing the dose in response to its efficacy to the patient. However, as we increase the dose, the risks of dose-dependent side effects increase. This creates a limit where we are forced to sacrifice the attainment of our therapeutic goal for the safety of our patient. The solution to this problem is the use of combination therapy. The use of two complementary antihypertensive agents in combination will always result in greater efficacy than high-dose monotherapy. For example, small doses of hydrochlorothiazide (HCTZ) (6.25 mg) added to small doses of bisoprolol (10 mg) are more effective than high-dose HCTZ monotherapy (25 mg) and more effective than high-dose bisoprolol (40 mg). Drug combinations using agents that act by different mechanisms have an additive effect. The use of combination therapy will provide greater efficacy, fewer side effects and greater convenience than can be achieved with

monotherapy, and most importantly, will increase significantly blood pressure control (Joel M. Neutel, Oxford College Journals, 2005). The object of this study is to determine the cost-effectiveness of the available combination therapy in the management of hypertension. Determining the cost-effectiveness ratio of each of these combination therapies would provide health care professionals a guide in providing medicine that will best fit the patients needs to manage both their disease and their finances.

Statement of the Problem This study will analyze the cost-effectiveness of combination therapy for the management of hypertension in patients ages 30 - 80 available in the market today. This study will answer the following questions: 1. Is there a significant difference in the cost factors stated below between Losartan + HCTZ and Bisoprolol + HCTZ in the management of hypertension? 1.1. Cost of Acquisition 1.2. Cost of Administration 1.3. Cost of Monitoring 1.4. Cost of Adverse Effects 2. Is there a significant difference between the total costs of Losartan + HCTZ and Bisoprolol + HCTZ in the management of hypertension? 3. Is there a significant difference in the cost factors when analyzed by the gender of the patients? 4. Is there a significant difference in the cost factors when analyzed by the age of the patients? 5. What is the incremental cost-effectiveness ratio of Losartan + HCTZ and Bisoprolol + HCTZ in the management of Hypertension?

Significance of the Study The purpose of this study is to determine the cost-effectiveness of the available combination therapy utilized in the management of hypertension using the cost factors in the management of the said disease. The results of this study will be a great contribution to those people who suffer hypertension. This pharmacoeconomic study could also be of great help to health professionals especially those from the Mindanao Heart Center and its Pharmacy and Therapeutics Committee in making formulary decisions, designing disease management programs and measuring the cost-effectiveness of programs in managed care. This pharmacoeconomic study could also encourage more cost-effective analyses to be performed in the hospital practice. Studies modeled like this one could be a great tool in aiding health care professionals in their choice of therapeutic agents. This study could also encourage more cost-effective analysis in the University of the Immaculate Conception. This type of research could help the students of the university be better prepared in their future career, being mindful of the relative costs of different medications available in the market. Methodology The descriptive design aims to gather information from the patient records of one of the tertiary hospital in Davao City it also include how the samples will be determine, how the data will be gather, interpreted and what statistical tool will be used to answer the research question of the study. Research Design The study will utilize the survey approach of research precisely the descriptive method. The researcher will be using cost-effective analysis to identify the most cost-effective of the available combination therapy for the management of hypertension for the elderly.

Research Locale The researchers will conduct the study in one of the tertiary hospital in Davao City. This is because the said establishment is a public tertiary hospital that caters to a large number of patients that qualify to be the subject of the study.

Research Subject The respondents of the study will be hypertensive patients, both male and female those are 30 to 80 years old and no preexisting condition. They will be purposively selected by the researchers.

Research Instruments This research will utilize a pharmacoeconomics consult particularly a basic pharmacoeconomic calculation sheet. This form helped structure the calculations and considerations in determining the cost-effectiveness of a drug. It incorporated all the basic information regarding the patient, the cost factors and the calculated results.

Sampling Procedure The researchers will use purposive sampling procedure. In the purposive sampling it targets a particular group of people. When the desired population for the study is rare or very difficult to locate and recruit for the study, purposive sampling may be the only option (Wadsworth Cengage Learning 2005). The actual composition of the sample itself does not determine whether or not it was a random (Lane, 2006). Research Procedure Data collection Before starting the project the protocol was submitted to Mindanao Heart Center Administration for approval. Data collection occurred between June to December 2011.

Measuring Cost All relevant of the study will be identify by their measurement and estimation. The cost of an intervention includes cost of therapy, cost of acquisition, cost of administration, cost of monitoring, and cost of adverse effects.

Determining Cost Effectiveness Cost-Effectiveness Ratio (CER) The Cost- effectiveness ratio is an important summary statistics for comparing the costs and effectiveness of Combizar and Ziac. It is a useful aid in statistical aid in decision making process and in allocation of healthcare resources (Pisapia, 2000). In addition, the cost-effectiveness ratio is the cost at which the new or alternative intervention delivers one unit of health benefit, relative to the standard intervention to which the new intervention is being compared (Gardiner et al.,2003).

Statistical Treatment A Single-Classification ANOVA and T-test will be used in the study because they provide an appropriate analysis in comparing the significant differences between two or more groups when given various treatments. The Single-Classification ANOVA analysis juxtaposed the cost-effectiveness between Ziac and Combizar in the treatment of Hypertension by determining the significant difference of the age and gender to the different cost factors. On the other hand, the T-test will be used to determine the significant difference of the cost factors between the use of Combizar and Ziac.