Economic evaluation of single-pill combination of indapamide and amlodipine in the treatment of arterial hypertension in the Polish setting

Abstract

A b s t r a c tBackground: Arterial hypertension is a common disorder that affects around 9 million adults in Poland. Single-pill combinations (SPCs) for the treatment of arterial hypertension have significant advantages over the free combinations, resulting in lower risk of cardiovascular events and lower consumption of medical resources. The current ESC/ESH 2013 guidelines for the first time recommend treatment with a combination of thiazide-like diuretic with calcium channel blocker. Currently, no such combination is reimbursed from public funds in Poland. Aim:To assess the economic value of treatment with SPC of indapamide and amlodipine (Tertens-AM ® ) for hypertensive patients compared with free combination therapy (FC), in the Polish setting. Methods:As there are currently no published data directly estimating the additional effect of using indapamide + amlodipine SPC vs. FC, two extreme approaches are presented: with difference in effectiveness due to improved adherence to the treatment estimated from published studies on other molecules used in hypertension such as SPCs and FCs -the base-case approach (1); and assuming no difference of effectiveness or adherence between SPC and FC of indapamide and amlodipine -the conservative approach (2). Modelling was carried out based on the Markov process in lifetime horizon. In the base-case approach, with the difference in effectiveness between SPC and FC, it was assumed that the differences in compliance translate into the differences in systolic blood pressure. Patients' characteristics were correlated with the risk of events associated with cardiovascular disease, based on the prediction algorithms from the Framingham Heart Study. Costs were considered from a National Health Fund (NHF) perspective and NHF and patient's perspective, and therefore direct medical costs were only included. Results:The treatment with SPC of indapamide and amlodipine in place of FC resulted in 7.6 additional days of life in full health and longer overall patient survival by 2.9 days. The replacement of FC with SPC would result in national savings from both NHF perspective and NHF and patient's perspective, irrespective of the assumption of the difference in adherence between SPC and FC. The savings would amount to 1.602-3.954 million .186 million PLN from NHF perspective and NHF and patient's perspective, respectively. Conclusions:The treatment with SPC of indapamide and amlodipine for hypertensive patients was found to be dominant over FC or at least less expensive than treatment with FC when the difference in effectiveness was neglected. The replacement of FC with SPC would result in savings from both NHF perspective and NHF and patient's perspective.

A randomized multicenter study on ambulatory blood pressure and arterial stiffness in patients treated with valsartan/amlodipine or nifedipine GITS

“…The new American and European hypertension guidelines unequivocally advocate early use of combination antihypertensive therapy in the management of hypertension, including single‐pill combination. The latter approach of combination antihypertensive therapy does have advantages, such as high adherence, low cost, more efficacy, less side effects, and so on . Moreover, co‐administration of two or more drugs with different modes of action may have improved clinical outcomes .…”

Use of single pill combinations in the treatment of arterial hypertension in Poland: The current practice and guidelines, the impact on reimbursement spending and patient co-payment

“…Apart from the immediate financial effect presented in this document, broadening indications for SPC reimbursement should also be expected to significantly influence the patient’s compliance and persistence, and consequently to influence AH monitoring indicators, the incidence of AH-related complications and pre-mature deaths, as well as the related costs, including indirect costs. As shown by the results of the analysis carried out in 2015 concerning the appropriateness, under Polish conditions, of treating AH patients with an indapamide and amlodipine SPC compared to polytherapy, SPC therapy means additional 7.6 days of life in full health and extra 2.9 days of survival [ 4 ]. Despite the relatively low clinical effects per patient, if the total population of AH patients is considered clinical benefits can be significant.…”

“…The strengths of using SPC include: a lower number of units taken by the patient, better tolerability of treatment, convenience of use, improved patient compliance, quicker blood pressure control, demonstrated better arterial pressure control in the population [ 1 – 3 , 23 – 25 ]. Compared to those who use the same active ingredients, in the same doses, but in separate units, patients taking SPC show: better adherence, a strong trend towards greater persistence in treatment continuation, a greater arterial pressure reduction, and greater pressure normalization [ 4 , 5 ].…”

Single-Pill Combination to Improve Hypertension Treatment: Pharmaceutical Industry Development

“…Less treatment complexity, accelerated time to control, improved patient adherence, fewer side effects, and reduced therapy inertia are all examples of cost reductions in hypertension treatment [ 1 ]. Significant benefits for health care systems have been identified, taking into account public spending for SPCs and FDC, e.g., [ 91 , 92 , 93 , 94 , 95 , 96 , 97 , 98 , 99 ]: valsartan/amlodipine; valsartan/hydrochlorothiazide; indapamide/amlodipine; olmesartan/amlodipine; amlodipine/valsartan/hydrochlorothiazide; atorvastatin/perindopril/amlodipine; olmesartan/amlodipine/hydrochlorothiazide. …”