Pbm-map drug Monograph: Aliskiren

Дата канвертавання24.04.2016
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In addition, one randomized controlled trial evaluated the tolerability of aliskiren in 183 patients with severe HTN (DBP > 105 mm Hg and < 120 mm Hg; mean BP 163/108 mm Hg at baseline). Although this was a tolerability trial, the authors reported similar efficacy with aliskiren-based compared to lisinopril-based treatment (SBP/DBP reduction of 20.0+15.3/18.5+8.7 mm Hg vs. 22.3+14.6/20.1+7.9 mm Hg, respectively). It was reported that 73.6% of patients on aliskiren were titrated from 150 mg to 300 mg and 65.5% were titrated from lisinopril 20 mg to 40 mg; 53.6% and 44.8% of patients had hydrochlorothiazide 25 mg added to their treatment regimen, respectively.7

In an unpublished trial of 8 weeks in over 800 patients with HTN and type 1 or 2 DM, treatment with a combination of aliskiren 300 mg and ramipril 10 mg resulted in a statistically significant reduction in DBP compared to either monotherapy (mean reduction 1.46 mm Hg and 2.07 mm Hg with combination vs. aliskiren or ramipril, respectively). The difference between aliskiren and ramipril monotherapy was not significant.2

Long-term Follow-up: The following results are data on file with the manufacturer but are included as they provide data on long-term treatment with aliskiren that are not available in the published literature. Unpublished data from over 1900 patients enrolled in an open-label extension trial evaluating the blood pressure lowering effects of one year of treatment with aliskiren showed that 85.6% and 86.2% of patients responded to treatment with aliskiren 150 mg and 300 mg, respectively (65.9% and 66.0% were controlled, respectively).2 Reduction from baseline in DBP was reported to be 13.5 mm Hg and 14.2 mm Hg in patients randomized to aliskiren 150 mg or 300 mg, respectively. The proportion of patients in the 150 mg treatment group who were up-titrated or those who received hydrochlorothiazide was not reported. Another trial (data on file) of 26 weeks with more than 800 patients randomized to aliskiren or ramipril reported treatment to be non-inferior (aliskiren reported to be superior to ramipril in the intent-to-treat population) for change from baseline in DBP; although the proportion of patients who were up-titrated or who received hydrochlorothiazide was not reported.2 The long-term effects of aliskiren on cardiovascular outcomes or mortality are not available in the published literature.

Acquisition Cost




Annual Price/Patient

Aliskiren 150 mg once daily




Aliskiren 300 mg once daily




Price Comparison of Other Antihypertensive Medications



Annual Price/Patient

Hydrochlorothiazide 12.5-50 mg once daily



Lisinopril 2.5-40 mg once daily



Nifedipine extended-release 30-60 mg once daily


Cost-Effectiveness Analysis2

An economic evaluation was conducted by the manufacturer comparing the incremental cost-effectiveness ratio (ICER) for treatment with aliskiren vs. losartan (an ARB) or ramipril (an ACEI) in patients with Stage 1 HTN (BP 140-159/90-99 mm Hg).2 The model was based on ability of the medication to reduce SBP and estimation of cardiovascular event rates and death associated with coronary heart disease and stroke, as calculated using the Framingham risk equations. Cost was based on hospitalizations as determined by DRG reimbursement, and daily average medication cost using wholesale acquisition cost, national estimates of daily average consumption and dose utilization, as well as taking into consideration dispensing fees, patient co-payments, and medication rebates.

According to the estimates and assumptions used in the model (i.e., 52 year old male, mean baseline SBP 150 mm Hg, mean baseline total cholesterol 224 mg/dL and HDL 48 mg/dL, nonsmoker, and without history of cardiovascular disease, DM, atrial fibrillation, or left ventricular hypertrophy, with a time horizon of 10 years), the ICER were calculated as follows: aliskiren vs losartan $68,935/life years gained; aliskiren vs ramipril $48,145/life years gained. When sensitivity analyses were performed for age and cardiovascular risk factors, the ICER tended to be lower with the range as follows: aliskiren vs losartan $20,444 (left ventricular hypertrophy) to 44,202 (DM)/life years gained; aliskiren vs ramipril $10,716 (left ventricular hypertrophy) to 28,988 (DM)/life years gained.
Limitations of the model included the use of change in SBP that was not a primary endpoint of the clinical trials with aliskiren, and the use of reductions in SBP from the manufacturer’s package insert rather than results from head-to-head comparison trials of aliskiren with losartan (published data) and with ramipril (unpublished data on file). If the model were modified based on cost estimates for the VA, the difference in price of the medications used for comparison would be an important factor in determining the ICER. In addition, the patient population of the VA would also influence the ICER.

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