Elsevier

Clinical Therapeutics

Volume 34, Issue 5, May 2012, Pages 1122-1131
Clinical Therapeutics

Pharmaceutical economics & health policy
Original research
Failure to Intensify Hypertension Therapy After Rejected Aliskiren Claims

An early version of this study was presented at the Academy of Managed Care Pharmacy Educational Conference; October 19–21 2011; Atlanta, Georgia.
https://doi.org/10.1016/j.clinthera.2012.04.003Get rights and content

Abstract

Background

Failure to intensify therapy when indicated is a serious problem in the management of hypertension. Patients having an antihypertensive prescription rejected because of utilization management tools may be at a high risk of failing to intensify their therapy when it is warranted.

Objective

The goal of this study was to investigate the patterns of therapy change after rejected aliskiren claims because of utilization management tools such as prior authorization, step therapy, and restrictive formulary.

Methods

A retrospective study was conducted using data from a large national pharmacy benefits manager. Patients with a rejected aliskiren claim because of utilization management and who were naive to aliskiren treatment before having a rejected aliskiren claim were included. Patients were followed up for 6 months after the initial rejected aliskiren claim to see whether there was a therapy change. Therapy change was defined as titration of old regimens, fulfillment of aliskiren, or fulfillment of a new antihypertensive medication not used previously.

Results

A total of 1955 patients were identified (mean age, 64.5 years; 54.4% female). Six months after having rejected aliskiren claims, 36.8% overcame the utilization management and filled aliskiren; 45.1% filled a new antihypertensive medication not used previously; and 10.8% patients titrated old antihypertensive medications. More than one quarter of patients (28.4%) had no change in their antihypertensive treatment. Logistic regression analysis revealed that patients rejected because of prior authorization (odds ratio = 4.00 [95% CI, 1.89–8.44]) or step therapy (odds ratio = 2.59 [95% CI, 1.26–5.32]) were more likely to have a therapy change compared with patients rejected because of a restrictive formulary.

Conclusions

A significant number of patients had no therapy change 6 months after having rejected aliskiren claims because of utilization management tools, indicating potential clinical inertia or lack of therapy intensification in hypertension management. Patients with restrictive formularies were least likely to have a therapy change. More aggressive follow-up with patients with a rejected claim may be warranted to reduce treatment gaps.

Introduction

High blood pressure is a prevalent condition both in the United States and worldwide. It was estimated that close to one third of adults in the United States had hypertension in 2005.1 Worldwide, the number of patients with hypertension reached >1 billion.2 Each year, 7.1 million deaths around the world can be attributed to hypertension.3

Blood pressure control is essential for reducing morbidity and mortality.3 Unfortunately, controlling blood pressure remains challenging. It was estimated that only 34% of patients in the United States had blood pressure under control between 1999 and 2000, below the Healthy People goal of 50% in 2010.

One challenge in controlling blood pressure is failure to intensify therapy despite the lack of proper blood pressure control. Most patients need 2 or more antihypertensive medications to control blood pressure.3 However, it has been observed that many patients did not have therapy intensified even when their blood pressures were not controlled.4, 5 Failure to intensify therapy can have significant implications for patient care. For example, research has shown that the odds of patients with low clinical inertia having blood pressure control were 33 times the odds of patients with high clinical inertia. A 50% reduction of clinical inertia can increase the blood pressure control rate from 45.9% to 65.9% in 1 year.5

One possible reason behind failure to intensify therapy may be formulary utilization management strategies. Previous research found that some patients did not have proper follow-up after experiencing a rejected claim. For example, research on step therapy restrictions on angiotensin-receptor blockers (ARBs) found that 12 months after an ARB claim was rejected because of the step therapy restrictions, 7% of patients did not have any antihypertensive medication claims.6

Direct renin inhibitors (DRIs) are a relatively new antihypertensive medication class. High-plasma renin activity has been shown to worsen renal- and cardiovascular-related outcomes in patients with hypertension and/or coronary artery disease.7, 8 Unlike other renin-angiotensin system–blocking agents such as angiotensin-converting enzyme inhibitors or ARBs, DRIs work by directly targeting renin and therefore do not lead to compensatory mechanisms to increase renin, providing a potentially safer way to control blood pressure.9, 10, 11, 12, 13, 14, 15 DRI is the only new antihypertensive drug class in the past 15 years, and, currently, aliskiren is the only DRI drug available on the market.

Because aliskiren is a relatively new antihypertensive medication, health plans may use utilization management tools (eg, prior authorization, step therapy, nonformulary placement) to control use of the drug. When these management tools are in place, patients may experience rejected aliskiren claims. If a large percentage of patients did not intensify their antihypertensive therapy after a rejected aliskiren claim, this should raise concern for physicians, health plans, and policy makers. The goal of this study was to investigate the patterns of therapy change after rejected aliskiren claims because of utilization management tools such as prior authorization, step therapy, and restrictive formulary.

Section snippets

Research Questions

The objective of this study was to investigate responses to rejected aliskiren claims generated by utilization management tools. Research has shown that patients using aliskiren tended to be patients who have tried multiple antihypertensive medications and had a higher rate of comorbid conditions compared with other antihypertensive agents, implying that aliskiren is often being prescribed for patients with more severe and/or clinically complicated conditions.16 Given the current pattern of

Descriptive Statistics

Figure illustrates the data construction process. A total of 7923 patients aged ≥18 years were found to have rejected aliskiren claims between April 2007 and April 2010. Of the 7923 patients, 4055 (51.2%) patients were rejected because of prior authorization, step therapy, or restrictive formulary. The remaining patients were rejected because of reasons unrelated to benefit design such as dispensed too soon, not eligible for benefit yet, or not a network pharmacy. The final sample contained

Discussion

Hypertension is a progressive disease, and frequent therapy intensification is needed to maintain blood pressure control. Because health plans frequently use utilization management tools to manage the use of antihypertensive medications, one concern is that some patients may fail to intensify therapy after being rejected of an antihypertensive medication. This research investigates responses, either by patients or providers, to rejected aliskiren claims because of 3 utilization management

Conclusions

This research yielded mixed findings regarding the effect of utilization management tools on aliskiren. These restrictions led to a significant number of patients not intensifying therapy when indicated. Conversely, these restrictions also encouraged a large number of patients to seek alternative and potentially less costly pharmacotherapy treatment. Health plans need to consider the advantages and disadvantages of utilization management strategies carefully and may need to implement more

Conflicts of Interest

This research was funded by Novartis Pharmaceuticals Corporation. Drs. Zeng and Patel are employees of MedImpact Healthcare Systems, Inc, who were paid by Novartis Pharmaceuticals in connection with the development of the manuscript. Drs. Park and Plauschinat are employed by Novartis Pharmaceuticals Corporation and own Novartis stock.

Acknowledgments

We acknowledge the excellent statistical programming support provided by Yuewen Gao for this project. An early version of the study was presented at the Academy of Managed Care Pharmacy Educational Conference; October 19–21 2011; Atlanta, Georgia. We appreciate the useful comments provided by the conference attendees.

Drs. Zeng and Patel participated in the study concept and design, acquisition and analysis of data, statistical interpretation of data, and revision of the manuscript. Dr. Zeng

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