Calendar | For Your Patients | PHA Main Site | Contact Us | About Us | Not a registered user? Sign up here.

Resource Library

Time and Cost Impact of Monthly Liver Function Monitoring Removal

Louise Durst

J. Carlsen

M. Kuchinski

L. Harner

D. Neves

Stephanie Harris

Glenna Traiger


  Sign in to add a review

Leave a Comment

Conference: 2012 International PHA Conference and Scientific Sessions

Release Date: 06.22.2012

Presentation Type: Abstracts

Durst L, Carlsen J, Kuchinski M ,  Harner L, Neves D,  Harris S,  Traiger G

Mayo Clinic, Rochester, MD, USA

RESEARCH OBJECTIVE: Pulmonary arterial hypertension (PAH) patients on endothelin receptor antagonists therapies were required to have a monthly liver function test (LFT) to obtain their medications through specialty pharmacies. In March 2011, the FDA removed this requirement for ambrisentan. This research objective was to explore the impact of monthly LFT monitoring requirement removal for payers, PAH providers, and specialty pharmacies among PAH patients treated with ambrisentan.

STUDY DESIGN: Primary research through telephone interviews was conducted with 5 commercial payer medical and pharmacy directors, 6 PAH nurses, and staff from 4 specialty pharmacies.  Savings in labor costs were calculated based on national wage averages for office-based physicians ($100.97), specialty nurses ($35.23), administrative staff ($14.31), pharmacists ($52.59) and pharmacy technicians ($14.10), as reported in 2010 U.S. Bureau of Labor Statistics.  Adjustment was added to hourly wages to account for fringe benefits, and for physicians and nurses, opportunity costs were calculated by multiplying each 30-minute increment of time saved by $68.97, Medicare’s national average payment rate for a level 3 patient visit. The time spent by all staff types on each LFT-related activity was then summed to produce the total time spent before and after the ambrisentan label change; the difference of these figures represents time savings associated with removal of the monthly LFT monitoring requirement. 

POPULATION STUDIEDPAH patients treated with ambrisentan

CONCLUSIONThe ambrisentan label change resulted in a significant reduction (69% on average) in the frequency of LFTs, leading to time and indirect cost savings across PAH providers and specialty pharmacies surveyed, as well as direct cost savings for payers.  The ambrisentan label reflects a unique FDA position; the removal of the monthly LFT monitoring requirement not only is a reflection of ambrisentan’s safe profile, but it also has led to decreased administrative and cost burden among PAH providers.

IMPLICATIONS FOR POLICY, DELIVERY OR PRACTICE:  The management of PAH patients requires extensive coordination among the patient, their support system, third-party payers, and healthcare professionals.  The reductions in time spent on LFT-related activities as reported in this study have enabled both providers and specialty pharmacies to devote more of their resources to patient management, education, and counseling.

PRIMARY FUNDING SOURCE: Research funded through Gilead Sciences Inc.

REFERENCE: Article published in American Health & Drug Benefits. Louise A. Durst, RN; John Carlsen, MHA; Megan Kuchinski, MPH; Lauren Harner, JD; Daniel Neves, BA; Stephanie J. Harris, RN, BSN; Glenna L. Traiger, RN, MSN, CNS-BC. Impact of the Removal of the Monthly Liver Function Test Requirement for Ambrisentan. American Health & Drug Benefits. 2012;5(2):94-101.