title: Impact of the removal of the monthly liver function test requirement for ambrisentan.
abstract: BACKGROUND
  The management of patients with pulmonary arterial hypertension (PAH) requires extensive coordination between patients, their support system, third-party payers, and healthcare professionals. For patients with PAH who are receiving endothelin receptor antagonists (ERAs), such cross-stakeholder coordination was needed to ensure compliance with a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) requirement for monthly liver function tests (LFTs). In March 2011, the FDA removed this requirement for ambrisentan (Letairis) in conjunction with a change to the product label.
  
  
  OBJECTIVE
  This study sought to explore the impact of the ambrisentan label change on payers, providers who treat PAH, and specialty pharmacies.
  
  
  METHODS
  This study, conducted in June and July 2011, involved telephone interviews with 5 medical/pharmacy directors in commercial health plans (representing 78,345,000 covered lives collectively); written surveys and telephone interviews with 6 nurses managing patients with PAH; and written surveys and telephone interviews with 4 staff members from specialty pharmacies to determine direct and indirect cost-savings associated with the removal of the monthly LFT requirement for ambrisentan. Qualitative telephone interviews with payer decision makers informed the cost-savings for payers. Direct cost-savings were calculated from the responses of the nurses managing PAH regarding the prescribing trends of their practices and the frequency of LFTs. Indirect cost-savings were calculated using time-savings data collected from the PAH-managing nurses and the specialty pharmacy staff, as well as from the US Bureau of Labor Statistics data regarding national wage averages for the respective staff.
  
  
  RESULTS
  Payers reported that REMS requirements did not play a large role in their plan's coverage or management of ERAs; although direct cost-savings resulting from the label change were an estimated $28 per patient per month, this amount is relatively small compared with the overall cost of PAH treatment for payers. The impact of the ambrisentan label change was more significant for providers and specialty pharmacies. The label change resulted in a significant, average 69% reduction in the frequency of LFTs for patients using ambrisentan. The average monthly time-savings realized by providers as a result of the label change was 12 minutes per patient receiving ambrisentan, and the average monthly direct and indirect cost-savings totaled $10.75 and $29.75, respectively, per patient taking ambrisentan. Telephone interviews with specialty pharmacies indicated that the average monthly time-savings for the 4 specialty pharmacies surveyed was 14 minutes per patient using ambrisentan, representing an 86.7% decrease in the amount of time specialty pharmacies spent on LFT-related administrative tasks for patients using ambrisentan.
  
  
  CONCLUSIONS
  Findings from this study indicate that the ambrisentan label change significantly reduced the number of LFTs for patients with PAH, resulting in time-savings or cost-savings for payers, providers, and specialty pharmacies.
authors.affiliation: Registered Nurse Research Study Coordinator, Mayo Clinic, Rochester, MN.
authors.forename: Louise A
authors.initials: LA
authors.lastname: Durst
authors.affiliation: Vice President, Covance Market Access Services Inc, Gaithersburg, MD.
authors.forename: John
authors.initials: J
authors.lastname: Carlsen
authors.affiliation: Director, Covance Market Access Services Inc, Gaithersburg, MD.
authors.forename: Megan
authors.initials: M
authors.lastname: Kuchinski
authors.affiliation: Associate, Covance Market Access Services Inc, Gaithersburg, MD.
authors.forename: Lauren
authors.initials: L
authors.lastname: Harner
authors.affiliation: Associate, Covance Market Access Services Inc, Gaithersburg, MD.
authors.forename: Daniel
authors.initials: D
authors.lastname: Neves
authors.affiliation: Nurse Coordinator, Pulmonary Vascular Disease Program, University of Washington Medical Center, Seattle.
authors.forename: Stephanie J
authors.initials: SJ
authors.lastname: Harris
authors.affiliation: Pulmonary Hypertension CNS, Pulmonary and Critical Care Medicine, David Geffen School of Medicine at UCLA.
authors.forename: Glenna L
authors.initials: GL
authors.lastname: Traiger