Conference: 2011 PH Professional Network Symposium
Release Date: 09.22.2011
Presentation Type: Abstracts
J. Beckman, RN, MSN 1, J. Lynch, RN, BSN2, H. Purl, RN, BSN, CCRC3, A. Allen, RN4, K. Frutiger, RN5, L. Leung, MPH6, and G. Traiger, RN, MSN7
1. Harbor UCLA Medical Center, Torrance, CA
2. Arizona Pulmonary Specialists, Phoenix, AZ
3. Baylor College of Medicine, Housten, TX
4. University of California, Davis, CA
5. University of Rochester, Rochester, NY
6. Gilead Sciences, Foster City, CA
7. University of California, Los Angeles, CA
PURPOSE: To assess the long term benefit of LabSync, a voluntary, web-based service designed to assist health care providers with all laboratory work associated with Letairis treatment, on patient persistency rates defined as the percent of LabSync and control patients maintaining continuous therapy during a designated timeframe.
BACKGROUND: Letairis is an endothelin receptor antagonist (ERA) indicated for the treatment of Group I PAH. Letairis is available only through a special restricted distribution program (the LETAIRIS Education and Access Program [LEAP]) that requires monthly pregnancy tests for female patients of childbearing potential. Recently, the FDA removed the potential for liver injury from Letairis' boxed warning and no longer requires monthly liver monitoring for distribution of therapy. LabSync works with patients, physicians and laboratory facilities to coordinate lab orders, resolve insurance issues, send patient appointment reminders, and provide lab results directly to office staff. In a previously published retrospective study of 6-12 months, patients enrolled in LabSync had greater persistency with Letairis, including more days on therapy and fewer missed refills than those not enrolled (Beckmann J et al., 2010 PHA Symposium). We studied whether persistency with LabSync occurred in patients enrolled for over 1 year (12 months).
METHODS: A retrospective third-party analysis was conducted of patients enrolled in LabSync and control subjects only enrolled in LEAP who had at least 12 months or 2 years of post-enrollment data as of March 2011. Patients were matched for age, gender, geographic location, total number of shipments received, days since most recent shipment (prior to LabSync enrollment), LEAP enrollment month, and whether patients were seen at PAH centers. The percentage of patients remaining on therapy after 12-24 months in each group was determined and persistency analysis was performed. A subgroup analysis was also performed for those patients new to therapy vs. those continuing therapy.
RESULTS: 624 LabSync and 1092 matched controls had post-enrollment data for 12 months; 328 LabSync and 659 matched controls had post-enrollment data for 2 years. LabSync patients remained on therapy at higher rates than the control group (72% vs. 64%) at 1 year; fewer LabSync patients stopped therapy due to death or adverse event (12% vs 15%), or physician/patient preference (16% vs. 21%) than control patients. New LabSync patients averaged significantly more days on therapy at 1 year (81 more days on therapy; p = 0.0199) and trended towards more days on therapy at 2 years (128 more days on therapy; p=0.1176) than control patients. LabSync patients missed fewer refills than control patients at 1 and 2 years (9.8% of test patients missed 3 or more refills vs 18.2% of control patients at 2 years). Furthermore, 75% of new LabSync patients were still on Letairis therapy at 1 year, compared to 57% of controls; this difference still existed, although less pronounced, at 2 years (78% vs. 72%).
CONCLUSIONS: LabSync patients discontinued therapy due to death, adverse event, or physician preference at a lower rate than non-LabSync patients. Furthermore, patients enrolled in LabSync showed greater persistency with Letairis as evidenced by more days on therapy and fewer missed refills compared to those not enrolled. This effect was preserved out to 2 years. Building on previous findings that persistency improvements were seen regardless of age and sex (Beckmann J et al., 2010 PHA International Conference), this analysis demonstrates that enrollment in LabSync may be beneficial to populations of patients where persistency is especially critical, including patients just starting Letairis therapy. With the change in requirements for monthly liver testing, future research is warranted on the ongoing impact of the LabSync Program.