Medication adherence is an important concern for both physicians and payers. Non-adherence can lead to treatment failure and death, as well as an increase in the use of costly resources. Available literature regarding adherence tends to focus on the effect of patient attributes on therapy usage. However, it is likely that attributes specific to the therapy itself (such as adverse events) also have an effect on whether patients are adherent. The ability to predict the adherence rates for a therapy based on its characteristics, particularly in comparison to those of comparator treatments, could add significant value to a product’s profile. The study herein was performed as a feasibility analysis to determine if it is possible to predict patient adherence based on a treatment’s profile. The analysis focuses on type 2 diabetes treatments. Relationships between individual product characteristics and product discontinuation rates were determined. Product characteristics (i.e., adverse event and success rates) were obtained from clinical trials and real-world discontinuation data were obtained from a physician survey. The products included were DPP4s, GLP-1s, basal insulins, and OADs and the attributes examined were nausea/vomiting, other GI effects, hypoglycemia, weight gain, and lack of success/efficacy. From these relationships, a predictive model was derived that would allow the user to estimate a therapy’s adherence based on its profile. The analysis found a clear correlation between weight change and discontinuation. The piecewise prediction model is as follows: Discontinuation = 0.2453*HbA1c reduction + 0.0144*weight change + 0.5090*proportion of patients with hypoglycemia + 0.0935*proportion of patients with GI side effects + 0.2368*proportion of patients with nausea/vomiting + 0.3943. Despite analysis limitations, study trends suggest that it would be feasible to construct a model predicting adherence based on a treatment’s profile. Due to the link between adherence and outcomes, this topic warrants further research.

ABSTRACT Background Despite the emergence of VEGFR-TKIs and mTORs in aRCC, considerable unmet medical needs remain. There are no published guidelines for 3rd line treatment in aRCC and, despite significant advances, these patients have limited treatment options. This analysis examines the overall survival of patients after discontinuation from a phase III, randomized, double-blind, placebo-controlled trial (RECORD-1), who received at least two targeted therapies. Methods All patients in RECORD-1 received at least one prior VEGFR-TKI before randomization to everolimus (EVE) or placebo. Demographics, treatment sequence and overall survival were reported for patients who discontinued EVE for reasons other than death and received additional targeted therapy with either sorafenib or sunitinib. Results Of the 416 patients in RECORD-1, 274 received EVE, 258 discontinued EVE for reasons other than death and approximately one third of those (N = 87) received sunitinib or sorafenib as additional targeted therapy following EVE (49.4% sorafenib only, 40.2% sunitinib only and 10.3% both). Baseline patient demographics at RECORD-1 enrollment are provided in the Table. Median time from EVE discontinuation to additional sunitinib or sorafenib therapy was 0.9 months (mean 1.7, SD 2.5). The median overall survival for patients from start of the additional sunitinib or sorafenib therapy after EVE discontinuation was 13.9 months (95% CI 10.6–17.2 mo). Baseline Characteristics Patients receiving sorafenib or sunitinib post-EVE N = 87 Male, n (%) 73 (83.9%) >= 65 years, n (%) 35 (40.2%) MSKCC Intermediate Risk n (%) 52 (59.8%) MSKCC Favorable Risk n (%) 29 (33.3%) KPS— > =90 n (%) 63 (72.4%) KPS—80 n (%) 20 (23.0%) Conclusions In this heavily pre-treated sub-population, following EVE discontinuation in RECORD-1, some patients experienced meaningful rescue therapy with a TKI, with a median overall survival of more than a year Clinical trials with investigational targeted therapies are ongoing, and may provide additional treatment options. Disclosure R. Casciano: Roman Casciano is an employee of Analytica LA-SER, which received funding for the research. L. Stern: Lee Stern is an employee of Analytica LA-SER, which received funding for the research. T. Brechenmacher: Thomas Brechenmacher is employed by Novartis Pharmaceuticals, which provided funding for the research. S. Stergiopoulos: Sotirios Stergiopoulos is employed by Novartis Pharmaceuticals, which provided funding for the research. J. Coombs: John Coombs is employed by Novartis Pharmaceuticals, which provided funding for the research. All other authors have declared no conflicts of interest.

Severe sepsis (SS) contributes to a high economic burden among critically ill patients. The objective of the study was to describe SS population and determine associated costs. Data was drawn from a large IHS (Jan 2002 to Dec 2008) and included two groups of adult patients; SSD: SS or septic shock ICD-9 code (995.92 and 785.52); and NSSD: SS criteria by Angus (2001) and Martin (2003). Patients were evaluated at index hospitalization, 30-days (30D), 30-days-6-months (30D-6M), and 6-months-1year (6M-1YR) post-discharge. Comorbidities, antibiotic use, supportive treatment, mortality, and costs were analyzed. Costs were adjusted to 2009 US Dollars using the overall urban CPI; 0.65 (cost-to-charge-ratio) was applied to charge data. Follow-up cost analysis was limited to patients with complete data at the beginning of each evaluation period. The cohort included 17,256 patients: 3,229 (19%) SSD and 14,027 (81%) NSSD. The groups had similar baseline demographics and comorbidities. SSD had a higher rate of ICU admission (81% vs. 47%). Nearly all received antibiotics. Supportive treatments included vasopressors (66% vs. 19%) and mechanical ventilation (71% vs. 39%). Mean length of stay (LOS) was 21±2d for SSD and 14±14d for NSSD. Hospital mortality was 40% for SSD and 11% for NSSD; overall mortality at 1-year pdschg was 61% and 39%, respectively. Mean cost of hospitalization was $75K±107K, with SSD costing almost double NSSD ($123K±149K vs. $64K±$91K). In all three follow-up periods, NSSD incurred higher costs ($18K±34K vs. $14K±27K for 30D, $54K±102K vs. $42K±81K for 30D-6M, and $34K±67K vs. $27K±56K for 6M-1YR. SSD patients have higher rates of mortality, both during hospitalization and in the year following, compared to NSSD patients. The higher mean hospitalization costs for SSD may be due to longer LOS/ more intensive resource use. The lower overall 1-year mortality rate in NSSD may be associated with higher follow-up costs.

Major orthopedic surgery patients are at high risk of venous thromboembolism (VTE) in-hospital and post-discharge. This study assessed real-world inpatient and outpatient thromboprophylaxis practices following knee or hip arthroplasty. Patients from the Henry Ford Health System aged ≥18 years undergoing knee and hip arthroplasty (January 1997–June 2007) were identified using Current Procedural Terminology codes from administrative databases. Patients with <18 months of continuous enrollment in the system’s health maintenance organization or with a current diagnosis of atrial fibrillation were excluded. Both inpatient and outpatient pharmacological prophylaxis was assessed. The analysis included 1393 (58.5%) patients following knee arthroplasty and 989 (41.5%) following hip arthroplasty. Average length of hospitalization was 4.9 days over the study period, although the median stay decreased from 5 days in 1997 to 3 days in 2007. Of patients included, 72.7% received pharmacological prophylaxis only in the inpatient setting following knee arthroplasty and 73.9% following hip arthroplasty. Both inpatient and outpatient pharmacological prophylaxis was received by 12.5% of knee and 12.3% of hip arthroplasty patients. Total length of pharmacological prophylaxis fluctuated between 2 to 4 days between 1997 and 2005, but increased to 11.5 ± 9.0 days in 2007. Although the duration of prophylaxis has recently increased, considerable numbers of hip and knee arthroplasty patients only receive prophylaxis for part of the time period recommended by guidelines. Further efforts are required to ensure the recommended duration of thromboprophylaxis is prescribed to all patients and continued outpatient VTE prophylaxis is provided.

e17531 Background: Following drug discontinuation for progression or adverse event in a clinical trial for relapsed or stage IV kidney cancer, supportive care including surgery, palliative radiotherapy, or bisphosphonates continue to be recommended by National Comprehensive Cancer Network (NCCN). However, published data on active therapeutic agents given to patients following study drug discontinuation in recent clinical trials is limited. Methods: World Health Organization Anatomical Therapeutic Chemical codes or therapeutic names, captured from the follow-up phase in a phase III clinical trial (RECORD-1) of patients with metastatic renal cell carcinoma (mRCC) patients, were used to describe antineoplastic therapies following discontinuation of study drug. Prior to trial, patients had progressed on at least one VEGFr-TKI therapy. Results: Of the 130 patients with follow-up after discontinuation of study drug, 78.5% received at least one of the following: corticosteroids, radiotherapy, protein kinase inhibitors, mTOR inhibitor, pyrimidine analogues, monoclonal antibodies, interferons, and investigational drugs. Among patients who received an active agent, nearly three-quarters (73.5%) utilized targeted therapy (protein kinase inhibitors, mTOR inhibitor, monoclonal antibodies). Conclusions: In a clinical trial setting with mRCC patients who have received several classes of systemic therapy, care delivered following study drug discontinuation often includes an active antineoplastic agent, despite the limited supportive evidence in this setting. While the placebo control with supportive care in a double-blind phase is acceptable to evaluate the efficacy and safety of a therapy for regulatory approval purposes, decision makers must also consider how these data may inform comparisons with the usual alternatives available to and used by physicians and patients in the non-trial setting. [Table: see text]

1141 Background: Breast cancer is associated with considerable health care resource utilization and patients who experience recurrent breast cancer require more costly care than patients who do not develop recurrent disease. Research has also shown that the cost associated with a distant recurrence is significantly greater than the cost associated with a contralateral or local-regional recurrence. Distant metastasis has also been shown to account for the greatest number of breast cancer recurrence events early in the course of the disease (2–3 years after surgery). In this study we evaluated the cost associated with breast cancer recurrence in postmenopausal women diagnosed with breast cancer between 1995 and 2005. Methods: Using data from the Henry Ford Health System, patients who were at least 45 year old at the time of diagnosis without a stage IV or unknown tumor were identified and included in the study. Patients had at least one year of continuous enrollment and received at least one of the following treatments: surgery, chemotherapy, radiation, or hormone therapy. Total health care costs incurred after distant, contralateral or local-regional recurrence were calculated up to one year after breast cancer or death and presented as mean cost per month. Results: A total of 1,649 women met the inclusion criteria. The mean age was 61 years, and most patients had surgery (99%). Other subsequent treatments included radiation (71%), chemotherapy (27%), and hormone therapy (51%). Stage I tumors were the most common (38%). Of the 232 patients who experienced a recurrence, distant (44%) was more common than contralateral (23%) or local-regional (34%). On average, patients with distant, contralateral, and local-regional recurrence incurred cost for approximately 7, 12, and 11 months, respectively. The mean cost per month associated with distant recurrence ($37,969) was significantly greater than contralateral ($10,934) or local-regional ($9,129) (P< 0.0001). Conclusions: Distant metastasis is the primary cause for breast cancer deaths. This study finds that in postmenopausal women, the greatest number of breast cancer recurrences was distant, and these are associated with significantly higher cost of care compared to local-regional or contralateral recurrence. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Novartis