scholarly journals Using Real World Evidence to Describe Pulmonary Arterial Hypertension Treatment Patterns, Healthcare Resource Utilization, and Costs Associated with PDE-5 Inhibitor Monotherapy

10.36469/9812 ◽  
2018 ◽  
Vol 5 (2) ◽  
pp. 206-219 ◽  
Author(s):  
George Ruiz ◽  
Jason Yeaw ◽  
Cassandra A. Lickert ◽  
Ajita P. De ◽  
Rolin L. Wade ◽  
...  

Background: Pulmonary arterial hypertension (PAH) is described by proliferation of small pulmonary arteries leading to increased pulmonary vascular resistance, right ventricular failure, and death. Research confirms long-term improvement in composite morbidity and mortality endpoints on some endothelin receptor antagonists alone and in combination with phosphodiesterase type 5 inhibitors (PDE-5is) but not with PDE-5i monotherapy. While current treatment guidelines incorporate these findings, a substantial number of patients are started or maintained on PDE-5i monotherapy.</p> Objectives: This study describes real-world clinical practice and treatment patterns with PDE-5i monotherapy including events indicative of clinical worsening, treatment modifications, adherence, allcause healthcare resource utilization, and costs. Methods: This retrospective study analyzed PharMetrics Plus claims data including 150 million lives; study period was January 1, 2009 through December 31, 2013. Eligible patients were ≥18 years with ≥1 inpatient or ≥2 outpatient claims ≥30 days apart, a diagnosis of pulmonary hypertension or other chronic pulmonary heart disease, and an initial PDE-5i prescription. To include only World Health Organization group 1 PAH patients, ≥1 encounter for right-heart catheterization or Doppler echocardiogram was required during the pre-index period. Results: PDE-5i monotherapy for PAH treatment was associated with high treatment modification rates, low adherence, increased healthcare resource utilization, and high costs. At 12 months post index, 41.5% of patients experienced treatment modification. For the index therapy, 47% of patients had ≥80% adherence to therapy. Almost 50% of patients had ≥1 hospitalization, with costs increased three fold to $197 111 compared to $59 164 for non-hospitalized patients. Conclusions: Initial treatment with PDE-5i monotherapy was associated with substantial direct medical costs, including hospitalizations and emergency department visits, low therapy adherence and a high rate of treatment modifications.

2018 ◽  
Vol 9 (1) ◽  
pp. 204589401881629 ◽  
Author(s):  
Sean Studer ◽  
Michael Hull ◽  
Janis Pruett ◽  
Eleena Koep ◽  
Yuen Tsang ◽  
...  

Several new medications for pulmonary arterial hypertension (PAH) have recently been introduced; however, current real-world data regarding US patients with PAH are limited. We conducted a retrospective administrative claims study to examine PAH treatment patterns and summarize healthcare utilization and costs among patients with newly diagnosed PAH treated in US clinical practice. Patients newly treated for PAH from 1 January 2010 to 31 March 2015 were followed for ≥12 months. Patient characteristics, treatment patterns, healthcare resource utilization, and costs were described. Adherence (proportion of days covered), persistence (months until therapy discontinuation/modification), and the probability of continuing the index regimen were analyzed by index regimen cohort (monotherapy versus combination therapy). Of 1637 eligible patients, 93.8% initiated treatment with monotherapy and 6.2% with combination therapy. The most common index regimen was phosphodiesterase type 5 inhibitor (PDE-5I) monotherapy (70.0% of patients). A total of 581 patients (35.5%) modified their index regimen during the study. Most patients (55.4%) who began combination therapy did so on or within six months of the index date. Endothelin receptor agonists (ERAs) and combination therapies were associated with higher adherence than PDE-5Is and monotherapies, respectively. Healthcare utilization was substantial across the study population, with costs in the combination therapy cohort more than doubling from baseline to follow-up. The majority of patients were treated with monotherapies (most often, PDE-5Is), despite combination therapies and ERAs being associated with higher medication adherence. Index regimen adjustments occurred early and in a substantial proportion of patients, suggesting that inadequate clinical response to monotherapies may not be uncommon.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 17-18
Author(s):  
Parameswaran Hari ◽  
Lita Araujo ◽  
Dominick Latremouille-Viau ◽  
Peggy Lin ◽  
Mikhail Davidson ◽  
...  

Background: Renal impairment (RI) is associated with substantial clinical and economic burden in patients with multiple myeloma (MM), but real-world data reporting on healthcare resource utilization (HRU) and outcomes in these patients are lacking. We assessed treatment patterns, overall survival (OS), HRU and associated costs across lines of therapy (LoT) in patients with MM who had baseline RI. Methods: We identified patients (aged ≥18 years) with continuous Part A, B and D coverage who initiated pharmacologic therapy for MM between January 1, 2012 and December 31, 2016. Baseline demographics, disease characteristics, and treatment patterns from first-line to fourth-line (1L-4L) were reported for all eligible patients (main cohort). Within this cohort, a subgroup of patients diagnosed with RI at baseline (RI subgroup) were identified using appropriate International Classification of Diseases (ICD)-9 and ICD-10 codes. Treatment regimens were identified during the first 60 days following start of each LoT; stem cell transplantation (SCT) in 1L was considered part of the 1L regimen. The end of each LoT was indicated by treatment augmentation, treatment switching (after &gt;60 days), discontinuation of all agents (for &gt;90 days), or death. Overall survival (Kaplan-Meier analysis) was defined as time from start of each LoT until death or censoring (end of data/Medicare coverage). All-cause HRU categories were identified during each LoT and reported as incidence rate per patient per month (PPPM); associated all-cause healthcare costs during LoT were reported in 2017 US$. Results are presented using standard descriptive statistics. Results: A main cohort of 10,026 patients was identified; of these, a RI subgroup of 714 patients with baseline RI was identified (7.1% of main cohort). At 1L initiation, the RI subgroup was generally younger (71.9 vs. 74.6 years), had a lower proportion of females (47.8% vs. 53.1%) and had a higher proportion of Medicare coverage for end-stage renal disease (62.9% vs. 6.3%) than the main cohort. Patients with RI had a higher mean Charlson Comorbidity Index score (excluding MM; 4.8 vs. 3.3) and a higher proportion of patients with comorbidities (anemia: 72.5% vs. 57.9%; diabetes with chronic complications: 38.7% vs. 27.1%; cardiovascular diseases: 97.2% vs. 82.5%) than the main cohort. In the RI subgroup, among patients who received SCT in 1L (n=76), bortezomib-dexamethasone (Vd) was the most frequent 1L regimen (39.5%), followed by bortezomib-lenalidomide-dexamethasone (VRd; 17.1%) and bortezomib-cyclophosphamide-dexamethasone (VCd; 15.8%). In patients who had no SCT in 1L, Vd was the most frequent 1L regimen (59.5%), followed by VCd (12.7%) and lenalidomide-dexamethasone (Rd; 12.1%). Among patients in the RI subgroup who progressed to 2L therapy, 61.7% received lenalidomide-based regimens in 1L. Newer MM therapies such as carfilzomib, pomalidomide, ixazomib, daratumumab, and elotuzumab were used more frequently in later LoTs (2L: 25.6%; 3L: 50.0%; 4L: 68.8%). Median OS from start of 1L was shorter in the RI subgroup than in the main cohort (29.9 vs. 46.5 months; Table), and this difference was consistent across each subsequent LoT. Incidence of HRU during 1L (Table) was generally higher in the RI subgroup than the main cohort, particularly for inpatient days (1.3 vs. 0.7 PPPM) and home health services (0.9 vs. 0.5 PPPM); this pattern was consistent between cohorts across each subsequent LoT. Total costs in the 1L RI subgroup vs. main cohort (Table) were $14,782 vs. $12,451; the cost differential was maintained across each subsequent LoT. The key driver of this difference was the additional medical service costs ($12,047 vs. $7,459 in 1L) incurred by patients with RI. Conclusion: Patients with MM who had baseline RI were shown to experience higher clinical and economic burden in real-world clinical practice than the overall MM population. This burden was maintained across LoTs. Efficacious regimens that help improve renal function with minimal toxicity would enable patients with MM and RI to persist with treatment and may help address unmet need in this subgroup of patients. Table Disclosures Hari: BMS: Consultancy; GSK: Consultancy; Janssen: Consultancy; Amgen: Consultancy; Takeda: Consultancy; Incyte Corporation: Consultancy. Araujo:Sanofi Genzyme: Current Employment. Latremouille-Viau:Sanofi Genzyme: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Novartis Pharmaceutical Corporation: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Lin:Sanofi Genzyme: Current Employment. Davidson:Sanofi Genzyme: Other: Mikhail Davidson is an employee of Analysis Group, Inc which received consultancy fees from Sanofi Genzyme.. Guerin:Sanofi Genzyme: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Abbvie: Consultancy, Other; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Sasane:Sanofi Genzyme: Current Employment.


2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 525-525
Author(s):  
H. Yang ◽  
A. P. Yu ◽  
Y. Yim ◽  
E. Yu ◽  
E. Wu

525 Background: Targeted therapies such as bevacizumab (BV) and cetuximab (CX) are important treatment options in mCRC. Real-world treatment patterns and resource utilization of mCRC patients (Pts) receiving BV and CX in second-line (2L) treatment are not well studied. Methods: Pts with mCRC were identified from the PharMetrics pharmacy and medical insurance claims database (2002-2009). Included Pts received BV or CX in 2L therapy. 2L was defined as change in therapy from first-line (1L) at least 4 weeks after 1L initiation. Healthcare resource utilization and costs were evaluated during the 6 months following 2L start. Results: A total of 2,188 Pts were included in the analysis, including 1,808 2L BV Pts and 380 2L CX Pts. Demographic and baseline characteristics were similar between groups. Pts' mean age was 61 years and 56% were male. Among all study Pts, 34.1% and 2.7% received BV and CX in 1L, respectively. 60.1% of Pts received oxaliplatin-based regimens in 1L. In 2L, irinotecan and oxaliplatin containing regimens were most commonly used. During the 6 months period following 2L therapy start, BV vs. CX Pts incurred significantly lower risk-adjusted total costs (difference: -$10,231, p=0.020) and inpatient costs ($-3,681, p<0.001). Mean targeted therapy cost was significantly higher for CX ($33,425) than BV ($23,622) (-$10,260, p<0.001). BV Pts incurred significantly less inpatient visits (0.5 vs. 0.7, p<0.001) compared to CX Pts and shorter duration of total hospital stay (3.6 vs. 5.6 days, p=0.007). Conclusions: In 2L treatment of mCRC Pts in the real world setting, BV was most used with oxaliplatin- and irinotecan-based regimens, whereas CX was commonly used with irinotecan-based regimens. Overall, less healthcare resource utilization and costs were observed in patients treated with 2L BV compared to 2L CX. Use of BV in 2L treatment of mCRC was associated with lower number of claims for targeted agents, lower healthcare costs and fewer hospitalizations than CX. [Table: see text] [Table: see text]


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