scholarly journals Real World Biologic Use and Switch Patterns in Severe Asthma: Data from the International Severe Asthma Registry and the US CHRONICLE Study

2022 ◽  
Vol Volume 15 ◽  
pp. 63-78
Author(s):  
Andrew N Menzies-Gow ◽  
Claire McBrien ◽  
Bindhu Unni ◽  
Celeste M Porsbjerg ◽  
Mona Al-Ahmad ◽  
...  
Keyword(s):  
Author(s):  
Jessica F. Most ◽  
Christopher S. Ambrose ◽  
Yen Chung ◽  
James L. Kreindler ◽  
Aimee Near ◽  
...  
Keyword(s):  

2016 ◽  
Vol 137 (2) ◽  
pp. AB242
Author(s):  
Susan Gabriel ◽  
Meryl Mendelson ◽  
Alexander J. Gillespie ◽  
Ben Hoskin

Author(s):  
Chun-Lan Chang ◽  
Xue Song ◽  
Tina Willson ◽  
Carol Duffy

Background: Based on the PARADIGM-HF trial, sacubitril/valsartan was approved for the treatment of patients with heart failure and reduced ejection fraction. This study provides an early view of its real-world utilization and dosing in the US before recent guideline updates. Methods: Adult patients with >=1 sacubitril/valsartan claim in 7/7/2015 - 3/31/2016 were selected from a large national claims dataset; their 1st sacubitril/valsartan claim was the index date. Data was required for >=24 months pre-index and >=3 months post-index. Dose at index and the maximum dose achieved post-index were obtained. Dose up-titration, defined as 1st appearance of a sacubitril/valsartan claim with a dose increase from the index strength, and the time to 1st dose increase were reported. Results: Among 981 qualified patients with a mean follow-up of 185 (SD ±81) days, 25% commenced sacubitril/valsartan on the suggested prescribing information (PI) starting dose of 49/51 mg b.i.d.; 58% started on 24/26 mg b.i.d.; 4% started on an even lower dose, and 13% indexed at the target maintenance dose of 97/103 b.i.d.. The target maintenance dose of 97/103 mg b.i.d. was achieved in 30% of patients. For those 856 patients indexing on <=49/51/ mg b.i.d., 58% had no dose up-titration post-index; 31% took >4 weeks to have up-titration initiated and 11% initiated up-titration within 4 weeks. Only 25% of Medicare patients compared to 35% of Commercial patients achieved the target dose of 97/103mg b.i.d.. (Table 1) Conclusion: Most patients commenced sacubitril/valsartan at lower doses than recommended in the PI and were poorly optimized, with the majority of patients having no upward dose titration. Approximately 13% actually indexed at the target maintenance dose. The reasons for these findings need further exploration. Healthcare providers should consider following the appropriate starting doses, with timely dose adjustment of sacubitril/valsartan as recommended in the PI to ensure patients receive the full clinical benefit of this medication as demonstrated in the PARADIGM-HF trial.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18727-e18727
Author(s):  
Robert Smith ◽  
Mei Xue ◽  
Natalie Dorrow ◽  
Prateesh Varughese ◽  
Cosima Hogea ◽  
...  

e18727 Background: Treatment for multiple myeloma (MM) over the past decade has significantly improved survival. In particular, 3 drug classes have altered the treatment paradigm for MM patients: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and CD38 monoclonal antibodies (anti-CD38s). Despite these advances, the majority of patients with MM will become refractory to PIs, IMiDs, and anti-CD38s, and limited evidence indicates these patients have poor outcomes. A retrospective study in the US showed that 275 patients treated at 14 academic institutions with prior exposure to a PI, IMiD, and anti-CD38 had median overall survival of 9.2 months. The aim of this study was to evaluate real-world treatment patterns and outcomes (duration of therapy and overall survival) of patients who had been treated with a PI, IMiD, and anti-CD38 in community practices in the US. Methods: This retrospective observational study was conducted using the Integra Connect (IC) database. The IC database includes electronic health data from structured and unstructured fields from 12 community practices on the East and West Coast of the US. Adult patients with ≥2 ICD-9/ICD-10 codes for MM on at least 2 separate dates, who received MM treatment between Jan 1, 2016, and Dec 31, 2019, with treatment history that included at least one PI, one IMiD, and one anti-CD38 (triple exposed), and initiated a subsequent line of therapy (s-LOT) after becoming triple exposed, were included. Duration of length of s-LOT was defined as number of days from start of s-LOT to last-day supply of s-LOT. Overall survival was defined as the length of time from start of s-LOT through death or the date of the last office visit. Results: A total of 501 patients were included in this analysis. The median age of patients was 64.9 years; 50% were male; 50% had commercial insurance. 82.8% of patients had ECOG 0 or 1 at diagnosis and had received a median of 3 prior lines of therapy (LOTs) before initiating s-LOT. Prior to initiating s-LOT, 91% had been exposed to bortezomib, 81% to carfilzomib, 94% to lenalidomide, 82% to pomalidomide, and 100% to daratumumab. In s-LOT, 95% received treatment that included same drug or same drug class (30% received bortezomib, 48% carfilzomib, 31% lenalidomide, 47% pomalidomide, and 31% daratumumab). The median duration of s-LOT was 78 days and median survival was 10.3 months (308 days) from initiation of s-LOT. Conclusions: For triple-class exposed patients, there is a lack of consensus on the most efficacious approach to subsequent treatment. The present study shows a significant amount of retreatment with previously used agents or classes among these patients with short duration of therapy and poor survival. As has been previously noted, new strategies and agents targeting novel aspects of MM are needed to improve outcomes for these patients. Disclosures: This study (213286) was sponsored by GlaxoSmithKline.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 57-57
Author(s):  
Robert M. Rifkin ◽  
Lisa Herms ◽  
Chuck Wentworth ◽  
Anupama Vasudevan ◽  
Kimberley Campbell ◽  
...  

57 Background: Biosimilars have potential to reduce healthcare costs and increase access in the United States, but lack of uptake has contributed to lost savings. Filgrastim-sndz was the first FDA-approved biosimilar, and much can be learned by evaluating its uptake. In February 2016, the US Oncology Network converted to filgrastim-sndz as its short-acting granulocyte colony-stimulating factor (GCSF) of choice for prevention of febrile neutropenia (FN) following myelosuppressive chemotherapy (MCT). To understand utilization and cost patterns, this study analyzes real-world data of GCSFs within a community oncology network during the initial period of conversion to the first biosimilar available in the US. Methods: This descriptive retrospective observational study used electronic health record data for female breast cancer (BC) patients receiving GCSF and MCT at high risk of FN. Patient cohorts were defined by first receipt of either filgrastim or filgrastim-sndz during the 410 days before and after biosimilar conversion. Healthcare resource utilization (HCRU) and costs for GCSF and complete blood counts (CBC) were collected at GCSF initiation through the earliest of 30 days following end of MCT, loss to follow up, death, or data cutoff. Results: 146 patients were identified: 81 (55.5%) filgrastim and 65 (44.5%) filgrastim-sndz. No directional differences existed in baseline characteristics between the cohorts. Higher proportions of filgrastim-sndz patients received dose-dense MCT (33.8% vs 22.2%). Time trends show an initial spike in HCRU and cost for filgrastim-sndz patients after formulary conversion, which subsequently decreased and converged to that of the filgrastim cohort after 12 months. When aggregated, the overall median total administration counts, per patient per month (PPPM) and dosage, were marginally higher for filgrastim-sndz (5 vs 3; 2.9 vs 1.4; 1920 vs 1440 mcg, respectively). Median PPPM costs were higher for filgrastim-sndz ($803 vs $545). Median CBC utilization and costs were higher for filgrastim-sndz (2.8 vs 2.5; $28 vs $23, respectively). Conclusions: This study provides insight into real-world HCRU and cost patterns after formulary conversion to a biosimilar for BC patients receiving MCT and GCSF. As a descriptive study, causal inferences cannot be made and an underlying effect from index chemotherapy cannot be excluded. Convergence of HCRU and costs after 12 months suggests that overall results may be driven by behavior at initial formulary switch. Since filgrastim-sndz was the first US biosimilar approved, the uptake may be indicative of an experience with biosimilar acceptance in general. Future real-world studies of biosimilars must consider inconsistent utilization and practice trends during the time frame directly following formulary conversion.


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