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besponsa medical policy

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besponsa medical policy
Inotuzumab Ozogamicin (Besponsa) - Medical Clinical Policy , Inotuzumab Ozogamicin (Besponsa) - Medical Policy - BCBSND, Welcome to BESPONSA® | BESPONSA®, Corporate Medical Policy - bluecrossnc.com, Clinical Policy: Inotuzumab Ozogamicin (Besponsa), Medical Policy - Amerigroup, , , .
Dang and colleagues (2018) stated that InO demonstrated preliminary anti-tumor activity and manageable toxicity in phase-I/II clinical trials for the treatment of R/R B‐cell NHL (B-NHL), as a single‐agent and in combination with rituximab (R‐InO).  Given this preliminary evidence, a 2‐arm, randomized, open‐label, phase-III clinical trial was conducted to compare the safety and efficacy of R‐InO with investigator's choice (IC) of rituximab plus bendamustine (R‐B) or rituximab plus gemcitabine (R‐G), in adults with R/R CD20+/CD22+ aggressive B‐NHL who were not candidates for high‐dose chemotherapy (HDC), with or without transplant.  The primary end-point was OS; 2 interim analyses (IAs) were planned when 40 % and 70 % of OS events were reached.  The trial was to be terminated for futility if p > 0.29 [hazard ratio (HR) greater than 0.9] or p > 0.10 (HR > 0.82) at the 1st or 2nd IA, respectively, or if p < 0.0073 for efficacy at the 2nd analysis.  The planned IA based on approximately 40 % of OS events (108 events) conducted in May 2013 yielded an estimated HR of greater than 0.9 for OS in the R‐InO versus IC arm; enrollment was thus stopped for futility.  Reported here were the final data from this trial (locked on July 24, 2014) to inform future research and potential clinical studies in this difficult‐to‐treat patient population.  Patient enrollment occurred between February 2011 and May 2013; a total of 338 patients were randomized [R‐InO, n = 166; IC, n = 172 (R‐B, n = 137; R‐G, n = 35).  Nearly all patients (91 %) had DLBCL at baseline; 68 % were aged greater than or equal to 65 years.  Age was the primary reason why enrolled patients were not candidates for HDC (R‐InO, 77 %; IC, 67 %); 332 patients received greater than or equal to 1 dose of study drug [median (range) number of treatment cycles: 3.0 (1.0 to 6.0) for R‐InO and R‐G, 3.5 (1.0 to 6.0) for R‐B; 94 patients completed treatment.  Common reasons for discontinuing were progressive disease/relapse (R‐InO, 50 % versus IC, 57 %) and AEs (R‐InO, 32 % versus IC, 17 % ).  Median (range) duration of follow‐up among surviving patients was 14.9 (0.4 to 32.8) months for R‐InO and 15.9 (0.1 to 31.2) months for IC; OS was not significantly different for R‐InO versus IC (p = 0.708; HR [95 % CI: 1.1 [0.8 to 1.4] ); Kaplan-Meier estimated median (95 % CI OS was 9.5 (7.0 to 14.5) and 9.5 (7.7 to 14.1) months (estimated probabilities of OS [95 % CI] at 18 months, 35 % [27 to 43 %] and 37 % [29 to 45 %]); PFS was also not significantly different for R‐InO versus IC (p = 0.27; HR [95 % CI)] = 0.9 [0.7 to 1.2]).  Median (95 % CI) PFS with R‐InO and IC were 3.7 (2.9 to 5.0) and 3.5 (2.8 to 4.9) months (estimated probabilities of PFS [95 % CI] at 18 months, 19 % [13 to 26 %] and 17 % [12 to 24 %]).  Notably, survival among patients receiving R‐InO was prolonged for those with higher versus lower baseline CD22 expression levels.  Among all randomized patients, the ORR (95 % CI) was 41 % (33 to 49 %) for R‐InO and 44 % (36 to 51 %) for IC (arm difference, 3 % [−8 to 13 %]; p = 0·714); Kaplan-Meier estimated median (95 % CI) duration of response (DOR) for R‐InO versus IC was 11.6 (7.8 to not reached [NR]) versus 6.9 (5.5 to 10.8) months (HR = 0.76 [0.47 to 1.25]; p = 0.142).  Median OS and PFS with R‐InO were 9.5 [95 % CI: 7.0 to 14.5] and 3.7 [2.9 to 5.0] months, respectively; ORR and DOR were 41 % and 11.6 months.  Although comparisons across studies require caution due to differences in design and patient characteristics, median OS and PFS with R‐InO in the previous study with refractory aggressive B‐NHL (n = 30) were shorter (OS, 8.8 [3.9 to NR] months; PFS, 1.9 [1.0 to 4.8] months), the ORR was lower (20 %), and the DOR is shorter (6.1 months).  Conversely, the median OS and PFS with R‐InO in the relapsed DLBCL cohort in the previous study (n = 47) were longer (OS, NR [34.7 to NR] months; PFS, 17.1 [7.8 to NR] months), the ORR was higher (74 %), and the DOR was longer (17.7 months).. Policy. Aetna considers inotuzumab ozogamicin (Besponsa) medically necessary for the treatment of adults (18 years of age or older) with relapsed or refractory CD22 positive (i.e., ≥5% blasts CD22-positive) B-cell precursor acute lymphoblastic leukemia (B-ALL) when either of the following criteria are met: Member has Philadelphia chromosome-positive. Inotuzumab ozogamicin (Besponsa™) is a CD22-directed antibody-drug conjugate approved for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). Policy Position.
BESPONSA is a prescription medicine used to treat adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). It is not known if BESPONSA is safe and effective in children under 18 years of age.. medical policy. When Inotuzumab (Besponsa) is covered Inotuzumab (Besponsa) is considered medically necessary for the treatment of patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Use of Inotuzumab (Besponsa) may be considered medically necessary for clinical indications not. at the end of this policy for important regulatory and legal information. Description . Inotuzumab ozogamicin (Besponsa™) is a CD22-directed antibody-drug conjugate. FDA Approved Indication(s) Besponsa is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Policy/Criteria. This document addresses uses of inotuzumab ozogamicin (Besponsa, Pfizer Inc., Philadelphia, PA). Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) consisting of a monoclonal antibody targeting CD22, a protein found on the surface of mature B-cells in most cases of acute lymphoblastic leukemia (ALL).. . .
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