To develop a patient decision aid and to prepare an overview of requirements for implementation. ... more To develop a patient decision aid and to prepare an overview of requirements for implementation. We developed a decision aid that fits the preferences of patients and health care professionals to ensure adequate uptake in clinical practice. A participatory design approach was used to acquire insight into preferences regarding the content and design of a decision aid and into barriers and aspects of the decision aid that facilitate implementation in clinical practice. Three focus group interviews with patients, their partners and health care professionals were conducted. A prototype of the decision aid was developed and presented to patients (n = 14) and health care professionals (n = 13) in semi-structured interviews. Patients (n = 5) participated in a usability study. Data were analysed by two independent coders. Health care professionals considered medical information on treatments and side effects as the most important aspect to be included in the decision aid. Patients also focu...
TPS578 Background: The randomized phase 3 JAVELIN Bladder 100 trial demonstrated overall and prog... more TPS578 Background: The randomized phase 3 JAVELIN Bladder 100 trial demonstrated overall and progression-free survival (OS and PFS) benefit with Ave 1LM for la/mUC not progressed with platinum-containing chemotherapy (PCT). PATRIOT II aims to understand real-world treatment (tx) patterns, patient-reported outcomes (PRO), and healthcare resource utilization (HCRU; eg, hospitalizations and emergency department visits) before and during Ave 1LM treatment. Methods: PATRIOT II is an ongoing, real-world, observational study in ≤25 US oncology centers with 1) an ambispective cohort of patients (pts) initiating PCT (n = 100), a subset of whom may continue to Ave 1LM and 2) a retrospective cohort initiated on Ave 1LM (n = 150). Sample size assumes noninferiority in HCRU and PRO pre and post 1LM initiation using paired t-tests with effect size of ≤0.3 as noninferior: ≥71 patients continuing to 1LM. In the ambispective cohort, pts with histologically confirmed la/mUC newly initiating 1L PCT are enrolled. While pts are receiving PCT and 1LM (for those who receive it), data will be collected on disease characteristics, response to tx, survival, adverse events (AEs), and HCRU for ≤52 wks after study initiation. PROs are captured using Rand SF-36 question 1, FACT Bladder Symptom Inventory – 18 and Cancer Treatment Satisfaction Questionnaire. Primary outcomes include OS and PFS from both PCT and 1LM initiation; secondary outcomes are changes in PROs and HCRU from PCT to 1LM. Analysis will be conducted at following time points: 1) baseline characteristics after full enrollment; 2) 6 months after study initiation to assess tx changes and rationale, OS, PFS, HCRU, and PRO changes from baseline; 3) at study conclusion (wk 52 after study initiation). In the retrospective cohort, pts with la/mUC who initiated Ave 1LM are enrolled. Chart data encompasses PCT and 1LM periods. Disease characteristics, response to tx, survival, AEs, and HCRU are collected. Primary outcomes are OS and PFS from initiation of PCT and 1LM start. Secondary outcomes are changes in HCRU before and after 1LM. Analysis will be conducted at following time points: 1) baseline characteristics after full enrollment, PCT, and response to tx; 2) 6 months after study initiation to assess tx changes since baseline, including dose changes, tx discontinuation/change rationale, survival rates (censoring for differential duration of follow-up), and HCRU outcomes; 3) at study conclusion to analyze endpoints up to wk 52 following study initiation. Analyses for both cohorts include Kaplan-Meier and Cox regression for time-to-event endpoints and paired t-tests for pre/post 1LM. Enrollment commenced in June 2021. 5 and 18 pts are enrolled to date in the ambispective and retrospective cohorts, respectively, from 6 of 11 activated sites. Initial results are anticipated in May 2022.
American Journal of Health-system Pharmacy, Apr 1, 2004
The antiemetic effectiveness of ondansetron 8 mg i.v, ondansetron 32 mg i.v, and granisetron 10 m... more The antiemetic effectiveness of ondansetron 8 mg i.v, ondansetron 32 mg i.v, and granisetron 10 microg/kg or 1 mg i.v. as prophylaxis in breast cancer patients regimens was studied. Data from six U.S. cancer centers were collected retrospectively for 224 patients who received cyclophosphamide-containing therapy between January 1998 and June 2002. Logistic-regression analysis was used to examine the likelihood of chemotherapy-induced nausea and vomiting (CINV) both on an unadjusted basis and controlling for concomitant radiation therapy and dexamethasone use. Seventy-six patients (34%) received ondansetron 32 mg, 68 (30%) received ondansetron 8 mg, and 80 (36%) received granisetron (either 10 microg/kg or 1 mg). Patients receiving ondansetron 8 mg were 2.5 times as likely to have CINV on an adjusted basis as granisetron recipients (p < 0.01). There was no increase in the risk of CINV with ondansetron 32 mg compared with granisetron. Patients treated with ondansetron 8 mg required more rescue antiemetics and more prophylactic antiemetics in subsequent chemotherapy cycles than patients in the other groups. In a retrospective multicenter study, granisetron 1 mg or 10 microg/kg and ondansetron 32 mg appeared more effective than ondansetron 8 mg in preventing acute CINV related to cyclophosphamide therapy.
465 Background: The JAVELIN Bladder 100 clinical trial demonstrated a significant overall surviva... more 465 Background: The JAVELIN Bladder 100 clinical trial demonstrated a significant overall survival and progression-free survival benefit with avelumab 1LM + best supportive care (BSC) vs BSC alone for la/mUC not progressing on platinum-based chemotherapy (PBC). PATRIOT-II aims to describe RW data for avelumab 1LM treatment (tx) of patients (pts) with la/mUC. Methods: PATRIOT-II collected data from pts with la/mUC treated in 37 geographically dispersed oncology practices/communities and academic centers in the US. Pts who initiated avelumab 1LM following PBC were retrospectively enrolled and will be followed up via medical record review for 52 weeks post avelumab 1LM initiation. This analysis focused on pt characteristics and tx data from la/mUC diagnosis through the PBC period and at avelumab 1LM initiation. Disease and PBC tx characteristics, as well as response to PBC, were assessed. All analyses were descriptive. Results: A total of 160 pts were enrolled (Table), 118 (74%) were white, non-Hispanic, 16 (10%), were Black, Asian, or Hispanic, and the rest unknown; 102 (64%) were current or former smokers. 77 (48%) were tested for PD-L1 via various assays, with 44 (57%) of those tumor samples reported as positive. 1L PBC was cisplatin-based in 100 (63%) of pts and carboplatin-based in 60 (38%). Pts received a median of 4 PBC cycles (interquartile range [IQR], 3-6) for a median of 13 weeks (IQR, 10-17). 31 (19%) discontinued PBC due to unacceptable side effects/toxicity. Best observed response was complete response in 21 (13%), partial response in 109 (68%), and stable disease in 17 (11%), with the remainder unknown. Median time to first imaging was 10 weeks (IQR, 5-14) after PBC initiation. 23 (14%) were hospitalized while receiving PBC, and 25 (16%) were seen in the emergency department. Pts proceeded to avelumab 1LM at a median of 4 weeks (IQR, 3-6) following PBC completion. Avelumab was administered at 800 mg every 2 weeks in 130 (81%), 10 mg/kg in 15 (9%), <800 mg in 8 (5%), and >800 mg in 7 (4%) pts. Conclusions: This ‘RW’ study offers valuable insights into characteristics and outcomes of pts with la/mUC treated in the US. Baseline factors, tx patterns and response to PBC were consistent with usual therapy paradigms in the 1L induction setting. Ongoing trials are evaluating the optimal number of PBC cycles and predictive biomarkers. Limitations include the retrospective nature, lack of randomization and central review, potential selection and confounding biases. [Table: see text]
414 Background: There are a lack of published real-world data on treatment patterns for patients ... more 414 Background: There are a lack of published real-world data on treatment patterns for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) previously treated with programmed death 1/ligand 1 inhibitor (PD-1/L1i) therapy. The objective of this study was to characterize the clinical characteristics and treatments among patients with la/mUC following discontinuation of first-line (1L) or second-line (2L) PD-1/L1i therapy. Methods: We performed a retrospective chart review at 26 geographically diverse clinical sites in the US. Patients aged ≥18 years with histologically or cytologically confirmed urothelial carcinoma and radiographic evidence of metastatic or locally advanced disease were identified. Included patients had initiated and subsequently discontinued PD-1/L1i therapy in the 1L or 2L setting for la/mUC between May 15, 2016-July 31, 2018. All patients had follow-up through October 31, 2019. Data were summarized using descriptive statistics. Results: Among the 300 patients included in the chart review, 198 (66%) received PD-1/L1i therapy as 1L and 102 (34%) as 2L therapy. Mean (SD) age at la/mUC diagnosis was 69.4 (8.7) years, and a majority of patients were male (66.0%) and White (74.7%). Consistent with age, most patients (82.7%) had comorbidities at la/mUC diagnosis; 39.7% hypertension, 23.7% coronary artery disease, 17.7% pulmonary disease, and 9.3% renal disease. At initiation of therapy, a higher proportion of patients who received 1L PD-1/L1i therapy had an Eastern Cooperative Oncology Group performance status of 2 or more than patients who received 2L PD-1/L1i therapy (36.8% vs 22.5%, respectively). Following discontinuation of PD-1/L1i therapy, 34% (n = 68) received subsequent therapy in 2L and 29% (n = 30) in third-line (3L). The most common subsequent therapies in 2L were gemcitabine monotherapy (24%), gemcitabine plus cisplatin or carboplatin (22%), PD-1/L1i therapy (22%), and taxane monotherapy (19%). The most common subsequent therapies received in 3L were taxane monotherapy (50%), pemetrexed (17%), and PD-1/L1i therapy (16%). Overall, switching from one PD-1/L1i therapy to another distinct PD-1/L1i therapy occurred in approximately 20% of patients, with “better efficacy/survival” noted by treatment teams as the most common reason for switching therapy among this subgroup. Conclusions: In this real-world case series, only a minority of patients with la/mUC who discontinued PD-1/L1i therapy received subsequent therapy. Among those that did, no clear standard of care was observed and approximately one-fifth of patients were treated with a second PD-1/L1i therapy after the first failed to control disease. Collectively, the data highlight significant unmet need for patients with la/mUC who discontinue PD-1/L1i therapy.
Journal of Oncology Pharmacy Practice, Dec 1, 2003
Background. Capecitabine is a novel fluoropyrimidine administered orally for treatment of gastroi... more Background. Capecitabine is a novel fluoropyrimidine administered orally for treatment of gastrointestinal and breast malignancies. Toxicity described with capecitabine includes hand-and-foot syndrome (HFS), a potentially painful inflammation of the hands and feet. Pyridoxine has been reported to produce improvement in HFS symptoms. We conducted our study to determine the incidence and severity of HFS symptoms in capecitabine patients and to assess the effects of pyridoxine administered as prophylaxis or treatment. Patients and methods. We retrospectively reviewed 99 charts of capecitabine patients receiving pyridoxine and 99 charts of those who had not. Results. Of the 99 pyridoxine patients, 73 (74%) received it as prophylaxis, with the remainder receiving pyridoxine as acute HFS treatment. The median number of capecitabine cycles administered was five, with first-reported HFS onset at cycle 2 in those receiving pyridoxine prophylaxis versus 1.5 in those not (P 5 0.06). Incidence was significantly associated with capecitabine dose, with 76% of patients experiencing HFS in the highest dose ranges compared with 40% in the lowest (P B 0.01). The data did not support that pyridoxine prophylaxis prevented overall HFS incidence in a greater proportion of patients compared with those who did not receive prophylaxis (60% versus 53%, respectively, P 5 NS). However, when used as treatment, a greater proportion of patients receiving pyridoxine reported symptom improvement compared with those not receiving the agent (65% versus 12%, P B0.001). No differences in 12-week tumor response were seen. Conclusion. The data do not support the use of pyridoxine as prophylaxis as neither the incidence nor the severity of HFS was affected. Once HFS develops, however, pyridoxine may provide some relief of HFS symptoms. A controlled trial of capecitabine with and without pyridoxine seems warranted.
Journal of managed care & specialty pharmacy, 2015
Chemodenervation with botulinum neurotoxin (BoNT) is recommended as first-line treatment for the ... more Chemodenervation with botulinum neurotoxin (BoNT) is recommended as first-line treatment for the management of cervical dystonia. The choice of BoNT for treatment is subject to the consideration of several factors, including cost. To compare the costs incurred by patients and payers for onabotulinumtoxinA (ONA) or abobotulinumtoxinA (ABO) for the treatment of cervical dystonia. We conducted a retrospective, noninterventional closed cohort study of cervical dystonia patients within a single U.S. private neurological practice. Patient and payer incurred costs from medical billing records for patients satisfying inclusion and exclusion criteria treated from November 1, 2009, through January 1, 2013, were de-identified and included in the analysis. Forty-seven patients initially treated with at least 3 consecutive cycles of ONA, followed by at least 3 consecutive cycles of ABO were included, representing 282 injection cycles available for analysis. Patients were required to have had a p...
To develop a patient decision aid and to prepare an overview of requirements for implementation. ... more To develop a patient decision aid and to prepare an overview of requirements for implementation. We developed a decision aid that fits the preferences of patients and health care professionals to ensure adequate uptake in clinical practice. A participatory design approach was used to acquire insight into preferences regarding the content and design of a decision aid and into barriers and aspects of the decision aid that facilitate implementation in clinical practice. Three focus group interviews with patients, their partners and health care professionals were conducted. A prototype of the decision aid was developed and presented to patients (n = 14) and health care professionals (n = 13) in semi-structured interviews. Patients (n = 5) participated in a usability study. Data were analysed by two independent coders. Health care professionals considered medical information on treatments and side effects as the most important aspect to be included in the decision aid. Patients also focu...
TPS578 Background: The randomized phase 3 JAVELIN Bladder 100 trial demonstrated overall and prog... more TPS578 Background: The randomized phase 3 JAVELIN Bladder 100 trial demonstrated overall and progression-free survival (OS and PFS) benefit with Ave 1LM for la/mUC not progressed with platinum-containing chemotherapy (PCT). PATRIOT II aims to understand real-world treatment (tx) patterns, patient-reported outcomes (PRO), and healthcare resource utilization (HCRU; eg, hospitalizations and emergency department visits) before and during Ave 1LM treatment. Methods: PATRIOT II is an ongoing, real-world, observational study in ≤25 US oncology centers with 1) an ambispective cohort of patients (pts) initiating PCT (n = 100), a subset of whom may continue to Ave 1LM and 2) a retrospective cohort initiated on Ave 1LM (n = 150). Sample size assumes noninferiority in HCRU and PRO pre and post 1LM initiation using paired t-tests with effect size of ≤0.3 as noninferior: ≥71 patients continuing to 1LM. In the ambispective cohort, pts with histologically confirmed la/mUC newly initiating 1L PCT are enrolled. While pts are receiving PCT and 1LM (for those who receive it), data will be collected on disease characteristics, response to tx, survival, adverse events (AEs), and HCRU for ≤52 wks after study initiation. PROs are captured using Rand SF-36 question 1, FACT Bladder Symptom Inventory – 18 and Cancer Treatment Satisfaction Questionnaire. Primary outcomes include OS and PFS from both PCT and 1LM initiation; secondary outcomes are changes in PROs and HCRU from PCT to 1LM. Analysis will be conducted at following time points: 1) baseline characteristics after full enrollment; 2) 6 months after study initiation to assess tx changes and rationale, OS, PFS, HCRU, and PRO changes from baseline; 3) at study conclusion (wk 52 after study initiation). In the retrospective cohort, pts with la/mUC who initiated Ave 1LM are enrolled. Chart data encompasses PCT and 1LM periods. Disease characteristics, response to tx, survival, AEs, and HCRU are collected. Primary outcomes are OS and PFS from initiation of PCT and 1LM start. Secondary outcomes are changes in HCRU before and after 1LM. Analysis will be conducted at following time points: 1) baseline characteristics after full enrollment, PCT, and response to tx; 2) 6 months after study initiation to assess tx changes since baseline, including dose changes, tx discontinuation/change rationale, survival rates (censoring for differential duration of follow-up), and HCRU outcomes; 3) at study conclusion to analyze endpoints up to wk 52 following study initiation. Analyses for both cohorts include Kaplan-Meier and Cox regression for time-to-event endpoints and paired t-tests for pre/post 1LM. Enrollment commenced in June 2021. 5 and 18 pts are enrolled to date in the ambispective and retrospective cohorts, respectively, from 6 of 11 activated sites. Initial results are anticipated in May 2022.
American Journal of Health-system Pharmacy, Apr 1, 2004
The antiemetic effectiveness of ondansetron 8 mg i.v, ondansetron 32 mg i.v, and granisetron 10 m... more The antiemetic effectiveness of ondansetron 8 mg i.v, ondansetron 32 mg i.v, and granisetron 10 microg/kg or 1 mg i.v. as prophylaxis in breast cancer patients regimens was studied. Data from six U.S. cancer centers were collected retrospectively for 224 patients who received cyclophosphamide-containing therapy between January 1998 and June 2002. Logistic-regression analysis was used to examine the likelihood of chemotherapy-induced nausea and vomiting (CINV) both on an unadjusted basis and controlling for concomitant radiation therapy and dexamethasone use. Seventy-six patients (34%) received ondansetron 32 mg, 68 (30%) received ondansetron 8 mg, and 80 (36%) received granisetron (either 10 microg/kg or 1 mg). Patients receiving ondansetron 8 mg were 2.5 times as likely to have CINV on an adjusted basis as granisetron recipients (p < 0.01). There was no increase in the risk of CINV with ondansetron 32 mg compared with granisetron. Patients treated with ondansetron 8 mg required more rescue antiemetics and more prophylactic antiemetics in subsequent chemotherapy cycles than patients in the other groups. In a retrospective multicenter study, granisetron 1 mg or 10 microg/kg and ondansetron 32 mg appeared more effective than ondansetron 8 mg in preventing acute CINV related to cyclophosphamide therapy.
465 Background: The JAVELIN Bladder 100 clinical trial demonstrated a significant overall surviva... more 465 Background: The JAVELIN Bladder 100 clinical trial demonstrated a significant overall survival and progression-free survival benefit with avelumab 1LM + best supportive care (BSC) vs BSC alone for la/mUC not progressing on platinum-based chemotherapy (PBC). PATRIOT-II aims to describe RW data for avelumab 1LM treatment (tx) of patients (pts) with la/mUC. Methods: PATRIOT-II collected data from pts with la/mUC treated in 37 geographically dispersed oncology practices/communities and academic centers in the US. Pts who initiated avelumab 1LM following PBC were retrospectively enrolled and will be followed up via medical record review for 52 weeks post avelumab 1LM initiation. This analysis focused on pt characteristics and tx data from la/mUC diagnosis through the PBC period and at avelumab 1LM initiation. Disease and PBC tx characteristics, as well as response to PBC, were assessed. All analyses were descriptive. Results: A total of 160 pts were enrolled (Table), 118 (74%) were white, non-Hispanic, 16 (10%), were Black, Asian, or Hispanic, and the rest unknown; 102 (64%) were current or former smokers. 77 (48%) were tested for PD-L1 via various assays, with 44 (57%) of those tumor samples reported as positive. 1L PBC was cisplatin-based in 100 (63%) of pts and carboplatin-based in 60 (38%). Pts received a median of 4 PBC cycles (interquartile range [IQR], 3-6) for a median of 13 weeks (IQR, 10-17). 31 (19%) discontinued PBC due to unacceptable side effects/toxicity. Best observed response was complete response in 21 (13%), partial response in 109 (68%), and stable disease in 17 (11%), with the remainder unknown. Median time to first imaging was 10 weeks (IQR, 5-14) after PBC initiation. 23 (14%) were hospitalized while receiving PBC, and 25 (16%) were seen in the emergency department. Pts proceeded to avelumab 1LM at a median of 4 weeks (IQR, 3-6) following PBC completion. Avelumab was administered at 800 mg every 2 weeks in 130 (81%), 10 mg/kg in 15 (9%), <800 mg in 8 (5%), and >800 mg in 7 (4%) pts. Conclusions: This ‘RW’ study offers valuable insights into characteristics and outcomes of pts with la/mUC treated in the US. Baseline factors, tx patterns and response to PBC were consistent with usual therapy paradigms in the 1L induction setting. Ongoing trials are evaluating the optimal number of PBC cycles and predictive biomarkers. Limitations include the retrospective nature, lack of randomization and central review, potential selection and confounding biases. [Table: see text]
414 Background: There are a lack of published real-world data on treatment patterns for patients ... more 414 Background: There are a lack of published real-world data on treatment patterns for patients with locally advanced or metastatic urothelial carcinoma (la/mUC) previously treated with programmed death 1/ligand 1 inhibitor (PD-1/L1i) therapy. The objective of this study was to characterize the clinical characteristics and treatments among patients with la/mUC following discontinuation of first-line (1L) or second-line (2L) PD-1/L1i therapy. Methods: We performed a retrospective chart review at 26 geographically diverse clinical sites in the US. Patients aged ≥18 years with histologically or cytologically confirmed urothelial carcinoma and radiographic evidence of metastatic or locally advanced disease were identified. Included patients had initiated and subsequently discontinued PD-1/L1i therapy in the 1L or 2L setting for la/mUC between May 15, 2016-July 31, 2018. All patients had follow-up through October 31, 2019. Data were summarized using descriptive statistics. Results: Among the 300 patients included in the chart review, 198 (66%) received PD-1/L1i therapy as 1L and 102 (34%) as 2L therapy. Mean (SD) age at la/mUC diagnosis was 69.4 (8.7) years, and a majority of patients were male (66.0%) and White (74.7%). Consistent with age, most patients (82.7%) had comorbidities at la/mUC diagnosis; 39.7% hypertension, 23.7% coronary artery disease, 17.7% pulmonary disease, and 9.3% renal disease. At initiation of therapy, a higher proportion of patients who received 1L PD-1/L1i therapy had an Eastern Cooperative Oncology Group performance status of 2 or more than patients who received 2L PD-1/L1i therapy (36.8% vs 22.5%, respectively). Following discontinuation of PD-1/L1i therapy, 34% (n = 68) received subsequent therapy in 2L and 29% (n = 30) in third-line (3L). The most common subsequent therapies in 2L were gemcitabine monotherapy (24%), gemcitabine plus cisplatin or carboplatin (22%), PD-1/L1i therapy (22%), and taxane monotherapy (19%). The most common subsequent therapies received in 3L were taxane monotherapy (50%), pemetrexed (17%), and PD-1/L1i therapy (16%). Overall, switching from one PD-1/L1i therapy to another distinct PD-1/L1i therapy occurred in approximately 20% of patients, with “better efficacy/survival” noted by treatment teams as the most common reason for switching therapy among this subgroup. Conclusions: In this real-world case series, only a minority of patients with la/mUC who discontinued PD-1/L1i therapy received subsequent therapy. Among those that did, no clear standard of care was observed and approximately one-fifth of patients were treated with a second PD-1/L1i therapy after the first failed to control disease. Collectively, the data highlight significant unmet need for patients with la/mUC who discontinue PD-1/L1i therapy.
Journal of Oncology Pharmacy Practice, Dec 1, 2003
Background. Capecitabine is a novel fluoropyrimidine administered orally for treatment of gastroi... more Background. Capecitabine is a novel fluoropyrimidine administered orally for treatment of gastrointestinal and breast malignancies. Toxicity described with capecitabine includes hand-and-foot syndrome (HFS), a potentially painful inflammation of the hands and feet. Pyridoxine has been reported to produce improvement in HFS symptoms. We conducted our study to determine the incidence and severity of HFS symptoms in capecitabine patients and to assess the effects of pyridoxine administered as prophylaxis or treatment. Patients and methods. We retrospectively reviewed 99 charts of capecitabine patients receiving pyridoxine and 99 charts of those who had not. Results. Of the 99 pyridoxine patients, 73 (74%) received it as prophylaxis, with the remainder receiving pyridoxine as acute HFS treatment. The median number of capecitabine cycles administered was five, with first-reported HFS onset at cycle 2 in those receiving pyridoxine prophylaxis versus 1.5 in those not (P 5 0.06). Incidence was significantly associated with capecitabine dose, with 76% of patients experiencing HFS in the highest dose ranges compared with 40% in the lowest (P B 0.01). The data did not support that pyridoxine prophylaxis prevented overall HFS incidence in a greater proportion of patients compared with those who did not receive prophylaxis (60% versus 53%, respectively, P 5 NS). However, when used as treatment, a greater proportion of patients receiving pyridoxine reported symptom improvement compared with those not receiving the agent (65% versus 12%, P B0.001). No differences in 12-week tumor response were seen. Conclusion. The data do not support the use of pyridoxine as prophylaxis as neither the incidence nor the severity of HFS was affected. Once HFS develops, however, pyridoxine may provide some relief of HFS symptoms. A controlled trial of capecitabine with and without pyridoxine seems warranted.
Journal of managed care & specialty pharmacy, 2015
Chemodenervation with botulinum neurotoxin (BoNT) is recommended as first-line treatment for the ... more Chemodenervation with botulinum neurotoxin (BoNT) is recommended as first-line treatment for the management of cervical dystonia. The choice of BoNT for treatment is subject to the consideration of several factors, including cost. To compare the costs incurred by patients and payers for onabotulinumtoxinA (ONA) or abobotulinumtoxinA (ABO) for the treatment of cervical dystonia. We conducted a retrospective, noninterventional closed cohort study of cervical dystonia patients within a single U.S. private neurological practice. Patient and payer incurred costs from medical billing records for patients satisfying inclusion and exclusion criteria treated from November 1, 2009, through January 1, 2013, were de-identified and included in the analysis. Forty-seven patients initially treated with at least 3 consecutive cycles of ONA, followed by at least 3 consecutive cycles of ABO were included, representing 282 injection cycles available for analysis. Patients were required to have had a p...
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