CLINICAL CHARACTERISTICS, TREATMENT PATTERNS AND HEALTH CARE RESOURCE UTILIZATION AMONG ITALIAN PATIENTS WITH RELAPSED REFRACTORY MULTIPLE MYELOMA: RESULTS FROM A PROSPECTIVE OBSERVATIONAL STUDY
(Abstract release date: 05/19/16)
EHA Library. Zagorska A. 06/09/16; 132987; E1438
Dr. Aleksandra Zagorska
Contributions
Contributions
Abstract
Abstract: E1438
Type: Eposter Presentation
Background
Knowledge of clinical practice and healthcare resource utilization (HCRU) in relapsed refractory multiple myeloma (RRMM) can inform and improve national treatment strategies.
Aims
To describe clinical and treatment characteristics, HCRU and associated costs in patients (pts) with RRMM in Italy compared to a general European cohort.
Methods
PREAMBLE (NCT01838512) is a prospective, multi-region (US, Canada, EU: Italy, France, UK, Germany), observational study with up to 3 years of follow up per pt. Eligible pts have ≥1 prior therapy for MM with disease progression from the most recent therapy, and have initiated index therapy with immunomodulatory drugs (IMiDs) and/or proteasome inhibitors (PIs) within 90 days prior to or 30 days after study consent. Demographics, treatment and HCRU data were collected, including hospitalizations, visits to healthcare professionals due to MM, diagnostic tests, MM treatments and concomitant medications. Costs were calculated by assigning standardized specific costs from Italy and other EU countries. Descriptive statistics from an interim analysis are reported.
Results
At the cutoff date (December 7th 2015), 764 of 815 enrolled pts had received treatment (509 in Europe, including 197 in Italy), with a median follow-up of 15.1 (Q1–Q3: 8–24) months. Pts were mostly male with mean age 68 years, both in Italy and the EU. At study entry the majority of pts were relapsed (Italy 76%; EU 80%) or refractory (Italy 23%; EU 20%). In Italy most pts were ISS stage I (44%) or II (33%); EU pts were equally spread across severity stages. In both cohorts 44% of pts had prior transplantation.72% of pts in Italy had comorbidities, commonly one (25%) or two (21%). Cardiovascular (40%) and metabolic (16%) disorders were most frequent. 39% of pts receiving PIs and 19% of pts receiving IMiDs had no comorbidities.In Italy for index therapy, 101 pts received IMiDs, 92 PIs and 4 IMiDs+PIs. The most common scheme amongst IMiDs was lenalidomide and amongst PIs bortezomib, both in combination with dexamethasone. Duration of index therapy varied between treatment types: median 8.8 (Q1–Q3: 3.9–14.2) months for IMiDs; 4.6 (2.8–6.2) for PIs; 4.4 (2.2–7.5) months for IMiD+PIs, with a similar pattern observed in the EU cohort. 52% of pts in Italy had received 1 prior line of therapy; most commonly bortezomib-based schemes.Average HCRU for RR MM patients during the first year of follow-up was lower in Italy compared to European cohort (Italy: mean 1.1 visit/year [max 27]; EU: 13.8 visits/year [max 112]). In both cohorts the number of visits decreased in subsequent years. In Italy HCRU differed by treatment: mean number of visits/year for pts treated with IMiD: 0.76, PI: 1.2, IMiD+PI: 7; the majority being hospital outpatient visits (68%) and all-cause hospitalization (17.5%). In the EU cohort, after outpatient visits (63%), most common were clinic/physician office visits (18%). The main reason for hospitalization was management of MM (Italy 78%; EU 67%).Cost distribution was heterogeneous among pts in both cohorts (median overall costs during index treatment: 116,000 (Q1–Q3: 78–152) euros in Italy; 88,000 (44–149) euros in the EU). Main cost drivers were MM treatments, concomitant medications (in Italy only for PI-treated pts) and hospitalizations.
Conclusion
Preliminary data from the PREAMBLE prospective observational study show variation in the management of RRMM pts in Italy having lower HCRU compared with the EU cohort. Routine management and disease progression continues to drive HCRU in MM.
Session topic: E-poster
Keyword(s): Cost analysis, Multiple myeloma, Practice, Treatment
Type: Eposter Presentation
Background
Knowledge of clinical practice and healthcare resource utilization (HCRU) in relapsed refractory multiple myeloma (RRMM) can inform and improve national treatment strategies.
Aims
To describe clinical and treatment characteristics, HCRU and associated costs in patients (pts) with RRMM in Italy compared to a general European cohort.
Methods
PREAMBLE (NCT01838512) is a prospective, multi-region (US, Canada, EU: Italy, France, UK, Germany), observational study with up to 3 years of follow up per pt. Eligible pts have ≥1 prior therapy for MM with disease progression from the most recent therapy, and have initiated index therapy with immunomodulatory drugs (IMiDs) and/or proteasome inhibitors (PIs) within 90 days prior to or 30 days after study consent. Demographics, treatment and HCRU data were collected, including hospitalizations, visits to healthcare professionals due to MM, diagnostic tests, MM treatments and concomitant medications. Costs were calculated by assigning standardized specific costs from Italy and other EU countries. Descriptive statistics from an interim analysis are reported.
Results
At the cutoff date (December 7th 2015), 764 of 815 enrolled pts had received treatment (509 in Europe, including 197 in Italy), with a median follow-up of 15.1 (Q1–Q3: 8–24) months. Pts were mostly male with mean age 68 years, both in Italy and the EU. At study entry the majority of pts were relapsed (Italy 76%; EU 80%) or refractory (Italy 23%; EU 20%). In Italy most pts were ISS stage I (44%) or II (33%); EU pts were equally spread across severity stages. In both cohorts 44% of pts had prior transplantation.72% of pts in Italy had comorbidities, commonly one (25%) or two (21%). Cardiovascular (40%) and metabolic (16%) disorders were most frequent. 39% of pts receiving PIs and 19% of pts receiving IMiDs had no comorbidities.In Italy for index therapy, 101 pts received IMiDs, 92 PIs and 4 IMiDs+PIs. The most common scheme amongst IMiDs was lenalidomide and amongst PIs bortezomib, both in combination with dexamethasone. Duration of index therapy varied between treatment types: median 8.8 (Q1–Q3: 3.9–14.2) months for IMiDs; 4.6 (2.8–6.2) for PIs; 4.4 (2.2–7.5) months for IMiD+PIs, with a similar pattern observed in the EU cohort. 52% of pts in Italy had received 1 prior line of therapy; most commonly bortezomib-based schemes.Average HCRU for RR MM patients during the first year of follow-up was lower in Italy compared to European cohort (Italy: mean 1.1 visit/year [max 27]; EU: 13.8 visits/year [max 112]). In both cohorts the number of visits decreased in subsequent years. In Italy HCRU differed by treatment: mean number of visits/year for pts treated with IMiD: 0.76, PI: 1.2, IMiD+PI: 7; the majority being hospital outpatient visits (68%) and all-cause hospitalization (17.5%). In the EU cohort, after outpatient visits (63%), most common were clinic/physician office visits (18%). The main reason for hospitalization was management of MM (Italy 78%; EU 67%).Cost distribution was heterogeneous among pts in both cohorts (median overall costs during index treatment: 116,000 (Q1–Q3: 78–152) euros in Italy; 88,000 (44–149) euros in the EU). Main cost drivers were MM treatments, concomitant medications (in Italy only for PI-treated pts) and hospitalizations.
Conclusion
Preliminary data from the PREAMBLE prospective observational study show variation in the management of RRMM pts in Italy having lower HCRU compared with the EU cohort. Routine management and disease progression continues to drive HCRU in MM.
Session topic: E-poster
Keyword(s): Cost analysis, Multiple myeloma, Practice, Treatment
Abstract: E1438
Type: Eposter Presentation
Background
Knowledge of clinical practice and healthcare resource utilization (HCRU) in relapsed refractory multiple myeloma (RRMM) can inform and improve national treatment strategies.
Aims
To describe clinical and treatment characteristics, HCRU and associated costs in patients (pts) with RRMM in Italy compared to a general European cohort.
Methods
PREAMBLE (NCT01838512) is a prospective, multi-region (US, Canada, EU: Italy, France, UK, Germany), observational study with up to 3 years of follow up per pt. Eligible pts have ≥1 prior therapy for MM with disease progression from the most recent therapy, and have initiated index therapy with immunomodulatory drugs (IMiDs) and/or proteasome inhibitors (PIs) within 90 days prior to or 30 days after study consent. Demographics, treatment and HCRU data were collected, including hospitalizations, visits to healthcare professionals due to MM, diagnostic tests, MM treatments and concomitant medications. Costs were calculated by assigning standardized specific costs from Italy and other EU countries. Descriptive statistics from an interim analysis are reported.
Results
At the cutoff date (December 7th 2015), 764 of 815 enrolled pts had received treatment (509 in Europe, including 197 in Italy), with a median follow-up of 15.1 (Q1–Q3: 8–24) months. Pts were mostly male with mean age 68 years, both in Italy and the EU. At study entry the majority of pts were relapsed (Italy 76%; EU 80%) or refractory (Italy 23%; EU 20%). In Italy most pts were ISS stage I (44%) or II (33%); EU pts were equally spread across severity stages. In both cohorts 44% of pts had prior transplantation.72% of pts in Italy had comorbidities, commonly one (25%) or two (21%). Cardiovascular (40%) and metabolic (16%) disorders were most frequent. 39% of pts receiving PIs and 19% of pts receiving IMiDs had no comorbidities.In Italy for index therapy, 101 pts received IMiDs, 92 PIs and 4 IMiDs+PIs. The most common scheme amongst IMiDs was lenalidomide and amongst PIs bortezomib, both in combination with dexamethasone. Duration of index therapy varied between treatment types: median 8.8 (Q1–Q3: 3.9–14.2) months for IMiDs; 4.6 (2.8–6.2) for PIs; 4.4 (2.2–7.5) months for IMiD+PIs, with a similar pattern observed in the EU cohort. 52% of pts in Italy had received 1 prior line of therapy; most commonly bortezomib-based schemes.Average HCRU for RR MM patients during the first year of follow-up was lower in Italy compared to European cohort (Italy: mean 1.1 visit/year [max 27]; EU: 13.8 visits/year [max 112]). In both cohorts the number of visits decreased in subsequent years. In Italy HCRU differed by treatment: mean number of visits/year for pts treated with IMiD: 0.76, PI: 1.2, IMiD+PI: 7; the majority being hospital outpatient visits (68%) and all-cause hospitalization (17.5%). In the EU cohort, after outpatient visits (63%), most common were clinic/physician office visits (18%). The main reason for hospitalization was management of MM (Italy 78%; EU 67%).Cost distribution was heterogeneous among pts in both cohorts (median overall costs during index treatment: 116,000 (Q1–Q3: 78–152) euros in Italy; 88,000 (44–149) euros in the EU). Main cost drivers were MM treatments, concomitant medications (in Italy only for PI-treated pts) and hospitalizations.
Conclusion
Preliminary data from the PREAMBLE prospective observational study show variation in the management of RRMM pts in Italy having lower HCRU compared with the EU cohort. Routine management and disease progression continues to drive HCRU in MM.
Session topic: E-poster
Keyword(s): Cost analysis, Multiple myeloma, Practice, Treatment
Type: Eposter Presentation
Background
Knowledge of clinical practice and healthcare resource utilization (HCRU) in relapsed refractory multiple myeloma (RRMM) can inform and improve national treatment strategies.
Aims
To describe clinical and treatment characteristics, HCRU and associated costs in patients (pts) with RRMM in Italy compared to a general European cohort.
Methods
PREAMBLE (NCT01838512) is a prospective, multi-region (US, Canada, EU: Italy, France, UK, Germany), observational study with up to 3 years of follow up per pt. Eligible pts have ≥1 prior therapy for MM with disease progression from the most recent therapy, and have initiated index therapy with immunomodulatory drugs (IMiDs) and/or proteasome inhibitors (PIs) within 90 days prior to or 30 days after study consent. Demographics, treatment and HCRU data were collected, including hospitalizations, visits to healthcare professionals due to MM, diagnostic tests, MM treatments and concomitant medications. Costs were calculated by assigning standardized specific costs from Italy and other EU countries. Descriptive statistics from an interim analysis are reported.
Results
At the cutoff date (December 7th 2015), 764 of 815 enrolled pts had received treatment (509 in Europe, including 197 in Italy), with a median follow-up of 15.1 (Q1–Q3: 8–24) months. Pts were mostly male with mean age 68 years, both in Italy and the EU. At study entry the majority of pts were relapsed (Italy 76%; EU 80%) or refractory (Italy 23%; EU 20%). In Italy most pts were ISS stage I (44%) or II (33%); EU pts were equally spread across severity stages. In both cohorts 44% of pts had prior transplantation.72% of pts in Italy had comorbidities, commonly one (25%) or two (21%). Cardiovascular (40%) and metabolic (16%) disorders were most frequent. 39% of pts receiving PIs and 19% of pts receiving IMiDs had no comorbidities.In Italy for index therapy, 101 pts received IMiDs, 92 PIs and 4 IMiDs+PIs. The most common scheme amongst IMiDs was lenalidomide and amongst PIs bortezomib, both in combination with dexamethasone. Duration of index therapy varied between treatment types: median 8.8 (Q1–Q3: 3.9–14.2) months for IMiDs; 4.6 (2.8–6.2) for PIs; 4.4 (2.2–7.5) months for IMiD+PIs, with a similar pattern observed in the EU cohort. 52% of pts in Italy had received 1 prior line of therapy; most commonly bortezomib-based schemes.Average HCRU for RR MM patients during the first year of follow-up was lower in Italy compared to European cohort (Italy: mean 1.1 visit/year [max 27]; EU: 13.8 visits/year [max 112]). In both cohorts the number of visits decreased in subsequent years. In Italy HCRU differed by treatment: mean number of visits/year for pts treated with IMiD: 0.76, PI: 1.2, IMiD+PI: 7; the majority being hospital outpatient visits (68%) and all-cause hospitalization (17.5%). In the EU cohort, after outpatient visits (63%), most common were clinic/physician office visits (18%). The main reason for hospitalization was management of MM (Italy 78%; EU 67%).Cost distribution was heterogeneous among pts in both cohorts (median overall costs during index treatment: 116,000 (Q1–Q3: 78–152) euros in Italy; 88,000 (44–149) euros in the EU). Main cost drivers were MM treatments, concomitant medications (in Italy only for PI-treated pts) and hospitalizations.
Conclusion
Preliminary data from the PREAMBLE prospective observational study show variation in the management of RRMM pts in Italy having lower HCRU compared with the EU cohort. Routine management and disease progression continues to drive HCRU in MM.
Session topic: E-poster
Keyword(s): Cost analysis, Multiple myeloma, Practice, Treatment
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