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A156	 VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8 	
Current data suggest that melanoma-related HCRU (hospice visits and hospitaliza-
tion) is lower among ipilimumab patients than those receiving other approved treat-
ments. Future analyses will present data for longer follow up and larger sample size.
PCN126
Relative Value Assessment: Characterizing the Benefit of Oncology
Therapies Through Diverse Metrics
Macaulay R1, Farrimond B1, Ahuja A2, Ademisoye E1, Shaw J3, Orsini L3
1PAREXEL Access Consulting, London, UK, 2PAREXEL Access Consulting, Chandigarh, India,
3Bristol-Myers Squibb, Princeton, NJ, USA
Objectives:The unmet need for oncology therapies is substantial.The introduction
of innovative, high-cost treatments, coupled with mounting budgetary pressures,
will necessitate value trade-offs across cancer types. Defining value will be criti-
cal to informing decision-making. Relative value assessment was conducted using
a diverse set of outcome metrics and treatment costs for a variety of metastatic
cancers.  Methods: A review of sources published between 1/1/2000-11/30/2015
identified outcomes data for approved treatments for metastatic cancers. Data were
extracted or derived for median and mean OS, milestone survival rates, and other
outcomes metrics. Relative outcomes were compared across treatments with and
without consideration of costs. In cost-outcome analyses, the cost per given survival
benefit identified agents with the highest relative value.  Results: Survival metric
results varied by agent within cancer type. For instance, when used for treating
NSCLC, nivolumab yielded the highest improvement in mean OS (4.1 months, pre-
treated squamous disease) and 1-year survival rate (10.8 percentage points, pre-
treated non-squamous disease), whereas afatinib yielded the highest median OS
improvement (4.1 months, 1st-line EGFR Del19 and L858R mutants). For treatment
of prostate cancer, abiraterone yielded the highest improvement in 1-year survival
rate (14.4 percentage points, pre-treated), while enzalutamide yielded the highest
median OS improvement (4.8 months, pre-treated) and sipuleucel-T the highest
mean OS improvement (3.6 months, 1st-line). Results of cost-value analyses varied
with the applied metric as some agents achieved a higher cost-value with some
metrics but not with others.  Conclusions: Valuing oncology therapies based on
improvements in median OS yields distinct results versus other survival metrics.
Unlike other metrics, median OS fails to account for long-term survival benefits.
Other frameworks developed for assessing the value of oncology therapies (e.g.,
ASCO, ESMO) are driven by median OS/PFS benefits and may not adequately value
long-term survival, which is the ultimate goal of cancer treatment.
CANCER – Patient-Reported Outcomes & Patient Preference Studies
PCN127
Economic Burden due to Treatment Non-Adherence in Patients with
Breast Cancer: A Systematic Review
Gupta J1, Joshi P2, Kamra S2, Sehgal M2
1PAREXEL International, New Delhi, India, 2PAREXEL International, Chandigarh, India
Objectives: Adherence to oral medications among patients with breast cancer
(BC) has been reported to be suboptimal. We conducted a systematic literature
review to assess the economic burden due to treatment non-adherence among
patients with BC.  Methods: Embase® and MEDLINE® were searched for the rel-
evant studies published post 2005. Each citation was reviewed by two independent
reviewers; any disagreement was resolved by a third reviewer. Results: Of the
595 citations obtained from the database search, three studies met the inclusion
criteria. Adherence to hormone therapy (two studies) was measured by proportion
of days covered and to lapatinib (one study) by medication possession ratio, time
to treatment interruption/discontinuation and time to end of continuous treat-
ment. The proportion of non-adherent patients ranged from 22% to 46% across
the included studies. In an economic evaluation, low adherence to tamoxifen was
found to be associated with an increased discounted medical cost of £5,970 (95%CI:
£4,644–£7,372) over an average patient’s lifetime. This study used data for women
with incident BC between 1993 and 2000 in theTayside region of Scotland. Key con-
tributors to increased cost were in-patient stay and other dispensing costs. Similarly,
among patients with non-metastatic BC, medical costs in the adherent group with
tamoxifen and aromatase inhibitors appeared to be lower than in the non-adherent
group during the 4-year study period (difference between non-adherent and adher-
ent: $1,476 [year 1], $8,008 [year 2], $-290 [year 3], and $1,857 [year 4]). Adjusted
medical costs were reported to be 31% less for adherent cohort. Among women
with metastatic BC, a statistically non-significant association was reported between
non-adherence to lapatinib and total healthcare costs (p= 0.870).  Conclusions:
Limited published evidence suggested that treatment non-adherence tends to
increase medical and overall healthcare costs in BC. Improvement in adherence can
help in reducing the economic burden in long-term and improve cost-effectiveness.
PCN128
A Systematic Review to Assess the Impact of Non-Adherence to
Treatments on Health Care Cost in Chronic Myeloid Leukemia
Gupta J1, Kamra S2, Joshi P2, Sehgal M2
1PAREXEL International, New Delhi, India, 2PAREXEL International, Chandigarh, India
Objectives: To assess the cost implications of non-adherence to treatment
among the patients with chronic myeloid leukemia (CML). Methods: Relevant
English-language studies were searched from Embase® and MEDLINE®.Two inde-
pendent reviewers reviewed each study and any disagreement was resolved by
third reviewer. Results: Six out of 216 studies were included. All studies were
retrospective in design and utilized medication possession ratio (MPR) to meas-
ure adherence except one, which utilized proportion of days covered. Treatments
assessed included imatinib in four studies and dasatinib, imatinib, and nilotinib in
two studies. Percentage of non-adherent patients ranged from 14% with dasatinib
to 66% with imatinib. Across the studies, higher adherence was associated with
lower total healthcare cost including medical, inpatient, and outpatient cost. In the
supportive care (BSC) and died. Patient characteristics, treatment outcomes, costs
and HRU were collected retrospectively from the beginning of the last completed
treatment line onwards, for patients receiving: second- or third-line lenalidomide
or bortezomib; fourth-line lenalidomide, bortezomib or bendamustine; any regi-
men as fifth line or greater; BSC only. Specific costs were obtained from the Italian
Drug Agency, the Ministry of Health and Codifa. Costs of other drugs and resources
(e.g. hospitalisation and laboratory tests) were estimated based on standardised
schedules.  Results: Physicians (n= 57) provided data on patients receiving active
treatment (n= 355) or BSC (n= 38). The mean (standard deviation [SD]) duration of
a therapy line (second to fourth line) was 15.6 (15.9) months (active treatment: 9.0
(7.9) months; treatment-free interval before progression: 6.6 (13.5) months). The
mean total cost (SD) per treatment line was € 38,402 (42,569); most costs were attrib-
utable to anti-tumour drugs (94.2%). The cost of managing adverse events (AEs)
ranged from € 79 to € 4,415 per event. Excluding anti-tumour drugs and managing
AEs, costs were incurred by laboratory tests (30% of total cost), hospitalisation (27%),
concomitant medication (26%), procedures (10%) and outpatient consultations (7%).
The mean total cost (SD) for BSC was € 3,169 (3969) for patients who progressed
following discontinuation of active treatment and € 2,485 (3844) for those who did
not progress before death.  Conclusions: In Italy, management of patients with
relapsed MM is expensive. Most costs result from anti-tumour drugs and AE man-
agement, and the remainder are attributable to laboratory tests, hospitalisation
and concomitant medication.
PCN124
Chart Review Study to Evaluate Health Care Resource Utilization
of Patients with Symptomatic Multiple Myeloma in the United
Kingdom
Gonzalez-McQuire S1,Yong K2, Flinois A3, Gazzola C3, Schoen P1, Campioni M1,
DeCosta L4, Fink L3
1Amgen (Europe) GmbH, Zug, Switzerland, 2University College London, London, UK, 3Kantar
Health, Paris, France, 4Amgen Ltd., Uxbridge, UK
Objectives: To evaluate the cost of care of patients with symptomatic multiple
myeloma (MM) in the United Kingdom (UK).  Methods: Oncologists and haema-
tologists completed case report forms for patients who, in the 3 months before
study initiation, either progressed after receiving specific treatment regimens (those
most commonly prescribed) or received best supportive care (BSC) and died. Patient
characteristics, treatment outcomes, costs and healthcare resource utilisation were
collected retrospectively from the beginning of the last completed line of treatment
onwards, for patients receiving: second-line lenalidomide or bortezomib; third-
line lenalidomide; fourth-line lenalidomide, pomalidomide or bendamustine; any
regimen as fifth line or greater; BSC only. Specific costs were obtained from the
UK Department of Health and MedicinesComplete. The costs of other drugs and
resources (e.g. hospitalisation and laboratory tests) were estimated based on stand-
ardised schedules.  Results: Physicians (n= 56) provided data on patients receiv-
ing active treatment (n= 346) and BSC (n= 41). The mean (standard deviation [SD])
duration of a treatment (DoT) line (second to fourth line) was 11.8 (8.6) months
(active treatment: 7.9 [6.4] months; treatment-free interval before progression: 3.9
[6.3] months). The mean (SD) total cost per treatment line was £34,296 (30,555)
and the mean (SD) cost per month during active treatment was £5,168 (4,151). The
mean (SD) total cost of BSC was £1,444 (2,831) for patients who progressed fol-
lowing active treatment discontinuation and £2,485 (3,844) for those who did not
progress before death. The mean (SD) total costs of managing patients with the
standard regimen of bortezomib and lenalidomide (second and third lines) were
£18,456 (7364) and £42,780 (37,690), respectively (mean [SD] durations of treatment
line, 13.1 [8.8] and 15.1 [11.0] months, respectively; mean total combined cost,
£59,423).  Conclusions: The DoT across lines was less than one year, illustrating
that MM remains difficult to treat.Treatment is associated with high costs.
PCN125
Health Care Resource Utilization among Advanced Melanoma
Patients in Europe
Sheahan K1, Zagorska A2, Kotapati S3, Le T4, Mathias SD5
1Bristol Myers Squibb, Princeton, NJ, USA, 2Bristol-Myers Squibb, Rueil Malmaison, France,
3Bristol-Myers Squibb, Princeton, NJ, USA, 4Bristol-Myers Squibb, Hopewell, NJ, USA, 5Health
Outcomes Solutions, Winter Park, FL, USA
Objectives: Health care resource utilization (HCRU), including inpatient and outpa-
tient visits, was analyzed to better understand resource consumption in real world
settings among advanced melanoma patients in Europe.  Methods: IMAGE is an
observational, multinational, prospective study focusing on treatment of patients
with advanced melanoma. Treatment may include ipilimumab or any other treat-
ment approved for advanced melanoma. As of March 24, 2015, 1280 patients in
North and South America, Europe,Australia, and Israel were enrolled. Sub-analysis
of all patients in 9 European countries (N= 1004) was conducted to reflect regional
HCRU.  Results: Ninety–six percent of patients had Stage IV melanoma upon
enrollment. Ninety percent (n= 906) had at least one melanoma-related healthcare
visit during the study period (from enrollment to analysis). Among patients with
melanoma related visits, 87% had at least one outpatient clinic visit, 54% were
hospitalized (some patients experienced both hospitalization and outpatient vis-
its). The total number of melanoma-related outpatient visits was 8553 (based on 6
month mean follow-up). Primary reasons for outpatient visits include management
of melanoma (89% of visits), treatment-related adverse events (5%), and surgical
intervention (1%). For ipilimumab patients (n= 851), the mean number of outpatient
visits was 9.6. Forty-seven percent had a melanoma-related hospitalization or hos-
pice visit. The mean number of hospitalizations or hospice visits was 3.2, and the
mean number of inpatient days was 19.3. For non-ipilimumab patients, the mean
number of outpatient visits was 8.6. Seventy-one percent had a melanoma-related
hospitalization or hospice visit. The mean number of hospitalizations or hospice
visits was 4.5, and the mean number of inpatient days was 18.9.  Conclusions:
Advanced melanoma is a significant health condition associated with high HCRU.

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PROs and Patient Preference Studies

  • 1. A156 VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8 Current data suggest that melanoma-related HCRU (hospice visits and hospitaliza- tion) is lower among ipilimumab patients than those receiving other approved treat- ments. Future analyses will present data for longer follow up and larger sample size. PCN126 Relative Value Assessment: Characterizing the Benefit of Oncology Therapies Through Diverse Metrics Macaulay R1, Farrimond B1, Ahuja A2, Ademisoye E1, Shaw J3, Orsini L3 1PAREXEL Access Consulting, London, UK, 2PAREXEL Access Consulting, Chandigarh, India, 3Bristol-Myers Squibb, Princeton, NJ, USA Objectives:The unmet need for oncology therapies is substantial.The introduction of innovative, high-cost treatments, coupled with mounting budgetary pressures, will necessitate value trade-offs across cancer types. Defining value will be criti- cal to informing decision-making. Relative value assessment was conducted using a diverse set of outcome metrics and treatment costs for a variety of metastatic cancers.  Methods: A review of sources published between 1/1/2000-11/30/2015 identified outcomes data for approved treatments for metastatic cancers. Data were extracted or derived for median and mean OS, milestone survival rates, and other outcomes metrics. Relative outcomes were compared across treatments with and without consideration of costs. In cost-outcome analyses, the cost per given survival benefit identified agents with the highest relative value.  Results: Survival metric results varied by agent within cancer type. For instance, when used for treating NSCLC, nivolumab yielded the highest improvement in mean OS (4.1 months, pre- treated squamous disease) and 1-year survival rate (10.8 percentage points, pre- treated non-squamous disease), whereas afatinib yielded the highest median OS improvement (4.1 months, 1st-line EGFR Del19 and L858R mutants). For treatment of prostate cancer, abiraterone yielded the highest improvement in 1-year survival rate (14.4 percentage points, pre-treated), while enzalutamide yielded the highest median OS improvement (4.8 months, pre-treated) and sipuleucel-T the highest mean OS improvement (3.6 months, 1st-line). Results of cost-value analyses varied with the applied metric as some agents achieved a higher cost-value with some metrics but not with others.  Conclusions: Valuing oncology therapies based on improvements in median OS yields distinct results versus other survival metrics. Unlike other metrics, median OS fails to account for long-term survival benefits. Other frameworks developed for assessing the value of oncology therapies (e.g., ASCO, ESMO) are driven by median OS/PFS benefits and may not adequately value long-term survival, which is the ultimate goal of cancer treatment. CANCER – Patient-Reported Outcomes & Patient Preference Studies PCN127 Economic Burden due to Treatment Non-Adherence in Patients with Breast Cancer: A Systematic Review Gupta J1, Joshi P2, Kamra S2, Sehgal M2 1PAREXEL International, New Delhi, India, 2PAREXEL International, Chandigarh, India Objectives: Adherence to oral medications among patients with breast cancer (BC) has been reported to be suboptimal. We conducted a systematic literature review to assess the economic burden due to treatment non-adherence among patients with BC.  Methods: Embase® and MEDLINE® were searched for the rel- evant studies published post 2005. Each citation was reviewed by two independent reviewers; any disagreement was resolved by a third reviewer. Results: Of the 595 citations obtained from the database search, three studies met the inclusion criteria. Adherence to hormone therapy (two studies) was measured by proportion of days covered and to lapatinib (one study) by medication possession ratio, time to treatment interruption/discontinuation and time to end of continuous treat- ment. The proportion of non-adherent patients ranged from 22% to 46% across the included studies. In an economic evaluation, low adherence to tamoxifen was found to be associated with an increased discounted medical cost of £5,970 (95%CI: £4,644–£7,372) over an average patient’s lifetime. This study used data for women with incident BC between 1993 and 2000 in theTayside region of Scotland. Key con- tributors to increased cost were in-patient stay and other dispensing costs. Similarly, among patients with non-metastatic BC, medical costs in the adherent group with tamoxifen and aromatase inhibitors appeared to be lower than in the non-adherent group during the 4-year study period (difference between non-adherent and adher- ent: $1,476 [year 1], $8,008 [year 2], $-290 [year 3], and $1,857 [year 4]). Adjusted medical costs were reported to be 31% less for adherent cohort. Among women with metastatic BC, a statistically non-significant association was reported between non-adherence to lapatinib and total healthcare costs (p= 0.870).  Conclusions: Limited published evidence suggested that treatment non-adherence tends to increase medical and overall healthcare costs in BC. Improvement in adherence can help in reducing the economic burden in long-term and improve cost-effectiveness. PCN128 A Systematic Review to Assess the Impact of Non-Adherence to Treatments on Health Care Cost in Chronic Myeloid Leukemia Gupta J1, Kamra S2, Joshi P2, Sehgal M2 1PAREXEL International, New Delhi, India, 2PAREXEL International, Chandigarh, India Objectives: To assess the cost implications of non-adherence to treatment among the patients with chronic myeloid leukemia (CML). Methods: Relevant English-language studies were searched from Embase® and MEDLINE®.Two inde- pendent reviewers reviewed each study and any disagreement was resolved by third reviewer. Results: Six out of 216 studies were included. All studies were retrospective in design and utilized medication possession ratio (MPR) to meas- ure adherence except one, which utilized proportion of days covered. Treatments assessed included imatinib in four studies and dasatinib, imatinib, and nilotinib in two studies. Percentage of non-adherent patients ranged from 14% with dasatinib to 66% with imatinib. Across the studies, higher adherence was associated with lower total healthcare cost including medical, inpatient, and outpatient cost. In the supportive care (BSC) and died. Patient characteristics, treatment outcomes, costs and HRU were collected retrospectively from the beginning of the last completed treatment line onwards, for patients receiving: second- or third-line lenalidomide or bortezomib; fourth-line lenalidomide, bortezomib or bendamustine; any regi- men as fifth line or greater; BSC only. Specific costs were obtained from the Italian Drug Agency, the Ministry of Health and Codifa. Costs of other drugs and resources (e.g. hospitalisation and laboratory tests) were estimated based on standardised schedules.  Results: Physicians (n= 57) provided data on patients receiving active treatment (n= 355) or BSC (n= 38). The mean (standard deviation [SD]) duration of a therapy line (second to fourth line) was 15.6 (15.9) months (active treatment: 9.0 (7.9) months; treatment-free interval before progression: 6.6 (13.5) months). The mean total cost (SD) per treatment line was € 38,402 (42,569); most costs were attrib- utable to anti-tumour drugs (94.2%). The cost of managing adverse events (AEs) ranged from € 79 to € 4,415 per event. Excluding anti-tumour drugs and managing AEs, costs were incurred by laboratory tests (30% of total cost), hospitalisation (27%), concomitant medication (26%), procedures (10%) and outpatient consultations (7%). The mean total cost (SD) for BSC was € 3,169 (3969) for patients who progressed following discontinuation of active treatment and € 2,485 (3844) for those who did not progress before death.  Conclusions: In Italy, management of patients with relapsed MM is expensive. Most costs result from anti-tumour drugs and AE man- agement, and the remainder are attributable to laboratory tests, hospitalisation and concomitant medication. PCN124 Chart Review Study to Evaluate Health Care Resource Utilization of Patients with Symptomatic Multiple Myeloma in the United Kingdom Gonzalez-McQuire S1,Yong K2, Flinois A3, Gazzola C3, Schoen P1, Campioni M1, DeCosta L4, Fink L3 1Amgen (Europe) GmbH, Zug, Switzerland, 2University College London, London, UK, 3Kantar Health, Paris, France, 4Amgen Ltd., Uxbridge, UK Objectives: To evaluate the cost of care of patients with symptomatic multiple myeloma (MM) in the United Kingdom (UK).  Methods: Oncologists and haema- tologists completed case report forms for patients who, in the 3 months before study initiation, either progressed after receiving specific treatment regimens (those most commonly prescribed) or received best supportive care (BSC) and died. Patient characteristics, treatment outcomes, costs and healthcare resource utilisation were collected retrospectively from the beginning of the last completed line of treatment onwards, for patients receiving: second-line lenalidomide or bortezomib; third- line lenalidomide; fourth-line lenalidomide, pomalidomide or bendamustine; any regimen as fifth line or greater; BSC only. Specific costs were obtained from the UK Department of Health and MedicinesComplete. The costs of other drugs and resources (e.g. hospitalisation and laboratory tests) were estimated based on stand- ardised schedules.  Results: Physicians (n= 56) provided data on patients receiv- ing active treatment (n= 346) and BSC (n= 41). The mean (standard deviation [SD]) duration of a treatment (DoT) line (second to fourth line) was 11.8 (8.6) months (active treatment: 7.9 [6.4] months; treatment-free interval before progression: 3.9 [6.3] months). The mean (SD) total cost per treatment line was £34,296 (30,555) and the mean (SD) cost per month during active treatment was £5,168 (4,151). The mean (SD) total cost of BSC was £1,444 (2,831) for patients who progressed fol- lowing active treatment discontinuation and £2,485 (3,844) for those who did not progress before death. The mean (SD) total costs of managing patients with the standard regimen of bortezomib and lenalidomide (second and third lines) were £18,456 (7364) and £42,780 (37,690), respectively (mean [SD] durations of treatment line, 13.1 [8.8] and 15.1 [11.0] months, respectively; mean total combined cost, £59,423).  Conclusions: The DoT across lines was less than one year, illustrating that MM remains difficult to treat.Treatment is associated with high costs. PCN125 Health Care Resource Utilization among Advanced Melanoma Patients in Europe Sheahan K1, Zagorska A2, Kotapati S3, Le T4, Mathias SD5 1Bristol Myers Squibb, Princeton, NJ, USA, 2Bristol-Myers Squibb, Rueil Malmaison, France, 3Bristol-Myers Squibb, Princeton, NJ, USA, 4Bristol-Myers Squibb, Hopewell, NJ, USA, 5Health Outcomes Solutions, Winter Park, FL, USA Objectives: Health care resource utilization (HCRU), including inpatient and outpa- tient visits, was analyzed to better understand resource consumption in real world settings among advanced melanoma patients in Europe.  Methods: IMAGE is an observational, multinational, prospective study focusing on treatment of patients with advanced melanoma. Treatment may include ipilimumab or any other treat- ment approved for advanced melanoma. As of March 24, 2015, 1280 patients in North and South America, Europe,Australia, and Israel were enrolled. Sub-analysis of all patients in 9 European countries (N= 1004) was conducted to reflect regional HCRU.  Results: Ninety–six percent of patients had Stage IV melanoma upon enrollment. Ninety percent (n= 906) had at least one melanoma-related healthcare visit during the study period (from enrollment to analysis). Among patients with melanoma related visits, 87% had at least one outpatient clinic visit, 54% were hospitalized (some patients experienced both hospitalization and outpatient vis- its). The total number of melanoma-related outpatient visits was 8553 (based on 6 month mean follow-up). Primary reasons for outpatient visits include management of melanoma (89% of visits), treatment-related adverse events (5%), and surgical intervention (1%). For ipilimumab patients (n= 851), the mean number of outpatient visits was 9.6. Forty-seven percent had a melanoma-related hospitalization or hos- pice visit. The mean number of hospitalizations or hospice visits was 3.2, and the mean number of inpatient days was 19.3. For non-ipilimumab patients, the mean number of outpatient visits was 8.6. Seventy-one percent had a melanoma-related hospitalization or hospice visit. The mean number of hospitalizations or hospice visits was 4.5, and the mean number of inpatient days was 18.9.  Conclusions: Advanced melanoma is a significant health condition associated with high HCRU.