- Email: [email protected]
Economic Evaluation of Cancer Medicines Usage at Uganda Cancer Institute
A886
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8
receiving the AD regimen and to identify covariates that explain the variability in exposure following oral administration. Methods: 31 mRCC patients receiving AD sunitinib were included. Plasma samples collected on day 29 of each treatment cycle after the start of the therapy. A nonlinear mixed effects modeling approach was utilized to evaluate the population PK properties of sunitinib and SU12662 as well as covariates. Monte Carlo simulation was also performed to predict the total trough level (TTL) of sunitinib and SU12662. Results: Sunitinib population means for CL/F and Vd/Fcentral were 13.8 L/h and 1,720 L, respectively. SU12662 population means for CL/F and Vd/F were 42.1 L/h and 1,410 L, respectively. Body surface area and ABCB1 polymorphism significantly influenced the CL/F variability of sunitinib: CL/Fcentral = 13.8× exp((BSA-1.75)× 2.08+(ABCB1type–0.67)× 0.61), ABCB1 – 0: wild type, 1: mutant type. The effect size of ABCB1 mutant type and BSA greater than 1.75 m2 in relation to sunitinib clearance was 31.14% (p= 0.006) and 22.11% (p= 0.011) respectively, relative to the reference group. Conclusions: Dose adjustment could be cautiously suggested by the magnitude of the predicted changes in exposure with the covariates in Asian mRCC patients.
The study was cross sectional study. The patients were randomly selected by taking the 6th patient in the treatment / dispensing queue, to participate in the study. 25 patients per day were randomly selected out of the 98 patients who were receiving chemotherapy. The study population was of 385 patients . Results: The cost of medicines supplied by government, donations and out of pocket cost were Shs. 103,000,000 (€ 26,410), Shs.153,000,000 (€ 39,230) and Shs.30,700,000 (€ 7,871) respectively. The proportions of the frequency of out- of- pocket costs were found to be 109 (28.3%), donations was found to cover 24 (6.2%) and government was found to be 357 (92.7%) of the medicines used at the Uganda Cancer Institute. Conclusions: The cost of donated medicines is high. It serves a small number of patients who seek care. While Uganda Cancer Institute dispenses cancer medicines to all patients free of charge, low availability leads to patients to purchase medicine in private Pharmacies. Some medicines cost a lot of money, leading to high patients’ expenditure and some patients do not buy at all. Progress will require a multi-faceted approach, as well as review of policies and regulations in place that focus on the availability and accessibility of cancer medicines in Uganda.
PCN10 Real World Experience of Sunitinib in Patients with Metastatic Renal Cell Carcinoma; Results from Compassionate use Program in Malaysia
PCN13 The Evpi of Treatment Strategies for Radioiodine-Refractory Differentiated Thyroid Cancer
Lee YY1, Lim TO2, Hong LW1 1Pfizer Malaysia, Kuala Lumpur, Malaysia, 2StatsConsulting, Petaling Jaya, Malaysia
1UCSF, San
Objectives: Sunitinib is an oral targeted small molecule inhibitor of vascular endothelial growth factor receptors indicated for treatment of advanced renal cell carcinoma (RCC). Robust data on efficacy and effectiveness for Sunitinib from global clinical trials and real world studies are available. However, local real world experience is rare. Methods: A global access program (SPAP) was commenced to provide sunitinib treatment on the basis of compassionate use to patients with advanced RCC. Program recruitment was done between 2008 and 2012. Sunitinib was administered in repeated 6-week cycles (4 weeks on and 2 weeks off) until occurrence of disease progression or unacceptable toxicity. All patient vital status was matched against the national death registration database on January 2016 using unique national identification number. Survival analysis was performed. Results: A total of 196 patients were enrolled from both private and government hospitals. Patient with incomplete date of diagnosis and national identifier were excluded. Forty one (41%) of the cohort was aged 60 years and below. 31% of the patients were female and over half of the patients were of Chinese ethnicity (68%). One third of patients underwent radiotherapy and 22% had chemotherapy. At baseline, 73%, 70% and 69% reported inadequate liver, renal and thyroid function, respectively. We found SPAP patients had greater overall median survival compare to the trial results, a difference of 6 months. This preliminary finding warrant further verification. Conclusions: Malaysia sunitinib overall survival data corresponds to clinical trial data. This implied that benefit of sunitinib extends beyond stringent criteria of clinical trial setting. PCN11 Patient Characteristics and Clinical Outcomes of Patients with Liver Cancer in a Tertiary-Care Hospital in Malaysia Shabaruddin FH, Jamil AA, Hashim H, Yunus RM, Mohamed R University of Malaya, Kuala Lumpur, Malaysia
Objectives: Liver cancer is a leading cause of cancer-related deaths worldwide. Barcelona Clinic Liver Cancer (BCLC) staging, which is based on tumour status, liver function and health status, can be used to determine treatment allocation to optimise clinical outcomes. This study aims to describe the patient characteristics and clinical outcomes of Malaysian patients with liver cancer treated in a tertiary-care hospital in Kuala Lumpur. Methods: Data from the medical records of patients with hepatocellular carcinoma liver cancer from 2007 to 2012 were collected in a retrospective study. Date of death was obtained from the National Registration Department in April 2014. Overall survival is defined as survival time from date of diagnosis until the end of life. Results: There were 208 patients (male: n= 158, 76%) who met the inclusion criteria (mean age 64 years, SD: 12, range: 23-92). The ethnic distributions were Chinese (n= 144, 69%), Malay (n= 42, 20%) and Indian (n= 22, 11%). Stages of liver cancer at diagnosis based on BCLC staging were: Stage A (n= 57, 27%), Stage B (n= 33, 16%), Stage C (n= 89, 43%) and Stage D (n= 29, 14%). The main active treatments received were: radiofrequency ablation (RFA) (n= 75, 36%), transarterial chemoembolization (TACE) (n= 71, 34%) and liver resection (n= 33, 16%). At the time of analysis, 173 patients (83%) were deceased, while the rest had censored data (n= 35, 17%). Median survivals for patients who received the following active treatment were: liver resection (71 months), RFA (35 months) and TACE (15 months). The median survivals of patients on sorafenib (10 months) and palliative care (4 months) reflected the place of these treatment modalities within current practice. Conclusions: This study has described the patient characteristics and clinical outcomes of patients with liver cancer in Malaysia. The findings suggest that treatment outcomes in the local setting are similar to results from other studies.
CANCER – Cost Studies PCN12 Economic Evaluation of Cancer Medicines Usage at Uganda Cancer Institute Mwesige B Uganda Cancer Institute, kampala, Uganda
Objectives: a) To determine the cost of medicine provided for by Government. b) To establish the proportion of medicines that patient’s buy-out of pocket costs. c) To determine the proportion of drug needs met through donation. Methods:
Huang W1, Chen L1, Ting J1, Cao V1, Sung H1, Yokokura M1, Wilson L2 Francisco, CA, USA, 2University of California, San Francisco, San Francisco, CA, USA
Objectives: Lenvatinib and sorafenib are the two most recently FDA-approved drugs for treating radioiodine (RAI)-refractory differentiated thyroid cancer (DTC). We compared the probabilistic cost-effectiveness of these two treatments with placebo and assessed the expected value of perfect information (EVPI) to identify the decision uncertainty for the optimal treatment. Methods: Using the costeffectiveness Markov Model, we ran a second-order Monte Carlo simulation with distributions using TreeAge software. We calculated the acceptability curve for each treatment and placebo to address the uncertainty around model inputs. We used the “Net Monetary Benefit” to calculate the EVPI as the difference between the expected value with and without perfect information and evaluated the expected benefit of reducing uncertainty for the optimal treatment decision. We determined EVPI per individual and for the population at risk at 1, 5 and 10 years at different WTP. We used SEER prevalence in 2015 for year 1 and added incidence for multiple year estimates of societal EVPI. Results: Lenvatinib was the most cost-effective treatment (ICER = $95,695/QALY) with extended dominance of sorafenib. The acceptability curve showed lenvatinib optimal only 37% and sorafenib 33% of time at WTP of $100,000/QALY showing considerable model uncertainty. The EVPI was $15,318/ person at $100,000 WTP. For an estimated 72,215 and 87,259 patients at risk over a five and ten-year time horizon, the EVPI was $111 million and $134 million respectively at $100,000 WTP. Conclusions: Our study suggests that lenvatinib is the optimal treatment for RAI-refractory DTC but with considerable uncertainty. The EVPI demonstrates a clinical trial must cost less than $111 or $134 million depending on expected life of treatments, to be worthwhile. A peak EVPI at WTP of $100,000 shows there is the most model uncertainty at our main decision point. Without more information, lenvatinib and sorafenib could both be cost-effective treatments. PCN14 Literature Review on Hospital Costs for Patients Undergoing Gastrectomy Chen BP1, Cheng H2, Hsiao C2 Inc., Somerville, NJ, USA, 2Global Health Economics and Market Access, Ethicon Inc., Cincinnati, OH, USA
1Ethicon
Objectives: This study aims to identify the range of direct hospital costs associated with a laparoscopy-assisted or open distal gastrectomy across different countries. Methods: A PubMed search was performed using the keywords: gastrectomy [MeSH] and cost/economic with results limited to publications of human subject studies in English from 2006 to February 2016. Studies comparing laparoscopyassisted to open surgical techniques for early gastric cancer were selected and studies of comparisons other than laparoscopy-assisted versus open procedures (e.g. robotic) were excluded. All abstracts were filtered, including meta-analysis, RCTs and observational studies excluding case studies. Results: A total of 28 studies were identified. The highest incidence of stomach cancer, as reflected in the literature was in Asia. Twelve of fourteen (86%) of the articles included in the analysis were conducted in Korea (3), Japan (3), China (5) and Taiwan (1). Seven meta-analyses showed that laparoscopy-assisted procedures resulted in longer operative time (44-113 minutes) and reduced intraoperative blood loss (108-122 ml), while six meta-analyses showed reduced hospital stay (1-5 days). Only one metaanalysis evaluated operating room cost and it showed that laparoscopy-assisted procedures were associated with higher cost. Operating room per minute cost was approximately $6 for open procedures and $11-$34 per minute for laparoscopies. The cost of medications during the inpatient stay ranged from $75-$81 for open procedures and $36-$73 for laparoscopies. Overall, the per-day cost for hospital stays ranged from $103-$317 for open procedures and from $116-$330 for laparoscopyassisted procedures. Conclusions: A Limited number of cost studies evaluating surgical procedures for early gastric cancer exists. Lacking high-quality economic analyses may confound the non-clinical stakeholders’ efforts to make evidenced based purchasing decisions. Countries with high rates of gastric cancer may lack the information necessary to develop fully informed health policy regarding the cost-effectiveness of advanced surgical treatments for gastric cancer.
PCN15 Cost Analysis of Different Sequential Treatment Regimens for Metastatic Renal Cell Carcinoma in China Wan Y1, Gao C2, Xue M1, Ren H3, Dong P4 International, Bethesda, MD, USA, 2Pharmerit International, Newton, MA, USA, 3Pfizer China, Shanghai, China, 4Pfizer Investment Co., Ltd., Beijing, China
1Pharmerit
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 8 0 7 – A 9 1 8
receiving the AD regimen and to identify covariates that explain the variability in exposure following oral administration. Methods: 31 mRCC patients receiving AD sunitinib were included. Plasma samples collected on day 29 of each treatment cycle after the start of the therapy. A nonlinear mixed effects modeling approach was utilized to evaluate the population PK properties of sunitinib and SU12662 as well as covariates. Monte Carlo simulation was also performed to predict the total trough level (TTL) of sunitinib and SU12662. Results: Sunitinib population means for CL/F and Vd/Fcentral were 13.8 L/h and 1,720 L, respectively. SU12662 population means for CL/F and Vd/F were 42.1 L/h and 1,410 L, respectively. Body surface area and ABCB1 polymorphism significantly influenced the CL/F variability of sunitinib: CL/Fcentral = 13.8× exp((BSA-1.75)× 2.08+(ABCB1type–0.67)× 0.61), ABCB1 – 0: wild type, 1: mutant type. The effect size of ABCB1 mutant type and BSA greater than 1.75 m2 in relation to sunitinib clearance was 31.14% (p= 0.006) and 22.11% (p= 0.011) respectively, relative to the reference group. Conclusions: Dose adjustment could be cautiously suggested by the magnitude of the predicted changes in exposure with the covariates in Asian mRCC patients.
The study was cross sectional study. The patients were randomly selected by taking the 6th patient in the treatment / dispensing queue, to participate in the study. 25 patients per day were randomly selected out of the 98 patients who were receiving chemotherapy. The study population was of 385 patients . Results: The cost of medicines supplied by government, donations and out of pocket cost were Shs. 103,000,000 (€ 26,410), Shs.153,000,000 (€ 39,230) and Shs.30,700,000 (€ 7,871) respectively. The proportions of the frequency of out- of- pocket costs were found to be 109 (28.3%), donations was found to cover 24 (6.2%) and government was found to be 357 (92.7%) of the medicines used at the Uganda Cancer Institute. Conclusions: The cost of donated medicines is high. It serves a small number of patients who seek care. While Uganda Cancer Institute dispenses cancer medicines to all patients free of charge, low availability leads to patients to purchase medicine in private Pharmacies. Some medicines cost a lot of money, leading to high patients’ expenditure and some patients do not buy at all. Progress will require a multi-faceted approach, as well as review of policies and regulations in place that focus on the availability and accessibility of cancer medicines in Uganda.
PCN10 Real World Experience of Sunitinib in Patients with Metastatic Renal Cell Carcinoma; Results from Compassionate use Program in Malaysia
PCN13 The Evpi of Treatment Strategies for Radioiodine-Refractory Differentiated Thyroid Cancer
Lee YY1, Lim TO2, Hong LW1 1Pfizer Malaysia, Kuala Lumpur, Malaysia, 2StatsConsulting, Petaling Jaya, Malaysia
1UCSF, San
Objectives: Sunitinib is an oral targeted small molecule inhibitor of vascular endothelial growth factor receptors indicated for treatment of advanced renal cell carcinoma (RCC). Robust data on efficacy and effectiveness for Sunitinib from global clinical trials and real world studies are available. However, local real world experience is rare. Methods: A global access program (SPAP) was commenced to provide sunitinib treatment on the basis of compassionate use to patients with advanced RCC. Program recruitment was done between 2008 and 2012. Sunitinib was administered in repeated 6-week cycles (4 weeks on and 2 weeks off) until occurrence of disease progression or unacceptable toxicity. All patient vital status was matched against the national death registration database on January 2016 using unique national identification number. Survival analysis was performed. Results: A total of 196 patients were enrolled from both private and government hospitals. Patient with incomplete date of diagnosis and national identifier were excluded. Forty one (41%) of the cohort was aged 60 years and below. 31% of the patients were female and over half of the patients were of Chinese ethnicity (68%). One third of patients underwent radiotherapy and 22% had chemotherapy. At baseline, 73%, 70% and 69% reported inadequate liver, renal and thyroid function, respectively. We found SPAP patients had greater overall median survival compare to the trial results, a difference of 6 months. This preliminary finding warrant further verification. Conclusions: Malaysia sunitinib overall survival data corresponds to clinical trial data. This implied that benefit of sunitinib extends beyond stringent criteria of clinical trial setting. PCN11 Patient Characteristics and Clinical Outcomes of Patients with Liver Cancer in a Tertiary-Care Hospital in Malaysia Shabaruddin FH, Jamil AA, Hashim H, Yunus RM, Mohamed R University of Malaya, Kuala Lumpur, Malaysia
Objectives: Liver cancer is a leading cause of cancer-related deaths worldwide. Barcelona Clinic Liver Cancer (BCLC) staging, which is based on tumour status, liver function and health status, can be used to determine treatment allocation to optimise clinical outcomes. This study aims to describe the patient characteristics and clinical outcomes of Malaysian patients with liver cancer treated in a tertiary-care hospital in Kuala Lumpur. Methods: Data from the medical records of patients with hepatocellular carcinoma liver cancer from 2007 to 2012 were collected in a retrospective study. Date of death was obtained from the National Registration Department in April 2014. Overall survival is defined as survival time from date of diagnosis until the end of life. Results: There were 208 patients (male: n= 158, 76%) who met the inclusion criteria (mean age 64 years, SD: 12, range: 23-92). The ethnic distributions were Chinese (n= 144, 69%), Malay (n= 42, 20%) and Indian (n= 22, 11%). Stages of liver cancer at diagnosis based on BCLC staging were: Stage A (n= 57, 27%), Stage B (n= 33, 16%), Stage C (n= 89, 43%) and Stage D (n= 29, 14%). The main active treatments received were: radiofrequency ablation (RFA) (n= 75, 36%), transarterial chemoembolization (TACE) (n= 71, 34%) and liver resection (n= 33, 16%). At the time of analysis, 173 patients (83%) were deceased, while the rest had censored data (n= 35, 17%). Median survivals for patients who received the following active treatment were: liver resection (71 months), RFA (35 months) and TACE (15 months). The median survivals of patients on sorafenib (10 months) and palliative care (4 months) reflected the place of these treatment modalities within current practice. Conclusions: This study has described the patient characteristics and clinical outcomes of patients with liver cancer in Malaysia. The findings suggest that treatment outcomes in the local setting are similar to results from other studies.
CANCER – Cost Studies PCN12 Economic Evaluation of Cancer Medicines Usage at Uganda Cancer Institute Mwesige B Uganda Cancer Institute, kampala, Uganda
Objectives: a) To determine the cost of medicine provided for by Government. b) To establish the proportion of medicines that patient’s buy-out of pocket costs. c) To determine the proportion of drug needs met through donation. Methods:
Huang W1, Chen L1, Ting J1, Cao V1, Sung H1, Yokokura M1, Wilson L2 Francisco, CA, USA, 2University of California, San Francisco, San Francisco, CA, USA
Objectives: Lenvatinib and sorafenib are the two most recently FDA-approved drugs for treating radioiodine (RAI)-refractory differentiated thyroid cancer (DTC). We compared the probabilistic cost-effectiveness of these two treatments with placebo and assessed the expected value of perfect information (EVPI) to identify the decision uncertainty for the optimal treatment. Methods: Using the costeffectiveness Markov Model, we ran a second-order Monte Carlo simulation with distributions using TreeAge software. We calculated the acceptability curve for each treatment and placebo to address the uncertainty around model inputs. We used the “Net Monetary Benefit” to calculate the EVPI as the difference between the expected value with and without perfect information and evaluated the expected benefit of reducing uncertainty for the optimal treatment decision. We determined EVPI per individual and for the population at risk at 1, 5 and 10 years at different WTP. We used SEER prevalence in 2015 for year 1 and added incidence for multiple year estimates of societal EVPI. Results: Lenvatinib was the most cost-effective treatment (ICER = $95,695/QALY) with extended dominance of sorafenib. The acceptability curve showed lenvatinib optimal only 37% and sorafenib 33% of time at WTP of $100,000/QALY showing considerable model uncertainty. The EVPI was $15,318/ person at $100,000 WTP. For an estimated 72,215 and 87,259 patients at risk over a five and ten-year time horizon, the EVPI was $111 million and $134 million respectively at $100,000 WTP. Conclusions: Our study suggests that lenvatinib is the optimal treatment for RAI-refractory DTC but with considerable uncertainty. The EVPI demonstrates a clinical trial must cost less than $111 or $134 million depending on expected life of treatments, to be worthwhile. A peak EVPI at WTP of $100,000 shows there is the most model uncertainty at our main decision point. Without more information, lenvatinib and sorafenib could both be cost-effective treatments. PCN14 Literature Review on Hospital Costs for Patients Undergoing Gastrectomy Chen BP1, Cheng H2, Hsiao C2 Inc., Somerville, NJ, USA, 2Global Health Economics and Market Access, Ethicon Inc., Cincinnati, OH, USA
1Ethicon
Objectives: This study aims to identify the range of direct hospital costs associated with a laparoscopy-assisted or open distal gastrectomy across different countries. Methods: A PubMed search was performed using the keywords: gastrectomy [MeSH] and cost/economic with results limited to publications of human subject studies in English from 2006 to February 2016. Studies comparing laparoscopyassisted to open surgical techniques for early gastric cancer were selected and studies of comparisons other than laparoscopy-assisted versus open procedures (e.g. robotic) were excluded. All abstracts were filtered, including meta-analysis, RCTs and observational studies excluding case studies. Results: A total of 28 studies were identified. The highest incidence of stomach cancer, as reflected in the literature was in Asia. Twelve of fourteen (86%) of the articles included in the analysis were conducted in Korea (3), Japan (3), China (5) and Taiwan (1). Seven meta-analyses showed that laparoscopy-assisted procedures resulted in longer operative time (44-113 minutes) and reduced intraoperative blood loss (108-122 ml), while six meta-analyses showed reduced hospital stay (1-5 days). Only one metaanalysis evaluated operating room cost and it showed that laparoscopy-assisted procedures were associated with higher cost. Operating room per minute cost was approximately $6 for open procedures and $11-$34 per minute for laparoscopies. The cost of medications during the inpatient stay ranged from $75-$81 for open procedures and $36-$73 for laparoscopies. Overall, the per-day cost for hospital stays ranged from $103-$317 for open procedures and from $116-$330 for laparoscopyassisted procedures. Conclusions: A Limited number of cost studies evaluating surgical procedures for early gastric cancer exists. Lacking high-quality economic analyses may confound the non-clinical stakeholders’ efforts to make evidenced based purchasing decisions. Countries with high rates of gastric cancer may lack the information necessary to develop fully informed health policy regarding the cost-effectiveness of advanced surgical treatments for gastric cancer.
PCN15 Cost Analysis of Different Sequential Treatment Regimens for Metastatic Renal Cell Carcinoma in China Wan Y1, Gao C2, Xue M1, Ren H3, Dong P4 International, Bethesda, MD, USA, 2Pharmerit International, Newton, MA, USA, 3Pfizer China, Shanghai, China, 4Pfizer Investment Co., Ltd., Beijing, China
1Pharmerit