Real-World Treatment Patterns and Costs of Care Among Brentuximab Vendotin-Treated Patients with Hodgkin Lymphoma in The United States

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Objectives: To examine the economic burden and health care utilization of breast cancer in the US Medicare population.  Methods: Prevalent cases of breast cancer patients were identified (International Classification of Diseases, 9th Revision, Clinical Modification diagnosis codes: 174.0, 174.1, 174.2, 174.3, 174.4, 174.5, 174.6, 174.8, 174.9, 175.0, 175.9) using national Medicare data from 01JAN2009-31DEC2013. The first diagnosis date was designated as the index date. Patients were required to have continuous medical and pharmacy benefits 1 year pre- and 1 year post-index date. Study outcomes, including health care utilization and costs, were described in the sample.  Results: Out of 682,543 identified patients diagnosed with breast cancer, 98.23% were women, and 88.64% were white. The mean age of the sample was 76.61 years (standard deviation [SD]= 7.27 years) and were more likely to reside in the South US region (38.07%). The average Charlson comorbidity index (CCI) score was 4.25 (SD= 3.42). The most frequently diagnosed comorbid conditions included hypertension (72.97%), other malignancies (52.48%), and diabetes (30.09%). Health care resource utilization was encountered in inpatient (24.37%), emergency room (24.17%), physician office (97.75%), outpatient hospital (87.98%), Skilled Nursing Facility (6.93%), Hospice (1.28%), Home Health Agency (15.62%), and Durable Medical Equipment (44.10%) claims. The main costs drivers were inpatient ($5,820), physician office ($6,944), outpatient hospital ($14,039), and Part D pharmacy costs ($2,296), resulting in $33,018 in total health care costs.  Conclusions: During a 12-month period, Medicare patients diagnosed with breast cancer reported significant health care utilization and costs. PCN104 Economic Evaluation of Targeted Therapies in Metastatic Clear Renal Cell Carcinoma in Canada Nazha S, Prevost N, Tanguay S, Vanhuyse M, Dragomir A McGill University Health Centre, Montreal, QC, Canada

Objectives: The objective of our study was to evaluate the economic impact of targeted therapies for the treatment of clear cell metastatic RCC in Canada using real-world data through the Canadian Kidney Cancer information system (CKCis).  Methods: The Canadian Kidney Cancer information system (CKCis) database was used to select the cohort of advances RCC collected prospectively over 15 centers of 6 Canadian provinces. Patients who had a diagnosis of RCC and metastatic RCC after January 1st 2011 were included.The database was used to describe the healthcare utilization of targeted therapies over the advanced phase of the disease and to estimate the associated cost. Unit costs of targeted therapies were pulled from the RAMQ list of medications.  Results: The cohort study consisted of 675 patients with advanced RCC. 38% of patients had a nephrectomy in addition to targeted therapies and 19% had a metastasectomy. The cost of targeted therapy per patient for a median follow-up of 23 months was $55,986. Using 2 lines of therapies cost in average $83,314 per patient for a median follow-up of 25 months. Few patients received 3 lines of treatment; this leads to an additional cost of $16,764, totalling an average of $100,078 per patient. We observed a decrease in the number of patients throughout the treatment lines. 366 patients had one treatment line, 132 had two treatment lines and 33 patients had three treatment lines.85% of patients received Sunitinib, 23.3% Everolimus, 21.6% Pazopanib and 11.5% were treated with Axitinib. Patients receiving a first-line targeted therapy were on treatment for a median of 10.5 months, 7.1 months for second-line therapy and 4.6 months for third line. 36% of patients progressed to a second-line treatment, and 9 %received a third line treatment.  Conclusions: The findings of this study might inform decisionmakers concerning budget planning and funding to provide health care services. PCN105 Cost of Sorafenib for Russian Government Drug Provision Program Frolov M1, Avxentyev N2, Derkach EV3 State Medical University, Volgograd, Russia, 2Research Institute of Finance, Moscow, Russian Federation, 3The Russian Presidential Academy of National Economy and Public Administration, Moscow, Russia

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pertinent cost components to identify unmet needs and opportunities  Methods: Systematic literature review was conducted in PubMed from 2006-2016 and conference proceedings of ASH, ASCO and ISPOR from 2013-2016. Search was limited to US-based human studies, published in English. Data on study and patient characteristics, and cost components were extracted from eligible studies. Cost components (converted to 2016$) included mean costs related to drugs, adverse event (AE), out-of-pocket (OOP), inpatient/outpatient, and office visits. Costs were reported by TKI-use, adherence levels and switching/failure as available.  Results: Of 126 titles screened, 14 studies (13 database analyses, 1 survey) were included. Annual cost paid by insurance plan (plan paid) for TKI-users was $69,812 vs. $58,616 for non-TKI users, and OOP costs ranged from $3,084-$3,756. Among TKI-users, total annual plan paid and OOP costs were $92,823 for 1st-line dasatinib/nilotinib and $71,292 for 1st-line imatinib. Total annual cost of patients on imatinib and with high adherence was $52,552-$65,093 and with low adherence was $119,893-$163,387. Annual cost inpatient and outpatient for AEs was $17,927 for femoral arterial stenosis and $15,966 for peripheral arterial occlusive disease among TKI-users. The costs related to treatment switching and failure were also captured. Indirect costs, OOP costs for 2nd generation TKIs, cost of AE by TKI, and cost of adherence for TKIs other than imatinib was not available.  Conclusions: The economic burden in CML is significant and driven by prescription, inpatient and outpatient costs and influenced by adherence. Costs related to AEs, switching, and treatment failure add to that burden. Gaps need to be addressed to better understand the economic burden of CML and identify opportunities related to unmet needs. Generic imatinib may lead to potential cost-savings. PCN107 Antineoplastic Drug Expenditure in Panama 2012-2014 Tribaldos Causadias de Suárez M, Gomez B Instituto Conmemorativo Gorgas de Estudios de la Salud, Panama, Panama

Objectives: The cost of cancer medications is continually increasing, mostly due to the introduction of targeted monoclonal antibodies. Panama, with a population of 3,867,535 and a GDP (2014) of $46,212 million, has a cancer incidence of 143.60/100,000 inhabitants that has been continuously increasing during the last decade. Prostate, cervix and breast cancer are the most frequent diagnoses. The objective is to calculate the antineoplastic drug expenditure (ANDE) in Panama, between 2012 and 2014.  Methods: Drug expenditure databases from the National Oncologic Institute and Social Security were reviewed. All medications cataloged as antineoplastic and immunomodulatory were considered ANDE and included in the analysis. Costs were not adjusted for inflation and are presented in nominal terms.  Results: Although total medication spending diminished from 2012 to 2014, ANDE increased from 30.29% ($65,444,381.40) to 35.95% ($76,327,361.37), respectively. In a stratified analysis, variations in the increment of ANDE were observed among institutions. In the Oncologic Institute, ANDE increased 30.31%: from $24,619,703.70 in 2012 to $35,329,894.15 in 2014, while in the Social Security, expenses remained almost the same, with an increment of 0.42%: from $40,824,677.70 in 2012 to $40,997,467.22 in 2014). The medications that accounted for the greater percentage of ANDE were irinotecan (9.19%), trastuzumab (8.65%) and bevanizumab (7.26%) in 2012, rituximab (8.97%), trastuzumab (8.76%) and brevanizumab (7.31%) in 2013 and rituximab (10.44%), imatinib (8.73%) and brevanizumab (6.86%) in 2014.  Conclusions: Antineoplastic drug expenditure has increasingly growing during the last years and constitutes the group of medication where the Panamanian Health System is investing the most. The increment in the incidence of cancer diagnosis and the utilization of monoclonal antibodies that usually are associated with elevated costs seem to be an explanatory factor. A comprehensive analysis including number of diagnosis and the use of treatment by type of cancer becomes paramount.

1Volgograd

Background: Sorafenib is the oral multiple tyrosine kinase inhibitor that is approved for treatment of advanced renal cell carcinoma (RCC), advanced hepatocellular carcinoma (HCC), and advanced radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). The government drug provision program (GDPP) in Russia currently covers the only option for targeted treatment of RCC - bevacizumab, but there are no available targeted drugs for HCC and RAI-refractory DTC.  Objectives: The aim of the study was to assess costs associated with inclusion of sorafenib into GDPP.  Methods: We calculated medication costs for a group of 100 patients: 87 with RCC, 10 with HCC and 3 with RAI-refractory DTC - during one year using sorafenib (400 mg twice daily). Proportion of patients with different tumors represents Russian morbidity structure. The costs for sorafenib were compared with current expenditures for the same group of patients in the framework of GDPP when 87 people with RCC receive combination of bevacizumab (10 mg per kg once in 2 weeks) and interferon alpha (9 millions ME three times per week) and others do not receive treatment.  Results: Sorafenib for RCC is the cost-saving alternative compared to bevacizumab + interferon alpha: $27,600 and $58,360 per patient-year. One-year sorafenib treatment of 100 patients with different types of tumors requires $2,8 million, which is $2,3 million less compared to current use of bevacizumab + interferon alpha for RCC patients only.  Conclusions: Including sorafenib into Russian GDPP will provide targeted treatment for patients with HCC and RAI-refractory DTC and decrease expenditures in the framework of the analyzed drug provision program if sorafenib replaces bevacizumab for RCC. PCN106 Economic Burden Associated with Chronic Myeloid Leukemia (CML) Treatments in The United States: A Systematic Literature Review Gala S, Shah A, Mwamburi M Market Access Solutions LLC, Raritan, NJ, USA

Objectives: The objective of this study was to conduct a comprehensive assessment of economic burden associated with CML outlining the contributions of

PCN108 Real-World Treatment Patterns and Costs of Care Among Brentuximab Vendotin-Treated Patients with Hodgkin Lymphoma in The United States Szabo SM1, Hirji I2, Johnston KM1, Juarez-Garcia A3, Subar M2, Connors JM4 1Broad Street Health Economics & Outcomes Research, Vancouver, BC, Canada, 2Bristol-Myers Squibb, Princeton, NJ, USA, 3Bristol-Myers Squibb Company, Ciudad de México, Mexico, 4British Columbia Cancer Agency Centre for Lymphoid Cancer (BCCA CLC), Vancouver, BC, Canada

Objectives: Brentuximab vedotin (BV) has changed the management of relapsed/ refractory (RR) classical Hodgkin lymphoma (cHL). Little information is available on how cHL is managed in routine clinical practice, particularly the progression to new lines of therapy and costs of care. The primary objective was to identify treatment patterns and treatment flow from time of diagnosis of cHL.  Methods: A retrospective observational study of adult patients initiating BV for RR cHL from 2011 to 2015 was conducted using Truven MarketScan US databases, with ≥ 6 months of enrollment before and following BV initiation. Treatments were classified based on chemotherapy dispensing and administration. All-cause healthcare resource use estimated mean per-patient monthly costs, stratified by treatment status and updated to 2016 US dollars.  Results: The cohort comprised 298 patients; 59% male, and mean age at initial diagnosis was 42 years. Median time from BV initiation to censoring was 61 weeks; median duration of BV treatment was 14.8 weeks; 34.2% received additional treatment post-BV. The most common treatments after BV were autologous stem cell transplantation (ASCT; 12.1%); bendamustine (11.7%); and gemcitabine/vinorelbine/liposomal doxorubicin (6.0%). Mean per-patient (95%CI) all-cause monthly costs while receiving BV were $27,400 ($24,779–$30,022). Drug costs 81.0%, outpatient costs 12.2%, and inpatient costs 6.7% of mean monthly costs. After discontinuation of BV, mean (95%CI) per-patient monthly costs were $24,040 ($18,469–$29,610) among those with no treatment after BV; $40,170 ($19,462–$60,871) among those with ASCT (+/- chemotherapy) after BV; and $25,230 ($20,172–$30,290) among those with chemotherapy only. Following BV discontinuation, drug costs comprised 43.4%, outpatient costs 18.3%, and inpatient costs 38.3% of monthly costs.  Conclusions: These findings augment the scarce real-world data on

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outcomes among RR cHL patients. Patients requiring treatment following BV continue to incur high monthly costs, highlighting the economic burden associated with managing patients in the RR cHL setting. PCN109 Course of Therapy, Resource Utilization and Costs for The Treatment of Metastatic Colorectal Cancer in Germany Grabe K, Pfeifer S, Osowski U Merck Serono, Darmstadt, Germany

Objectives: Analysing the course of therapy, resource utilization and costs for treatment of metastatic colorectal cancer (mCRC) in Germany. DATA AND  Methods: The study is based on the Leipziger Gesundheitsforen - a sickness fund dataset of more than 5 million insured persons including pharmaceutical, outpatient and inpatient data from 2007 until 2013. Between 816 (2007) and 1,116 (2013) persons had a first documentation of ICD-10-codes C18-21 (first diagnosis CRC) as well as C77-79 (metastases) and were classified as mCRC patients. Several analyses were performed to identify the most commonly used first-line combination therapies, average treatment durations (Kaplan-Maier-estimation), second-line therapies, therapy switches, resource utilization, best-supportive care and therapy costs.  Results: Nearly half of the mCRC patients were treated with only one therapy line, the other half at least with two lines. The most frequently used first-line therapy was the combination of 5-flourouracil, bevacizumab, folinic acid and oxaliplatin for both patient groups (average treatment duration: 192 days). Patients with more than one line were mostly treated second-line with the combination of 5-flourouracil, bevacizumab, folinic acid and irinotecan (average treatment duration: 156 days). On average the patients received 10 cycles of the combination treatment. Due to the high prices of these drugs (2,677€  resp. 2,288€  per cycle), the co-medications (the most often prescribed were dexamthason, granisetron and ondansetron), the hospitalization (three days per stay in average) and the physician/oncologist visits (biweekly), mCRC is associated with high treatment costs.  Conclusions: This study analysed the course of therapy, resource utilization and costs for the treatment of metastatic colorectal cancer (mCRC) in Germany. The combination of 5-flourouracil, bevacizumab, folinic acid and oxaliplatin was the most often used first-line therapy. For the second-line treatment oxaliplatin was switched to irinotecan. Due to the high resource utilization and the expensive therapies, mCRC is associated with a high economic burden. PCN110 Drug Utilisation of Braf Inhibitors for Melanoma in Ireland Gorry C, McCullagh LM, Barry M National Centre for Pharmacoeconomics, Dublin, Ireland

Objectives: The aim of this study is to review the utilisation of the BRAF inhibitors vemurafenib (V) and dabrafenib (D) in Ireland.  Methods: Anonymised data from the Primary Care Reimbursement Service (PCRS) database from March 2013 (first availability of V) to December 2015 was extracted and reviewed. The database includes details of the patient administrative region, gender, date of birth, and the date and cost of each claim. Data analysis was conducted using Microsoft Excel 2010 Version 14.0.7116.5000 and R version 3.2.3. Bootstrapping was used to estimate the cost per patient.  Results: A total of 494 claims for a BRAF inhibitor were made from March 2013-December 2015; 55.3% for V compared to 44.7% for D. Claims were made for 99 unique claimants. 53.1% of incident claimants were male. The number of incident cases annually was 21, 36 and 42 in the years 2013-2015 respectively. Market share of incident patients declined for V to 22.4% following the introduction of D in September 2014. The mean number of claims per patient for both agents was 4.3. The mean cost per patient was € 27,185.22 for D and € 36,129.49 for V. The median time to treatment discontinuation (TTD) for V was 78 days (95% CI 47, 128), compared to 157 days  Conclusions: There has been significant uptake of BRAF inhibitors since their introduction in March 2013. Reimbursement of D resulted in a significant decline in market share for V. The longer TTD with D is most likely due to concomitant use with the MEK inhibitor trametinib, available via a compassionate access program. Median TTD with V is similar to that seen in pivotal registration trials. PCN111 Dose Extension and Costs of Lanreotide Autogel 120 Mg Used in Routine Neuroendocrine Tumors Care In Poland – 2- Years Data From Lanro-Net Study Orlewska E1, Bednarczuk T2, Kaminski G3, Budlewski T4, Kos-Kudla B5 Kochanowski University, Kielce, Poland, 2Medical University of Warsaw, Warsaw, Poland, 3Military Institute of Medicine, Warsaw, Poland, 4Central Clinical Hospital , Ministry of Internal Affairs, Warsaw, Poland, 5Silesian Medical University, Katowice, Poland

1Jan

Objectives: to determine the treatment patterns and to evaluate the mean costs of lanreotide Autogel 120 mg (ATG120) administered as part of routine neuroendocrine tumors (NETs) care in Poland.  Methods: national, multicenter, non-interventional, observational prospective (24-months) study. Eligible patients were adults with symptomatic NETs treated with ATG120 at least 3 months before inclusion. Mean time between injections and mean cost of ATG120 during the 2-years were assessed. The mean time between injections was defined as the sum (across all recommended intervals) of the length of each recommended interval multiplied by the ratio between the time on that interval and the total time on ATG120. Costs were calculated in PLN from the public health-care payer and patient perspective for the year 2016 (1 PLN= 0.25 EURO).  Results: 54 patients were enrolled in 12 centers across Poland (50% male, mean age 60.5 years, 36.5% in performance status 0, 50% with primary tumor in gastrointestinal tract, 83.3% with ≥ 2 metastases) and 33 completed the study. Mean (SD) and median time of exposure was 1.4 (0.72) and 1.7 years, respectively. At enrollment 9 patients (16.7%) received ATG120 at an extended dosing interval (>  28 days). During 2-years the mean number of days between injections was 31.68 (SD 6.71), time interval between injections was extended in 4 patients, changes in the treatment were reported in 5 patients. ATG120 was administered predominantly in out-patient setting (53.7%), only once at home by caregiver, in

all other cases by nurse. The real-world cost of ATG120 per patient/28 days was 4212.5 PLN and 3.8 PLN from the public payer and patient perspective, respectively and was lower than the cost for standard 28 days dosing interval (4766.19 and 4.27, respectively)  Conclusions: Finding that mean time between injections is >  28 days support the potential for ATG120 of reducing treatment burden. PCN112 Metastatic Colorectal Cancer In Croatia - Cost of Disease Study Bencina G GSK, Zagreb, Croatia

Objectives: Colorectal cancer is one of the most common cancer sites representing 17% of cancer incidence in males and 8% of cancer incidence in females in Croatia. In 2013, there were 3 070 new cases of colorectal cancer in Croatia and more than 2 000 death cases. The aim of this study was to evaluate resource use and costs associated with the treatment of metastatic colorectal cancer (mCRC) in Croatia in 2013.  Methods: Publicly available data on the costs related to mCRC treatment were used as input for Markov model with 4 week cycles. The main sources for the number of cases were the Croatian Institute of Public Health Yearbook for 2013 and Croatian Cancer Registry data. For the unit cost list of Diagnosis-Related Groups codes was source. Costs of drugs were taken from national drug reimbursement list. When country-specific information was unavailable, reference to international data was used. Only direct medical costs were taken into consideration, using governmental perspective.  Results: In 2013, costs related to mCRC treatment amounted to a total cost of €  47,401,869. Drug costs represent more than 47% of expenditure with a total cost of €  22,432,380. In total drug expenditure 86% were costs for 1st line treatment, 13% for 2nd line and 1% for 3rd line treatment of mCRC.  Conclusions: Colorectal cancer represents an important health and economic burden in Croatia. In Croatia it is still diagnosed in late stages with 17% of patients diagnosed with metastatic disease. Results of this study may be usefull to evaluate preventive strategies which have been developed to prevent colorectal cancer and cost associated with this disease. PCN113 Analysing The Evolution of Cancer Drug Prices in France Since 2000 Peirone V1, Toueg R2, Houzelot D1, de Paz B1 1PRIORITIS Market Access, Paris, France, 2Paris Descartes University, MALAKOFF, France

Objectives: In the last couple of years, drugs prices have become a recurring subject of conversation in the world of healthcare. Using the Prismaccess HTA and pricing database, our aim was to investigate the evolution of drug prices in oncology in France since 2000 and interpret the data.   Methods: We examined cancer drugs evaluated by the Transparency Commission since 2000 with an ASMR I, II and III, which represent significant progress compared to their relevant comparator (ASMR IV and V representing marginal and no added benefit respectively). The price history of each product has been extracted from the database, along with their patient population and other key parameters. We have calculated the annual treatment costs of these oncology drugs based on their Summary of Product Characteristics dosage for their main indication. We have excluded orphan drugs due to the bias associated with the small target population that they represent and the very high prices that are negotiated for them.  Results: Our results (n= 28) show that there has been a slow but steady increase in treatment costs from 2000 until 2011. Beyond that point, annual costs per treatment in the 2012 – 2015 period were double from that of the 2008 – 2011 period. This could be explained by major medical advances, where innovative therapies are designed towards recently discovered biological targets, thereby restricting the number of patients eligible for such drugs, which in turn favors high drug prices.  Conclusions: Drug prices in France are fixed according to the target population and added benefits compared to comparators (captured by the ASMR). The notably high costs observed in the 2012 – 2015 period could be explained by more innovative drugs with smaller target populations, as opposed to the previous 10 years in France, marked by drugs with small added benefits. PCN114 Estimating The Management Cost of HPV-Related Low-Grade and Precancerous High-Grade Lesions in France Uhart M1, Jacob JA2, Gagnon JA3, Bianic F4, Bergeron C5, Largeron N1 Pasteur MSD, Lyon, France, 2Mapi Group, Uxbridge, UK, 3Mapi Group, London, UK, 4Mapi Group, Nanterre, France, 5Laboratoire Cerba, Saint-Ouen-l’Aumône, France

1Sanofi

Objectives: There are an estimated 32,263 to 61,861 cases of high-grade cervical precancerous lesions every year in France. A nonavalent HPV vaccine is now licensed in Europe with the potential to prevent close to 90% of cervical cancers and approximately 50% of low-grade and 80% of high-grade cervical lesions. Although precancerous lesion treatment costs have previously been evaluated, these data are unlikely to reflect current clinical practice. To address this limitation and accurately appraise the respective economic burden, this study sought to determine the costs of HPV-related low-grade and precancerous high-grade cervical lesion management in France.  Methods: A probabilistic decision tree was constructed according to current French guidelines to simulate the management pathway of a woman diagnosed with a cervical lesion. An expert clinician validated the pathway. The episode of care extended from the initial abnormal cytology to either treatment or discharge to routine recall. Unit costs for consultations, screening and diagnostic tests, and treatment were collected from national sources, as were epidemiological data. Costs were also reported by pathway stages (i.e., screening, diagnosis, treatment, and follow-up) and by initial cytology (smear test) result.  Results: The average cost of care per episode was 261.06€  for low-grade and 1,280.05€  for high-grade lesions. Costs were skewed towards the follow-up phase, accounting for 48% of costs in low-grade and 68% in high-grade lesions. Stratified according to initial cytology result, the average episode cost was 179.00€  for a cytological sample presenting atypical squamous cells of undetermined significance (ASC-US), 191.74€  for lowgrade squamous intraepithelial lesion (LSIL), and 1,086.16€  for either of high-grade squamous intraepithelial lesion (HSIL) or atypical squamous cells–cannot exclude