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evidence, in appropriate timelines, to Payer. Results from clinical development were supported with analysis performed on Real World Data from preexisting academic database. PCN299 Red and Processed Meat Intake Perception in the Portuguese Population: Association with the WHO Alert of 2015 – Preliminary Results of the Malert Study Garagarza Antunes C1, Inácio AC2, Martins C3, Neves I4, Preto A5, Laires PA6 Medical Care, Lisbon, Portugal, 2Hospital de Santa Maria—CHLN, Lisbon, Portugal, 3Smile.up Clínicas Dentárias, Lisbon, Portugal, 4Instituto de Medicina Preventiva e Saúde Pública, Lisbon, Portugal, 5MSD - Animal Health, Lisbon, Portugal, 6Faculdade de Medicina da Universidade de Lisboa, Lisbon Academic Medical Center, Lisbon, Portugal, Lisbon, Portugal 1aFresenius
Objectives: The mALERT study aims to evaluate changes in the intake of red meat (RM) and processed meat (PM) in the Portuguese population after the 2015 WHO warning about its carcinogenic risk. Methods: This is a cross-sectional, descriptive and analytical study with data collection through telephone interviews, which included adults living in Portugal with decision-making autonomy in their food choices. Telephone numbers were randomly generated (including fixed and mobile network from all Portugal regions), ensuring the possibility of selection of listed and unlisted numbers. Socio-demographic and characterization data about the consumption of RM and PM were collected, as well as beliefs and perceptions associated with consumption of RM and PM associated with the alert. Results: A total of 34 individuals completed the questionnaire. Mean age was 44.8 ± 14.7 years, 71% were females and 56% were married. 44% of the respondents claimed to be well informed about the risks and benefits of meat consumption and 85% considered very important to know such information. Regarding meat consumption, most of the sample (91%) reported a weekly based intake of RM, while 65% indicated a weekly ingestion of PM. Among those who claimed to have knowledge about the WHO warning (58.8%), 27.3% and 20% reduced RM and PM consumption, respectively. However, more than a half (53%) was not concerned with it. In the future, the respondents intend to reduce the consumption of RM (50%) and PM (41%), whereas almost all stated that they will reduce the intake of RM and PM if they receive a medical recommendation to do so (94%). Conclusions: This preliminary data suggests a positive impact of the WHO alert about the RM and PM consumption. Nevertheless, this will be further analyzed in the final results of the mALERT study with a broader and representative sample of the Portuguese population. PCN300 Evaluation of Supportive Care in the Cancer Patients on Chemotherapy in a Developing Country: A Comparision of Clinical Practice with Standard Guidelines HimanshuPatel , Parthasarathi G JSS College of Pharmacy, Mysore, JSS University, Mysore, India
Objectives: This study was conducted to assess quality use of supportive care prescribed to patients on cancer chemotherapy. Methods: This was a prospective study conducted for a period of six months at private cancer center. Medical records of the patients on chemotherapy were reviewed and patients were interviewed during study period to study the use of supportive care. Evaluation of supportive care included reviewing quality use of anti-emetics, colony stimulating factors (CSF), analgesics, antibiotics and protein supplements. Quality use of supportive care was reviewed with respect to standard international recommendations and clinicians’ consensus of the study hospital. Results: A total of 850 patients were enrolled in this study. Majority patients on highly emetogenic regimen (48%) were prescribed with combination of metoclopramide and dexamethasone followed by combination of 5-HT3 antagonist and dexamethasone (46%). Use of neurokinin receptor antagonist was highly restricted (n= 6%) due to unaffordability of patients. Only 144 (30%) of 480 patients who were on highly myelosuppressive chemotherapy were prescribed with prophylaxis of Filgrastim or Pegfilgrastim. CSF are not reimbursed for patients under government schemes and so its use was highly restricted (28 of 294 patients) despite of the need. Majority of the patients were prescribed with tramadol with or without non-steroidal analgesics (86%) for cancer related pain. Use of opioids like morphine was limited due to drug shortage at pharmacy. Fentanyl was used in limited patients due to financial constraints. Protein supplements were prescribed fairly (76%) for patients under private insurance whereas they were prescribed rarely (14%) for patients under government insurance schemes. Conclusions: Use of supportive care was not in well compliant with standard recommendations. Poor quality of supportive care delayed treatment schedules due to drug toxicities in our patients. Majority patients treated under government schemes had poor quality of supportive care compare to private patients. PCN301 Predictors of PD-L1 Testing in Non-Small Cell Lung Cancer DiBonaventura M1, Meyers A2, Higginbottom K3, Morimoto Y4, Ilacqua J3 Healthcare, New York, NY, USA, 2Ipsos Healthcare, Washington, DC, USA, 3Ipsos Healthcare, Mahwah, NJ, USA, 4Ipsos Healthcare, Tokyo, Japan 1Ipsos
Objectives: Programmed death-ligand 1 (PD-L1) is an immune-related biomarker expressed on different tumor cells of different tumor types, including non-small cell lung cancer (NSCLC). Because of the availability of PD-L1 inhibitor therapies, testing for the PD-L1 biomarker has become common practice in clinical settings. The objective of this study was to determine the factors associated with patients being tested across several countries. Methods: A multi-country retrospective medical chart-review of NSCLC patients was conducted by cancer-treating physicians in the United States (N= 7,334), 5EU (France, Germany, Italy, Spain, UK; N= 16,549), and Japan (N= 3,492) between Q2 2015 and Q1 2016. Physicians randomly selected patient charts currently on an anti-cancer regimen and abstracted data on patient demographics, disease status, treatment patterns, and biomarker status. Logistic regression models were conducted to predict testing status from patient history and physician
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characteristics. Results: A total of 20,575 patients were included (63.9% male; mean age= 64.7 years); 20.7% received a PD-L1 test. Testing was most common in Germany (36.1%) and least common in Japan (1.92%). Tested patients were younger, had higher ECOG scores, and more likely to be male, a current smoker, treated by a hematologist/oncologist, and treated in a university/teaching hospital (all p< .05). Logistic regression results suggested the strongest predictors of testing were being in Germany (odds ratio [OR] = 4.28), stage at diagnosis (stages IIc [OR= 3.02] and III [OR= 4.08] were more likely to be tested than stage IV), and higher ECOG scores (score of 4 vs. 0: OR= 5.41; score of 3 vs. 0: OR= 2.92) (all p< .05). Conclusions: As immunooncology therapies, such as a PD-L1 inhibitors, become more common, biomarker testing will continue to play an important role in clinical practice. The results suggest significant variability across countries for PD-1L testing among NSCLC patients, with performance status and staging being more predictive of patient testing than physician setting or specialty. PCN302 Application of Payment by Results Schemes in Oncology in Italy: Relation Between Timing for the Evaluation of Treatment Failures and Median Progression Free Survival (PFS) from Clinical Trials Ferrario M, Vittoria G, Deroo V, Giuliani G Roche Spa, Monza, Italy
Objectives: Performance based agreements have been quite widely used in Italy to provide access for high costs oncologic drugs and minimize uncertainties of real life benefits. The aim of this analysis was to overview the Roche experience in terms of payment by results (Pbr) schemes in oncology and investigate the relation between timing for the evaluation of treatment failures and observed outcomes from Phase III clinical trials. Methods: A retrospective analysis of the Roche payment by results schemes in place in Italy was conducted. For each drug included in the analysis it was collected: A) the negotiated timing to assess the treatment failure for Pbr (TTPbr), B) the median PFS observed in clinical trials for the experimental drug (ePFS), C) the median PFS observed in clinical trials for the control arm (cPFS). The mean ratios between TTPbr and ePFS and between TTPbr and cPFS were calculated to identify potential correlations. High level of correlation was expected if TTPbr/PFS ratio was close to 1. Results: 10 Roche products or different indications of the same product were identified as candidates for the analysis from 2008 to 2015. The timing for the evaluation of treatment failures for Pbr varies between 2 and 8 months, depending on the type of tumour and line of therapy. The mean TTPbr/ePFS ratio was 0,44 (±0,12) while the mean TTPbr/cPFS ratio was 0,77 (±0,42). Conclusions: Even if no clear evidence of a concordance between TTPbr and PFS was found, median PFS observed in clinical trials for the control arm seems to be a more reliable evidence to identify the timing to evaluate treatment failures compared to the experimental one. A more precise estimate could be obtained from Time to Off Treatment (TTOT) curves, which considers discontinuation of treatment not only for progression and death but also for toxicity. PCN303 Does The Trend Towards Value Frameworks Require New Approaches to Evidence Development and Health Technology Assessment? Teale CW1, Entwistle J1, Freeman S2 1GfK, Melton Mowbray, UK, 2GfK, London, UK
Objectives: To identify the extent to which value framework approaches are aligned with evidence development and health technology assessment, and could provide a foundation for value-based pricing, conditional access, personalized reimbursement, and risk sharing. Methods: Secondary research of HTA systems in EU5 to identify the extent to which value framework approaches are currently incorporated, and of recently launched drugs (N= 15) to ascertain the extent to which at launch relevant robust data were available to enable relative value to be assessed. Analogue analyses (N= 20) to identify the drivers of success/failure of value-based pricing, conditional access, personalized reimbursement, and risk sharing schemes. Results: Barriers include availability of appropriate data, lack of peer-reviewed publications, non-randomised trial designs, endpoint difference that result in methodological challenges, and limitations of HTA systems to incorporate in their decision-making. Opportunities include the identification of additional areas of differentiation between products that might be used to inform price (valuebased pricing), market access, formulary and clinical guideline positioning, and drive uptake (value-based utilisation). Successful implementation of value-based pricing, conditional access, personalized reimbursement, and innovative risk sharing requires the alignment of 4 factors - payer willingness; a relevant “open access” data infrastructure; transparent and methodologically robust analytics; a systematic approach to defining relative value perceived as unbiased, relevant, comprehensive, and accepted by key stakeholders. Conclusions: For closer alignment, value frameworks and decision-making systems must adapt to recognise the evolutionary and comprehensive nature of evidence. Data post marketing approval should be incorporated in future revisions of value frameworks and should not be limited only to drugs studied head to head in randomised controlled trials. Outcomes data from real-world clinical practise should be incorporated to recognise the influence of diagnostics and the use of new technologies that influence outcomes through monitoring adherence and health state, triggering interventions in disease management, and predicting events. PCN304 The Effects of Pay for Response and Maximum Price CAP Schemes on Payer and Provider Risk Hawkins N, Wu O, Adler A University of Glasgow, Glasgow, UK
Objectives: The objective of the study was to compare the risk borne by payers and technology or healthcare providers under maximum payment cap and pay for response schemes using a simulation study. Methods: Overall and progression-free
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survival data were simulated for a population of 10,000 patients receiving either a new treatment of best supportive care. Trials samples were repeatedly taken from the population data. For each trial prices were set at the maximum acceptable price assuming a cost-effectiveness threshold of £20,000. Base case prices were estimated assuming no “risk share” scheme; assuming a price cap scheme where the maximum cost was capped for individual patients; and a pay for response scheme where the drug was only reimbursed for patients who had not progressed by a given timepoint. The loss to payers - incurred if price paid based on the trial was greater than the price at which the drug was cost-effective was cost-effective across the population - and loss to providers – incurred if the revenue in the populations was less than that estimated based on the trial - was estimated for each simulated trial. The expected losses were then estimated over all the simulated trials Results: The price cap scheme increased the expected loss for payers and decreased the expected loss for providers compared to the base case. The pay for response scheme reduced the expected loss to payers and increased the expected loss for providers. The pay for response scheme was sensitive to the choice of evalution timepoint. Conclusions: It may be possible to design either price cap or pay for response schemes that increase expected returns for both parties when risk preferences are considered. Relative risk preferences of both parties should be explicitly considered when designing such schemes PCN305 Treatment Pattern Differences Across the United States, Western Europe, and Japan Among Patients with Metastatic Renal Cell Carcinoma DiBonaventura M1, Higginbottom K2, Meyers A3, Morimoto Y4, Ilacqua J2 Healthcare, New York, NY, USA, 2Ipsos Healthcare, Mahwah, NJ, USA, 3Ipsos Healthcare, Washington, DC, USA, 4Ipsos Healthcare, Tokyo, Japan 1Ipsos
Objectives: Renal cell carcinoma (RCC) is responsible for 13,500 deaths annually in the United States alone. Although historically difficult to treat for patients with advanced disease, a number of promising therapies are on the horizon. The objective of this study was to document the current treatment patterns for patients with metastatic RCC and how they vary regionally. Methods: A retrospective chart review of RCC patients was conducted by physicians in the United States (N= 9,481), 5EU (France, Germany, Italy, Spain, UK; N= 5,840), and Japan (N= 695) between Q2 2015 and Q1 2016. Physicians randomly selected patient charts currently on an anticancer regimen and abstracted data on patient demographics, disease status, and treatment patterns. Treatments patterns were reported descriptively and compared across countries using chi-square tests. Results: A total of 16,016 patients were included. The mean age was 64.8 years (SD= 10.7) with 64.6% of patients being male. Nearly two-thirds (65.4%) of patients had an ECOG score of 1. Sunitinib was the most common first-line (1L) therapy across all regions (US: 73.8% to Japan: 32.4%). Pazopanib was the second-most common 1L therapy in 5EU (23.0%) but less used in Japan (11.2%) the US (6.0%). Both interferon alpha (16.0%) and axitinib (15.8%) were disproportionately more common in Japan (p< .05). Axitinib (2L across regions: 15-50%; 3L across regions: 7-36%) and everolimus (2L across regions: 14-40%; 3L across regions: 40-62%) were the most common later-line treatments regardless of country. Conclusions: Sunitinib is an important part of 1L therapy across countries, though regional variation exists. Regional consistency was more common in later lines in which axitinib and everolimus had similar usage patterns. Given the upcoming availability of additional therapy options, this study provides an important baseline assessment of current treatment patterns in the US, Western Europe, and Japan.
PCN306 Patterns of Care Among Pancreatic Cancer Patients: Findings from a u.s. Real-world claims-based analysis Kish J1, Maida T2, Feinberg BA1, Biggs C2, Mujumdar U1, Chopra D1, Laney J1, Kennedy G2 Health, Dublin, OH, USA, 2NewLink Genetics Inc, Austin, TX, USA
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Objectives: Estimates of the proportion of patients in the US who are resected, who receive chemotherapy (neoadjuvant, adjuvant, metastatic), what regimens are used, and demographic and clinical differences have not been adequately explored. Methods: Individuals with pancreatic cancer (ICD-9= 157.x, excluding 157.4) diagnosed between 03/2012-06/2015 were selected from the Inovalon More2 claims database. Resected patients were identified by the CPT codes (48140, 48146, 48150, 48152-5). Systemic therapies were identified by J/NDC codes. Neoadjuvant = chemotherapy prior to resection; adjuvant = chemotherapy ≤ 90 days post-resection; metastatic = initiation of chemotherapy after progression (ICD-9:196.0-196.3, 196.5196.6, 197.0-197.8, 198.0-198.8) or > 180 post-resection. Results: Of 7159 pancreatic cancer patients, 15.2% (n= 1014) patients were resected and 85.8% (n= 6145) were not resected. Non-resected patients were older (mean age 62.7 v 65.8, p< 0.14) , less likely to have commercial health insurance (39.7% v 26.1%, p< 0.01), have a higher Charlson comorbidity index (3.9 v 3.6, p< 0.01), and less likely to receive chemotherapy (54.4% v 38.6%, p< 0.01). The most common chemotherapy agents used among resected were: neoadjuvant (n= 99), FOLFIRINOX= 32.3%, gemcitabine (gem)= 23.2% and gem + protein-bound paclitaxel (pbp)= 11.1%; adjuvant (n= 330), gem= 51.2%, capecitabine (cap)= 13.6% and 5-FU= 9.1% (and 7.0% received gem + cap – ongoing APACT trial); metastatic (n= 161), gem= 50.0%, gem + pbp= 11.1% and 5-FU + gem= 10.4%. Non-resected patients received: gemcitabine= 27.3%, FOLFIRINOX= 20.7%, gemcitabine + protein-bound paclitaxel= 19.1%. Conclusions: These real-world data illustrate that the vast majority of patients are unresected and without systemic therapy, a dismal reality in an era of so much progress in cancer treatment. Equally disturbing is the finding that near half of resected patients don’t receive adjuvant chemotherapy, a strategy that recent trials prove significantly increases overall survival. Strategies designed to establish earlier diagnosis, increase surgical eligibility, optimize adjuvant treatment, and develop novel systemic therapies are critically needed.
PCN307 The Association Between Initiation of Guideline Recommended First-Line Systemic Therapy and Healthcare Costs and Utilization in a Metastatic Non-Small Cell Lung Cancer (MNSCLC ) Population Casebeer AW1, Hopson S1, Drzayich Antol D2, Li Y2, Khoury R3, DeClue RW2, Parikh A3, Michael T3, Stemkowski S1, Bunce M3 1Humana, Inc., Louisville, VA, USA, 2Comprehensive Health Insights, Inc., Louisville, KY, USA, 3Genentech, South San Francisco, CA, USA
Objectives: Guideline recommended initiated therapy (GRI) for mNSCLC has been associated with lower outpatient costs. We evaluated the relationship between GRI and total healthcare costs and utilization. Methods: mNSCLC patients that initiated infusion therapy in 2013-14 were identified from Humana claims and treatment authorizations. A claims-based model predicting disability was used to approximate performance status (PS) from procedure, diagnosis, and durable medical equipment codes. Patients receiving GRI with > 1 cycle of a National Comprehensive Cancer Network recommended infused first-line therapy based on age, PS, or targeted therapies regardless of age and PS, were included in the study. Index date was date of first infusion. P-values were generated from chi-square and t-tests. Costs were presented as mean differences. A generalized linear model controlling for pre-index costs, age, gender, region, comorbidity burden, PS, plan type, months of follow-up and treatment regimen assessed the relationship between GRI and cost. Results: Of 1,458 patients, 347 (23.8%) were non-GRI. Non-GRI were older (71.9 + 7.4 vs 70.0 + 7.5 years, P< 0.0001), more frequently dual-eligible for Medicare/ Medicaid (23.1% vs 10.5%, P< 0.0001), and had low-income subsidy (30.3% vs 16.7%, P< 0.0001). Pre-index, non-GRI had higher inpatient (+$2,517, P= 0.0096), emergency room (ER) (+$226, P= 0.010), and lower outpatient costs (-$1,739, P= 0.0002). Postindex, non-GRI had more inpatient stays (49.2% vs 58.5%, P= 0.0026) and ER visits (55.0% vs 62.8%, P= 0.0102). GRI had greater post-index total (+$8,807, P= 0.0005), oncology-related (+7,449, P= 0.0018), physician office (+5,612, P= 0.0006) and pharmacy costs (+1,501, P= 0.0157). In a multivariable model controlling for patient-level characteristics, no cost differences by GRI were found. Conclusions: Unadjusted analyses indicated pre-index costs were higher for non-GRI mNSCLC patients and post-index costs were higher for GRI mNSCLC patients; however, these differences were explained by patient characteristics in adjusted multivariable analyses. This suggests factors influencing patient GRI status, and not GRI status itself, lead to cost differentials within this population. PCN308 Real World Treatment Patterns in Metastatic and/or Unresectable Gastric Cancer Patients in Brazil Novick D1, Vieira FM1, Victorino AP2, Cubero DI3, Beato CA4, Minowa E5, Julian G6 1Eli Lilly and Company, Windlesham, Surrey, UK, 2Instituto COI de Educação e Pesquisa, Rio de Janeiro, Brazil, 3Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, Brazil, 4Fundação Amaral Carvalho, Jaú, Brazil, 5Kantar Health, São Paulo, Brazil, 6Evidências - Kantar Health, São Paulo, Brazil
Objectives: Little evidence is available on the management of patients with Advanced Gastric Cancer (AGC) after failure of 1st-line treatment. This study presents real-world data on patient characteristics and treatment patterns for these patients in Brazil. Methods: Data from medical charts were collected from 5 centers. Eligible patients were ≥ 18 years old, diagnosed with unresectable or metastatic GC, between January 2011 and December 2014, had received 1st-line chemotherapy treatment, had ≥ 3 months of follow-up after 1st-line discontinuation, and had not participated in a clinical trial. Data were summarized using descriptive statistics. Results: Out of 494 charts screened, 154 were eligible (n= 98 [63.6%] from public healthcare institutions). Mean age was 61.1 years and 57.1% of patients were male; 55.2% and 18.8% progressed to second- and third-line therapies, respectively. ECOG performance status (PS) during 1st-line treatment was PS= 0 in 25.0%, PS= 1 in 59.5%, and PS= 2 in 14.7%. During 2nd-line treatment, it was PS= 0 in 18.2%, PS= 1 in 54.6%, and PS= 2 in 25.5%. Twenty-one and 19 different regimens were used as 1st- and 2nd-line treatments, respectively. CapeOx (31; 20.1%), FOLFOX (26; 16.9%) and EOX (14; 9.1%) were the most frequent 1st-line regimens, while irinotecan (29; 34.1%), paclitaxel (16; 18.8%) and CapeOx (5; 5.9%) prevailed in 2nd-line treatment. Supportive care was observed among 14.5% of the patients, only after 1stline treatment. The median overall survival since AGC diagnosis was 16.9 (95%CI [13.6-20.5]) months in all patients, and 15.0 (95% CI [12.4-19.3]) and 20.0 (95% CI [15.4-27.6]) months in patients from public and private institutions, respectively (p= 0.23). Conclusions: Treatment patterns for patients with AGC in Brazilian institutions are highly heterogeneous. The low rates of supportive care without active treatment warrant further study The results of this study may contribute to the development of new strategies and guidelines for AGC management in Brazil. PCN309 Treatment Rates in Patients with HER2+ Metastatic Breast Cancer and the Factors Influencing Treatment Decision Colomer R1, Hall P2, szkultecka-Debek M3, Bondi R4, Flinois A5, Auziere S5, Le Cleach J5 1Hospital Universitario La Princesa, Madrid, Spain, 2Edinburgh Cancer Research UK Centre, Edinburgh, UK, 3Roche, Warsaw, Poland, 4Roche, Basel, Switzerland, 5Kantar Health, Paris, France
Objectives: Determine which factors influence the likelihood to receive an antitumor treatment for HER2+ metastatic Breast Cancer (mBC) Methods: This retrospective chart review conducted in 2016 collected information from patient medical records in the UK, Italy, Spain and the Netherlands. 204 oncologists documented all HER2+ mBC patients seen during a 2-3 week period. The 3068 documented patients were classified as those receiving an anti-tumor treatment (ATT) and those receiving supportive care only (SCo, no ATT). Results: 10% of patients with HER2+ mBC did not receive a first ATT at metastatic stage and received SCo. Patients receiving SCo were diagnosed later (74 y.o. on average vs. 59) and had a degraded performance score (65% with PS 2+ vs. 14%) compared to patients receiving 1st mBC ATT. Patients in the SCo group were also more frequently diagnosed with de novo mBC (70% vs. 52%), with cerebral metastases (26% vs. 7%) and with metastases in at least 2 sites