German Amnog Benefit Assessment: The Type Of Appropriate Comparator Makes The Difference

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appraisals. This research aims to evaluate how the reformed CDF has been utilised in the year since its implementation.  Methods: NICE Final Appraisal Determinations for Single Technology Appraisals of oncology drugs from (29/07/2016-16/06/2017) were identified and key data extracted.  Results: 35 oncology drug appraisals were identified, 27 (77%) were recommended/optimised, 4 (11%) were not recommended, only 4 (11%; osimertinib, brentuximab vedotin [BV], pembrolizumab, and olaratumab) were referred to the CDF. For osimertinib, pembrolizumab, and olaratumab, the greatest uncertainty in its cost-effectiveness analysis related to its long-term survival extrapolations, intended to primarily be resolved through the subsequent availability of clinical trial data. For BV, the key uncertainty was the proportion of patients bridging to stem cell transplant from BV. This is to be investigated through a prospective analysis while BV is CDF-funded; in parallel, a retrospective analysis of patients previously-treated with BV under the ‘old’ CDF will be undertaken.  Conclusions: The newly reformed CDF has only been utilised in a small minority of appraisals to date. Collecting uncontrolled observational data may not be a suitable mechanism to address most key uncertainties in the appraisal of oncology drugs (often related to long-term survival extrapolations and [if based on a single-arm study] suitable comparator data). The BV example illustrates where the CDF can address a key area of uncertainty. However, in practice, the CDF may act as a temporary access mechanism for oncology treatments that receive market authorization based on early/ single-arm trial data until longer-term and/or Phase III data are available. PCN271 The Impact Of Cancer Drugs Fund Reforms On Reimbursement Of Oncology Drugs In The UK Macaulay R, Dave K, Walsh SC PAREXEL International, London, UK

Objectives: The Cancer Drugs Fund (CDF) was set up in 2011 to enable cancer patients in England to access therapies that are not routinely publically reimbursed. Initially, inclusion was based on clinical criteria only with free-pricing for CDFincluded therapies. However, due to escalating costs, in October 2014, economic criteria were introduced. In 2016, the original fund was closed and the CDF became a temporary reimbursement fund under the remit of NICE to collect observational data to inform subsequent technology appraisals. This research aims to evaluate what effect the introduction and reform of the CDF has had on NICE recommendation rates.  Methods: All NICE Single Technology Appraisal (STAs) guidance for oncology drugs were screened up to 24/05/2017 and the date and outcome were extracted and were stratified by CDF status.  Results: 118 STAs were identified, 68% had recommended outcomes (defined as ‘recommended’ or ‘optimised’) and 32% had not recommended outcomes (defined as ‘only in research’ or ‘not recommended’). Of 37 STAs prior to the introduction of the CDF, 68% were recommended. Of 28 STAs during the initial free-pricing phase of the CDF, only 43% were recommended. Of 21 STAs whilst the CDF incorporated economic evaluations, 76% were recommended. Of 32 STAs following the 2016 CDF reforms, 84% were recommended (one through the newly reformed CDF).  Conclusions: After the CDF was initially introduced there was a notable drop in the NICE recommendation rate. This suggests that the CDF provided an alternative market access route with free-pricing that companies preferentially entered (versus obtaining a NICE recommendation). Indeed, since economic evaluations were introduced there has been a prominent corresponding increase in NICE recommendation rates, which has been further pronounced since the CDF closed in 2016, reflecting the renewed importance of NICE recommendations for national reimbursement in oncology. PCN272 Experiences With Price Competition Of Biosimilar Drugs In Hungary

20 (2017) A399–A811

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Objectives: As the average life expectancy of Koreans increases, the prevalence of prostate cancer (Pca) is increasing in men aged 70 years or older. But, in the absence of pattern data of primary treatment for elder patients was unable to health care policy for prostate cancer. This study aims to examine the medical patterns of major for prostate cancer.  Methods: The treatment patterns of Pca were analyzed by using the linked data of the Korea Central Cancer Registry and National Health Insurance Service (NHIS), using International Classification of Diseases, 10th diagnosis codes. To analyze the status of medical use of Pca, the database of NHIS claims in 2002–2014 was used. The treatment pattern due to Pca were investigated according to year based on the details of age, insurance type, primary treatment type, hospital type, comorbidity and cancer stage.  Results: Overall 71,223 patients were identified and 45,197 new medical users were selected. In terms of the stage of cancer, the proportion of ‘Localized’ group increased from 46% in 2005 to 58% in 2013. Patients that the Charlson’s Comorbidity Index is 1 point at the time of the first diagnosis had the most proportion at 26.78%, and the proportion of 4 points or more tended to increase annually for 11 years from 2003 to 2013. However, there was a continuous increasing trend in surgery (including robot surgery) from 23.7% in 2003 to 48.5% in 2013. Among those who received hormone therapy as a first treatment in patients aged 75-79 increased annually from 20.8% in 2003 to 27.3% in 2013, and patients aged 80 or more tended to increase.  Conclusions: Considering the increased prevalence of elder patients with Pca, it is important to understand the real-world status of medical treatment and to generate evidence for support decision-making of national health policy in Korea. PCN274 Payer Management Of High-Cost Brand-On-Brand Combination Therapies In Oncology Sherwin G, Gee A ICON plc, London, UK

Objectives: In recent years, brand-on-brand combinations of high-cost therapies have become a reality in the oncology space, particularly in areas such as multiple myeloma. The synergistic value of combining drugs with complementary mechanisms of action is expected to considerably bolster the benefit to the patient; however, the cost of using branded combinations increases exponentially due to the longer treatment duration, therefore making the regimen unaffordable. This research aims to explore pricing and market access issues that health systems have encountered during the evaluation of such therapies and potential solutions to make these regimens more affordable.  Methods: In-depth reviews of published sources were conducted, including a thorough analogue assessment. Primary research interviews with fifteen payers in the EU5 markets were conducted to support analysis and conclusions; payers were selected based on their involvement in the pricing and market access processes in their respective country and to reflect the different layers of decision-making (national, regional and/or local).  Results: The majority of drugs included within brand-on-brand combinations are already perceived as expensive in monotherapy, therefore, willingness to pay for a combined regimen is low. Payers are increasingly looking to innovative pricing models beyond simple discounts and in agreement with different manufacturers of the various therapies including within combination regimens in order manage budget impact. However, the complexity of the agreements and potentially unfair reflection of the value-based price for individual drugs is problematic.  Conclusions: Aligning the differing priorities of patients, payers and manufacturers is critical for finding mutually beneficial solutions. The operating models of both payers and manufacturers will require innovation in order to meet these increasing needs.

Hornyák L1, Nagy Z2, Tálos Z1, Endrei D2, Ágoston I2, Csákvári T3, Boncz I2 1Csolnoky Ferenc Hospital, Veszprém, Hungary, 2University of Pécs, Pécs, Hungary, 3University of Pécs, Zalaegerszeg, Hungary

PCN275 Cancer Drugs In Algeria And Six Other Countries: A Cross-Country Price Comparison Study

Objectives: The aim of our study is to analyse the biosimilar bids of the Hungarian National Health Insurance Fund Administration in case of colony-stimulating factor (CSF).  Methods: The data used in this analysis was derived from the financing database of Hungarian National Health Insurance Fund Administration, and they covered the interval between July 1, 2011 and June 30, 2014.  Results: Owing to the first price bidding, two biosimilars were awarded the status of preferred drugs. One biosimilar drug still obtained reimbursement, and it was available to the patients for a refund of 1500 HUF. Another biosimilar and an original drug lost their reimbursement. Owing to second price bidding, three biosimilar drugs became available for the patients, but it was for a unified refund of 300 HUF/box. During the 12 months prior to the bid process, 13974 patients received G-CFS treatment and 13352 and 13185 patients received it during the first and second year after the bid process, respectively. This shows a decrease of 4.5% in the number of patients during the first year after the bid process, followed by a further decrease of 1.3% during the second year relative to that before the bid process. The total amount of money spent on the reimbursement of G-CSF drugs during the year before bid process amounted to 7.49 billion HUF. This amount was reduced by 44% to 4.49 billion HUF in the first year following the bid process. In the second year, the amount of subsidization amounted to 3.6 billion HUF, indicating a 51.9% decrease relative to that before the bid process.  Conclusions: The analyses of the Hungarian price competition bid of biosimilar products showed a minimal decline in the number of patients under treatment by colony-stimulating factor while the health insurance reimbursement of these drugs significantly decreased.

Hedibel M, Kandi Z, Hidra RS Faculty of Medecine Algiers, Algiers, Algeria

PCN273 Treatment Pattern Of Patients Diagnosed With Prostate Cancer In Korea: A Trend Analysis Using Nationwide Health Insurance Database Park E, Kang M, Shim J, Kang S, Yang J, Choi I National Evidence-based Healthcare Collaborating Agency (NECA), Seoul, Korea, Republic of (South)

Objectives: The objective is to analyze whether cancer drugs are less or more expensive in Algeria than in 7 other countries in the world (Morocco, France, United Kingdom, Brazil, United States and Malaysia).  Methods: Based on the economic situation and the high prices of oncology medicines, we chose to survey official list prices at ex-factory level for 17 originator cancer drugs (breast cancer, lung cancer and prostate cancer) from the in-patient sector in Algeria and 7 countries from inside (France and Turkey) and outside its country basket for IRP as of April 2017. Drug data were provided by official websites except for Algeria where a questionnaire has been completed from representatives of the ministry of health. The prices of these drugs were compared per unit (i.e. per vial). Malaysia turned out to be an unreliable comparator because of the extreme variability of price data. Therefore, we decided to exclude it from our study.  Results: The study showed that there is a large disparity between the lowest and the highest priced drug ranging from 31% to 812%. The United States had all drug prices in the fourth quartile (100%), followed by Brazil (57%). Prices ranking most frequently in the first quartile were observed in Algeria (59%), Morocco (44%) and France (20%). Overall, in Algeria prices ranked at a low level; whereas US had the most expensive prices.  Conclusions: The large disparity in medicines prices is likely to result from national health policies. However, the prices surveyed do not include discounts because these are confidential. Since IRP is based on the official list prices, even if Algeria’s prices are the lowest, the funding organizations risk overpaying. Therefore, changes in the Algerian pricing policy by moving to risk sharing agreements may be a serious option to have more attractive prices. PCN276 German Amnog Benefit Assessment: The Type Of Appropriate Comparator Makes The Difference Templin C, Billig S, Damen D, Kulp W Xcenda GmbH, Hannover, Germany

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Objectives: For benefit assessment of new pharmaceuticals in Germany, G-BA defines appropriate comparators of four categories: one specific drug, a list of drugs, patient individualized therapy, and best supportive care (BSC). The aim of the study was to reveal the impact of the category on the added benefit.  Methods: Information on appropriate comparators and benefit assessment were retrieved from a databank containing information on all AMNOG dossiers in the field of oncology. Dossiers were analyzed for data on indication, target population, line of therapy, appropriate comparator, and added benefit.  Results: 66 relevant dossiers including 129 separate (sub-)labels were identified. Appropriate comparators assigned by G-BA were distributed as follows: 33 (26%) specific drug, 39 (30%) list of drugs, 23 (18%) patient individualized therapy, and 34 (26%) BSC. About 50% of all assessed sublabels within the categories “specific drug” and “list of drugs” gained an added benefit (45.5% and 46.2%, respectively). In nearly all of these dossiers direct evidence to the assigned comparator was presented. 41.2% (n= 14) of the indications in the category “BSC” gained an added benefit. In 3 dossiers no direct evidence to the appropriate comparator was presented. Nevertheless, 2 of these dossiers achieved an added benefit. In contrast, an added benefit was granted for only 30.4% (n= 7) of sublabels, which belonged to the category “patient individualized care”, 9 of the dossiers in this category did not show direct evidence to the appropriate comparator; however, 3 of these dossiers achieved an added benefit.  Conclusions: A specific drug or BSC are the most commonly assigned appropriate comparators in oncology dossiers. If a specific drug is the appropriate comparator, it seems inevitable to present direct evidence in order to gain an added benefit. For BSC and patient individualized therapy, G-BA seems to be more permissive regarding the acceptance of evidence not directly matching the appropriate comparator. PCN277 Rates Of Uptake Of Novel Agents In Cancer (Prostate, Melanoma, And Lung): Considerations For Forecasting In Economic Evaluations Kish J1, Feinberg B2 1Cardinal Health Specialty Solutions, Dallas, TX, USA, 2Cardinal Health, Dublin, OH, USA

Objectives: With recent drug approvals in prostate, melanoma and lung cancers, determining the uptake rate is important to understand their budgetary impact for national and private payers. This research describes the patterns in uptake of novel anti-cancer agents in the US and discusses the importance of developing timedependent budget/cost-effectiveness models.  Methods: Unique patients initiating therapy approved between 01/01/2011-12/31/2016 for prostate, melanoma and lung cancer were counted by quarter (Q) in the Symphony Health pharmacy and medical claims database (≥ 1 Rx claim and ≥ 1 medical claim for indication-specific diagnosis). Mean time to peak utilization was assessed. Trends in utilization were evaluated using linear regression. Model fit was based on r2. Sub-analyses were conducted to describe the influence of clinical and market forces (new clinical data, competitor launch, expanded indications) on utilization.  Results: Mean years from approval to peak utilization was: abiraterone(abi)= 4, enzalutamide(enza)= 4.5, ipilimumab(ipi)= 2.3, dabrafenib/trametinib(dab/tra)= 3.5, afatinib(afa)= 4.5, crizontinb(criz)= 4.5. A quadratic model (x2) showed a downward trend in abi use beginning in 2015 Q2 (r2= 0.97). A cubic model (x3) for enza showed stable rates since 2016 Q3 (r2= 0.98). Expanded indications increased the slope of the uptake curves for both drugs. Use of ipi began to decline in 2014 Q3 (x2,r2= 0.84) at the time of approval of nivolumab. Similarly, utilization of dab/tra appears (x3,r2= 0.95) to be now declining(42% less dab/tra from 2015 Q1-2016 Q4), approximately 2 quarters following launch of nivolumab. Afa use appeared to begin to decline(x3,r2= 0.96) while criz appeared stable (x3,r2= 0.96).  Conclusions: This research demonstrates that it takes several years from approval to attain peak market share. Uptake is not a linear process and market forces drive utilization patterns. Payers, whether national or private, should request time-dependent uptake factors in the calculation of budget impact models or forecasts to accurately reflect rates of adoption. Historical data can be used to inform such models. PCN278 Characteristics Of Patients Treated With Cetuximab-Based Extreme Regimen In 1ST Line R/M Scchn Cancer In Real Life Setting, In France In 2012-2015 Guigay J1, Chamorey E1, van Hille B2, Seronde A2, Le Tourneau C3 Cancer Center Antoine Lacassagne, NICE Cedex 2, France, 2Merck s.a.s., LYON, France, 3Institut Curie, Paris, France 1Comprehensive

Objectives: The objective of the study was to assess the EXTREME chemotherapy regimen in real life setting. In this abstract, we present patient characteristics and primary endpoint which was the rate of patients with relative dose intensity (RDI) of cetuximab ≥  80% in patients with 1st line R/M SCCHN.  Methods: DIRECT is a national, observational, longitudinal, multicenter, cohort-type study performed in adult patients with R/M SCCHN treated in first-line with cetuximab according to the administration schedule of the EXTREME study in usual medical practice. Sociodemographics, clinical and management data were collected through e-CRF, and the analysis of the full sample was defined as all subjects who received at least one dose of cetuximab after the loading dose.  Results: Of the prospective population (n= 169), 157 patients received at least the loading dose of cetuximab for R/M SCCHN, and 140 received at least one dose of cetuximab in addition to the loading dose. Among them, 96 had received chemotherapy in the LA SCCHN setting, and 30 patients had previously received cetuximab. 139 patients had recurrent disease, whereas 17 metastasis upon initial diagnosis. 29.9% of patients in DIRECT were ≥  65 years old, 85.4% were males, 18.4% of patients had an Eastern Cooperative Oncology Group performance status (ECOG PS) of ≥  2. Regarding the primary endpoint, mean RDI for these patients (n= 130) for the whole treatment was 86.1% ± 16.1%, and 63.1% had an RDI ≥  80%. 72 patients (45.9%) continued cetuximab in maintenance phase.  Conclusions: Baseline characteristics of the DIRECT prospective patient population who received at least the loading dose of cetuximab were quite similar to those in the EXTREME trial. Results demonstrated that the EXTREME regimen is a feasible treatment regimen in a real world setting.

PCN279 The Case For Combination Therapy - Clinical And Economic Value Differentiation Strategies In Saturated Oncology Therapy Areas Haycock L1, O’Rourke M1, Solon C2, Chalmers M1 1CBPartners, London, UK, 2CBPartners, San Francisco, CA, USA

Objectives: Market saturation or commoditisation is an increasingly frequent occurrence in the healthcare industry, and brings with it the challenge of value differentiation. The aim of this research was to analyse value differentiation strategies utilised by a selection of case studies in saturated oncology therapy areas.  Methods: In-depth analysis of national HTA decisions was undertaken for selected oncology case studies in France, Germany, and England; these included novel therapies recently approved in relapsed / refractory multiple myeloma (RRMM), advanced melanoma, and non-small cell lung cancer (NSCLC), which have encountered an influx of novel products over the last five years. Descriptive analysis identified key decision drivers behind each appraisal, and an assessment of successful value differentiation strategies was also conducted.  Results: Despite perceived ‘market saturation’, most HTA decisions reviewed in RRMM, advanced melanoma and ALK+ NSCLC were ultimately positive (11/11, 9/11 and 5/6, respectively). While efficacy / safety outcomes are key decision-drivers in all HTA appraisals, they were the only drivers cited in FRA / GER appraisals, while NICE appraisals also cited cost-effectiveness, end-of-life criteria and treatment variety. Regardless of decision-drivers cited within appraisals, notable value differentiation strategies were employed by manufacturers to ensure a successful outcome. In RRMM, fixed drug combinations were a key differentiation strategy implemented, with KYPROLISTM (carfilzomib, AMGEN) seeking approval for a doublet combination in cost-effectiveness markets (ENG) and a triplet combination in clinical-effectiveness markets (FRA / GER). This method was also observed in advanced melanoma with success of the OPDIVOTM / YERVOYTM (nivolumab / ipilimumab, BMS) combination in ENG. Additional value differentiation strategies employed by manufacturers included mechanism of action and mode of administration.  Conclusions: HTA bodies in FRA, GER and ENG remain receptive to novel therapies in saturated therapy areas. However, alternative value differentiation strategies can and have been employed to improve market access success in these scenarios. PCN280 Analysis Of Pharmacy Claims For High Cost Drugs: Ruxolitinib Utilisation And Expenditure In Ireland Hickey N1, Corcoran A1, Usher C2, Barry M1, McCullagh L1 College Dublin, Dublin, Ireland, 2National Centre for Pharmacoeconomics, Dublin, Ireland

1Trinity

Objectives: To analyse Irish national utilisation and health payer expenditure on ruxolitinib (from January 2015-December 2015 inclusive). To compare this realworld data to the utilisation and expenditure predicted at the time of the decision making process.  Methods: Predicted utilisation and expenditure data was derived from the National Centre for Pharmacoeconomic (NCPE) website. The NCPE considers the cost effectiveness and likely budget impact of all new drugs for which reimbursement by the health payer is sought. Real-world data was derived form a retrospective analysis of the national pharmacy claims database of dispensed ruxolitinib (ATC code LO1XE18). The total number of individuals who had received at least one prescription for the drug over the 12 month study period was determined. The gender/age distribution of the cohort were established. Total expenditure was ascertained.  Results: In 2013, the NCPE had evaluated ruxolitinib for the treatment of splenomegaly/disease-related symptoms in primary myelofibrosis, post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. The budget impact analysis assumed that there would be 24 patients initiated on treatment in year 1 post reimbursement, and about 11 annually thereafter. The annual gross impact was estimated to increase from € 1.20 million (year 1) to € 2.61 million (year 5). The drug was reimbursed in 2014 subsequent to price negotiations. Real-world analysis indicated that, in 2015 (year 2 post reimbursement), 81 (65.4% male) individuals had received at least one dose of ruxolitinib. The mean age of the male and female cohorts were 74 (± 9.3) and 70.7 (± 8.9) years respectively; no significant difference between age distributions was detected. Total expenditure was € 2.65 million.  Conclusions: Our analysis demonstrates how real-world utilisation can differ from pre-reimbursement estimates and highlights the benefit that this real-world information could bring to the decision making process, particularly in relation to monitoring affordability. PCN281 Real-World Evaluation Of Physician Attitudes Towards The Prescription Of Androgen Deprivation Therapy For Patients With Prostate Cancer Wittrup-Jensen KU1, Hallworth P2, Alvarez ML3, Rider A4 1Ferring Pharmaceuticals, Copenhagen S, Denmark, 2Adelphi Real World, Bollington, Cheshire, UK, 3Ferring International Center SA, Saint-Prex, Switzerland, 4Adelphi Real World, Cheshire, UK

Objectives: We sought to understand drivers for real-world treatment decisions among physicians prescribing androgen deprivation therapy (ADT) in Europe.  Methods: A disease specific programme, collected data from 81 urologists across Belgium (n= 8), France (n= 29), Germany (n= 20) and Italy (n= 24) between February and May, 2015. Data on physician demographics and prescribing habits were collected through physician-completed online surveys and patient record forms. Opinion questions were scored on a seven-point scale from strongly agree to strongly disagree. All data were anonymised and treated in accordance with national data collection regulations.  Results: Physicians were grouped by frequency of prescription of the GnRH Antagonist, degarelix, as regular prescribers (n= 30), low-prescribers (n= 31) or non-prescribers (n= 20). Physician demographics showed those who regularly prescribed, tended to be more recently qualified (67% vs 30%), worked at larger university hospitals (56% vs 7%) and were actively involved in clinical trials (43% vs 10%), compared to non-prescribers, respectively. Approximately one-third of physicians thought that current treatments were good at controlling the disease, and the