Variation In Health Technology Assessment And Reimbursement Decisions In England, France, And Germany: Spotlight On The Impact Of Uncertainty

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for innovative products, still very limited number of Managed Entry Agreements have been implemented in the region. Majority of the market access initiatives include projects to increase capacity and infrastructure in health care system or simple price discounts, rather than value based partnerships to improve access to innovative treatments in the region. PCN310 Barriers To Effective Treatment Of Patients With Cll In Poland In Comparison To The United Kingdom Wladysiuk M, Rolska P, Stozek-Tutro A HTA Consulting, Krakow, Poland

Background: CLL (Chronic Lymphocytic Leukaemia) is the most common form of leukaemia in Western countries. Although recent therapeutic options have notably improved the clinical outcomes, for patients with contraindications against the use of B-cell receptor inhibitors (BCRi) CLL remains an incurable disease. Epidemiological data show a substantially lower 5-year survival rate for people with CLL in Eastern Europe (including Poland) compared to the Northern European countries (54% vs. 78%). This review will focus on targeted agents, such as ibrutinib, idelalisib and venetoclax, currently approved by EMA, and immunotherapies: rituximab, obinutuzumab, ofatumumab. Objectives: Literature review to identify barriers to effective treatment of patients with CLL in Poland vs the United Kingdom.  Methods: Non-systematic search of PubMed, Web of Science and Embase databases was performed to identify relevant publications. Additionally, clinical practice recommendations, reimbursement lists of drugs in Poland and the UK, list of registered therapies in Europe were searched on 15th June 2017.  Results: At present, the biggest barrier for Polish patients with CLL and physicians is the limited range of reimbursed therapies, not covering the most innovative therapies. There were 3342 patients received at least one line of treatment for CLL in 2015 in Poland and only two innovative drugs, rituximab and obinutuzumab, are reimbursed in the CLL indication. In contrast, all new drugs are licensed in the UK: ibrutinib, idelalisib, rituximab, obinutuzumab, ofatumumab are recommended by NICE and venetoclax is under appraisal. In Poland, there is a narrow group of patients requiring special treatment due to contraindications against the use of BCRi (about 25- 26% of patients).  Conclusions: Poland is lagging behind the Western countries in terms of availability of recent effective treatments for patients with CLL. Despite the implementation of more effective therapeutic options in Europe, the patients’ needs have not been fully met in Poland. PCN312 Variation In Health Technology Assessment And Reimbursement Decisions In England, France, And Germany: Spotlight On The Impact Of Uncertainty Horscroft JA, Chapman A, Philips Z, Akehurst R BresMed Health Solutions, Sheffield, UK

Objectives: European health technology assessment (HTA) bodies vary with regards to methodology, willingness to accept uncertainty, and preferences for different types of evidence. Previous studies have revealed substantial differences in the focus of European HTA processes and final decisions on recommendation. We therefore set out to explore how exactly the variation in decision drivers results in discrepancies in recommendations between the payer archetypes.  Methods: A critical review of HTA reports from NICE (England), HAS (France), and IQWiG (Germany) was conducted. These agencies were selected because they are representative of different payer archetypes, have large associated markets, and are relatively transparent in reporting. Qualitative semi-structured interviews provided added context. Cabazitaxel and pixantrone were selected as case studies due to the mixture of recommendations and rejections received for these products in the target countries. The review investigated the key evidence considered and the agencies’ responses to the evidence, particularly with regards to accounting for uncertainty.  Results: Cabazitaxel was approved for prostatic neoplasms by HAS and IQWiG, yet rejected by NICE on the grounds of a high ICER (~£90,000/QALY). On the other hand, pixantrone received restricted approval for non-Hodgkin’s lymphoma by NICE and HAS, despite uncertainties created by a small trial population and post hoc sub-group analyses, while IQWiG found no added benefit. The inconsistency in decision-making in European HTA processes is therefore likely to relate, in part, to the relative emphasis placed on different aspects of the clinical and economic evidence, and the willingness of agencies to accept associated uncertainty.  Conclusions: While understanding the international HTA processes is important, establishing the key drivers for previous decisions across agencies could be an efficient way to achieve approval and access. This is best achieved through a combination of expert elicitation and a critical review of previous HTA decisions. PCN313 Characteristics Of The Dietary Habits Of Cancer Patients And Structure Of Consumption Of Basic Food Products Batagoeva Z1, Sharmanov T2, Satbayeva E1, Seitaliyeva A1, Doszhanova B1, Esetova K1, Amirkulova M1, Parmankulova T1, Izatova A1, Kadyrova D1, Kim I1, Smagulova G1 1Asfendiyarov Kazakh National Medical University, Almaty, Kazakhstan, 2Kazakh Academy of nutrition, Almaty, Kazakhstan

Objectives: Study of the feeding habits of cancer patients in comparison with current norms of consumption of products.  Methods: We carried out a comparative analysis of actual nutrition of surveyed patients with the recommended norms of food consumption, which were used in Kazakh Research Institute of Oncology and Radiology. Also we calculated the value of nutrients in a variety of diets in percentage of the average recommended by FAO/WHO values and WHO recommended lower limit of value.  Results: The results of the study showed that the energy value of the ration of actual nutrition of the patients with oncological hospitals was below 200 kcal in comparison with the norms of content of nutrients. The total consumption of proteins, carbohydrates was lower also. Slightly exceeded the fat consumption and percentage of fat calorie of 33.8%. Carbohydrate calories

provided to 52.0%, which is also sufficient. The percentage of carbohydrate in the diet was increased in 2 times. From micronutrients in the diet of patients was revealed lack of calcium, phosphorus, and also expressed a lack of iodine, zinc, selenium, folic acid, vitamin A, vitamin E, thiamine, Niacin. Of the required amount of 40.8 g. dietary fiber patients received a total of 8.8 grams. The value of protein in the actual nutrition of patients conforms to the standards but significantly exceeded the recommended value of FAO/WHO.  Conclusions: Thus, in the actual nutrition of patients in the Oncology hospitals the energy value of the ration of dietary intake, intake of total proteins, fats, carbohydrates was low than the approved standard. Especially pronounced was the lack of dietary fiber, micronutrients. In the hospitals of Kazakhstan it is necessary to apply the methods of correction of the protein component of the diet using a composite of mixtures with a high biological value and a set of essential nutrients. PCN314 BRCA1/2-Mutated Breast Cancer In Select EU Markets: Incidence, Treatable Populations, And Potential Market Size For Parp Inhibitors Isherwood A1, Duval A1, Parihar N2 1Decision Resources Group, London, UK, 2Decision Resources Group, Bangalore, India

Objectives: The germline BRCA1/2-mutation-positive population in breast cancer has long been identified, but is not well characterized in epidemiological research. PARP inhibitors are a class of drugs in development for germline BRCA1/2-mutationpositive breast cancer. This study sought to provide germline BRCA1/2-mutationpositive breast cancer epidemiology to facilitate the generation of a market forecast for PARP inhibitors across 15 European countries.  Methods: Using peer-reviewed sources, we determined the proportion of germline BRCA1/2-mutation-positive breast cancer cases by molecular subtype. We then applied this proportion to the Decision Resources Group (DRG) breast cancer incident cases and metastatic drug-treatable populations by subtype, across the countries under study. We used interviews with breast cancer experts and secondary market research to model patient progression between lines of metastatic treatment. We used database pricing sources to estimate the cost of PARP inhibitor treatment.  Results: We estimate that 4% of newly diagnosed breast cancer cases are BRCA-mutation-positive, with the greatest prevalence of this mutation (14%) occurring among triple-negative (HR-/HER2-) patients in the 15 European countries under study. The triple-negative subtype accounts for 50% of first-line metastatic patients with BRCA mutations. Our findings indicate that over 3,900 BRCA1/2-mutated breast cancer patients will be diagnosed and eligible for treatment across the 15 markets under study in 2017. If PARP inhibitors effectively penetrate adjuvant and metastatic treatment settings, sales of these agents could exceed US$ 400 million across the 15 countries considered in 2027.  Conclusions: Triple-negative patients account for the majority of diagnosed stage I-III (44%) and metastatic (50%) BRCA1/2-mutation-positive breast cancer cases. Lower numbers of BRCA1/2-mutated breast cancers can be found in the remaining three subtypes, however the total size of this population holds the potential to support healthy market sales. PCN315 Impact Of Time To Reimbursement Of Drug Treatments For Non-Small Cell Lung On Patient Outcomes In Europe And Latin America Smith N, Meletiche D, Beckerman R Maple Health Group, LLC, New York, NY, USA

Objectives: This study investigated the impact of time to reimbursement of drug treatments for non-small cell lung cancer (NSCLC) on life-years (LYs) and quality-adjusted life-years (QALYs) in patients in Europe and Latin America (LatAm).  Methods: The time delay for marketing authorization and reimbursement was estimated by comparing the time between US FDA approval for a market basket of NSCLC products (nivolumab, pembrolizumab, critozinib, ceritinib, gefitinib, erlotinib, and afatinib) and the dates of marketing authorization and reimbursement by public payers in five European (EU5: United Kingdom, France, Germany, Spain, Italy) and four LatAm (Mexico, Colombia, Argentina, Brazil) countries. A cost-utility model consisting of three health states (progression-free survival (PFS), progressive disease, death) was used to estimate LYs and QALYs for each product and existing standard of care (SoC). Transition probabilities were estimated from median PFS and overall survival (OS) data from products’ respective FDA labels. NSCLC incidence rates and health state utilities were sourced from health technology assessment reports. Population-level LYs and QALYs were calculated by multiplying countrylevel NSCLC incidence by the estimated per-patient LYs and QALYs lost due to lack of reimbursement of each product in each geography.  Results: The median time to access in the EU5 for the NSCLC market basket was 278 days; no product was reimbursed in LatAm according to publicly available sources. The product associated with the largest amount of LYs and QALYs lost was nivolumab (1,806 and 901, respectively), due to lack of reimbursement in the UK and LatAM. Despite LatAm having fewer total NSCLC patients than the EU5 (~25k vs. ~40k), population-level LYs and QALYs lost were greater (LYs: 2,425 vs. 985; QALYs: 1,719 vs. 813).  Conclusions: Slower access to innovative medicines has a significant impact on population-level patient outcomes across the EU and LatAm, highlighting the need to accelerate access to novel therapies in NSCLC. PCN316 Emerging Markets Tiered Pricing: A Quantitative Assessment Of Local Affordability And Existing Price To Patient Walsh K, Jaffar S, Thakerar S Navigant Consulting, London, UK

Objectives: Investigate the role of tiered pricing on patient access while considering the factors affecting pharmaceutical pricing in major emerging markets including but not limited to budget constraints, pharmaceutical distribution mark ups, capacity of Govt. to pay for medicines, patient affordability, role of NGOs, lack of trust in generics, wide spread availability of fake medicines, divergence of published list