S116 Abstracts Poster Session, Sunday 29 January 2017 disease, significant benefit consideration and applicant categorization (Table 1). At the time of OD application, 41.6% of products with OD for rare neoplastic disorders was in preclinical phase, while this was 65.1% of OD for other rare indications (p < 005). Thirty percent of agents for rare neo- plastic disorders reached phase 1 clinical trials, whilst this was only 19.3% of agents for other rare indications (p < 005). The same trend was observed for the stage of development at the time of the latest annual report. Conclusion: The products that have been granted OD for rare neoplastic disorders are at a later stage of development compared to OD products for other rare indications. Conflict of interest: Advisory Board: MC is a member of the Scientific Advice Working Party (SAWP) at European Medicines Agency (EMA); KL is head of Orphan Medicines at European Medicines Agency (EMA). Other Substantive Relationships: A donation from Sanofi-Genzyme to KU Leuven covered some research costs; KP is funded by Flanders Innovation & Entrepreneurship. 972 ORAL Clinician-guided versus USS-guided lymph node fine needle aspiration: Should we be performing more biopsies in clinic? A. Strong 1 , T. Banks 1 , C. Lewis 1 , S. Rannan-Eliya 1 . 1 Royal Victoria Infirmary, Department of Plastic Surgery, Newcastle upon Tyne, United Kingdom Background: Regional metastases of skin malignancies to lymph node basins must be cytologically confirmed prior to lymph node dissection using fine needle aspiration (FNA) biopsy. FNA can be performed ‘manually’ in clinic as an outpatient procedure or under ultrasound (USS) guidance. Anecdotally, clinician-guided FNA is time-consuming and samples may be insufficient requiring repeat sampling. However, waiting for ultrasound- guided FNA may lead to significant delay in treatment, heightened patient anxiety and increased health care costs. Thus, we aimed to evaluate waiting times, costs and the proportion of insufficient samples/inconclusive results for patients undergoing clinician or USS-guided FNA biopsies. Materials and Methods: A retrospective analysis of all patients in a supra-regional service, undergoing clinician or USS-guided FNA biopsy for skin malignancy over a 5-year period. Lymph nodes identified as being suitable for clinic-based biopsy were those clinically palpable and which could be manually stabilised and away from high risk sites. To improve the diagnostic accuracy of clinician-guided FNA biopsy, cytology technicians were available in clinic to immediately evaluate sample quality. Results: 180 patients were identified (102 male, 78 female; mean age 68 years, range 25−99 years) with a range of skin malignancies (133 melanoma; 10 Merkel cell carcinoma; 37 squamous cell carcinoma). 48 FNA biopsies were performed by surgeons in clinic, while 132 were USS- guided, with similar numbers performed in the neck, axilla and groin between both groups. Clinician-guided FNAs were performed in a mean time of 0 days (range 0 days) from decision to biopsy. Comparatively, mean time for USS-guided FNAs was 14 days (range 0−54 days). Insufficient/ inconclusive samples were identified in 4/10% of clinician-guided biopsies and 5/7% of USS-guided biopsies. Overall, 85% of clinician-guided and 88% USS-guided biopsies provided a definitive result at first biopsy. Cost analysis identified a potential saving of £4800 per annum if suitable lymph nodes were biopsied in clinic versus under USS-guidance. Conclusions: Thus, clinician-guided FNA biopsy should be offered over USS if expertise is available and lymph node site and stability are suitable. We feel this provides immediate validation of sample ‘adequacy’, less patient anxiety and earlier block dissection if required. Furthermore, clinician-guided FNAs are significantly cheaper than USS guided with comparable accuracy and results. No conflict of interest. Poster Session (Sunday 29 January 2017) Health Economics of Cancer 1023 POSTER Can biosimilar products enhance resources utilization and quality of services for cancer treatment? A. Abotaleb 1 . 1 WHO consultant & MOH technical adviser, health economics & policies national fund, Cairo, Egypt Background: One of the major products in treatment expenditures at oncology field is biological products, which increase economic burden on payers and may lead to treatment restrictions due to high cost of biologicals. Introducing biosimilars products may offer safe, effective, sometimes cost saving alternative to innovator biological therapies. Biosimilars definition: According to WHO, “Similar to an already licensed reference biotherapeutic product in terms of quality, safety & efficacy”. The main objective is to measure the impact of introducing biosimilars to the oncology treatment through evaluating (guidelines modification, numbers of treated patients, price discounts for innovator products and quality of service introduced to the patients). Methods: Data analyzed for 113,429 cancer patient for the last 3 years from national data base including (treatment guidelines − quality of service surveys − reimbursement lists − price offers for innovator). Local biosimilars guidelines was the reference for estimating local biosimilars. Results: Introducing biosimilars products to Egyptian market in the last 3 years led to changing the following: Neutropenia guidelines were modified for including GCSF as a routine treatment for both prophylaxis and after chemotherapy. Breast cancer treatment guidelines were modified for HER2+ to include monoclonal second brand therapy as standard of care for both adjuvant and metastatic cases. Lymphoma treatment guidelines for NHL type were modified to include monoclonal antibodies second brand therapy as a standard of care. Price discounts for innovator products were found to be in the range of 35% to 66%. Surveys illustrated that reducing time of treatment for neutropenia patients, hospitalization time decreased due to modification of neutropenia guidelines. Was major findings at quality of service surveys. Conclusion: Introducing biosimilars to the oncology field may lead to offer safe, effective efficient solution for controlling budget and enhancing health service. Biosimilars may have a major role for achieving perfect computation at oncology field. But there is a need for conducting more studies and tools to guarantee safety and efficacy of biosimilar products. No conflict of interest. 1024 POSTER Prioritization of lines of hormonal treatment and its impact on patient outcomes and resources for metastatic breast cancer A. Abotaleb 1 . 1 WHO consultant & MOH technical adviser, National Fund, Cairo, Egypt Background: As a result of developing new lines of hormonal treatment for metastatic breast cancer patients the need was raised for prioritization strategy for enhancing patient outcomes including (quality of life − economic value − clinical effectiveness) and efficient resource management to treat more patients and reduce economic burden on payer. The objective of this study is to determine impact of using Fluvestrant 500 mg prior to (Everolimus 10 mg + Exemestane) as line of treatment to enhance patient outcomes (quality of life − economic value − clinical effectiveness) & resource utilization for metastatic breast cancer of estrogen-receptor-positive, locally advanced or metastatic breast cancer in postmenopausal women whose cancer has relapsed on or after adjuvant anti-estrogen therapy, or who have disease progression on anti-estrogen therapy. Methods: A cost-utility analysis from the payer perspective the Ministry of Health and Population was conducted to maximize health gain for the patients while ensuring the most efficient use of the finite resources available. Markov chain simulation model: The model used a hypothetical cohort of 100 subjects with three health states: first, metastatic until disease progression; second, best supportive care; and third, death. Quality of life data were incorporated in the model to make adjusted results. Quality of life was calculated using utility score derived from DA Cameron (2008). Clinical and safety data for Fluvestrant 500 were taken from the CONFIRM study and those for Everolimus plus Exemestane were taken from BELRO 2. Study costs used were the local ones according to the national fund list. Discounting was applied at 3.5% annually. The results obtained were in terms of ICER and number of QALYs. Uncertainty analyses: To test the stability of our results to variation in the estimates of the input model parameters, we performed various one- dimensional sensitivity analyses. Time horizon was estimated as 3 years. Results: Total costs, QALY and ICER after three years, according to the model, are shown in the table. Treatment strategy Cumulative cost Cumulative QALYs ICER Interpretation Fluvestrant 500 mg 102,888 EGP 1.58 −8593 EGP/QALY Fluvestrant is dominating (cost saving) Everolimus plus Exemestane 107,663 EGP 1.02 Difference −4,775 EGP 0.56