The Impact Of The Study Design Submitted For The Early Benefit Assessment On The Pricing For Oncologic Drugs

VA L U E I N H E A LT H

expenditure explain the access restrictions imposed in various markets.  Methods: Therapies approved for breast, kidney, lung, and prostate cancer, multiple myeloma, and melanoma in Australia, Belgium, Canada, Denmark, France, Germany, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the UK were identified (2006– 2016). For each indication, reimbursement decisions by national agencies were identified and classified according to the level of access restriction on clinically eligible population (none, partial, or full). GDPPC and health expenditure as a proportion of GDP were identified from published sources; mean values over the study period were calculated and related to the restrictions.  Results: Reimbursement agencies often do not explain the reasons for restrictions, suggesting a lack of transparency in decision-making. Across 65 cancer drug/indication combinations covering 892 reimbursement decisions by individual agencies, countries with a similar GDPPC such as Australia, Canada, and Germany showed variable rates of full restriction (0–31% of licensed indications). Poland and Portugal, with lower GDPPC, restricted 69% and 60%, respectively; however Spain, with a similarly low GDPPC, applied less restrictions at the national level. Furthermore, Poland, Australia, Italy, and the UK, with < 9% mean health expenditure as a proportion of GDP, restricted access in a high percentage of indications while Germany, France, and the Netherlands, with ≥ 10% mean health expenditure, imposed far fewer restrictions.  Conclusions: Access to cancer therapies varies between countries with similar GDP; healthcare expenditure as a proportion of GDP was moderately predictive of all reimbursement restrictions. The findings suggest unwarranted limitations and inequitable access to cancer treatment among countries with similar living standards, and potential inefficiencies in the organization of healthcare. PCN305 Access Perceptions: A Key Driver Of Non-Small Cell Lung Cancer (NSCLC) Targeted Therapy Prescription In Russia Graham A1, Byrne K2, Pepper K1, Silvey M1 Real World, Manchester, UK, 2Adelphi Real World, Bollington, Cheshire, UK

1Adelphi

Objectives: Literature on restrictions on access to innovative oncology treatments in Russia is limited. This research aims to assess the restrictions placed on targeted NSCLC therapies and the related impact on prescribing.  Methods: Data were drawn from the Adelphi Disease Specific Programme (DSP) in NSCLC conducted in Q1 2017. Medical oncologists, actively managing patients with NSCLC, completed a workload questionnaire, survey and patient record forms (PRFs) for up to the next 10 of their consulting NSCLC patients. In addition to clinical considerations, participating oncologists were asked their perceptions of the level of administrative controls for targeted treatments.  Results: 53 physicians provided perceptions of access restrictions and completed 329 PRFs. Within the epidermal growth factor receptor (EGFR) class, gefitinib was considered available according to approved indication without further restriction by 59% of physicians, decreasing to 54% for erlotinib and 11% for afatinib. 37% considered gefitinib available, but with restrictions beyond the approved indication, increasing to 39% for erlotinib and 48% for afatinib. Levels of prescribing followed perceived access with 31 of 329 patients currently receiving gefitinib, 9 erlotinib and 2 afatinib. Ease of reimbursed access was considered an important criterion of product choice (mean score of 5.8, on scale of 1-7 with 7 being very important); > 50% physicians included this in their top 5 considerations in first-line treatment selection with just under half reporting the same in later-line settings.  Conclusions: A correlation between prescribing levels and perceived access was observed within the EGFR class in Russia; this finding is consistent with the reported importance of reimbursed access in product selection. Reasons for perceived differences in access were not explored; the extent to which they relate to administrative controls, time since launch, familiarity or other factors should be explored to understand factors affecting patients’ access to innovative oncology products. PCN306 The Impact Of The Study Design Submitted For The Early Benefit Assessment On The Pricing For Oncologic Drugs Beinhauer I1, Dintsios C2 1University of Cologne, Köln, Germany, 2Heinrich Heine University of Düsseldorf, Düsseldorf, Germany

Objectives: Aim: of this study was to analyse if the design of the clinical studies influences the price negotiations according to the German AMNOG law between the pharmaceutical companies and the National Association of Statutory Health Insurance Funds. The analysis was conducted for all Oncologic drugs that underwent the early benefit assessment since its introduction in 2011 and had negotiated prices up to September 2016.  Methods: It was differentiated between additive (new therapy in addition to baseline therapy) and substitutive study designs (baseline therapy is replaced through new therapy) with an added or no added benefit. The study design was analysed with the dossiers of the pharmaceutical companies submitted to the Federal Joint Committee. Subgroup specific costs were calculated as annual therapy costs with the German price databank (Lauertaxe) and compared with the costs of the comparative drugs to quantify price premiums (multiplicative and additive premiums). Further price influencing factors were analysed in univariate and multivariate regression analysis and the budget impact for the statutory health insurance was considered.  Results: For additive and substitutive study designs with an added benefit a premium was negotiated on the annual therapeutic costs of the comparative drug. The median and the mean of the premium of substitutive designs was higher than for additive designs, if the comparative therapy was different to best supportive care. The multiplicative premium for the substitutive design was 15,07 vs. 2,29 for the additive design. EU-Prices and the population size had a significant effect on the reimbursement price.  Conclusions: The mean reimbursement prices are higher for substitutive designs than for additive designs. Since the number of cases was small for some categories (e.g. additive design and no additional benefit), further analyses should be performed, when more oncologic drugs passed the AMNOG.

20 (2017) A399–A811

A467

PCN307 The Difference Between Regulatory And Market Access Decisions On Treatment Availability For New Drugs In Six Common Cancers Across Australia, Canada, And Europe McKendrick J1, Malcolm B2, Sheahan K3, Katsoulis IA1, Song X1, van Loon J1 1PRMA Consutling, Fleet, UK, 2Bristol-Myers Squibb, Uxbridge, UK, 3Bristol Myers Squibb, Princeton, NJ, USA

Objectives: Patient access to cancer therapies can be limited due to restrictions set by national or regional health technology assessment (HTA) and/or pricing and reimbursement (P&R decision makers). This research explores variation from regulatory to P&R decisions impacting clinically eligible patients’ ability to receive appropriate pharmacotherapies.  Methods: HTA and P&R assessments from Australia, Belgium, Canada, Denmark, France, Germany, Italy, the Netherlands, Poland, Portugal, Spain, Sweden, and the UK were obtained for oncology drugs approved in six cancers (breast, kidney, lung, multiple myeloma, melanoma, and prostate) by the European Medicines Association, Therapeutic Goods Association and Health Canada during 2006–2016. From published HTA documents, indications were classified according to the level of restriction between the regulatory label population, and those eligible for reimbursed access. The number of impacted patients was estimated from published epidemiology and budget impact data; potential survival gains from the pharmacotherapy were applied to estimate the impact of (disability) life years lost.  Results: Of the 65 drug/indication combinations identified, in 50% no market access restrictions were imposed beyond the regulatory label; 22% of HTA decisions were not yet published, and 13% resulted in restriction to all clinically eligible patients across all countries; Poland, Scotland and Australia had the highest percentage of restrictions to licensed indications. A further 15% of HTA assessments limited access to a subgroup of the licensed population. Reasons for these limitations were infrequently reported across countries but when cited focused on price /budget impact and challenges around efficacy.  Conclusions: Discrepancies between regulatory and reimbursement decisions in Australia, Canada and Europe can impact health outcomes of cancer patients who are clinically eligible for treatment. There is variability in the factors that drive HTA/P&R decision making at the national level, and often the reasons for discrepancies between regulatory and HTA decisions are not transparent. PCN308 Systematic Literature Review On Multi-Indication Pricing Models In Oncological Drugs Manganelli A1, Badia X2, Gonzalez P3 1CRES-UPF, Barcelona, Spain, 2Omakase Consulting, Barcelona, Spain, 3Bristol-Myers Squibb, Madrid, Spain

Objectives: Drugs approved for multiple indications already represent more than 50% of the major oncological drugs in 2014 and are estimated to become 75% by 2020. A different clinical efficacy could be observed by indication and by patient subpopulation. However, the current pricing systems assign a unique price independent of the indication, therefore price and clinical value do not necessarily align. The objective is to investigate the public information about pricing model agreements, and pros/cons for payors and laboratories.  Methods: A systematic literature review, both in academic and gray sources without country restriction, identifies published models of indication-specific pricing (ISP), their pros/cons for payors and laboratories and their possible implementation in Spain.  Results: We found three ways of reflecting indication-specific value in prices: (1) a blended price depending on the value and the number of patients in each indication; (2) a price depending on the indication, through different discount or different price; (3) different brands for the same molecule. These have been used in Italy, Switzerland, Australia and the UK. Italy is the country with the highest number of ISP examples, which could be leveraged for its implementation in other countries. The main obstacle is to monitor that the drug is used in the indication it is paid for.  Conclusions: Indicationspecific pricing is a novel tool in many countries, though Italy already implemented it quite widely. More drugs have multiple indications, so aligning price and value will become more compelling in the next future. We show that their implementation is feasible and no major hurdle impedes it in Spain. PCN309 Managed Entry Agreements (MEA): Analysis Of The Current Situation In Middle East And North Africa Dokuyucu O1, Gol D1, Arslan B2, Incioglu F2, Ozbek O2 1AMGEN, Istanbul, Turkey, 2QuintilesIMS, Istanbul, Turkey

Objectives: Managed Entry Agreements (MEA) are increasingly implemented in European countries and other developed markets. Aim of this study is to understand the types of market access initiatives implemented to ease budgetary hurdles and enable access to patients in Middle East and North Africa.  Methods: Data collected through primary and secondary market research (Sep–Nov/16) from local pharma industry experts in regulatory and market access, clinical pharmacists and physicians involved in formulary enlistment decisions and market access initiatives implemented by pharmaceutical companies. The project scope was limited to identify initiatives implemented for innovative and mostly biologic drugs in oncology, hematology and other specialty care therapy areas.  Results: Identified 63 cases in 9 countries and categorized them under two main buckets: 1) enable access initiatives that target registration, pricing and reimbursement barriers, and 2) create demand initiatives that aim to drive uptake of drugs upon launch and address issues around awareness, affordability and adherence. 46 of the 63 cases are under create demand with an emphasis on awareness and accessibility across all countries due to limited diagnosis and treatment capability. Initiatives targeting pricing and affordability are mostly identified in countries which have relatively limited government funding or public healthcare coverage. UAE, Egypt, Saudi Arabia and Algeria, respectively are the most active countries in terms of market access initiatives in the region.  Conclusions: Even though access is the main barrier