Biosimilar Uptake In The Uk- An Evolving Story?

VA L U E I N H E A LT H

20 (2017) A399–A811

A707

the technology. As of April 2017, NICE has introduced a cost-effectiveness element to the appraisal process requiring an additional cost per quality adjusted life year (QALY) assessment prior to approval with a threshold set at £300,000/QALY. The benefits of such analysis beyond augmentation in economic efficiency is to allow greater consistency and comparability of patient access as other drugs undergoing NICE appraisal have to identify their cost-effectiveness estimates. The counter argument however is that the cost-effectiveness framework does not adequately account for unmet need as real world evidence is limited in these patient groups (therefore widening confidence intervals for efficacy parameters) whilst the disjointed nature of existing service provision within the NHS systematically inflates the costs of treatment.  Conclusion: HST evaluated drugs will be less likely to gain approval even at the £300,000/QALY threshold, and this extra health economic burden will only further slow access to drugs for these vulnerable patients with considerable unmet need.

analysis of country specific legislation, government body requirements and recommendations.  Results: Non-interventional studies collecting patient reported outcomes, preferences and perceptions of a disease and its treatment, require a formal review from an Ethic Committee (EC) in France, Germany and UK. In France, these studies involve human subjects and therefore require a formal review and approval from patient and data protection agencies. In Germany, they can be classified as an ‘Anwendungsbeobachtung’ and an EC review is highly recommended. In the UK, studies without ‘material ethical issues’ are suitable for a Proportionate Review instead of full REC.  Conclusions: Considering the increasing demand and the extended benefits brought by these patient studies, we wonder why they are excluded from the upcoming regulation for a European harmonized process. We encourage legislators to extend the scope of this new regulation and offer a common and faster ethics review to facilitate the conduct of such studies without mitigating patient protection.

PHP315 But Will They Trade Health? Developing An Economic Value Framework for Oncology

PHP318 Bringing Molecular Diagnostic Tests Into Clinical Practice: Mapping The Evidence Pathway

Briggs A1, Baba C1, Lipitz-Snyderman A2, Kaltenboeck A2, Mcintosh E1, Bach PB2 of Glasgow, Glasgow, UK, 2Memorial Sloan Kettering Cancer Center, New York, NY, USA

Thompson AJ1, Allen AJ2, Bouttell J3, Gavan S1, Graziado S4, Hall PS5, McMeekin PM6, Smith AF7, Uchegbu I8, Vale L2, Payne K1 1The University of Manchester, Manchester, UK, 2Newcastle University, Newcastle upon Tyne, UK, 3The University of Glasgow, Glasgow, UK, 4Newcastle upon Tyne Hospitals, Newcastle upon Tyne, UK, 5University of Edinburgh, Edinburgh, UK, 6The University of Northumbria, Newcastle upon Tyne, UK, 7The University of Leeds, Leeds, UK, 8Imperial College London, London, UK

1University

Objectives: Value frameworks in health care are proliferating often with very little input from economists. In particular, a number of oncology value frameworks have emerged, perhaps due to the greater costs of novel therapies in the cancer space. But none of these value frameworks include weights that economists would recognise as legitimate values. Building on previous qualitative work that identified health and non-health attributes of cancer treatment, the aim of this study was to design a discrete choice experiment (DCE) to identify trade-offs between identified attributes.  Methods: Previously reported qualitative focus group work with cancer patients, oncology clinicians and oncology nurses identified treatment convenience, existence of treatment alternatives, disease rarity, quality of evidence and prognosis without treatment as important attributes alongside the traditional health gain associated with treatment. These results informed the design and undertaking of a DCE piloted in June 2017 with a convenience sample (n= 45) where subjects where asked to choose between covering two alternative treatments in a new health plan. Quality-adjusted life expectancy (QALE) is used as a payment vehicle and the pilot tested whether respondents would be willing to give up health gains associated with treatment for the other identified attributes.  Results: Conditional logistic regression identified statistically significant preferences for less inconvenient treatments, treatments with no alternatives, higher evidence quality, helping those with shorter prognosis and provide more QALE gains. Only the number of people affected (rarity of disease) was insignificant.  Conclusions: The pilot phase of this ongoing study demonstrates that whilst the health-gains of cancer therapies are predominantly prioritised, other attributes are important and participants were prepared to trade health gains. The pilot results will be used to inform the design of a population study to identify the relative weight for the creation of a value framework in oncology with economically robust weights. PHP316 Biosimilar Uptake In The Uk- An Evolving Story? Hendrich J, Boodhna T WG Access, London, UK

Since the first approval of a biosimilar medicine in the EU in 2006, biosimilars have promised to deliver a more cost-effective solution for off-patent biologics, and by extension improve patient access to these medicines. A recent report highlights that the entrance of biosimilars into a therapeutic space increases price competition, thus driving down the price. Between 2016 and 2020, the addressable biosimilars market (i.e. biologics losing patent protection) in the EU5 and US has been estimated at € 47bn, of which the UK accounts for € 9bn. Despite this potential for saving in a health service facing substantial funding challenges, coupled with NICE recommendations for the use of biosimilars where possible, the uptake of biosimilars across the UK has been noted as slow by several reports. The factors influencing this should be addressed to ensure that maximal benefits of biosimilars can be realised in the UK. Several studies and reports have been identified between 2010 and 2017 which examine the slow uptake of biosimilars in the UK. These range from physician concern over biosimilar efficacy/safety to a general perceived lack of information from manufacturers and across the NHS. There is evidence to suggest that these concerns persist to this day, although recently the NHS have taken a more active leadership role to “to improve clinician confidence and clarify understanding amongst decision makers. PHP317 Regulatory Requirements for Non-Interventional Studies Collecting Patient Preferences and Experiences In France, Germany and The UK Sluga O’Callaghan M, Ansquer V, Frugier G, Mai C AplusA Real World, LYON, France

Background: Patient participation in medical decision making is increasingly recognized as a key component in the redesign of health care processes and is advocated as a means to improve patient safety. The European Medicines Agency (EMA) has understood that patient preferences, notions and experiences have the potential to improve the quality and delivery of medical care, reduce overall costs and improve outcomes by accelerating the understanding of how best to incorporate new therapies and technologies into everyday clinical practice. Essentially, these data help fill the knowledge gap between clinical trials and actual clinical practice. Therefore, the demand for data, directly reported by a patient that is based on his or her perception of a disease and its treatment, has strongly increased over the last few years. Today, the legal framework required to set-up these studies varies across European countries.  Methodology: Documentary Method – critical

Currently, there is a lack of clarity as to how new molecular diagnostics can navigate the development ‘pathway’ and go from discovery and research into routine clinical practice. Compared with therapeutics, the development pathway for diagnostics is more complex and fragmented, leading to low uptake. At the end of the current pathway, regulatory organisations such as NICE in the UK often have to assess diagnostic technologies without robust ‘end-to-end’ studies demonstrating the full impact on patient benefits and costs. Where significant evidence gaps exist, assessment by NICE can often prove a challenge with promising technologies failing to secure positive recommendations as a result. Unlike therapeutics, implementation within the NHS for NICE-approved diagnostics is not mandatory, leading to further uncertainty for developers as to whether there is a return on investment. A clear and explicit description of the diagnostic pathway and the role of economic evidence could help to (1) improve research efficiency by informing the identification and collection of appropriate data earlier in the development process; (2) identify methodological work needed to improve the rigor of such research; and (3) align evidence generation to the needs of local and national decision-makers. The objective of this conceptual study is to describe a ‘map’ of the current development pathway for new diagnostic technologies within England and Scotland and describe the type of economic evidence needed to support the development process at each defined stage of the pathway. Drawing upon the collective experience of health economists working within the UK diagnostics landscape, the pathway will differentiate between types of diagnostics (e.g. ‘companion’ versus ‘standalone’) and delineate the differences between evidence generation and assessment for diagnostics compared with therapeutics. The different types of economic evidence required by NICE and local funders will also be discussed and the implications for likely implementation highlighted. PHP319 Concept of Pharmaceutical Care In The Brazilian Legislation Chagas MO1, Porto CC2, Chaveiro N2, Chagas VO2, Assis DL1, Chagas FA3 Federal de Goiás, Jataí, Goiás, Brazil, 2Universidade Federal de Goiás, Goiânia, Goiás, Brazil, 3Instituto Federal de Goiás, Jataí, Goiás, Brazil

1Universidade

Pharmaceutical assistance, pharmaceutical care, pharmaceutical services, pharmacotherapeutic profile, and dispensing are designations used in laws, decrees, resolutions, and edicts concerning activities of pharmacists, without a specific distinction among them. Objectives: To analyze designations that cover the duties of clinical pharmacists, that is, professionals who participate in the healthcare system with regard to health promotion, prevention, and recovery.METHOD:Analysis of legal documents, since Decree no. 20.377/1931,which regulated the practice of the pharmaceutical profession in Brazil, until Law 13.021/14,which recognized pharmacies as healthcare facilities.  Results: Seventeen legal documents were identified, including decrees, laws, resolutions, and edicts issued by Brazil’s Presidency of the Republic, Ministry of Health, Pharmacy Federal Council, and National Health Surveillance Agency.There is no standardization of concepts of the terms used, causing conceptual misunderstanding.  Conclusion: The lack of standardization of terms associated with pharmaceutical activities brings negative consequences for the practice of the profession.Pharmaceutical care is the most appropriate expression to coverthe duties that pharmacists must assume as components of the healthcare system. PHP320 Improving Transparency In Health Technology Assessment Santos AS1, Guerra-JuniorAa 2, Ruas CM1 1Universidade Federal de Minas Gerais, Belo Horizonte, Brazil, 2SUS Collaborating Centre CCATES - Universidade Federal de Minas Gerais, Belo Horizonte, Brazil

Introduction: The goal of Health Technology Assessment (HTA) agencies is to issue recommendations to inform decision makers about the incorporation of technologies. In general, the HTA process lacks transparency due to effectiveness and safety data dependent on ex post evaluation, the possibility of selective outcomes and bias in sampling, dosing and statistical analysis and economic evaluations based on unvalidated models and arbitrary threshold values.  Objectives: The aim of this work is to evaluate methods to improve transparency on the HTA process.  Methods: Electronic search on Medline, Lilacs, Science Direct and Google Scholar and a complementary search in references of included studies and conference abstracts in January 2017.  Results: The transparency of the HTA process can