Positive Externalities of austerity? The Case of Smoking Cessation During the Financial Crisis in Greece

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eligible for a CEESP assessment. Among all the medicines declared eligible for an assessment 29 have been granted an ASMR IV, V or “not reimbursed”.  Conclusions: The CEESP assessment is meant to inform the price negotiation with the pricing committee (CEPS). The decision to conduct a CEESP assessment is based on the ASMR claimed by the manufacturer. However, the TC may eventually grant the drug a lower ASMR, meaning that the CEESP assessment that was conducted was not justified. This has an economic impact on the overall HAS budget as CEESP is potentially assessing drugs unnecessarily. PHP269 Quality Assured Use of Pharmaceuticals: Does German Gba Follow Ema? Menzler J1, Minartz C1, Thienel P2, Neubauer AS1 for Health- and Pharmaeconomics (IfGPh), Muenchen, Germany, 2Institute for Healtheconomics (IfG), Muenchen, Germany

1Institute

Objectives: After receiving the EMA approval for Europe, it is mandatory for pharmaceuticals in Germany to complete the AMNOG process to receive reimbursement. Finally the responsible G-BA (joint federal committee) publishes a decision not only on the added benefit of the drug, but also on any specific requirements for the quality assured use. These requirements may differ from the EPAR and SmPC specifications for quality assured use of the drug.  Methods: For all 110 AMNOG applications started and finished between January 2015 and June 2017 we compared the specifications of the AMNOG decision for quality assured use with the respective EPAR and SmPC documents. We categorized differences and determined its relative amounts.  Results: The G-BA decisions were clustered into three groups: [A] Complete agreement with the EPAR/SmPC documents (52%), [B] Concretization of the EPAR/SmPC requirements (41%) and [C] divergent requirements by G-BA (7%). In cases of category [B] the G-BA named the type of specialized physicians indicated by the EMA phrasing “…a physician experienced with…”. All products of category [C] receiving divergent specifications (7%, n= 8) were orphan drugs and two of them had an oncologic indication while the others were for metabolic diseases. While EPAR and SmPC mentioned “health care professionals” or had no specific assignation, the G-BA assigned the application of the drug to specific disciplines. The G-BA gives no explicit reasons for this decision, but the orphan drug status appears to be an important driver.  Conclusions: In case of rare diseases German Health authorities request supervision by a specialized and experienced physician, also in cases where the EMA does not. This should be taken into concern when the market entry of an orphan drug is projected, especially for critical indications like cancer or severe neurologic and metabolic diseases. PHP270 Relative Value of Evidem Mcda Framework for Reflective Drug Evaluation Among Therapeutic Positioning Report Evaluators From The Spanish Agency of Medicines Hernández C1, Blázquez A1, Gil A2, Badia X2 1Spanish Agency of Medicinal Products and Medical Devices (AEMPS), Madrid, Spain, 2Omakase Consulting, Barcelona, Spain

Objectives: To assess the value of applying reflective MCDA to the generation of drug Therapeutic Positioning Reports (TPR) in Spain.  Methods: TRP are evaluation reports performed by the AEMPS to support P&R in Spain. AEMPS healthcare professionals involved in the generation of TPR participated in two MCDA sessions using the EVIDEM (v 4.0) framework. TPR currently considers the assessment of “comparative effectiveness”, “safety”, “criteria of use” and “follow-up” for the drug under assessment. In each session, the EVIDEM criteria were presented and weighted using a direct rating scale (1: low relative importance; 5: high relative importance). An example of the assessment of a biological drug in psoriasis was used to rate the evidence matrix and numbers were used to establish a reflective discussion among participants.  Results: A total of 15 AEMPS representativesparticipated in the session. Using a direct rating scale, the criteria considered most important (≥ 4.0 points) were: “comparative effectiveness” (4.5), “disease severity” (4.5), “comparative safety / tolerability” (4.3), “type of therapeutic benefit” (4.1), “unmet needs” (4.1) and “quality of evidence” (4.0). The criteria considered less important (≤ 3.0) were “comparative cost consequences – non-medical costs (2.9), “size of affected population” (2.9) and “expert consensus/clinical practice guidelines” (2.8). The scores assigned to each criterium regarding the comparative drug assessment were discussed to understand the value contribution of each criteria to the overall drug value.  Conclusions: The relative importance assigned by participants to the priority criteria used in TPR (comparative effectiveness and safety) was highly consistent. Additional criteria not included explicitly in TPR, such as, “disease severity”, “quality of evidence” and “unmet needs” were also classified as very relevant. In general, reflective MCDA was considered as a positive methodology which could add transparent reasoning behind evaluators’ discussions during TPR generation. PHP271 Maintaining The Belt And Road – The Impact of ‘Brexit’ on UK Market Access Wang GD, Macaulay R PAREXEL International, London, UK

Objectives: Most new innovative medicines access European markets through the European Medicines Agency (EMA) centralised authorisation procedure. Post-Brexit, a new UK national regulatory process will be required. This research explores possible UK regulatory access scenarios post-Brexit and discusses their market access implications.  Methods: Publically available resources from the EMA, Swissmedic, NoMA, MHRA, BAG, EAK, HOD were screened for information on regulatory approval process(es). All NICE and SMC single technology appraisal guidances were screened and the outcome and date extracted (01/01/2011 to 31/05/2017).  Results: Norway is not in the EU but is in the EEA and is a full member of CHMP and participates in the centralised authorisation process. Switzerland is an independent country within Europe with a separate regulatory process, but

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has a customs-union with Liechtenstein, which is in the EEA, where precedence has been set on recognition of Swiss Marketing Authorisations. NICE and the SMC conduct HTAs for reimbursement of new therapies in the UK. However, 11% and 14% of their appraisals have been non-submissions, and recommendations have been at an average delay of 17.1 and 10.5 months, respectively. Whilst the UK is 7th largest market in the World, the top 20 list includes 5 other EU countries.  Conclusions: Post-Brexit, UK regulatory approval could follow a model of rapid targeted assessment and approval of EMA-authorised products, parallel work-sharing of UK-EMA hybrid application, and/or mutual recognition agreements. These could substantially impact market access; although the UK is a large market, many companies already choose not to submit to NICE/SMC due to the difficulties in securing positive reimbursement recommendations. The prospect of an additional access hurdle formed by a separate UK-specific regulatory process may further deter some companies. Negotiations need to minimise the potential disruption to current approval and HTA recommendation timeframes to ensure that life-saving medicines are available in the UK.

HEALTH CARE USE & POLICY STUDIES – Population Health PHP272 Positive Externalities of austerity? The Case of Smoking Cessation During the Financial Crisis in Greece Pavi E1, Naoum V1, Athanasakis K2, Kyriopoulos J1 School of Public Health, Athens, Greece, 2Open University of Cyprus, Latsia, Nicosia, Greece

1National

Objectives: Austerity measures imposed on Greece have led to increasing unemployment and decreasing income affecting lifestyle behaviours such as tobacco consumption especially for the socioeconomically disadvantaged population. The aim of the present study was to investigate the factors associated with quitting smoking and quitting smoking during the crisis in Greece.  Methods: Data were extracted from the 2016 “Health and Welfare” national survey conducted by the Hellenic National School of Public Health. The sample consisted of 2,002 adults. In order to investigate the determinants of quitting smoking and quitting smoking during the crisis, two binary logistic regression models were constructed. Quitting smoking was dichotomized as “ex-smokers” versus “smokers” while quitting smoking during the crisis as “quitted smoking during the crisis” (2010 to 2016) versus “quitted before the crisis” (up to 2009). Independent variables included socio-economic factors, factors relating to health and health behaviors, as well as to the economic crisis and a health services support factor. As a scale indicator (Cronbach’s α = 0.76), economic distress, quantified the perceived impact of crisis on each individual in relation to household financial hardship.  Results: Overall, 36.9% of the sample were smokers, 16.0% ex-smokers and 47.1% non-smokers. Of all ex-smokers, 43.9% quitted smoking during the crisis. Factors associated with quitting smoking were age (95% CI: 1.02, 1.06), occupational status: unemployed (95% CI: 1.42, 4.82) and pensioner (95% CI: 1.00, 3.25), economic distress score (95% CI: 0.53, 0.92) and number of cigarettes (95% CI: 1.04, 1.07) A statistically significant influence of age (95% CI: 0.93, 0.96) and economic distress score (95% CI: 1.08, 2.49) was found for quitters during the crisis.  Conclusions: While economic distress is negatively associated with quitting smoking, it is positively associated with quitting during the crisis, rendering smoking cessation a positive by-product of the crisis.

Health Care Use & Policy Studies – Prescribing Behavior & Treatment Guidelines PHP274 Development of Pharmacoeconomic Guidelines In Ukraine: Methodological Issues And Policy Implications Piniazhko O1, Zalis’ka O1, Nemeth B2 Halytsky Lviv National Medical University, Lviv, Ukraine, 2Syreon Research Institute, Budapest, Hungary

1Danylo

Objectives: Pharmacoeconomic (PE) guidelines are used as standards for preparation of studies to be included in applications for reimbursement, procurement of drugs, guides for conducting a study, or templates for evaluating the economic study reports. Submission guidelines can provide a list of the official requirements of a health care decision-making body in a country concerning pharmaceutical reimbursement submissions with an economic evaluation section. This study aimed to set up a framework for the development of a methodological guideline PE for health technology assessment (HTA) reports submitted to the Expert Committee on selection and use of essential medicines due to current legislation in Ukraine in 2017.  Methods: In 2017 a literature review was conducted on several submission guidelines (England&Wales, Finland, Poland, Scotland, Spain, Israel, Thailand, Australia), the EUnetHTA Core Model and other methodological guidelines. Based on these documents and taking into account the local setting a preliminary country-specific PE guideline for Ukraine was developed by a research team of experts.  Results: The initial version of the PE guideline as part of a submission guideline includes the following sections: research question, perspective of analysis, time horizon, methods of analysis, cost assessment, health outcomes assessment, modelling, discounting, sensitivity analysis, budget impact analysis, limitations and discussions, presentation of results and final conclusions. The feasibility of the guideline will be tested and discussed with various stakeholders in a structured and transparent way.  Conclusions: The implemented submission guideline with an economic evaluation section will facilitate the appraisal of medicines based on objective and transparent information which will allow decision-makers and pharmaceutical companies to justify the reimbursement of new medicines based on cost-effectiveness and budget impact analysis.