Market Uptake Of Pharmaceutical Innovations In Germany - Regulatory Approaches And Its Consequences

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HAS criteria. With the Algerian epidemiological transition and the high drug costs, the assessment could be reinforced with heath economic evaluations in order to optimize health care expenditures. PHP54 Arbitration Board Setting Reimbursement Amounts For Pharmaceutical Innovations In Germany When Price Negations Between Payors And Manufacturers Fail: An Empirical Analysis Of 5 Years’ Experience Ludwig S1, Dintsios C2 1HGC, Düsseldorf, Germany, 2Heinrich Heine University of Düsseldorf, Düsseldorf, Germany

Objectives: In Germany, an arbitration board is setting reimbursement amounts for drug innovations when price negations between payors and manufacturers fail. Our aim was to empirically analyze all arbitrations since the reform of Germany’s Pharmaceuticals’ Market (AMNOG) came into effect.  Methods: All available relevant documents up to January 2016 were screened and the identified contentious issues between the negotiation parties’ extracted. Reimbursement requests of both negotiating parties and the arbitrations were transformed into a comparable format based on defined daily doses and contrasted among each other.  Results: In the given period 16 arbitrations took place. The arbitration board is implementing the same criteria used in the negotiations between manufacturers and payors. Almost all arbitrations dealt with generic appropriate comparative therapies. Reimbursement amounts set by arbitration were on average 38.4% below the mean of payors’ and manufacturers’ requests (69.2% below the manufacturers’ requests). The corresponding prescription volumes were arranged rather centrally. All arbitrations refer to a one year contract period. The arbitration board rarely decided on further technical contentious points. Hence, no heuristics referring to them were derivable.  Conclusions: There is evidence for a quasi-algorithmic approach of the arbitration board, even though it is legally determined that it has to decide while taking the peculiar conditions of each case into due consideration including the characteristics of the respective therapeutic area. The balance of interests proved to be within a very narrow space albeit it concerns in principle discretionary decisions. Thus, the purpose of arbitration seems to be not achieved. PHP55 The Evolution And Comparison Of Hta Assesment Organisations In Selected European Countries Beletsi A, Koutrafouri V, Karampli E, Pavi E National School of Public Health, Athens, Greece

Objectives: Health Technology Assessment is a decision making and policy formulation tool in the health sector. The purpose of this study was to examine and compare selected European countries with different maturity in the use of HTA.  Methods: Countries were selected on the basis of long established HTA institutions (Group A: England, Germany, France, Sweden) and comparatively recent established HTA (Group B: Poland, Romania, Hungary, Romania). A systematic literature review was performed and collected information was reviewed by two independent researchers. Comparative analysis of HTA organizations in the respective countries was carried out based on the analytical framework by Hutton et al (2006).  Results: In Group A countries, the assessment is done by independent HTA institutions with specific guidelines; criteria used include effectiveness, safety, and economic data. They critically appraise local data with emphasis on relative effectiveness and the therapeutic added value based on the optimal treatment/ comparator. The main objective of HTA in this group of countries is equal access to care, and assessing value for money. Group B countries have established HTA agencies with formal procedures, however they differ in the way HTA is organized and the extent it influences decision making. They generally follow the standards of other more mature HTA organizations and often consult the decisions of more developed countries; however the transferability of HTA results across different countries is an important limitation. Effectiveness, safety and therapeutic added value are the key criteria but considerable emphasis is also given on the budget impact of new therapies.  Conclusions: HTA is widely used for assessing new technologies for the benefit of patients, and as a cost estimation tool for state budgets. HTA organizations have been established and developed dynamically in high income countries, but also in countries with limited resources, with distinctive operational characteristics and priorities. PHP56 Does Real World Evidence Support Conclusions From Experimental Evidence In Decision-Making Processes In Poland? Wilk N1, Wierzbicka N2, Skrzekowska-Baran I2, Moć ko P1, Tomassy J1, Kloc K1 1Arcana Institute, Kraków, Poland, 2Janssen-Cilag Polska, Warsaw, Poland

Objectives: The aim of the study was to identify and quantify the relation between Real World Evidence (RWE) and experimental evidence (EE) in decision-making processes on public funding of drugs in Poland.  Methods: The analysis included data published by the Agency for Health Technology Assessment and Tariff System between 01.2012-09.2015. Both for RWE and EE the study type, number of participants and reliability score were analysed.  Results: Of the 58 decision-making processes RWE confirmed results of EE in 61% of cases. In 23% there was no data available for assessment of relationship between RWE and EE. The remaining 16% related to RWE negating EE both in favour or disfavour of a drug (7% and 9%, respectively). RWE accounts for less than half of the evidence considered in the processes (45%) weighted by number of patients. The patients weighted share of RWE in a single process ranges from 2% up to 100%. Studies with a control group represent 99% of EE and 90% of RWE, all weighted by number of patients. RWE was twice less frequently assessed for reliability compared to EE (48% vs. 93%). High quality evidence was more often found in EE (66%) compared to RWE (50%). In a small fraction of processes the best available evidence were low quality EE and RWE (4% vs. 6%).  Conclusions: RWE is playing important role as it stands for nearly half of all the evidence considered in decision-making processes on public funding of

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drugs in Poland. In the majority of processes RWE confirms conclusions based on EE. RWE is of high quality slightly less often than EE, however it is twice less frequently assessed for reliability. As pharma companies strive to develop high quality RWE it still does not receive the attention it deserves from public funding decision makers. PHP57 Real World Evidence In Decision-Making Processes On Public Funding Of Drugs In Poland Wilk N1, Wierzbicka N2, Skrzekowska-Baran I2, Tomassy J1, Kloc K1, Stankowicz P1, Włodek A1 1Arcana Institute, Kraków, Poland, 2Janssen-Cilag Polska, Warsaw, Poland

Objectives: Real World Evidence (RWE) is data from actual medical practice related to efficacy, safety and costs in opposition to experimental settings. The aim of this study was to assess the use and impact of RWE in decision-making processes in Poland.  Methods: The analysis was based on data from the Agency for Health Technology Assessment and Tariff System (AOTMiT) published between 01.201209.2015 in Verification Analyses (VA), Statements of the Transparency Council (STC) and Recommendations of the President of AOTMiT (RPA).  Results: RWE was identified in 53% of VAs, 21% of STCs and 35% of RPAs. Predominantly, RWE was included in reimbursement applications by MAH, however in 4% of VAs AOTMiT analysts found RWE themselves. Most of RWE related to safety (89%) and less to effectiveness (55%). In up to ¾ of RWE including processes, RWE was not evaluated. When RWE was assessed, AOTMiT analysts and the President slightly more often judged that it was insufficient than sufficient (10% vs 9% and 14% vs 12%, respectively), while the TC was nearly twice more restrictive (19% vs 10%). The longitudinal analysis of RWE in AOTMiT evaluations shows steady increase in the number of processes with RWE in 2012-2014 (31, 40, 64 processes) with apparent decline in 2015 to estimated 36 processes p.a. The share of processes with RWE had a peak in 2014 (59% vs 48% in both 2012 and 2013). The share for 2015 including September data is 36%, which is the lowest in the analysed period.  Conclusions: Applications with RWE more often had a positive Statement/Recommendation/Decision compared to those without RWE. There is a considerable lack of consistency in identification of RWE on the three distinct levels of assessment and appraisal within the AOTMiT. A growing importance of RWE can be observed, however, the sustainability of this growth remains uncertain. PHP58 Market Uptake Of Pharmaceutical Innovations In Germany Regulatory Approaches And Its Consequences Witte J, Greiner W School of Public Health, Bielefeld University, Bielefeld, Germany

Objectives: Regulation of new pharmaceuticals in Germany is characterized by an early benefit assessment process and free pricing within one year after formal approval followed by price negotiations. Both is relevant for market uptake analysis, as there is no direct prescription or reimbursement regulation based on assessment results. Since introduction of the Pharmaceutical Market Restructuring Act in 2011, over 200 benefit assessment procedures have been concluded. Yet, the impact of the results on prescription behavior remains unknown.  Methods: Based on prescription data from a large German sickness fund we examined to what extend the market uptake of pharmaceutical innovations increase in relation to the amount of additional benefit within twelve months after assessment results were published by the Federal Joint Committee (FJC).  Results: Our findings indicate that there is no correlation of the amount of additional benefit and likelihood of prescription. Mean overall market uptake one year after FJC-decision is 12.4%. Products with a large benefit (“considerable”) feature a slightly smaller adjusted uptake-rate (14.2%) than those with no approved benefit (14.7%). Medicines with a “minor” benefit show an uptake-rate of 12.6%, whereas those whose benefit is “not quantifiable” show the lowest with 9.8%. For market volume adjusted and unadjusted rates will be presented. Recent examples for interacting factors that might affect the likelihood of early adoption will be discussed.  Conclusions: As prices remain free in the first year of market appearance in Germany, health insurers claimed need for regulation as especially new hepatitis therapies rapidly gained market volume and were responsible for an exceeding increase in expenditures. Results of the pharmaceutical dialogue event indicate, that prospectively a revenue caps could be introduced instead of shortening the timeframe of free pricing. Simulation results on the impact of a revenue cap will be presented to estimate potential coverage of this regulatory approach. PHP59 Health Technology Assessment In Brazil: Metrics From The Reports Of The National Commission For Incorporation Of Technologies (Conitec) Lemmer T, Piedade AD, de Oliveira RW, Moreira Ed, Julian G Evidências - Kantar Health, São Paulo, Brazil

Objectives: Created in 2011, the National Commission for Incorporation of Technologies (CONITEC) is the health and technology assessment body that evaluates the incorporation of new technologies in the Brazilian public healthcare system. Additionally, CONITEC also participates in the development/approval or alteration of national clinical guidelines. Therefore, the objective of this study is to describe CONITEC´s reports regarding type of evaluation, budget impact models and economic studies profile. Methods: We reviewed all CONITEC´s decision reports published up to June 9th2016 regarding type of assessment (such as incorporation, exclusion, alteration, and clinical guidelines), applicants’ profile, and type of economic evaluation performed.  Results: Most of the 205 reports assessed requests for incorporation of technologies (86%), while requests for exclusions and adoption of clinical guidelines accounted for 6% and 4% of the reports, respectively. Public entities submitted 54% of the requests, followed by pharmaceutical industries (29%) and non-identified applicants (10%). Only 37% of all requests for incorporation