Italian Timings In New Drugs Approval: An Up-To-Date Analysis

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country should have an appropriate insight into these recommendations, since they pertain to spending of public money. Consequently, the goal of this study was to examine how the formally existing fundamental right to information has been exercised in reality in Poland and how the execution of this right has changed in recent years.  Methods: All recommendations on financing new technologies published by the President of the AOTM/AOTMiT within two predefined equal periods of time between 2013 and 2015 were analysed. The texts of the recommendations were evaluated with regard to the frequency of blinding their parts to the public, their readability and clarity of messages. The gathered data and assessments were subjected to statistical analysis. The descriptive statistics were conducted (mean, standard deviation, frequency, range), as well as the Pearson’s Chi-square test for independence was used to assess relationships. Results: The frequency and intensity of censoring the published HTA-based recommendations on reimbursement of health technologies has diminished. The text readability and clarity of message resulting from recommendations has improved. The improvements were made without issuing any new laws or regulations and they occurred due to the changed interpretation of the already existing legislation, as well as the change in culture and public communication policy.  Conclusions: The positive changes in the public communication policy should be maintained. The transparency of the HTA-based recommendations should be increased further in some areas in the future. PHP49 Italian Timings In New Drugs Approval: An Up-To-Date Analysis Lanati EP, Lidonnici D, Ronco V MA Provider Srl, Milano, Italy

Objectives: The present study analyses the timings of recently approved new drugs in Italy, pointing out the whole national process duration, from submission to price and reimbursement decision published on the Italian Official Journal.  Methods: We screened all reports published on the Italian Medicines Agency website regarding the monthly decisional meetings of the two commissions in charge of discussing the pricing and reimbursement requests presented by pharma companies (Technical Scientific Committee and Price and Reimbursement Committee). The public reports have been analysed since January 2015 onward, focusing on new drugs approved by EMA with centralised procedure, and integrated with information taken from the Italian Official Journal. This was the basis for the creation of a database that will be monthly updated. For each drug analysed a number of standard checkpoint have been highlighted in order to measure the minimum, average and maximum timing for each approval phase.  Results: The dataset collected up to June 2016 consisted of 94 drugs mentioned in AIFA report. They have been divided into four groups according to the available information: drugs still under assessment (8), drugs with no P&R request available (43), drugs with the information of the starting date of the procedure (reception of hard copy of the P&R dossier) (24), drugs which concluded the procedure since January 2015 (19). A complete analysis was focused on the last groups, pointing out a mean approval time of 115 days (min 36 max 246). Other checkpoints revealed the time between different phases: mean CTS-CPR 79 days (min 2 max 191); mean CPR-OJ publication 40 days (min 23 max 120).  Conclusions: Even if Italian pharma regulatory framework has also been indicated as one of the most up-to-date, Italy has always been pointed at as a slow country in terms of approval timings of new drugs. The analysis reveals a possible improving trend. PHP50 Development Of Predictive Models For The Analysis Of The List Of Vital Essential And Necessary Drugs Compilation Kolbin A1, Prasolov A2, Maksimkina E3, Balykina Y2, Golant Z4, Polushin Y1, Kurylev A1, Vilum I1 1First Pavlov State Medical University of St. Petersburg, Saint Petersburg, Russia, 2Saint Petersburg State University, Saint Petersburg, Russia, 3Ministry of Healthcare of the Russian Federation, Moscow, Russian Federation, 4Saint Petersburg State Chemical-Pharmaceutical Academy, Saint Petersburg, Russian Federation

Objectives: For the first time a formalized principle (scores, expert opinions) for  medicine inclusion in the restrictive lists was introduced in the Russian Federation in 2014. The aim of the study was to build a linear predictive model for drug inclusion in the List of Vital Essential and Necessary (VEN) Drugs on the basis of data analysis for 2016, and to compare the results with the ones obtained from the models developed in 2014.  Methods: The analysis included data on 141 drug dossiers with 43 positive decisions. Previously developed linear models were used to identify the rule according to which scores and expert opinions (expert organization (EO) and main external experts (ME)) characterizing considered drugs would correspond to the final decision of the interdisciplinary committee (IE): “approve” or “reject” inclusion.  Results: Analysis showed that the model for the EO conclusion had an error of 7.09% (12.4% in 2014), i.e. it could be affirmed that when making recommendations for the medicine inclusion in the VEN list, EO decision is based on the obtained scores. For the ME model the corresponding error was 7% (10% in 2014). Given the clear positive trend, decision makers adopted the formalized approach. The model for the final IE decision had an error of about 42% (previously 35%). This means that predicting the final IE decision on the basis of scoring, EO and ME opinions is possible only with a 58% probability, which is close to the adoption of “random” decision.  Conclusions: Linear models are a valuable tool for predicting drug inclusion in the VEN lists. At the same time, the current system requires its modification and clarification. The analysis revealed no significant effect of EO and ME on the final decision made by IE. The total amount of points, as well as accounting pharmacoeconomic data examination, are often left unclaimed. PHP51 Early Benefit Assessment Of Drugs And The Value-Based Healthcare Concept – A Qualitative Inquiry Within The Pharmaceutical Industry Martschinke B, Traut A EBS Business School, Oestrich-Winkel, Germany

Objectives: The German healthcare system introduced an early benefit assessment for new active ingredients and successive price negotiations with payers in 2011. This paper analyzes how the assessment is in accordance with Porter’s concept of value-based healthcare and which specific value-based starting points pharmaceutical companies possess during drug development and benefit assessment. It is further investigated which importance patient benefits possess for pharmaceutical companies and how the benefit assessment led to changes in strategies and structures. Future tendencies for development are discussed.  Methods: A literature review established the linkages between the value-based healthcare concept (Michael Porter) and the German market-access process. Seven in-depth, qualitative interviews were conducted with German executives from the research-driven pharmaceutical industry in May 2016 according to a semi-structured interview guideline. The data was coded and analyzed.  Results: The market-access process and the value-based healthcare concept mainly match in aspects of clinical outcome measures, pricing approaches and cost-benefit-assessments. All pharmaceutical companies interviewed act patient-oriented. This influences study design by increasingly gathering quality of life data. Several companies are open to new healthcare models as well as new pricing models (f.i. outcome-based pricing; capitation). However, major challenges exist both internally and externally: discrepancies with payers about payback period (short-term financial planning of statutory health insurances), inconsistencies in the study design, marketing authorization and HTA requirements between different countries, and implicit as well as explicit organizational change on different hierarchy levels and departments. Market-access/HEOR departments are gaining importance while marketing/sales departments remain important (with changes in certain task areas).  Conclusions: The results reveal an increasing shift towards value-based elements in healthcare for pharmaceutical companies, payers and public authorities. However, major obstacles and methodological challenges still exist. More appreciation and respect for each other need to be developed in order to establish successful initiatives jointly which are focusing stronger on treatment outcomes of patients. PHP52 Access To Innovative Medicines In The Czech Republic: Length Of Price And Reimbursement (P&R) Procedures Klimes J, Fuksa L, Vocelka M Department of Social and Clinical Pharmacy, Faculty of Pharmacy, Charles University in Prague, Hradec Králové, Czech Republic

Objectives: Since January 2008, the Czech Republic (CZ) regulation on P&R processes in drugs follows both specific assessment and formal proceeding rules including timelines based on EU Transparency Directive. But only much later (2012/2013), specific methodologies for mandatory budget impact and cost-effectiveness analyses were issued by Czech P&R decision body (State Institute for Drug Control; SUKL) formalizing the SUKL’s position as a national HTA agency for appraisal of medicines. The aim of the present study was to describe how the current status quo affects the actual length of the procedures concerning innovations.  Methods: Lists of administrative proceedings and individual proceeding files, were both accessed via public SUKL web page. First, all proceedings initiated between January 2013 and February 2016 were identified (N =  4,153). Consequently, only P&R proceedings on innovative medicines were selected: the inclusion criteria were strictly limited to first-in-class drugs at their 1st submission. The selected proceedings (N =  65) were then analysed and followed up to May 10th 2016.  Results: At the time of data collection closure, 40 procedures had at least appraisal report issued, out of which 28 had also decision issued. The average time until the first appraisal report was 9.2 (± 3.9) months. The average procedure length, i.e. until decision publication, was 12.9 (± 4.8) months. No correspondence or relation was observed between the procedure length and drug-related properties of the dossier, such as budget impact size or medicine therapeutic area.  Conclusions: Combination of the very formal administrative character and rigorous scientific evaluation, together with parallel complex negotiations between the proceeding’s stakeholders, apparently leads to delays in P&R decisions, i.e. patients’ access. The key question for the regulators possibly remains how to increase SUKL’s throughput, i.e. reduce delays, without stepping down on the recently acquired high-quality scientific assessment and rigour. PHP53 Drug Pricing And Reimbursement Processes In Algeria Soualmi R1, Bouabidi A2, Djahdou Z2, Ziouani S3, Kaddar M1, Mansouri K2 1ISPOR Chapter Algeria, Algiers, Algeria, 2Algiers University, Algiers, Algeria, 3Univ Paris-Sud, Faculty of Pharmacy, GRADES, Châtenay-Malabry, France

Context: Health expenditures are increasing steadily worldwide and drug prices weigh heavily on those spendings. Algeria does not escape this trend. However, the Algerian reimbursement system is one of the most generous in Africa and Middle East as 90% (38 million people) of the entire population is insured, making the Algerian reimbursement system, one of the most attractive in the region.  Objectives: The objective of this study was to identify and schematize the medicine pricing and reimbursement processes in Algeria, and to highlight the main criteria in payer’s decision making.  Methods: A literature review and interviews with experts from the economic committee and the drug reimbursement committee were conducted. The collected data were analysed thoroughly to schematize the processes.  Results: The drug pricing assessment is assured by the economic committee which makes its evaluation according to the drug’s origin, the medical benefit and the prices in benchmark countries. The generic drug price has to be at least 30% lower than the brand’s price. The drug reimbursement committee is in charge of proposing a list of registered drugs that will be reimbursed by the Social Security, and of determining the reference list price that will constitutes the maximum price on the basis of which the reimbursement will be made. This committee’s assessment is based on the analysis of the drug medical benefit and on the added medical benefit, following the French Health Authority (HAS) criteria.  Conclusions: The pricing assessment is mainly based on external reference pricing and the reimbursement on the drug medical benefit following the