ISPOR Beijing 2014 - Costello ?· ISPOR Beijing 2014 Conference Report Costello Medical Singapore Pte…

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<ul><li><p>ISPOR Beijing 2014Conference Report</p><p>Costello Medical Singapore Pte LtdLevel 28, Gateway East, 152 Beach RoadSingapore, 189721 +65 68 27 56 37www.costellomedical.com</p></li><li><p>ISPOR Beijing 2014 Conference Report Copyright Costello Medical Singapore Pte Ltd 1</p><p>ISPOR Beijing 2014 Conference Report</p><p>Costello Medical Consulting attended the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 6th Asia-Pacific Conference in Beijing, China from 6th to 9th Sep 2014. </p><p>Overall, more than 600 research presentations, issue panels and workshops, revolving around the conference theme Patients: The Center of Evolving Health Care in Asia-Pacific were presented. A summary of the most interesting and relevant topics is provided below, covering:</p><p>Hearing the Patients Voice in Health Care Decision Making in Asia</p><p>Electronic Health Records and Real World Evidence</p><p>China Health Care Reform: Who Gains and Who Loses?</p><p>Health Technology Assessment and Reimbursement Decisions in Asia-Pacific</p><p>Methodological Issues in Health Economics and Outcomes Research</p><p>Hearing the Patients Voice in Health Care Decision Making in Asia</p><p> In Korea and Taiwan, engaging patients and patient organisations should be considered as part of the market access strategy for a new drug launch.</p><p> In China, such patient-engagement strategies may also be effective to improve reimbursement rates for treatments of high-burden or priority diseases. </p><p> Key Points for Industry</p><p>One of the main topics of the conference, addressed in the first plenary session and throughout the program, was Hearing the Patients Voice in Health Care Decision Making in Asia. Representatives from China, Taiwan, Korea and New Zealand gave their perspectives on the extent of patient involvement in each of these countries.1,2</p><p>In Korea, patient representatives are involved at the advisory, review, appraisal and decision making stages of drug reimbursement applications. Similarly, the health technology assessment (HTA) process in Taiwan consults patient representatives, even though these representatives do not have a vote towards the final reimbursement decision. In contrast, the decision framework in New Zealand focuses entirely on health outcomes and budget management, excluding considerations of patient values. In China, healthcare decisions are made across several government departments and there is no HTA process, hence the patient voice is not methodically considered when making healthcare decisions. However, Tao Guan, the General Secretary of Beijing Haemophilia Home Care Center, discussed how the efforts of his charity to raise disease awareness, educate patients and lobby for health insurance policy changes resulted in haemophilia A being listed as a special outpatient disease under the Chinese Medical Insurance Policy, thus securing a higher reimbursement rate for treatments for this condition. </p></li><li><p>ISPOR Beijing 2014 Conference Report Copyright Costello Medical Singapore Pte Ltd 2</p><p>ISPOR Beijing 2014 Conference Report</p><p>The second plenary session of the conference discussed considerations for the development, collection and use of electronic health records (EHRs) in the Asia-Pacific region.3 </p><p>Examples of EHR databases from Hangzhou city in China and the Electronic Health Record Research Unit in Japan were provided. The Hangzhou database collects electronic data relating to patient treatment and monitoring, as well as auditing and financial information. This aims to act as a reservoir of data that can be applied to aid clinical controls, such as smart warnings if diagnosis and treatment processes are deviating from established pathways, and to improve the efficiency of the insurance system through creation of auditing rules. Dr Naoto Kume from Kyoto University in Japan discussed how their EHR database targeted at hospitals and pharmacies has also been anonymised to provide a separate clinical study database that can be used as a source of extensive data for University hospitals, academics and industry researchers. </p><p>Additionally, the current and potential uses of EHRs to inform pharmaceutical policy in Australia were presented. These included: supporting submissions for listing products on the Pharmaceutical Benefits Scheme; supporting budget impact assessments pre- and post-launch; evaluating drug utilisation and whether this conforms to the funded listing; pharmacovigilance and safety signalling; risk management, and pharmacoepidemiological research. The plenary closed with a presentation that highlighted the B.R.I.D.G.E. TO DATA programme an online reference for population healthcare databases, including EHR systems, organised into 75 standardised fields to facilitate comparison of system structure and information content.4 </p><p>A related workshop at the conference provided a more conceptual outlook on the increasing role for real world evidence (RWE) in healthcare decision-making. RWE includes EHRs and is an important component of big data a term that refers to the high frequency capture of large volumes of varied, often unstructured data. This workshop noted how the healthcare industry is currently lagging behind other consumer-facing industries in terms of data sharing and establishment of RWE databases, not least because the different stakeholders (payers, manufacturers, patients and providers) have divergent objectives. Nonetheless, there are incentives for increased stakeholder collaboration, for instance through the use of risk sharing schemes between pharmaceutical companies and payers, and research alliances between the pharmaceutical industry and providers.5 </p><p>Electronic Health Records and Real World Evidence</p><p> The pharmaceutical industry will increasingly need to understand how to collect and analyse large volumes of RWE.</p><p> This will be important as hospitals and reimbursement authorities increasingly turn to big data, including RWE, to inform decision-making.</p><p> The B.R.I.D.G.E. TO DATA program is a reference of global online RWE databases, which can aid in directing evidence generation in new markets.</p><p> Key Points for Industry</p></li><li><p>ISPOR Beijing 2014 Conference Report Copyright Costello Medical Singapore Pte Ltd 3 </p><p>ISPOR Beijing 2014 Conference Report</p><p>The final plenary session addressed the changes implemented under the recent healthcare reform in China. The speakers discussed whether the reform, launched in 2009, has been successful in meeting its aim of bringing equality and quality of care for all patients.6 </p><p>One of the key policies of the reform was to extend healthcare insurance to the majority of the population. In 2014, 97% of the population is covered by one of the three state-led programs: the Urban Employee Basic Medical Insurance, the Urban Resident Basic Medical Insurance and the New Cooperative Medical Insurance. However, affordability of healthcare, particularly for rural Chinese, remains an issue due to low reimbursement rates and high out-of pocket expenses.</p><p>One of the main consequences of expanding healthcare insurance has been a substantial increase in demand for healthcare services, coupled with inadequate expansion of healthcare infrastructure to meet this demand, leading in long waiting times to access healthcare services. This issue is further aggravated by the reliance in China on hospital-based healthcare over primary care, which results in hospitals becoming crowded with patients who could be treated in a primary care setting, thus delaying care for these patients but also for those patients who do require hospital-based treatment. </p><p>The key next step currently underway in China is reform of the drug pricing system. The current practice of hospitals and doctors adding a mark-up to medications is expected to be phased out, to remove the incentive doctors have to overprescribe medications in order to generate revenue. However this requires a fundamental shift in the financing of the healthcare system, to replace the revenue that hospitals and doctors would lose by stopping mark-ups on medications. Furthermore, the government has also announced this year that price caps will be removed on over 500 low-cost medications,7 and it is believed that the government will eventually extend this policy to other medications as healthcare reform continues. The wider reform to drug-pricing and healthcare financing will thus have a major impact on market access strategies for new therapies in China and the results of pilot programmes will be instructive for companies planning market access activities in the medium-term. </p><p>China Health Care Reform: Who Gains and Who Loses?</p><p> Reform of Chinas drug-pricing and sales processes will impact market access strategies in China. Results from pilot studies should be used to update market access strategies in the medium-term.</p><p> Key Points for Industry</p></li><li><p>ISPOR Beijing 2014 Conference Report Copyright Costello Medical Singapore Pte Ltd 4 </p><p>ISPOR Beijing 2014 Conference Report</p><p>The results of HTA processes in the region have been shown to have significant implications not only on listing decisions, but on the pricing structures and final list price of therapeutics. It is therefore imperative that manufacturers are able demonstrate and communicate a products value during the HTA process, in order to be successful in this region.</p><p>Innovation, and how manufacturers can be rewarded for this through the HTA process, continues to be a key discussion point at ISPOR. In Asia an often-cited example is Taiwan, where the HTA and reimbursement processes provide fixed pricing structures with price mark-ups awarded based on the comparative effectiveness, safety and convenience of a product, in an attempt to incentivise innovation. In addition, manufacturers are encouraged to submit local clinical and pharmacoeconomic studies to gain further price increases.8 However, an analysis by Costello Medical demonstrated that the majority of new drugs accepted for reimbursement since 2011 in Taiwan were deemed to offer similar therapeutic value to comparators already on the market, with very few breakthrough products being accepted.9 This conclusion highlights the challenges facing manufacturers in the Asia-Pacific region in demonstrating innovation in the HTA process. </p><p>It was also argued that decision makers are increasingly using HTA as a gate-keeping assessment tool, which may lead to a potential market access barrier for innovative therapeutics. High prices of innovative therapies were acknowledged to reduce patient accessibility in the region, either through negative reimbursement decisions or from high out of pocket expenses.10 Approaches to combat such pricing barriers were discussed at the meeting; specifically, attempts in China, such as patient assistance programmes (PAPs), pay-for-performance programs (PFP)/risk-sharing schemes, and supplementary private healthcare insurance were highlighted. In addition, Adrian Towse, President-Elect of ISPOR, summarised the conclusions of a Performance-Based Risk-Sharing Arrangement (PBRSA) task force, suggesting that approaches such as budget capping, utilisation capping and discounting could be used to aid wider access to a greater number of therapeutics for patients in the future.11 </p><p>Health Technology Assessment and Reimbursement Decisions in Asia-Pacific</p><p> There is a concern that HTA in Asia represents a barrier for innovative therapeutics, due to their perceived high costs.</p><p> Strategies to address this issue with payers include: </p><p> Patient assistance programmes</p><p> Risk-sharing schemes</p><p> Budget capping</p><p> Utilisation capping</p><p> Key Points for Industry</p></li><li><p>ISPOR Beijing 2014 Conference Report Copyright Costello Medical Singapore Pte Ltd </p><p>ISPOR Beijing 2014 Conference Report</p><p>Throughout the conference, several workshops were devoted to discussing advanced methods for the development of health economic models and conducting outcomes research. One of these workshops focused on the development of individual simulation models for HTA submissions in Asia-Pacific. The speakers provided an overview of commonly-used modelling techniques and discussed the advantages and disadvantages of each of them in a variety of modelling situations. Discrete event simulation, an emerging modelling method, was concluded to be the most appropriate technique in most situations.12 </p><p>The possibility of including data from observational studies in network meta-analyses was discussed by experts in one of the sessions. Data extracted from such studies can be used to construct informative priors in a Bayesian framework, especially when there are a limited number of randomised controlled trials. One of the main issues highlighted was around the problems that may arise when meta-analyses are conducted sequentially as new evidence becomes available. Repetitive testing may produce significant results by chance, and the need to correct p-values under sequential analysis was presented together with the appropriate statistical methods.13</p><p>The use of a Global Effectiveness Report (GER) was also introduced during one of the sessions to discuss how the use, availability and understanding of network meta-analyses for HTA can be improved on a global level. The GER can be understood as a move away from journal publications towards a peer-reviewed repository of globally-available evidence that healthcare managers and HTA agencies can access and adapt to make decisions locally.14</p><p>The theory, methodology and applications of determining the expected value of perfect information (EVPI) was explored in a workshop at the conference. In principle, the EVPI is the price that you would be willing to pay to gain access to perfect information. The session discussed how this framework could be applied to healthcare decision modelling; specifically, it outlined how EVPI could be used to reduce decision uncertainty (eg. when deciding whether or not to reimburse a new technology) or to prioritise various research objectives by identifying those areas in which additional data collection would be of most value. However, it was noted that the current use of this technique is low within the healthcare industry and further applications remain to be established.15 </p><p> Innovative approaches are available to assist industry in evidence development and value communication, including:</p><p> Individual simulation models</p><p> Meta-analyses incorporating RCT and observational data</p><p> Manufacturers should thus consider if new approaches may be better suited to their requirements in Asia-Pacific. </p><p>Methodological Issues in Health Economics and Outcomes Research</p><p>Further Assistance</p><p>If you would like any further information on the themes or research presented above, please do not hesitate to contact us. </p><p>For a summary of these topics, or for any further information, please contact Craig Brooks-Rooney at: craig.brooks-rooney@costellomedical.com. </p><p>Alternatively, please refer to our website at www.costellomedical.com. </p><p>5</p><p> Key Points for Industry</p><p>mailto:craig.brooks-rooney%40cost...</p></li></ul>