Health Technology Assessment HTA & CER  Industry Overview Pharma IQ  Sector Report & Resources June 2011 In Association With
Contents 3. The Potential Benefits of HTA Centralisation 5. HTA: Developing Strategies for Understanding Value-Based Prici...
It is quickly becoming clear in the pharmaceutical industry that price and value are two defining issues, with organisatio...
However, she pointed out that the activities of these commissions are often limited to a partial evaluation, which general...
Value-based pricing is one issue which divides those in the pharmaceutical industry and the medical community. Much of thi...
Effects of value-based pricing According to Panos Kanavos, Julia Manning, David Taylor, Willemien Schurer and Kyle Checchi...
Health Technology Assessment (HTA) is climbing up the agenda in many European countries due to increasing healthcare costs...
Fletcher also spoke of Biopharma’s increasing attention to focus on products for sub-populations she said: In addition, a ...
The US government's heavy investment in comparative effectiveness research (CER) will not transform the healthcare system,...
“ President Obama sees ever-rising health care costs as a principal threat to the nation's fiscal solvency and believes th...
Additional Resources INTERVIEW: Where is Health Technology Assessment Going? With Chrissie Fletcher, Director and Head of ...
Proving Safety, Efficacy and Cost-Effectiveness to Fast-Track Reimbursement The Web's Largest Online HTA and CER Conferenc...
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Health Technology Assessment - HTA & CER Industry Overview 2011

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Pharma IQ Sector Report & Resources June 2011

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Health Technology Assessment - HTA & CER Industry Overview 2011

  1. 1. Health Technology Assessment HTA & CER Industry Overview Pharma IQ Sector Report & Resources June 2011 In Association With
  2. 2. Contents 3. The Potential Benefits of HTA Centralisation 5. HTA: Developing Strategies for Understanding Value-Based Pricing 7. HTA Climbs Up the European Agenda due to Lack of Resources 9. Heavy Investment in CER will not Transform US Healthcare System 11. Additional Resources 12. Global HTA & CER Forum Authors: Andrea Charles | Tim Haidar | Helen Winsor Pharma IQ 2010 - 2011
  3. 3. It is quickly becoming clear in the pharmaceutical industry that price and value are two defining issues, with organisations constantly striving to develop optimum strategies for understanding value-based pricing, maximising cost-effectiveness and fast-tracking reimbursement. However, proving value for money has become far more difficult in recent times, while an increased emphasis on clinical efficacy has resulted in the remit of reimbursement being expanded to clinical design and firms designing trials with this in mind. Many have made the argument for centralised purchasing of medical devices as a means of cutting revenue and ensuring reimbursement, but this may not be the case, according to one expert. It was an issue recently explored by Rosanna Tarricone, executive director of the European Health Technology Institute for Socio-Economic Research and an associate professor at Bocconi University. She claimed that centralised purchasing of medical devices does not necessarily reduce prices, and medical devices are sometimes undervalued as analysis only focuses on short-term financial and economic perspectives and fails to look at the bigger picture. With the advent of the credit crunch, reimbursement took on a whole new level of importance in the pharmaceutical industry, with this area of health economics only set to increase in the months ahead, and the expert highlighted this. Professor Tarricone pointed to one Italian study conducted between 2007 to 2009 by the General Directorate of Drugs and Medical Devices at the Italian Ministry of Health, in cooperation with CERGAS Bocconi University. She said that its aim was to investigate the main aspects of procurement procedures, expenditures and consumption of medical devices, as well as capital equipment for imaging, with cardiovascular, orthopaedic, neurosurgery and neuroradiology products being explored. "Data shows that while procurement procedures become more centralised, prices coefficient of variation (CV) decreases to almost nil. However, such phenomenon is not correlated with the inter-regional prices variability observed for each category of medical devices. "In other words, centralised purchases are not always predictive of lower prices," Professor Tarricone explained. Another investigation was the presence of HTA Commissions, with the expert revealing that almost all the local health authorities sampled for the survey had established a HTA Commission for medical devices. The Potential Benefits of HTA Centralisation
  4. 4. However, she pointed out that the activities of these commissions are often limited to a partial evaluation, which generally focuses on short-term financial and economic perspectives. "This approach is also confirmed by the purchasing analysis that mainly focuses on the most valuable economic criterium, excluding any other evaluation of the value of medical devices," Professor Tarricone added. According to the specialist, this report demonstrates a "growing acknowledgement" from local health authorities that more effective tools for the assessment and management of medical devices are required. One country which has migrated towards centralised purchasing of medical devices is China, which in 2009 reinstated central purchasing programmes in the form of public tenders - or bidding processes - and then expanded this to include more medical supplies and products. The move was made after the basic healthcare system in the country deteriorated and costs rose, with public outcry to control prices prompting the government to take control of products and services as part of the universal healthcare reform. So far, the results have been mixed, with increased government investment achieving the objective of reducing the healthcare cost to the average patient. However, the long-term viability of this is still being questioned, particularly as there are 17,000 government-owned healthcare institutions in China, and so it is questionable if all of their needs can be served by the products contained on one list. Centralised purchasing has also been viewed by many as harking back to an economy controlled by the government, with poor judgment and corruption. It is clear that the debate about the efficacy of centralised HTA is far from over, and in the meantime it will be up to those who adopt the method to prove its worth as a viable cost-cutter with minimal side-effects.  Thoughts? Give your feedback here
  5. 5. Value-based pricing is one issue which divides those in the pharmaceutical industry and the medical community. Much of this debate centres around how value is defined. This is a subject which has once again been thrust into the spotlight following the announcement of changes taking place within the UK National Institute for Health and Clinical Excellence (NICE). Changes within the pharmaceutical industry such as the rise of personalised medicine are also likely to have an effect on the development of value-based pricing which makes developing optimum strategies for the practice incredibly important. UK changes Under the current system used by NICE, the body is required to make a decision on whether a drug should be available to patients on the NHS based on the price provided by the producer. Plans announced by the UK's coalition government when it entered office involved implementing a value based pricing system from January 2014 when the existing Pharmaceutical Price Regulation Scheme expires. Upon launching a consultation into the system in December 2010, the health secretary Andrew Lansley said: "Value-based pricing will ensure that the price the NHS pays for medicines are based on an assessment of its value, looking at the benefits for the patient, unmet need, therapeutic innovation and benefit to society as a whole." Although the change in the system means NICE will no longer have approval of the drugs available, the body will still have an advisory role in the process, which includes "assessing the clinical benefits of new medicines and giving authoritative evidenced-based advice to clinicians". In response to the proposals, the Association of the British Pharmaceutical Industry (APBI) said consideration must be given to ensure the new system allows for consistent access to drugs and "must also fairly recognise and reward innovation and investment in research and development." Dr. Richard Barker, director general of the APBI, said: "The UK continues to lag behind Europe in the uptake of innovative medicines despite having amongst the lowest prices, so price alone is clearly not the main driver of access in the NHS." Work on developing the new pricing process with new drug companies is set to begin in April. HTA: Developing Strategies for Understanding Value-Based Pricing
  6. 6. Effects of value-based pricing According to Panos Kanavos, Julia Manning, David Taylor, Willemien Schurer and Kyle Checchi, authors of the 2020health report, the current system for the approval of drugs in the UK is the reason why the country's pharmaceutical industry has experienced such strong growth. Writing for PJ Online, Omar Ali also pointed out a maximum reimbursement level for drug producers would be included within the price thresholds when they're established, which pharmaceutical companies are likely to dispute. The thresholds would be established if drugs were shown to be relevant in one of three categories; a greater burden of illness, therapeutic innovation or a wider benefit to society. Ali said these factors will lead to the pharmaceutical industry adapting to produce fewer "copy cat" drugs, paying more attention to diseases with unmet needs and investing more in phase II and III clinical trials – changes which were said to be already taking place. The health2020 report into value-based pricing also laid out a number of suggestions to ensure the system continues to support diseases which are classed as having high unmet medical needs and personalised medicine by "redefining market exclusivity periods." It recommended the creation of an innovation commission, which the report claims would 'form a bridge between research and commercialisation.' Of course, value-based pricing is likely to have differing effects in countries which do not have a free public health service, however the same questions regarding how value is defined and the impact such changes could have on the pharmaceutical industry remain. Thoughts? Give your feedback here
  7. 7. Health Technology Assessment (HTA) is climbing up the agenda in many European countries due to increasing healthcare costs and budgetary pressures. Limited resource According to the European Society of Intensive Care Medicine (ESICM), assessing health technology is a critically important focus of healthcare providers and funding agencies due to the major resource limitations that affect healthcare today. Between 5 and 10 percent of the gross domestic product is spent on healthcare in Europe. Health Technology Assessment is a multi-disciplinary approach in which medical technologies, such as drugs and devices are assessed in terms of their clinical performance and cost effectiveness. HTA is increasingly being used by governments to identify which drugs and devices offer best value for money. Their ultimate goals are to improve the healthcare decision-making process, reduce waste and deliver cost efficient healthcare. In the second paper of the A Healthy Market? series, An Introduction to Health Technology Assessment , Dr. Meir P Pugatch, director of research, and Francesca Ficai, senior researcher from the Stockholm Network, said: “Governments find themselves dealing with growing demands for the financing of innovative health-related technologies without the necessary budgetary resources”. Many European countries have used HTA in various forms for many years and have established HTA bodies and programs, such as the National Institute for Health and Clinical Excellence (NICE) in the UK and the Institute for Quality and Efficiency in Health Care (IQWiG) in Germany. Market access and manufacturers Medicine watchdogs such NICE and IQWiG, give payers advice on which drugs and devices are effective. They may also have the power to recommend which products will receive reimbursement. As these decisions can reduce or expand the market access of a product, manufacturers who cannot show that their products are perform well and are value for money, may find their market access limited. As a result, manufacturers are spending more time on planning their research, to ensure they can provide the data need to support their formal HTA submissions. This process is often referred to as the “4th hurdle”. In a recent interview with Pharma IQ Chrissie Fletcher, director and head of international biostatistics at Amgen, said: “The Health Technology Assessment dossier is really the single opportunity that people have to convince payers of the value of a new product coming through. So in order to do that effectively, the more that that data is available for that dossier, and it’s reported in the right way, means that you’re going to have your best chance. And it should be as comprehensive and as transparent and as unbiased as possible.” HTA Climbs Up the European Agenda due to Lack of Resources
  8. 8. Fletcher also spoke of Biopharma’s increasing attention to focus on products for sub-populations she said: In addition, a lot of our work is beginning to focus around sub-populations of interest. In particular, heath authorities are looking to see do we have any sub-populations, which are more cost effective. So often we need to make sure that we come up, we have enough data in the literature to look at sub-populations not of our own drugs, but also of our comparators.” HTA will change how we do business Many stakeholders in healthcare believe  HTA is the key to better health services. Earlier this year, Dr Béresniak, chief executive of Data Mining International in Switzerland, a partner in the ECHOUTCOME project and leader of one of the Work Packages, said to European Commission CORDIS: “Most European decision-makers require health technology assessment (HTA) studies to evaluate costs and performance of health interventions.” As a result, manufacturers of drugs and devices will continue to evolve their research practices, to ensure their products demonstrate efficacy and value for money. Fletcher said: “I believe the Health Technology Assessment is evolving, it has been evolving for a number of years; the importance is continuing to increase. In particular, a couple of areas that I’d like to discuss today are the concept of the relative effectiveness or, in the US it’s often termed the comparative effectiveness research. This is obviously really going to be a fundamental change in how we do our business.” Thoughts? Give your feedback here
  9. 9. The US government's heavy investment in comparative effectiveness research (CER) will not transform the healthcare system, due to the large numbers of uninsured Americans who need to be absorbed into the system.  Integrating the uninsured In a recent review  Comparative Effectiveness Research: A Progress Report , Dr. Harold C. Sox, former editor of the Annals of Internal Medicine said: "Comparative effectiveness research does not address the millions of uninsured Americans, who need to be integrated in the health care system. In the next decade, the United States must absorb 32 million currently uninsured people into the health care system while simultaneously improving the quality of care and slowing cost increases. These accomplishments will require a transformation of U.S. health care.” Government backs CER to improve outcomes Comparative effectiveness research compares the benefits and the risks of diagnostic tests and treatments against each other, to enable healthcare providers, payers and patients to make the best health care decisions and improve outcomes. In 2009 the American Recovery and Reinvestment Act (ARRA) allocated $1.1 billion of funding for comparative effectiveness research as part of its plan to transform the U.S. healthcare system. The fund was divided between 3 agencies, The Agency for Healthcare Research and Quality received $300 million, the National Institutes of Health received $400 million, and the same amount was given to the Office of the Secretary of the Department of Health and Human Services. To coordinate research and guide the investment a Federal Coordinating Council for Comparative Effectiveness Research was formed. In public announcement of the appointed council members, HHS Spokeswoman Jenny Backus said: “Comparative effectiveness research can improve care for all Americans and is an important element of President Obama’s health reform plan.” Tackling the deficit According to the World Health Organisation, the U.S. healthcare system ranks 37th among the healthcare systems of 200 countries, and has one of the highest healthcare expenditures in the world. This accounted to 17.5% of its GDP (2009) as compared to an average of 8% to 9% in the Organisation for Economic Co-operation and Development (OECD) countries. With limited resources in the current economic climate and rising health care costs, investing in CER is seen as one way of tackling the deficit. The US government acknowledges that if ways are not found to reduce the deficit, the economic health of America is at stake. Since federal legislation has launched CER into the limelight. Sox said that the federal agencies have spent the majority of the funding quickly and wisely. Heavy Investment in CER will not Transform US Healthcare System
  10. 10. “ President Obama sees ever-rising health care costs as a principal threat to the nation's fiscal solvency and believes that research can help to solve the problem. Because he has taken the first steps to test this hypothesis, the immediate future of CER looks bright,” said Sox. Cost-effectiveness going one step further Dr. Milton C. Weinstein, Henry J. Kaiser Professor and Director of the Program on Economic Evaluation of Medical Technology at the Harvard School of Public Health said in a Medscape One-on-One: Comparative Effectiveness : “An important feature of comparative effectiveness research is that it is quantitative. So, in addition to assessing whether one approach is better than another, one tries to ask the question, "How much better is one approach over another?" Comparative effectiveness research may focus only on the clinical benefit of a particular drug or surgical intervention, but can also look at the cost-effectiveness of treatment. “Cost-effectiveness can be thought of as a type of comparative effectiveness research that goes a step further. In addition to evaluating the comparative health outcomes of alternative approaches to a condition, it also looks at the comparative costs, with the idea that if there are interventions that are underutilised but have very good value and cost relatively little and produce large improvements in outcome, resources could be channelled to them and possibly taken away from other interventions that are either totally ineffective or may be effective, but only very slightly so, and at a very high price,” said Weinstein. Long-term future for CER unclear It will be a while before we can measure the direct results of CER funding and whether it has it has done its part to improve health outcomes and reduce healthcare costs.   Sox warns that it is not the magic solution:  “Even if it succeeds in providing clearer guidance on what works best and in whom, CER could still become the scapegoat for failure to achieve the larger goals of health care reform,”said Sox. Thoughts? Give your feedback here
  11. 11. Additional Resources INTERVIEW: Where is Health Technology Assessment Going? With Chrissie Fletcher, Director and Head of International Biostatistics at Amgen Chrissie Fletcher, Director and Head of International Biostatistics at Amgen, talks to Helen Winsor from Pharma IQ, about innovation in clinical design, analysis and reporting. Fletcher discusses how she sees health economists and statisticians interacting going forwards, why there is so much emphasis on reporting for reimbursement and whether she expects pharma companies will try and do this more in-house, in the future. Fletcher also offers her thoughts on health economists who do not have a statistical background, how she sees the HTA evolving and its place in the next 5-10 years. Dr. Franz Hessel, Director of International Health Economics Outcomes Research at Abbott, talks to Andrea Charles from Pharma IQ, about the approaches authorities in leading pharmaceutical markets have taken to the use of Health Technology Assessment (HTA) and how he thinks HTA will develop over the next few years. Ansgar Hebborn, Head of the Global Payer & HTA Program Policy at F Hoffmann-La Roche, joins Tim Haïdar from Pharma IQ, to analyse major trends and implications for the research-based pharmaceutical industry. Firstly he sums up who decides on what constitutes value in the various countries, before discussing how we can align diverging evidentiary standards and expectations of different stakeholders in Europe and beyond. He also talks about the new German attempt to implement its version of "value-based pricing" and how this compares to VB progress in the UK. INTERVIEW: Top Tips for Preparing Health Technology Submissions With Dr. Franz Hessel, Director of International Health Economics Outcomes Research at Abbott INTERVIEW: Trends in European HTA With Ansgar Hebborn, Head of the Global Payer & HTA Program Policy at F Hoffmann-La Roche
  12. 12. Proving Safety, Efficacy and Cost-Effectiveness to Fast-Track Reimbursement The Web's Largest Online HTA and CER Conference Developing optimum strategies for understanding health technology assessment requirements, demonstrating comparative effectiveness and speeding reimbursement in the pharmaceutical industry &quot;Last year's stimulus legislation pumped $1.1 billion into CER, and a new tax in this year's healthcare reform law will translate into annual CER funding that will reach an estimated $500 million in 2014&quot; Annals of Internal Medicine, 2011. &quot; Few recent issues in drug development and health systems management have generated more commentary, and more controversy, than health technology assessment (HTA). The keen interest in HTA stems from the high stakes involved .&quot; (Value in Health, September 2009) Price and value are two of the defining issues in pharmaceuticals today. With national health systems feeling the pressure of the credit crunch, proving value for money and comparative effectiveness has risen on the agenda for all pharma and bio companies seeking reimbursement. Health technology assessment agencies and patient opinions now play a much bigger role in the reimbursement process, and with this, understanding how to best prove efficacy, safety and comparative effectiveness is one of the biggest discussion areas of our time. Indeed, reimbursement decisions now have to be taken into consideration at a clinical design level, with companies complying with HTA requirements as early as Phase I. With this in mind, Pharma IQ's Global HTA and CER Forum 2011 provides a unique opportunity to understand HTA and CER requirements across the globe. Learn what's required from agencies in Europe, USA, Australia and Canada, and gain first-hand insight from pharma and bio companies who've successfully incorporated HTA and CER into their development and reimbursement process. We look forward to having you join us at the forefront of this crucial debate. Glossary Event Highlights How it Works FAQ’s Agenda Check out the Early Bird Sale!! Meet Your Speakers Pricing Register Today << Meet the Speakers Get your Early Bird discount Now Highlights - Our panel of assembled experts from industry, academia & HTA bodies will help you to: - Speed your reimbursement processes with input from NICE, OHE and HIQA amongst others - Explore the efforts of standardisation of HTA in Europe - Implement a best practice on value-based pricing: NICE and the Centre for Health Economics give us their perspective - Performance-based reimbursement and how it will impact the way you work: the OHE discuss the coming trend - Align your HTA strategies with insight from GSK, Roche and Amgen - Design product development programmes to maximise reimbursement success

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