Comparative Effectiveness: Real-World Evidence of Outcomes

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Denise Myshko

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Comparative effectiveness research is going to have a huge impact on every stakeholder in healthcare delivery. It requires a much broader view of the healthcare system so that information will exist about a patient’s outcome as he or she moves from diagnosis to treatment in the healthcare system. Comparative effectiveness data are geared broadly to multiple decision makers to provide real-world evidence of the outcomes of various treatments. But challenges remain about developing high-quality data and how those data will be used. For physicians, comparative effectiveness is going to provide the ability to analyze treatment choices and pick what’s best for their individual patients. For patients, it’s going to provide them with a lot more information that can help set their expectations for their treatment. For payers, comparative effectiveness will provide support for decision-making… Sidebar: Comparative Effectiveness Good CER Practices The Real World of Comparative ­Effectiveness Research Comparative Research Priorities Consumers Are Skeptical About Evidence-Based Healthcare Health Economics Spending Increases 45% in Emerging Markets; 8% in the U.S. Thought Leaders Larry Atkins. Executive Director, U.S. ­Public Policy, Merck & Co. Inc., a global healthcare leader that provides prescription medicines, vaccines, biologic therapies, and consumer care and animal health products. For more information, visit merck.com. Lee Blansett. Senior VP, Kantar Health, a healthcare-focused global consultancy and marketing insights company. For more information, visit kantarhealth.com. J. Jaime Caro. Senior VP of Health Economics, United BioSource Corp., a global scientific and medical affairs organization that partners with life-sciences companies. For more information, visit unitedbiosource.com. Nick Colucci. President and CEO, Publicis Healthcare Communications Group, a network of healthcare communications agencies. For more information, visit publicishealthcare.com. Bill Crown, Ph.D. President, i3 Innovus, ­provides a scientific view of the marketplace — health economics, outcomes, and late-phase research — to deliver the scientific evidence at any phase of the product lifecycle. For more ­information, visit i3global.com. John Doyle, Dr. P.H. VP and Practice Leader for the Consulting Group, Quintiles, a fully integrated biopharmaceutical services ­company offering clinical, commercial, consulting, and capital solutions worldwide. For more ­information, visit quintiles.com/consulting. Richard Gliklich, M.D. President and CEO, Outcome, a leading provider of patient registries, studies, quality improvement programs, and ­integrated technologies for evaluating real-world outcomes. For more information, visit ­outcome.com. Paul Keckley. Executive Director, Deloitte ­Center for Health Solutions, the health services research arm of Deloitte LLP. For more ­information, visit deloitte.com. Ken Kramer, Ph.D. Senior VP, Medical Director, Alpha & Omega, a strategic medical communications firm and a part of The Core Nation group of companies. For more information, visit ­aandomedcomms.com, or e-mail ken.k@aandomedcomms.com. Daniel Todd. Senior Director, Health Policy, EMD Serono Inc., an affiliate of Merck KGaA. For more information, visit emdserono.com. Comparative effectiveness research is going to have a huge impact on every stakeholder in healthcare delivery. It requires a much broader view of the healthcare system so that information will exist about a patient’s outcome as he or she moves from diagnosis to treatment in the healthcare system. Comparative effectiveness data are geared broadly to multiple decision makers to provide real-world evidence of the outcomes of various treatments. But challenges remain about developing high-quality data and how those data will be used. For physicians, comparative effectiveness is going to provide the ability to analyze treatment choices and pick what’s best for their individual patients. For patients, it’s going to provide them with a lot more information that can help set their expectations for their treatment. For payers, comparative effectiveness will provide support for decision-making about product access and formulary placement that is based on real-world outcomes. Some experts say this could be a positive for the pharmaceutical industry, providing an opportunity to be seen as creating an improvement to the standard of care. Others worry that comparative effectiveness could be used to determine reimbursement and access. One thing is for sure: pharma companies are going to have to think about the impact of comparative effectiveness and the entire value proposition for their products much earlier in the development stage. The Research Institute The reform law establishes a nonprofit corporation known as the Patient-Centered Outcome Research Institute (PCORI). Our experts discuss the implications of this oversight group. Gliklich. Outcome. The law aims to establish a framework for comparative effectiveness. It designates about $500 million a year to fund the activities of the PCORI, which is a nonprofit organization that is not technically a government agency. The first order of business is to elect a board of governors, which is what they are currently doing. The second order of business will be to create a methods committee. What’s unknown is how PCORI will execute on its mission. There has to be a framework for how all of the different types of studies are catalogued and how the different types of questions that decision-makers have will be answered. We need to have a broader understanding of experimental research, observational research, and modeling and how these relate to each other for various types of questions. If the organization can establish a framework, that would be a starting point so that PCORI and others can look at which projects to fund. Doyle. Quintiles. Comparative effectiveness research opens up a new avenue of information gathering around a drug’s use and outcomes in the real world. Many types of institutions and companies have launched their own comparative effectiveness studies, some in the public sector and some in the private sector. The law does two things: it catalyzes CER, and at the same time, it recognizes that there have to be some rules to the road. PCORI is a quasi-governmental institute with some representation from the marketplace that will prioritize the research agenda. What is needed is a methodical and systematic way to prioritize the different initiatives. The institute needs to be open-minded and look to outside experts from the private sector for ongoing research. I would suggest that the organization also look outside the United States to try to learn from other agencies that are evaluating the real-world performance of technologies. This should be viewed as natural progression of a product’s investigation. One of the reasons this new institute is important is that payers do comparative effectiveness research; and some of that research they share publicly and some they don’t. The CMS also is using this type of information to make coverage and reimbursement decisions, such as ‘coverage with evidence development’ policy decisions. There should be some convergence between the economics, CER, and evaluating the value of technology compared with the parallel track of the FDA’s evaluation of safety. We need to do a better job at evaluating real-world drug performance in terms of risk-benefit and comparative effectiveness. Keckley. Deloitte. The passage of this legislation is the convergence of three major trends. First, there has been an explosion of science. There are about 80 randomized controlled trials today being published somewhere in the world. Second, we have more clinical analytic tools now. There are entire departments devoted to clinical bioinformatics, and researchers are mining clinical data warehouses to determine probabilities to develop various types of algorithms and predictive models. Third, and I think most significantly, we have now an impetus in the health reform movement toward the use of electronic health records, and that provides a means of capturing real-time data. In addition, there is the overriding question of cost. This is where the PCORI comes in. The question is: does what we do to treat patients matter or does what we do just drive up costs. The institute is a straightforward and appropriate effort to mine all of the science that is being created with all these tools and make the data publicly available. PCORI and the Agency for Healthcare Research and Quality (AHRQ) will sit side by side. AHRQ will continue with its traditional model of working with academic institutions to look at the science and conduct studies. This new 21-member group will look at comparative effectiveness from the viewpoint of various industries. Atkins. Merck. The quality of decision-making around treatment and coverage and reimbursement — whether on an individual or societal basis — will be improved if there are more and better data comparing the therapies that are available for any particular condition. Drug companies receive approval for their products by establishing efficacy in trials in controlled settings. These randomized, controlled trials are necessary for establishing causal relationships and isolating the effect of a single intervention, but they are not sufficient to understand how that treatment may work in the general population or to know the circumstances under which one treatment may be preferable to another. There is a lack of high-quality evidence on comparative effectiveness at this point — particularly evidence comparing different types of interventions, such as surgery and drugs, for example. Often payers are in a position of having to decide on covering a widely adopted procedure or intervention and they really don’t know whether it improves health outcomes. Payers make judgments now on innovations with a limited amount of information. Everyone in the health system will be better served with more and higher quality evidence. The new, independent coordinating body, PCORI, is well-designed to pull together resources and to get support from stakeholders across the system. It is an important step forward, but it is only one piece of a large enterprise already in place. PCORI’s contribution will, hopefully, be to develop research standards, focus resources where the evidence need is greatest, and raise the level of research activity and quality. Todd. EMD Serono. A main objective for PCORI will be to determine the best means to disseminate information to patients and providers and work with many stakeholders to establish priorities. This is a narrower mandate than some earlier proposals. There is great promise in comparative effectiveness, but there is also great threat. There is the challenge of establishing broad policy, which has the potential of limiting access to treatments. As we all know, typically treatments aren’t a one-size-fits-all therapeutic solution. There doesn’t seem to be an appetite in this country to go toward a NICE (National Institute for Health and Clinical Excellence) model used in the United Kingdom, where cost-effectiveness analysis is used to restrict patient access and limit reimbursement. There was $1.1 billion in the 2009 stimulus funding for comparative effectiveness, and AHRQ got $400 million of these funds. Those projects will continue and funding will be fully allocated by September 2010. AHRQ’s role will likely increasingly be focused on the dissemination of information. The one thing that AHRQ lacked was the authority or the input from the private sector to set research priorities. PCORI is the national body that will set priorities. Again, the danger of CER is over-simplification. In terms of our healthcare system, we have to keep this in context. Drug costs are only about 15% of overall healthcare costs. Certainly CER holds great promise for advancing knowledge about medical intervention and is going to be a good tool for understanding and getting better value for healthcare dollars, but it is not going to be the silver bullet to solve our healthcare cost problems. Caro. United BioSource. The new institute could be either a terrific force or it could be a waste of money and time. This is going to depend a lot on how PCORI is led. The United States has an opportunity to innovate and not take the same pathways that other countries have taken. Pharma and Comparative ­Effectiveness Our experts discuss the impact of comparative effectiveness on the industry, from development through marketing. Todd. EMD Serono. Companies are going to have to think about the impact of comparative effectiveness and the entire value proposition for their products much earlier in the development stage. With or without federally funded comparative effectiveness, this is the direction the industry is going. Certainly, there is going to have to be more effort to differentiate products on label. Atkins. Merck. More widespread use of comparative effectiveness research in healthcare decision making can stimulate more attention to comparative risk and benefit in development. Placing the contribution of the new drug therapy in the context of treatments that are already available and understanding how that contribution varies for subgroups of the population will have an impact on companies’ go/no-go decisions on development. Companies will gain a competitive edge by processing that information earlier and making decisions on the basis of better information. Doyle. Quintiles. Comparative effectiveness provides pharma companies with an enormous opportunity to be rewarded for their innovation but it also gives them a responsibility to continue to update the profiles of their products. A drug’s approval is just the beginning. Companies have to start to create new channels of information gathering in the real world. This has already started with mandated REMS and the FDA safety Sentinel Initiatives. But the industry should not have to wait for a mandate for comparative effectiveness; companies need to come up with new techniques to follow their products and know how the products are being used, where they fit in the healthcare system, and how they’re performing over time. They also need to create a continuous feedback loop to their development programs to design a better product going forward. Kramer. Alpha & Omega. Comparative effectiveness is going to produce better treatment because more information is going to be available up front. If a brand is going to be evaluated based on comparative effectiveness research, it only makes sense for pharma companies to do comparative effectiveness proactively instead of having third parties do retrospective analyses. Comparative effectiveness analyses will ultimately help pharmaceutical companies develop the strongest argument for informing physicians why their treatment is the best option for patients. For marketing companies, instead of just producing a detail aid that talks about x percentage increase or decrease of something, it will perhaps extend the discussion to include additional outcomes that are going to have expanded meaning. The latter will certainly speak to the sensibilities of those with interests in managed care. Caro. United BioSource. If the comparative effectiveness movement heads in the right direction, it will be extremely beneficial because it could help guide the development of products to meet healthcare needs. The bad thing that can happen is for comparative effectiveness to develop the way it has in the United Kingdom. The system there sets up perverse incentives that companies then respond to, whatever they are. If they are told that to be covered, a product has to meet a cost-effectiveness ratio of x then companies do everything they can to meet cost-effectiveness x. They are not likely to develop products that don’t meet that standard because it will be impossible to get them covered. A better approach — and hopefully the United States will move in this direction — is to evaluate what the needs are in the population and set the system up so that companies feel compelled to try to fulfill those needs because they are rewarded better if they do. Gliklich. Outcome. This is the first year we’ve seen receptivity and understanding among a broad group of stakeholders that if they don’t produce this evidence, someone else will. The information that decision-makers want is not even a comparison of drug A to drug B, but data people need to make decisions. Pharmaceutical companies understand this, but it can be very risky and expensive for them to conduct head-to-head trials. This has led people to ask if there are ways that they can use observational methods. Representatives from the industry estimate that they’re going to be tacking on hundreds of millions of dollars to their research development programs for comparative effectiveness for a single drug. This is going to have an impact all the way back to go/no-go decisions earlier in development because companies are going to have to plan not only for getting approval and postmarketing commitments but also the other studies they may need to do. Comparative effectiveness is the new path to marketing a product. Marketing is no longer going to be able to rely just on preapproval trials and vague assertions about how a new product is better in the real world. A formulary committee is going to want to evaluate the dossier on more specific information, particularly for products in a class for which there are available therapies. The committee is going to want to know why a product is more effective than what is currently available. Smart marketing organizations are going to recognize this and put their dollars toward comparative effectiveness. Blansett. Kantar Health. I don’t think it is a pharma company’s job, per se, to conduct comparative effectiveness studies. It is their job to demonstrate the efficacy of the products they are bringing to the market. The healthcare reform law is going to work reasonably well, because as an independent organization it is going to set priorities and control the funding. Independence from Medicare and Medicare authorities is a big issue. But pharma companies are, absolutely, going to have to think about how they design their Phase III trials. Companies may need to look to modify later-phase trials where it makes sense to collect additional data to help support comparative effectiveness later on. There will also be a strong argument for postmarketing research, registries, and observational studies. This is already happening in the cancer area where a product can receive accelerated approval with the understanding and agreement that the manufacturer will conduct Phase IV follow-up studies and produce data proving the product is safe and effective in the larger population. Colucci. Publicis. In the end, companies will do what they need to do to make their medicines available to those who most need them. Maybe it’s my eternal optimism, but I think the industry will do the right thing. Every industry has processes that can be performed better, and the pharma industry has shown it is driven by doing things right most of the time. If comparative effectiveness is broadly looked at in the way that it should be, then there is no doubt in my mind that the appropriate use of drugs will prove the best and most cost-effective way to approach illness. Doyle. Quintiles. For marketing, comparative effectiveness is very exciting. Evidence-based marketing gives companies an opportunity to address not just the features and benefits of products but also the drug’s real-world performance. In the past, I think marketing was handcuffed to the clinical trial data as the proof of value. Going forward, the clinical trial data are the initial contribution to a pool of evidence. New channels — registries, REMS, Phase IV trials, and other postlaunch activities — will be constructed to continue to create evidence of value for a product. But there is an interesting new challenge: there will be new stakeholders who are more sophisticated and who are demanding customized information about real-world drug performance. Policymakers, payers, patients, and even physicians are now asking for evidence of value. Crown. i3 Innovus. Comparative effectiveness research will affect the gamut of drug development, starting with who is enrolled in the trial and how the data are collected. It is widely recognized that the inclusion and exclusion criteria of clinical trials result in study populations that are substantially different from those who end up being treated with the product in the real world. Also, clinical trials measure average treatment effects, often masking variations in response among patient subgroups defined as race, gender, age, medical co-morbidities, and concomitant medications. Treatment options that work better in niche populations may benefit from CER; this is especially true for treatments that have favorable compliance/adherence or side-effect profiles and perform better than alternatives in clinical practice. This focus on overall effectiveness, rather than narrowly defined efficacy, will in turn lead to database studies, registries, and Phase IV trials that are designed specifically to address the limitations of conclusions drawn from meta analyses of the clinical trial literature. Changes are also expected in the tools used to identify patients likely to benefit from a treatment. Without a diagnostic tool to identify likely responders — or screen out non-responders — it will be difficult to effectively wring the costs of non-response out of the healthcare system. A diagnostic tool such as this will allay payer fears of therapeutic creep in the use of expensive biologics to new indications. F PharmaVOICE welcomes comments about this article. E-mail us at feedback@pharmavoice.com. A challenge is going to be ­determining what needs to be evaluated to drive more informed decisions. Dr. Ken Kramer Alpha & Omega The biggest issue is the ­potential for CER to be used as a blunt instrument to restrict reimbursement and access. The fear is that ­policymakers will extrapolate data to a broader ­population. Daniel Todd EMD Serono The Patient Protection and Affordable Care Act, passed in March, builds on last year’s stimulus bill, which had already allocated $1.1 billion to investigate comparative effectiveness or a look at patient outcomes in real-world settings. The healthcare reform law provides additional funding and sets up a nonprofit ­institute to determine priorities and provide direction. Comparative effectiveness research will affect the gamut of drug ­development, starting with who is enrolled in the trial and how the data are collected. Dr. Bill Crown i3 Innovus Fast FACT Despite spending more on care than any other industrialized nation — $2.4 trillion in 2008 — the United States lags behind other countries on many measures of health, such as infant mortality and chronic disease burden. Institute of Medicine It would be unnatural and unlikely for Medicare and commercial ­payers not to try to find a way to use comparative ­effectiveness information to guide coverage. Lee Blansett Kantar Health Comparative Effectiveness The Department of Health and Human Services defines comparative effectiveness as the conduct and synthesis of research comparing the benefits and harms of different interventions and strategies to prevent, diagnose, treat, and monitor health conditions in real-world settings. The purpose of this research is to improve health outcomes by developing and disseminating evidence-based information to patients, clinicians, and other decision-makers, responding to their expressed needs, about which interventions are most effective for which patients under specific circumstances. A report released last year from the Institute of Medicine (IOM) recommends 100 health topics that should get priority attention and funding and spells out actions needed to ensure that a comparative effectiveness research initiative will be a sustained effort with a continuous process for updating priorities as needed and that the results are put into clinical practice. But there is a disconnect between the central tenets of evidence-based healthcare and the knowledge, values, and beliefs held by many consumers, according to a recent study by Health Affairs. Editor’s note: Please see the digital edition of PharmaVOICE for more on these studies. A concern that I have is what ­criteria are going to be used to determine comparative ­effectiveness. Nick Colucci Publicis Healthcare Communications The question is: does what we do to treat patients matter or does what we do just drive up costs? Paul Keckley Deloitte Comparative effectiveness ­provides ­pharma companies with an enormous ­opportunity to be rewarded for their ­innovation and it also makes them responsible for continuing to update the value profiles of their ­products. Dr. John Doyle Quintiles Consulting Good CER Practices There is a growing recognition that randomized clinical trials alone will not fill the information gaps caused by the escalated demand for data to support decision making. Experimental studies, such as clinical trials, provide the strongest level of evidence because the groups being compared are similar except for their randomization to treatment. Observational studies are more challenging to analyze and interpret because the various reasons that doctors and patients choose different treatments are often related to the patients’ severity of illness and medical histories. The GRACE principles (Good Research for Comparative Effectiveness) describe a hierarchy of evidence for observational research on comparative effectiveness that can be used by decision makers, as well as key elements of good practice, including defining research questions and methods; collecting valid, clinically relevant data; analyzing, interpreting, and reporting data; and conducting these studies in accordance with accepted good practices. The methodological challenges in observational studies of comparative effectiveness primarily stem from the lack of randomization to treatment. This lack of randomization leads to concern about bias and confounding. These can be addressed through study design (exclusion, matching, or restricting the study groups to new drug users) or by analysis (restriction, stratification, or mathematical modeling), but the lack of clarity about the exact methodologies used and the ongoing debate about the best practices to use can lead to results that are not valid. The intent of the GRACE principles is to provide guidance for the execution and evaluation of observation studies of comparative effectiveness to enable decision makers to distinguish high-quality research. A key part of the GRACE initiative is creating a Web-based, freely accessible library of real-world case studies that illustrate how observational comparative effectiveness studies can be used to support decision-making for product access, formulary placement, treatment guidelines, or any other decisions relating to approval for payments or adopting use. The principles offer a set of guided questions that may be a useful guide for observational studies of comparative effectiveness. Three questions represent the GRACE Principles for evaluating non-randomized studies of comparative effectiveness: • Were the study plans, including research questions, main comparisons, outcome, etc., specified in advance of conducting the study? • Was the study conducted and analyzed in a manner consistent with good practices, and reported in enough details for evaluation and replication? • How valid is the interpretation of comparative effectiveness for the population of interest, assuming sound methodology and appropriate follow-up? Source: The GRACE Initiative, April 2010. For more information, visit graceprinciples.org. Comparative effectiveness is the new path to marketing. Marketing is no longer going to be able to rely on vague assertions about how a ­product is better in the real world. Dr. Richard Gliklich Outcome Comparative Research Priorities A report released last year from the Institute of Medicine (IOM) recommends 100 health topics that should get priority attention and funding from a new national research effort to identify which healthcare services work best. It also spells out actions and resources needed to ensure that this comparative effectiveness research initiative will be a sustained effort with a continuous process for updating priorities as needed and that the results are put into clinical practice. A committee convened by the IOM developed the list of priority topics at the request of Congress as part of a $1.1 billion effort to improve the quality and efficiency of healthcare through comparative effectiveness research outlined in the American Recovery and Reinvestment Act of 2009. The 100 priority areas reflect the insights of health professionals, consumer advocates, policy analysts, and others who submitted nominations through an online form that was open to any individual or organization and through presentations at public meetings. The committee received 1,268 unique topic suggestions, which it narrowed to 100 based on a set of criteria that included its charge to develop a balanced portfolio. The list reflects a range of clinical categories, populations to be studied, categories of interventions, and research methodologies. The committee developed its list of priorities independent from the comparative effectiveness research activities that other organizations have been charged to do through the American Recovery and Reinvestment Act. The report also recommends actions necessary to establish an ongoing comparative effectiveness research effort that would not only carry out studies on the 100 recommended initial topics, but also develop priorities for future research and translate the knowledge gained into improvements in clinical care. Source: Institute of Medicine. For more information, visit iom.edu. There is a fundamental disconnect between the central tenets of evidence-based healthcare and the knowledge, values, and beliefs held by many consumers, according to a recent study by the research group Health Affairs. For healthcare experts, variation — in quality among healthcare providers, the evidence base regarding therapies, and the effectiveness and cost-effectiveness of treatment options — is understood. Yet such concepts are unfamiliar to many Americans. The study found that for consumers to truly engage in using evidence for decision-making, they have to be informed about the relevant choices for their own situation; value the use of evidence in making those decisions, even if it contradicts conventional wisdom; and accept their role in this process and feel capable and ready to assume it. Key findings: • Misconceptions: Participants had crucial misconceptions about the underlying concepts of evidence-based healthcare. They found terms such as “medical evidence,” “quality guidelines,” and “quality standards” unfamiliar and confusing. Additionally, only 34% of participants ever recalled having a physician discuss what scientific research had shown about the best way to manage their care. Many participants assumed that their healthcare providers always based decisions on medical evidence, which to them consists just of “things like my test results and medical history.” • Beliefs And Values: Study participants consistently voiced a number of values and beliefs that were at odds with evidence-based approaches. Although focus-group participants could envision a healthcare provider’s making an occasional mistake, they found it hard to believe that providers could deliver truly substandard care. Although policy experts define guidelines as best clinical practices based on a large body of medical evidence, focus-group participants perceived them as rigid rules that interfere with providers’ ability to draw upon their medical training and experience to tailor their care to the characteristics of individual patients. Participants also believed that any new treatment is improved treatment. This attitude may help explain the survey finding that only 47% of respondents agreed that it is reasonable to pay less out of pocket for the most effective treatments and drugs. Linking cost sharing to clinical effectiveness may be perceived as restricting treatment options, particularly for unproven therapies. • More Costly Care Is Better: A substantial portion of focus group and interview participants expressed the view that “you get what you pay for.” A third (33%) of survey respondents agreed or strongly agreed with the statement that “medical treatments that work the best usually cost more than treatments that don’t work as well.” Although 27% disagreed or strongly disagreed, 40% reported that they were not sure about this. • Behaviors In The Medical Encounter: The survey results indicate that many consumers do not engage in behaviors that could be beneficial to them during medical encounters. More than half of the respondents had never taken notes during a medical appointment (55%) or brought online information to discuss with their doctor (60%). Almost half had never brought someone to provide support or advocacy (44%). In addition, 28% of the respondents had never brought questions to ask their doctor. Patients often rely heavily on their doctors for information, interpretation, and guidance on treatment options. Thus, they may be reluctant to question or challenge what the doctor advises. In the survey, 41% of respondents reported that they had not asked questions or told their doctor about medical problems, because the doctor seemed rushed or they were unsure about how to talk to him or her. Source: Health Affairs. For more information, visit content.healthaffairs.org. Health Economics Spending Increases 45% in Emerging Markets; 8% in the U.S. Pharmacoeconomics spending is increasing by 8% this year in the United States, but winning company buy-in remains a challenge for many health economics teams, according to a new study by Cutting Edge Information. Sixty-six percent of surveyed respondents across all life-sciences sectors reported having higher spending levels, while 27% expected spending to stay the same, and only 7% reported a decrease. Health economics spending in Europe and Canada increased 21% and emerging markets have seen a 45% increase in funding, according to the new study, Health Economics and Outcomes Research: U.S., Europe, Canada and Emerging Markets. “Rising budgets for health economics and outcomes research makes sense, as payers’ requirements are becoming increasingly complex and stringent,” says Jason Richardson, president of Cutting Edge Information. “Companies also use the data to inform portfolio decisions throughout drug development and commercialization.” The growth in emerging markets underscores the industry’s desire to expand capabilities in these regions. Small pharmaceutical and biotechnology companies made the largest increases in their pharmacoeconomics investments, with average spending growth of 55%. Large and midsized drugmakers also showed a smaller, but healthy growth rate of about 15%. Medical device companies’ average spending on health economics has remained flat. Research findings emphasize that teams must continue working to achieve buy-in and prove value, a task especially difficult for a specialized function that often must use economically complex vocabulary to communicate long-term value. Project participants identified communication with internal and external clients as a key challenge because stakeholders bring widely varying perceptions about the value of pharmacoeconomics. Source: Cutting Edge Information. For more information, visit cuttingedgeinfo.com/health-economics.

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